Acupuncture for amnestic mildcognitive impairment: a meta-analysisof randomised controlled trials

Min Deng,1 Xu-Feng Wang2

1Department of Neurology,Zhongnan Hospital of WuhanUniversity, Wuhan, Hubei430000, China2Department of General Surgery,Renmin Hospital of WuhanUniversity, Wuhan, Hubei430000, China

Correspondence toWang Xu-Feng, Department ofGeneral Surgery, RenminHospital of Wuhan University,99 Zhangzhidong Road, Wuhan,Hubei 430000, China;ywxf1011@163.com

Accepted 12 June 2016Published Online First4 August 2016

To cite: Deng M, Wang X-F.Acupunct Med 2016;34:342–348.

ABSTRACTObjective Mild cognitive impairment (MCI) is apre-dementia state; 5–10% of cases per year willevolve into dementia. MCI can be amnestic(AMCI) or non-amnestic. AMCI is associated witha higher risk of progression. In recent years,interest in acupuncture as a potential treatmentfor AMCI has grown. The aim of this meta-analysis was to estimate the clinical effectivenessand safety of acupuncture for AMCI.Methods Randomised controlled trials (RCTs)of acupuncture versus medical treatment forAMCI were identified using the followingdatabases from inception to July 2015:PubMed; Medline; CENTRAL; Chinese ScientificJournal Database; The Chinese AcupunctureTrials Register; China National KnowledgeInfrastructure (CNKI); and Wanfang database.Data were extracted from RCTs meeting theinclusive criteria according to Cochranemethods. Meta-analyses were conducted usingRev Man V.5.3 software.Results Five trials involving 568 subjects wereincluded. Meta-analysis showed thatparticipants receiving acupuncture had betteroutcomes than those receiving nimodipine withgreater clinical efficacy rates (odds ratio (OR)1.78, 95% CI 1.19 to 2.65; p<0.01), mini-mental state examination (MMSE) scores (meandifference (MD) 0.99, 95% CI 0.71 to 1.28;p<0.01), and picture recognition score (MD2.12, 95% CI 1.48 to 2.75; p<0.01). Meta-analysis also showed acupuncture inconjunction with nimodipine significantlyimproved MMSE scores (MD 1.09, 95% CI 0.29to 1.89; p<0.01) compared to nimodipinealone. Three trials reported adverse events.Methodological quality of the included studieswas judged to be generally poor.Conclusions Acupuncture appears effective forAMCI when used as an alternative or adjunctivetreatment; however, caution must be exercisedgiven the low methodological quality ofincluded trials. Further, more rigorouslydesigned studies are needed.

INTRODUCTIONDementia is characterised by progressivecognitive decline and is an increasinglycommon phenomenon within our ageingpopulation.1 The most common type ofdementia is Alzheimer’s disease (AD),which accounts for at least half of casesand is a permanent and irreversibledisease.2 Mild cognitive impairment(MCI) refers to a transitional statebetween normal ageing and dementia.Around 5–10% of cases of MCI willevolve into dementia per year.3–5 As apre-dementia stage, MCI is defined by asubtle, clinical deterioration in memoryperformance to a level below that ofnormal ageing but which does not consti-tute a clinical diagnosis of dementia.5

A Canadian study demonstrated thatalmost half of patients with MCI willprogress to fulfill the diagnostic criteriaof dementia after 5 years.6 MCI based onmemory deficits can be categorised asamnestic (AMCI) and non-amnestic.AMCI is characterised by a decline inmemory capacity with retention oflargely intact executive functions.7 It hasbeen confirmed that AMCI patients havea higher chance of proceeding to ADthan those with no such cognitive altera-tions.8 Cognitive impairments and psy-chological symptoms form an integralpart of MCI. To date, no intervention hasbeen proven to prevent conversion todementia. However, several studies havesuggested that acupuncture might bebeneficial in MCI.9

Traditional Chinese acupuncture hasbeen practised for more than 3000 years.Recent research has reported that acu-puncture may be an effective adjunctivetherapy for neurological diseases, includ-ing stroke,10 Parkinson’s disease,11 vascu-lar dementia,12 and AD.13 In recentyears, a number of basic and clinical

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studies have provided evidence that acupuncture isbeneficial for the treatment of dementia or MCI.14 15

The potential mechanisms of action underlying itsputative effects in cognitively impaired patientsinclude enhanced release of neurotrophic factors,reduced oxidative stress and expression of apoptosis-related genes, improved synaptic plasticity, and prolif-eration and survival of neuronal precursor cells in thehippocampal CA1 and dentate gyrus area.16–18

Although the use of acupuncture for AMCI hasattracted growing interest, a comprehensive evaluationof the effect of the acupuncture intervention onbehavioural and psychological symptoms of AMCIcompared with other treatments is lacking. Therefore,the aim of the present study was to perform a system-atic review and meta-analysis of clinical trials of acu-puncture for the treatment of patients with AMCI.

METHODSInclusion criteriaRandomised controlled trials (RCTs) or quasi-randomised clinical trials evaluating the comparativeeffectiveness of acupuncture for AMCI were included.Diagnostic criteria were adopted in accordance withthe 2006 Chinese expert consensus on cognitive dys-function19 and other clinical guidelines.5 For a studyto be included, patients in the experimental groupneeded to have received acupuncture (either alone orin conjunction with other treatment modalities) andpatients in the control group needed to have beenreceiving another active treatment. The outcome mea-surements needed to include at least one authorityscale of cognitive assessment such as the Montrealcognitive assessment (MoCA), mini-mental stateexamination (MMSE), clock drawing task (CDT) orWechsler memory scale (WMS). There was no limita-tion placed on language of publication or publicationtype.

Literature search and study selectionWe performed a medical literature search of the fol-lowing databases from their inception until July 2015:PubMed; Medline; Cochrane Central Register ofControlled Trials (CENTRAL); Chinese ScientificJournal Database; The Chinese Acupuncture TrialsRegister; China National Knowledge Infrastructure(CNKI); and the Wanfang Database. The key searchterms in these databases were as follows: [‘mild cogni-tive impairment’ OR ‘amnestic mild cognitive impair-ment’ OR ‘cognitive impairment’ OR ‘MCI’ OR‘AMCI’] AND [‘acupuncture’ OR ‘meridian’ OR ‘acu-puncture treatment’ OR ‘acupuncture therapy’].Animal experiments, reviews and duplicate articleswere excluded.

Data extraction and quality assessmentTwo reviewers (X-FW and MD) independently evalu-ated the search results, identified studies meeting our

inclusion criteria, and collected the relevant informa-tion using a standardised data extraction form, whichincluded the name of the author, year of publication,number of participants, average age of the partici-pants, details of acupuncture treatment, type ofcontrol, treatment course, cognitive outcome measure-ments, adverse effects, and quality of trial design. Riskof bias of the included RCTs was evaluated using theCochrane criteria.20 Any disagreements regardingmethodological quality were resolved by discussionuntil consensus was reached.

Data synthesis and statistical analysisThe statistical analysis was performed using RevManV.5.3 (Cochrane Collaboration). Effect estimates fordichotomous data were presented as odds ratios (ORs)with their 95% confidence intervals (CIs) and con-tinuous data were presented as mean differences(MDs) and their 95% CIs. The standard χ2 test and I2

test were used to assess the heterogeneity of the data.A random effects model was employed when therewas significant heterogeneity, otherwise a fixed effectsmodel was used.

RESULTSLiterature searchOur initial electronic database search identified 215potential literature citations, from which 34 dupli-cated articles, 108 animal studies, and six reviewswere excluded. Following the initial screening of titlesand abstracts, 57 studies were excluded because theywere either case reports (two studies), lacked a com-parison group (25 studies) or because the trials didnot focus on acupuncture therapy for AMCI (30studies). Ten randomised trials were obtained for full-text assessment. After applying the inclusion criteria,five studies14 21–24 were ultimately included in thequalitative synthesis and meta-analysis. A flowdiagram of the search strategy is shown in figure 1.

Characteristics of included trialsThe five included RCTs were published between 2012and 2013. The total number of AMCI participantswas 568, with 288 patients allocated to the acupunc-ture group (experimental group) and 280 patientsallocated to receive conventional medication, namelynimodipine (control group). Three trials directly com-pared acupuncture with nimodipine (comparativeeffectiveness) and two trials examined the role of acu-puncture as an adjunct to nimodipine, whereinpatients in both groups received medical therapy andwere randomised to receiving additional acupunctureor not. The number of participants in each studyvaried from 26 to 94 and acupuncture treatment wasprovided three to five times per week for 8 weeks inall but one trial, in which treatment lasted 3 months.All trials used electroacupuncture (EA) (frequency 3–

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15 Hz, intensity 2–4 mA) and each treatment sessionlasted 30 min. The most frequently used acupuncturepoints were GV20 (Baihui), GB20 (Fengchi), GV24(Shenting) and Sishencong. Outcome measuresincluded clinical efficacy rate, MMSE, picture recogni-tion, CDT, MBI (modified Barthel index), and HDS-R(revised Hasegawa dementia scale). Other character-istics of the studies are summarised in table 1.

Methodological qualityAll five included studies reported the baseline data ofthe participants and mentioned random sequence gen-eration. One trial21 used a random number table toallocate participants to treatment groups. Thesequence generation of another trial24 was based onvisiting time point and was therefore considered toonly be quasi-randomised. The remaining threetrials14 22 23 did not describe the method of randomsequence generation. No trial mentioned allocationconcealment and none used a sham intervention,

therefore blinding of participants or practitioners wasnot applicable to this review. The methodologicalquality of each trial is summarised in figure 2.

Acupuncture versus conventional therapyThree trials14 21 22 randomising a total of 403 patientscompared acupuncture with nimodipine. Clinical effi-cacy rate at the end of the treatment was reported inall three trials with no significant heterogeneity(I2=0%, p=0.73, figure 3A). Meta-analysis demon-strated that the clinical efficacy rate was significantlyhigher in the acupuncture group compared with thecontrol group (OR 1.78, 95% CI 1.19 to 2.65;p<0.01). MMSE at the end of the treatment was alsomeasured in all three trials with minimal heterogen-eity (I2=5%, p=0.35, figure 3B).14 21 22 Meta-analysis showed that acupuncture significantlyimproved MMSE scores relative to the control group(MD 0.99, 95% CI 0.71 to 1.28; p<0.01). Picture

Figure 1 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2009 flow diagram.

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recognition at the end of the treatment was measured intwo of the trials14 22 with 342 patients in total and nosignificant heterogeneity (I2=0%, p=0.56, figure 3B).Meta-analysis demonstrated that acupuncture improvedpicture recognition scores compared to the controlgroup (MD 2.12, 95% CI 1.48 to 2.75; p<0.01).Finally, two trials14 21 included CDT scores; however,one of these14 did not report CDT results after treat-ment. The other21 reported that patients treated withacupuncture did not significantly increase their CDTscores compared with those of the control group.

Acupuncture as an adjunct to conventional therapyTwo trials23 24 evaluated acupuncture as an adjunct tonimodipine. One trial24 reported that patients treatedwith acupuncture and nimodipine exhibited increasedclinical efficacy rate compared to treatment withnimodipine alone (figure 4A). The other23 showedthat patients treated with acupuncture and nimodipinehad increased picture recognition scores compared tonimodipine therapy alone (figure 4B). MMSE at theend of the treatment was measured in two trials23 24

with 174 patients and moderate heterogeneity(I2=49%, p=0.16, figure 4B). Meta-analysis foundthat acupuncture combined with nimodipine signifi-cantly improved MMSE scores compared to nimodi-pine therapy alone (MD 1.09, 95% CI 0.29 to 1.89;p<0.01).

Adverse eventsThree studies22–24 reported adverse events in detail.The adverse events associated with acupunctureincluded errhysis at the needle sites23 24 and faintingduring treatment.22 Adverse events associated withnimodipine therapy predominantly consisted ofgastrointestinal reactions and mild headache.22 Two

studies14 21 did not report whether any adverse eventsor side effects had occurred in the experimental orcontrol groups.

DISCUSSIONAlthough acupuncture has been used clinically in themanagement of AMCI in recent years,14 no systematicreview or meta-analysis has been performed to eva-luate the effectiveness of acupuncture specifically forthis condition. The present study analysed data fromfive RCTs involving 568 individuals to summarise andevaluate the available evidence on the efficacy andsafety of acupuncture therapy for AMCI. All trialsused EA in the treatment group. Moreover, thetreatment was generally consistent in several otherrespects, including the number, frequency andduration of the acupuncture sessions, the acupunc-ture points selected and the comparator groups, allof which might have helped decrease clinicalheterogeneity to some extent. Our meta-analysissuggested that acupuncture treatment had a signifi-cant effect on clinical efficacy rate compared to animodipine control group. Similarly, acupuncturetherapy significantly improved MMSE and picturerecognition scores compared with nimodipine therapy.Overall, our meta-analysis suggests that acupuncturewas a useful therapy in improving cognitive functionfor patients with AMCI. It also suggested that acu-puncture was effective when used as an adjunctivetreatment to nimodipine for AMCI. However, theseseemingly positive findings must be interpreted cau-tiously due to the low methodological quality of theincluded RCTs. Furthermore, in this review, onlythree of five studies mentioned adverse events. Theside effects of the treatment group were acupuncturepoint errhysis and fainting during acupuncture treat-ment, while those of the nimodipine control group

Table 1 Characteristics of included studies

Study (firstauthor/year)

Participants,male/female

Mean age(years) Intervention Course of treatment

OutcomemeasuresE C E C E C E C

Zhang 201314 80 (39/41) 75 (37/38) 71 72 Scalp EA Nimodipine 30 min, once a day,3 days for a week,8 weeks

30 mg/pill,3 times a day,8 weeks

MMSE, picturerecognition, CDT

Zhao Y 201221 26 (12/4) 26 (9/4) 73.35 72.96 Scalp EA Nimodipine 30 min, once a day,3 days for a week,8 weeks

30 mg/pill,3 times a day,8 weeks

MMSE, CDT

Zhao L 201222 94 (46/48) 93 (44/49) 69 67 Scalp EA Nimodipine 30 min, once a day,3 days for a week,8 weeks

30 mg/pill,3 times a day,8 weeks

MMSE, picturerecognition

Luo 201323 40 40 Unavailable Scalp EA plusnimodipine

Nimodipine 30 min, once a day,3 days for a week,8 weeks

30 mg/pill,3 times a day,8 weeks

MMSE, picturerecognition

Li 201224 48 (30/18) 46 (24/22) 68.29 69.22 EA plusnimodipine

Nimodipine 30 min, once a day,5 days for a week,3 months

30 mg/pill,3 times a day,3 months

MMSE, MBI,HDS-R

C, control group; CDT, clock drawing task; E, experimental group; EA, electroacupuncture; HDS-R, revised Hasegawa dementia scale; MBI, modified Barthelindex; MMSE, mini-mental state examination.

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included gastrointestinal reaction and mild headache.The two other RCTs did not report on adverse eventsor side effects at all. Thus, although the existing litera-ture on acupuncture suggests that it is a relatively safe

treatment modality, conclusions regarding the safetyof acupuncture therapy specifically for AMCI cannotbe reached.The methodological quality of the included studies

was judged to be generally poor because there washigh or unclear risk of bias. Three of the five RCTsincluded in this meta-analysis mentioned randomsequence generation, but failed to describe concretelythe way in which it was achieved. The randomsequence generation of one trial was performedaccording to visiting time points, which is not consid-ered true randomisation. No study reported allocationconcealment or blinding assessment. The suboptimalmethodological quality of the primary data (poorinternal validity) unavoidably inhibits a robust evalu-ation of the effectiveness of acupuncture for AMCI.There were several potential limitations of this

review. Although one trial was published in English,all included RCTs were conducted in China, whichmight implicate publication bias.25 Chinese patientsmay have a preference for acupuncture treatment overmedical intervention, and the design of the includedstudies did not control for potential placebo effects.Therefore, rigorous clinical studies in Western settingsshould be considered before extrapolating the resultsto other populations. Future trials should also takeplacebo effects into consideration in order to provideevidence of a specific effect of acupuncture.26 27 Thesample populations of included studies in thismeta-analysis were small, with >100 patientsrecruited in only two of the five trials. Additionally,differences in acupuncture practitioners might intro-duce deviations in the effect size attributable to acu-puncture therapy.Given the methodological limitations of the current

evidence base, we would recommend that future clin-ical trials should be conducted more rigorously and bereported in accordance with the ConsolidatedStandards of Reporting Trials (CONSORT) state-ment28 for RCTs and the Standards for ReportingInterventions in Clinical Trials of Acupuncture(STRICTA) guidelines29 for acupuncture studies.Allocation concealment and blinding of outcomeassessors should be applied, and the type of random-isation and acupuncture procedures should bedescribed in detail. Although acupuncture therapy isgenerally well tolerated, a condition-specific safetyevaluation should also be rigorously carried out andreported in future trials.In conclusion, the results of this meta-analysis

suggest that acupuncture therapy has a significantpositive effective on cognitive and memory functionin patients with AMCI compared with nimodipinealone. The results also show that acupuncture iseffective as an adjunctive treatment to nimodipine forAMCI. Due to the small number of available RCTsand the relatively poor methodological quality of theavailable evidence, further rigorously-designed studies

Figure 2 Risk of bias summary of included studies.

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Figure 4 Forest plot of acupuncture plus nimodipine (experimental group) versus nimodipine alone (control group) for treatment ofamnestic mild cognitive impairment. MMSE, mini-mental state examination.

Figure 3 Forest plot of acupuncture (experimental group) versus nimodipine (control group) for treatment of amnestic mildcognitive impairment. MMSE, mini-mental state examination; CDT, clock drawing task.

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with large samples are needed to evaluate systematic-ally the effectiveness and safety of acupuncturetherapy for AMCI patients.

Acknowledgements We would like to thank Miss Li Ming-Xingfor her assistance in preparing this manuscript.

Contributors All authors contributed to the writing andredrafting of the manuscript. X-FW had the original idea.X-FWand MD conducted the study. X-FWanalysed the results.

Competing interests None declared.

Provenance and peer review Not commissioned; externallypeer reviewed.

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