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Complementary Therapies in Clinical Practice (2008) 14, 264–272

1744-3881/$ - sdoi:10.1016/j.c

�CorrespondE-mail addr

www.elsevierhealth.com/journals/ctnm

An exploratory study of women’s experiences andkey stakeholders views of moxibustion for cephalicversion in breech presentation

Mary Mitchella,�, Katherine Allenb

aUniversity of the West of England, Faculty of Health and Life Sciences, Blackberry Hill, Stapleton,Bristol BS16 1DD, UKbNorth Bristol NHS Trust, UK

KEYWORDSMoxibustion;Breech presentation;Complementarytherapies

ee front matter & 2008tcp.2008.05.002

ing author. Tel.: +44 117ess: mary.mitchell@uwe

Summary A phenomenological research approach was taken to explore women’sfeelings and experiences of using moxibustion for cephalic version in breechpresentation. Eight women with an uncomplicated breech presentation at term wereoffered moxibustion. Qualitative interviews were carried out before and after thetreatment and women completed daily logs of their experiences. Womenexperienced anxieties about the implications of breech presentation and the optionsoffered to them. All women carried out the treatment successfully and overallexperiences were positive. Compliance was excellent and women reported fewnegative effects. The partner’s co-operation was important to ensure that theprocedure was carried out effectively and safely. Key stakeholders were alsointerviewed to determine their views on the requirements of implementingmoxibustion into the maternity services. The need for research evidence ofeffectiveness was a priority. In addition, a number of practical issues are suggestedfor consideration in the implementation of a service or in future research designs.& 2008 Elsevier Ltd. All rights reserved.

Background

In 3–4% of pregnancies at term, the baby willpresent as breech. Breech presentation may beassociated with uterine or foetal abnormalities butusually it is an error of orientation.1 Vaginal breechdelivery is associated with significantly greater

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3288892..ac.uk (M. Mitchell).

risks compared with cephalic birth.2 Although thereis much debate on the mode of delivery for abreech presentation, much of the current researchsuggests it is safer that these babies be delivered bycaesarean section.2–4 However, caesarean section ismajor surgery and there are health risks for thecurrent and future pregnancies.5 It is also knownthat caesarean delivery adversely impacts on awoman’s feelings and perceptions about her birthexperience.6 Furthermore, rising caesarean birth

d.

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Women’s experiences and stakeholders views of moxibustion 265

rates are a public health concern.7 Tiran8 suggeststhat women with a breech presentation areincreasingly looking for options to improve theirchances of having a natural birth.

Various methods have been identified to encou-rage the breech to turn. These include posturaltechniques, external cephalic version (ECV) andmoxibustion. Although postural technique is accep-table to women and is without side effects, it hasnot been found to increase the rates of sponta-neous version.9,10 ECV has been found to signifi-cantly reduce the risk of caesarean section inbreech pregnancies at term.11 Thus, the RCOG12

suggest that all women with an uncomplicatedbreech pregnancy at term should be offered ECV.However, the procedure is not without risks and asa result needs to be carried where facilities for anemergency caesarean section are immediatelyavailable.13–15 EVC is also not always offered inpractice, perhaps because of a lack of skilledpersonnel.16 In addition, women also report theprocedure to be painful and the acceptability ofECV for women has not been fully established.7,12

Moxibustion, a traditional Chinese medicine aoffers an alternative approach to encouragingcephalic version of the breech. It involves burningmoxa (the herb Artemis vulgaris) to heat theacupuncture point, Bladder 67, on both feet10–15min daily for 7–14 days. Apart from a risk ofburning, no adverse effects on women or infantshave been observed.17 Studies in China reportsuccess rates of between 74% and 90% in turningthe breech, which compares to a spontaneousversion rate of 47% without treatment.18 Theoptimum time for moxibustion appears to be33–34 weeks,18 when amniotic fluid is at itsmaximum and before the breech becomes engaged.An 11-year audit by Budd19 found that moxibustionincreased spontaneous version rates up to 25%.A Cochrane review20 of the effectiveness and safetyof moxibustion for breech presentation suggeststhat it may be effective in reducing the need forECV but highlighted the need for further rando-mised controlled trials and the need to evaluatematernal satisfaction.

There is evidence in UK of increasing interest incomplementary therapies by pregnant women andsome maternity units have successfully integratedcomplementary therapies within mainstreamcare.21 However, while moxibustion appears to bewidely used and acceptable to pregnant women inChina,18 there have been concerns regarding itsacceptability to western women.22 Indeed, in anItalian study by Cardini22 many of the womenfound moxibustion unacceptable largely due to the‘unpleasant odour’ of the moxa. Consequently,

participant compliance was poor and the studyfailed to show any significant differences in versionrates between treatment and non-treatmentgroups.

In order to obtain funds to evaluate the efficacyof moxibustion, it is imperative to explore itsacceptability to women in this country. Thus, theaim of this research was to offer women with anuncomplicated breech presentation at term mox-ibustion and explore their views about breechpresentation, the options offered to them and todocument their experiences of using moxibustion.In addition, Williams and Mitchell23 acknowledgethe importance of involving key stakeholders andexploring the acceptability and implications ofproviding a moxibustion service in the NHS; there-fore, stakeholder views were also sought.

Research methodology

A phenomenological approach was adopted toexplore women’s experiences of moxibustion treat-ment. The purpose of phenomenological research isto describe phenomena as they are lived andexperienced by the individuals and thus is appro-priate to fulfil the aims of this study. Creswell24

suggests that this approach is appropriate when theresearcher is interested in describing commonexperiences of participants in relation to a givenphenomenon. The aim is to present the partici-pant’s experiences with clarity and meaningthrough a process of interpretation.25 The re-searcher begins by studying individual examples oflarger phenomena and gradually, via a process ofinductive reasoning, an understanding of the wholeis achieved.24–26

Research methods

In-depth interviews were carried out with womenbefore and after the moxibustion treatment.Interviewing is a popular method in phenomenol-ogy. It allows for the process of exploration andgives freedom to expand a phenomenon notpreviously considered. Open-ended questions wereutilised, with additional probing questions used toclarify points made as women reflected on theirexperiences. All interviews were carried out at atime and place suggested by the participant; in allcases this was in the participant’s home. The pre-moxibustion interviews were carried out by K.A.immediately before the first moxibustion sessionand lasted approximately 15–20min. The focus ofthis interview was women’s feelings about breechpresentation, the options offered to them and their

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Table 1 Moxibustion protocol.

� Women must have a confirmed breechpresentation, no contraindications and be noless than 33-weeks gestation.� Women and their partners are taught how to usemoxibustion.� Competence in lighting the moxibustion sticks,conducting the treatment and extinguishing themoxa are assessed.� Women are supplied with the moxa sticks, a fireblanket and extinguishing material.� The treatment requires the partner to light themoxibustion sticks and hold them over theacupuncture points Bladder 67 (see photo) onboth feet for 15min.� This procedure is carried out twice a day for atotal for 7 days.� Continuing support is offered for the duration ofthe treatment.� A repeat ultrasound is carried out to confirmfoetal presentation.� If the moxibustion is unsuccessful, an ECV is

M. Mitchell, K. Allen266

reasons for choosing moxibustion. The post-mox-ibustion interviews were carried out by M.M. Thiswas to ensure that participants would feel moreable to express their perceptions about thepreparation and teaching for the use of moxibus-tion to a researcher who was not involved at thatstage. These interviews lasted between 20 and90min. The interview focussed on women’s prac-tical experiences of moxibustion and their viewsand perceptions of this treatment option. Inaddition, participants were asked to record in alog, their daily experiences of using moxibustion.The logs enabled the researchers to gain an insightinto the lived experiences of the woman whileundergoing moxibustion treatment and facilitatedan understanding of their needs during this time.27

Semi-structured interviews with key stakeholderswere also carried out to explore their views andpractical issues surrounding the implementationof a moxibustion service within the maternityservices. All interviews were tape-recorded.

offered and mode of delivery discussed.

Population and sample

A purposive sample of eight women provided theresearchers with ample qualitative data to meetthe aims of the study. Within a phenomenologicalapproach, it is essential that the sample reflectsthose with the relevant experience to permit anunderstanding of the phenomenon being studied.26

Potential participants were identified by mid-wives once a breech presentation was confirmed.Information leaflets were provided and K.A. gavefurther information if required before recruitmentinto the study. The inclusion criteria included thefollowing: ultrasound-confirmed breech presenta-tion, no contraindications for moxibustion treat-ment, agreement of the obstetrician and thesupport of a partner to carry out the treatment.Participants were all white Caucasian women.

A purposive sample of key stakeholders includedthe midwife providing the moxibustion service,the obstetrician who was the Trust lead forbreech presentation and the Director of MidwiferyServices.

Moxibustion protocol

Once recruited into the study, women and theirpartners were taught how to use moxibustion. Toadhere to the health and safety requirements, theresearch midwife assessed their competence inlighting, conducting the treatment and extinguish-ing the moxa. The treatment was then carried outtwice a day for a total of 7 days. Women were

supplied with the moxa sticks, a fire blanket andextinguishing material. All participants were givencontact details of the research midwife, shouldthey require further support (see Table 1).

Ethical considerations

The principles that concern the rights of individualswhen undertaking research were addressed through-out the study. These are the right not to be harmed,informed consent, voluntary participation, confidenti-ality and anonymity.24,28 Ethics approval was obtained

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Women’s experiences and stakeholders views of moxibustion 267

by the trust and the university ethics committee.Health and Safety, Research and Development, man-agerial and consultant support were all agreed upon.The women and the key stakeholders received aninformation leaflet and were asked to sign a consentform. Participants had the right to withdraw at anytime without detriment and they understood exactlytheir role in the research as recommended by Griegand Taylor.29 The tape-recordings were kept in asecure location and participants were promised thatonce the study was complete, they would bedestroyed. Participants allocated their own pseudo-nym for use in the publication of findings. Confidenti-ality and anonymity were guaranteed.

Data analysis

Tape recordings were transcribed verbatim. Thestudy yielded a large amount of qualitative data,which was subject to thematic and contentanalysis. The guidelines described by Hallet30 werefollowed: acquisition of a sense of meaning,extraction of significant statement, formulation ofsignificant statements into a more general restate-ment and organisation of formulated meanings intothemes. To enhance rigour and trustworthiness ofthe analysis process, K.A. and M.M. analysed thedata separately and then agreed the themesthrough an iterative and reflexive process (Table 2).

Research findings and discussion

Pre-moxa interviews: feelings about breech

All the participants expressed worry, disappoint-ment or fear on discovering their baby was in abreech position. Some of their anxieties andworries were immediate in that they understood

Table 2 Themes from the analysis of qualitativedata.

Research findings: themes

Pre-moxibustiontreatmentinterviews

Women’s feelings aboutbreechInfluences on choices andreasons for choosingmoxibustion

Post-moxibustioninterviews

Views and experiences ofmoxibustion.Practicalities.

Key stakeholdersinterviews

Views about moxibustion.Practicalities ofimplementing a service.

the impact of breech presentation on birth. Othersdid not appreciate the full implications that wereonly realised on either further reading or followingdiscussion with the obstetrician.

shocked and going into the unknown of whatwould happen (Susan)

The fears and anxieties expressed by thesewomen are somewhat justified. Vaginal deliveryof a breech presentation is associated with morerisks for the mother and baby compared with acephalic presentation,3 and delivery by caesareansection is known to increase maternal mortalityand morbidity compared to normal birth.31–33

Women who give birth by caesarean sectionoften experience feelings of failure, and dimi-nished self-esteem, compared with birth by vaginaldelivery.6,34

I know statistically its maybe a higher risk for themother, there is risk of infections, there is alsorisks of future pregnancies not being as smoothas they would be without the scar and there is asort of vanity reason about the scar, general fearof operations and just the whole thing (Claire)

When participants were presented with therange of options such as, vaginal delivery of thebreech, caesarean section and ECV, they realisedtheir desire for a natural birth may not beachieved. Women’s desire to have a vaginaldelivery has also been confirmed by a number ofstudies.35–38

very disappointed its hard to explain, I have gonethrough a lot of effort to keep everything verynatural, I mean its just not the way its meant tobe done (Claire)

As recommended by the RCOG,12 all participantswere offered an ECV. Half of our participantsaccepted the offer of ECV even though theyexpressed anxiety about the procedure. For parti-cipants, the decision-making process was challen-ging and anxiety provoking due to time constraints.

It was really difficult as we were told we had tomake decisions quite quickly but all we had weresome leaflets. (Susan)

It seemed that women were often left to makedecisions without a great deal of support. Nasseret al.39 found that the use of a decision aid, forwomen with a breech presentation, increased theirknowledge base and feelings of being in control,leading to decreased anxiety. Such a tool may havehelped the women in our study, as it was evidentthat they experienced decisional conflict anduncertainty.

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Initially we decided to go ahead with it but theday before we did a bit more research and Iwasn’t 100% sure. I wasn’t happy about it, soliterally the day before we decided not to gothrough with it. (Susan)

Women were concerned about ECV for a numberof reasons, including pain, the perceived invasive-ness of the procedure and risks to the baby.

Only that it felt quite invasive, the thought offorcibly moving the baby round put me off(Louise)

These feelings have also been reported byothers,38,40 but may have been related to the lackof information women received and how the risksand benefits were explained to them.

Accepting moxibustion: influences on choice

A number of factors influenced women’s desire toreceive moxibustion, in particular, a perceptionthat moxibustion was natural and non-invasive.Complementary medicine is commonly perceivedby pregnant women and midwives as being safe.41

Because it is not very intrusive basically it’squite a natural thing and I thought I may as welltry something more with a more naturalapproach to it. (Bill)

However, this assumption is not always correctand documented risks associated with some typesof complementary medicine have been documen-ted.42 Only one woman expressed caution about thesafety of moxibustion but was prepared to acceptthe treatment and make her own risk assessment.

I wouldn’t have carried it on if I thought thatthere was something toxicy. I didn’t know whatthe burning sticks were like. But it was clear,very quickly that I didn’t think there wasanything, they are very inoffensive things(Claire)

Women had little knowledge and no experienceof moxibustion but their experience of othercomplementary therapies influenced their deci-sions. They accessed the Internet to enhance theirknowledge and inform their decisions.

I have used things like reflexology and massagebefore to great effect and I didn’t see any reasonnot to try it. (Louise)

The woman in this study chose moxibustion forpragmatic reasons, with the aim of improving theoutcomes for themselves and their babies, adecision which gave them a sense of control. These

are often reasons given for choosing complemen-tary therapies.43 Indeed, many of the women chosemoxibustion rather than have an ECV. Woman whohad experienced both moxibustion and ECV, de-scribed moxibustion as feeling safer and lessuncomfortable.

Analysis of post-moxibustion interviewsand daily logs

Experiences of using moxibustion

Women were asked about their experiences of usingmoxibustion, and the daily logs were analysed forboth negative and positive aspects of the treat-ments. All but one of the women experiencedincreased foetal movements either during or afterthe treatment. Moxibustion has been shown toincrease foetal movements18,22 and this mayexplain how moxibustion influences cephalic ver-sion. In addition, women described a change in thenature of foetal movements.

It was kind of 5 minutes in (moxibustion) and Istarted feeling movement and they progressedthroughout the day and then baby was moving alot afterwards and it was quite strong move-ments (Anita)

Yes they were sort of deeper, if you know what Imean, a lot more um less tickly and moreactually belly churning if you know what I mean?(Louise)

These experiences reinforced the belief thatmoxibustion was having an effect and contributedto women’s motivation to continue with the regi-men. All the women expressed positive feelings andused a variety of words including relaxing, plea-sant, safe and enjoyable. Certainly, the ancillaryaspects of complementary therapies such as therelaxing effects and the therapeutic relationshipwith practitioners are cited as contributing sig-nificantly to the effects of CAM treatments.44

Several women expressed how moxibustion gavethem the opportunity to focus on their pregnancy,with one woman describing how it helped her toconnect with her baby and another the opportunityto spend time with her partner. Moxibustion may beunique among complementary therapies in thissituation as women were reliant on their partnersto administer the therapy.

It does relax you quite a lot and its sort of a bitconnected if you see what I meany. the whole

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being pregnant thingy. sort of I suppose closerto the baby (Bill).

it’s a really nice time to sit with your partner andhave a chat and be really relaxed and if it workswell brilliant but if not you have not lostanything (Anita)

Few unpleasant effects were noted. One womandescribed how strong foetal movements made herfeel nauseous. In other studies, women experi-enced more numerous discomforts, including asense of tenderness and pressure in the epigastricregion, abdominal pain because of contractions,and nausea and throat problems due to theunpleasant odour of the moxa.18,22 Even though‘‘smokeless’’ moxa was used in this study, somewomen found it gave off a slight aroma, althoughno one described it as being offensive.

It was a bit whiffy actually, It felt like when youhad incense burning, but open the window and itwas gone. (Kate)

Other effects experienced included a desire toempty the bladder and an increase in bowelmovements although the latter was viewed favour-ably by the participant.

Practicalities of using moxibustion

Many of the participants stressed the importance ofbeing in a comfortable position, wearing looseclothing and having their back supported. Mostwomen positioned themselves for the treatmentwith their legs elevated and with their partnerssitting or kneeling in front of them. Betts45

describes different positions for moxibustion butthis has not been addressed in research. All thewomen choose to have moxibustion to both feetconcurrently rather than doing each foot individu-ally. The partners’ comfort was also importantduring the treatment with one woman describingthis in some detail

I think the most important thing is it was easy forme to be comfortable because I was sat withboth feet up. On one occasion we tried to do itsat on the settee and he got a bad back after10 minutes so it was more important for him tobe comfortable because he was actually doing it.(Louise)

The role partners played and that their involve-ment was integral to the successful and safeimplementation of the moxibustion regimen.Furthermore, women acknowledged the impor-tance of their partner being committed to the

moxibustion treatments. One woman discussed howher partner lost interest when the moxibustionappeared to have no affect on the baby’s move-ments. The role of the partner has not beenaddressed in other studies.

Practically it is very easy. I would say theproblem is that my husband, you know thoughtit was a bity. well he was definitely doing it tosort of humour me and so by the end of the weekwas very fed up with doing it. I mean he did it,and he did it for me but I had to sort of nag himinto it. (Claire)

Current research suggests that moxibustion is asafe procedure17,18,20 There is, however, a slightrisk of blistering the skin as the moxa is extremelyhot when lit.46 All participants complied withsafety procedures. However, several of the partici-pants in our study expressed feelings of anxietyabout being burnt and how important it was forthem to trust their partner.

At first I was worried that he might burn me andat first as well when we first tried it, it tended toget hot quite quickly. He tended to get a bit tooclose and then too far away and then too close.Then after the first day it was a lot better(Zippy).

One woman reported that her partner burnt hisfinger and another that her toe had been burnt butwhen questioned it transpired that it was more thesensation of heat as the skin did not reddenor blister. Overall, women’s experiences werepositive and compliance was excellent in contrastto the study of Cardini.22 Although anxious initiallyboth women and their partners’ confidence in-creased over time, they found the procedure easyto carry out and no concerns were raised regardingsafety.

Stakeholder analysis themes

Views about moxibustion

All stakeholders felt that moxibustion had thepotential to confer benefits to women in terms ofincreased choices. This is a common view cited inrelation to the contribution that complementarytherapies can make to improving maternity serviceprovision.23

the benefit for women is to be able to offer themsome choice and that you could actually say thisis an alternative to using ECV (Alice)

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The midwife practitioner and the midwiferymanager were more open to the benefits ofmoxibustion particularly when they viewed it fromthe perspective of the woman. However, attitudesto complementary therapies are not always posi-tive, particularly when their mode of action is notwell understood, such as moxibustion.47 Astin48

acknowledges that a complex range of factors areinfluential in peoples decisions to use complemen-tary therapies and as such no simple explanationsuch as that given by one of the key stakeholdersoffers a complete picture

we have no real idea that it (moxibustion) worksit fits new age type replacement for religion andscience attitude that many people had particu-larly sort of relatively well educated middleclass people who too often don’t have muchappreciation of science. (Anthony)

Consumers are not always concerned about thescientific evidence for CAM, preferring to maketheir own decisions based on their beliefs andtestimonials from others.49 However, the need forresearch evidence was influential in determiningthe stakeholder’s views of whether moxibustionshould be offered within the maternity services.

I think that standard (research evidence ofeffectiveness and safety) should apply to every-thing, we shouldn’t be spending scarce resourceson stuff that is not proven whether itsybackground is complementary or otherwise.(Anthony)

This view is pertinent given the current emphasison evidence-based practice and the need todemonstrate cost efficiencies. Indeed, the Houseof Lords50 believes that the same standard ofresearch evidence should apply to CAM as conven-tional medicine in terms of considering prioritiesfor service development. However, even whenresearch evidence demonstrates efficacy and costeffectiveness, this is not a guarantee of NHSfunding51 and thus there may be underlyingattitudes and assumptions made about the provi-sion of CAM in the NHS and this was alluded to bythe one of the key stakeholders.

I think that’s where with complementary thera-pies you really have got to show evidencebecause there will be amongst some cliniciansa certain amount of scepticism um you knowwitch craft whatever you know that they evenmore so you have to be able to produce theevidence (Alice)

However, all stakeholders were of the opinionthat should the evidence base be strong enough

there was the potential for implementation intothe NHS.

Practicalities of implementing a service

The stakeholders also discussed the practicalitiesthat should be considered in the implementation ofa moxibustion service.

In an ideal world you would do is have a clinicwhere all the suspected breeches would bescanned, at least one day a week, the sameday as a moxibustion clinic and then if theywanted to try moxibustion they could comestraight in (Flora)

The midwives role in providing such a service wasalso acknowledged. The responsibility for the mid-wife to undertake specific training, maintaincompetence and work within the Midwives Rulesand Code of Conduct52 and Trust policy wasrecognised.

I don’t see why any midwife could not teachwomen to do it really, it’s so simple. It wouldhave to be a Trust policy and they would have tohave training, every midwife would have tospeak to her supervisor (Flora)

The midwife moxibustion practitioner had a clearview of some of the practical implications and theissues that would need to be resolved in providing aservice. The biggest challenge was recruitingwomen at a gestation early enough to offer theprocedure with time to refer for ECV if necessary. Inpractice, it proved very difficult recruiting womenat the optimum gestation of 33–34 weeks as womenwere not referred for ultrasonography to confirmthe breech presentation until 36 weeks gestation.

I would like to see them at 34 weeks becausethat’s what the research says is the mostsuccessful for moxibustion. But with currentpractice you don’t even send them for a scanat 37 weeks, so time is a big issue really, youneed 7 days of moxa before so an ECV can beoffer if it fails (Flora)

Special scanning clinic where all women who aresuspected breech are sent and researcher attendsclinic. It would be important for these practicalissues to be resolved prior to implementation ofsuch a service but in the view of stakeholders, untilfurther scientific evidence of effectiveness isdemonstrated it would be unlikely that such aservice would be considered.

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Conclusion

Our study revealed that at least for some women,the diagnosis of breech presentation caused con-siderable anxiety and concern. Like other studies,their worries centred round the consequences tothemselves and their babies of delivering a breechbaby vaginally or having a caesarean section.34,35,38

Women were disappointed at the loss of opportu-nity to experience a normal birth but expressedadditional worries about the option of ECV, eventhough this may have been their only option toachieve a vaginal delivery. All women expressedconcerns about the perceived invasiveness of ECV.They articulated their concerns mostly with thenotion that ECV was forcing the baby to turn, thisthey felt was unnatural and likely to causeproblems. Coupled with the knowledge of at leastsome of the implications of delivering a breechbaby vaginally or having a caesarean sectionwomen were very happy to accept the offer ofmoxibustion. The women gave considerablethought to all their options and as such should notbe viewed as ‘‘gullible consumers’’ as some havesuggested53 but discerning women who made aninformed choice about the use of moxibustion.

The practice of carrying out the moxibustiontreatments was unproblematic; women found thestrategies that worked best for themselves andtheir partners. All but one woman reportedincrease in foetal movements and a change in thenature of the movements either during or after themoxibustion treatment. Women reported a range ofother effects, mostly pleasant. Few problems wereexperienced and compliance was excellent. Boththese findings are in contrast to the study ofCardini22 where more unpleasant effects werenoted and compliance was poor. Our findings inthis respect may be due to women activelychoosing the option of moxibustion, the use ofsmokeless moxa and the nature of the supportparticipants received both before and while under-going the treatment.

From the key stakeholders perspective, before amoxibustion service could be established in the NHSevidence of effectiveness and cost efficiency wouldneed to be demonstrated. There was a consensusthat midwives if properly trained could carry outthe treatment, as long as Trust policies were inplace. Midwife referral policies for diagnosis ofbreech presentation would need to emphasise theimportance of referral before 33 weeks. Thebiggest challenge in introducing such a service orconducting further research would be its ability tobe responsive to demand given the short timeintervals between diagnosis of a breech baby and

time required for the full range of treatmentoptions.

The view that further research is needed bymulti-site randomised controlled trails was alsoexpressed. The design of any such trial should takeinto consideration the practicalities of offering theservice particularly in relation to recruiting womenat the optimum gestation and with sufficient timefor a full range of treatment options to beprovided, use of smokeless moxa and adequatetraining and support for midwives and women inthe treatment. Consideration should be given formore innovative trial designs that take account ofpatient preference such as block randomisation orthe Zelen technique that permits randomisationprior to recruitment; thus, patients know what theyare consenting to at the point they give consent.54

Acknowledgements

We would like to acknowledge the support of PatTurton (Principal lecturer UWE) for her assistance inthe early stages of this study and the UWE SmallResearch Grant Scheme for providing the funding.

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