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    Acupuncture:

    efficacy, safety and practice

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    Acupuncture:

    efficacy, safety andpractice

    Board of Science and Education

    British Medical Association

    harwood academic publishers

    Australia Canada France

    Germany India Japan

    Luxembourg Malaysia The

    Netherlands Russia

    Singapore Switzerland Thailand

    United Kingdom

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    Copyright 2000 British Medical Association

    Published by license under the Harwood AcademicPublishers imprint,

    part of The Gordon and Breach Publishing Group.

    This edition published in the Taylor & Francis e-Library,2005.

    To purchase your own copy of this or any of Taylor &Francis or Routledges collection of thousands of eBooks

    please go to www.eBookstore.tandf.co.uk.

    All rights reserved.

    No part of this book may be reproduced or utilized in anyform or by

    any means, electronic or mechanical, includingphotocopying and

    recording, or by any information storage or retrieval system,without

    permission in writing from the publisher. Printed in theUnited

    Kingdom.

    Amsteldijk 1661st Floor

    1079 LH Amsterdam

    The NetherlandsBritish Library Cataloguing in Publication Data

    A catalogue record for this book is available from the BritishLibrary.

    ISBN 0-203-98996-1 Master e-book ISBNISBN 90-5823-164-X (soft cover)

    Cover photograph: Telegraph Colour Library

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    Contents

    List of tables xi

    List of figures xii

    1 Introduction 1

    Growth in the use ofComplementary andAlternative Medicine (CAM)

    1

    BMA policy on CAM 4 Annual Representative Meeting

    1998 policy 5

    Scope of the report 6

    2 The evidence base ofacupuncture

    7

    Introduction 7

    Clinical trials of acupuncture 12

    Methodological difficulties 22

    Future research 24

    3 Safety: a review of adverse

    reactions to acupuncture

    37

    Introduction 37

    Physical injuries 38

    Infections 39

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    Other adverse reactions 41

    Contraindications of

    acupuncture

    43

    Difficulties with the evaluationof adverse reaction reports

    44

    Adverse reactions toacupuncture in perspective

    46

    4 Education and training 49

    Introduction 49

    Principles of CAM education 50

    Teaching acupuncture 53

    Acupuncture organisations 57

    National guidelines for

    acupuncture training

    60

    Summary 61

    5 Acupuncture in primary care 63

    Introduction 63

    Provision of CAM by general

    practitioners

    64

    GPs knowledge aboutacupuncture

    65

    BMA surveyThe use ofacupuncture in primary careservices

    67

    Discussion 776 Future developments 83

    Introduction 83

    Efficacy, safety and training 83

    v

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    Survey of GPs 84

    Funding 85

    Cost-effectiveness 88

    Integration into the NHS 89

    Recommendations 94

    Appendix I: Glossary 99

    Appendix II: Acupuncture organisations 105

    Appendix III: Current position ofacupuncture in the UK

    107

    References 115

    Index 127

    vi

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    Editorial Board

    A publication from the BMA Science Department andthe Board of Science and Education.

    Chairman, Board of Scienceand Education

    Sir William Asscher

    Head of ProfessionalResources and Research

    Group

    Professor VivienneNathanson

    Editor Dr David Morgan

    Research and writing Laura Conway

    Contributors Marcia Darvell

    Lisa Davies

    Professor Edzard Ernst

    Hilary Forrester

    Kate ThomasDr Adrian White

    Editorial secretariat Nicholas HarrisonDawn Whyndham

    Indexer Richard jones

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    Board of Science andEducation

    This report was prepared under the auspices of theBoard of Science and Education of the British MedicalAssociation, whose membership for 1999/00 was asfollows:

    Sir Peter Froggatt President, BMA

    Professor B R Hopkinson Chairman, RepresentativeBody, BMA

    Dr I G Bogle Chairman of BMA Council

    Dr W J Appleyard Treasurer, BMA

    Sir William Asscher Chairman, Board of Scienceand Education

    Dr P H Dangerfield Deputy Chairman, Board of Science and Education

    Dr A ElsharkawyDr H W K Fell

    Dr R Gupta (Deputy)

    Dr S Hajioff

    Dr V Leach

    Dr N D L Olsen

    Professor M R Rees

    Dr S J RichardsMiss S Somjee

    Dr P Steadman (Deputy)

    Dr S Taylor

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    Acknowledgements

    The Association is grateful for the help provided by theBMA Committees and many outside experts andorganisations, and would particularly like to thank: Dr

    Joel Bonnet, Dr Imogen Evans, Val Hopwood, SimonFielding, Simon Mills, Felicity Moir, the acupunctureorganisations listed in Appendix II, Butterworth-Heinemann, and the researchers who providedinformation about their current work. We are alsoindebted to the GP members who took time to provideus with detailed responses to our postal survey.

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    List of tables

    Table 1: Summary of methodological details ofreviews of the clinical effectiveness of

    acupuncture

    26

    Table 2: Controlled clinical trials ofacupuncture for back pain

    27

    Table 3: Controlled trials of acupuncture forneck pain

    29

    Table 4: Controlled trials of acupuncture forosteoarthritis

    31

    Table 5: Systematic reviews of acupuncture for

    various indications

    32

    Table 6: Controlled clinical trials ofacupuncture for smoking cessation

    33

    Table 7: Controlled clinical trials ofacupuncture for stroke

    33

    Table 8: Controlled trials of acupuncture fordental pain

    35

    Table 9: GPs views on which type of healthcareprofessional should provideacupuncture services

    71

    Table 10: Source of GP knowledge aboutacupuncture

    74

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    List of figures

    Figure 1: Percentage of GPs arranging specificCAM therapies for their patients

    69

    Figure 2: Percentage of GPs arrangingacupuncture treatment for differentconditions

    70

    Figure 3: Which healthcare professionalsactually provide the acupuncturetreatment?

    72

    Figure 4: GPs reasons for not arrangingacupuncture treatment for their

    patients

    74

    Figure 5: GPs reasons for wanting acupunctureavailable on the NHS

    76

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    1Introduction

    The British Medical Association (BMA) Board ofScience and Education was established to supportthe Association in its founding aim to promote themedical and allied sciences and to maintain thehonour and interests of the medical profession. Part ofthe remit of the Board is to undertake research studieson a wide range of key public health issues on behalfof the Association and to provide reports and guidanceto the profession and information to the public onhealth related matters which are of general concern.When endorsed by BMA Council, the reports arepublished as BMA policy reports to influence doctors,Government, policy makers, the professions, the mediaand the public. Over the past two decades particularly,

    the Board has helped to formulate BMA policy oncomplementary and alternative medicine (CAM) andpublished two major reports (BMA, 1986; BMA, 1993).

    Growth in the use of Complementaryand Alternative Medicine (CAM)

    The NHS spends considerable money on the treatmentof chronic and undifferentiated disease, conditions forwhich patients often seek help from CAM. The Officeof Health Economics in 1991 recorded an NHSexpenditure of 1 billion per annum with respect to

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    these conditions, which in 2000 is likely to beexceeded. By 1995 it was estimated that 39.5% of GPpartnerships in England were providing access to

    complementary therapy for their NHS patients(Thomas et al., 1995). This provision may be via theprimary care team itself, referral to one of six NHShomoeopathic hospitals, to pain clinics or to privatepractitioners, or through the employment ofcomplementary practitioners in GP practices. Thomaset al.(2000) estimated that the NHS provided 10% of

    contacts to six established CAM therapies(acupuncture, medical herbalism, chiropractic,osteopathy, homoeopathy and hypnotherapy) in theyear 1997/8.

    In its second report to the Department of Health, theCentre for Complementary Health Studies in Exeterestimated that up to 5 million people may have

    consulted a practitioner specialising in CAM in thelast year, and an incalculable extra number may haveconsulted a statutory health professional practisingCAM (Mills and Budd, 2000). Up to one third of UKcancer patients use complementary therapies andmany oncology units and hospices offer at least oneCAM therapy to patients (Kohn, 1999). Acupuncture

    and homoeopathy are the most commonly providedtherapies, and acupuncture is now reported to beavailable in 86% of NHS chronic pain services (DoH,1999).

    Current estimates indicate that there could be morethan 60,000 CAN practitioners and possibly 20,000statutory health professionals regularly practising avariety of CAM therapies in the UK Of these, there areabout 2,050 acupuncture practitioners (an increase of36% in two years) and 3,530 statutory healthpractitioners practising acupuncture (an increase of51% in two years).

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    The rapid growth in popularity of CAM suggests agreater degree of public awareness with what they maysee as the limitations of orthodox medicine and

    concern over the side effects of ever more potent drugs(FIM, 1997). It coincides with the growing view withinconventional healthcare practice that a renewedemphasis needs to be placed on the patient-doctorrelationship and on seeing patients as individuals inthe personal and social settings in which their problemsdevelop. This view is reflected in both the GMCs 1993

    report, Tomorrows Doctors, and the BMAs report,Complementary Medicine: New Approaches to GoodPractice, published in the same year. It is alsoconsistent with the current emphasis in the NHS of

    basing treatment on proven effectiveness and on valuefor money.

    A shift in attitude within the medical profession is

    reflected in the BMAs present policy and in the use ofthe term complementary rather than alternative. Alarge national postal survey of GPs showed that manyhave an open mind as to the value of such treatmerits(GMSC, 1992), with many GP partnerships in Englandproviding access to some form of complementarytherapy for NHS patients (Thomas et al.,1995).

    Writing in 1998, the President of the Royal Collegeof Physicians of London (RCP) commented, we can nolonger ignore the existence of alternative therapieswe, in the Royal College of Physicians, haveestablished a committee to advise the college on howwe should handle the alternative therapies. Disbeliefamong conventional practitioners has at least beenreplaced by a healthy skepticism and a clear wish toexamine the evidence sensibly and logically (RCP,1998). The RCP has since sent a questionnaire to itsmembers to gauge their use of CAM and attitudetowards it.

    INTRODUCTION 3

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    BMA policy on CAM

    The 1993 BMA policy report continues to reflect the

    Associations policy on CAM. Patients are increasinglyasking doctors about CAM therapies, and it is currentlydifficult for patients and doctors to identify thosetherapists who are competent and adequately trainedto carry out such treatments. Doctors are duty bound todelegate care only to those whom they believe arecompetent, and it may be important for the patientsdoctor to maintain continuing clinical control of thepatients treatment. While medical practitioners arefree to practise whatever form of medicine isappropriate for the patient, they remain accountable tothe General Medical Council for all treatments.However, how can doctors be certain that theirpatients are safe when delivered into the hands of aCAM practitioner?

    The BMAs policies on CAM have reflected aparticular interest in the discrete clinical disciplinesofhomoeopathy, osteopathy, chiropractic, acupunctureand herbal medicine. These are distinguished fromother therapies by having more establishedfoundations of training, are increasingly the therapiesof choice for the UK public, but also have in common

    the greatest potential to do harm to the patientdirectly, since they involve physical manipulation orinvasive techniques, and/or by misdiagnosis oromission (BMA, 1993).

    Last year the BMAs General Practitioner Committee(GPC) issued guidance on referrals to complementarytherapists indicating that GPs can safely referpatients

    to complementary therapists who are registered asdoctors or nurses, and also to registered practitionersin osteopathy and chiropractic, and confirmed thatGPs can delegatetreatment to other CAM practitioners,

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    subject to a number of criteria (GPC, 1999). Indelegating to a CAM practitioner GPs are advised to:

    Satisfy themselves that the treatment seemsappropriate and is likely to benefit the patient

    Pass on any necessary information about the patientto the therapist, with the patients clear consent

    Retain responsibility for managing the patients care(as stated by the GMC, 1998).

    Annual Representative Meeting1998policy

    The 1998 BMA Annual Representative Meeting raisedissues concerning efficacy and safety, with specificreference to acupuncture, and the following resolutionwas passed:

    That this Representative Body asks the Board ofScience [and Education] to investigate the scientific

    basis and efficacy of acupuncture and the quality oftraining and standards of competence in itspractitioners.

    The BMA Board of Science and Education hasundertaken a comprehensive review of some of themajor aspects of acupuncture, examining the published

    literature, obtaining education and traininginformation from acupuncture organisations,universities and so forth, and communicating withpractitioners. Importantly, a national postal survey of arandom sample of GPs was undertaken in 1999 whichhas provided new comprehensive data and informationabout GPs knowledge and use of acupuncture in the

    UK today.To ensure that a wide range of views was obtained in

    support of this study, the BMA science secretariatsought information from the main organisations which

    INTRODUCTION 5

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    act as professional bodies for acupuncturists from thecomprehensive list provided by the University ofExeter (Mills and Peacock, 1997; Mills and Budd,

    2000) (see Appendix II).

    Scope of the report

    The majority of issues considered in this report, such assafety, efficacy and training, are important to all usersof acupuncture, whether NHS patients, or private, self-

    referred patients. However, the issue ofcost- effectiveness applies most strongly to itsprovision in the NHS, and not to private practices.With 90% of the consultations being private, anestimated 450 million per annum is spent on out-of-pocket fees for treatment (Thomas et al.,2000).

    This first chapter has provided background to the

    BMAs policies on CAM and the remit of this report.The question of the clinical effectiveness and efficacyof acupuncture treatment for a variety of medicalconditions is addressed in chapter 2, where the resultsof key clinical trials are summarised. Chapters 3and 4discuss the important issues of the safety ofacupuncture, and the training and education of itspractitioners. The main results of the BMA 1999 postalsurvey of UKGPs are presented in chapter 5, gaugingthe attitudes and knowledge that GPs have aboutacupuncture, and the extent to which it is being offeredto patients. Finally, future developments in theprovision of CAM, particularly acupuncture, areexamined in chapter 6, including funding and researchissues, cost-effectiveness, and its integration into the

    NHS. The BMAs recommendations for future actionare presented.

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    2The evidence base of

    acupuncture

    Introduction

    The study and practice of complementary andalternative medicine (CAM) is now at a newcrossroads. In the West, the growth in the number andvariety of CAM therapies is a fairly recent

    phenomenon, and the rate of patient consultations fortreatments is increasing rapidly (Eisenberg et al.,1998),with snapshots in time illustrating this phenomenon(Eisenberg et al., 1993; Thomas et al., 1995;MacLennan et al.,1996; Ernst and White, 2000). Withthis increase comes the question of its position withinthe UK healthcare system, and whether the time has

    come to aim for its integration into the NHS. For this tooccur, a sound evidence base of the therapies efficacyis required.

    Practitioners of acupuncture generally follow one oftwo broad theoretical bases, Traditional ChineseMedicine (TCM) or Western acupuncture.Acupuncture research is complicated by the number

    and diversity of practices and schools of instruction(see chapter 4). Each may use a different approach andmost are based on the concepts of TCM, although thereis a growing interest in purely biomedical or Westernacupuncture. Since there is no evidence that any one

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    approach is superior, this report does not distinguishbetween the training or techniques covered byindividual schools or courses.

    Traditional Chinese Medicine

    Complementary medicine and natural therapies havetheir origins in the civilisations of Babylon, Egypt andChina, of about 3,000 years ago. The Chinese

    developed a system of medicine based on anextraordinarily detailed knowledge of herbal remedies,combined with acupuncture. TCM is practised throughan holistic approach and focuses on the unity of thehuman body with its environment.

    The TCM picture of the human body presents aconstruction of energetic functions, as opposed to the

    traditional Western view of the body based onstructure (anatomy) and function (physiology), withthe various parts operating together as systems in amechanical manner. TCM suggests that about 365acupuncture points are present on the human body,arranged in lines or channels (meridians)there are 12main meridians along which energy or Qi flows in acoherent and ordered manner. If the flow is interruptedfor any reason, then ill health can occur. It is thought

    by some that acupuncture is preventive medicine,enabling them to maintain and improve their level ofhealth, perhaps even enhancing an individualsresistance to infections. In illness, acupuncture seeksto stimulate the appropriate point along the affectedchannel, permitting the energy to become balanced and

    to flow freely once more. Diagnosis is based on closeexamination of the patients tongue and pulse, withcareful questioning to explore the signs and symptomsof the diseases. Treatments are based on the evaluation

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    of the diagnosis to rebalance the Yin and Yangdeficiency or excess in the body (ie, the negative andpositive polarisations of Qi).

    The Western approach toacupuncture

    The Western approach to acupuncture, as oftenpractised in the UK, is a non-traditional version basedon modern concepts of neuroanatomy and physiology.

    This considers the gate theory of pain, acting via thenervous, endocrine and immune systems, rather thanthe traditional theory of meridians. Fewer needles may

    be used and are left in situ for a much shorter timecompared to TCM practice. An important concept isthat of the trigger pointan area of increasedsensitivity within a muscle thought to cause a

    characteristic pattern of referred pain in a related areaof the body.This brief report cannot explore the theories and

    practice that make up the art and science ofacupuncture in detail. Readers are advised to consultspecialist literature; two new contributions fromHarwood Academic Publishers are currently in press(Chan and Lee, in press; Cheung, Li and Wong, inpress). However the chapters that follow are based on acomprehensive study of the published literature frompeer-reviewed journals and present an up-to-datereview of the efficacy, safety and application ofacupuncture in the UK

    Views on acupuncturePractitioners of some CAM therapies support the viewthat science does have a place within their fields ofpractice. Concepts of science-based, evidence-based

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    and placebo-controlled are being discussed, with newresearch trials planned or underway.

    Some major providers of complementary medicine

    within the NHS, such as the Royal LondonHomoeopathic Hospital (RLHH), are clearly seeking toestablish CAM as a form of evidence-based medicine.This CAM centre provides a range of different CAMtreatments including acupuncture, and has an ongoingprogramme of research involving clinical trials,clinical audit and literature reviews. These have

    concluded that there is strong evidence thatacupuncture can have specific therapeutic effects(RLHH, 1999).

    For others, traditional concepts of life force, Qi,energy, potentisation, and healing continue to be ofgreater importance than the science base of thetherapies. The holistic approach aims to treat the

    whole person, and may lead to an improvement inthe patient by inducing a feeling of wellbeing, even ifthe physical condition is not markedly improved.However, this does not preclude the measurement ofoutcomes, and it is necessary to identify theappropriate ones. The relationship between thetherapist and patient, the degree of confidence inspired

    within the patient for both therapy and therapist, andany placebo effect, could be significant factors inachieving a successful outcome.

    A number of differing views on the value ofacupuncture have been expressed by keyorganisations. The World Health Organizationencourages and supports countries to identify safe andeffective remedies and practices for acupuncture use inpublic and private health services, and has producedguidelines on basic training and safety in acupuncture(WHO, 1999). The Royal Society, in providingevidence to the House of Lords Inquiry (1999) on

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    CAM, reported that meta-analyses of published studieshave largely shown beneficial effects for the treatmentof pain but commented that reports may show

    publication bias (i.e. the selective publication ofpapers).

    However, the European Commission in their five-year study (Co-operation in Science and TechnologyAction B4, 1998) of unconventional medicine,concluded that the only good evidence available forthe effectiveness of acupuncture was for nausea and

    vomiting, while the evidence for the effectiveness ofacupuncture in the treatment of various painfulconditions, smoking cessation and asthma, was notconvincing. Despite this, they conclude,acupunctureis recommended by a number ofexperts and organisations including the World HealthOrganization. The American National Institutes of

    Health concluded in their consensus statement (1997)that promising results have emerged, for example inadult postoperative and chemotherapy nausea andvomiting, and in postoperative dental pain. Theystated, there is sufficient evidence of acupuncturesvalue to expand its use into conventional medicine andto encourage further studies of its physiology and

    clinical value.Ernst and White (1999a) have recently published acomprehensive appraisal of acupuncture, commenting,since the development of the concept of evidence-

    based healthcare, therapies must establish theirefficacy, safety and cost-effectiveness by means ofrigorous studies. Indeed they suggest that scientificvalidation of CAM therapies has become an ethicalimperative due to its prevalence in the UK (Ernst andWhite, 2000). Information on the evidence base ofacupuncture should help doctors, patients, researchersand purchasers of healthcare become more informed

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    on the value of acupuncture and its likely place withinthe NHS.

    Clinical trials of acupuncture

    In conventional medicine the randomised controlledtrial (RCT) is the gold standard of evidence(van Haselen and Fisher, 1999), hence there is a callfor the same standard to be used for unconventionalmedicine. In a RCT, patients for whom a certain

    treatment may be of benefit are randomly allocated to atreatment or control group and followed forward intime. If participants are unaware of their assignedstatus, then they are said to be blinded or masked.Studies where only the research participants areunaware of their assigned status are known as single-

    blind studies, whereas when both the research

    participants and the investigators are unaware of theirassigned status, the studies are known as double-blind.Trials of acupuncture must be single blind, as the

    acupuncturist is aware if the participant is in thecontrol group where a placebo is being administered(Filshie and White, 1998). Different forms of controlprocedures have emerged: sham acupuncture can beemployed, involving needling away from classicalpoint locations. Sham acupuncture has been shown tohave some clinical effect mainly due to placebo,although this is most marked in painful conditions andnausea (Filshie and White, 1998). However, it has beendifficult to find suitable sham acupuncture techniquesthat appear indistinguishable from a needle, yet areinert. Tapping the skin, placing needles only

    superficially, or needling the wrong points, have beenused, but are likely to produce a physiologicalresponse similar to needling and thus lead to anunderestimate of the effect of acupuncture. This

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    problem appears to have been solved recently(Streitberger and Kleinhenz, 1998) with thedevelopment of a placebo acupuncture needle which

    appears to result in a similar sensation to a normalacupuncture needle without actually piercing the skin.

    Randomised controlled trials can provide evidence ofwhether acupuncture can work, but only in anexperimental setting on a selected group of patients. Afurther form of clinical trial is known as the pragmaticrandomised controlled trial, where studies using

    random allocation to intervention or control groups areused to compare two different treatments. They aredesigned to assess the comparative effectiveness of thedifferent treatments as they are delivered in a realworld setting. In the context of acupuncture research,their aim would be to determine whether it is betterthan other available treatment options. Cost-

    effectiveness assessments can also be made using thismethodology. Cost-effectiveness is a comparativeconcepttreatment can only be more or less cost-effective than some other form of management ortreatment (Thomas and Fitter, 1997).

    This chapter evaluates the evidence for and againstthe effectiveness of acupuncture, based on systematic

    reviews of controlled clinical trials for the followingconditions:

    Back pain (Ernst and White, 1998) Neck pain (White and Ernst, 1999) Osteoarthritis (Ernst, 1997a) Recurrent headache (Melchart et al.,1999) Nausea and vomiting (Vickers, 1996)

    Smoking cessation (White et al.,1999) Weight loss (Ernst, 1997b) Stroke (Ernst and White, 1996) Dental pain (Ernst and Pittler, 1998)

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    sufficient agreement to separate the trials into threelevels of adequacy of acupuncture.

    Of the twelve included studies of back pain (see

    table 2, page 28), nine provided details of responderrate and could be combined in a metaanalysis. A totalof 377 participants were included. Six of thesestudies reached the threshold of three points onthe Jadad scale. The overall Odds Ratio was 2.30(95% CI 1.284.13), indicating that acupuncture wassignificantly better than various control interventions.

    The results of three out of the twelve studies weremarkedly more positive, but no explanation for thiscould be found. Combining the results of the fourplacebo controlled studies produced an Odds Ratio of1.37 (95% CI 0.842.25), indicating that there was nosignificant difference between real and placeboacupuncture.

    A subsequent review (van Tulder et al., 1999) ofessentially the same studies used different assessmentcriteria, concluding that the studies could not becombined in a meta-analysis since the form ofacupuncture used and type of participants involvedwere not sufficiently homogeneous. They concludedthat because the review did not clearly indicate that

    acupuncture is effective in the management of lowback pain, they would not recommend it as a regulartreatment for patients with low back pain.

    However, as van Tulder and colleagues pointed outthemselves, the levels of evidence used in their reviewwere arbitrary, since there is no agreement on how toassess the strength of evidence. Other levels ofevidence could lead to different conclusions. The

    Jadad score was used for quality assessment in Ernstand Whites (1998) review, and indeed a differentconclusion was reached. In terms of the heterogeneityof the studies, although different forms of acupuncture

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    were used in the studies, it is likely that there was acommonality at least of point-selection: all involvedtreatment using either classical acupuncture points in

    the area of the pain, or tender/trigger points in theassociated muscles. It would therefore seem reasonableto combine the results of these studies under thegeneral heading of acupuncture. Patient populationswere diverse, some having leg pain as well as backpain, and some having previously undergone backsurgery. The inclusion of patients with diverse

    diagnoses should not be particularly problematic sinceacupuncture treatment would not be altered drasticallyto account for symptoms, and in any case this diversitywould tend to bias the results against acupuncturerather than being in favour. Therefore, the balance ofevidence does seem to suggest that acupuncture can beuseful in the treatment of back pain.

    There is clearly a need for more research into the useof acupuncture for back pain. At present, the NHS isfunding a pragmatic randomised controlled trial intothe clinical and economic benefits of providingacupuncture services to patients with low back painassessed as suitable for primary care management(Thomas et al.,1999).

    Acupuncture for neck pain

    A systematic review found fourteen RCTs whichcompared acupuncture (White and Ernst, 1999) withvarious interventions for the treatment of neck pain(see table 3, page 30). Half scored at least three pointson the Jadad scale. The overall results of these studies

    were precisely balanced, with seven positive and sevennegative. Looking at the individual comparisons,acupuncture was superior to waiting list (that is, noadditional treatment) in one study, and either equal to

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    or superior to physiotherapy in three studies. In fivestudies, needling did not prove to be superior toplacebo controls. The clinical impression exists among

    acupuncturists that neck pain usually responds well toacupuncture.

    This review concludes that neck pain does improvewith acupuncture, but there is no clear evidence thatthis is due to the needling or the overall effect of thetherapeutic encounter.

    Acupuncture for osteoarthritis

    Thirteen studies were identified in a systematic reviewof acupuncture for osteoarthritis in any joint, (Ernst,1997) of which seven reported a positive result and sixa negative one (see table 4, page 32). Of the positivestudies, the majority failed to control for placebo

    effects. Of the five placebo-controlled studies, fourfound no difference between the effect of acupunctureand the effect of sham. As with neck pain, it is unclearwhether the clinical benefits which many patientsexperience from acupuncture are a specific or a non-specific response.

    Acupuncture for recurrent headacheIn a systematic review of RCTs for migraine andtension headache, 22 RCTs were included (see table 5,page 33) (Melchart et al.,1999). The quality of studieswas variable, with a median Jadad score of two.Acupuncture was compared to sham acupuncture in14 studies, the majority of which showed at least a

    trend in favour of acupuncture. Pooled results for theresponder ratios were 1.55 (95% CI 1.042.33) formigraine and 1.49 (95% CI 0.962.30) for tensionheadache. The authors concluded that, overall, the

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    existing evidence suggests that acupuncture has a rolein the treatment of recurrent headache but the qualityand amount of evidence is not fully convincing.

    Nausea and vomiting

    For the treatment of nausea and vomiting, acupunctureis usually given at a single site, known as P6 on theinner wrist. An early review found 33 controlled trialsof acupuncture (and related forms of stimulation) for

    nausea and vomiting either postoperatively, or in earlypregnancy or due to chemotherapy (see table 5, page33) (Vickers, 1996). In four trials, the acupuncture wasgiven under anaesthetic: all these were negative. Of theremaining 29 trials, 27 demonstrated a significant effectof acupuncture compared to various controlprocedures.

    In a subsequent review restricted to treatment fornausea in pregnancy (Murphy, 1998), seven studies onacupressure were found, but none on acupuncture.(Acupressure involves the stimulation of acupuncturepoints by finger pressure rather then needles). Thereliability of the studies and success of the controlinterventions were called into question, and anadditional rigorous study was included, which had anegative outcome. Murphy concluded thatacupuncture seemed to be both safe and probablyhelpful to pregnant women with nausea, but that itwas far from clear whether this effect depended on theprecise positioning of the stimulus.

    A meta-analysis of acupuncture for postoperativenausea and vomiting (Lee and Done, 1999) combined

    19 studies involving 1,679 participants. The medianJadad score was three. In four studies involvingchildren, there were no differences between P6stimulation and control groups for nausea or vomiting

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    at any time period. In adults, the results favoured P6stimulation over sham controls for both nauseaexperienced within six hours after surgery (relative

    risk 0.34, 95% CI 0.200.58) and vomiting experiencedwithin six hours after surgery (relative risk 0.47, 95%CI 0.340.64). Numbers needed to treat, that is, thenumber of patients that would need to receiveacupuncture to avoid nausea or vomiting in onepatient compared with the control condition, were four(3 to 6) and five (4 to 8) respectively. Sample size or

    types of control did not affect this result, but when theanalysis for nausea was restricted to high qualitystudies the result was no longer significant. The resultsfor nausea and vomiting experienced 048 hours aftersurgery did not find that P6 stimulation was superiorto placebo. The results also show that P6 stimulationhas equivalent effectiveness to antiemetic drugs in

    preventing vomiting, both shortly after surgery (06hours), and a while after surgery (up to 48 hours after).

    Stimulation of the P6 point has also been implicatedin the prevention of motion sickness (Gahlinger, 1999),and wristbands can be purchased as a therapeutic aid.One study of such bands found no evidence of areduction in motion sickness symptoms (Bruce et al.,

    1990), but a possible reason for this failure was theinfrequent stimulation of the point due to lack of wristmovement. In a later study, however, which involvedregular manual pulse pressure of the P6 point, asignificant reduction in the severity of symptoms wasfound (Hu et al.,1995).

    Acupuncture for smoking cessationand weight loss

    Acupuncture has gained a reputation for assisting themanagement of certain behaviours, particularly

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    effects of acupuncture in improving the recovery fromstroke are mostly non-specific in nature.

    Acupuncture for dental pain

    Dental pain provides an accessible, temporary andrelatively reproducible model for testing the analgesiceffect of acupuncture. It has been studied both inlaboratory experiments and during actual dentalsurgery; 16 controlled trials of either sort of dental pain

    were included in a systematic review (see table 8, page36). The quality of the studies was generally poor, withonly two scoring at least three out of a possible fivepoints on the Jadad scale. The great majority of studiessuggest that acupuncture does have an effect greaterthan placebo in reducing dental pain. In particular, allfour studies of acupuncture for experimental dental

    pain were positive. Of the eight studies in which someblinding was incorporated, only one was negative.This suggests that acupuncture does have genuineeffects in reducing dental pain, though the effect issmall and probably not important clinically. Thisresult has theoretical importance in indicating thatacupuncture can have measurable analgesic effects.

    Other conditions

    Systematic reviews of acupuncture for fibromyalgia,(Berman et al., 1999) and temporomandibular jointdysfunction (Ernst and White, 1999b) have promisingresults but more research is required, particularly sham-controlled RCTs. Systematic reviews of acupuncture for

    asthma (Linde et al., 2000), rheumatic diseases(Lautenschlaeger, 1997), and for tinnitus (Park, et al.inpress) have shown no evidence of an effect in theseconditions.

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    Summary

    According to the current evidence, acupuncture

    appears to be more effective than sham acupuncture orother control interventions for nausea and vomiting(most convincing for post-operative symptoms inadults), and for back pain, dental pain and migraine.The present evidence is unclear as to whether theresponse of osteoarthritis and neck pain toacupuncture is more than non-specific. Acupuncturesrole in recovery from stroke, and the treatment oftension headache, fibromyalgia andtemporomandibular joint dysfunction is stilluncertain. Acupuncture appears not to be superior tosham acupuncture for smoking cessation or weightloss.

    Methodological difficultiesResearch in complementary and alternative medicinein general is limited by lack of funding, lack ofresearch skills, lack of an academic infrastructure andlack of patients (RLHH, 1999). In 1996 only 0.08% ofresearch funding in the NHS was allocated tocomplementary medicine (Ernst, 1996). In addition,

    clinical trials are not without their critics; they havebeen criticised for investigating conditions and usingtreatment techniques which may not be representativeof those treated and used in practice (RLHH, 1999).The use of the randomised controlled trial inacupuncture studies has been considered a particularintellectual challenge, as it is often considered that

    there are more potential difficulties than in therandomised, double-blind, crossover controlledclinical trials used to evaluate pharmaceutical agents.

    A common assertion among skeptics is that theresults of complementary therapies, including

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    acupuncture, are built solely on what is known as theplacebo effect, that is, an improvement in the conditionof an ill individual that occurs in response to

    treatment but cannot be considered due to the specifictreatment used. The placebo effect is often consideredin a pejorative sense, as it is confused with the non-specific noise of placebo that must be eliminated fromclinical trials in order to determine the effectiveness ofparticular pharmacological interventions (Harrington,1997). However, the placebo effect may have a value for

    patients. Cochrane, an early advocate of therandomised controlled trial and former director of theMedical Research Councils Epidemiology Unit,indicated that effectiveness due to placebo should not

    be discounted without consideration of the economiceffects. He argued (Black et al., 1984) that the use ofplacebos in the correct place should be encouraged,

    but that what is inefficient, is the use of relativelyexpensive drugs as placebos. Further research isrequired to investigate the presence of a placebo effectin acupuncture, comparing acupuncture with shamacupuncture and other placebo controls.

    Clearly, in real clinical situations, effectiveness andefficacy include issues such as cost-effectiveness and

    clinical safety, as well as issues related to clinicaltrials. The placebo effect in itself should not be areason for discounting complementary therapyresearch, as the usefulness of a medical intervention inpractice is different from assessing formal efficacy(NIH, 1997). It has been stated that one possibleadvantage for acupuncture use is that the incidence ofadverse effects is substantially lower than that ofmany drugs or other accepted medical procedures usedfor the same condition. (NIH, 1997). In a recent surveyof GPs and directors of public health in the UK (vanHaselen and Fisher, 1999) it was found that although

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    randomised controlled trials and safety were the keyconsiderations for the purchasing of complementarytherapies, audit outcome data from homoeopathic

    hospitals, economic evaluation and availability ofliterature were also rated highly for importance. TheEuropean Committee for Homoeopathy also recentlyemphasised the importance of effectiveness researchfor example, using observational studies (EuropeanCommittee for Homeopathy 1997), and Black (1996)called for the advocates of RCTs and the advocates of

    observational studies to work in mutual recognition ofthe complementary roles of the two approaches.

    However, the randomised controlled clinical trial,and the pragmatic RCT, remain important linchpins ofmedical research. Although they may be considered inconjunction with other forms of research such asobservational techniques, acupuncture research must

    provide evidence of clinical efficacy which enablesacupuncture techniques to be compared withconventional medicine.

    Future research

    The Royal London Homoeopathic Hospital (1999) hasidentified questions that need to be answered byresearch in the field of complementary medicine,which can be applied specifically to acupunctureresearch:

    How large is the effect of acupuncture? Are the overall long-term effects of a acupuncture

    treatment greater than some reasonable alternative

    such as surgery or drug treatment? How cost-effective is acupuncture? Is acupuncture additional to, or can it replace,

    conventional treatments such as drugs?

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    Which conditions is acupuncture most effective for? Which patients benefit most from acupuncture?

    Randomised controlled trials with rigorousmethodological controls are essential if medicalpractitioners are to make decisions for referral toacupuncturists based on a scientific basis. However, itmay also be the case that complementary research isrequired in order to answer some of the questions aboveand provide a full picture of the effectiveness and

    efficacy of acupuncture in clinical practiceforexample, case studies, health status measurement(Jenkinson and McGee, 1998), cost-effectivenessanalysis and observational studies (Black, 1996). Sucha combination of research methods, including therandomised controlled trial, may provide answers tothe outstanding questions raised by the Royal London

    Homoeopathic Hospital, but it is clear that currentstandards of research into the clinical effectiveness ofacupuncture require greater methodological rigour.

    Finally, it is important to consider that effectivenessmeasures in clinical trials do not take intoconsideration the comparative merits of particularforms of treatment. As health service resources arefinite, considerations of cost and unwanted effects ofparticular treatments need to be considered. In the UK,the National Institute of Clinical Excellence has beenestablished to consider the value of particulartreatments in clinical practice, and is well placed toconsider acupuncture and produce guidance for theNHS.

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    Table 1:Summary of methodological details of reviews of theclinical effectiveness ofacupuncture

    Source:Ernst E (1999). Clinical effectiveness of acupuncture:an overview of systematic reviews. In E Ernst & A White(eds.) Acupuncture: a scientific appraisal. Oxford:Butterworth-Heinemann

    Reprinted by permission of Butterworth-Heinemann

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    Table 2: Controlled clinical trials of acupuncture forback pain

    Acup=acupuncture; EA=electroacupuncture; NS=notsignificant; VAS=visual analogue scale.

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    Source:Ernst E (1999). Clinical effectiveness of acupuncture:an overview of systematic reviews. In E Ernst & A White(eds.) Acupuncture: a scientific appraisal. Oxford:Butterworth-HeinemannReprinted by permission of Butterworth-Heinemann

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    Table 3: Controlled trials of acupuncture for neck pain

    Acup=acupuncture; EA=electroacupuncture;OA=osteoarthritis; ROM=range of movement; stats=statistics;VAS=visual analogue scale.

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    Source:Ernst E (1999). Clinical effectiveness of acupuncture:an overview of systematic reviews. In E Ernst & A White(eds.) Acupuncture: a scientific appraisal. Oxford:Butterworth-HeinemannReprinted by permission of Butterworth-Heinemann

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    Table 4: Controlled trials of acupuncture for osteoarthritis

    RCT=randomised controlled trial; ROM=range of motion;TENS=transcutaneous nerve stimulation; VAS= visualanalogue scale.Source:Ernst E (1999). Clinical effectiveness of acupuncture:an overview of systematic reviews. In E Ernst & A White(eds.) Acupuncture: a scientific appraisal. Oxford:Butterworth-HeinemannReprinted by permission of Butterworth-Heinemann

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    Table 5: Systematic reviews of acupuncture for variousindications

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    Table 6: Controlled clinical trials of acupuncture forsmoking cessation

    1Two parallel groups unless stated otherwiseEA=electroacupuncture

    Table 7: Controlled clinical trials of acupuncture for stroke

    RCT=randomised controlled trial.1Experimental groups received regular acupuncture inaddition.

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    Source:Ernst E (1999). Clinical effectiveness of acupuncture:an overview of systematic reviews. In E Ernst & A White(eds.) Acupuncture: a scientific appraisal. Oxford:Butterworth-HeinemannReprinted by permission of Butterworth-Heinemann

    Source:Ernst E (1999). Clinical effectiveness of acupuncture:

    an overview of systematic reviews. In E Ernst & A White(eds.) Acupuncture: a scientific appraisal. Oxford:Butterworth-HeinemannReprinted by permission of Butterworth-Heinemann

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    Table 8: Controlled trials of acupuncture for dental pain

    CCT=controlled clinical trial; RCT=randomised clinical trial.

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    Source:Ernst E (1999). Clinical effectiveness of acupuncture:

    an overview of systematic reviews. In E Ernst & A White(eds.) Acupuncture: a scientific appraisal. Oxford:Butterworth-HeinemannReprinted by permission of Butterworth-Heinemann

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    3Safety: a review of adverse

    reactions to acupuncture

    Introduction

    It has been assumed in the past that acupuncture posesno risk, or very little risk, to the patient, and being anatural and holistic therapy is safer than conventionalmedicine and drug therapy (MacPherson, 1999).

    However, with its growth in popularity in Westernsociety came the need for evidence of its safety, andwith that came reports of adverse events from aroundthe world (Rampes and James, 1995; Ernst and White,1997, 1999; Peuker and Filler, 1997). A review byRampes and James (1995), after a search of twodatabases (Medline and AMED), identified only 216

    instances of serious complications worldwide over a20-year period. The authors concluded thatconsidering that 3% of the adult population of the UKwere found to have consulted acupuncturists in 1984,that is, approximately 1.7 million people (Fulder,1988), these figures are reassuring, particularly as thegrowth in the number of acupuncturists in the UK in

    the past two years has been substantial (seeAppendix III). The complications generally fall intothree main areas, physical injuries, infections andother adverse reactions.

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    Physical injuries

    The most serious adverse effect that can be incurred

    during acupuncture is unilateral or bilateralpneumothorax. Insertion of needles into the thorax,particularly the intercostal spaces, paraspinal areas andsupraclavicular regions can result in the puncture ofthe pleura and the lung parenchyma, and is potentiallyfatal. Several cases have been documented, forexample, Rampes and James (1995) discovered 32reported cases worldwide over a 27-year period, whilstRampes and Peuker (1999) conclude thatapproximately 100 cases can bc found in scientificpublications worldwide. A Norwegian study (Norheimand Fnneb, 1996) estimated that pneumothoraxmight be seen once every 120 years in a full timeacupuncture practice.

    Other documented physical injuries include

    cardiovascular traumas (Schiff, 1965; Nieda et al.,1973; Cheng, 1991; Hasegawa et al.,1991; Halvoren etal., 1995; Kataoka, 1997), deep vein thrombosis andlocalised nerve damage (Bensoussan and Myers, 1996).Traumas to the spinal cord during needle insertion ordue to migration of retained needles have also beenreported, although the majority of these cases are a

    result of the Japanese practice of Okibari involvingpermanent deep needle insertion. This technique isneither taught nor practised in the West, although itsside effects are frequently cited in the literature,adding to the confusion surrounding the issue of thesafety of acupuncture (MacPherson, 1999).

    Many of the injuries can be avoided by ensuring

    acupuncturists are fully trained in anatomy andphysiology, with particular emphasis on teaching thelocation and depth of the major organs. Even the most

    basic first aid course has such a component.

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    Infections

    The invasive nature of acupuncture lends itself to the

    spread of infection when not practised safely orhygienically. Acupuncture has been implicated in thetransmission of hepatitis, HIV and various bacterialinfections including septicaemia (Pierik, 1982). TheBritish Blood Transfusion Service lists acupuncture asa condition necessitating temporary deferral for twelvemonths after the completion of the treatment ifperformed by someone other than a registered medicalpractitioner or health professional, or a member of theBritish Acupuncture Council (BAcC). (For furtherinformation telephone 0845 7711711). Members ofBAcC can provide their patients, who wish to donate

    blood, with certificates confirming that the treatmentwas provided by an acupuncturist registered with theorganisation.

    Reports in the UK in the late 1970s of viral hepatitisinfections from acupuncture needles (CDSC, 1977;Boxall, 1978) were influential in encouragingpractitioners to use sterile disposable needles and thesituation improved (Rampes and Peuker, 1999).However, there have since been further reports, withRampes and James (1995) listing 126 reported cases of

    viral hepatitis, and Norheims 1996 review revealing100 cases of acupuncture-related hepatitis B and Creported between 1981 and 1994. All reports have incommon the fact that sterilising procedures wereinadequate.

    There is no definitive evidence to support anyconcern that acupuncture needles can spread the HIV

    virus (Rampes and Peuker, 1999). However, there havebeen three cases of individuals acquiring HIV whoreportedly had no other risk factors for the virus, otherthan attending an acupuncture clinic (Vittecoq et al.,1989a, Castro et al., 1988). However, due to lack of

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    information in these cases it cannot be proven thatacupuncture was the causal factor (Chamberland et al.,1989; Vittecoq et al.,1989b), and there could have been

    some other undisclosed risk factors, such as sexualpractice (MacPherson and Gould, 1998).

    The Department of Health has issued advice topractitioners of complementary and alternativemedicine on the precautions to take to avoid thetheoretical risk of transmission of variant Creutzfeldt-jakob Disease (vCJD) (DoH, April 2000). They state that

    although there is currently no evidence to link anycases of vCJD to date with any surgical procedures orwith transmission by blood, the Department cannotrule out a possible risk and so considers it prudent totake precautions to avoid this theoretical transmissionwherever possible. Practitioners of acupuncture arespecifically told to have regard to this advice, and are

    advised to ensure that any needles or studs thatpuncture the skin are used only once, in line with theguidelines issued by WHO (1999).

    Inadequate or improper sterilisation techniques are aserious risk factor and this is recognised byacupuncture professional bodies, and reflected in theircodes of practice. Transmission of infections can be

    avoided if all practitioners use only pre-steriledisposable needles rather than reusable needles thatrequire sterilisation. As Norheims (1996) reviewfound, all the cases of hepatitis transmission had incommon inadequate sterilisation procedures, and mostof the adverse events were due to insufficient basicmedical knowledge, low hygiene standards andinadequate acupuncture education.

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    Other adverse reactions

    A range of other adverse events has been documented

    which are perhaps less serious than those documentedhere. These include bleeding on withdrawal of theneedle (Chung, 1980), bruising at the site of insertion(Redfearne, 1991; Tuke, 1979), depression, insomnia,increased pain, burns from moxibustion (Bensoussanand Myers, 1996), and fainting (Chen et al., 1990;Rajanna, 1983; Verma and Khamesra, 1989). Cases ofskin reaction to metals have also been described(Castelain et al.,1987; Fisher 1976; Tanii et al.,1991)which can be avoided by using stainless steel needleswithout chrome and nickel.

    One of the most frequently reported side effects isdrowsiness, which may have implications for thosewho drive following treatment. One study (Brattberg,1986) found that 56% of patients would have been at

    risk of an accident had they driven after treatment. Theauthor speculated that this drowsiness might be theresult of a fall in blood pressure or blood sugar, or therelease of endogenous opiates, but that it would beimpossible to predict who would experience it. Henceit was advised that, as with medication which mightinduce fatigue, patients should be warned against

    driving a car immediately after receiving acupuncturetreatment. The study did not mention patientsconcurrent medication however, and whether suchmedication may have contributed to or enhancedacupuncture drowsiness (Rampes, 1998). TheAcupuncture Association of CharteredPhysiotherapists advises their members in their Code of

    Ethics and Practice to recommend to their patients thatthey should not drive after treatment, until they recoverfrom any drowsiness.

    The risk of indirect adverse events such as mis-diagnosis or risk of omission has been discussed (Ernst,

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    1995) and needs to be addressed since it hasimplications for training, practice and health caredelivery mechanisms. Since the extent of the problem

    is difficult to quantify due to its very nature,precautionary measures must be taken to reduce therisk. Practitioners should receive sufficient training toenable them to know the jurisdiction of their practiceand its limitations. This is essential in order to preventthe application of inappropriate treatments (BMA,1993). Acupuncturists should also encourage their

    patients to inform their GPs that they are receivingacupuncture treatment. Australias National Health andMedical Research Council (1989) proposed that theundetected presence of a serious pathology by apractitioner of acupuncture is probably the mostimportant of risks. Mills (1996) advocates the provisionof a level of orthodox diagnostic training equivalent to

    that received by medical practitioners to counteractthis possibility. A system of quantifying the risk isrequired in order to end the current state ofspeculation.

    Practitioners should consider the potential forinteractions between adverse reactions to acupunctureand adverse reactions to orthodox drugs being taken at

    the time of treatment. For example, acupuncturistsshould have some awareness of drugs that causedrowsiness, since overall drowsiness experienced bythe patient after acupuncture treatment may beexacerbated. The importance of acupuncturepractitioners finding out their patients medicalhistories and general practitioners knowing about theirpatients use of acupuncture is paramount to theavoidance of such situations.

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    Contraindications of acupuncture

    Acupuncture is contraindicated in a number of

    situations which practitioners should be well aware of,and include: when patients are taking anticoagulantmedication, when press needles (for auricularacupuncture) are used in patients with prosthetic ordamaged heart valves, or when patients withpacemakers receive electroacupuncture.Electroacupuncture is also contraindicated if there islack of skin sensation and in case of impairedcirculation, severe arterial disease, undiagnosed fever,or severe skin lesions (WHO, 1999). The WHO (1999)advises that acupuncture is only used duringpregnancy with great caution since the needling andmanipulation of certain points may induce stronguterine contractions. The report advises traditionally,acupuncture, and moxibustion are contraindicated for

    puncture points on the lower abdomen andlumbosacral region during the first trimester. After thethird month, points on the upper abdomen andlumbosacral region, and points which cause strongsensations should be avoided, together with earacupuncture points that may also induce labour. TheOrganization lists pregnancy as a condition that is

    contraindicated by electroacupuncture.Rampes (1998) advises particular caution when

    acupuncture involves points on the thorax andimmunosuppressed patients, and identified generalprecautions, which are always necessary:

    Remember orthodox diagnostic skills

    Use sterile disposable needles Use aseptic technique with press needles Lie the patient down during treatment Advise patient to avoid driving after treatment Count needles before and after treatment

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    Observe patients for bleeding.

    Difficulties with the evaluation ofadverse reaction reports

    The system of reporting adverse reactions to drugs andtreatment in orthodox medicine is an area whichattracts a great deal of debate in the medical world,with concerns about under-reporting (Pierfitte et al.,1999) and problems with spontaneous reporting.

    Hence, it is hardly surprising that there are issuessurrounding the reporting of adverse reactions inacupuncture. A major problem with the adversereaction case studies which characterise this field ofwork is that often they do not contain sufficientinformation with which to critically appraise them(Ernst, 1995). Ernst suggested that future case studies

    should contain details of:

    Which acupuncture techniques were used Who gave it The timing of the adverse reaction Its reversibility Confounding factors.

    White et al.,(1997) described different methods whichcould be used to assess the incidence of adversereactions in complementary medicine, ie systematicliterature reviews, surveys of patients andpractitioners, case control studies, case registers,spontaneous reporting and observational studies. Theyconcluded that spontaneous reporting is the most

    powerful method available, and is used widely in post-marketing surveillance of drugs. Systematic literaturereviews, as cited in this chapter, are dependent oncurrent databases for their literature. However, these

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    may not be complete due to under-reporting of minorinjuries by practitioners due to the frequency of theiroccurrence, or of more significant injuries due to GPs

    lack of knowledge that their patient receivedacupuncture (Norheim and Fnneb,1996). They alsocannot be used to accurately estimate incidence, sincethe number of treatments given per year is unknown. Asurvey, using members of the British MedicalAcupuncture Society, of adverse events is currentlyunderway using the spontaneous reporting technique at

    the Department of Complementary Medicine in Exeter.Aside from academic work to assess the occurrence

    of adverse events, it is important to consider whatindividual practitioners can do. Mills (1996) suggeststhat awareness needs to be raised among CAMpractitioners, and recommends that the researchdepartments of the professional CAM organisations

    establish adverse effect reporting schemes. The firststage of this, he suggests, would be to familiarise thepractising members with the process, perhaps usingthe organisations annual conferences to introduce themeasure and develop and pilot an appropriate reportformat. Rampes (1998), on the other hand,recommends the establishment of a national database

    for acupuncture adverse reactions similar to the BritishCommittee of Safety of Medicines system of reportingof drug adverse reactions. This would collect andevaluate all reports of reactions to acupuncture,disseminate results to practitioners, and could beextended to cover other CAM therapies.

    MacPherson and Gould (1998) recommended thatthe acupuncture profession undertake a UK-wide studyto examine the key risks and their frequency ofoccurrence, which could demonstrate that theprofession is concerned and responsible, as well as

    being useful in helping to promote good practice in the

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    (approximately 12,459 treatments) resulted in adverseevents (faintness, fainting, haematoma, pneumothoraxand retained needles). Considering that the Medicines

    Control Agency receives approximately 17,00018,000UK reports of suspected adverse reactions to allmedicines each year, of which 55% are serious and 3%are fatal (Hansard, 2000), the incidence of adversereactions to acupuncture appears relatively low.

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    4Education and training

    Introduction

    There are a variety of ways in which acupuncture canbe taught and practised. Broadly speaking, apractitioner of traditional acupuncture will make anindividual diagnosis by interpreting the patients

    symptoms and signs according to Chinese theory andassessment of yin-yang energy status, and will thenapply needles to specific points to rebalance energy,or Qi. However, they may often also incorporateelements of orthodox medical diagnosis, whichconstitute the curriculum of many TCM acupuncturecourses. Adjunctive therapies, including moxibustion

    (burning of herbs), massage, prescription for Chineseherbs, and advice on lifestyle and diet, are commonlyalso given. A practitioner of Western-styleacupuncture will take a conventional medical historyand perform an examination. Acupuncture will beregarded as one of a number of therapeutic options andrather than moving the life force or Qi, brief needling,

    (perhaps with fewer needles) is intended to stimulatenerve endings, and stimulate the release of endogenousopioids and other neurotransmitters. Within agreedparameters, a certain amount of diversity inacupuncture training establishments is healthy in

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    catering for the individual needs of students and thedifferent approaches and expertise among the teachingstaff.

    Principles of CAM education

    The BMA (1993) suggested certain broad principleswhich could be appliedalbeit at different levels fordifferent therapiesto all training programmes forpersons who intend to use CAM. As a primary step, it

    is essential that each therapy should establish a corecurriculum, setting out the basic competenciesrequired for the practise of that therapy by allpractitioners, medical and non-medical alike. Coursesshould be of credible duration and type, to providecompetent practitioners. Good practice would alsosuggest that a minimum, core basic science/medical

    curriculum should be compulsory for all practicesclaiming to have a therapeutic influence. Thisfoundation course might include some basicknowledge of pharmacology and an appreciation of thehazards in removing patients from prescribedmedication, for instance, in interrupting a course ofantibiotics. Most fundamentally, such a basic coursewould instil in all practitioners understanding of theways in which apparently innocent symptomsoftenthe common onescan often be indicative of seriousdisease. This element of core medical knowledge isassociated with the need for therapists to establish thelimits of their competence, and to be aware of when itis necessary to actively encourage the involvement ofthe patients doctor (Box 1).

    Secondly, a regulatory body for a given therapyshould assume responsibility for the clinical andprofessional accreditation of training establishments,

    by assessing compliance with established minimum

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    standards in a particular therapy. The accreditationstatus could be renewable, probably every five years.Agreement on minimum requirements of training to

    ensure competence is needed for different levels ofpractitioners.

    Box 1: Competencies that acupuncturists and otherCAM therapistsshould be able to demonstrate (BMA,1993)

    Competencies for CAM therapists

    A sound knowledge of anatomy, physiology,pathology, basic medical therapeutics, andthe principles of their own therapeuticmodality. The practitioner must also have

    acquired a sufficient depth of knowledge ofthe principles of medicine and thepathological process of disease, and be awareof the physiological basis for their treatmentand modality.

    The ability to collect relevant informationfrom the taking of an appropriate case historyand an examination of the patient enabling

    the practitioner to formulate an appropriatediagnosis and effective treatment plan, aswell as the likely prognosis and any suitableprophylaxis.

    An ability to conduct and interpret a relevantclinical examination and use currentlyaccepted clinical testing procedures as well

    as an ability to interpret any ancillary tests. In reaching a diagnosis, a practitioner mustbe able to show that he or she has thoughtdifferentially using a rationale based uponcurrent knowledge of anatomy, physiology,

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    and pathology, demonstrating that he or shehas considered not only the potentialcontraindications of treatment but also has an

    awareness that symptoms manifested by thepatient may be emanating from a site or causedistant from the presenting problem, and may

    be indicative of serious underlying disease. The practitioner should demonstrate an

    awareness of the relevance of a patientspersonal life history, including psychological

    aspects, inherited predispositions, previousmedical history, life-style factors, and socialand occupational background. This isparticularly important so that the patientsown expectations will be considered informulating a treatment plan.

    Practitioners should show an awareness oflimits of competence and the scope of their

    particular therapy, together with a knowledgeof absolute and relative contra-indications totherapy. With this goes the ability torecognise conditions where a particulartreatment is inappropriate, and also when apatient is suffering from a condition thatrequires immediate referral to the patients

    GP. They should show an awareness of the needto plan a particular course of treatment and

    be able to anticipate its effectiveness with thepatient concerned. A practitioner should beable to communicate his or her findings,diagnosis, prognosis and prophylaxis, whereappropriate, not only to the patients GP but

    also to the patient, in such a way that thepatients own expectations are taken intoconsideration.

    Practitioners should show an awareness ofthe need to evaluate and monitor the

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    patients progress in line with the proposedtreatment plan and an awareness that, ifanticipated outcomes are not met,

    consideration should be given to referral tothe appropriate agency.

    Teaching acupuncture

    Techniques and philosophies in acupuncture havebeen evolving for over 3,000 years in a wide range ofcountries and these diverse traditions have beenreflected in the training provided in national colleges.Many schools of Traditional Chinese Medicine in theWest teach acupuncture based on the twelve pulses

    and the law of five elements. Some current Chineseteaching can be based on much simpler forms of TCMand in many instances just local acupuncture pointsare used to treat pain and no attempt is made toevaluate or treat the underlying imbalances of vitalenergy. Western science seeks to explain the possibleeffects of acupuncture in terms of effects on humoralmediation via the circulation of neuro-transmitters andother hormones in the cerebrospinal fluid and bloodstream (Hopwood, 1993), whilst also recognising thevalue of the holistic approach.

    Acupuncture treatment is now very popular in theUSA and it is estimated that 912 million patients visitacupuncturists each year for treatments that involve upto 120 million needles (Lao, 1996). American doctors,

    osteopaths and chiropractors may use acupuncturewithout any or only limited extra training, according toindividual State law. Other practitioners requirespecific training and for about the past 20 years State

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    law has required acupuncturists to be licensedaccording to criteria developed by an AcupunctureExamining Committee and subsequently the National

    Commission for the Certification of Acupuncturists(NCCA). The examinations consisted of both writtenand practical tests.

    At the present time, anyone within the UK can usethe title acupuncturist and, in common with manyother CAM therapies, acupuncture is not regulated bystatute and there are a number of different

    organisations, colleges and so forth offering training,education or registration in the subject.The major acupuncture bodies listed by the Universityof Exeter (Mills and Peacock, 1997; Mills and Budd,2000) are:

    The British Acupuncture Council

    The British Medical Acupuncture Society British Academy of Western Acupuncture The Acupuncture Association of Chartered

    Physiotherapists The Fook Sang Acupuncture and Chinese Herbal

    Practitioners Association

    The European Federation of Modern Acupuncture

    The Modern Acupuncture Association.

    (See Appendix II)

    British Acupuncture AccreditationBoard (BAAB)

    As a result of a joint initiative of the Council forComplementary and Alternative Medicine and theCouncil for Acupuncture (CCAM/CFA) in the UK, astructure for accrediting independent schools andcolleges of acupuncture was developed, and in

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    November 1990 the British Acupuncture AccreditationBoard (BAAB) was formally established. The Councilfor Acupuncture became the British Acupuncture

    Council (BAcC), in l995.Important questions to be addressed in acupuncture

    training include:

    what constitutes minimum professional standardsfor new practitioners?

    what constitutes an acceptable standard for on-going

    practice? when is full competence achieved? what professional monitoring or training input is

    required in post-registration years? what are key training issues related to safety,

    referral and management of patients?

    The core syllabus now published by the UK BAAB andsupported by the British Acupuncture Councilincludes topics such as history taking, basic theory,knowledge of acupuncture points, methods ofdiagnosis and treatment principles and techniques,including issues of safety and sterile procedures,anatomy, physiology, and research methods. TheBAAB also puts great emphasis on professional

    competencies. The aim of training should also be toencourage the development of a reflective, research-minded practitioner with qualities of integrity,humanity, caring, trust, responsibility, respect andconfidentiality (Shifrin, 1995).

    Acupuncture courses

    A BMA survey of CAM bodies (1993) reflected thatthere was a considerable range of standards,aspirations, and levels of training for practitioners ofCAM therapies. At one end of the spectrum, the

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    discrete clinical disciplines require levels of trainingcommensurate with the responsibilities such therapistshave to patients in their care, and courses for such

    disciplines are now likely to be degree equivalents. ABMA survey of UK higher education establishments in1996 revealed that over 100 modules or completecourses in CAM subjects were being provided inuniversities, medical schools and faculties of nursing(Morgan et al.,1998). Little information, however, wasprovided about specific research projects or research

    infrastructure, and none related directly toacupuncture.

    The BMA 1993 report recognised that particularskills need to be acquired in order to achievecompetence in different therapies, and highlighted theGeneral Medical Councils statement that a question ofserious professional misconduct may arise by a doctor

    persisting in unsupervised practice of a branch ofmedicine without having the appropriate knowledgeand skill or having acquired the experience which isnecessary. Therefore, doctors (and nurses,physiotherapists and other healthcare professionals)may undertake specialised training to provide themwith the necessary skills to understand and/or carry out

    acupuncture or other CAM therapies. One provider ofCAM treatment specified that treatment iscomplementary to conventional medicine and notalternative and that all staff are members of theappropriate state registered health professions (RLHH,1997). The BMA recommended in ComplementaryMedicine: New Approaches to Good Practice (BMA,1993) that all medically qualified practitioners whowish to carry out acupuncture (and indeed any CAMtherapy) should undertake recognised training in thatfield.

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    University teaching

    Acupuncture is now established as a degree course at

    Bachelor level in at least two UK universities, run overthree or five years, with a higher degree Masters courseavailable for qualified physiotherapists. Graduatesshould have spent considerable time gaining clinicalexperience with patients, together with a soundknowledge of basic medical sciences, point selectionand research methodology. Colleges and otherinstitutions offering acupuncture education andtraining are able to apply to the BAAB for theinstitution and/or courses to be accredited. Therigorous accreditation process should ensure that onlythose organisations complying substantially with 17essential requirements achieve recognised status(BAAB, 1998). The assessment programme shouldensure that each training establishment is externally

    monitored against known assessment criteria. It shouldbe expected that acupuncture students from anytraining background, as well as those practising theother discrete clinical disciplines, should be able todemonstrate the levels of competence recommended

    by the BMA (1993) (Box 1).

    Acupuncture organisations

    Medically qualified individuals can undertake part-time training (for example, short courses of up to fivedays duration or during weekends) provided by theBritish Medical Acupuncture Society (BMAS).Qualifications are awarded at basic, intermediate and

    advanced level and BMAS accreditation requires 100hours of learning and a presentation of 100 fullydocumented cases. Full training and clinicalexperience in acupuncture leads to the Diploma inMedical Acupuncture. BMAS promotional literature

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    confirms that teaching on the basic course is based onscientific explanations for acupuncture as far aspossible, but it also involves traditional Chinese

    concepts at a simple level, when there is still noWestern explanation for the effects in particulardisease.

    The Acupuncture Association of CharteredPhysiotherapists (AACP) provides four categories ofmembership, according to the degree of trainingundertaken. An advanced member will be a fully

    qualified state registered physiotherapist who willhave undertaken at least 200 hours of trainingtheAACP confirms that individuals in this category arelikely to be practising Traditional ChineseAcupuncture, but also to be involved in research.

    The British Acupuncture Council has providedsubstantive guidelines for acupuncture education for

    institutions wishing to be accredited by BAcC. Suchcourses require study over 3,600 hours, with 200 hourspersonal management of patients through all aspects oftheir treatment. Courses will include biomedicalsciences, anatomy and safe needling, diagnosis ofserious underlying pathology, ethics and practicemanagement.

    The British Academy of Western Acupuncture(BAWA) is affiliated with BMAS, and was founded inorder to promote, enhance and unify the practice ofacupuncture in the UK. It aims to ensure a highstandard of practice within the NHS and privatesectors. Membership is open to those with suitablemedical qualifications including medical doctors,physiotherapists, and registered general nurses with aminimum of three years post-graduate experience.There are two grades of membership, granted tograduates of the BAWA Education DepartmentsLicentiate Course.

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    The Fook Sang Association is an independent bodyoffering specialist professional training in scientificand traditional methods of Chinese acupuncture and

    herbal medicine as taught in China. The organisationoffers flexible prescriptions in natural Chinese herbalmedicine, including Chinese Folk Medicine usinggenuine Chinese diagnosis.

    The European Federation of Modern Acupuncture isan umbrella organisation enabling trainingestablishments to enter into dialogue on matters of

    training standards. Individual membership level isdependent on the degree of training undertaken at

    basic, intermediate and advanced level. Practitionerspractise modern acupuncture using a variety ofmeans to measure the activity of acupuncture points/meridians, prior to treatment. Electronic, electrical and

    bioresonance devices are commonly used.

    Members of the Modern Acupuncture Associationundertake acupuncture training, clinical and tutorialstudies, together with bioresonance or Voll systems,clinical kinesiology and auricular therapy.