Comparison of Magnetic Auriculotherapy, Laser ...

Research ArticleComparison of Magnetic AuriculotherapyLaser Auriculotherapy and Their Combination for Treatment ofInsomnia in the Elderly A Double-Blinded Randomised Trial

Lorna K P Suen 1 A Molassiotis1 S K W Yueng1 and C H Yeh 2

1School of Nursing The Hong Kong Polytechnic University Hung Hom Hong Kong2School of Nursing Johns Hopkins University 525 N Wolfe St Room 421 Baltimore MD 21205 USA

Correspondence should be addressed to Lorna K P Suen lornasuenpolyueduhk

Received 2 April 2019 Accepted 7 May 2019 Published 21 May 2019

Academic Editor Mario Ledda

Copyright copy 2019 Lorna K P Suen et alThis is an open access article distributed under theCreative Commons Attribution Licensewhich permits unrestricted use distribution and reproduction in any medium provided the original work is properly cited

Background Insomnia is common amongst the elderly With the adverse effects of prolonged use of hypnotics the exploration ofnoninvasive and nonpharmacological complementary methods for insomnia is warranted Auriculotherapy (AT) is a therapeuticapproach where specific points on the auricle are stimulated to manage various physiological disorders The purpose of this studyis to determine the desirable treatment modality using AT to improve the sleep conditions of the elderly Methods A three-arm double-blinded randomised trial was conducted on 145 eligible subjects This study investigated three minimally invasiveprocedures namely laser auriculotherapy (LAT) magneto-auriculotherapy (MAT) and their combination Seven auricular pointswere used Treatment was performed three times a week for six weeks Subjects were assessed at baseline six weeks and follow-upafter six weeks three months and six months Generalised estimating equations were used to evaluate interactions amongst thegroups over time based on the Pittsburgh SleepQuality Index (PSQI) sleep parameters using actigraphicmonitoring health-relatedquality of life (HRQOL) using SF-12 and PHQ-9 for depression status Results The treatment effects of the three procedures werecomparable Significant improvements were found in all of the subjective measures (PSQI HRQOL and PHQ-9) for individualgroups over time Improvements in the objective sleep parameters using actigraphic monitoring were detected in subjects whoreceived MAT procedures but not in those who received LATThe combined MAT and LAT approach did not show any advantageoverMATConclusionsThe treatment effects of the three procedures were comparable in subjective parameters but not by objectivemeasures using actigraphicmonitoring Longer therapeutic course andmore frequent administration of LATmay be considered infuture trials to achieve the optimal treatment effectTrial Registration This trial is registeredwith ClinicalTrialsgov NCT02970695registered May 2016

1 Background

Insomnia is common amongst the elderly and in somecountries the reported prevalence rate is over 60 [1] Elderlypeople have difficulty falling asleep and maintaining sleepdue to frequent awakenings [1] Sleep loss in the agingpopulation is associated with depression anxiety increasedsuicidal risks comorbid chronic conditions and high fre-quency of accidents and falls [2ndash4] Moreover chronic sleepdisturbance can seriously compromise the overall quality oflife of those who suffer from it [5 6] Given the adverse effectsof prolonged use of hypnotics such as morning sedationimpaired balance drug dependence depression and amnesia

[1 7] the exploration of noninvasive and nonpharmaco-logical complementary methods for insomnia amongst theelderly is warranted

Auriculotherapy (AT) is a traditional Chinese medicine(TCM) approach in which the ear is viewed as a microsystemof the body [8] AT is a therapeutic method where specificpoints on the auricle are stimulated to treat various bodilydisorders Different materials such as acupuncture needlespress tack needles seeds magnetic pellets or low-energylaser could be applied on auricular points (denoted as ldquoacu-pointsrdquo in this paper) located on the external ear for therapeu-tic effect [8ndash11] However auricular acupuncture may inducepatientsrsquo discomfort and cause infection and inflammation

HindawiEvidence-Based Complementary and Alternative MedicineVolume 2019 Article ID 3651268 19 pageshttpsdoiorg10115520193651268

2 Evidence-Based Complementary and Alternative Medicine

in the puncture sites Magneto-auriculotherapy (MAT) hasgradually emerged as a popular intervention for treatingmany chronic problems such as insomnia [12] low backpain [13] constipation [14] and hypertension [15] Theeffectiveness of magnetic pellets may be attributed to thefunctional changes caused by the interaction of magneticfields with biological tissues Such changes may be related tomoving ions in blood [16]

Laser auriculotherapy (LAT) has also been widely usedin different medical conditions including insomnia [17]pain relief [18] and weight reduction [19] The combinationof LAT and other treatments proposed in the literatureproduces a synergistic effect LAT has been combined withear point pressing to treat bed wetting in children [20] andwith auricular pressing therapy for alcoholic addiction [21]According to TCM the laser beam irradiates and stimulatesthe acupoint and activates the therapeutic effects of qi (energyflow) thereby regulating the functions of zang-fu (internalorgans) and restoring yin-yang (equilibrium) to produce atherapeutic effect [22]

Laser treatment is noninvasive painless and presentsno risk of infection or cross infection [22] As such thetherapeutic benefits of laser combined with MAT meritfurther investigation LAT followed by MAT optimises thetherapeutic effect because the latter allows continuous stim-ulation of acupoints after the laser treatment as long as themagnet pellets on the ears are in situ

In this study three minimally invasive proceduresnamely LAT MAT and their combination were investigatedto determine the desirable treatment modality using ATto improve the sleep conditions of the elderly Comparedwith the separate treatment procedures of MAT and LATtheir combined used is hypothesised to be more effective inimproving the sleep conditions and thereby the quality of lifeof the elderly with insomnia

2 Methods

21 Design This study employed a three-arm double-blindedrandomised trial Eligible subjects were randomly dividedinto three groups by using a computer-generated randomisedtable and the equal proportion rule (111)The randomcodingwas concealed from the subjects and evaluator by usingopaque envelopes

211 Settings and Participants Through convenience sam-pling subjects were recruited from elderly centres in HongKong A recruitment talk on AT was given to potentialsubjects in the targeted elderly centres The definition ofinsomnia is adapted from existing literature [23] After apreliminary screening volunteers aged 65 years or abovewere recruited if they have the following symptoms (1)difficulty falling or staying asleep andor frequent noctur-nal awakenings at least three nights per week (2) sleepdisturbance lasting for a minimum of 6 months and (3)poor quality of sleep as indicated by a PSQI score greaterthan five All the subjects fulfilled the criteria stipulated forthe diagnosis of insomnia in the lsquoDiagnostic and StatisticalManual of Mental Disordersrsquo fifth edition [24]The exclusion

criteria were as follows (1) presence of profound physicalillnesses such as stroke (2) diagnosis of obstructive sleepapnoea (3) wearing a hearing aid or pacemaker in situ(to prevent the magnetic pellets from interfering with thedevices) (4) received ATwithin the preceding sixmonths (5)suffering from aural injuries or infections and (6) inability tounderstand instructions or provide consent

22 Intervention and Procedures

221 Acupoints Selection Seven auricular points namelyldquoshenmenrdquo ldquoheartrdquo ldquoliverrdquo ldquospleenrdquo ldquokidneyrdquo ldquoocciputrdquoand ldquosubcortexrdquo (Figure 1) were selected because they pro-mote sleep as verified in a previous study by the first author[12] The selection was based on the nomenclature andlocation of acupoints published by the China StandardisationOrganising Committee (GBT 13734-2008) [25] Therapywas delivered by research personnel (SY) who had receivedintensive coaching from the first author (LS) Establishing theinterrater reliability and accuracy of the ear point identifica-tion scheme ensured the fidelity of the study

222 Groupings Group 1 (Placebo LAT and MAT) The laserdevice was switched to ldquopower offrdquo mode (ie deactivated)for acupoint lsquostimulationrsquo to achieve blinding and the placeboeffect before the MATThe subjects were asked to wear a pairof laser-protective goggles to lsquoblindrsquo them during treatmentMAT was then applied by placing magnetic pellets on theselected acupoints (Figure 2) Each magnetic pellet has anaverage gausspellet magnetic flux density of approximately200 Gs (20 mT) and a diameter of 176 mm

Group 2 (LAT and Placebo MAT) A laser device (PointerPulse) was used for LATThedevice has a wavelength of 650nm average output power of 25 mW energy density of 054Jcm2 for 1 minute and a pulse of 10Hz which is a commonlyacceptable dosage for clinical use [18 26] LAT used low-levellaser therapy (LLLT) in which the energy level emitted fromthe device is comparable with that of the teaching pointerThecontinuous mode of the device was used to directly treat theacupoints for one minute (Figure 3) A plaster centred with asmall dried stem of Junci medulla a soft perennial plant wasprovided to mimic MAT In a previous study J medulla wassuccessfully adopted as a placebo because it did not induceany physical pressure on the acupoints of the ear [12]

Group 3 (Combined AT) The subjects received the com-bined LAT and MAT The procedures for applying LAT andMAT were identical to the abovementioned descriptions

223 Procedures Therapies were administered at elderlycentres adjacent to the subjectsrsquo residences The followingprocedures were standardised across the three groups toenhance the blinding effect All therapies were administeredin a room assigned for research purposes Laser-protectivegoggles specific for the wavelengths of the laser device wereprovided to the subjects and researchers for eye protection

The auricle of every subject was cleaned with 75 iso-propyl alcohol before therapy Only one ear was treated at atimeThe treatment was applied alternately to the right ear inthe first visit and then to the left ear in the subsequent visit

Evidence-Based Complementary and Alternative Medicine 3

Shenmen

Spleen

Subcortex

Internal acupoint

Occiput

Heart

Liver

Kidney

Figure 1 Selected auricular points for insomnia

Figure 2 Administration of magneto-auriculotherapy

We replaced the experimental objects (ie magnetic pelletsfor true MAT or J medulla for placebo MAT) every otherday that is three times a week (except Sunday) to preventlocal irritation of acupoints The total treatment period wassix weeks

Participation in the study was voluntary Writteninformed consent was obtained from each subject uponexplaining the risks and benefits of their participationEthical approval was obtained from the Human ResearchEthics Review Committee of the Hong Kong PolytechnicUniversity The study was conducted in accordance with theDeclaration of Helsinki Given their multiple visits to thecentres to receive treatment the subjects were provided atravel subsidy in the form of supermarket coupons uponcompletion of the study

224 Treatment Effect Evaluation Thesubjectswere assessedat baseline at six weeks (postintervention) and duringfollow-up after six weeks three months and six months Toachieve evaluator blinding the assessment was conductedby a different researcher who was unaware of the treatmentmodality given to the subjects PSQI which was used tocollect data related to the sleep conditions of the subjectswas considered as the primary outcomeThis instrument wasscored from 0 to 21 and scores greater than five indicatedpoor sleep quality Chong andCheung [27] validated theCan-tonese PSQI and reported a high internal consistency of 075

The secondary outcomes considered are as follows(1) actigraphic monitoring was conducted to collect sleepparameters including sleep latency (minutes) waking aftersleep onset (minutes) total sleep time (hours) and sleep


Figure 3 Administration of laser auriculotherapy

efficiency () An Actiwatchrsquo Spectrum Plus device with0025G ultra-high sensitivity and 32 Hz sampling rate wasused in actigraphic monitoring The subjects were requestedto wear the device on the wrist of their nondominant hand 24hours a day for 7 consecutive days to determine the overallsleep conditions within a certain period Data were collectedin epochs every 30 second These epoch-by-epoch data werestored in the internal memory of the device until theycould be downloaded to a computer Actiware 6 ActigraphAnalysis Software was used for sleep analysis (2)TheChinese(HK) SF-12 v2copy an abbreviated version of the SF36 healthquestionnaire was used to evaluate the health-related qualityof life (HRQOL) of the subjects This instrument covered 12items and the resultswere presented by a physical componentscore (PCS) and a mental component score (MCS) PCS andMCS ranged from 0 to 100 with higher scores indicatingbetter HRQOL [28] (3) Patient Health Questionnaire (PHQ-9) was also used This instrument was validated as a usefultool for assessing depression status The scores ranged from0 to 27 and high scores indicated severe depression status[29] The scale had a Cronbachrsquos alpha of 082 and therecommended cut-off score was 8 [30]

The subjectsrsquo expectations and satisfaction towards thetherapy were evaluated using a 10-point scale with highscores indicating high expectations or satisfaction [31] Datawere likewise collected on sociodemographic characteris-tics including age gender marital status educational levelreligion number of family members body mass indexsingleshared bed comorbid illnesses use of sleeping pillsor aids and current medications taken Similarly monitoredwere the recruitment rate compliance rate of the treatmentprotocol and adverse effects arising from the therapy

225 Data Analyses Descriptive statistics were determinedon the sociodemographic and clinical characteristics of the

subjects The estimated mean and standard error were com-puted for the outcome variables of each time point Associa-tion amongst categorical variables was estimated using x2 testor Fisherrsquos exact test where appropriate to identify significantvariables for inclusion in the generalised estimating equa-tions (GEE) for adjustment One-way analysis of variancewas used to examine group differences Primary analysiswas conducted using GEE model with an autoregressioncorrelation structure to evaluate interactions amongst thegroups over time (baseline to six months follow-up) on theprimary outcome (ie PSQI score) and secondary outcomes(sleep parameters using 24-hour actigraphic monitoringquality of life using SF-12 and PHQ-9) Missing data werehandled usingGEE and assumed to be random [32]Themainanalysis was repeated at postintervention and during thefollow-up sessions (up to six months) for sensitivity analysisSPSS version 250 (IBM Corporation USA) was used for allstatistical analyses All statistical tests were two sided withsignificance level set at 005

3 Results

The study was conducted from May 2016 to May 2018Data were collected from 11 centres for the elderly and therecruitment rate was 886 A total of 147 eligible subjectswere randomly divided into three groups (Group 1=50Group2=46 and Group 3=51)

31 Participantsrsquo Characteristics The recruited subjects hadan average age of 7529 yearsplusmn 699 with a mean durationof insomnia for 1012 plusmn 1067 years Majority of the subjects(700) did not take any medication to manage their sleepproblems The groups were essentially comparable and wellbalanced in terms of sociodemographic variables includ-ing gender distribution body mass index education level


marital status comorbid illnesses and regular medicationstaken However age showed slight significant differencesamongst the groups and thus this variable was adjusted inthe GEE models in subsequent analyses According to the24-hour actigraphic recordings the subjects had an averageof poor sleep quality (PSQI 1263 plusmn324 sleep efficiency7233 plusmn1609) long sleep latency (2703 plusmn 2313 minutes)short total sleep time (376 plusmn 196 hours) and waking aftersleep onset (9031plusmn 8853minutes)The subjects also hadmilddepression (PHQ-9 947 plusmn 607) and low HRQOL in termsof physical component (4139 plusmn 851) and mental component(4668 plusmn 1234) (Table 1)

32 Compliance Expectation and Satisfaction towards theTreatment Compliance with the intervention protocol washigh at an average of 952 (n = 140) of the subjects contin-ued with postintervention and all follow-up measurementsuntil six months The recruitment flowchart is illustrated inFigure 4 Althoughmajority of the subjects (653) had nevertried complementary and alternative treatments they gener-ally exhibited strong confidence in the proposed therapy (782of 10) and had a relatively high expectation of its effectiveness(773 of 10) before the trial After the intervention the subjectsin Group 1 had the highest satisfaction from the therapy(786) followed by those in Group 3 (758) and Group 2 (702)A correlation analysis was conducted between expectationsof the treatment effect and sleep parameters (PSQI SE)However no significant relationship was detected (pgt005)Over 75 of the subjects (n = 109) indicated that they woulddefinitely recommend the therapy to others No specificadverse effects were observed arising from the therapyapart from 16 cases (109) who reported having mild skinirritation on the ears due to the adhesive tapes that were usedto hold the experimental tools in place and 20 cases (136)who felt tenderness on the acupoints (most of these subjectsreceived MAT) The number of subjects who believed thatthey might be receiving placebo treatment was higher inGroup 1 than in the other groups although majority of thesubjects (90) believed that they were not receiving placebo(Table 2)

33 Treatment Effect The differences in the primary andsecondary outcomes of the three groups across differenttime points were compared through GEE model analysiswith adjustment for age In general no significant differ-ences were detected in the outcomes (including PSQI sleepparameters measured by actigraphic monitoring SF-12 andPHQ-9) of the three groups (Table 3) However significantdifferences were found in all of the subjective measuresincluding PSQI (Figure 5) SF-12 (physical andor mentalcomponents) (Figures S1 and S2) and PHQ-9 (Figure 6) forindividual groups over time When the sleep conditions wereevaluated by actigraphic monitoring significant differencesin lsquowaking after sleep onsetrsquo (minutes) (Figure S3) and lsquosleepefficiencyrsquo () (Figure S4) were detected only in Groups 1and 3 (Table 4) The completersrsquo analysis showed consistentfindings on the primary and secondary outcomes of thetrial

4 Discussion

Numerous studies that used AT to manage sleep problemsin China encountered methodological flaws which renderedtheir findings unconvincingThe commonproblems includedlack of details on how randomisation and allocation conceal-ment were conducted absence of objective measurementsand a control or placebo group as well as failure to report theuse of blinding and selective reporting of findings [33ndash35]The present study was performed using a scientific approachto identify the optimum treatment protocol forAT in improv-ing the sleep conditions and quality of life of the elderlywith insomnia This meticulous randomised controlled trial(RCT) could provide scientific evidence regarding causalrelationships between interventions and outcomes

In general the treatment effect was comparable amongstthe three AT protocols However significant improvementswere observed in all of the subjective measures includingsleep conditions measured by PSQI HRQOL and depressionstatus for individual groups over time When the sleepconditions were evaluated by objective measures using acti-graphic monitoring significant differences in ldquowaking aftersleep onsetrdquo (minutes) and ldquosleep efficiencyrdquo () were onlynoted in Groups 1 and 3 The use of actigraphs has beenwidely recognised as an objective measurement that couldprovide longitudinal assessment of sleep patterns in a naturalenvironment [36 37]This technique could similarly providevalidmeasures thatmay not be influenced by subject bias Sig-nificant reduction in the awakening time after sleep onset andincrease in sleep efficiency were only detected in subjects whoreceived MAT protocols (ie Groups 1 and 3) but not in thosewho received only the LAT protocol Despite the improvedsleep efficiency of the subjects at postintervention and duringthe follow-up periods the evaluated indices remained below85 a common cut-off percentage that indicates the presenceof sleep disturbances [38] Sleep efficiency is calculated bydividing the total sleep time by total bedtime a higher sleepefficiency means better sleep quantity and quality A longtherapeutic course such as 10ndash12 weeks may be necessaryto further elevate sleep efficiency to a desirable level throughsustainable treatment effect

MAT could provide continuous stimulation of acupointsas long as the magnetic pellets on the ears are in situ and thesubjects could receive laser stimulation to the acupoints onthe day of treatment The synergistic effect of the combinedMAT and LAT was demonstrated in two previous trials[39 40] conducted by the research team In a double-blindRCT for osteoarthritic knee the subjects who received thecombined AT protocols exhibited stronger treatment effectsin terms of pain relief ambulation status and range of kneemovements compared with those treated with separate MATor LAT [39] whereas in another double-blinded RCT foraging males with lower urinary tract symptoms a combinedAT protocol exhibited a stronger therapeutic effect in reliev-ing voiding problems improving the urinary flow rate andminimizing the postvoid residual urine than the placebogroup or MAT alone [40] However the combined MAT andLAT approach did not show any advantage over the separateMAT protocol in current studyTherefore a greater frequency


Table1So

ciod

emograph

icandbaselin

echaracteristicso

fthe

participantssample(

N=147)

All

(N=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Age

(years)

j0025lowast

Mean(SD)

7529(699)

7602(702)

7680(616

)7320(729)

Gender

Male

197

57

permil0907

Female

128

4341

44Ed

ucationlevel

Prim

aryor

below

100

3235

330734

Second

ary

3915

915

Tertiary

orabove

83

23

Marita

lstatus

Sing

le5

21

20971

Marrie

d82

2926

27DivorcedWidow

ed60

1919

22Re

ligion

No

7526

2227

permil0895

Yes

7224

2424

Body

massind

ex(kgm2)

2229(373)

2285(348)

2150(357)

2246(404)

j0076

Shared

bed

No

109

3338

38permil0188

Yes

3817

813

Living

alon

eNo

6620

2719

permil0079

Yes

8130

1932


Table1Con

tinued

All

(N=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Sleeping

pills

taken

No

103

3433

360391

Previous

user

3214

711

Currentu

ser

122

64

Durationof

insomnia

(years)

Mean(SD)

1012

(1067)

923(

834)

1115

(1309)

1006(1040

)j

0678

Com

orbidillness

No

225

512

permil0488

Yes

125

4541

39Re

gulard

rugs

taken

No

3210

715

permil044

1Yes

11540

3936

PSQI(total)(0-21)

1263(324)

1267(315

)1289(413

)1235(234)

j0715

Sleeplatency(

min)

2703(2313)

2656(2376)

2868(2486)

2600(2119)

j0839

Totalsleep

time(

hours)

376

(196)

393

(193)

374

(186)

362

(210

)j

0734

Wakea

ftersleep

onset

(minutes)

9031

(8853)

9206(914

4)9003(995

6)8886(7595)

j0984

Sleepeffi

ciency

()

7233

(1609)

7244(1591)

7425(

1604)

7050(1642)

j0521

SF-12(PCS

)4139

(851)

4065(758)

4143(969)

4207(836)

j0707

SF-12(M

CS)

4668(1234)

4822(117

6)46

19(1349)

4562(118

9)j

0542

PHQ-9

947(607)

954(534)

952(669)

935(

626)

j0986

SDstand

arddeviation

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

njOne-w

ayanalysisof

varia

nce

Fisherrsquosexacttest

permilCh

i-squ

aretest

lowastStatisticallysig

nificantatPlt005


Table2Re

ported

adversee

ffectsexpectationsand

satisfactiontowards

thetherapy

yen

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Havey

ouused

complem

entary

therapiesinthep

ast

permil0423

No

96(653

)33

3330

Yes

51(347

)17

1321

How

muchfaith

doyouhave

incomplem

entary

therapiesin

general

(0to

10)

782(213

)840

(194)

748(218

)75

5(218

)j

0056

Expectationfortreatmenteffect

towards

MAT

(0to

10)

741(210)

796(211)

693

(203)

731(207)

j0051


towards

LAT

(0to

10)

741(213)

808

(200)

687

(209)

725(

215)

j0016lowast

Averagee

xpectatio

nfor

treatmenteffect

(0to

10)

773(213

)840

(203)

720(203)

757(218

)j

0016lowast

Earitchinessyen

16(109

)8lowast

(resolve

automatically)

2lowast(resolve

automatically)

6lowast(resolve

automatically)

---


Table2Con

tinued

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Tend

ernesson

acup

ointsyen

20(136

)9lowast

(resolve

automatically)

1lowast(resolve

automatically)

10lowast

(resolve

automatically)

---

Satisfactiontowards

therapy(

0to

10)yen

758(237

)78

6(203)

702(268)

758(237

)j

0225

Thou

ghtthattheymight

bereceivingplacebotre

atmentyen

No

126(900

)39

4146

0011lowast

Yes

14(100

)10

31

Will

recommendthistherapyto

othersyen

0166

Definitelywill

109(757

)38

2942

Maybe

20(139

)5

96

No

15(104

)6

72

Mean(stand

arddeviation)

unlessotherw

iseno

ted

ΩAssociatio

nbetweenvaria

bles

was

determ

ined

bychi-s

quarea

nalyseso

rFish

errsquos-exacttestw

here

approp

riate

Evaluated

beforetheinterventio

nyenE

valuated

after

theinterventionhasb

eencompleted

lowastldquoC

ertainrdquoc

ausality

jOne-w

ayanalysisof

varia

nce


permilCh

i-squ

aretest


nificantatPlt005


Table3Outcomev

ariables

acrossthreeg

roup

satd

ifferenttim

epoints

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PSQI(total)(0-21)

Baselin

e1268(044)

1290(062)

1234(034)

Postinterventio

n94

6(052

)99

1(055)

848

(051)

023

(-14

418

9)-065(

-23610

6)087

(-055230)

6we

eksfollowup

907(053

)92

5(065)

926(054)

-050(-207197)

053

(-114219)

-058(-254138)

3mon

thsfollowup

912(079)

781(068)

906(058)

-154(-400

093)

027

(-18

8242)

-181(-399037)

6-mon

thfollo

wup

820

(062)

796(067)

846

(066)

-047(-268175)

059

(-13

8256)

-106(-316105)

Sleeplatency(minutes)

Baselin

e2682(333

)2916

(359)

2517

(286)

Postinterventio

n2529(297)

2500(332

)2617

(303)

(-1329802)

223

(-8111257)

-486(-1533

560)

6we

eksfollowup

1935(322)

2656(339

)2368(330)

487

(-77

31747)

567

(-589172

3)-080(-11771018

)3m

onthsfollowup

1799

(337

)2129(356)

2390(422)

096

(-11491341)

725(

-6932143)

-629(-2065807)

6-mon

thfollo

wup

1966(531

)2342(539

)1907(434)

143(-15791864)

076

(-15341686)

067

(-15851718)

Totalslee

ptim

e(hours)

Baselin

e393

(027)

375

(028)

361

(030)

Postinterventio

n393

(249)

405

(030)

396

(029)

031(-067128)

035

(-065136)

-005(

-117108)

6we

eksfollowup

381

(027)

390

(029)

385

(025)

027

(06812

3)036

(-059131

)-009(-116099)

3mon

thsfollowup

366

(044)

426

(049)

338

(024)

077

(-081236)

0034(-13

213

9)074

(-061209)

6-mon

thfollo

wup

392

(049)

442

(061)

371

(045)

068

(-10

3238)

0112(-14

516

8)057

(-114227)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

Wakea

fterslee

ponset

(minutes)

Baselin

e9232

(1283)

9051(1464)

8833

(1031)

Postinterventio

n6944(1041)

7160(949)

6584(886)

397

(-22032996)

038

(-23412418

)358

(-24423159)

6we

eksfollowup

5145(510

)6140(860)

6234(707)

1176

(-24444795)

1488(-1749472

5)-313

(-39793354)

3mon

thsfollowup

5082(913

)7474

(2096)

6390(1200

)2573(

-3806

895

1)1706

(-304364

55)

867

(-55727306)

6-mon

thfollo

wup

4881(96

6)8087(2646

)6159(110

4)3387(-385710630)

1677(-307164

24)

1710

(-55558975)

Sleepeffi

ciency()

Baselin

e7234(223)

7406(238)

7070(223)

Postinterventio

n7828(190)

7694(193)

7886(164)

-306(-852240)

222

(-406

850)

-528(-116110

5)6we

eksfollowup

7757(180)

7614

(249)

7457(221)

-314

(-93

1303)

-136(-77

1500

)-178(-875518

)12-w

eekfollo

wup

8132

(198)

7802(356)

7882(234)

-503(

-1544

539

)-087(-1027854)

-416

(-1543710)

6-mon

thfollo

wup

7602(

484)

7737

(464)

8019

(220)

-037

(-14641390)

581

(-618178

0)-618

(-1897662)

SF-12

(PCS

)Ba

selin

e40

87(109)

4184(137

)4164(119

)-

Postinterventio

n44

46(123)

4312

(138)

4296(122)

231

(-600

139

)-227(-569114

)-0035

(-362355)

6-we

eksfollowup

4504(134)

4258(144)

4033

(151)

-342(-75

1066

)-547(-98

9-106)lowast

205

(-206

615

)3m

onthsfollowup

4555(

134)

4621(14

2)4130(166)

-031

(-469407)

-502(

-953

-052)lowast

472

(013

930)lowast

6-mon

thfollo

wup

4626(136)

4596(141)

4199(229)

-126(-563311)

-503(

-1055048)

377

(-206

960)

SF-12

(MCS

)Ba

selin

e4799(163)

4577(195)

4605(163)

Postinterventio

n5184(164)

4735(

178)

5058(137

)-226(-710257)

0675(-402537

)-294(-74

215

4)6we

eksfollowup

5097(161)

5089(184)

5315

(165)

214

(-262690)

412

(-095918

)-198(-673277)

3mon

thsfollowup

4805(231

)5131

(227)

5055(

176)

548

(-15

21247)

444

(-18

01067)

104(-538747)

6-mon

thfollo

wup

5164(200)

5224(205)

5105(220)

282

(-383947)

135(-524794)

147(-541836)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PHQ-9

(0-27)

Baselin

e95

2(074

)94

8(096)

940(086)

Postinterventio

n630

(071)

677

(095)

646

(079)

0504(-15

2252)

028

(-17

8235)

022

(-17

2217)

6we

eksfollowup

687

(100)

649

(111)

500

(071)

-035(

-273204

)-175(-429078)

141(-064345)

3mon

thsfollowup

658

(120)

568

(129)

655

(119

)ndash0

87(-393221)

009

(-308326)

-096(-405214

)6-mon

thfollo

wup

477

(097)

582

(130)

568

(105)

110(-18

8401)

104(-18

7395)

006

(-307318

)nE

stimated

meanandsta

ndarderror(SE

)from

generalized

estim

atingequatio

ns

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

n998787Ad

juste

dfora

ge


nificantatPlt005


Table4Ch

ange

indifferent

outcom

evariables

over

timefor

individu

algrou

psusinggeneralized

estim

atingequatio

ns

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

1PlaceboLA

TampMAT

(119899=5

0)PS

QI(0-21total)

-321(-456-187)

000

0lowastlowastlowast

-361(-483-238)

000

0lowastlowastlowast

-356(-528-18

3)000

0lowastlowastlowast

-447(-595-300

)000

0lowastlowastlowast

Sleeplatency(

minutes)

-153

(-897592)

0688

-747(-1674

181)

0115

-883(-1748-018)

004

5lowast-716

(-1908475)

0239

Totalsleep

time(

hours)

-001(-059058)

0989

-012

(-069045)

0681

-027(-13

9086)

064

2-001(-112

109)

0985

Wakea

ftersleep

onset

(minutes)

-2287

(-3801-774

)0003lowastlowast

-4087

(-6338

-1836)

000

0lowastlowastlowast

-414

9(-7447-852

)0014lowast

-4351

(-7726-976

)0012lowast

Sleepeffi

ciency

()

594

(212

976

)0002lowastlowast

522

(13690

9)000

8lowastlowast

898

(3071490)

0003lowastlowast

368

(-5991335)

0455

SF12

(PCS

)359

(109609)

000

5lowastlowast

416

(10672

7)000

9lowastlowast

468

(16477

2)0003lowastlowast

538

(258819)

000

0lowastlowastlowast

SF12

(MCS

)385

(02974

1)0034lowast

298

(061657)

0103

006

(-476488)

0980

365

(-083812

)0110

PHQ-9

(0-27)

-322(-473-17

1)000

0lowastlowastlowast

-265(-463-066

)000

9lowastlowast

-294(-517-071)

0010lowast

-475(

-669-282)

000

0lowastlowastlowast

Group

2LA

TampplaceboMAT

(n=4

6)PS

QI(0-21total)

-299(-396-202)

000

0lowastlowastlowast

-366(-526-205)

000

0lowastlowastlowast

-509(-685-333)

000

0lowastlowastlowast

-494(-660

-328)

000

0lowastlowastlowast

Sleeplatency(

minutes)

-416

(-1178346)

0284

-259(-1115596)

0552

-787(-168210

8)0085

-574

(-1818

671)

0366

Totalsleep

time(

hours)

030

(-047108)

044

4015

(-061092)

0695

051

(-061162)

0375

067

(-064

197)

0316

Wakea

ftersleep

onset

(minutes)

-1891

(-40

04223)

0080

-291

1(-574

9-072)

004

4lowast-1576

(-70403888)

0572

-964(-74215494)

0770

Sleepeffi

ciency

()

288

(-10

3678)

0148

208

(-272689)

0396

396

(-4621253)

0366

331

(-7321395)

0542

SF12

(PCS

)12

8(-14

4400

)0357

074

(-19

1339)

0585

437

(121753)

000

7lowastlowast

412

(07574

9)0017lowast

SF12

(MCS

)15

8(-16

8485)

0341

512

(199825)

000

1lowastlowast

554

(0481061)

0032lowast

647

(1551139)

0010lowast

PHQ-9

(0-27)

-272(

-406-138)

000

0lowastlowastlowast

-299(-431-16

7)000

0lowastlowastlowast

-380(-592-16

9)000

0lowastlowastlowast

-366(-591-14

1)000

1lowastlowast


Table4Con

tinued

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

3Com

binedAT

(n=5

1)PS

QI(0-21total)

-386(-491-282)

000

0lowastlowastlowast

-308(-420-19

5)000

0lowastlowastlowast

-328(-457-200

)000

0lowastlowastlowast

-388(-518258)

000

0lowastlowastlowast

Sleeplatency(

minutes)

070

(-647788)

0848

-180(-870510

)0610

-158(-128296

7)0784

-640(-1734454)

0251

Totalsleep

time(

hours)

035

(-046

116

)0399

024

(-052100)

0535

-023(

-099052)

0543

010

(-10

012

1)0858

Wakea

ftersleep

onset

(minutes)

-2249

(-40

86-412

)0016lowast

-2598

(-4925-272)

0029lowast

-2443

(-586297

6)0161

-2674

(-60

4970

1)0120

Sleepeffi

ciency

()

816

(118

1314)

000

1lowastlowast

387

(-118891)

0133

812

(0801544)

0030lowast

949(231

1668)

0010lowast

SF12

(PCS

)13

2(-10

1364

)0268

-131

(-445182)

0413

-035(

-367298)

0839

035

(-440

510

)0886

SF12

(MCS

)452

(146759)

000

4lowastlowast

710(352

1067)

000

0lowastlowastlowast

450

(055845)

0026lowast

500

(018

982)

004

2lowastPH

Q-9

(0-27)

-294(-435-15

3)000

0lowastlowastlowast

-440(-597-283)

000

0lowastlowastlowast

-285(

-510

-059)

0013lowast

-371(-589-154)

000

1lowastlowast

SEstand

arderrorCI

con

fidence

interval

Timepoints(1)=

baselin

e(2)=

postintervention

(3)=

6-we

ekfollo

wup

(4)

=3-mon

thfollo

wup

and

(5)=

6-mon

thfollo

w-up

998787Ad

juste

dfora

ge

PSQI=

Pittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire


nificantatPlt005

lowastlowastStatisticallysig

nificantatPlt001

lowastlowastlowastStatisticallysig

nificantatPlt000

1


Randomised (n=147)

44 completed (957)Lost to follow-up (n=1)

Trip (n=1)



Sickness (n=1)

Three-Month Follow-Up



Trip (n=1)


Six-Week Follow-Up

Assessed for eligibility (n=166)

Excluded (n=19)

Not meeting inclusion criteria (n=9)Declined to participate (n=3)Poor cognitive functions (n=7)

Enrollment

Group 1Placebo LAT + MAT

(n=50)

Group 3Combined intervention

(LAT + MAT)(n=51)

Allocation

Group 2LAT+ placebo MAT

(n=46)

49 completed (961)Loss to follow-up (n=2)

Hospitalization (n=2)




Mobility restriction (n=1)

Post-Intervention

Figure 4 Flowchart of recruitment

for LAT administration such as daily application adoptedin previous studies [41ndash44] may be considered in futurestudies to enhance the treatment effect and possibly improveits synergistic effect when combined with MAT

Numerous clinical trials reported the use of MAT ondifferent disorders including but not limited to sleep dis-turbances [12 45 46] low back pain [13] constipation [14]and obesity [47] The effectiveness of MAT may relate to the

interaction of magnetic fields with blood flow and calciumchannel proteins in the cell membrane Such interactionsmay elicit functional body changes [16 48 49] MeanwhileLAT is a noninvasive alternative to needle acupuncture [22]and has been adopted to increase pain threshold [50] aswell as relieve musculoskeletal pain [18] and insomnia [17]The laser beam not only irradiates and stimulates acupointsbut also triggers the energy flow (qi) and regulates the


Baseline Post-intervention 6-week follow-up 3-month follow-up 6-month follow-upDifferent Timepoints

Group 1Group 2Group 3

6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)

Figure 5 Pittsburgh Sleep Quality Index (PSQI 0 to 21) across time


Baseline Post intervention 6-week follow-up 3-month follow-up 6-month follow-up

Different Timepoints

4

5

6

7

8

9

10

11

PHQ

scor

e

Figure 6 Patient Health Questionnaire (PHQ-9 0 to 27) across time

functions of internal organs to achieve a therapeutic effect[22]

According to neuroembryonic theory Dr Paul Nogierviewed the auricle as a homunculus of the human bodyand has a similar shape to an inverted foetus [8] As suchappropriate stimulation of specific ear acupoints can achievetherapeutic effects [51] In the present study the selection ofauricular acupoints was based on the TCM theory and ideasborrowed from modern medicine For example treating the

ldquoheartrdquo can calm the mind while soothing the ldquoliverrdquo couldregulate the flow of qi particularly when insomnia is causedby liver qi stagnation [52] ldquoShenmenrdquo and ldquoocciputrdquo arebelieved to tranquilise the mind and the lsquosubcortexrsquo canharmonise cortex excitement and inhibition [12]

A population-based epidemiological study conducted on5000 subjects in Hong Kong reported that insomnia washighly prevalent amongst Chinese adults and was associatedwith poor mental status and quality of life [53] The present


study reported PCS scores of the subjects comparable withthose of Hong Kong people with insomnia (4321 in ourstudy versus 4139 population norm) but stated a slightlyhigherMCS (4668 versus 3636)HRQOL (in PCS andMCS)improved and depression declined over time in subjectstreated with AT Thus quality of life and emotional statusof the subjects may be positively associated with sleepimprovement after the therapy

No specific adverse effectswere observed to arise from thetherapy apart from a small number of reported cases (109)having mild skin irritation on the ears from the adhesivetapes used to hold the experimental tools in place Moreover20 cases (136) reported tenderness on the acupoints andmost of these subjects received MAT According to theauricular diagnosis system the areas of the auricle withheightened tenderness upon touching correspond to specificareas of the body where pathological conditions exist [5455] Applying magnetic pellets may induce physical pressureon the ear acupoints and cause tenderness especially incases with disequilibrium of bodily functions (eg insomnia)corresponding to specific acupoints The tenderness on thereflective acupoints experienced by the subjects may beconsidered part of the treatment process rather than adverseeffects of AT

The high compliance rate (952) and positive impres-sion of the therapy indirectly indicated that blinding wassuccessful because of the successful placebo applicationin the trial Over 75 of the participants expressed thatthey would definitely recommend the therapy to othersThe findings of this trial can provide valuable informationand increase understanding of the therapeutic effect of ATwhether separate or combinedMATandLAT Longer therapyduration may be considered in future trials to determinefurther improvements in the outcome variables The pro-posed treatment approach can be considered as a noninvasivestrategy for managing insomnia amongst the elderly

Although actigraphic monitoring is a reliable objectivemeasure in sleep study changes in different sleep stagescaused by the therapy cannot be ascertained The recruitedelders generally obtained low education levels and had amean age of over 75 and therefore using a sleep log toverify the actigraphic data was not feasible Night-to-nightvariability in the sleeping patterns of subjects may also beaffected by physical psychological andor environmentalfactors Due to the above limitations the actigraphic datamust be interpreted with caution The exact mechanismsremain unknown regarding the interaction of magnetic fieldswith biological tissues which results in functional changesFurther studies from the biomedical perspective are requiredto elucidate the biological pathway of the treatment and effectsuch as to examine the impact of the treatment protocolson the changes in sleep biomarkers when sleep prosperity isachieved

5 Implications

This study provides valuable findings regarding the therapeu-tic effect of different protocols usingMAT LAT or their com-bination In general the AT protocols under testing may be

considered as a noninvasive approach with minimal adverseeffects for managing sleep problems amongst the elderlyThe findings of this study provide important implications toguide future research and apply evidence-based practice inthe community via service provision tomanage this commonproblem

6 Conclusion

The treatment effects of the three protocols were comparablein terms of self-reported sleep conditions HRQOL anddepression status In several parameters such therapeuticeffects may be sustained at six-month follow-up Significantimprovement in the objective sleep parameters could beobserved in subjects who received MAT protocols but notin those who received LAT The combined MAT and LATapproach did not show any advantage over MAT Longertherapeutic course and more frequent administration of LATmay be considered in future trials to achieve the optimaltreatment effect In general the proposed AT protocolswere demonstrated to be a well-received treatment modalitywith minimal adverse effects and effectively improved sleepconditions of the elderly with insomnia

Data Availability

The datasets used andor analysed during the current studyare available from the corresponding author on reasonablerequest

Ethical Approval

Ethical approval from the Human Research Ethics ReviewCommittee of the Hong Kong Polytechnic University wasgranted [Reference no HSEARS20151129001] Participationin the study was on a voluntary basis All potential par-ticipants were assured that they could withdraw from thestudy at any time Personal information and data remainedconfidential and anonymous

Consent

Written informed consent was obtained from each partici-pant upon recruitment

Conflicts of Interest

The authors declare that they have no conflicts of interest

Authorsrsquo Contributions

Lorna K P Suen was the principal investigator Lorna KP Suen A Molassiotis and C H Yeh were involved inconception and design of the study S K W Yueng collectedthe data Lorna K P Suen was responsible for data analysisLorna K P Suen drafted the manuscript with the supportof all authors All authors read and approved the finalmanuscript


Acknowledgments

The authors extend their appreciation to the elderly centresand participants for their sincere support for this studyThis project was supported by the Health and MedicalResearch Fund Food and Health Bureau Hong Kong SARGovernment (13144061)

Supplementary Materials

Figure S1 wake after sleep onset (minutes) across timeFigure S2 sleep efficiency () across time Figure S3 SF-12(physical component) across time Figure S4 SF-12 (mentalcomponent) across time (Supplementary Materials)

References

[1] K K Gulia and V M Kumar ldquoSleep disorders in the elderly agrowing challengerdquo Psychogeriatrics vol 18 no 3 pp 155ndash1652018

[2] V Sagayadevan E Abdin S Binte Shafie et al ldquoPrevalenceand correlates of sleep problems among elderly SingaporeansrdquoPsychogeriatrics vol 17 no 1 pp 43ndash51 2017

[3] J Yu I Rawtaer J Fam et al ldquoSleep correlates of depression andanxiety in an elderly Asian populationrdquo Psychogeriatrics vol 16no 3 pp 191ndash195 2016

[4] Y Zhang M Cifuentes X Gao G Amaral and K L TuckerldquoAge- and gender-specific associations between insomnia andfalls in Boston Puerto Rican adultsrdquo Quality of Life Researchvol 26 no 1 pp 25ndash34 2017

[5] M van de Laar D Pevernagie P van Mierlo and S OvereemldquoCorrelates of general quality of life are different in patientswithprimary insomnia as compared to patients with insomnia andpsychiatric comorbidityrdquoPsychology HealthampMedicine vol 22no 2 pp 172ndash183 2017

[6] M R Rosekind and K B Gregory ldquoInsomnia risks and costshealth safety and quality of liferdquo The American Journal ofManaged Care vol 16 no 8 pp 617ndash626 2010

[7] D J Buysse ldquoInsomniardquo The Journal of the American MedicalAssociation vol 309 no 7 pp 706ndash716 2013

[8] T OlesonAuriculotherapyManual Churchill Livingstone Else-vier Edinburgh Scotland 4th edition 2014

[9] S AbbateChinese Auricular Acupuncture CRC Press Taylor ampFrancis Group Boca Raton Fla USA 2nd edition 2015

[10] N Soliman Solimanrsquos Auricular Therapy Textbook New Local-izations And Evidence Based Therapeutic Approaches Author-House Bloomington Indiana 2008

[11] L K P Suen T K SWong andAWN Leung ldquoIs there a placefor auricular therapy in the realm of nursingrdquo ComplementaryTherapies in Nursing and Midwifery vol 7 no 3 pp 132ndash1392001

[12] L K P Suen T K S Wong and A W N Leung ldquoEffectivenessof auricular therapy using magnetic pearls on sleep promotionin the elderlyrdquo The American Journal of Chinese Medicine vol30 no 4 pp 429ndash499 2002

[13] L K P Suen and E M C Wong ldquoLongitudinal changes in thedisability level of the elders with low back pain after auriculo-therapyrdquo Complementary Therapies in Medicine vol 16 no 1pp 28ndash35 2008

[14] M K Li T F D Lee and K P L Suen ldquoComplementary effectsof auricular acupressure in relieving constipation symptoms

and promoting disease-specific health-related quality of life arandomized placebo-controlled trialrdquo Complementary Thera-pies in Medicine vol 22 no 2 pp 266ndash277 2014

[15] L K P Suen S Y Chair D R Thompson et al ldquoTraditionalauriculotherapy for hypertension a pilot randomized trialrdquoJournal of Cardiovascular Disease vol 2 pp 19ndash24 2014

[16] DWRamey ldquoMagnetic and electromagnetic therapyrdquo ScientificReview of Alternative Medicine vol 2 no 1 pp 13ndash19 1998

[17] S Y Yao ldquo46 cases of insomnia treated by semiconductor laserirradiation on auricular pointsrdquo Journal of Traditional ChineseMedicine vol 19 no 4 pp 298-299 1999

[18] W J Kneebone ldquoLaser acupuncture as a pain relief modalityrdquoPractical Pain Management pp 64ndash68 2008

[19] W-L Hu C-H Chang and Y-C Hung ldquoClinical observationson laser acupuncture in simple obesity therapyrdquo AmericanJournal of Chinese Medicine vol 38 no 5 pp 861ndash867 2010

[20] C X Zhao ldquoLaser acupuncture combined with ear-pointpressing for bed-wettingrdquo International Journal of ClinicalAcupuncture vol 6 no 1 pp 69ndash71 1995

[21] Q Xia ldquoLaser auriculotherapy combined with auricular press-ing therapy in 30 cases with alcoholic addictionrdquo ChineseJournal of Information on Traditional Chinese Medicine vol 13no 2 p 56 2006 (Chinese)

[22] D Z Tian ldquoLaser acupuncture andTCM (Part I)rdquo InternationalJournal of Clinical Acupuncture vol 7 no 4 pp 397ndash399 1996

[23] T Roth ldquoInsomnia Definition prevalence etiology and con-sequencesrdquo Journal of Clinical Sleep Medicine vol 3 no 5 ppS7ndashS10 2007

[24] Diagnostic and Statistical Manual of Mental Disorders TheDiagnosis of Insomnia (DSM-5) American Psychiatric Associ-ation Arlington VA USA 5th edition 2013

[25] China Standardization Organizing Committee Nomenclatureand Location of Auricular Points (GBT 13734-2008) ZhijianPublishingHouse and Standards Press of China Beijing China2008

[26] R Round G Litscher and F Bahr ldquoAuricular acupuncturewith laserrdquo Evidence-Based Complementary and AlternativeMedicine vol 2013 Article ID 984763 22 pages 2013

[27] A M L Chong and C-K Cheung ldquoFactor structure of aCantonese-version pittsburgh sleep quality indexrdquo Sleep andBiological Rhythms vol 10 no 2 pp 118ndash125 2012

[28] C L K Lam E Y Y Tse and B Gandek ldquoIs the standard SF-12Health Survey valid and equivalent for a Chinese populationrdquoQuality of Life Research vol 14 no 2 pp 539ndash547 2005

[29] AMartinW Rief A Klaiberg and E Braehler ldquoValidity of thebrief Patient Health Questionnaire Mood Scale (PHQ-9) in thegeneral populationrdquo General Hospital Psychiatry vol 28 no 1pp 71ndash77 2006

[30] Z Liu Y Yu M Hu et al ldquoPHQ-9 and PHQ-2 for screeningdepression in chinese rural elderlyrdquo PLoS ONE vol 11 no 3Article ID e0151042 2016

[31] D Kalauokalani D C Cherkin K J Sherman T D Koepselland R A Deyo ldquoLessons from a trial of acupuncture andmassage for low back pain patient expectations and treatmenteffectsrdquoThe Spine Journal vol 26 no 13 pp 1418ndash1424 2001

[32] M L Bell N J Horton H M Dhillon V J Bray and JVardy ldquoUsing generalized estimating equations and extensionsin randomized trials with missing longitudinal patient reportedoutcome datardquo Psycho-Oncology vol 27 no 9 pp 2125ndash21312018


[33] Y Q Chen and Y Shao ldquoThe combined use of acupuncture andauriculotherapy for patients with insomnia of yin deficiencysyndromerdquo Guangdong Medical Journal vol 34 no 6 pp 966-967 2013

[34] C X Ma ldquoThe combined use of foot bathing and auricular seedpressing for improving sleep quality of the eldersrdquo Journal ofQilu Nursing vol 19 no 21 pp 90-91 2013

[35] Y Wang and X Z Zhu ldquoInfluence of acupoint sticking com-bined with ear pressure beans therapy on sleep quality of elderlypatientswith different syndromes of insomniardquoChineseNursingResearch vol 29 no 7A p 2394 2015

[36] J H Chen LWaite LMKurina R AThistedMMcClintockand D S Lauderdale ldquoInsomnia symptoms and actigraph-estimated sleep characteristics in a nationally representativesample of older adultsrdquoThe Journals of Gerontology vol 70 no2 pp 185ndash192 2015

[37] C M Moore S J Schmiege and E E Matthews ldquoActigraphyand sleep diary measurements in breast cancer survivors dis-crepancy in selected sleep parametersrdquo Behavioral Sleep Medi-cine vol 13 no 6 pp 472ndash490 2015

[38] KM Blytt B Bjorvatn B Husebo and E Flo ldquoClinically signi-ficant discrepancies between sleep problems assessed by stan-dard clinical tools and actigraphyrdquo BMC Geriatrics vol 17 no1 Article ID 253 2017

[39] L K Suen C H Yeh and S K Yeung ldquoUsing auriculotherapyfor osteoarthritic knee among elders a double-blinded ran-domised feasibility studyrdquoBMCComplementary andAlternativeMedicine vol 16 no 1 article no 257 p 9 2016

[40] L K Suen C H Yeh S K Yeung and J W Yeung ldquoIs thecombined auriculotherapy approach superior tomagneto-auri-culotherapy alone in aging males with lower urinary tractsymptoms A randomized controlled trialrdquoThe Aging Male pp1ndash12 2019

[41] Y F Li ldquoLaser auriculotherapy for30 cases of coronary heartdiseasesrdquo Journal of Community Health vol 2 no 1 p 89 2004(Chinese)

[42] G Y Liang ldquoThe use of laser auriculotherapy for insomnia in30 cancer patientsrdquoClinicalMedical Practical Journal vol 5 no6 2006 (Chinese)

[43] L H Sun ldquoHe-Ne laser irradiation plus acupuncture for acnevulgaris in 36 casesrdquo Shanghai Journal of Traditional ChineseMedicine vol 38 no 9 pp 43-44 2004 (Chinese)

[44] G-Y Zhou ldquoModerate and severe sudden deafness treated withlow-energy laser irradiation combined with auricular acupointstickingrdquoChinese Acupuncture ampMoxibustion vol 32 no 5 pp413ndash416 2012 (Chinese)

[45] C Lo W C Liao J J Liaw et al ldquoThe stimulation effect ofauricular magnetic press pellets on older female adults withsleep disturbance undergoing polysomnographic evaluationrdquoEvidence-Based Complementary and Alternative Medicine vol2013 Article ID 530438 8 pages 2013

[46] L K P Suen T K S Wong A W N Leung andW C Ip ldquoThelong-term effects of auricular therapy using magnetic pearls onelderly with insomniardquo Complementary Therapies in Medicinevol 11 no 2 pp 85ndash92 2003

[47] C H Hsieh T-J Su Y-W Fang and P-H Chou ldquoEfficacy oftwo different materials used in auricular acupressure on weightreduction and abdominal obesityrdquo American Journal of ChineseMedicine vol 40 no 4 pp 713ndash720 2012

[48] S L Henry M J Concannon and G J Yee ldquoThe effect of mag-netic fields on wound healingrdquo Journal of Plastic Surgery vol 8pp 393ndash399 2008

[49] C L M Koch M Sommarin B R R Persson L G Salfordand J L Eberhardt ldquoInteraction between weak low frequencymagnetic fields and cell membranesrdquo Bioelectromagnetics vol24 no 6 pp 395ndash402 2003

[50] H Sampaio-Filho S K Bussadori M L Goncalves et al ldquoLow-level laser treatment applied at auriculotherapypoints to reducepostoperative pain in third molar surgery A randomizedcontrolled single-blinded studyrdquo PLoS ONE vol 13 no 6Article ID e0197989 2018

[51] P W Hou H C Hsu Y W Lin et al ldquoThe history mechanismand clinical application of auricular therapyrdquo Evid Based Com-plement Alternat Med Article ID 495684 13 pages 2015

[52] C X Feng X H Bai and Y Du Chinese Auricular TherapyScientific and Technical Documents Publishing House BeijingChina 1994

[53] W S Wong and R Fielding ldquoPrevalence of insomnia amongChinese adults in Hong Kong a population-based studyrdquoJournal of Sleep Research vol 20 no 1 pp 117ndash126 2011

[54] L K P Suen C H Yeh J Y M Kwan et al ldquoAssociation ofauricular reflective points and status of Type 2 diabetesmellitusa matched case-control studyrdquo Evidence-Based Complementaryand Alternative Medicine vol 2015 Article ID 981563 11 pages2015

[55] L Suen C Yeh S Yeung et al ldquoAssociation between auricularsignals and the risk factors of metabolic syndromerdquoMedicinesvol 4 no 3 p 45 2017

Stem Cells International

Hindawiwwwhindawicom Volume 2018


MEDIATORSINFLAMMATION

of

EndocrinologyInternational Journal of



Disease Markers


BioMed Research International

OncologyJournal of



Oxidative Medicine and Cellular Longevity


PPAR Research

Hindawi Publishing Corporation httpwwwhindawicom Volume 2013Hindawiwwwhindawicom

The Scientific World Journal

Volume 2018

Immunology ResearchHindawiwwwhindawicom Volume 2018

Journal of

ObesityJournal of



Computational and Mathematical Methods in Medicine


Behavioural Neurology

OphthalmologyJournal of


Diabetes ResearchJournal of



Research and TreatmentAIDS


Gastroenterology Research and Practice


Parkinsonrsquos Disease

Evidence-Based Complementary andAlternative Medicine

Volume 2018Hindawiwwwhindawicom

Submit your manuscripts atwwwhindawicom


in the puncture sites Magneto-auriculotherapy (MAT) hasgradually emerged as a popular intervention for treatingmany chronic problems such as insomnia [12] low backpain [13] constipation [14] and hypertension [15] Theeffectiveness of magnetic pellets may be attributed to thefunctional changes caused by the interaction of magneticfields with biological tissues Such changes may be related tomoving ions in blood [16]

Laser auriculotherapy (LAT) has also been widely usedin different medical conditions including insomnia [17]pain relief [18] and weight reduction [19] The combinationof LAT and other treatments proposed in the literatureproduces a synergistic effect LAT has been combined withear point pressing to treat bed wetting in children [20] andwith auricular pressing therapy for alcoholic addiction [21]According to TCM the laser beam irradiates and stimulatesthe acupoint and activates the therapeutic effects of qi (energyflow) thereby regulating the functions of zang-fu (internalorgans) and restoring yin-yang (equilibrium) to produce atherapeutic effect [22]

Laser treatment is noninvasive painless and presentsno risk of infection or cross infection [22] As such thetherapeutic benefits of laser combined with MAT meritfurther investigation LAT followed by MAT optimises thetherapeutic effect because the latter allows continuous stim-ulation of acupoints after the laser treatment as long as themagnet pellets on the ears are in situ

In this study three minimally invasive proceduresnamely LAT MAT and their combination were investigatedto determine the desirable treatment modality using ATto improve the sleep conditions of the elderly Comparedwith the separate treatment procedures of MAT and LATtheir combined used is hypothesised to be more effective inimproving the sleep conditions and thereby the quality of lifeof the elderly with insomnia

2 Methods

21 Design This study employed a three-arm double-blindedrandomised trial Eligible subjects were randomly dividedinto three groups by using a computer-generated randomisedtable and the equal proportion rule (111)The randomcodingwas concealed from the subjects and evaluator by usingopaque envelopes

211 Settings and Participants Through convenience sam-pling subjects were recruited from elderly centres in HongKong A recruitment talk on AT was given to potentialsubjects in the targeted elderly centres The definition ofinsomnia is adapted from existing literature [23] After apreliminary screening volunteers aged 65 years or abovewere recruited if they have the following symptoms (1)difficulty falling or staying asleep andor frequent noctur-nal awakenings at least three nights per week (2) sleepdisturbance lasting for a minimum of 6 months and (3)poor quality of sleep as indicated by a PSQI score greaterthan five All the subjects fulfilled the criteria stipulated forthe diagnosis of insomnia in the lsquoDiagnostic and StatisticalManual of Mental Disordersrsquo fifth edition [24]The exclusion

criteria were as follows (1) presence of profound physicalillnesses such as stroke (2) diagnosis of obstructive sleepapnoea (3) wearing a hearing aid or pacemaker in situ(to prevent the magnetic pellets from interfering with thedevices) (4) received ATwithin the preceding sixmonths (5)suffering from aural injuries or infections and (6) inability tounderstand instructions or provide consent

22 Intervention and Procedures

221 Acupoints Selection Seven auricular points namelyldquoshenmenrdquo ldquoheartrdquo ldquoliverrdquo ldquospleenrdquo ldquokidneyrdquo ldquoocciputrdquoand ldquosubcortexrdquo (Figure 1) were selected because they pro-mote sleep as verified in a previous study by the first author[12] The selection was based on the nomenclature andlocation of acupoints published by the China StandardisationOrganising Committee (GBT 13734-2008) [25] Therapywas delivered by research personnel (SY) who had receivedintensive coaching from the first author (LS) Establishing theinterrater reliability and accuracy of the ear point identifica-tion scheme ensured the fidelity of the study

222 Groupings Group 1 (Placebo LAT and MAT) The laserdevice was switched to ldquopower offrdquo mode (ie deactivated)for acupoint lsquostimulationrsquo to achieve blinding and the placeboeffect before the MATThe subjects were asked to wear a pairof laser-protective goggles to lsquoblindrsquo them during treatmentMAT was then applied by placing magnetic pellets on theselected acupoints (Figure 2) Each magnetic pellet has anaverage gausspellet magnetic flux density of approximately200 Gs (20 mT) and a diameter of 176 mm

Group 2 (LAT and Placebo MAT) A laser device (PointerPulse) was used for LATThedevice has a wavelength of 650nm average output power of 25 mW energy density of 054Jcm2 for 1 minute and a pulse of 10Hz which is a commonlyacceptable dosage for clinical use [18 26] LAT used low-levellaser therapy (LLLT) in which the energy level emitted fromthe device is comparable with that of the teaching pointerThecontinuous mode of the device was used to directly treat theacupoints for one minute (Figure 3) A plaster centred with asmall dried stem of Junci medulla a soft perennial plant wasprovided to mimic MAT In a previous study J medulla wassuccessfully adopted as a placebo because it did not induceany physical pressure on the acupoints of the ear [12]

Group 3 (Combined AT) The subjects received the com-bined LAT and MAT The procedures for applying LAT andMAT were identical to the abovementioned descriptions

223 Procedures Therapies were administered at elderlycentres adjacent to the subjectsrsquo residences The followingprocedures were standardised across the three groups toenhance the blinding effect All therapies were administeredin a room assigned for research purposes Laser-protectivegoggles specific for the wavelengths of the laser device wereprovided to the subjects and researchers for eye protection

The auricle of every subject was cleaned with 75 iso-propyl alcohol before therapy Only one ear was treated at atimeThe treatment was applied alternately to the right ear inthe first visit and then to the left ear in the subsequent visit


Shenmen

Spleen

Subcortex

Internal acupoint

Occiput

Heart

Liver

Kidney













3 Results







4 Discussion





Table1So

ciod

emograph

icandbaselin

echaracteristicso

fthe

participantssample(

N=147)

All

(N=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Age

(years)

j0025lowast

Mean(SD)

7529(699)

7602(702)

7680(616

)7320(729)

Gender

Male

197

57

permil0907

Female

128

4341

44Ed

ucationlevel

Prim

aryor

below

100

3235

330734

Second

ary

3915

915

Tertiary

orabove

83

23

Marita

lstatus

Sing

le5

21

20971

Marrie

d82

2926

27DivorcedWidow

ed60

1919

22Re

ligion

No

7526

2227

permil0895

Yes

7224

2424

Body

massind

ex(kgm2)

2229(373)

2285(348)

2150(357)

2246(404)

j0076

Shared

bed

No

109

3338

38permil0188

Yes

3817

813

Living

alon

eNo

6620

2719

permil0079

Yes

8130

1932


Table1Con

tinued

All

(N=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Sleeping

pills

taken

No

103

3433

360391

Previous

user

3214

711

Currentu

ser

122

64

Durationof

insomnia

(years)

Mean(SD)

1012

(1067)

923(

834)

1115

(1309)

1006(1040

)j

0678

Com

orbidillness

No

225

512

permil0488

Yes

125

4541

39Re

gulard

rugs

taken

No

3210

715

permil044

1Yes

11540

3936

PSQI(total)(0-21)

1263(324)

1267(315

)1289(413

)1235(234)

j0715

Sleeplatency(

min)

2703(2313)

2656(2376)

2868(2486)

2600(2119)

j0839

Totalsleep

time(

hours)

376

(196)

393

(193)

374

(186)

362

(210

)j

0734

Wakea

ftersleep

onset

(minutes)

9031

(8853)

9206(914

4)9003(995

6)8886(7595)

j0984

Sleepeffi

ciency

()

7233

(1609)

7244(1591)

7425(

1604)

7050(1642)

j0521

SF-12(PCS

)4139

(851)

4065(758)

4143(969)

4207(836)

j0707

SF-12(M

CS)

4668(1234)

4822(117

6)46

19(1349)

4562(118

9)j

0542

PHQ-9

947(607)

954(534)

952(669)

935(

626)

j0986

SDstand

arddeviation

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

njOne-w

ayanalysisof

varia

nce


permilCh

i-squ

aretest


nificantatPlt005


Table2Re

ported

adversee


satisfactiontowards

thetherapy

yen

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Havey

ouused

complem

entary

therapiesinthep

ast

permil0423

No

96(653

)33

3330

Yes

51(347

)17

1321

How

muchfaith

doyouhave

incomplem

entary

therapiesin

general

(0to

10)

782(213

)840

(194)

748(218

)75

5(218

)j

0056


towards

MAT

(0to

10)

741(210)

796(211)

693

(203)

731(207)

j0051


towards

LAT

(0to

10)

741(213)

808

(200)

687

(209)

725(

215)

j0016lowast

Averagee

xpectatio

nfor

treatmenteffect

(0to

10)

773(213

)840

(203)

720(203)

757(218

)j

0016lowast

Earitchinessyen

16(109

)8lowast

(resolve

automatically)

2lowast(resolve

automatically)

6lowast(resolve

automatically)

---


Table2Con

tinued

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Tend

ernesson

acup

ointsyen

20(136

)9lowast

(resolve

automatically)

1lowast(resolve

automatically)

10lowast

(resolve

automatically)

---

Satisfactiontowards

therapy(

0to

10)yen

758(237

)78

6(203)

702(268)

758(237

)j

0225

Thou

ghtthattheymight


atmentyen

No

126(900

)39

4146

0011lowast

Yes

14(100

)10

31

Will


othersyen

0166

Definitelywill

109(757

)38

2942

Maybe

20(139

)5

96

No

15(104

)6

72

Mean(stand

arddeviation)

unlessotherw

iseno

ted

ΩAssociatio

nbetweenvaria

bles

was

determ

ined

bychi-s

quarea

nalyseso

rFish

errsquos-exacttestw

here

approp

riate

Evaluated


nyenE

valuated

after

theinterventionhasb

eencompleted

lowastldquoC

ertainrdquoc

ausality

jOne-w

ayanalysisof

varia

nce


permilCh

i-squ

aretest


nificantatPlt005


Table3Outcomev

ariables

acrossthreeg

roup

satd

ifferenttim

epoints

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PSQI(total)(0-21)

Baselin

e1268(044)

1290(062)

1234(034)

Postinterventio

n94

6(052

)99

1(055)

848

(051)

023

(-14

418

9)-065(

-23610

6)087

(-055230)

6we

eksfollowup

907(053

)92

5(065)

926(054)

-050(-207197)

053

(-114219)

-058(-254138)

3mon

thsfollowup

912(079)

781(068)

906(058)

-154(-400

093)

027

(-18

8242)

-181(-399037)

6-mon

thfollo

wup

820

(062)

796(067)

846

(066)

-047(-268175)

059

(-13

8256)

-106(-316105)


Baselin

e2682(333

)2916

(359)

2517

(286)

Postinterventio

n2529(297)

2500(332

)2617

(303)

(-1329802)

223

(-8111257)

-486(-1533

560)

6we

eksfollowup

1935(322)

2656(339

)2368(330)

487

(-77

31747)

567

(-589172

3)-080(-11771018

)3m

onthsfollowup

1799

(337

)2129(356)

2390(422)

096

(-11491341)

725(

-6932143)

-629(-2065807)

6-mon

thfollo

wup

1966(531

)2342(539

)1907(434)

143(-15791864)

076

(-15341686)

067

(-15851718)

Totalslee

ptim

e(hours)

Baselin

e393

(027)

375

(028)

361

(030)

Postinterventio

n393

(249)

405

(030)

396

(029)

031(-067128)

035

(-065136)

-005(

-117108)

6we

eksfollowup

381

(027)

390

(029)

385

(025)

027

(06812

3)036

(-059131

)-009(-116099)

3mon

thsfollowup

366

(044)

426

(049)

338

(024)

077

(-081236)

0034(-13

213

9)074

(-061209)

6-mon

thfollo

wup

392

(049)

442

(061)

371

(045)

068

(-10

3238)

0112(-14

516

8)057

(-114227)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

Wakea

fterslee

ponset

(minutes)

Baselin

e9232

(1283)

9051(1464)

8833

(1031)

Postinterventio

n6944(1041)

7160(949)

6584(886)

397

(-22032996)

038

(-23412418

)358

(-24423159)

6we

eksfollowup

5145(510

)6140(860)

6234(707)

1176

(-24444795)

1488(-1749472

5)-313

(-39793354)

3mon

thsfollowup

5082(913

)7474

(2096)

6390(1200

)2573(

-3806

895

1)1706

(-304364

55)

867

(-55727306)

6-mon

thfollo

wup

4881(96

6)8087(2646

)6159(110

4)3387(-385710630)

1677(-307164

24)

1710

(-55558975)

Sleepeffi

ciency()

Baselin

e7234(223)

7406(238)

7070(223)

Postinterventio

n7828(190)

7694(193)

7886(164)

-306(-852240)

222

(-406

850)

-528(-116110

5)6we

eksfollowup

7757(180)

7614

(249)

7457(221)

-314

(-93

1303)

-136(-77

1500

)-178(-875518

)12-w

eekfollo

wup

8132

(198)

7802(356)

7882(234)

-503(

-1544

539

)-087(-1027854)

-416

(-1543710)

6-mon

thfollo

wup

7602(

484)

7737

(464)

8019

(220)

-037

(-14641390)

581

(-618178

0)-618

(-1897662)

SF-12

(PCS

)Ba

selin

e40

87(109)

4184(137

)4164(119

)-

Postinterventio

n44

46(123)

4312

(138)

4296(122)

231

(-600

139

)-227(-569114

)-0035

(-362355)

6-we

eksfollowup

4504(134)

4258(144)

4033

(151)

-342(-75

1066

)-547(-98

9-106)lowast

205

(-206

615

)3m

onthsfollowup

4555(

134)

4621(14

2)4130(166)

-031

(-469407)

-502(

-953

-052)lowast

472

(013

930)lowast

6-mon

thfollo

wup

4626(136)

4596(141)

4199(229)

-126(-563311)

-503(

-1055048)

377

(-206

960)

SF-12

(MCS

)Ba

selin

e4799(163)

4577(195)

4605(163)

Postinterventio

n5184(164)

4735(

178)

5058(137

)-226(-710257)

0675(-402537

)-294(-74

215

4)6we

eksfollowup

5097(161)

5089(184)

5315

(165)

214

(-262690)

412

(-095918

)-198(-673277)

3mon

thsfollowup

4805(231

)5131

(227)

5055(

176)

548

(-15

21247)

444

(-18

01067)

104(-538747)

6-mon

thfollo

wup

5164(200)

5224(205)

5105(220)

282

(-383947)

135(-524794)

147(-541836)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PHQ-9

(0-27)

Baselin

e95

2(074

)94

8(096)

940(086)

Postinterventio

n630

(071)

677

(095)

646

(079)

0504(-15

2252)

028

(-17

8235)

022

(-17

2217)

6we

eksfollowup

687

(100)

649

(111)

500

(071)

-035(

-273204

)-175(-429078)

141(-064345)

3mon

thsfollowup

658

(120)

568

(129)

655

(119

)ndash0

87(-393221)

009

(-308326)

-096(-405214

)6-mon

thfollo

wup

477

(097)

582

(130)

568

(105)

110(-18

8401)

104(-18

7395)

006

(-307318

)nE

stimated

meanandsta

ndarderror(SE

)from

generalized

estim

atingequatio

ns

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

n998787Ad

juste

dfora

ge


nificantatPlt005


Table4Ch

ange

indifferent

outcom

evariables

over

timefor

individu

algrou

psusinggeneralized

estim

atingequatio

ns

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

1PlaceboLA

TampMAT

(119899=5

0)PS

QI(0-21total)

-321(-456-187)

000

0lowastlowastlowast

-361(-483-238)

000

0lowastlowastlowast

-356(-528-18

3)000

0lowastlowastlowast

-447(-595-300

)000

0lowastlowastlowast

Sleeplatency(

minutes)

-153

(-897592)

0688

-747(-1674

181)

0115

-883(-1748-018)

004

5lowast-716

(-1908475)

0239

Totalsleep

time(

hours)

-001(-059058)

0989

-012

(-069045)

0681

-027(-13

9086)

064

2-001(-112

109)

0985

Wakea

ftersleep

onset

(minutes)

-2287

(-3801-774

)0003lowastlowast

-4087

(-6338

-1836)

000

0lowastlowastlowast

-414

9(-7447-852

)0014lowast

-4351

(-7726-976

)0012lowast

Sleepeffi

ciency

()

594

(212

976

)0002lowastlowast

522

(13690

9)000

8lowastlowast

898

(3071490)

0003lowastlowast

368

(-5991335)

0455

SF12

(PCS

)359

(109609)

000

5lowastlowast

416

(10672

7)000

9lowastlowast

468

(16477

2)0003lowastlowast

538

(258819)

000

0lowastlowastlowast

SF12

(MCS

)385

(02974

1)0034lowast

298

(061657)

0103

006

(-476488)

0980

365

(-083812

)0110

PHQ-9

(0-27)

-322(-473-17

1)000

0lowastlowastlowast

-265(-463-066

)000

9lowastlowast

-294(-517-071)

0010lowast

-475(

-669-282)

000

0lowastlowastlowast

Group

2LA

TampplaceboMAT

(n=4

6)PS

QI(0-21total)

-299(-396-202)

000

0lowastlowastlowast

-366(-526-205)

000

0lowastlowastlowast

-509(-685-333)

000

0lowastlowastlowast

-494(-660

-328)

000

0lowastlowastlowast

Sleeplatency(

minutes)

-416

(-1178346)

0284

-259(-1115596)

0552

-787(-168210

8)0085

-574

(-1818

671)

0366

Totalsleep

time(

hours)

030

(-047108)

044

4015

(-061092)

0695

051

(-061162)

0375

067

(-064

197)

0316

Wakea

ftersleep

onset

(minutes)

-1891

(-40

04223)

0080

-291

1(-574

9-072)

004

4lowast-1576

(-70403888)

0572

-964(-74215494)

0770

Sleepeffi

ciency

()

288

(-10

3678)

0148

208

(-272689)

0396

396

(-4621253)

0366

331

(-7321395)

0542

SF12

(PCS

)12

8(-14

4400

)0357

074

(-19

1339)

0585

437

(121753)

000

7lowastlowast

412

(07574

9)0017lowast

SF12

(MCS

)15

8(-16

8485)

0341

512

(199825)

000

1lowastlowast

554

(0481061)

0032lowast

647

(1551139)

0010lowast

PHQ-9

(0-27)

-272(

-406-138)

000

0lowastlowastlowast

-299(-431-16

7)000

0lowastlowastlowast

-380(-592-16

9)000

0lowastlowastlowast

-366(-591-14

1)000

1lowastlowast


Table4Con

tinued

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

3Com

binedAT

(n=5

1)PS

QI(0-21total)

-386(-491-282)

000

0lowastlowastlowast

-308(-420-19

5)000

0lowastlowastlowast

-328(-457-200

)000

0lowastlowastlowast

-388(-518258)

000

0lowastlowastlowast

Sleeplatency(

minutes)

070

(-647788)

0848

-180(-870510

)0610

-158(-128296

7)0784

-640(-1734454)

0251

Totalsleep

time(

hours)

035

(-046

116

)0399

024

(-052100)

0535

-023(

-099052)

0543

010

(-10

012

1)0858

Wakea

ftersleep

onset

(minutes)

-2249

(-40

86-412

)0016lowast

-2598

(-4925-272)

0029lowast

-2443

(-586297

6)0161

-2674

(-60

4970

1)0120

Sleepeffi

ciency

()

816

(118

1314)

000

1lowastlowast

387

(-118891)

0133

812

(0801544)

0030lowast

949(231

1668)

0010lowast

SF12

(PCS

)13

2(-10

1364

)0268

-131

(-445182)

0413

-035(

-367298)

0839

035

(-440

510

)0886

SF12

(MCS

)452

(146759)

000

4lowastlowast

710(352

1067)

000

0lowastlowastlowast

450

(055845)

0026lowast

500

(018

982)

004

2lowastPH

Q-9

(0-27)

-294(-435-15

3)000

0lowastlowastlowast

-440(-597-283)

000

0lowastlowastlowast

-285(

-510

-059)

0013lowast

-371(-589-154)

000

1lowastlowast

SEstand

arderrorCI

con

fidence

interval

Timepoints(1)=

baselin

e(2)=

postintervention

(3)=

6-we

ekfollo

wup

(4)

=3-mon

thfollo

wup

and

(5)=

6-mon

thfollo

w-up

998787Ad

juste

dfora

ge

PSQI=

Pittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire


nificantatPlt005


nificantatPlt001


nificantatPlt000

1


Randomised (n=147)


Trip (n=1)



Sickness (n=1)




Trip (n=1)


Six-Week Follow-Up


Excluded (n=19)


Enrollment


(n=50)


(LAT + MAT)(n=51)

Allocation


(n=46)







Post-Intervention








6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)





4

5

6

7

8

9

10

11

PHQ

scor

e











5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of




















Shenmen

Spleen

Subcortex

Internal acupoint

Occiput

Heart

Liver

Kidney













3 Results







4 Discussion





Table1So

ciod

emograph

icandbaselin

echaracteristicso

fthe

participantssample(

N=147)

All

(N=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Age

(years)

j0025lowast

Mean(SD)

7529(699)

7602(702)

7680(616

)7320(729)

Gender

Male

197

57

permil0907

Female

128

4341

44Ed

ucationlevel

Prim

aryor

below

100

3235

330734

Second

ary

3915

915

Tertiary

orabove

83

23

Marita

lstatus

Sing

le5

21

20971

Marrie

d82

2926

27DivorcedWidow

ed60

1919

22Re

ligion

No

7526

2227

permil0895

Yes

7224

2424

Body

massind

ex(kgm2)

2229(373)

2285(348)

2150(357)

2246(404)

j0076

Shared

bed

No

109

3338

38permil0188

Yes

3817

813

Living

alon

eNo

6620

2719

permil0079

Yes

8130

1932


Table1Con

tinued

All

(N=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Sleeping

pills

taken

No

103

3433

360391

Previous

user

3214

711

Currentu

ser

122

64

Durationof

insomnia

(years)

Mean(SD)

1012

(1067)

923(

834)

1115

(1309)

1006(1040

)j

0678

Com

orbidillness

No

225

512

permil0488

Yes

125

4541

39Re

gulard

rugs

taken

No

3210

715

permil044

1Yes

11540

3936

PSQI(total)(0-21)

1263(324)

1267(315

)1289(413

)1235(234)

j0715

Sleeplatency(

min)

2703(2313)

2656(2376)

2868(2486)

2600(2119)

j0839

Totalsleep

time(

hours)

376

(196)

393

(193)

374

(186)

362

(210

)j

0734

Wakea

ftersleep

onset

(minutes)

9031

(8853)

9206(914

4)9003(995

6)8886(7595)

j0984

Sleepeffi

ciency

()

7233

(1609)

7244(1591)

7425(

1604)

7050(1642)

j0521

SF-12(PCS

)4139

(851)

4065(758)

4143(969)

4207(836)

j0707

SF-12(M

CS)

4668(1234)

4822(117

6)46

19(1349)

4562(118

9)j

0542

PHQ-9

947(607)

954(534)

952(669)

935(

626)

j0986

SDstand

arddeviation

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

njOne-w

ayanalysisof

varia

nce


permilCh

i-squ

aretest


nificantatPlt005


Table2Re

ported

adversee


satisfactiontowards

thetherapy

yen

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Havey

ouused

complem

entary

therapiesinthep

ast

permil0423

No

96(653

)33

3330

Yes

51(347

)17

1321

How

muchfaith

doyouhave

incomplem

entary

therapiesin

general

(0to

10)

782(213

)840

(194)

748(218

)75

5(218

)j

0056


towards

MAT

(0to

10)

741(210)

796(211)

693

(203)

731(207)

j0051


towards

LAT

(0to

10)

741(213)

808

(200)

687

(209)

725(

215)

j0016lowast

Averagee

xpectatio

nfor

treatmenteffect

(0to

10)

773(213

)840

(203)

720(203)

757(218

)j

0016lowast

Earitchinessyen

16(109

)8lowast

(resolve

automatically)

2lowast(resolve

automatically)

6lowast(resolve

automatically)

---


Table2Con

tinued

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Tend

ernesson

acup

ointsyen

20(136

)9lowast

(resolve

automatically)

1lowast(resolve

automatically)

10lowast

(resolve

automatically)

---

Satisfactiontowards

therapy(

0to

10)yen

758(237

)78

6(203)

702(268)

758(237

)j

0225

Thou

ghtthattheymight


atmentyen

No

126(900

)39

4146

0011lowast

Yes

14(100

)10

31

Will


othersyen

0166

Definitelywill

109(757

)38

2942

Maybe

20(139

)5

96

No

15(104

)6

72

Mean(stand

arddeviation)

unlessotherw

iseno

ted

ΩAssociatio

nbetweenvaria

bles

was

determ

ined

bychi-s

quarea

nalyseso

rFish

errsquos-exacttestw

here

approp

riate

Evaluated


nyenE

valuated

after

theinterventionhasb

eencompleted

lowastldquoC

ertainrdquoc

ausality

jOne-w

ayanalysisof

varia

nce


permilCh

i-squ

aretest


nificantatPlt005


Table3Outcomev

ariables

acrossthreeg

roup

satd

ifferenttim

epoints

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PSQI(total)(0-21)

Baselin

e1268(044)

1290(062)

1234(034)

Postinterventio

n94

6(052

)99

1(055)

848

(051)

023

(-14

418

9)-065(

-23610

6)087

(-055230)

6we

eksfollowup

907(053

)92

5(065)

926(054)

-050(-207197)

053

(-114219)

-058(-254138)

3mon

thsfollowup

912(079)

781(068)

906(058)

-154(-400

093)

027

(-18

8242)

-181(-399037)

6-mon

thfollo

wup

820

(062)

796(067)

846

(066)

-047(-268175)

059

(-13

8256)

-106(-316105)


Baselin

e2682(333

)2916

(359)

2517

(286)

Postinterventio

n2529(297)

2500(332

)2617

(303)

(-1329802)

223

(-8111257)

-486(-1533

560)

6we

eksfollowup

1935(322)

2656(339

)2368(330)

487

(-77

31747)

567

(-589172

3)-080(-11771018

)3m

onthsfollowup

1799

(337

)2129(356)

2390(422)

096

(-11491341)

725(

-6932143)

-629(-2065807)

6-mon

thfollo

wup

1966(531

)2342(539

)1907(434)

143(-15791864)

076

(-15341686)

067

(-15851718)

Totalslee

ptim

e(hours)

Baselin

e393

(027)

375

(028)

361

(030)

Postinterventio

n393

(249)

405

(030)

396

(029)

031(-067128)

035

(-065136)

-005(

-117108)

6we

eksfollowup

381

(027)

390

(029)

385

(025)

027

(06812

3)036

(-059131

)-009(-116099)

3mon

thsfollowup

366

(044)

426

(049)

338

(024)

077

(-081236)

0034(-13

213

9)074

(-061209)

6-mon

thfollo

wup

392

(049)

442

(061)

371

(045)

068

(-10

3238)

0112(-14

516

8)057

(-114227)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

Wakea

fterslee

ponset

(minutes)

Baselin

e9232

(1283)

9051(1464)

8833

(1031)

Postinterventio

n6944(1041)

7160(949)

6584(886)

397

(-22032996)

038

(-23412418

)358

(-24423159)

6we

eksfollowup

5145(510

)6140(860)

6234(707)

1176

(-24444795)

1488(-1749472

5)-313

(-39793354)

3mon

thsfollowup

5082(913

)7474

(2096)

6390(1200

)2573(

-3806

895

1)1706

(-304364

55)

867

(-55727306)

6-mon

thfollo

wup

4881(96

6)8087(2646

)6159(110

4)3387(-385710630)

1677(-307164

24)

1710

(-55558975)

Sleepeffi

ciency()

Baselin

e7234(223)

7406(238)

7070(223)

Postinterventio

n7828(190)

7694(193)

7886(164)

-306(-852240)

222

(-406

850)

-528(-116110

5)6we

eksfollowup

7757(180)

7614

(249)

7457(221)

-314

(-93

1303)

-136(-77

1500

)-178(-875518

)12-w

eekfollo

wup

8132

(198)

7802(356)

7882(234)

-503(

-1544

539

)-087(-1027854)

-416

(-1543710)

6-mon

thfollo

wup

7602(

484)

7737

(464)

8019

(220)

-037

(-14641390)

581

(-618178

0)-618

(-1897662)

SF-12

(PCS

)Ba

selin

e40

87(109)

4184(137

)4164(119

)-

Postinterventio

n44

46(123)

4312

(138)

4296(122)

231

(-600

139

)-227(-569114

)-0035

(-362355)

6-we

eksfollowup

4504(134)

4258(144)

4033

(151)

-342(-75

1066

)-547(-98

9-106)lowast

205

(-206

615

)3m

onthsfollowup

4555(

134)

4621(14

2)4130(166)

-031

(-469407)

-502(

-953

-052)lowast

472

(013

930)lowast

6-mon

thfollo

wup

4626(136)

4596(141)

4199(229)

-126(-563311)

-503(

-1055048)

377

(-206

960)

SF-12

(MCS

)Ba

selin

e4799(163)

4577(195)

4605(163)

Postinterventio

n5184(164)

4735(

178)

5058(137

)-226(-710257)

0675(-402537

)-294(-74

215

4)6we

eksfollowup

5097(161)

5089(184)

5315

(165)

214

(-262690)

412

(-095918

)-198(-673277)

3mon

thsfollowup

4805(231

)5131

(227)

5055(

176)

548

(-15

21247)

444

(-18

01067)

104(-538747)

6-mon

thfollo

wup

5164(200)

5224(205)

5105(220)

282

(-383947)

135(-524794)

147(-541836)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PHQ-9

(0-27)

Baselin

e95

2(074

)94

8(096)

940(086)

Postinterventio

n630

(071)

677

(095)

646

(079)

0504(-15

2252)

028

(-17

8235)

022

(-17

2217)

6we

eksfollowup

687

(100)

649

(111)

500

(071)

-035(

-273204

)-175(-429078)

141(-064345)

3mon

thsfollowup

658

(120)

568

(129)

655

(119

)ndash0

87(-393221)

009

(-308326)

-096(-405214

)6-mon

thfollo

wup

477

(097)

582

(130)

568

(105)

110(-18

8401)

104(-18

7395)

006

(-307318

)nE

stimated

meanandsta

ndarderror(SE

)from

generalized

estim

atingequatio

ns

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

n998787Ad

juste

dfora

ge


nificantatPlt005


Table4Ch

ange

indifferent

outcom

evariables

over

timefor

individu

algrou

psusinggeneralized

estim

atingequatio

ns

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

1PlaceboLA

TampMAT

(119899=5

0)PS

QI(0-21total)

-321(-456-187)

000

0lowastlowastlowast

-361(-483-238)

000

0lowastlowastlowast

-356(-528-18

3)000

0lowastlowastlowast

-447(-595-300

)000

0lowastlowastlowast

Sleeplatency(

minutes)

-153

(-897592)

0688

-747(-1674

181)

0115

-883(-1748-018)

004

5lowast-716

(-1908475)

0239

Totalsleep

time(

hours)

-001(-059058)

0989

-012

(-069045)

0681

-027(-13

9086)

064

2-001(-112

109)

0985

Wakea

ftersleep

onset

(minutes)

-2287

(-3801-774

)0003lowastlowast

-4087

(-6338

-1836)

000

0lowastlowastlowast

-414

9(-7447-852

)0014lowast

-4351

(-7726-976

)0012lowast

Sleepeffi

ciency

()

594

(212

976

)0002lowastlowast

522

(13690

9)000

8lowastlowast

898

(3071490)

0003lowastlowast

368

(-5991335)

0455

SF12

(PCS

)359

(109609)

000

5lowastlowast

416

(10672

7)000

9lowastlowast

468

(16477

2)0003lowastlowast

538

(258819)

000

0lowastlowastlowast

SF12

(MCS

)385

(02974

1)0034lowast

298

(061657)

0103

006

(-476488)

0980

365

(-083812

)0110

PHQ-9

(0-27)

-322(-473-17

1)000

0lowastlowastlowast

-265(-463-066

)000

9lowastlowast

-294(-517-071)

0010lowast

-475(

-669-282)

000

0lowastlowastlowast

Group

2LA

TampplaceboMAT

(n=4

6)PS

QI(0-21total)

-299(-396-202)

000

0lowastlowastlowast

-366(-526-205)

000

0lowastlowastlowast

-509(-685-333)

000

0lowastlowastlowast

-494(-660

-328)

000

0lowastlowastlowast

Sleeplatency(

minutes)

-416

(-1178346)

0284

-259(-1115596)

0552

-787(-168210

8)0085

-574

(-1818

671)

0366

Totalsleep

time(

hours)

030

(-047108)

044

4015

(-061092)

0695

051

(-061162)

0375

067

(-064

197)

0316

Wakea

ftersleep

onset

(minutes)

-1891

(-40

04223)

0080

-291

1(-574

9-072)

004

4lowast-1576

(-70403888)

0572

-964(-74215494)

0770

Sleepeffi

ciency

()

288

(-10

3678)

0148

208

(-272689)

0396

396

(-4621253)

0366

331

(-7321395)

0542

SF12

(PCS

)12

8(-14

4400

)0357

074

(-19

1339)

0585

437

(121753)

000

7lowastlowast

412

(07574

9)0017lowast

SF12

(MCS

)15

8(-16

8485)

0341

512

(199825)

000

1lowastlowast

554

(0481061)

0032lowast

647

(1551139)

0010lowast

PHQ-9

(0-27)

-272(

-406-138)

000

0lowastlowastlowast

-299(-431-16

7)000

0lowastlowastlowast

-380(-592-16

9)000

0lowastlowastlowast

-366(-591-14

1)000

1lowastlowast


Table4Con

tinued

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

3Com

binedAT

(n=5

1)PS

QI(0-21total)

-386(-491-282)

000

0lowastlowastlowast

-308(-420-19

5)000

0lowastlowastlowast

-328(-457-200

)000

0lowastlowastlowast

-388(-518258)

000

0lowastlowastlowast

Sleeplatency(

minutes)

070

(-647788)

0848

-180(-870510

)0610

-158(-128296

7)0784

-640(-1734454)

0251

Totalsleep

time(

hours)

035

(-046

116

)0399

024

(-052100)

0535

-023(

-099052)

0543

010

(-10

012

1)0858

Wakea

ftersleep

onset

(minutes)

-2249

(-40

86-412

)0016lowast

-2598

(-4925-272)

0029lowast

-2443

(-586297

6)0161

-2674

(-60

4970

1)0120

Sleepeffi

ciency

()

816

(118

1314)

000

1lowastlowast

387

(-118891)

0133

812

(0801544)

0030lowast

949(231

1668)

0010lowast

SF12

(PCS

)13

2(-10

1364

)0268

-131

(-445182)

0413

-035(

-367298)

0839

035

(-440

510

)0886

SF12

(MCS

)452

(146759)

000

4lowastlowast

710(352

1067)

000

0lowastlowastlowast

450

(055845)

0026lowast

500

(018

982)

004

2lowastPH

Q-9

(0-27)

-294(-435-15

3)000

0lowastlowastlowast

-440(-597-283)

000

0lowastlowastlowast

-285(

-510

-059)

0013lowast

-371(-589-154)

000

1lowastlowast

SEstand

arderrorCI

con

fidence

interval

Timepoints(1)=

baselin

e(2)=

postintervention

(3)=

6-we

ekfollo

wup

(4)

=3-mon

thfollo

wup

and

(5)=

6-mon

thfollo

w-up

998787Ad

juste

dfora

ge

PSQI=

Pittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire


nificantatPlt005


nificantatPlt001


nificantatPlt000

1


Randomised (n=147)


Trip (n=1)



Sickness (n=1)




Trip (n=1)


Six-Week Follow-Up


Excluded (n=19)


Enrollment


(n=50)


(LAT + MAT)(n=51)

Allocation


(n=46)







Post-Intervention








6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)





4

5

6

7

8

9

10

11

PHQ

scor

e











5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of

























3 Results







4 Discussion





Table1So

ciod

emograph

icandbaselin

echaracteristicso

fthe

participantssample(

N=147)

All

(N=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Age

(years)

j0025lowast

Mean(SD)

7529(699)

7602(702)

7680(616

)7320(729)

Gender

Male

197

57

permil0907

Female

128

4341

44Ed

ucationlevel

Prim

aryor

below

100

3235

330734

Second

ary

3915

915

Tertiary

orabove

83

23

Marita

lstatus

Sing

le5

21

20971

Marrie

d82

2926

27DivorcedWidow

ed60

1919

22Re

ligion

No

7526

2227

permil0895

Yes

7224

2424

Body

massind

ex(kgm2)

2229(373)

2285(348)

2150(357)

2246(404)

j0076

Shared

bed

No

109

3338

38permil0188

Yes

3817

813

Living

alon

eNo

6620

2719

permil0079

Yes

8130

1932


Table1Con

tinued

All

(N=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Sleeping

pills

taken

No

103

3433

360391

Previous

user

3214

711

Currentu

ser

122

64

Durationof

insomnia

(years)

Mean(SD)

1012

(1067)

923(

834)

1115

(1309)

1006(1040

)j

0678

Com

orbidillness

No

225

512

permil0488

Yes

125

4541

39Re

gulard

rugs

taken

No

3210

715

permil044

1Yes

11540

3936

PSQI(total)(0-21)

1263(324)

1267(315

)1289(413

)1235(234)

j0715

Sleeplatency(

min)

2703(2313)

2656(2376)

2868(2486)

2600(2119)

j0839

Totalsleep

time(

hours)

376

(196)

393

(193)

374

(186)

362

(210

)j

0734

Wakea

ftersleep

onset

(minutes)

9031

(8853)

9206(914

4)9003(995

6)8886(7595)

j0984

Sleepeffi

ciency

()

7233

(1609)

7244(1591)

7425(

1604)

7050(1642)

j0521

SF-12(PCS

)4139

(851)

4065(758)

4143(969)

4207(836)

j0707

SF-12(M

CS)

4668(1234)

4822(117

6)46

19(1349)

4562(118

9)j

0542

PHQ-9

947(607)

954(534)

952(669)

935(

626)

j0986

SDstand

arddeviation

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

njOne-w

ayanalysisof

varia

nce


permilCh

i-squ

aretest


nificantatPlt005


Table2Re

ported

adversee


satisfactiontowards

thetherapy

yen

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Havey

ouused

complem

entary

therapiesinthep

ast

permil0423

No

96(653

)33

3330

Yes

51(347

)17

1321

How

muchfaith

doyouhave

incomplem

entary

therapiesin

general

(0to

10)

782(213

)840

(194)

748(218

)75

5(218

)j

0056


towards

MAT

(0to

10)

741(210)

796(211)

693

(203)

731(207)

j0051


towards

LAT

(0to

10)

741(213)

808

(200)

687

(209)

725(

215)

j0016lowast

Averagee

xpectatio

nfor

treatmenteffect

(0to

10)

773(213

)840

(203)

720(203)

757(218

)j

0016lowast

Earitchinessyen

16(109

)8lowast

(resolve

automatically)

2lowast(resolve

automatically)

6lowast(resolve

automatically)

---


Table2Con

tinued

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Tend

ernesson

acup

ointsyen

20(136

)9lowast

(resolve

automatically)

1lowast(resolve

automatically)

10lowast

(resolve

automatically)

---

Satisfactiontowards

therapy(

0to

10)yen

758(237

)78

6(203)

702(268)

758(237

)j

0225

Thou

ghtthattheymight


atmentyen

No

126(900

)39

4146

0011lowast

Yes

14(100

)10

31

Will


othersyen

0166

Definitelywill

109(757

)38

2942

Maybe

20(139

)5

96

No

15(104

)6

72

Mean(stand

arddeviation)

unlessotherw

iseno

ted

ΩAssociatio

nbetweenvaria

bles

was

determ

ined

bychi-s

quarea

nalyseso

rFish

errsquos-exacttestw

here

approp

riate

Evaluated


nyenE

valuated

after

theinterventionhasb

eencompleted

lowastldquoC

ertainrdquoc

ausality

jOne-w

ayanalysisof

varia

nce


permilCh

i-squ

aretest


nificantatPlt005


Table3Outcomev

ariables

acrossthreeg

roup

satd

ifferenttim

epoints

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PSQI(total)(0-21)

Baselin

e1268(044)

1290(062)

1234(034)

Postinterventio

n94

6(052

)99

1(055)

848

(051)

023

(-14

418

9)-065(

-23610

6)087

(-055230)

6we

eksfollowup

907(053

)92

5(065)

926(054)

-050(-207197)

053

(-114219)

-058(-254138)

3mon

thsfollowup

912(079)

781(068)

906(058)

-154(-400

093)

027

(-18

8242)

-181(-399037)

6-mon

thfollo

wup

820

(062)

796(067)

846

(066)

-047(-268175)

059

(-13

8256)

-106(-316105)


Baselin

e2682(333

)2916

(359)

2517

(286)

Postinterventio

n2529(297)

2500(332

)2617

(303)

(-1329802)

223

(-8111257)

-486(-1533

560)

6we

eksfollowup

1935(322)

2656(339

)2368(330)

487

(-77

31747)

567

(-589172

3)-080(-11771018

)3m

onthsfollowup

1799

(337

)2129(356)

2390(422)

096

(-11491341)

725(

-6932143)

-629(-2065807)

6-mon

thfollo

wup

1966(531

)2342(539

)1907(434)

143(-15791864)

076

(-15341686)

067

(-15851718)

Totalslee

ptim

e(hours)

Baselin

e393

(027)

375

(028)

361

(030)

Postinterventio

n393

(249)

405

(030)

396

(029)

031(-067128)

035

(-065136)

-005(

-117108)

6we

eksfollowup

381

(027)

390

(029)

385

(025)

027

(06812

3)036

(-059131

)-009(-116099)

3mon

thsfollowup

366

(044)

426

(049)

338

(024)

077

(-081236)

0034(-13

213

9)074

(-061209)

6-mon

thfollo

wup

392

(049)

442

(061)

371

(045)

068

(-10

3238)

0112(-14

516

8)057

(-114227)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

Wakea

fterslee

ponset

(minutes)

Baselin

e9232

(1283)

9051(1464)

8833

(1031)

Postinterventio

n6944(1041)

7160(949)

6584(886)

397

(-22032996)

038

(-23412418

)358

(-24423159)

6we

eksfollowup

5145(510

)6140(860)

6234(707)

1176

(-24444795)

1488(-1749472

5)-313

(-39793354)

3mon

thsfollowup

5082(913

)7474

(2096)

6390(1200

)2573(

-3806

895

1)1706

(-304364

55)

867

(-55727306)

6-mon

thfollo

wup

4881(96

6)8087(2646

)6159(110

4)3387(-385710630)

1677(-307164

24)

1710

(-55558975)

Sleepeffi

ciency()

Baselin

e7234(223)

7406(238)

7070(223)

Postinterventio

n7828(190)

7694(193)

7886(164)

-306(-852240)

222

(-406

850)

-528(-116110

5)6we

eksfollowup

7757(180)

7614

(249)

7457(221)

-314

(-93

1303)

-136(-77

1500

)-178(-875518

)12-w

eekfollo

wup

8132

(198)

7802(356)

7882(234)

-503(

-1544

539

)-087(-1027854)

-416

(-1543710)

6-mon

thfollo

wup

7602(

484)

7737

(464)

8019

(220)

-037

(-14641390)

581

(-618178

0)-618

(-1897662)

SF-12

(PCS

)Ba

selin

e40

87(109)

4184(137

)4164(119

)-

Postinterventio

n44

46(123)

4312

(138)

4296(122)

231

(-600

139

)-227(-569114

)-0035

(-362355)

6-we

eksfollowup

4504(134)

4258(144)

4033

(151)

-342(-75

1066

)-547(-98

9-106)lowast

205

(-206

615

)3m

onthsfollowup

4555(

134)

4621(14

2)4130(166)

-031

(-469407)

-502(

-953

-052)lowast

472

(013

930)lowast

6-mon

thfollo

wup

4626(136)

4596(141)

4199(229)

-126(-563311)

-503(

-1055048)

377

(-206

960)

SF-12

(MCS

)Ba

selin

e4799(163)

4577(195)

4605(163)

Postinterventio

n5184(164)

4735(

178)

5058(137

)-226(-710257)

0675(-402537

)-294(-74

215

4)6we

eksfollowup

5097(161)

5089(184)

5315

(165)

214

(-262690)

412

(-095918

)-198(-673277)

3mon

thsfollowup

4805(231

)5131

(227)

5055(

176)

548

(-15

21247)

444

(-18

01067)

104(-538747)

6-mon

thfollo

wup

5164(200)

5224(205)

5105(220)

282

(-383947)

135(-524794)

147(-541836)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PHQ-9

(0-27)

Baselin

e95

2(074

)94

8(096)

940(086)

Postinterventio

n630

(071)

677

(095)

646

(079)

0504(-15

2252)

028

(-17

8235)

022

(-17

2217)

6we

eksfollowup

687

(100)

649

(111)

500

(071)

-035(

-273204

)-175(-429078)

141(-064345)

3mon

thsfollowup

658

(120)

568

(129)

655

(119

)ndash0

87(-393221)

009

(-308326)

-096(-405214

)6-mon

thfollo

wup

477

(097)

582

(130)

568

(105)

110(-18

8401)

104(-18

7395)

006

(-307318

)nE

stimated

meanandsta

ndarderror(SE

)from

generalized

estim

atingequatio

ns

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

n998787Ad

juste

dfora

ge


nificantatPlt005


Table4Ch

ange

indifferent

outcom

evariables

over

timefor

individu

algrou

psusinggeneralized

estim

atingequatio

ns

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

1PlaceboLA

TampMAT

(119899=5

0)PS

QI(0-21total)

-321(-456-187)

000

0lowastlowastlowast

-361(-483-238)

000

0lowastlowastlowast

-356(-528-18

3)000

0lowastlowastlowast

-447(-595-300

)000

0lowastlowastlowast

Sleeplatency(

minutes)

-153

(-897592)

0688

-747(-1674

181)

0115

-883(-1748-018)

004

5lowast-716

(-1908475)

0239

Totalsleep

time(

hours)

-001(-059058)

0989

-012

(-069045)

0681

-027(-13

9086)

064

2-001(-112

109)

0985

Wakea

ftersleep

onset

(minutes)

-2287

(-3801-774

)0003lowastlowast

-4087

(-6338

-1836)

000

0lowastlowastlowast

-414

9(-7447-852

)0014lowast

-4351

(-7726-976

)0012lowast

Sleepeffi

ciency

()

594

(212

976

)0002lowastlowast

522

(13690

9)000

8lowastlowast

898

(3071490)

0003lowastlowast

368

(-5991335)

0455

SF12

(PCS

)359

(109609)

000

5lowastlowast

416

(10672

7)000

9lowastlowast

468

(16477

2)0003lowastlowast

538

(258819)

000

0lowastlowastlowast

SF12

(MCS

)385

(02974

1)0034lowast

298

(061657)

0103

006

(-476488)

0980

365

(-083812

)0110

PHQ-9

(0-27)

-322(-473-17

1)000

0lowastlowastlowast

-265(-463-066

)000

9lowastlowast

-294(-517-071)

0010lowast

-475(

-669-282)

000

0lowastlowastlowast

Group

2LA

TampplaceboMAT

(n=4

6)PS

QI(0-21total)

-299(-396-202)

000

0lowastlowastlowast

-366(-526-205)

000

0lowastlowastlowast

-509(-685-333)

000

0lowastlowastlowast

-494(-660

-328)

000

0lowastlowastlowast

Sleeplatency(

minutes)

-416

(-1178346)

0284

-259(-1115596)

0552

-787(-168210

8)0085

-574

(-1818

671)

0366

Totalsleep

time(

hours)

030

(-047108)

044

4015

(-061092)

0695

051

(-061162)

0375

067

(-064

197)

0316

Wakea

ftersleep

onset

(minutes)

-1891

(-40

04223)

0080

-291

1(-574

9-072)

004

4lowast-1576

(-70403888)

0572

-964(-74215494)

0770

Sleepeffi

ciency

()

288

(-10

3678)

0148

208

(-272689)

0396

396

(-4621253)

0366

331

(-7321395)

0542

SF12

(PCS

)12

8(-14

4400

)0357

074

(-19

1339)

0585

437

(121753)

000

7lowastlowast

412

(07574

9)0017lowast

SF12

(MCS

)15

8(-16

8485)

0341

512

(199825)

000

1lowastlowast

554

(0481061)

0032lowast

647

(1551139)

0010lowast

PHQ-9

(0-27)

-272(

-406-138)

000

0lowastlowastlowast

-299(-431-16

7)000

0lowastlowastlowast

-380(-592-16

9)000

0lowastlowastlowast

-366(-591-14

1)000

1lowastlowast


Table4Con

tinued

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

3Com

binedAT

(n=5

1)PS

QI(0-21total)

-386(-491-282)

000

0lowastlowastlowast

-308(-420-19

5)000

0lowastlowastlowast

-328(-457-200

)000

0lowastlowastlowast

-388(-518258)

000

0lowastlowastlowast

Sleeplatency(

minutes)

070

(-647788)

0848

-180(-870510

)0610

-158(-128296

7)0784

-640(-1734454)

0251

Totalsleep

time(

hours)

035

(-046

116

)0399

024

(-052100)

0535

-023(

-099052)

0543

010

(-10

012

1)0858

Wakea

ftersleep

onset

(minutes)

-2249

(-40

86-412

)0016lowast

-2598

(-4925-272)

0029lowast

-2443

(-586297

6)0161

-2674

(-60

4970

1)0120

Sleepeffi

ciency

()

816

(118

1314)

000

1lowastlowast

387

(-118891)

0133

812

(0801544)

0030lowast

949(231

1668)

0010lowast

SF12

(PCS

)13

2(-10

1364

)0268

-131

(-445182)

0413

-035(

-367298)

0839

035

(-440

510

)0886

SF12

(MCS

)452

(146759)

000

4lowastlowast

710(352

1067)

000

0lowastlowastlowast

450

(055845)

0026lowast

500

(018

982)

004

2lowastPH

Q-9

(0-27)

-294(-435-15

3)000

0lowastlowastlowast

-440(-597-283)

000

0lowastlowastlowast

-285(

-510

-059)

0013lowast

-371(-589-154)

000

1lowastlowast

SEstand

arderrorCI

con

fidence

interval

Timepoints(1)=

baselin

e(2)=

postintervention

(3)=

6-we

ekfollo

wup

(4)

=3-mon

thfollo

wup

and

(5)=

6-mon

thfollo

w-up

998787Ad

juste

dfora

ge

PSQI=

Pittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire


nificantatPlt005


nificantatPlt001


nificantatPlt000

1


Randomised (n=147)


Trip (n=1)



Sickness (n=1)




Trip (n=1)


Six-Week Follow-Up


Excluded (n=19)


Enrollment


(n=50)


(LAT + MAT)(n=51)

Allocation


(n=46)







Post-Intervention








6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)





4

5

6

7

8

9

10

11

PHQ

scor

e











5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of























4 Discussion





Table1So

ciod

emograph

icandbaselin

echaracteristicso

fthe

participantssample(

N=147)

All

(N=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Age

(years)

j0025lowast

Mean(SD)

7529(699)

7602(702)

7680(616

)7320(729)

Gender

Male

197

57

permil0907

Female

128

4341

44Ed

ucationlevel

Prim

aryor

below

100

3235

330734

Second

ary

3915

915

Tertiary

orabove

83

23

Marita

lstatus

Sing

le5

21

20971

Marrie

d82

2926

27DivorcedWidow

ed60

1919

22Re

ligion

No

7526

2227

permil0895

Yes

7224

2424

Body

massind

ex(kgm2)

2229(373)

2285(348)

2150(357)

2246(404)

j0076

Shared

bed

No

109

3338

38permil0188

Yes

3817

813

Living

alon

eNo

6620

2719

permil0079

Yes

8130

1932


Table1Con

tinued

All

(N=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Sleeping

pills

taken

No

103

3433

360391

Previous

user

3214

711

Currentu

ser

122

64

Durationof

insomnia

(years)

Mean(SD)

1012

(1067)

923(

834)

1115

(1309)

1006(1040

)j

0678

Com

orbidillness

No

225

512

permil0488

Yes

125

4541

39Re

gulard

rugs

taken

No

3210

715

permil044

1Yes

11540

3936

PSQI(total)(0-21)

1263(324)

1267(315

)1289(413

)1235(234)

j0715

Sleeplatency(

min)

2703(2313)

2656(2376)

2868(2486)

2600(2119)

j0839

Totalsleep

time(

hours)

376

(196)

393

(193)

374

(186)

362

(210

)j

0734

Wakea

ftersleep

onset

(minutes)

9031

(8853)

9206(914

4)9003(995

6)8886(7595)

j0984

Sleepeffi

ciency

()

7233

(1609)

7244(1591)

7425(

1604)

7050(1642)

j0521

SF-12(PCS

)4139

(851)

4065(758)

4143(969)

4207(836)

j0707

SF-12(M

CS)

4668(1234)

4822(117

6)46

19(1349)

4562(118

9)j

0542

PHQ-9

947(607)

954(534)

952(669)

935(

626)

j0986

SDstand

arddeviation

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

njOne-w

ayanalysisof

varia

nce


permilCh

i-squ

aretest


nificantatPlt005


Table2Re

ported

adversee


satisfactiontowards

thetherapy

yen

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Havey

ouused

complem

entary

therapiesinthep

ast

permil0423

No

96(653

)33

3330

Yes

51(347

)17

1321

How

muchfaith

doyouhave

incomplem

entary

therapiesin

general

(0to

10)

782(213

)840

(194)

748(218

)75

5(218

)j

0056


towards

MAT

(0to

10)

741(210)

796(211)

693

(203)

731(207)

j0051


towards

LAT

(0to

10)

741(213)

808

(200)

687

(209)

725(

215)

j0016lowast

Averagee

xpectatio

nfor

treatmenteffect

(0to

10)

773(213

)840

(203)

720(203)

757(218

)j

0016lowast

Earitchinessyen

16(109

)8lowast

(resolve

automatically)

2lowast(resolve

automatically)

6lowast(resolve

automatically)

---


Table2Con

tinued

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Tend

ernesson

acup

ointsyen

20(136

)9lowast

(resolve

automatically)

1lowast(resolve

automatically)

10lowast

(resolve

automatically)

---

Satisfactiontowards

therapy(

0to

10)yen

758(237

)78

6(203)

702(268)

758(237

)j

0225

Thou

ghtthattheymight


atmentyen

No

126(900

)39

4146

0011lowast

Yes

14(100

)10

31

Will


othersyen

0166

Definitelywill

109(757

)38

2942

Maybe

20(139

)5

96

No

15(104

)6

72

Mean(stand

arddeviation)

unlessotherw

iseno

ted

ΩAssociatio

nbetweenvaria

bles

was

determ

ined

bychi-s

quarea

nalyseso

rFish

errsquos-exacttestw

here

approp

riate

Evaluated


nyenE

valuated

after

theinterventionhasb

eencompleted

lowastldquoC

ertainrdquoc

ausality

jOne-w

ayanalysisof

varia

nce


permilCh

i-squ

aretest


nificantatPlt005


Table3Outcomev

ariables

acrossthreeg

roup

satd

ifferenttim

epoints

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PSQI(total)(0-21)

Baselin

e1268(044)

1290(062)

1234(034)

Postinterventio

n94

6(052

)99

1(055)

848

(051)

023

(-14

418

9)-065(

-23610

6)087

(-055230)

6we

eksfollowup

907(053

)92

5(065)

926(054)

-050(-207197)

053

(-114219)

-058(-254138)

3mon

thsfollowup

912(079)

781(068)

906(058)

-154(-400

093)

027

(-18

8242)

-181(-399037)

6-mon

thfollo

wup

820

(062)

796(067)

846

(066)

-047(-268175)

059

(-13

8256)

-106(-316105)


Baselin

e2682(333

)2916

(359)

2517

(286)

Postinterventio

n2529(297)

2500(332

)2617

(303)

(-1329802)

223

(-8111257)

-486(-1533

560)

6we

eksfollowup

1935(322)

2656(339

)2368(330)

487

(-77

31747)

567

(-589172

3)-080(-11771018

)3m

onthsfollowup

1799

(337

)2129(356)

2390(422)

096

(-11491341)

725(

-6932143)

-629(-2065807)

6-mon

thfollo

wup

1966(531

)2342(539

)1907(434)

143(-15791864)

076

(-15341686)

067

(-15851718)

Totalslee

ptim

e(hours)

Baselin

e393

(027)

375

(028)

361

(030)

Postinterventio

n393

(249)

405

(030)

396

(029)

031(-067128)

035

(-065136)

-005(

-117108)

6we

eksfollowup

381

(027)

390

(029)

385

(025)

027

(06812

3)036

(-059131

)-009(-116099)

3mon

thsfollowup

366

(044)

426

(049)

338

(024)

077

(-081236)

0034(-13

213

9)074

(-061209)

6-mon

thfollo

wup

392

(049)

442

(061)

371

(045)

068

(-10

3238)

0112(-14

516

8)057

(-114227)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

Wakea

fterslee

ponset

(minutes)

Baselin

e9232

(1283)

9051(1464)

8833

(1031)

Postinterventio

n6944(1041)

7160(949)

6584(886)

397

(-22032996)

038

(-23412418

)358

(-24423159)

6we

eksfollowup

5145(510

)6140(860)

6234(707)

1176

(-24444795)

1488(-1749472

5)-313

(-39793354)

3mon

thsfollowup

5082(913

)7474

(2096)

6390(1200

)2573(

-3806

895

1)1706

(-304364

55)

867

(-55727306)

6-mon

thfollo

wup

4881(96

6)8087(2646

)6159(110

4)3387(-385710630)

1677(-307164

24)

1710

(-55558975)

Sleepeffi

ciency()

Baselin

e7234(223)

7406(238)

7070(223)

Postinterventio

n7828(190)

7694(193)

7886(164)

-306(-852240)

222

(-406

850)

-528(-116110

5)6we

eksfollowup

7757(180)

7614

(249)

7457(221)

-314

(-93

1303)

-136(-77

1500

)-178(-875518

)12-w

eekfollo

wup

8132

(198)

7802(356)

7882(234)

-503(

-1544

539

)-087(-1027854)

-416

(-1543710)

6-mon

thfollo

wup

7602(

484)

7737

(464)

8019

(220)

-037

(-14641390)

581

(-618178

0)-618

(-1897662)

SF-12

(PCS

)Ba

selin

e40

87(109)

4184(137

)4164(119

)-

Postinterventio

n44

46(123)

4312

(138)

4296(122)

231

(-600

139

)-227(-569114

)-0035

(-362355)

6-we

eksfollowup

4504(134)

4258(144)

4033

(151)

-342(-75

1066

)-547(-98

9-106)lowast

205

(-206

615

)3m

onthsfollowup

4555(

134)

4621(14

2)4130(166)

-031

(-469407)

-502(

-953

-052)lowast

472

(013

930)lowast

6-mon

thfollo

wup

4626(136)

4596(141)

4199(229)

-126(-563311)

-503(

-1055048)

377

(-206

960)

SF-12

(MCS

)Ba

selin

e4799(163)

4577(195)

4605(163)

Postinterventio

n5184(164)

4735(

178)

5058(137

)-226(-710257)

0675(-402537

)-294(-74

215

4)6we

eksfollowup

5097(161)

5089(184)

5315

(165)

214

(-262690)

412

(-095918

)-198(-673277)

3mon

thsfollowup

4805(231

)5131

(227)

5055(

176)

548

(-15

21247)

444

(-18

01067)

104(-538747)

6-mon

thfollo

wup

5164(200)

5224(205)

5105(220)

282

(-383947)

135(-524794)

147(-541836)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PHQ-9

(0-27)

Baselin

e95

2(074

)94

8(096)

940(086)

Postinterventio

n630

(071)

677

(095)

646

(079)

0504(-15

2252)

028

(-17

8235)

022

(-17

2217)

6we

eksfollowup

687

(100)

649

(111)

500

(071)

-035(

-273204

)-175(-429078)

141(-064345)

3mon

thsfollowup

658

(120)

568

(129)

655

(119

)ndash0

87(-393221)

009

(-308326)

-096(-405214

)6-mon

thfollo

wup

477

(097)

582

(130)

568

(105)

110(-18

8401)

104(-18

7395)

006

(-307318

)nE

stimated

meanandsta

ndarderror(SE

)from

generalized

estim

atingequatio

ns

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

n998787Ad

juste

dfora

ge


nificantatPlt005


Table4Ch

ange

indifferent

outcom

evariables

over

timefor

individu

algrou

psusinggeneralized

estim

atingequatio

ns

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

1PlaceboLA

TampMAT

(119899=5

0)PS

QI(0-21total)

-321(-456-187)

000

0lowastlowastlowast

-361(-483-238)

000

0lowastlowastlowast

-356(-528-18

3)000

0lowastlowastlowast

-447(-595-300

)000

0lowastlowastlowast

Sleeplatency(

minutes)

-153

(-897592)

0688

-747(-1674

181)

0115

-883(-1748-018)

004

5lowast-716

(-1908475)

0239

Totalsleep

time(

hours)

-001(-059058)

0989

-012

(-069045)

0681

-027(-13

9086)

064

2-001(-112

109)

0985

Wakea

ftersleep

onset

(minutes)

-2287

(-3801-774

)0003lowastlowast

-4087

(-6338

-1836)

000

0lowastlowastlowast

-414

9(-7447-852

)0014lowast

-4351

(-7726-976

)0012lowast

Sleepeffi

ciency

()

594

(212

976

)0002lowastlowast

522

(13690

9)000

8lowastlowast

898

(3071490)

0003lowastlowast

368

(-5991335)

0455

SF12

(PCS

)359

(109609)

000

5lowastlowast

416

(10672

7)000

9lowastlowast

468

(16477

2)0003lowastlowast

538

(258819)

000

0lowastlowastlowast

SF12

(MCS

)385

(02974

1)0034lowast

298

(061657)

0103

006

(-476488)

0980

365

(-083812

)0110

PHQ-9

(0-27)

-322(-473-17

1)000

0lowastlowastlowast

-265(-463-066

)000

9lowastlowast

-294(-517-071)

0010lowast

-475(

-669-282)

000

0lowastlowastlowast

Group

2LA

TampplaceboMAT

(n=4

6)PS

QI(0-21total)

-299(-396-202)

000

0lowastlowastlowast

-366(-526-205)

000

0lowastlowastlowast

-509(-685-333)

000

0lowastlowastlowast

-494(-660

-328)

000

0lowastlowastlowast

Sleeplatency(

minutes)

-416

(-1178346)

0284

-259(-1115596)

0552

-787(-168210

8)0085

-574

(-1818

671)

0366

Totalsleep

time(

hours)

030

(-047108)

044

4015

(-061092)

0695

051

(-061162)

0375

067

(-064

197)

0316

Wakea

ftersleep

onset

(minutes)

-1891

(-40

04223)

0080

-291

1(-574

9-072)

004

4lowast-1576

(-70403888)

0572

-964(-74215494)

0770

Sleepeffi

ciency

()

288

(-10

3678)

0148

208

(-272689)

0396

396

(-4621253)

0366

331

(-7321395)

0542

SF12

(PCS

)12

8(-14

4400

)0357

074

(-19

1339)

0585

437

(121753)

000

7lowastlowast

412

(07574

9)0017lowast

SF12

(MCS

)15

8(-16

8485)

0341

512

(199825)

000

1lowastlowast

554

(0481061)

0032lowast

647

(1551139)

0010lowast

PHQ-9

(0-27)

-272(

-406-138)

000

0lowastlowastlowast

-299(-431-16

7)000

0lowastlowastlowast

-380(-592-16

9)000

0lowastlowastlowast

-366(-591-14

1)000

1lowastlowast


Table4Con

tinued

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

3Com

binedAT

(n=5

1)PS

QI(0-21total)

-386(-491-282)

000

0lowastlowastlowast

-308(-420-19

5)000

0lowastlowastlowast

-328(-457-200

)000

0lowastlowastlowast

-388(-518258)

000

0lowastlowastlowast

Sleeplatency(

minutes)

070

(-647788)

0848

-180(-870510

)0610

-158(-128296

7)0784

-640(-1734454)

0251

Totalsleep

time(

hours)

035

(-046

116

)0399

024

(-052100)

0535

-023(

-099052)

0543

010

(-10

012

1)0858

Wakea

ftersleep

onset

(minutes)

-2249

(-40

86-412

)0016lowast

-2598

(-4925-272)

0029lowast

-2443

(-586297

6)0161

-2674

(-60

4970

1)0120

Sleepeffi

ciency

()

816

(118

1314)

000

1lowastlowast

387

(-118891)

0133

812

(0801544)

0030lowast

949(231

1668)

0010lowast

SF12

(PCS

)13

2(-10

1364

)0268

-131

(-445182)

0413

-035(

-367298)

0839

035

(-440

510

)0886

SF12

(MCS

)452

(146759)

000

4lowastlowast

710(352

1067)

000

0lowastlowastlowast

450

(055845)

0026lowast

500

(018

982)

004

2lowastPH

Q-9

(0-27)

-294(-435-15

3)000

0lowastlowastlowast

-440(-597-283)

000

0lowastlowastlowast

-285(

-510

-059)

0013lowast

-371(-589-154)

000

1lowastlowast

SEstand

arderrorCI

con

fidence

interval

Timepoints(1)=

baselin

e(2)=

postintervention

(3)=

6-we

ekfollo

wup

(4)

=3-mon

thfollo

wup

and

(5)=

6-mon

thfollo

w-up

998787Ad

juste

dfora

ge

PSQI=

Pittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire


nificantatPlt005


nificantatPlt001


nificantatPlt000

1


Randomised (n=147)


Trip (n=1)



Sickness (n=1)




Trip (n=1)


Six-Week Follow-Up


Excluded (n=19)


Enrollment


(n=50)


(LAT + MAT)(n=51)

Allocation


(n=46)







Post-Intervention








6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)





4

5

6

7

8

9

10

11

PHQ

scor

e











5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of




















Table1So

ciod

emograph

icandbaselin

echaracteristicso

fthe

participantssample(

N=147)

All

(N=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Age

(years)

j0025lowast

Mean(SD)

7529(699)

7602(702)

7680(616

)7320(729)

Gender

Male

197

57

permil0907

Female

128

4341

44Ed

ucationlevel

Prim

aryor

below

100

3235

330734

Second

ary

3915

915

Tertiary

orabove

83

23

Marita

lstatus

Sing

le5

21

20971

Marrie

d82

2926

27DivorcedWidow

ed60

1919

22Re

ligion

No

7526

2227

permil0895

Yes

7224

2424

Body

massind

ex(kgm2)

2229(373)

2285(348)

2150(357)

2246(404)

j0076

Shared

bed

No

109

3338

38permil0188

Yes

3817

813

Living

alon

eNo

6620

2719

permil0079

Yes

8130

1932


Table1Con

tinued

All

(N=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Sleeping

pills

taken

No

103

3433

360391

Previous

user

3214

711

Currentu

ser

122

64

Durationof

insomnia

(years)

Mean(SD)

1012

(1067)

923(

834)

1115

(1309)

1006(1040

)j

0678

Com

orbidillness

No

225

512

permil0488

Yes

125

4541

39Re

gulard

rugs

taken

No

3210

715

permil044

1Yes

11540

3936

PSQI(total)(0-21)

1263(324)

1267(315

)1289(413

)1235(234)

j0715

Sleeplatency(

min)

2703(2313)

2656(2376)

2868(2486)

2600(2119)

j0839

Totalsleep

time(

hours)

376

(196)

393

(193)

374

(186)

362

(210

)j

0734

Wakea

ftersleep

onset

(minutes)

9031

(8853)

9206(914

4)9003(995

6)8886(7595)

j0984

Sleepeffi

ciency

()

7233

(1609)

7244(1591)

7425(

1604)

7050(1642)

j0521

SF-12(PCS

)4139

(851)

4065(758)

4143(969)

4207(836)

j0707

SF-12(M

CS)

4668(1234)

4822(117

6)46

19(1349)

4562(118

9)j

0542

PHQ-9

947(607)

954(534)

952(669)

935(

626)

j0986

SDstand

arddeviation

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

njOne-w

ayanalysisof

varia

nce


permilCh

i-squ

aretest


nificantatPlt005


Table2Re

ported

adversee


satisfactiontowards

thetherapy

yen

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Havey

ouused

complem

entary

therapiesinthep

ast

permil0423

No

96(653

)33

3330

Yes

51(347

)17

1321

How

muchfaith

doyouhave

incomplem

entary

therapiesin

general

(0to

10)

782(213

)840

(194)

748(218

)75

5(218

)j

0056


towards

MAT

(0to

10)

741(210)

796(211)

693

(203)

731(207)

j0051


towards

LAT

(0to

10)

741(213)

808

(200)

687

(209)

725(

215)

j0016lowast

Averagee

xpectatio

nfor

treatmenteffect

(0to

10)

773(213

)840

(203)

720(203)

757(218

)j

0016lowast

Earitchinessyen

16(109

)8lowast

(resolve

automatically)

2lowast(resolve

automatically)

6lowast(resolve

automatically)

---


Table2Con

tinued

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Tend

ernesson

acup

ointsyen

20(136

)9lowast

(resolve

automatically)

1lowast(resolve

automatically)

10lowast

(resolve

automatically)

---

Satisfactiontowards

therapy(

0to

10)yen

758(237

)78

6(203)

702(268)

758(237

)j

0225

Thou

ghtthattheymight


atmentyen

No

126(900

)39

4146

0011lowast

Yes

14(100

)10

31

Will


othersyen

0166

Definitelywill

109(757

)38

2942

Maybe

20(139

)5

96

No

15(104

)6

72

Mean(stand

arddeviation)

unlessotherw

iseno

ted

ΩAssociatio

nbetweenvaria

bles

was

determ

ined

bychi-s

quarea

nalyseso

rFish

errsquos-exacttestw

here

approp

riate

Evaluated


nyenE

valuated

after

theinterventionhasb

eencompleted

lowastldquoC

ertainrdquoc

ausality

jOne-w

ayanalysisof

varia

nce


permilCh

i-squ

aretest


nificantatPlt005


Table3Outcomev

ariables

acrossthreeg

roup

satd

ifferenttim

epoints

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PSQI(total)(0-21)

Baselin

e1268(044)

1290(062)

1234(034)

Postinterventio

n94

6(052

)99

1(055)

848

(051)

023

(-14

418

9)-065(

-23610

6)087

(-055230)

6we

eksfollowup

907(053

)92

5(065)

926(054)

-050(-207197)

053

(-114219)

-058(-254138)

3mon

thsfollowup

912(079)

781(068)

906(058)

-154(-400

093)

027

(-18

8242)

-181(-399037)

6-mon

thfollo

wup

820

(062)

796(067)

846

(066)

-047(-268175)

059

(-13

8256)

-106(-316105)


Baselin

e2682(333

)2916

(359)

2517

(286)

Postinterventio

n2529(297)

2500(332

)2617

(303)

(-1329802)

223

(-8111257)

-486(-1533

560)

6we

eksfollowup

1935(322)

2656(339

)2368(330)

487

(-77

31747)

567

(-589172

3)-080(-11771018

)3m

onthsfollowup

1799

(337

)2129(356)

2390(422)

096

(-11491341)

725(

-6932143)

-629(-2065807)

6-mon

thfollo

wup

1966(531

)2342(539

)1907(434)

143(-15791864)

076

(-15341686)

067

(-15851718)

Totalslee

ptim

e(hours)

Baselin

e393

(027)

375

(028)

361

(030)

Postinterventio

n393

(249)

405

(030)

396

(029)

031(-067128)

035

(-065136)

-005(

-117108)

6we

eksfollowup

381

(027)

390

(029)

385

(025)

027

(06812

3)036

(-059131

)-009(-116099)

3mon

thsfollowup

366

(044)

426

(049)

338

(024)

077

(-081236)

0034(-13

213

9)074

(-061209)

6-mon

thfollo

wup

392

(049)

442

(061)

371

(045)

068

(-10

3238)

0112(-14

516

8)057

(-114227)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

Wakea

fterslee

ponset

(minutes)

Baselin

e9232

(1283)

9051(1464)

8833

(1031)

Postinterventio

n6944(1041)

7160(949)

6584(886)

397

(-22032996)

038

(-23412418

)358

(-24423159)

6we

eksfollowup

5145(510

)6140(860)

6234(707)

1176

(-24444795)

1488(-1749472

5)-313

(-39793354)

3mon

thsfollowup

5082(913

)7474

(2096)

6390(1200

)2573(

-3806

895

1)1706

(-304364

55)

867

(-55727306)

6-mon

thfollo

wup

4881(96

6)8087(2646

)6159(110

4)3387(-385710630)

1677(-307164

24)

1710

(-55558975)

Sleepeffi

ciency()

Baselin

e7234(223)

7406(238)

7070(223)

Postinterventio

n7828(190)

7694(193)

7886(164)

-306(-852240)

222

(-406

850)

-528(-116110

5)6we

eksfollowup

7757(180)

7614

(249)

7457(221)

-314

(-93

1303)

-136(-77

1500

)-178(-875518

)12-w

eekfollo

wup

8132

(198)

7802(356)

7882(234)

-503(

-1544

539

)-087(-1027854)

-416

(-1543710)

6-mon

thfollo

wup

7602(

484)

7737

(464)

8019

(220)

-037

(-14641390)

581

(-618178

0)-618

(-1897662)

SF-12

(PCS

)Ba

selin

e40

87(109)

4184(137

)4164(119

)-

Postinterventio

n44

46(123)

4312

(138)

4296(122)

231

(-600

139

)-227(-569114

)-0035

(-362355)

6-we

eksfollowup

4504(134)

4258(144)

4033

(151)

-342(-75

1066

)-547(-98

9-106)lowast

205

(-206

615

)3m

onthsfollowup

4555(

134)

4621(14

2)4130(166)

-031

(-469407)

-502(

-953

-052)lowast

472

(013

930)lowast

6-mon

thfollo

wup

4626(136)

4596(141)

4199(229)

-126(-563311)

-503(

-1055048)

377

(-206

960)

SF-12

(MCS

)Ba

selin

e4799(163)

4577(195)

4605(163)

Postinterventio

n5184(164)

4735(

178)

5058(137

)-226(-710257)

0675(-402537

)-294(-74

215

4)6we

eksfollowup

5097(161)

5089(184)

5315

(165)

214

(-262690)

412

(-095918

)-198(-673277)

3mon

thsfollowup

4805(231

)5131

(227)

5055(

176)

548

(-15

21247)

444

(-18

01067)

104(-538747)

6-mon

thfollo

wup

5164(200)

5224(205)

5105(220)

282

(-383947)

135(-524794)

147(-541836)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PHQ-9

(0-27)

Baselin

e95

2(074

)94

8(096)

940(086)

Postinterventio

n630

(071)

677

(095)

646

(079)

0504(-15

2252)

028

(-17

8235)

022

(-17

2217)

6we

eksfollowup

687

(100)

649

(111)

500

(071)

-035(

-273204

)-175(-429078)

141(-064345)

3mon

thsfollowup

658

(120)

568

(129)

655

(119

)ndash0

87(-393221)

009

(-308326)

-096(-405214

)6-mon

thfollo

wup

477

(097)

582

(130)

568

(105)

110(-18

8401)

104(-18

7395)

006

(-307318

)nE

stimated

meanandsta

ndarderror(SE

)from

generalized

estim

atingequatio

ns

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

n998787Ad

juste

dfora

ge


nificantatPlt005


Table4Ch

ange

indifferent

outcom

evariables

over

timefor

individu

algrou

psusinggeneralized

estim

atingequatio

ns

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

1PlaceboLA

TampMAT

(119899=5

0)PS

QI(0-21total)

-321(-456-187)

000

0lowastlowastlowast

-361(-483-238)

000

0lowastlowastlowast

-356(-528-18

3)000

0lowastlowastlowast

-447(-595-300

)000

0lowastlowastlowast

Sleeplatency(

minutes)

-153

(-897592)

0688

-747(-1674

181)

0115

-883(-1748-018)

004

5lowast-716

(-1908475)

0239

Totalsleep

time(

hours)

-001(-059058)

0989

-012

(-069045)

0681

-027(-13

9086)

064

2-001(-112

109)

0985

Wakea

ftersleep

onset

(minutes)

-2287

(-3801-774

)0003lowastlowast

-4087

(-6338

-1836)

000

0lowastlowastlowast

-414

9(-7447-852

)0014lowast

-4351

(-7726-976

)0012lowast

Sleepeffi

ciency

()

594

(212

976

)0002lowastlowast

522

(13690

9)000

8lowastlowast

898

(3071490)

0003lowastlowast

368

(-5991335)

0455

SF12

(PCS

)359

(109609)

000

5lowastlowast

416

(10672

7)000

9lowastlowast

468

(16477

2)0003lowastlowast

538

(258819)

000

0lowastlowastlowast

SF12

(MCS

)385

(02974

1)0034lowast

298

(061657)

0103

006

(-476488)

0980

365

(-083812

)0110

PHQ-9

(0-27)

-322(-473-17

1)000

0lowastlowastlowast

-265(-463-066

)000

9lowastlowast

-294(-517-071)

0010lowast

-475(

-669-282)

000

0lowastlowastlowast

Group

2LA

TampplaceboMAT

(n=4

6)PS

QI(0-21total)

-299(-396-202)

000

0lowastlowastlowast

-366(-526-205)

000

0lowastlowastlowast

-509(-685-333)

000

0lowastlowastlowast

-494(-660

-328)

000

0lowastlowastlowast

Sleeplatency(

minutes)

-416

(-1178346)

0284

-259(-1115596)

0552

-787(-168210

8)0085

-574

(-1818

671)

0366

Totalsleep

time(

hours)

030

(-047108)

044

4015

(-061092)

0695

051

(-061162)

0375

067

(-064

197)

0316

Wakea

ftersleep

onset

(minutes)

-1891

(-40

04223)

0080

-291

1(-574

9-072)

004

4lowast-1576

(-70403888)

0572

-964(-74215494)

0770

Sleepeffi

ciency

()

288

(-10

3678)

0148

208

(-272689)

0396

396

(-4621253)

0366

331

(-7321395)

0542

SF12

(PCS

)12

8(-14

4400

)0357

074

(-19

1339)

0585

437

(121753)

000

7lowastlowast

412

(07574

9)0017lowast

SF12

(MCS

)15

8(-16

8485)

0341

512

(199825)

000

1lowastlowast

554

(0481061)

0032lowast

647

(1551139)

0010lowast

PHQ-9

(0-27)

-272(

-406-138)

000

0lowastlowastlowast

-299(-431-16

7)000

0lowastlowastlowast

-380(-592-16

9)000

0lowastlowastlowast

-366(-591-14

1)000

1lowastlowast


Table4Con

tinued

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

3Com

binedAT

(n=5

1)PS

QI(0-21total)

-386(-491-282)

000

0lowastlowastlowast

-308(-420-19

5)000

0lowastlowastlowast

-328(-457-200

)000

0lowastlowastlowast

-388(-518258)

000

0lowastlowastlowast

Sleeplatency(

minutes)

070

(-647788)

0848

-180(-870510

)0610

-158(-128296

7)0784

-640(-1734454)

0251

Totalsleep

time(

hours)

035

(-046

116

)0399

024

(-052100)

0535

-023(

-099052)

0543

010

(-10

012

1)0858

Wakea

ftersleep

onset

(minutes)

-2249

(-40

86-412

)0016lowast

-2598

(-4925-272)

0029lowast

-2443

(-586297

6)0161

-2674

(-60

4970

1)0120

Sleepeffi

ciency

()

816

(118

1314)

000

1lowastlowast

387

(-118891)

0133

812

(0801544)

0030lowast

949(231

1668)

0010lowast

SF12

(PCS

)13

2(-10

1364

)0268

-131

(-445182)

0413

-035(

-367298)

0839

035

(-440

510

)0886

SF12

(MCS

)452

(146759)

000

4lowastlowast

710(352

1067)

000

0lowastlowastlowast

450

(055845)

0026lowast

500

(018

982)

004

2lowastPH

Q-9

(0-27)

-294(-435-15

3)000

0lowastlowastlowast

-440(-597-283)

000

0lowastlowastlowast

-285(

-510

-059)

0013lowast

-371(-589-154)

000

1lowastlowast

SEstand

arderrorCI

con

fidence

interval

Timepoints(1)=

baselin

e(2)=

postintervention

(3)=

6-we

ekfollo

wup

(4)

=3-mon

thfollo

wup

and

(5)=

6-mon

thfollo

w-up

998787Ad

juste

dfora

ge

PSQI=

Pittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire


nificantatPlt005


nificantatPlt001


nificantatPlt000

1


Randomised (n=147)


Trip (n=1)



Sickness (n=1)




Trip (n=1)


Six-Week Follow-Up


Excluded (n=19)


Enrollment


(n=50)


(LAT + MAT)(n=51)

Allocation


(n=46)







Post-Intervention








6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)





4

5

6

7

8

9

10

11

PHQ

scor

e











5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of




















Table1Con

tinued

All

(N=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Sleeping

pills

taken

No

103

3433

360391

Previous

user

3214

711

Currentu

ser

122

64

Durationof

insomnia

(years)

Mean(SD)

1012

(1067)

923(

834)

1115

(1309)

1006(1040

)j

0678

Com

orbidillness

No

225

512

permil0488

Yes

125

4541

39Re

gulard

rugs

taken

No

3210

715

permil044

1Yes

11540

3936

PSQI(total)(0-21)

1263(324)

1267(315

)1289(413

)1235(234)

j0715

Sleeplatency(

min)

2703(2313)

2656(2376)

2868(2486)

2600(2119)

j0839

Totalsleep

time(

hours)

376

(196)

393

(193)

374

(186)

362

(210

)j

0734

Wakea

ftersleep

onset

(minutes)

9031

(8853)

9206(914

4)9003(995

6)8886(7595)

j0984

Sleepeffi

ciency

()

7233

(1609)

7244(1591)

7425(

1604)

7050(1642)

j0521

SF-12(PCS

)4139

(851)

4065(758)

4143(969)

4207(836)

j0707

SF-12(M

CS)

4668(1234)

4822(117

6)46

19(1349)

4562(118

9)j

0542

PHQ-9

947(607)

954(534)

952(669)

935(

626)

j0986

SDstand

arddeviation

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

njOne-w

ayanalysisof

varia

nce


permilCh

i-squ

aretest


nificantatPlt005


Table2Re

ported

adversee


satisfactiontowards

thetherapy

yen

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Havey

ouused

complem

entary

therapiesinthep

ast

permil0423

No

96(653

)33

3330

Yes

51(347

)17

1321

How

muchfaith

doyouhave

incomplem

entary

therapiesin

general

(0to

10)

782(213

)840

(194)

748(218

)75

5(218

)j

0056


towards

MAT

(0to

10)

741(210)

796(211)

693

(203)

731(207)

j0051


towards

LAT

(0to

10)

741(213)

808

(200)

687

(209)

725(

215)

j0016lowast

Averagee

xpectatio

nfor

treatmenteffect

(0to

10)

773(213

)840

(203)

720(203)

757(218

)j

0016lowast

Earitchinessyen

16(109

)8lowast

(resolve

automatically)

2lowast(resolve

automatically)

6lowast(resolve

automatically)

---


Table2Con

tinued

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Tend

ernesson

acup

ointsyen

20(136

)9lowast

(resolve

automatically)

1lowast(resolve

automatically)

10lowast

(resolve

automatically)

---

Satisfactiontowards

therapy(

0to

10)yen

758(237

)78

6(203)

702(268)

758(237

)j

0225

Thou

ghtthattheymight


atmentyen

No

126(900

)39

4146

0011lowast

Yes

14(100

)10

31

Will


othersyen

0166

Definitelywill

109(757

)38

2942

Maybe

20(139

)5

96

No

15(104

)6

72

Mean(stand

arddeviation)

unlessotherw

iseno

ted

ΩAssociatio

nbetweenvaria

bles

was

determ

ined

bychi-s

quarea

nalyseso

rFish

errsquos-exacttestw

here

approp

riate

Evaluated


nyenE

valuated

after

theinterventionhasb

eencompleted

lowastldquoC

ertainrdquoc

ausality

jOne-w

ayanalysisof

varia

nce


permilCh

i-squ

aretest


nificantatPlt005


Table3Outcomev

ariables

acrossthreeg

roup

satd

ifferenttim

epoints

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PSQI(total)(0-21)

Baselin

e1268(044)

1290(062)

1234(034)

Postinterventio

n94

6(052

)99

1(055)

848

(051)

023

(-14

418

9)-065(

-23610

6)087

(-055230)

6we

eksfollowup

907(053

)92

5(065)

926(054)

-050(-207197)

053

(-114219)

-058(-254138)

3mon

thsfollowup

912(079)

781(068)

906(058)

-154(-400

093)

027

(-18

8242)

-181(-399037)

6-mon

thfollo

wup

820

(062)

796(067)

846

(066)

-047(-268175)

059

(-13

8256)

-106(-316105)


Baselin

e2682(333

)2916

(359)

2517

(286)

Postinterventio

n2529(297)

2500(332

)2617

(303)

(-1329802)

223

(-8111257)

-486(-1533

560)

6we

eksfollowup

1935(322)

2656(339

)2368(330)

487

(-77

31747)

567

(-589172

3)-080(-11771018

)3m

onthsfollowup

1799

(337

)2129(356)

2390(422)

096

(-11491341)

725(

-6932143)

-629(-2065807)

6-mon

thfollo

wup

1966(531

)2342(539

)1907(434)

143(-15791864)

076

(-15341686)

067

(-15851718)

Totalslee

ptim

e(hours)

Baselin

e393

(027)

375

(028)

361

(030)

Postinterventio

n393

(249)

405

(030)

396

(029)

031(-067128)

035

(-065136)

-005(

-117108)

6we

eksfollowup

381

(027)

390

(029)

385

(025)

027

(06812

3)036

(-059131

)-009(-116099)

3mon

thsfollowup

366

(044)

426

(049)

338

(024)

077

(-081236)

0034(-13

213

9)074

(-061209)

6-mon

thfollo

wup

392

(049)

442

(061)

371

(045)

068

(-10

3238)

0112(-14

516

8)057

(-114227)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

Wakea

fterslee

ponset

(minutes)

Baselin

e9232

(1283)

9051(1464)

8833

(1031)

Postinterventio

n6944(1041)

7160(949)

6584(886)

397

(-22032996)

038

(-23412418

)358

(-24423159)

6we

eksfollowup

5145(510

)6140(860)

6234(707)

1176

(-24444795)

1488(-1749472

5)-313

(-39793354)

3mon

thsfollowup

5082(913

)7474

(2096)

6390(1200

)2573(

-3806

895

1)1706

(-304364

55)

867

(-55727306)

6-mon

thfollo

wup

4881(96

6)8087(2646

)6159(110

4)3387(-385710630)

1677(-307164

24)

1710

(-55558975)

Sleepeffi

ciency()

Baselin

e7234(223)

7406(238)

7070(223)

Postinterventio

n7828(190)

7694(193)

7886(164)

-306(-852240)

222

(-406

850)

-528(-116110

5)6we

eksfollowup

7757(180)

7614

(249)

7457(221)

-314

(-93

1303)

-136(-77

1500

)-178(-875518

)12-w

eekfollo

wup

8132

(198)

7802(356)

7882(234)

-503(

-1544

539

)-087(-1027854)

-416

(-1543710)

6-mon

thfollo

wup

7602(

484)

7737

(464)

8019

(220)

-037

(-14641390)

581

(-618178

0)-618

(-1897662)

SF-12

(PCS

)Ba

selin

e40

87(109)

4184(137

)4164(119

)-

Postinterventio

n44

46(123)

4312

(138)

4296(122)

231

(-600

139

)-227(-569114

)-0035

(-362355)

6-we

eksfollowup

4504(134)

4258(144)

4033

(151)

-342(-75

1066

)-547(-98

9-106)lowast

205

(-206

615

)3m

onthsfollowup

4555(

134)

4621(14

2)4130(166)

-031

(-469407)

-502(

-953

-052)lowast

472

(013

930)lowast

6-mon

thfollo

wup

4626(136)

4596(141)

4199(229)

-126(-563311)

-503(

-1055048)

377

(-206

960)

SF-12

(MCS

)Ba

selin

e4799(163)

4577(195)

4605(163)

Postinterventio

n5184(164)

4735(

178)

5058(137

)-226(-710257)

0675(-402537

)-294(-74

215

4)6we

eksfollowup

5097(161)

5089(184)

5315

(165)

214

(-262690)

412

(-095918

)-198(-673277)

3mon

thsfollowup

4805(231

)5131

(227)

5055(

176)

548

(-15

21247)

444

(-18

01067)

104(-538747)

6-mon

thfollo

wup

5164(200)

5224(205)

5105(220)

282

(-383947)

135(-524794)

147(-541836)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PHQ-9

(0-27)

Baselin

e95

2(074

)94

8(096)

940(086)

Postinterventio

n630

(071)

677

(095)

646

(079)

0504(-15

2252)

028

(-17

8235)

022

(-17

2217)

6we

eksfollowup

687

(100)

649

(111)

500

(071)

-035(

-273204

)-175(-429078)

141(-064345)

3mon

thsfollowup

658

(120)

568

(129)

655

(119

)ndash0

87(-393221)

009

(-308326)

-096(-405214

)6-mon

thfollo

wup

477

(097)

582

(130)

568

(105)

110(-18

8401)

104(-18

7395)

006

(-307318

)nE

stimated

meanandsta

ndarderror(SE

)from

generalized

estim

atingequatio

ns

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

n998787Ad

juste

dfora

ge


nificantatPlt005


Table4Ch

ange

indifferent

outcom

evariables

over

timefor

individu

algrou

psusinggeneralized

estim

atingequatio

ns

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

1PlaceboLA

TampMAT

(119899=5

0)PS

QI(0-21total)

-321(-456-187)

000

0lowastlowastlowast

-361(-483-238)

000

0lowastlowastlowast

-356(-528-18

3)000

0lowastlowastlowast

-447(-595-300

)000

0lowastlowastlowast

Sleeplatency(

minutes)

-153

(-897592)

0688

-747(-1674

181)

0115

-883(-1748-018)

004

5lowast-716

(-1908475)

0239

Totalsleep

time(

hours)

-001(-059058)

0989

-012

(-069045)

0681

-027(-13

9086)

064

2-001(-112

109)

0985

Wakea

ftersleep

onset

(minutes)

-2287

(-3801-774

)0003lowastlowast

-4087

(-6338

-1836)

000

0lowastlowastlowast

-414

9(-7447-852

)0014lowast

-4351

(-7726-976

)0012lowast

Sleepeffi

ciency

()

594

(212

976

)0002lowastlowast

522

(13690

9)000

8lowastlowast

898

(3071490)

0003lowastlowast

368

(-5991335)

0455

SF12

(PCS

)359

(109609)

000

5lowastlowast

416

(10672

7)000

9lowastlowast

468

(16477

2)0003lowastlowast

538

(258819)

000

0lowastlowastlowast

SF12

(MCS

)385

(02974

1)0034lowast

298

(061657)

0103

006

(-476488)

0980

365

(-083812

)0110

PHQ-9

(0-27)

-322(-473-17

1)000

0lowastlowastlowast

-265(-463-066

)000

9lowastlowast

-294(-517-071)

0010lowast

-475(

-669-282)

000

0lowastlowastlowast

Group

2LA

TampplaceboMAT

(n=4

6)PS

QI(0-21total)

-299(-396-202)

000

0lowastlowastlowast

-366(-526-205)

000

0lowastlowastlowast

-509(-685-333)

000

0lowastlowastlowast

-494(-660

-328)

000

0lowastlowastlowast

Sleeplatency(

minutes)

-416

(-1178346)

0284

-259(-1115596)

0552

-787(-168210

8)0085

-574

(-1818

671)

0366

Totalsleep

time(

hours)

030

(-047108)

044

4015

(-061092)

0695

051

(-061162)

0375

067

(-064

197)

0316

Wakea

ftersleep

onset

(minutes)

-1891

(-40

04223)

0080

-291

1(-574

9-072)

004

4lowast-1576

(-70403888)

0572

-964(-74215494)

0770

Sleepeffi

ciency

()

288

(-10

3678)

0148

208

(-272689)

0396

396

(-4621253)

0366

331

(-7321395)

0542

SF12

(PCS

)12

8(-14

4400

)0357

074

(-19

1339)

0585

437

(121753)

000

7lowastlowast

412

(07574

9)0017lowast

SF12

(MCS

)15

8(-16

8485)

0341

512

(199825)

000

1lowastlowast

554

(0481061)

0032lowast

647

(1551139)

0010lowast

PHQ-9

(0-27)

-272(

-406-138)

000

0lowastlowastlowast

-299(-431-16

7)000

0lowastlowastlowast

-380(-592-16

9)000

0lowastlowastlowast

-366(-591-14

1)000

1lowastlowast


Table4Con

tinued

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

3Com

binedAT

(n=5

1)PS

QI(0-21total)

-386(-491-282)

000

0lowastlowastlowast

-308(-420-19

5)000

0lowastlowastlowast

-328(-457-200

)000

0lowastlowastlowast

-388(-518258)

000

0lowastlowastlowast

Sleeplatency(

minutes)

070

(-647788)

0848

-180(-870510

)0610

-158(-128296

7)0784

-640(-1734454)

0251

Totalsleep

time(

hours)

035

(-046

116

)0399

024

(-052100)

0535

-023(

-099052)

0543

010

(-10

012

1)0858

Wakea

ftersleep

onset

(minutes)

-2249

(-40

86-412

)0016lowast

-2598

(-4925-272)

0029lowast

-2443

(-586297

6)0161

-2674

(-60

4970

1)0120

Sleepeffi

ciency

()

816

(118

1314)

000

1lowastlowast

387

(-118891)

0133

812

(0801544)

0030lowast

949(231

1668)

0010lowast

SF12

(PCS

)13

2(-10

1364

)0268

-131

(-445182)

0413

-035(

-367298)

0839

035

(-440

510

)0886

SF12

(MCS

)452

(146759)

000

4lowastlowast

710(352

1067)

000

0lowastlowastlowast

450

(055845)

0026lowast

500

(018

982)

004

2lowastPH

Q-9

(0-27)

-294(-435-15

3)000

0lowastlowastlowast

-440(-597-283)

000

0lowastlowastlowast

-285(

-510

-059)

0013lowast

-371(-589-154)

000

1lowastlowast

SEstand

arderrorCI

con

fidence

interval

Timepoints(1)=

baselin

e(2)=

postintervention

(3)=

6-we

ekfollo

wup

(4)

=3-mon

thfollo

wup

and

(5)=

6-mon

thfollo

w-up

998787Ad

juste

dfora

ge

PSQI=

Pittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire


nificantatPlt005


nificantatPlt001


nificantatPlt000

1


Randomised (n=147)


Trip (n=1)



Sickness (n=1)




Trip (n=1)


Six-Week Follow-Up


Excluded (n=19)


Enrollment


(n=50)


(LAT + MAT)(n=51)

Allocation


(n=46)







Post-Intervention








6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)





4

5

6

7

8

9

10

11

PHQ

scor

e











5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of




















Table2Re

ported

adversee


satisfactiontowards

thetherapy

yen

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Havey

ouused

complem

entary

therapiesinthep

ast

permil0423

No

96(653

)33

3330

Yes

51(347

)17

1321

How

muchfaith

doyouhave

incomplem

entary

therapiesin

general

(0to

10)

782(213

)840

(194)

748(218

)75

5(218

)j

0056


towards

MAT

(0to

10)

741(210)

796(211)

693

(203)

731(207)

j0051


towards

LAT

(0to

10)

741(213)

808

(200)

687

(209)

725(

215)

j0016lowast

Averagee

xpectatio

nfor

treatmenteffect

(0to

10)

773(213

)840

(203)

720(203)

757(218

)j

0016lowast

Earitchinessyen

16(109

)8lowast

(resolve

automatically)

2lowast(resolve

automatically)

6lowast(resolve

automatically)

---


Table2Con

tinued

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Tend

ernesson

acup

ointsyen

20(136

)9lowast

(resolve

automatically)

1lowast(resolve

automatically)

10lowast

(resolve

automatically)

---

Satisfactiontowards

therapy(

0to

10)yen

758(237

)78

6(203)

702(268)

758(237

)j

0225

Thou

ghtthattheymight


atmentyen

No

126(900

)39

4146

0011lowast

Yes

14(100

)10

31

Will


othersyen

0166

Definitelywill

109(757

)38

2942

Maybe

20(139

)5

96

No

15(104

)6

72

Mean(stand

arddeviation)

unlessotherw

iseno

ted

ΩAssociatio

nbetweenvaria

bles

was

determ

ined

bychi-s

quarea

nalyseso

rFish

errsquos-exacttestw

here

approp

riate

Evaluated


nyenE

valuated

after

theinterventionhasb

eencompleted

lowastldquoC

ertainrdquoc

ausality

jOne-w

ayanalysisof

varia

nce


permilCh

i-squ

aretest


nificantatPlt005


Table3Outcomev

ariables

acrossthreeg

roup

satd

ifferenttim

epoints

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PSQI(total)(0-21)

Baselin

e1268(044)

1290(062)

1234(034)

Postinterventio

n94

6(052

)99

1(055)

848

(051)

023

(-14

418

9)-065(

-23610

6)087

(-055230)

6we

eksfollowup

907(053

)92

5(065)

926(054)

-050(-207197)

053

(-114219)

-058(-254138)

3mon

thsfollowup

912(079)

781(068)

906(058)

-154(-400

093)

027

(-18

8242)

-181(-399037)

6-mon

thfollo

wup

820

(062)

796(067)

846

(066)

-047(-268175)

059

(-13

8256)

-106(-316105)


Baselin

e2682(333

)2916

(359)

2517

(286)

Postinterventio

n2529(297)

2500(332

)2617

(303)

(-1329802)

223

(-8111257)

-486(-1533

560)

6we

eksfollowup

1935(322)

2656(339

)2368(330)

487

(-77

31747)

567

(-589172

3)-080(-11771018

)3m

onthsfollowup

1799

(337

)2129(356)

2390(422)

096

(-11491341)

725(

-6932143)

-629(-2065807)

6-mon

thfollo

wup

1966(531

)2342(539

)1907(434)

143(-15791864)

076

(-15341686)

067

(-15851718)

Totalslee

ptim

e(hours)

Baselin

e393

(027)

375

(028)

361

(030)

Postinterventio

n393

(249)

405

(030)

396

(029)

031(-067128)

035

(-065136)

-005(

-117108)

6we

eksfollowup

381

(027)

390

(029)

385

(025)

027

(06812

3)036

(-059131

)-009(-116099)

3mon

thsfollowup

366

(044)

426

(049)

338

(024)

077

(-081236)

0034(-13

213

9)074

(-061209)

6-mon

thfollo

wup

392

(049)

442

(061)

371

(045)

068

(-10

3238)

0112(-14

516

8)057

(-114227)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

Wakea

fterslee

ponset

(minutes)

Baselin

e9232

(1283)

9051(1464)

8833

(1031)

Postinterventio

n6944(1041)

7160(949)

6584(886)

397

(-22032996)

038

(-23412418

)358

(-24423159)

6we

eksfollowup

5145(510

)6140(860)

6234(707)

1176

(-24444795)

1488(-1749472

5)-313

(-39793354)

3mon

thsfollowup

5082(913

)7474

(2096)

6390(1200

)2573(

-3806

895

1)1706

(-304364

55)

867

(-55727306)

6-mon

thfollo

wup

4881(96

6)8087(2646

)6159(110

4)3387(-385710630)

1677(-307164

24)

1710

(-55558975)

Sleepeffi

ciency()

Baselin

e7234(223)

7406(238)

7070(223)

Postinterventio

n7828(190)

7694(193)

7886(164)

-306(-852240)

222

(-406

850)

-528(-116110

5)6we

eksfollowup

7757(180)

7614

(249)

7457(221)

-314

(-93

1303)

-136(-77

1500

)-178(-875518

)12-w

eekfollo

wup

8132

(198)

7802(356)

7882(234)

-503(

-1544

539

)-087(-1027854)

-416

(-1543710)

6-mon

thfollo

wup

7602(

484)

7737

(464)

8019

(220)

-037

(-14641390)

581

(-618178

0)-618

(-1897662)

SF-12

(PCS

)Ba

selin

e40

87(109)

4184(137

)4164(119

)-

Postinterventio

n44

46(123)

4312

(138)

4296(122)

231

(-600

139

)-227(-569114

)-0035

(-362355)

6-we

eksfollowup

4504(134)

4258(144)

4033

(151)

-342(-75

1066

)-547(-98

9-106)lowast

205

(-206

615

)3m

onthsfollowup

4555(

134)

4621(14

2)4130(166)

-031

(-469407)

-502(

-953

-052)lowast

472

(013

930)lowast

6-mon

thfollo

wup

4626(136)

4596(141)

4199(229)

-126(-563311)

-503(

-1055048)

377

(-206

960)

SF-12

(MCS

)Ba

selin

e4799(163)

4577(195)

4605(163)

Postinterventio

n5184(164)

4735(

178)

5058(137

)-226(-710257)

0675(-402537

)-294(-74

215

4)6we

eksfollowup

5097(161)

5089(184)

5315

(165)

214

(-262690)

412

(-095918

)-198(-673277)

3mon

thsfollowup

4805(231

)5131

(227)

5055(

176)

548

(-15

21247)

444

(-18

01067)

104(-538747)

6-mon

thfollo

wup

5164(200)

5224(205)

5105(220)

282

(-383947)

135(-524794)

147(-541836)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PHQ-9

(0-27)

Baselin

e95

2(074

)94

8(096)

940(086)

Postinterventio

n630

(071)

677

(095)

646

(079)

0504(-15

2252)

028

(-17

8235)

022

(-17

2217)

6we

eksfollowup

687

(100)

649

(111)

500

(071)

-035(

-273204

)-175(-429078)

141(-064345)

3mon

thsfollowup

658

(120)

568

(129)

655

(119

)ndash0

87(-393221)

009

(-308326)

-096(-405214

)6-mon

thfollo

wup

477

(097)

582

(130)

568

(105)

110(-18

8401)

104(-18

7395)

006

(-307318

)nE

stimated

meanandsta

ndarderror(SE

)from

generalized

estim

atingequatio

ns

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

n998787Ad

juste

dfora

ge


nificantatPlt005


Table4Ch

ange

indifferent

outcom

evariables

over

timefor

individu

algrou

psusinggeneralized

estim

atingequatio

ns

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

1PlaceboLA

TampMAT

(119899=5

0)PS

QI(0-21total)

-321(-456-187)

000

0lowastlowastlowast

-361(-483-238)

000

0lowastlowastlowast

-356(-528-18

3)000

0lowastlowastlowast

-447(-595-300

)000

0lowastlowastlowast

Sleeplatency(

minutes)

-153

(-897592)

0688

-747(-1674

181)

0115

-883(-1748-018)

004

5lowast-716

(-1908475)

0239

Totalsleep

time(

hours)

-001(-059058)

0989

-012

(-069045)

0681

-027(-13

9086)

064

2-001(-112

109)

0985

Wakea

ftersleep

onset

(minutes)

-2287

(-3801-774

)0003lowastlowast

-4087

(-6338

-1836)

000

0lowastlowastlowast

-414

9(-7447-852

)0014lowast

-4351

(-7726-976

)0012lowast

Sleepeffi

ciency

()

594

(212

976

)0002lowastlowast

522

(13690

9)000

8lowastlowast

898

(3071490)

0003lowastlowast

368

(-5991335)

0455

SF12

(PCS

)359

(109609)

000

5lowastlowast

416

(10672

7)000

9lowastlowast

468

(16477

2)0003lowastlowast

538

(258819)

000

0lowastlowastlowast

SF12

(MCS

)385

(02974

1)0034lowast

298

(061657)

0103

006

(-476488)

0980

365

(-083812

)0110

PHQ-9

(0-27)

-322(-473-17

1)000

0lowastlowastlowast

-265(-463-066

)000

9lowastlowast

-294(-517-071)

0010lowast

-475(

-669-282)

000

0lowastlowastlowast

Group

2LA

TampplaceboMAT

(n=4

6)PS

QI(0-21total)

-299(-396-202)

000

0lowastlowastlowast

-366(-526-205)

000

0lowastlowastlowast

-509(-685-333)

000

0lowastlowastlowast

-494(-660

-328)

000

0lowastlowastlowast

Sleeplatency(

minutes)

-416

(-1178346)

0284

-259(-1115596)

0552

-787(-168210

8)0085

-574

(-1818

671)

0366

Totalsleep

time(

hours)

030

(-047108)

044

4015

(-061092)

0695

051

(-061162)

0375

067

(-064

197)

0316

Wakea

ftersleep

onset

(minutes)

-1891

(-40

04223)

0080

-291

1(-574

9-072)

004

4lowast-1576

(-70403888)

0572

-964(-74215494)

0770

Sleepeffi

ciency

()

288

(-10

3678)

0148

208

(-272689)

0396

396

(-4621253)

0366

331

(-7321395)

0542

SF12

(PCS

)12

8(-14

4400

)0357

074

(-19

1339)

0585

437

(121753)

000

7lowastlowast

412

(07574

9)0017lowast

SF12

(MCS

)15

8(-16

8485)

0341

512

(199825)

000

1lowastlowast

554

(0481061)

0032lowast

647

(1551139)

0010lowast

PHQ-9

(0-27)

-272(

-406-138)

000

0lowastlowastlowast

-299(-431-16

7)000

0lowastlowastlowast

-380(-592-16

9)000

0lowastlowastlowast

-366(-591-14

1)000

1lowastlowast


Table4Con

tinued

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

3Com

binedAT

(n=5

1)PS

QI(0-21total)

-386(-491-282)

000

0lowastlowastlowast

-308(-420-19

5)000

0lowastlowastlowast

-328(-457-200

)000

0lowastlowastlowast

-388(-518258)

000

0lowastlowastlowast

Sleeplatency(

minutes)

070

(-647788)

0848

-180(-870510

)0610

-158(-128296

7)0784

-640(-1734454)

0251

Totalsleep

time(

hours)

035

(-046

116

)0399

024

(-052100)

0535

-023(

-099052)

0543

010

(-10

012

1)0858

Wakea

ftersleep

onset

(minutes)

-2249

(-40

86-412

)0016lowast

-2598

(-4925-272)

0029lowast

-2443

(-586297

6)0161

-2674

(-60

4970

1)0120

Sleepeffi

ciency

()

816

(118

1314)

000

1lowastlowast

387

(-118891)

0133

812

(0801544)

0030lowast

949(231

1668)

0010lowast

SF12

(PCS

)13

2(-10

1364

)0268

-131

(-445182)

0413

-035(

-367298)

0839

035

(-440

510

)0886

SF12

(MCS

)452

(146759)

000

4lowastlowast

710(352

1067)

000

0lowastlowastlowast

450

(055845)

0026lowast

500

(018

982)

004

2lowastPH

Q-9

(0-27)

-294(-435-15

3)000

0lowastlowastlowast

-440(-597-283)

000

0lowastlowastlowast

-285(

-510

-059)

0013lowast

-371(-589-154)

000

1lowastlowast

SEstand

arderrorCI

con

fidence

interval

Timepoints(1)=

baselin

e(2)=

postintervention

(3)=

6-we

ekfollo

wup

(4)

=3-mon

thfollo

wup

and

(5)=

6-mon

thfollo

w-up

998787Ad

juste

dfora

ge

PSQI=

Pittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire


nificantatPlt005


nificantatPlt001


nificantatPlt000

1


Randomised (n=147)


Trip (n=1)



Sickness (n=1)




Trip (n=1)


Six-Week Follow-Up


Excluded (n=19)


Enrollment


(n=50)


(LAT + MAT)(n=51)

Allocation


(n=46)







Post-Intervention








6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)





4

5

6

7

8

9

10

11

PHQ

scor

e











5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of




















Table2Con

tinued

All

(n=147)

Group

1PlaceboLA

TampMAT

(n=5

0)

Group

2LA

TampplaceboMAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)P-value

Tend

ernesson

acup

ointsyen

20(136

)9lowast

(resolve

automatically)

1lowast(resolve

automatically)

10lowast

(resolve

automatically)

---

Satisfactiontowards

therapy(

0to

10)yen

758(237

)78

6(203)

702(268)

758(237

)j

0225

Thou

ghtthattheymight


atmentyen

No

126(900

)39

4146

0011lowast

Yes

14(100

)10

31

Will


othersyen

0166

Definitelywill

109(757

)38

2942

Maybe

20(139

)5

96

No

15(104

)6

72

Mean(stand

arddeviation)

unlessotherw

iseno

ted

ΩAssociatio

nbetweenvaria

bles

was

determ

ined

bychi-s

quarea

nalyseso

rFish

errsquos-exacttestw

here

approp

riate

Evaluated


nyenE

valuated

after

theinterventionhasb

eencompleted

lowastldquoC

ertainrdquoc

ausality

jOne-w

ayanalysisof

varia

nce


permilCh

i-squ

aretest


nificantatPlt005


Table3Outcomev

ariables

acrossthreeg

roup

satd

ifferenttim

epoints

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PSQI(total)(0-21)

Baselin

e1268(044)

1290(062)

1234(034)

Postinterventio

n94

6(052

)99

1(055)

848

(051)

023

(-14

418

9)-065(

-23610

6)087

(-055230)

6we

eksfollowup

907(053

)92

5(065)

926(054)

-050(-207197)

053

(-114219)

-058(-254138)

3mon

thsfollowup

912(079)

781(068)

906(058)

-154(-400

093)

027

(-18

8242)

-181(-399037)

6-mon

thfollo

wup

820

(062)

796(067)

846

(066)

-047(-268175)

059

(-13

8256)

-106(-316105)


Baselin

e2682(333

)2916

(359)

2517

(286)

Postinterventio

n2529(297)

2500(332

)2617

(303)

(-1329802)

223

(-8111257)

-486(-1533

560)

6we

eksfollowup

1935(322)

2656(339

)2368(330)

487

(-77

31747)

567

(-589172

3)-080(-11771018

)3m

onthsfollowup

1799

(337

)2129(356)

2390(422)

096

(-11491341)

725(

-6932143)

-629(-2065807)

6-mon

thfollo

wup

1966(531

)2342(539

)1907(434)

143(-15791864)

076

(-15341686)

067

(-15851718)

Totalslee

ptim

e(hours)

Baselin

e393

(027)

375

(028)

361

(030)

Postinterventio

n393

(249)

405

(030)

396

(029)

031(-067128)

035

(-065136)

-005(

-117108)

6we

eksfollowup

381

(027)

390

(029)

385

(025)

027

(06812

3)036

(-059131

)-009(-116099)

3mon

thsfollowup

366

(044)

426

(049)

338

(024)

077

(-081236)

0034(-13

213

9)074

(-061209)

6-mon

thfollo

wup

392

(049)

442

(061)

371

(045)

068

(-10

3238)

0112(-14

516

8)057

(-114227)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

Wakea

fterslee

ponset

(minutes)

Baselin

e9232

(1283)

9051(1464)

8833

(1031)

Postinterventio

n6944(1041)

7160(949)

6584(886)

397

(-22032996)

038

(-23412418

)358

(-24423159)

6we

eksfollowup

5145(510

)6140(860)

6234(707)

1176

(-24444795)

1488(-1749472

5)-313

(-39793354)

3mon

thsfollowup

5082(913

)7474

(2096)

6390(1200

)2573(

-3806

895

1)1706

(-304364

55)

867

(-55727306)

6-mon

thfollo

wup

4881(96

6)8087(2646

)6159(110

4)3387(-385710630)

1677(-307164

24)

1710

(-55558975)

Sleepeffi

ciency()

Baselin

e7234(223)

7406(238)

7070(223)

Postinterventio

n7828(190)

7694(193)

7886(164)

-306(-852240)

222

(-406

850)

-528(-116110

5)6we

eksfollowup

7757(180)

7614

(249)

7457(221)

-314

(-93

1303)

-136(-77

1500

)-178(-875518

)12-w

eekfollo

wup

8132

(198)

7802(356)

7882(234)

-503(

-1544

539

)-087(-1027854)

-416

(-1543710)

6-mon

thfollo

wup

7602(

484)

7737

(464)

8019

(220)

-037

(-14641390)

581

(-618178

0)-618

(-1897662)

SF-12

(PCS

)Ba

selin

e40

87(109)

4184(137

)4164(119

)-

Postinterventio

n44

46(123)

4312

(138)

4296(122)

231

(-600

139

)-227(-569114

)-0035

(-362355)

6-we

eksfollowup

4504(134)

4258(144)

4033

(151)

-342(-75

1066

)-547(-98

9-106)lowast

205

(-206

615

)3m

onthsfollowup

4555(

134)

4621(14

2)4130(166)

-031

(-469407)

-502(

-953

-052)lowast

472

(013

930)lowast

6-mon

thfollo

wup

4626(136)

4596(141)

4199(229)

-126(-563311)

-503(

-1055048)

377

(-206

960)

SF-12

(MCS

)Ba

selin

e4799(163)

4577(195)

4605(163)

Postinterventio

n5184(164)

4735(

178)

5058(137

)-226(-710257)

0675(-402537

)-294(-74

215

4)6we

eksfollowup

5097(161)

5089(184)

5315

(165)

214

(-262690)

412

(-095918

)-198(-673277)

3mon

thsfollowup

4805(231

)5131

(227)

5055(

176)

548

(-15

21247)

444

(-18

01067)

104(-538747)

6-mon

thfollo

wup

5164(200)

5224(205)

5105(220)

282

(-383947)

135(-524794)

147(-541836)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PHQ-9

(0-27)

Baselin

e95

2(074

)94

8(096)

940(086)

Postinterventio

n630

(071)

677

(095)

646

(079)

0504(-15

2252)

028

(-17

8235)

022

(-17

2217)

6we

eksfollowup

687

(100)

649

(111)

500

(071)

-035(

-273204

)-175(-429078)

141(-064345)

3mon

thsfollowup

658

(120)

568

(129)

655

(119

)ndash0

87(-393221)

009

(-308326)

-096(-405214

)6-mon

thfollo

wup

477

(097)

582

(130)

568

(105)

110(-18

8401)

104(-18

7395)

006

(-307318

)nE

stimated

meanandsta

ndarderror(SE

)from

generalized

estim

atingequatio

ns

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

n998787Ad

juste

dfora

ge


nificantatPlt005


Table4Ch

ange

indifferent

outcom

evariables

over

timefor

individu

algrou

psusinggeneralized

estim

atingequatio

ns

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

1PlaceboLA

TampMAT

(119899=5

0)PS

QI(0-21total)

-321(-456-187)

000

0lowastlowastlowast

-361(-483-238)

000

0lowastlowastlowast

-356(-528-18

3)000

0lowastlowastlowast

-447(-595-300

)000

0lowastlowastlowast

Sleeplatency(

minutes)

-153

(-897592)

0688

-747(-1674

181)

0115

-883(-1748-018)

004

5lowast-716

(-1908475)

0239

Totalsleep

time(

hours)

-001(-059058)

0989

-012

(-069045)

0681

-027(-13

9086)

064

2-001(-112

109)

0985

Wakea

ftersleep

onset

(minutes)

-2287

(-3801-774

)0003lowastlowast

-4087

(-6338

-1836)

000

0lowastlowastlowast

-414

9(-7447-852

)0014lowast

-4351

(-7726-976

)0012lowast

Sleepeffi

ciency

()

594

(212

976

)0002lowastlowast

522

(13690

9)000

8lowastlowast

898

(3071490)

0003lowastlowast

368

(-5991335)

0455

SF12

(PCS

)359

(109609)

000

5lowastlowast

416

(10672

7)000

9lowastlowast

468

(16477

2)0003lowastlowast

538

(258819)

000

0lowastlowastlowast

SF12

(MCS

)385

(02974

1)0034lowast

298

(061657)

0103

006

(-476488)

0980

365

(-083812

)0110

PHQ-9

(0-27)

-322(-473-17

1)000

0lowastlowastlowast

-265(-463-066

)000

9lowastlowast

-294(-517-071)

0010lowast

-475(

-669-282)

000

0lowastlowastlowast

Group

2LA

TampplaceboMAT

(n=4

6)PS

QI(0-21total)

-299(-396-202)

000

0lowastlowastlowast

-366(-526-205)

000

0lowastlowastlowast

-509(-685-333)

000

0lowastlowastlowast

-494(-660

-328)

000

0lowastlowastlowast

Sleeplatency(

minutes)

-416

(-1178346)

0284

-259(-1115596)

0552

-787(-168210

8)0085

-574

(-1818

671)

0366

Totalsleep

time(

hours)

030

(-047108)

044

4015

(-061092)

0695

051

(-061162)

0375

067

(-064

197)

0316

Wakea

ftersleep

onset

(minutes)

-1891

(-40

04223)

0080

-291

1(-574

9-072)

004

4lowast-1576

(-70403888)

0572

-964(-74215494)

0770

Sleepeffi

ciency

()

288

(-10

3678)

0148

208

(-272689)

0396

396

(-4621253)

0366

331

(-7321395)

0542

SF12

(PCS

)12

8(-14

4400

)0357

074

(-19

1339)

0585

437

(121753)

000

7lowastlowast

412

(07574

9)0017lowast

SF12

(MCS

)15

8(-16

8485)

0341

512

(199825)

000

1lowastlowast

554

(0481061)

0032lowast

647

(1551139)

0010lowast

PHQ-9

(0-27)

-272(

-406-138)

000

0lowastlowastlowast

-299(-431-16

7)000

0lowastlowastlowast

-380(-592-16

9)000

0lowastlowastlowast

-366(-591-14

1)000

1lowastlowast


Table4Con

tinued

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

3Com

binedAT

(n=5

1)PS

QI(0-21total)

-386(-491-282)

000

0lowastlowastlowast

-308(-420-19

5)000

0lowastlowastlowast

-328(-457-200

)000

0lowastlowastlowast

-388(-518258)

000

0lowastlowastlowast

Sleeplatency(

minutes)

070

(-647788)

0848

-180(-870510

)0610

-158(-128296

7)0784

-640(-1734454)

0251

Totalsleep

time(

hours)

035

(-046

116

)0399

024

(-052100)

0535

-023(

-099052)

0543

010

(-10

012

1)0858

Wakea

ftersleep

onset

(minutes)

-2249

(-40

86-412

)0016lowast

-2598

(-4925-272)

0029lowast

-2443

(-586297

6)0161

-2674

(-60

4970

1)0120

Sleepeffi

ciency

()

816

(118

1314)

000

1lowastlowast

387

(-118891)

0133

812

(0801544)

0030lowast

949(231

1668)

0010lowast

SF12

(PCS

)13

2(-10

1364

)0268

-131

(-445182)

0413

-035(

-367298)

0839

035

(-440

510

)0886

SF12

(MCS

)452

(146759)

000

4lowastlowast

710(352

1067)

000

0lowastlowastlowast

450

(055845)

0026lowast

500

(018

982)

004

2lowastPH

Q-9

(0-27)

-294(-435-15

3)000

0lowastlowastlowast

-440(-597-283)

000

0lowastlowastlowast

-285(

-510

-059)

0013lowast

-371(-589-154)

000

1lowastlowast

SEstand

arderrorCI

con

fidence

interval

Timepoints(1)=

baselin

e(2)=

postintervention

(3)=

6-we

ekfollo

wup

(4)

=3-mon

thfollo

wup

and

(5)=

6-mon

thfollo

w-up

998787Ad

juste

dfora

ge

PSQI=

Pittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire


nificantatPlt005


nificantatPlt001


nificantatPlt000

1


Randomised (n=147)


Trip (n=1)



Sickness (n=1)




Trip (n=1)


Six-Week Follow-Up


Excluded (n=19)


Enrollment


(n=50)


(LAT + MAT)(n=51)

Allocation


(n=46)







Post-Intervention








6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)





4

5

6

7

8

9

10

11

PHQ

scor

e











5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of




















Table3Outcomev

ariables

acrossthreeg

roup

satd

ifferenttim

epoints

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PSQI(total)(0-21)

Baselin

e1268(044)

1290(062)

1234(034)

Postinterventio

n94

6(052

)99

1(055)

848

(051)

023

(-14

418

9)-065(

-23610

6)087

(-055230)

6we

eksfollowup

907(053

)92

5(065)

926(054)

-050(-207197)

053

(-114219)

-058(-254138)

3mon

thsfollowup

912(079)

781(068)

906(058)

-154(-400

093)

027

(-18

8242)

-181(-399037)

6-mon

thfollo

wup

820

(062)

796(067)

846

(066)

-047(-268175)

059

(-13

8256)

-106(-316105)


Baselin

e2682(333

)2916

(359)

2517

(286)

Postinterventio

n2529(297)

2500(332

)2617

(303)

(-1329802)

223

(-8111257)

-486(-1533

560)

6we

eksfollowup

1935(322)

2656(339

)2368(330)

487

(-77

31747)

567

(-589172

3)-080(-11771018

)3m

onthsfollowup

1799

(337

)2129(356)

2390(422)

096

(-11491341)

725(

-6932143)

-629(-2065807)

6-mon

thfollo

wup

1966(531

)2342(539

)1907(434)

143(-15791864)

076

(-15341686)

067

(-15851718)

Totalslee

ptim

e(hours)

Baselin

e393

(027)

375

(028)

361

(030)

Postinterventio

n393

(249)

405

(030)

396

(029)

031(-067128)

035

(-065136)

-005(

-117108)

6we

eksfollowup

381

(027)

390

(029)

385

(025)

027

(06812

3)036

(-059131

)-009(-116099)

3mon

thsfollowup

366

(044)

426

(049)

338

(024)

077

(-081236)

0034(-13

213

9)074

(-061209)

6-mon

thfollo

wup

392

(049)

442

(061)

371

(045)

068

(-10

3238)

0112(-14

516

8)057

(-114227)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

Wakea

fterslee

ponset

(minutes)

Baselin

e9232

(1283)

9051(1464)

8833

(1031)

Postinterventio

n6944(1041)

7160(949)

6584(886)

397

(-22032996)

038

(-23412418

)358

(-24423159)

6we

eksfollowup

5145(510

)6140(860)

6234(707)

1176

(-24444795)

1488(-1749472

5)-313

(-39793354)

3mon

thsfollowup

5082(913

)7474

(2096)

6390(1200

)2573(

-3806

895

1)1706

(-304364

55)

867

(-55727306)

6-mon

thfollo

wup

4881(96

6)8087(2646

)6159(110

4)3387(-385710630)

1677(-307164

24)

1710

(-55558975)

Sleepeffi

ciency()

Baselin

e7234(223)

7406(238)

7070(223)

Postinterventio

n7828(190)

7694(193)

7886(164)

-306(-852240)

222

(-406

850)

-528(-116110

5)6we

eksfollowup

7757(180)

7614

(249)

7457(221)

-314

(-93

1303)

-136(-77

1500

)-178(-875518

)12-w

eekfollo

wup

8132

(198)

7802(356)

7882(234)

-503(

-1544

539

)-087(-1027854)

-416

(-1543710)

6-mon

thfollo

wup

7602(

484)

7737

(464)

8019

(220)

-037

(-14641390)

581

(-618178

0)-618

(-1897662)

SF-12

(PCS

)Ba

selin

e40

87(109)

4184(137

)4164(119

)-

Postinterventio

n44

46(123)

4312

(138)

4296(122)

231

(-600

139

)-227(-569114

)-0035

(-362355)

6-we

eksfollowup

4504(134)

4258(144)

4033

(151)

-342(-75

1066

)-547(-98

9-106)lowast

205

(-206

615

)3m

onthsfollowup

4555(

134)

4621(14

2)4130(166)

-031

(-469407)

-502(

-953

-052)lowast

472

(013

930)lowast

6-mon

thfollo

wup

4626(136)

4596(141)

4199(229)

-126(-563311)

-503(

-1055048)

377

(-206

960)

SF-12

(MCS

)Ba

selin

e4799(163)

4577(195)

4605(163)

Postinterventio

n5184(164)

4735(

178)

5058(137

)-226(-710257)

0675(-402537

)-294(-74

215

4)6we

eksfollowup

5097(161)

5089(184)

5315

(165)

214

(-262690)

412

(-095918

)-198(-673277)

3mon

thsfollowup

4805(231

)5131

(227)

5055(

176)

548

(-15

21247)

444

(-18

01067)

104(-538747)

6-mon

thfollo

wup

5164(200)

5224(205)

5105(220)

282

(-383947)

135(-524794)

147(-541836)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PHQ-9

(0-27)

Baselin

e95

2(074

)94

8(096)

940(086)

Postinterventio

n630

(071)

677

(095)

646

(079)

0504(-15

2252)

028

(-17

8235)

022

(-17

2217)

6we

eksfollowup

687

(100)

649

(111)

500

(071)

-035(

-273204

)-175(-429078)

141(-064345)

3mon

thsfollowup

658

(120)

568

(129)

655

(119

)ndash0

87(-393221)

009

(-308326)

-096(-405214

)6-mon

thfollo

wup

477

(097)

582

(130)

568

(105)

110(-18

8401)

104(-18

7395)

006

(-307318

)nE

stimated

meanandsta

ndarderror(SE

)from

generalized

estim

atingequatio

ns

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

n998787Ad

juste

dfora

ge


nificantatPlt005


Table4Ch

ange

indifferent

outcom

evariables

over

timefor

individu

algrou

psusinggeneralized

estim

atingequatio

ns

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

1PlaceboLA

TampMAT

(119899=5

0)PS

QI(0-21total)

-321(-456-187)

000

0lowastlowastlowast

-361(-483-238)

000

0lowastlowastlowast

-356(-528-18

3)000

0lowastlowastlowast

-447(-595-300

)000

0lowastlowastlowast

Sleeplatency(

minutes)

-153

(-897592)

0688

-747(-1674

181)

0115

-883(-1748-018)

004

5lowast-716

(-1908475)

0239

Totalsleep

time(

hours)

-001(-059058)

0989

-012

(-069045)

0681

-027(-13

9086)

064

2-001(-112

109)

0985

Wakea

ftersleep

onset

(minutes)

-2287

(-3801-774

)0003lowastlowast

-4087

(-6338

-1836)

000

0lowastlowastlowast

-414

9(-7447-852

)0014lowast

-4351

(-7726-976

)0012lowast

Sleepeffi

ciency

()

594

(212

976

)0002lowastlowast

522

(13690

9)000

8lowastlowast

898

(3071490)

0003lowastlowast

368

(-5991335)

0455

SF12

(PCS

)359

(109609)

000

5lowastlowast

416

(10672

7)000

9lowastlowast

468

(16477

2)0003lowastlowast

538

(258819)

000

0lowastlowastlowast

SF12

(MCS

)385

(02974

1)0034lowast

298

(061657)

0103

006

(-476488)

0980

365

(-083812

)0110

PHQ-9

(0-27)

-322(-473-17

1)000

0lowastlowastlowast

-265(-463-066

)000

9lowastlowast

-294(-517-071)

0010lowast

-475(

-669-282)

000

0lowastlowastlowast

Group

2LA

TampplaceboMAT

(n=4

6)PS

QI(0-21total)

-299(-396-202)

000

0lowastlowastlowast

-366(-526-205)

000

0lowastlowastlowast

-509(-685-333)

000

0lowastlowastlowast

-494(-660

-328)

000

0lowastlowastlowast

Sleeplatency(

minutes)

-416

(-1178346)

0284

-259(-1115596)

0552

-787(-168210

8)0085

-574

(-1818

671)

0366

Totalsleep

time(

hours)

030

(-047108)

044

4015

(-061092)

0695

051

(-061162)

0375

067

(-064

197)

0316

Wakea

ftersleep

onset

(minutes)

-1891

(-40

04223)

0080

-291

1(-574

9-072)

004

4lowast-1576

(-70403888)

0572

-964(-74215494)

0770

Sleepeffi

ciency

()

288

(-10

3678)

0148

208

(-272689)

0396

396

(-4621253)

0366

331

(-7321395)

0542

SF12

(PCS

)12

8(-14

4400

)0357

074

(-19

1339)

0585

437

(121753)

000

7lowastlowast

412

(07574

9)0017lowast

SF12

(MCS

)15

8(-16

8485)

0341

512

(199825)

000

1lowastlowast

554

(0481061)

0032lowast

647

(1551139)

0010lowast

PHQ-9

(0-27)

-272(

-406-138)

000

0lowastlowastlowast

-299(-431-16

7)000

0lowastlowastlowast

-380(-592-16

9)000

0lowastlowastlowast

-366(-591-14

1)000

1lowastlowast


Table4Con

tinued

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

3Com

binedAT

(n=5

1)PS

QI(0-21total)

-386(-491-282)

000

0lowastlowastlowast

-308(-420-19

5)000

0lowastlowastlowast

-328(-457-200

)000

0lowastlowastlowast

-388(-518258)

000

0lowastlowastlowast

Sleeplatency(

minutes)

070

(-647788)

0848

-180(-870510

)0610

-158(-128296

7)0784

-640(-1734454)

0251

Totalsleep

time(

hours)

035

(-046

116

)0399

024

(-052100)

0535

-023(

-099052)

0543

010

(-10

012

1)0858

Wakea

ftersleep

onset

(minutes)

-2249

(-40

86-412

)0016lowast

-2598

(-4925-272)

0029lowast

-2443

(-586297

6)0161

-2674

(-60

4970

1)0120

Sleepeffi

ciency

()

816

(118

1314)

000

1lowastlowast

387

(-118891)

0133

812

(0801544)

0030lowast

949(231

1668)

0010lowast

SF12

(PCS

)13

2(-10

1364

)0268

-131

(-445182)

0413

-035(

-367298)

0839

035

(-440

510

)0886

SF12

(MCS

)452

(146759)

000

4lowastlowast

710(352

1067)

000

0lowastlowastlowast

450

(055845)

0026lowast

500

(018

982)

004

2lowastPH

Q-9

(0-27)

-294(-435-15

3)000

0lowastlowastlowast

-440(-597-283)

000

0lowastlowastlowast

-285(

-510

-059)

0013lowast

-371(-589-154)

000

1lowastlowast

SEstand

arderrorCI

con

fidence

interval

Timepoints(1)=

baselin

e(2)=

postintervention

(3)=

6-we

ekfollo

wup

(4)

=3-mon

thfollo

wup

and

(5)=

6-mon

thfollo

w-up

998787Ad

juste

dfora

ge

PSQI=

Pittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire


nificantatPlt005


nificantatPlt001


nificantatPlt000

1


Randomised (n=147)


Trip (n=1)



Sickness (n=1)




Trip (n=1)


Six-Week Follow-Up


Excluded (n=19)


Enrollment


(n=50)


(LAT + MAT)(n=51)

Allocation


(n=46)







Post-Intervention








6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)





4

5

6

7

8

9

10

11

PHQ

scor

e











5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of




















Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

Wakea

fterslee

ponset

(minutes)

Baselin

e9232

(1283)

9051(1464)

8833

(1031)

Postinterventio

n6944(1041)

7160(949)

6584(886)

397

(-22032996)

038

(-23412418

)358

(-24423159)

6we

eksfollowup

5145(510

)6140(860)

6234(707)

1176

(-24444795)

1488(-1749472

5)-313

(-39793354)

3mon

thsfollowup

5082(913

)7474

(2096)

6390(1200

)2573(

-3806

895

1)1706

(-304364

55)

867

(-55727306)

6-mon

thfollo

wup

4881(96

6)8087(2646

)6159(110

4)3387(-385710630)

1677(-307164

24)

1710

(-55558975)

Sleepeffi

ciency()

Baselin

e7234(223)

7406(238)

7070(223)

Postinterventio

n7828(190)

7694(193)

7886(164)

-306(-852240)

222

(-406

850)

-528(-116110

5)6we

eksfollowup

7757(180)

7614

(249)

7457(221)

-314

(-93

1303)

-136(-77

1500

)-178(-875518

)12-w

eekfollo

wup

8132

(198)

7802(356)

7882(234)

-503(

-1544

539

)-087(-1027854)

-416

(-1543710)

6-mon

thfollo

wup

7602(

484)

7737

(464)

8019

(220)

-037

(-14641390)

581

(-618178

0)-618

(-1897662)

SF-12

(PCS

)Ba

selin

e40

87(109)

4184(137

)4164(119

)-

Postinterventio

n44

46(123)

4312

(138)

4296(122)

231

(-600

139

)-227(-569114

)-0035

(-362355)

6-we

eksfollowup

4504(134)

4258(144)

4033

(151)

-342(-75

1066

)-547(-98

9-106)lowast

205

(-206

615

)3m

onthsfollowup

4555(

134)

4621(14

2)4130(166)

-031

(-469407)

-502(

-953

-052)lowast

472

(013

930)lowast

6-mon

thfollo

wup

4626(136)

4596(141)

4199(229)

-126(-563311)

-503(

-1055048)

377

(-206

960)

SF-12

(MCS

)Ba

selin

e4799(163)

4577(195)

4605(163)

Postinterventio

n5184(164)

4735(

178)

5058(137

)-226(-710257)

0675(-402537

)-294(-74

215

4)6we

eksfollowup

5097(161)

5089(184)

5315

(165)

214

(-262690)

412

(-095918

)-198(-673277)

3mon

thsfollowup

4805(231

)5131

(227)

5055(

176)

548

(-15

21247)

444

(-18

01067)

104(-538747)

6-mon

thfollo

wup

5164(200)

5224(205)

5105(220)

282

(-383947)

135(-524794)

147(-541836)


Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PHQ-9

(0-27)

Baselin

e95

2(074

)94

8(096)

940(086)

Postinterventio

n630

(071)

677

(095)

646

(079)

0504(-15

2252)

028

(-17

8235)

022

(-17

2217)

6we

eksfollowup

687

(100)

649

(111)

500

(071)

-035(

-273204

)-175(-429078)

141(-064345)

3mon

thsfollowup

658

(120)

568

(129)

655

(119

)ndash0

87(-393221)

009

(-308326)

-096(-405214

)6-mon

thfollo

wup

477

(097)

582

(130)

568

(105)

110(-18

8401)

104(-18

7395)

006

(-307318

)nE

stimated

meanandsta

ndarderror(SE

)from

generalized

estim

atingequatio

ns

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

n998787Ad

juste

dfora

ge


nificantatPlt005


Table4Ch

ange

indifferent

outcom

evariables

over

timefor

individu

algrou

psusinggeneralized

estim

atingequatio

ns

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

1PlaceboLA

TampMAT

(119899=5

0)PS

QI(0-21total)

-321(-456-187)

000

0lowastlowastlowast

-361(-483-238)

000

0lowastlowastlowast

-356(-528-18

3)000

0lowastlowastlowast

-447(-595-300

)000

0lowastlowastlowast

Sleeplatency(

minutes)

-153

(-897592)

0688

-747(-1674

181)

0115

-883(-1748-018)

004

5lowast-716

(-1908475)

0239

Totalsleep

time(

hours)

-001(-059058)

0989

-012

(-069045)

0681

-027(-13

9086)

064

2-001(-112

109)

0985

Wakea

ftersleep

onset

(minutes)

-2287

(-3801-774

)0003lowastlowast

-4087

(-6338

-1836)

000

0lowastlowastlowast

-414

9(-7447-852

)0014lowast

-4351

(-7726-976

)0012lowast

Sleepeffi

ciency

()

594

(212

976

)0002lowastlowast

522

(13690

9)000

8lowastlowast

898

(3071490)

0003lowastlowast

368

(-5991335)

0455

SF12

(PCS

)359

(109609)

000

5lowastlowast

416

(10672

7)000

9lowastlowast

468

(16477

2)0003lowastlowast

538

(258819)

000

0lowastlowastlowast

SF12

(MCS

)385

(02974

1)0034lowast

298

(061657)

0103

006

(-476488)

0980

365

(-083812

)0110

PHQ-9

(0-27)

-322(-473-17

1)000

0lowastlowastlowast

-265(-463-066

)000

9lowastlowast

-294(-517-071)

0010lowast

-475(

-669-282)

000

0lowastlowastlowast

Group

2LA

TampplaceboMAT

(n=4

6)PS

QI(0-21total)

-299(-396-202)

000

0lowastlowastlowast

-366(-526-205)

000

0lowastlowastlowast

-509(-685-333)

000

0lowastlowastlowast

-494(-660

-328)

000

0lowastlowastlowast

Sleeplatency(

minutes)

-416

(-1178346)

0284

-259(-1115596)

0552

-787(-168210

8)0085

-574

(-1818

671)

0366

Totalsleep

time(

hours)

030

(-047108)

044

4015

(-061092)

0695

051

(-061162)

0375

067

(-064

197)

0316

Wakea

ftersleep

onset

(minutes)

-1891

(-40

04223)

0080

-291

1(-574

9-072)

004

4lowast-1576

(-70403888)

0572

-964(-74215494)

0770

Sleepeffi

ciency

()

288

(-10

3678)

0148

208

(-272689)

0396

396

(-4621253)

0366

331

(-7321395)

0542

SF12

(PCS

)12

8(-14

4400

)0357

074

(-19

1339)

0585

437

(121753)

000

7lowastlowast

412

(07574

9)0017lowast

SF12

(MCS

)15

8(-16

8485)

0341

512

(199825)

000

1lowastlowast

554

(0481061)

0032lowast

647

(1551139)

0010lowast

PHQ-9

(0-27)

-272(

-406-138)

000

0lowastlowastlowast

-299(-431-16

7)000

0lowastlowastlowast

-380(-592-16

9)000

0lowastlowastlowast

-366(-591-14

1)000

1lowastlowast


Table4Con

tinued

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

3Com

binedAT

(n=5

1)PS

QI(0-21total)

-386(-491-282)

000

0lowastlowastlowast

-308(-420-19

5)000

0lowastlowastlowast

-328(-457-200

)000

0lowastlowastlowast

-388(-518258)

000

0lowastlowastlowast

Sleeplatency(

minutes)

070

(-647788)

0848

-180(-870510

)0610

-158(-128296

7)0784

-640(-1734454)

0251

Totalsleep

time(

hours)

035

(-046

116

)0399

024

(-052100)

0535

-023(

-099052)

0543

010

(-10

012

1)0858

Wakea

ftersleep

onset

(minutes)

-2249

(-40

86-412

)0016lowast

-2598

(-4925-272)

0029lowast

-2443

(-586297

6)0161

-2674

(-60

4970

1)0120

Sleepeffi

ciency

()

816

(118

1314)

000

1lowastlowast

387

(-118891)

0133

812

(0801544)

0030lowast

949(231

1668)

0010lowast

SF12

(PCS

)13

2(-10

1364

)0268

-131

(-445182)

0413

-035(

-367298)

0839

035

(-440

510

)0886

SF12

(MCS

)452

(146759)

000

4lowastlowast

710(352

1067)

000

0lowastlowastlowast

450

(055845)

0026lowast

500

(018

982)

004

2lowastPH

Q-9

(0-27)

-294(-435-15

3)000

0lowastlowastlowast

-440(-597-283)

000

0lowastlowastlowast

-285(

-510

-059)

0013lowast

-371(-589-154)

000

1lowastlowast

SEstand

arderrorCI

con

fidence

interval

Timepoints(1)=

baselin

e(2)=

postintervention

(3)=

6-we

ekfollo

wup

(4)

=3-mon

thfollo

wup

and

(5)=

6-mon

thfollo

w-up

998787Ad

juste

dfora

ge

PSQI=

Pittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire


nificantatPlt005


nificantatPlt001


nificantatPlt000

1


Randomised (n=147)


Trip (n=1)



Sickness (n=1)




Trip (n=1)


Six-Week Follow-Up


Excluded (n=19)


Enrollment


(n=50)


(LAT + MAT)(n=51)

Allocation


(n=46)







Post-Intervention








6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)





4

5

6

7

8

9

10

11

PHQ

scor

e











5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of




















Table3Con

tinued

Pairw

isecomparis

onsb

etwe

engrou

ps998787

Group

1PlaceboLA

Tamp

MAT

(n=5

0)

Group

2LA

Tampplacebo

MAT

(n=4

6)

Group

3Com

binedAT

(n=5

1)Group

1vsG

roup

2Group

1vsG

roup

3Group

3vs

Group

2

Estim

ated

mean

(SE)

nEstim

ated

mean

(SE)

nEstim

ated

mean

(SE)

n120573(95

CI)

120573(95

CI)

120573(95

CI)

PHQ-9

(0-27)

Baselin

e95

2(074

)94

8(096)

940(086)

Postinterventio

n630

(071)

677

(095)

646

(079)

0504(-15

2252)

028

(-17

8235)

022

(-17

2217)

6we

eksfollowup

687

(100)

649

(111)

500

(071)

-035(

-273204

)-175(-429078)

141(-064345)

3mon

thsfollowup

658

(120)

568

(129)

655

(119

)ndash0

87(-393221)

009

(-308326)

-096(-405214

)6-mon

thfollo

wup

477

(097)

582

(130)

568

(105)

110(-18

8401)

104(-18

7395)

006

(-307318

)nE

stimated

meanandsta

ndarderror(SE

)from

generalized

estim

atingequatio

ns

PSQIPittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire

for

depressio

n998787Ad

juste

dfora

ge


nificantatPlt005


Table4Ch

ange

indifferent

outcom

evariables

over

timefor

individu

algrou

psusinggeneralized

estim

atingequatio

ns

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

1PlaceboLA

TampMAT

(119899=5

0)PS

QI(0-21total)

-321(-456-187)

000

0lowastlowastlowast

-361(-483-238)

000

0lowastlowastlowast

-356(-528-18

3)000

0lowastlowastlowast

-447(-595-300

)000

0lowastlowastlowast

Sleeplatency(

minutes)

-153

(-897592)

0688

-747(-1674

181)

0115

-883(-1748-018)

004

5lowast-716

(-1908475)

0239

Totalsleep

time(

hours)

-001(-059058)

0989

-012

(-069045)

0681

-027(-13

9086)

064

2-001(-112

109)

0985

Wakea

ftersleep

onset

(minutes)

-2287

(-3801-774

)0003lowastlowast

-4087

(-6338

-1836)

000

0lowastlowastlowast

-414

9(-7447-852

)0014lowast

-4351

(-7726-976

)0012lowast

Sleepeffi

ciency

()

594

(212

976

)0002lowastlowast

522

(13690

9)000

8lowastlowast

898

(3071490)

0003lowastlowast

368

(-5991335)

0455

SF12

(PCS

)359

(109609)

000

5lowastlowast

416

(10672

7)000

9lowastlowast

468

(16477

2)0003lowastlowast

538

(258819)

000

0lowastlowastlowast

SF12

(MCS

)385

(02974

1)0034lowast

298

(061657)

0103

006

(-476488)

0980

365

(-083812

)0110

PHQ-9

(0-27)

-322(-473-17

1)000

0lowastlowastlowast

-265(-463-066

)000

9lowastlowast

-294(-517-071)

0010lowast

-475(

-669-282)

000

0lowastlowastlowast

Group

2LA

TampplaceboMAT

(n=4

6)PS

QI(0-21total)

-299(-396-202)

000

0lowastlowastlowast

-366(-526-205)

000

0lowastlowastlowast

-509(-685-333)

000

0lowastlowastlowast

-494(-660

-328)

000

0lowastlowastlowast

Sleeplatency(

minutes)

-416

(-1178346)

0284

-259(-1115596)

0552

-787(-168210

8)0085

-574

(-1818

671)

0366

Totalsleep

time(

hours)

030

(-047108)

044

4015

(-061092)

0695

051

(-061162)

0375

067

(-064

197)

0316

Wakea

ftersleep

onset

(minutes)

-1891

(-40

04223)

0080

-291

1(-574

9-072)

004

4lowast-1576

(-70403888)

0572

-964(-74215494)

0770

Sleepeffi

ciency

()

288

(-10

3678)

0148

208

(-272689)

0396

396

(-4621253)

0366

331

(-7321395)

0542

SF12

(PCS

)12

8(-14

4400

)0357

074

(-19

1339)

0585

437

(121753)

000

7lowastlowast

412

(07574

9)0017lowast

SF12

(MCS

)15

8(-16

8485)

0341

512

(199825)

000

1lowastlowast

554

(0481061)

0032lowast

647

(1551139)

0010lowast

PHQ-9

(0-27)

-272(

-406-138)

000

0lowastlowastlowast

-299(-431-16

7)000

0lowastlowastlowast

-380(-592-16

9)000

0lowastlowastlowast

-366(-591-14

1)000

1lowastlowast


Table4Con

tinued

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

3Com

binedAT

(n=5

1)PS

QI(0-21total)

-386(-491-282)

000

0lowastlowastlowast

-308(-420-19

5)000

0lowastlowastlowast

-328(-457-200

)000

0lowastlowastlowast

-388(-518258)

000

0lowastlowastlowast

Sleeplatency(

minutes)

070

(-647788)

0848

-180(-870510

)0610

-158(-128296

7)0784

-640(-1734454)

0251

Totalsleep

time(

hours)

035

(-046

116

)0399

024

(-052100)

0535

-023(

-099052)

0543

010

(-10

012

1)0858

Wakea

ftersleep

onset

(minutes)

-2249

(-40

86-412

)0016lowast

-2598

(-4925-272)

0029lowast

-2443

(-586297

6)0161

-2674

(-60

4970

1)0120

Sleepeffi

ciency

()

816

(118

1314)

000

1lowastlowast

387

(-118891)

0133

812

(0801544)

0030lowast

949(231

1668)

0010lowast

SF12

(PCS

)13

2(-10

1364

)0268

-131

(-445182)

0413

-035(

-367298)

0839

035

(-440

510

)0886

SF12

(MCS

)452

(146759)

000

4lowastlowast

710(352

1067)

000

0lowastlowastlowast

450

(055845)

0026lowast

500

(018

982)

004

2lowastPH

Q-9

(0-27)

-294(-435-15

3)000

0lowastlowastlowast

-440(-597-283)

000

0lowastlowastlowast

-285(

-510

-059)

0013lowast

-371(-589-154)

000

1lowastlowast

SEstand

arderrorCI

con

fidence

interval

Timepoints(1)=

baselin

e(2)=

postintervention

(3)=

6-we

ekfollo

wup

(4)

=3-mon

thfollo

wup

and

(5)=

6-mon

thfollo

w-up

998787Ad

juste

dfora

ge

PSQI=

Pittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire


nificantatPlt005


nificantatPlt001


nificantatPlt000

1


Randomised (n=147)


Trip (n=1)



Sickness (n=1)




Trip (n=1)


Six-Week Follow-Up


Excluded (n=19)


Enrollment


(n=50)


(LAT + MAT)(n=51)

Allocation


(n=46)







Post-Intervention








6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)





4

5

6

7

8

9

10

11

PHQ

scor

e











5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of




















Table4Ch

ange

indifferent

outcom

evariables

over

timefor

individu

algrou

psusinggeneralized

estim

atingequatio

ns

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

1PlaceboLA

TampMAT

(119899=5

0)PS

QI(0-21total)

-321(-456-187)

000

0lowastlowastlowast

-361(-483-238)

000

0lowastlowastlowast

-356(-528-18

3)000

0lowastlowastlowast

-447(-595-300

)000

0lowastlowastlowast

Sleeplatency(

minutes)

-153

(-897592)

0688

-747(-1674

181)

0115

-883(-1748-018)

004

5lowast-716

(-1908475)

0239

Totalsleep

time(

hours)

-001(-059058)

0989

-012

(-069045)

0681

-027(-13

9086)

064

2-001(-112

109)

0985

Wakea

ftersleep

onset

(minutes)

-2287

(-3801-774

)0003lowastlowast

-4087

(-6338

-1836)

000

0lowastlowastlowast

-414

9(-7447-852

)0014lowast

-4351

(-7726-976

)0012lowast

Sleepeffi

ciency

()

594

(212

976

)0002lowastlowast

522

(13690

9)000

8lowastlowast

898

(3071490)

0003lowastlowast

368

(-5991335)

0455

SF12

(PCS

)359

(109609)

000

5lowastlowast

416

(10672

7)000

9lowastlowast

468

(16477

2)0003lowastlowast

538

(258819)

000

0lowastlowastlowast

SF12

(MCS

)385

(02974

1)0034lowast

298

(061657)

0103

006

(-476488)

0980

365

(-083812

)0110

PHQ-9

(0-27)

-322(-473-17

1)000

0lowastlowastlowast

-265(-463-066

)000

9lowastlowast

-294(-517-071)

0010lowast

-475(

-669-282)

000

0lowastlowastlowast

Group

2LA

TampplaceboMAT

(n=4

6)PS

QI(0-21total)

-299(-396-202)

000

0lowastlowastlowast

-366(-526-205)

000

0lowastlowastlowast

-509(-685-333)

000

0lowastlowastlowast

-494(-660

-328)

000

0lowastlowastlowast

Sleeplatency(

minutes)

-416

(-1178346)

0284

-259(-1115596)

0552

-787(-168210

8)0085

-574

(-1818

671)

0366

Totalsleep

time(

hours)

030

(-047108)

044

4015

(-061092)

0695

051

(-061162)

0375

067

(-064

197)

0316

Wakea

ftersleep

onset

(minutes)

-1891

(-40

04223)

0080

-291

1(-574

9-072)

004

4lowast-1576

(-70403888)

0572

-964(-74215494)

0770

Sleepeffi

ciency

()

288

(-10

3678)

0148

208

(-272689)

0396

396

(-4621253)

0366

331

(-7321395)

0542

SF12

(PCS

)12

8(-14

4400

)0357

074

(-19

1339)

0585

437

(121753)

000

7lowastlowast

412

(07574

9)0017lowast

SF12

(MCS

)15

8(-16

8485)

0341

512

(199825)

000

1lowastlowast

554

(0481061)

0032lowast

647

(1551139)

0010lowast

PHQ-9

(0-27)

-272(

-406-138)

000

0lowastlowastlowast

-299(-431-16

7)000

0lowastlowastlowast

-380(-592-16

9)000

0lowastlowastlowast

-366(-591-14

1)000

1lowastlowast


Table4Con

tinued

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

3Com

binedAT

(n=5

1)PS

QI(0-21total)

-386(-491-282)

000

0lowastlowastlowast

-308(-420-19

5)000

0lowastlowastlowast

-328(-457-200

)000

0lowastlowastlowast

-388(-518258)

000

0lowastlowastlowast

Sleeplatency(

minutes)

070

(-647788)

0848

-180(-870510

)0610

-158(-128296

7)0784

-640(-1734454)

0251

Totalsleep

time(

hours)

035

(-046

116

)0399

024

(-052100)

0535

-023(

-099052)

0543

010

(-10

012

1)0858

Wakea

ftersleep

onset

(minutes)

-2249

(-40

86-412

)0016lowast

-2598

(-4925-272)

0029lowast

-2443

(-586297

6)0161

-2674

(-60

4970

1)0120

Sleepeffi

ciency

()

816

(118

1314)

000

1lowastlowast

387

(-118891)

0133

812

(0801544)

0030lowast

949(231

1668)

0010lowast

SF12

(PCS

)13

2(-10

1364

)0268

-131

(-445182)

0413

-035(

-367298)

0839

035

(-440

510

)0886

SF12

(MCS

)452

(146759)

000

4lowastlowast

710(352

1067)

000

0lowastlowastlowast

450

(055845)

0026lowast

500

(018

982)

004

2lowastPH

Q-9

(0-27)

-294(-435-15

3)000

0lowastlowastlowast

-440(-597-283)

000

0lowastlowastlowast

-285(

-510

-059)

0013lowast

-371(-589-154)

000

1lowastlowast

SEstand

arderrorCI

con

fidence

interval

Timepoints(1)=

baselin

e(2)=

postintervention

(3)=

6-we

ekfollo

wup

(4)

=3-mon

thfollo

wup

and

(5)=

6-mon

thfollo

w-up

998787Ad

juste

dfora

ge

PSQI=

Pittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire


nificantatPlt005


nificantatPlt001


nificantatPlt000

1


Randomised (n=147)


Trip (n=1)



Sickness (n=1)




Trip (n=1)


Six-Week Follow-Up


Excluded (n=19)


Enrollment


(n=50)


(LAT + MAT)(n=51)

Allocation


(n=46)







Post-Intervention








6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)





4

5

6

7

8

9

10

11

PHQ

scor

e











5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of




















Table4Con

tinued

Post-

hoca

nalyses998787

(1)v

s(2)

(1)v

s(3)

(1)v

s(4)

(1)v

s(5)

120573(95

CI)

p-value

120573(95

CI)

119901-value

120573(95

CI)

p-value

120573(95

CI)

p-value

Group

3Com

binedAT

(n=5

1)PS

QI(0-21total)

-386(-491-282)

000

0lowastlowastlowast

-308(-420-19

5)000

0lowastlowastlowast

-328(-457-200

)000

0lowastlowastlowast

-388(-518258)

000

0lowastlowastlowast

Sleeplatency(

minutes)

070

(-647788)

0848

-180(-870510

)0610

-158(-128296

7)0784

-640(-1734454)

0251

Totalsleep

time(

hours)

035

(-046

116

)0399

024

(-052100)

0535

-023(

-099052)

0543

010

(-10

012

1)0858

Wakea

ftersleep

onset

(minutes)

-2249

(-40

86-412

)0016lowast

-2598

(-4925-272)

0029lowast

-2443

(-586297

6)0161

-2674

(-60

4970

1)0120

Sleepeffi

ciency

()

816

(118

1314)

000

1lowastlowast

387

(-118891)

0133

812

(0801544)

0030lowast

949(231

1668)

0010lowast

SF12

(PCS

)13

2(-10

1364

)0268

-131

(-445182)

0413

-035(

-367298)

0839

035

(-440

510

)0886

SF12

(MCS

)452

(146759)

000

4lowastlowast

710(352

1067)

000

0lowastlowastlowast

450

(055845)

0026lowast

500

(018

982)

004

2lowastPH

Q-9

(0-27)

-294(-435-15

3)000

0lowastlowastlowast

-440(-597-283)

000

0lowastlowastlowast

-285(

-510

-059)

0013lowast

-371(-589-154)

000

1lowastlowast

SEstand

arderrorCI

con

fidence

interval

Timepoints(1)=

baselin

e(2)=

postintervention

(3)=

6-we

ekfollo

wup

(4)

=3-mon

thfollo

wup

and

(5)=

6-mon

thfollo

w-up

998787Ad

juste

dfora

ge

PSQI=

Pittsbu

rghsle

epqu

ality

index

SF-12(PCS

)ph

ysicalcompo

nent

score

SF-12(M

CS)mentalcom

ponent

score

PHQ-9P

atient

Health

Question

naire


nificantatPlt005


nificantatPlt001


nificantatPlt000

1


Randomised (n=147)


Trip (n=1)



Sickness (n=1)




Trip (n=1)


Six-Week Follow-Up


Excluded (n=19)


Enrollment


(n=50)


(LAT + MAT)(n=51)

Allocation


(n=46)







Post-Intervention








6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)





4

5

6

7

8

9

10

11

PHQ

scor

e











5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of




















Randomised (n=147)


Trip (n=1)



Sickness (n=1)




Trip (n=1)


Six-Week Follow-Up


Excluded (n=19)


Enrollment


(n=50)


(LAT + MAT)(n=51)

Allocation


(n=46)







Post-Intervention








6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)





4

5

6

7

8

9

10

11

PHQ

scor

e











5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of






















6

7

8

9

10

11

12

13

14

PSQ

I (To

tal)





4

5

6

7

8

9

10

11

PHQ

scor

e











5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of
























5 Implications



6 Conclusion


Data Availability


Ethical Approval


Consent







Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of




















Acknowledgments




References






























































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of















































of




Disease Markers



OncologyJournal of





PPAR Research



Volume 2018


Journal of

ObesityJournal of



















Comparison of Magnetic Auriculotherapy, Laser ...

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