acupuncture research: strategies for clinical evaluation:...

Advance Access Publication 23 April 2007 eCAM 2008;5(2)237–240doi:10.1093/ecam/nem028

Meeting Report

Acupuncture Research: Strategies for Clinical Evaluation:Workshop Report, York, July 5–8, 2006

Val Hopwood1 and Hugh MacPherson2

1Honorary Research Fellow, Complementary Medicine Research Unit, University of Southampton,Southampton SO16 5S, UK and 2Senior Research Fellow in Department of Health Sciences,University of York, York YO10 5DD, UK

This report summarizes a ground-breaking workshop on the strategic direction of acupunctureresearch which was held in York in early July 2006. Three days were spent discussing the history,the philosophy and the practicalities of researching acupuncture. Attending the workshopwere an international group of researchers with varied backgrounds, including acupuncturists,physicians, physiotherapists, sociologists and anthropologists. Supported by theMedical ResearchCouncil’s Health Services Research Collaboration, Elsevier and others, this workshop wasan opportunity to brainstorm the issues and to the concerns in the field and set out directionsfor research that would tackle some of the major challenges facing the acupuncture researchcommunity.

Keywords: acupuncture – complex interventions – non-specific effects – research

Introduction

A ground-breaking workshop on the strategic direction

of acupuncture research was held in York in early July

2006. Three days were spent discussing the history, the

philosophy and the practicalities of researching acupunc-

ture. Attending the workshop were an international

group of researchers with varied backgrounds, including

acupuncturists, physicians, physiotherapists, sociologists

and anthropologists. Supported by the Medical Research

Council’s Health Services Research Collaboration,

Elsevier and others, this workshop was an opportunity

to brainstorm the issues and the concerns in the field and

set out directions for research that would tackle some of

the major challenges facing the acupuncture research

community. Linked to the workshop was the plan that

presenters at the workshop would also take the lead in

writing chapters that would contribute to a book to be

published by Elsevier.This workshop consisted of a series of presentations

from acupuncture researchers each of which had input

from two or three others. Underpinning these presenta-

tions were several themes that, to a lesser or greater

extent, informed the strategic direction taken by those

attending the workshop including:

(i) an understanding that the field of acupuncture

research is a developing one; we have come so far

already, but we have much further to go(ii) an excitement about the opportunities to learn

from what has gone before, rather than having to

always reinvent the wheel(iii) a commitment to inclusivity—in the styles of

acupuncture to be investigated, in the breadth of

appropriate methods that might be suitable, and

in the range of investigators that we encourage to

engage in research(iv) a sensitivity to the medicine, the tradition, and the

orientation to acupuncture being a unique and

person-centered approach

For reprints and all correspondence: Val Hopwood, University ofSouthampton, Complementary Medicine Research Unit,Primary Medical Care, Aldermoor Health Centre, Aldermoor Close,Southampton, SO16 5ST. Tel: þ44 (0)23 8024 1073; Fax: þ44 (0)238070 1125; E-mail: [email protected]

� 2007 The Author(s).This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work isproperly cited.

http://creativecommons.org/

(v) a respect for good ‘orthodox’ research practices(vi) a creativity that identifies current challenges and

opportunities as well as possible future strategicdirections

(vii) an enthusiasm for improving clinical practice suchthat research is not an end in itself.

History of Acupuncture Research

Stephen Birch outlined the background to acupunctureresearch, particularly as it pertains to the West.He offered a brief history of acupuncture as a way ofintroducing the diversity of current practice. He thenexplored some key philosophical differences betweenoriental and western approaches to developing a knowl-edge base, and how there could be a mismatch in theevaluation of a holistic medicine when using a reduc-tionist methodology. Following on from a brief introduc-tion to acupuncture research; his presentation concludedby identifying some useful perspectives for understandingthe complexity of acupuncture and its diversity. Theseincluded the need for research studies to be designed in away that the data collected accurately reflected thepatients, the practitioners and the style of acupuncturebeing tested.

Patients’ Perspectives and Utilization ofAcupuncture

Claire Cassidy set out research strategies used to mapthe patterns of utilization and experience of acupuncturepatients. The aim of this is to explore not just who isusing acupuncture but also to tease out from patientstheir reasons why. This calls for more in-depth investiga-tion, where qualitative methods such as interviews canreveal patients’ perceptions and experiences, and whatthey particularly value about the treatment process.Claire Cassidy set out the case for multiple perspectives;with no one research method providing answers to all theresearch questions. Strategies for research may involvecollecting either qualitative data or quantitative data, orperhaps some mixture of both. In this presentation sheparticularly stressed the importance of the patient’sperspective and the value this has for all types ofacupuncture research.

The Safety of Acupuncture

Hugh MacPherson then explored approaches to research-ing acupuncture safety. We have to assume thatacupuncture can only be shown to be safe when wehave robust evidence. In this context he set out the keymethods that have been used to identify and quantify thelevels of risk associated with acupuncture. Given thecurrent level of evidence, it is increasingly accepted that

acupuncture can be considered safe in competent hands.There remain however a number of challenges. Theseinclude exploring the inherent variability and sensitivityof patients in their reactions to acupuncture. We alsoknow little about the relationship between short-termreactions, which may be aggravations to treatment, andtheir association with health outcomes. The goal of manyof these types of research endeavours is to improve thesafety of routine practice, and further research is likely toenhance this process.

The Practice of Acupuncture

Rosa Schnyer in her presentation described acupunctureas a complex treatment intervention which has developedfrom its rich and diverse history. She set out the breadthof current approaches and styles of acupuncture basedon the traditions from Asia. Such diversity raises uniquechallenges when conducting to evaluate the clinicalimpact. This presentation addressed a range of questionssuch as how specific are the actions of the acupuncturepoints, how reliable are acupuncturists’ diagnoses, andhow far can acupuncture be standardized withoutcompromising the integrity of the intervention. ThenRosa suggested some useful pointers for developingresearch strategies that combine an intellectual rigour ofgood science with a focus on evaluating the impact ofacupuncture as a dynamic and interactive intervention.

Patient Centered Outcomes from Acupuncture

Charlotte Paterson then opened up the question of howbest to measure the outcomes and processes of acupunc-ture from the patient’s perspective. First the case wasmade that the patient should be central to the measuringprocess. Then she moved on to the need to identify whatpatients actually value about treatment, which oftenincludes broader changes, that is, changes to more thanthe presenting symptom. These broader changes caninclude whole person effects, and even a shift in socialand personal identity. This presentation explored howthese measures of broader change can be captured byspecific outcome measures. This creates the opportunityof mapping change in this broader way in larger-scalestudies and clinical trials.

Treatment Effects: Non-Experimental Designs

Adrian White, in the first of three presentationson ‘effectiveness’ of acupuncture, focused on non-experimental studies, those where we can exploretreatment effects and outcomes from routine care yetwithout the benefit of a control group for comparativepurposes. He set out an array of non-experimentalresearch methods that range from single and multiplecase series through to surveys and qualitative studies.

238 Meeting Report

Also included in this presentation were an overview ofthe potential of pilot studies to assess feasibility of largerscale analyses and clinical trials. While non-experimentalstudies are not ‘definitive’ in the way that randomizedcontrolled trials can be said to be, nevertheless there aresome challenging aspects to these endeavours. There is aneed to maintain the quality of the non-experimentalresearch methods while at the same time identifying thebuilding blocks for treatment effects and outcomes.

Comparing Acupuncture with Other HealthcareInterventions

Karen Sherman then talked about comparing treatmenteffects of acupuncture with other types of health care.She identified the methods by which we can ascertainwhether acupuncture is more or less effective whencompared with a reasonable comparison. She set out afield guide for such research, clarifying the differencesbetween effectiveness and efficacy, and between prag-matic and explanatory trials. With the focus of thispresentation more on pragmatic and effectiveness, sheprovided good examples of how these studies havecontributed to the evidence base for acupuncture.This approach lends itself well to analyses of cost-effectiveness, an important concern when there arelimited resources and decisions be made about theirallocation. We also explored some of the challenges, forexample the potential limitations imposed when theacupuncture is constrained in a trial treatment protocol.

Efficacy of Components of Acupuncture

Peter White set out the research methods to investigatethe efficacy of components of acupuncture. In contrast tothe previous presentation, these methods are more aboutestablishing efficacy per se using explanatory trials. As ineffectiveness studies, efficacy studies require researchersto ensure the design will lead to as little bias as possible.Potential sources of bias were explored, and in particularfor efficacy the role of a sham or placebo arm forcomparative purposes was presented. Peter White thenreviewed a range of sham techniques that have been usedin placebo-controlled studies, as well as an assessment oftheir limitations. One concern is that placebo or shamacupuncture seems not to be physiologically inert, aswould be ideal in a control. We moved on to questionwhether it is actually possible to fully control for‘placebo’ effects, especially when acupuncture is practicedas a dynamic and interactive intervention. Neverthelessthere continues to be a need for rigorous methods thatminimize bias, for establishing how well acupunctureworks and for identifying what components of acupunc-ture to which any putative benefit can be ascribed.

Biological Correlates and Mechanisms

Richard Hammerschlag presented research into thebiological correlates and physiological mechanismsof acupuncture. He started by explaining the differencesbetween correlations and mechanisms. Correlations aresimply associations between some aspect of acupunctureand a biological measure, and they will occur at somestage along the causal pathway. Mechanisms howeverare the fundamental processes of acupuncture thatinitiate and drive physiological change, and knowledgeof these can be helpful for many reasons. He showedhow clinical practice can inform the direction of researchinto physiological mechanisms. He also showed howmechanism research can inform clinical practice. In thispresentation he provided an overview of the types ofmechanisms that have been identified, assessed thestrength and limitations of these approaches andprovided suggestions for moving the field forward.The importance of this work was stressed, since it maywell provide a challenge to the dominant biomedicalmodel of health and disease, with the potential forfurthering credibility for acupuncture.

Evidence Synthesis: Systematic Reviews andMeta-Analyses

Klaus Linde presented how it is to bring the evidencetogether and synthesize it in systematic reviews and meta-analyses. First he set out how systematic reviews aredone, with clear research questions, explicit methods foridentifying and selecting relevant studies from literatureand critically appraising them. He provided a shorthistory of systematic reviews of acupuncture and high-lighted how differing interpretations can lead to differentconclusions. This leads us into several challenges, such asthe variability of study designs used in acupuncture trials,as well the variability in the styles of acupuncture thathave been under scrutiny. Given the diversity of currentacupuncture practice, assessing the adequacy of acupunc-ture in clinical trials was flagged as a major concern.Nevertheless there continues to be an important rolefor synthesizing clinically relevant evidence in systematicreviews.

Engaging Practicing Acupuncturists inResearch Activity

On behalf of Peter Wayne, who was unable to attend toworkshop, Karen Sherman invited the workshop toconsider the process by which acupuncturists and otherscan become involved in research. Research can bedaunting, and so in this presentation it was emphasizedhow research can be tackled by working in collaborationwith others. Research projects can for example beinitiated at acupuncture schools and colleges, and a

eCAM 2008;5(2) 239

number of examples were cited where small-scale projectshave led to a useful understanding and perspective.The workshop attendees stressed the need for someuseful guidelines for conducting such studies, includinghaving a clear research question, building a team ofcollaborators and obtaining the necessary ethics per-missions. Acupuncturists have an essential role insupporting projects initiated by established researchgroups. The expertise of practicing acupuncturists caninform research designs and help establish appropriatetreatment protocols so that the acupuncture evaluated isclinically relevant. In conclusion, clearly acupuncturistshave an essential role in promoting acupuncture researchthat respects the integrity of the medicine.

Research Strategies for of the Future

George Lewith concluded the workshop with a ‘blueskies’ session where he asked for everyone’s ideas andthoughts about acupuncture research. In particular hefocused attention on the need for a clearer strategicdirection if we are to move the field forward. A numberof key dimensions emerged which include the importanceof the patient’s perspective, the need to consider bothqualitative and quantitative methods, and the imperativeof seeing acupuncture as a dynamic and interactivetreatment modality. A number of challenges lie ahead,

not least the challenge of seeing acupuncture as acomplex intervention so as not to lose important aspectsof care in the process of evaluating it. Another challengeis that of establishing a placebo control that is sufficientlyinert to unequivocally establish which components ofacupuncture work. The need to see acupuncture researchas an emerging discipline was also stressed, with manydebates and discussions ahead that will shape the field.

Acknowledgements

Thanks are due to Anne Burton who helped organize theworkshop. We also acknowledge financial support for theworkshop from the Medical Research Council’s HealthServices Research Collaboration, Elsevier, Stichting forTraditional East Asian Medicine, Foundation forTraditional Chinese Medicine, and the AcupunctureResearch Resources Center as well as personal contribu-tions from George Lewith and Richard Hammerschlag.Also attending the workshop and contributing todiscussions were Richard Blackwell, Mark Bovey, MikeFitter, Lixing Lao, Val Hopwood and Kate Thomas.Hugh MacPherson is supported by a Department ofHealth award in complementary and alternativemedicine.

Received January 6, 2007; accepted January 24, 2007

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