development of a fertility acupuncture protocol: defining an acupuncture treatment protocol to...

10
Development of a Fertility Acupuncture Protocol: Defining an Acupuncture Treatment Protocol to Support and Treat Women Experiencing Conception Delays Suzanne Cochrane, BTW, DTCM, BAS, 1 Caroline A. Smith, PhD, 1 and Alphia Possamai-Inesedy, PhD 2 Abstract Background: The influence of acupuncture on female fertility is of interest to people in clinical practice and acupuncture researchers. Despite developing research in the field, there is a marked absence of research defining an adequate treatment to support and treat women experiencing delays in conceiving. Objectives: The aims of this study were to develop a consensus among acupuncture fertility specialists on what is adequate acupuncture treatment to promote female fertility in the periconception period; to examine what acupuncturists do in a consultation; to examine their actions and their exchanges with their patients; and to finalize an acupuncture intervention for a clinical trial of fertility problems. Design and subjects: An online consensus-building technique was used among acupuncturists who are recog- nized experts in the field of women’s reproductive health. The 10 subjects were selected on the basis of their published work with respect to treating female fertility problems or on the recommendation of researchers who had published articles in this discipline. All 10 subjects currently, or until recently, treated (some exclusively) women facing fertility problems using acupuncture as one of the modalities to address these problems. Results: Although the participants were relatively diverse, a consensus emerged regarding the best way to provide acupuncture to women with fertility problems. Along the way, a rich vein of qualitative data emerged about the way in which acupuncture is applied. These data included, for example, the high value placed on differential diagnosis and the importance of the practitioner–patient relationship for the therapeutic outcome. Conclusions: Consensus building among experts provides a transparent method of protocol development suited to acupuncture research that will then hold relevance to clinical practice. Introduction A necdotal reports from clinicians indicate that acu- puncture is increasingly being used to promote and en- hance fertility. To explore the contribution acupuncture can make to a woman’s fertility, regulation of her menstrual cycle, and her level of awareness of her own fertility, a pragmatic randomized controlled trial was designed and planned. Gi- ven that a treatment protocol for this trial is not on public record, the proposed study necessitated the development of a credible and valid protocol. Examining reports of previous acupuncture research of- fers little guidance concerning a well-tested acupuncture protocol for promoting female fertility. The literature indi- cates there is a range of methodological options to fashion such an intervention. When there was no rigorous research to identify a protocol, the practice was to rely on a standard or classic text or to accept the guidance of an experienced practitioner. Articles on protocols based on classic texts would typically state: ‘‘ The categories and points for treat- ment are in common use in China.’’ 1 A researcher who was guided by a senior acupuncturist would state: ‘‘Acupoints and sham points were chosen by a study acupuncturist with 15 years of experience in treating[the condition stud- ied]and were approved by 3 other senior acupuncturists.’’ 2 There are interventions that are individualized according to theoretical constructs, palpation, and presenting symp- toms. Articles on using these criteria, for example, would discuss ‘‘local tender points anddistant acupuncture points according to the ‘near and far’ technique, depending on the condition being treated,’’ 3 and state that ‘‘[a]cupuncture was performed according to the rules of Traditional Chinese Medicine, including diagnostic palpation to identify sensitive spots.’’ 4 More recently, there have been attempts to determine 1 Center for Complementary Medicine Research, University of Western Sydney, Campbelltown Campus, Penrith, New South Wales, Australia. 2 School of Social Sciences, University of Western Sydney, Bankstown Campus, Penrith, New South Wales, Australia. THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE Volume 17, Number 4, 2011, pp. 329–337 ª Mary Ann Liebert, Inc. DOI: 10.1089/acm.2010.0190 329

Upload: alphia

Post on 01-Apr-2017

213 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Development of a Fertility Acupuncture Protocol: Defining an Acupuncture Treatment Protocol to Support and Treat Women Experiencing Conception Delays

Development of a Fertility Acupuncture Protocol:Defining an Acupuncture Treatment Protocol to Support

and Treat Women Experiencing Conception Delays

Suzanne Cochrane, BTW, DTCM, BAS,1 Caroline A. Smith, PhD,1 and Alphia Possamai-Inesedy, PhD2

Abstract

Background: The influence of acupuncture on female fertility is of interest to people in clinical practice andacupuncture researchers. Despite developing research in the field, there is a marked absence of research definingan adequate treatment to support and treat women experiencing delays in conceiving.Objectives: The aims of this study were to develop a consensus among acupuncture fertility specialists on whatis adequate acupuncture treatment to promote female fertility in the periconception period; to examine whatacupuncturists do in a consultation; to examine their actions and their exchanges with their patients; and tofinalize an acupuncture intervention for a clinical trial of fertility problems.Design and subjects: An online consensus-building technique was used among acupuncturists who are recog-nized experts in the field of women’s reproductive health. The 10 subjects were selected on the basis of theirpublished work with respect to treating female fertility problems or on the recommendation of researchers whohad published articles in this discipline. All 10 subjects currently, or until recently, treated (some exclusively)women facing fertility problems using acupuncture as one of the modalities to address these problems.Results: Although the participants were relatively diverse, a consensus emerged regarding the best way toprovide acupuncture to women with fertility problems. Along the way, a rich vein of qualitative data emergedabout the way in which acupuncture is applied. These data included, for example, the high value placed ondifferential diagnosis and the importance of the practitioner–patient relationship for the therapeutic outcome.Conclusions: Consensus building among experts provides a transparent method of protocol development suitedto acupuncture research that will then hold relevance to clinical practice.

Introduction

Anecdotal reports from clinicians indicate that acu-puncture is increasingly being used to promote and en-

hance fertility. To explore the contribution acupuncture canmake to a woman’s fertility, regulation of her menstrual cycle,and her level of awareness of her own fertility, a pragmaticrandomized controlled trial was designed and planned. Gi-ven that a treatment protocol for this trial is not on publicrecord, the proposed study necessitated the development of acredible and valid protocol.

Examining reports of previous acupuncture research of-fers little guidance concerning a well-tested acupunctureprotocol for promoting female fertility. The literature indi-cates there is a range of methodological options to fashionsuch an intervention. When there was no rigorous researchto identify a protocol, the practice was to rely on a standard

or classic text or to accept the guidance of an experiencedpractitioner. Articles on protocols based on classic textswould typically state: ‘‘ The categories and points for treat-ment are in common use in China.…’’1 A researcher who wasguided by a senior acupuncturist would state: ‘‘Acupointsand sham points were chosen by a study acupuncturist with15 years of experience in treating…[the condition stud-ied]…and were approved by 3 other senior acupuncturists.’’2

There are interventions that are individualized accordingto theoretical constructs, palpation, and presenting symp-toms. Articles on using these criteria, for example, woulddiscuss ‘‘local tender points and…distant acupuncture pointsaccording to the ‘near and far’ technique, depending on thecondition being treated,’’3 and state that ‘‘[a]cupuncture wasperformed according to the rules of Traditional ChineseMedicine, including diagnostic palpation to identify sensitivespots.’’4 More recently, there have been attempts to determine

1Center for Complementary Medicine Research, University of Western Sydney, Campbelltown Campus, Penrith, New South Wales,Australia.

2School of Social Sciences, University of Western Sydney, Bankstown Campus, Penrith, New South Wales, Australia.

THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINEVolume 17, Number 4, 2011, pp. 329–337ª Mary Ann Liebert, Inc.DOI: 10.1089/acm.2010.0190

329

Page 2: Development of a Fertility Acupuncture Protocol: Defining an Acupuncture Treatment Protocol to Support and Treat Women Experiencing Conception Delays

usual practice by seeking a consensus of practitioners. Re-searchers would write that ‘‘[s]tudy interventions were de-veloped by consensus of acupuncture experts andsocieties,’’5,6 or that ‘‘[t]he treatment strategies for…weredeveloped in a consensus process with acupuncture expertsfrom two major German societies for medical acupuncture.’’7

Clarification of effectiveness is possible when there arelarge numbers of studies that contain an accumulation ofevidence. In a systematic review8 of randomized controlledtrials (RCTs; including 33 of 386 possible trials) on acu-puncture for treating a specific neurologic disorder, the re-viewers recommended a standard acupuncture protocol.

Another approach to arriving at a suitable treatment de-sign is through extrapolating data from studies on thephysiologic mechanisms of acupuncture and the results ofanimal studies, for example as Liu et al. did.9

Against this idea of a single standard prescription for allcases, there has been the counter-perspective of ‘‘[t]he acu-puncture point prescriptions used were individualised toeach patient and were at the discretion of the acupunctur-ist.’’10 It has become clear in acupuncture research that thereis a conundrum around what MacPherson and Schroer calleda ‘‘trade off between a tightly and a loosely defined complexintervention.’’11

To address this trade-off, more-sophisticated and complexmeans of fashioning an intervention are being developed.Sinclair-Lian and colleagues, for example, outline a methodthat ‘‘formalizes a procedure to develop and individualize anacupuncture treatment plan that accurately reflects standardclinical practice yet can be used in a clinical trial.’’12 In asimilar attempt to address complexity, Schnyer and her col-leagues aimed to develop ‘‘an ecologically valid and viablemultimodal treatment intervention’’ applying Japanese acu-puncture.13 They used ‘‘manualization,’’ a method thatstandardizes treatment by providing the acupuncturist witha method or algorithm that can be adapted to each patient.

With respect to female fertility the acupuncture literatureprovides some guidance for suitable treatment approachesbut overwhelmingly requires practitioners to individualizetheir treatments to the presenting situations of the womenrequiring treatment. No definitive studies have been con-ducted evaluating acupuncture in this way. However, thereis increasing evidence14 that using acupuncture to addressfemale infertility is both popular and effective, acting on arange of mechanisms related to reproduction. Because of thedispersed and uncoordinated nature of acupuncture re-search, there is divergence in methodology that challengesattempts to conduct systematic meta-analyses. Consultationwith acupuncturists experienced in using acupuncture toenhance and promote female fertility offered the opportunityto build a treatment protocol from clinical experience.

The objectives of this study were to establish the likelyparameters of a protocol through indepth interviews withacupuncturists who specialize in female fertility, then to usea focus group to explore the value of these guidelines andseek a consensus.

Methods

Ethics approval was granted by the University of WesternSydney’s Human Research Ethics Committee in 2009 and thestudy was undertaken at the University’s Centre for Com-

plementary Medicine Research (Campbelltown Campus,Penrith South DC, Australia) between March and September2009. The study consisted of two phases.

Phase 1

The first phase of this study included intensive inter-viewing of key participants, which was undertaken to pro-vide initial input for the discussion forum. Three intensiveinterviews were conducted with Australian practitioners,exploring how they worked with women with fertilityproblems. All three practitioners had >20 years experience asacupuncturists and had spent much of that time workingpredominantly with women who had gynecologic problems.The three interviewees were selected because of their expe-rience, their histories of thoughtful reflection on their ownwork (which was apparent in publications, teaching, andpast discussions with the author), and their accessibility forinterviewer. A semistructured interview guide was devel-oped, based around two main themes. These practitionerswere asked about their practices and what factors theyconsidered important when working with women with fer-tility problems. These interviews followed a similar scriptand all central themes were covered in each interview. Theinterviews were conducted by S.C. (who has a similarbackground and experience); two were conducted in personand one was conducted via audiovisual conferencing. Theinterviews were digitally recorded and professionally tran-scribed. Each interview lasted approximately 1 hour.

An analysis of each interview provided the basis forquestions posed to the recruited fertility acupuncture spe-cialists. Issues such as the interviewees’ views of what acu-puncture does; their approaches to treating women withfertility problems and how these approaches were differentfrom those used to treat other conditions; courses of treat-ment; the roles of lifestyle advice and modification; thetherapeutic relationships established; and approaches to di-agnosis and treatment were discussed. At the conclusion ofthe third interview, it became clear that sufficient materialhad been generated to guide the larger forum discussion.Grounded theory15–19 was used as a guiding approach togenerate data and codify and theorize based on data fromparticipants in the field.

Phase 2

The research aim of the second phase of this study was todevelop a consensus among acupuncture fertility specialistson what comprises adequate acupuncture treatment to pro-mote female fertility in the periconception period and toexamine what acupuncturists do in consultations (i.e., ac-tions and exchanges with patients). A short-term onlinediscussion forum was established with selected experts infertility acupuncture and fertility acupuncture research. Theprimary criterion for recruitment was practitioners who hadwritten publications on the use of Chinese medicine in fe-male fertility/infertility. Other, secondary, guiding criteriawere attempts to achieve a geographic spread of recruits andrepresentation of the diversity within acupuncture practicestyles or paradigms.

Recruitment was begun via mail (electronic and postal) offertility acupuncture specialists. Theoretical sampling wasused to extend the network to maximize relevant participa-

330 COCHRANE ET AL.

Page 3: Development of a Fertility Acupuncture Protocol: Defining an Acupuncture Treatment Protocol to Support and Treat Women Experiencing Conception Delays

tion via a second round of recruitment, which includedacupuncturists who were recommended by those chosen inthe first recruitment round.

The work of the focus group was to be predominantlyconducted asynchronously by e-mail and through an elec-tronic Nexus website (Confluence Wiki) that was set upthrough the cooperation of the University of Western Sydney.Participants were first asked to consider a series of data col-lected from the extended interviews (Box 1); respond withtheir thoughts, feelings, experiences and suggestions; and thenreact to the responses given by other participants. A discus-sion was generated, resulting in a rich environment of thoughtand idea formation. The investigator facilitated and moder-ated discussion attempting to maximize the discussion, clarifydetail, and identify points of consensus and difference. Parti-cipants’ responses to the questions were collated, and aquestionnaire of statements was developed, based on theseresponses. Using a modified Delphi process the question-naire was distributed asking participants to rank the state-ments according to relevance to fertility acupuncture.Response options were: ‘‘Highly relevant’’ ‘‘Relevant,’’ ‘‘Mildlyrelevant,’’ ‘‘Not relevant,’’ and ‘‘No comment.’’ Survey-monkey, a web-based survey program, was used for distri-bution and evaluation of the statements. If> 80% consensus

was reached, a second Delphi round was not considered to benecessary.

Data analysis

Data generated by the online discussion and the extendedinterviews were coded, memos were prepared describingemerging concepts, and any new theoretical perspectiveswere documented for dissemination.

Grounded theory was used as a guiding approach, in boththe extended interviews (phase 1) and in the forum responses(phase 2), to finalize the content of the final survey; to gen-erate data; and to codify and theorize from the data gener-ated by the interviews, written responses, and discussion.

Results

In-depth interviews

The responses provided insight into the complexity re-presented within the therapeutic exchange of acupuncturewhen applied to women with fertility problems. One (1) re-spondent reported: ‘‘It’s a different journey when you areworking with someone who is trying to [become] preg-nant…you know, it’s a very different emotional journey.’’

Box 1. Questions for Forum Discussion

1. The definition of acupunctureWhat constitutes ‘‘acupuncture’’? What do you dowhen you do acupuncture?

2. Acupuncture treatment and menstrual cycleWhat do you each think is essential in an acupuncturetreatment of a woman designed to promote conception?Is the stage of her menstrual cycle the key indicator ofwhich treatment principle, point selection, and nee-dling technique you use?How precise is it necessary to be? For example, is a Day8 treatment very different from a Day 10 treatment?

3. Traditional Chinese Medicine/Oriental Medicine

diagnosisHow important is the differential diagnosis to acu-puncture point choice?

4. Timing of acupunctureDoes timing matter? In relation to the menstrual cy-cle? Season? Time of day? What timing is important ifwomen are intending to undertake ART? Or acu-puncture between ART cycles?*

5. Number of acupuncture treatmentsHow many treatments are necessary to be adequate(for maximizing fertility)? Would you expect to giveacupuncture weekly? More than weekly? Monthly?

6. Needling technique

In reporting on acupuncture research it is importantto specify details such as needling depth, needle di-rection, insertion mode, retention time, manipulation,order of insertion, unilateral or bilateral. Are thereparticular techniques that you would deem essentialin acupuncture for fertility management?

7. Relationship with patientHow important is the therapeutic relationship infertility acupuncture? Is this more important thanwhen treating other disorders?

8. Lifestyle components

How important is lifestyle change? Do you givespecific diet and exercise recommendations to fertilitypatients? Does this advice vary with differential di-agnosis or is it standard? What is it?

9. Collaboration with other therapiesDo you work collaboratively with other modalities(e.g., herbalism, homeopathy, counseling, nutrition)?Does this nonacupuncture health care make a majorcontribution to the treatment package?

10. Importance of biomedicine

How important is a biomedical diagnosis to yourchoice of acupuncture treatment? Do you require afull biomedical workup (blood tests, ultrasounds,laparoscopy) prior to treatment?

11. Referral onAt what point do you advise a patient to stop treatment?Refer on to ART or adoption services? What are theindicators that you use to seek other treatment options?

12. Treatment environmentHave you created a special environment in which totreat women with fertility problems? What are thecomponents of that place?

13. Personal agency

How important is your personal style or how you areon the day/at the point of treatment?

14. Specific acupuncture pointsAre there particular acupuncture points that are es-sential to fertility treatment?*ART, assisted reproductive technologies.

ACUPUNCTURE FOR FERTILITY 331

Page 4: Development of a Fertility Acupuncture Protocol: Defining an Acupuncture Treatment Protocol to Support and Treat Women Experiencing Conception Delays

Another stated: ‘‘They’ve probably got a little bit more in-vested in what I can do or not do, than someone who’scoming for a different sort of disorder.’’ A third practitionerstated: ‘‘It’s not just their bod[ies]; it’s their huge trust thatthey place in you.…and, especially when you’ve got thatadded thing of, you know, you’re [their] last resort.’’ Theseresponses pointed to the importance of the practitioner–patient relationship and led to the inclusion of the followingquestion on the forum: ‘‘How important is the therapeuticrelationship in fertility acupuncture? Is this more importantthan when treating other disorders?’’

The most apparently challenging question was: ‘‘What doyou do when you do acupuncture?’’ All 3 respondents hes-itated. One answered ‘‘what do you mean, what do Ido?…sometimes I’m really clear about what I’m doing.Sometimes I’m not.’’ Another responded: ‘‘Do you want tocome back to that one? That’s a really big one and, yeah, Idon’t think there’s an easy answer to that.’’ The third offereda notion of facilitating another’s access to ‘‘energetic balanceand harmony.’’ This question was therefore retained in itsentirety into the forum discussion.

Although the most consistent response to requests fordetails on treatment approaches from the initial three inter-viewees was ‘‘[i]t depends…’’—on how the woman is on theday, on what other support she has, on how informed she isabout her own body and fertility, and so on—guidelines thatcould be applied generally did emerge. These practitionersconsidered both Chinese medical pattern differentiation anda biomedical understanding of factors, such as hormonalclimate, as essential frameworks for successful work withWestern women. This response was echoed in the focusgroup, although an emphasis on the Chinese medical per-spective was considered most critical.

Sensitivity to the perceived or expressed needs of the fe-male patient was a theme in each interview. The particularvulnerability of women dealing with the prospect of infer-tility dominated the interviews. There was a subtheme thatsuggested the practitioners had some difficulty balancingtheir own needs against the needs of their clientele. Eachrespondent reported using different methods to navigatethrough this conflict. As this issue was more concerned withpersonal practice, it was not included as a theme in thesubsequent focus group forum.

Attention to the treatment environment was also empha-sized by the 3 respondents, with imparting a sense of safetyto patients being primary. This issue then was taken forward

to the focus group, in which 1 member reported giving at-tention to detail in her treatment room and sent photos of herclinic room. Another practitioner reported that he did notattend at all to such details and just required a serviceablespace in which to work. In this way issues, were flagged forinclusion in the broader forum.

The extended interviews with key informants generated arange of topics that were collated into the 14 questions posedto the forum participants (Box 1).

Online forum

In all, 23 acupuncturists were approached to participate;19 replied and 10 accepted the invitation to participate,signed consent forms and completed the process. Those whodeclined were unable to due to pressure of work, personalcircumstances or little expertise in acupuncture. (Table 1)

At least 5 of the participants had extensive biomedicaltraining mostly undertaken prior to their involvement inChinese medicine. All reported specializing in or primarilyundertaking fertility treatments.

This question of what acupuncture is and does attractedresponses that spoke to the complexity of acupuncture as anintervention and a diversity of views: One respondentstated: ‘‘I use acupuncture to bring the body back towardsnormal functioning and to optimise each menstrual phase.It depends how deviated from normal functioning the bodyhas become as to how successful acupuncture alone willbe.’’ Another respondent stated: ‘‘The obvious is placingneedles at specific points throughout the body. However,‘acupuncture’ is so much more than that.’’ And, yet anotherrespondent stated: ‘‘As the Nei Jing says, ‘above all, inneedling, we must be rooted in spirit. ‘Having a relation-ship with what the patient is presently going through iscrucial to having a feel for the appropriate direction theacupuncture treatment takes.…when we are connected tothe patient, our points are guided by a deeper under-standing, and takes us to the actual points that are appro-priate in that moment.’’ Although evidence of differentconceptions was apparent in the individual responses to themore general questions, there was still more agreementthan differences overall.

All respondents indicated that the tradition of Chinesemedicine was central to their practices, despite the domi-nance of biomedical perspectives in contemporary Westernapproaches to female fertility.

Table 1. Focus Group Participants

Participant Residence Years of experience Gender Mode Postgraduate study

1 United Kingdom 18 Male TCM Yes2 United Kingdom 17 Female TCM/‘‘eclectic’’ Yes3 United States 15 Female TCM/WM Research4 United States 14 Female TCM/fertility retreats Yes5 (team) United States 62 (26þ 27þ 8) Female TCM/WM Yes6 United States 10 Male TCM Yes7 United States 20 Female TCM Yes8 United States 7 Female TCM Yes9 Australia 20 Female Acupuncture Yes10 Australia 30 Female TCM Yes

TCM, Traditional Chinese Medicine; WM, Western medicine.

332 COCHRANE ET AL.

Page 5: Development of a Fertility Acupuncture Protocol: Defining an Acupuncture Treatment Protocol to Support and Treat Women Experiencing Conception Delays

Table 2. Survey: Components of Fertility Acupuncture Protocol for Clinical Practice

Survey itemNo

commentNo

relevanceMildlyrelevant Relevant

Highlyrelevant

1. Acupuncture should be considered a complex interven-tion encompassing more than the technique of needling; itencompasses the therapeutic relationship and the range ofChinese medicine modalities such as diet and lifestyleadvice.

1 0 1 1 7

2. Fertility acupuncture should be a specialist endeavor requiring:a. Knowledge of reproductive endocrinology/physiology 0 0 0 3 7b. Knowledge of TCM gynecology 0 0 0 1 9c. Knowledge of ART procedures 0 0 1 1 8d. Personal capacity to professionally engage with women’s

fertility journeys.0 0 0 3 7

3. Treatment should be based on a diagnosis of patterndifferentiation.

0 0 1 2 6

4. Treatment should be based on time in the menstrualcycle—responding to at least 4 phases of the cycle.

0 0 2 6 2

5. Treatment should include a response to the patient’s spiritor presenting emotional state.

0 0 1 4 5

6. Biomedical information should inform decisions aboutdiagnosis and treatment.

0 1 0 6 3

7. Consideration of acupuncture treatment should be pre-cisely timed and acupoints selected for specific patientgroups (e.g., timing for reluctant ovulators or embryotransfer or ovarian stimulation during IVF).

0 1 2 3 4

8. Differential diagnosis should include the following patterns:a. Kidney Yang/Yin Deficiency/Vacuity 0 0 0 3 7b. Liver Blood Deficiency/Vacuity 0 0 0 4 6c. Heart Yin &/or Blood Deficiency/Vacuity 0 0 1 4 5d. Spleen Qi Deficiency 0 0 0 4 6e. Liver Qi Stagnation 0 0 0 3 7f. Blood Stasis 0 0 0 3 7g. Phlegm/Damp Accumulation 0 0 0 4 6h. Assessment of the Spirit. 0 1 0 2 7

9. Weekly acupuncture treatments should be a minimumwhen using an acupuncture-only intervention.

0 0 0 6 4

10. 3 months of acupuncture treatment should be anadequate intervention periconceptually.

0 0 4 5 1

11. Acupuncture techniques:a. 20 minutes should be a minimum for needle retention 0 0 1 8 1b. Deqi should be a felt response to needling 0 1 3 4 2c. Needle manipulation for tonification (bufa) or reduction

(xiefa) should be applied0 0 6 3 1

d. Actual technique should be dependent on patient pre-sentation

0 0 0 6 4

e. Electroacupuncture for ovarian stimulation or to move qi& blood as appropriate.

0 1 3 4 2

12. The practitioner-patient relationship should be devel-oped as a central part of the acupuncture intervention.

0 0 1 5 4

13. Lifestyle & dietary changes based on differential diag-nosis should be a component of an acupuncture inter-vention.

0 0 1 4 5

14. Lifestyle recommendations should include:a. Stop smoking 0 0 0 2 8b. No recreational drugs/substance abuse 0 0 0 2 8c. Moderate alcohol 0 0 1 1 8d. No coffee 0 1 2 6 1e. Appropriate exercise for constitution (not vigorous) 0 1 0 5 4f. Relaxation & rest 0 0 1 2 7g. Emotional support 0 0 0 6 4

(continued)

ACUPUNCTURE FOR FERTILITY 333

Page 6: Development of a Fertility Acupuncture Protocol: Defining an Acupuncture Treatment Protocol to Support and Treat Women Experiencing Conception Delays

The high degree of agreement evident in most of thewritten responses to the questions posed in the FertilityAcupuncture Protocol (FAP) website and e-mail was sus-tained in the final survey (Table 2) in which each statementwas ranked for its relevance to a fertility acupuncture pro-tocol. Most participants rated most of the statements as‘‘relevant’’ or ‘‘highly relevant.’’ A consistent duality of

opinion did not emerge, and, when ‘‘no relevance’’ waschosen, it was only ever by a single respondent. For example,only a single respondent considered there was no relevanceto assessing the Spirit in differential diagnosis; or excludingcoffee from dietary prohibition; or that biomedical informa-tion should inform diagnosis. There were only two optionsin which ‘‘no comment’’ was chosen, indicating that

FIG. 1. Responses to ‘‘Fertility acupuncture should be a specialist endeavor requiring.…’’ TCM, Traditional ChineseMedicine; ART, assisted reproductive technologies.

Table 2. (Continued)

Survey itemNo

commentNo

relevanceMildlyrelevant Relevant

Highlyrelevant

h. Improved nutrition 0 0 0 6 3i. Nutritional supplements 0 1 0 7 1j. Stress management. 0 0 0 5 5

15. Collaboration with other modalities of care (e.g., coun-seling, herbalism) should be undertaken when appro-priate or when sought by patient

0 0 1 4 5

16. Explicit referral on or termination of treatment should beconsidered when an inadequate response is encounteredwithin 6 months, although this will vary with patients

0 0 3 6 1

17. Treatment environment should recognize patient’s need for:a. Safety 0 0 0 6 4b. Quiet 0 0 1 8 1c. Rest & calming 0 0 1 5 4d. Confidentiality 0 0 0 4 6e. Professionalism 0 0 0 4 6

18. The practitioner should be:a. Attentive 0 0 0 4 6b. Caring & supportive 0 0 0 3 7c. Engaged/patient-focused 0 0 0 3 7d. Able to have a professional relationship between practi-

tioner and patient based on trust0 0 0 3 7

19. Acupoints that should be considered include:a. Extraordinary Meridians/channels 0 0 0 5 5b. Abdominal points in follicular phase 0 0 0 4 6c. Back shu points in luteal phase 0 1 1 6 2d. Shen/Spirit calming points such as Yintang, chest Kidney

channel points0 0 0 6 4

e. Lumbosacral points &/or abdominal points such as zigongfor stimulating ovulation

0 0 0 5 5

TCM, Traditional Chinese Medicine; ART, assisted reproductive technologies; IVF, in vitro fertilization.

334 COCHRANE ET AL.

Page 7: Development of a Fertility Acupuncture Protocol: Defining an Acupuncture Treatment Protocol to Support and Treat Women Experiencing Conception Delays

participants made a commitment of their views in mostinstances.

The gradations of relevance did differentiate more in thesurvey than was clear in the respondents’ comments. Inquestion 2 (Fig. 1), for example, 9 of 10 respondents con-sidered knowledge of Traditional Chinese Medicine (TCM)gynecology highly relevant to a fertility acupuncturist,whereas knowledge of assisted reproduction technologies(ART) procedures were relevant but not as relevant.

Or comparing the answers to questions 3–6, presented inFigure 2, on the basis of treatment, ‘‘differential diagnosis’’outstripped other factors as ‘‘highly relevant,’’ although allfactors were considered relevant (except 1 respondent ex-cluded ‘‘biomedical information’’). When viewed pro-portionally in the diagram, however, variations do appear inemphasis or weighting.

Within differential diagnosis (Fig. 3) there is high consis-tency in defining the relevant categories or patterns whichcan contribute to female fertility problems.

Discussion

The aim of an agreed adequate acupuncture protocolfor female infertility, which can then be applied in the clin-

ical trial, was the outcome from this process. In additiongreater understanding of what constitutes an acupunc-ture treatment and how acupuncturists work has emergedfrom the extensive interviews and the subsequent discussionforum.

The indepth interviews with the 3 acupuncturists inphase one of the study displayed the qualities—also appar-ent in the forum discussion—of a deeply felt duty of care, arespect for the tradition to which they belonged, and a pre-paredness to embrace the insights of biomedicine in the re-productive arena. All respondents appeared to approachthe task asked of them with careful reflection, given thedifficult issues in applying an ‘‘ancient’’ medicine to the bothhighly technical and incommensurable field of reproductivehealth.

A number of important issues emerged from the study,which have implications for practice:

� Acupuncture should be considered ‘‘a complex in-tervention encompassing more than the technique ofneedling; it encompasses the therapeutic relation-ship and the range of Chinese medicine modalities,such as diet and lifestyle advice,’’ as one respondentput it.

FIG. 3. Responses to ‘‘differential diagnosis should include.…’’

FIG. 2. Responses regarding guiding diagnostic principles.

ACUPUNCTURE FOR FERTILITY 335

Page 8: Development of a Fertility Acupuncture Protocol: Defining an Acupuncture Treatment Protocol to Support and Treat Women Experiencing Conception Delays

� Working effectively with infertility has become a spe-cialist endeavor beyond the knowledge and skill set offrontline acupuncture practitioners.

� Inclusion and emphasis on the Spirit or emotional stateof women influencing fertility (this is consistent with theChinese medical concept of the bao mai, which links theHeart and the Uterus).

� The relationship between practitioner and patient isanother tool in the therapeutic alliance.

Examining acupuncture interventions alone does notrepresent most Chinese medical clinical practice fully. Mostfertility acupuncturists use at least Chinese herbal medicineas an adjunct to amplify their treatment strategies. Un-fortunately, this study did not have the capacity to includethese adjunctive therapies. A broader examination of therange of Chinese medicine approaches to fertility is war-ranted.

Strengths

The strengths of the methodology are that, at minimalexpense, leading specialists were gathered to exchange viewswith their peers. The use of a grounded theory approachallowed the parameters and substance of discussion toemerge from the field—the experience of people steeped inan understanding of Chinese medicine and its clinical ap-plication to female fertility in a modern context. Thesefindings can be applied to other settings.

Limitations

One of the limitations of this research was the under-standing of expertise that directed recruitment of partici-pants. It is an assumption that publications and visibility tocolleagues represents the highest level of expertise. Otherrecruitment methods may have exposed a different group ofpeople for the study. Those practitioners who had no websitepresence or for whom an e-mail address was not publiclyaccessible were approached by mail or fax. None of thoseapproached in this way responded to the invitation. At leastpartially, this may be explained by the inaccessibility of anonline consultative process dependent upon technologicalexpertise they may not have possessed.

There are a number of concerns arising from the samplingin this study. One is that none of the participants were fromEast Asia—China, Japan, or Korea—the classical ‘‘homelandsand engine rooms’’ of acupuncture. Another concern is thatthe sample was predominantly American, and all respon-dents were from the English-speaking West—6 of the 10acupuncturists worked in the United States, 2 in Great Brit-ain, and 2 in Australia. This can be explained in severalways—English-speaking or translated journals were used tolocate published researchers; both the recruitment and dis-cussion was in English; perhaps the notion of a fertilityspecialty in acupuncture is a phenomenon in only thesecountries; using a sampling technique that followed net-works inevitably located other respondents who wereknown to the core respondents. One participant, Jane Lyt-tleton, has written a seminal text on the use of Chinesemedicine for infertility.20 It is possible that the consensusachieved in this study is an artifact of how knowledge, suchas this text, is transmitted within the professional network.

Conclusions

Although this study did not specify in detail which acu-puncture points should be used on a woman presenting in aparticular way at a particular time of her menstrual cycle, thestudy does provide guiding principles considered to be ofgreat relevance by leaders in the field of female fertility.These guiding principles can be manualized and used as aframework to inform treatments both within practice settingsand semistandardized for research purposes. The develop-ment of best-practice guidelines will have implications forclinical practice and this consensus-between-experts methodof achieving such guidelines provides a transparent methodof protocol development suited to acupuncture research thatwill too hold relevance to clinical practice.

Acknowledgments

The authors wish to acknowledge and thank the fol-lowing specialist acupuncturists for their willing, goodhumored, and learned contributions: Dr. Belinda Anderson,Emma Cannon, Dianne Cridennda, Alice Domar and hercolleagues at the Domar Centre, Andrew Flower, RandineLewis, Jane Lyttleton, Lara Rosenthal, Ray Rubio and AssocProfessor Caroline Smith. S.C. would also like to acknowl-edge the assistance of Jan McLay-Jamieson for her help andsupport and the editorial advice of Dr. Ben Colagiuri.Funding for this project was made to the University ofWestern Sydney by the Australian National Institute ofComplementary Medicine.

Disclosure Statement

No conflicts of interests exist.

References

1. Knight B, Mudge C, Openshaw S, et al. Effect of acupunc-ture on nausea of pregnancy: A randomized, controlled trial.Obstet Gynecol 2001;97:184–188.

2. Assefi NP, Sherman KJ, Jacobsen C, et al. A randomizedclinical trial of acupuncture compared with sham acupunc-ture in fibromyalgia. Ann Intern Med 2005;143:10–19.

3. Giles L, Muller R. Chronic spinal pain syndromes: A clinicalpilot trial comparing acupuncture, a nonsteroidal anti-in-flammatory drug, and spinal manipulation. J ManipulativePhysiol Ther 1999;22:376–381.

4. Irnich D, Behrens N, Molzen H, et al. Randomised trial ofacupuncture compared with conventional massage and"sham" laser acupuncture for treatment of chronic neck pain.BMJ 2001;322:1574–1578.

5. Linde K, Streng A, Jurgens S, et al. Acupuncture for patientswith migraine: A randomized controlled trial. JAMA2005;293:2118–2125.

6. Melchart D, Streng A, Hoppe A, et al. Acupuncture in pa-tients with tension-type headache: Randomised controlledtrial. BMJ 2005;331:376–382

7. Brinkhaus B, Witt CM, Jena S, et al. Acupuncture in patientswith chronic low back pain: A randomized controlled trial.Arch Intern Med 2006;166:450–457.

8. Zheng H, Li Y, Chen M. Evidence based acupuncturepractice recommendations for peripheral facial paralysis.Am J Chin Med 2009;37:35–43.

9. Liu SY, Hsieh CL, Wei TS, et al. Acupuncture stimulationimproves balance function in stroke patients: A single-blinded

336 COCHRANE ET AL.

Page 9: Development of a Fertility Acupuncture Protocol: Defining an Acupuncture Treatment Protocol to Support and Treat Women Experiencing Conception Delays

controlled, randomized study. Am J Chin Med 2009;37:483–494.

10. Vickers AJ, Rees RW, Zollman CE, et al. Acupuncture forchronic headache in primary care: Large, pragmatic, ran-domised trial. BMJ 2004;328;744.

11. MacPherson H, Schroer S. Acupuncture as a complex in-tervention for depression: A consensus method to develop astandardised treatment protocol for a randomised controlledtrial. Complement Ther Med 2007;15:92–100.

12. Sinclair-Lian N, Hollifield M, Menache M, et al. Developinga Traditional Chinese Medicine diagnostic structure for post-traumatic stress disorder. J Altern Complement Med 2006;12:45–57.

13. Schnyer RN, Iuliano D, Kay J, et al. Development of proto-cols for randomized sham-controlled trials of complextreatment interventions: Japanese acupuncture for endome-triosis-related pelvic pain. J Altern Complement Med 2008;14:515–522.

14. Stener-Victorin E, Humaidan P. Use of acupuncture in fe-male infertility and a summary of recent acupuncturestudies related to embryo transfer. Acupunct Med 2006;24:157–163.

15. Charmaz K. Grounded theory: Objectivist and constructivistmethods. In: Denzin NK, Lincoln YS, eds. Strategies ofQualitative Inquiry, 2nd ed. Thousand Oaks, CA: SagePublications, 2003:249–291.

16. Charmaz K. Constructing Grounded Theory: A PracticalGuide Through Qualitative Analysis. London: Sage Pub-lications, 2006.

17. Corbin J, Strauss A. Basics of Qualitative Research: Techni-ques and Procedures for Developing Grounded Theory, 3rded. Los Angeles: Sage Publications, 2008.

18. Denzin NK, Lincoln YS, eds. Strategies of Qualitative In-quiry, 2nd ed. Thousand Oaks, CA: Sage Publications, 2003.

19. Dey I. Grounding Grounded Theory: Guidelines for Quali-tative Inquiry. London: Academic Press, 1999.

20. Lyttleton J. Treatment of Infertility with Chinese Medicine.Edinburgh: Churchill Livingstone, 2004.

Address correspondence to:Suzanne Cochrane, BSW, DTCM, BAS

Centre for Complementary Medicine ResearchUniversity of Western Sydney

Building 5Campbelltown Campus

Locked Bag 1797Penrith, New South Wales, 2751

Australia

E-mail: [email protected]

ACUPUNCTURE FOR FERTILITY 337

Page 10: Development of a Fertility Acupuncture Protocol: Defining an Acupuncture Treatment Protocol to Support and Treat Women Experiencing Conception Delays