Standards For Reporting Interventions
In Controlled Trials Of Acupuncture:
The STRICTA Recommendations

Hugh MacPherson, BSc, PhD, MBAcC,1
Adrian White, MA, BM, BCh., DipMedAc,2
Mike Cummings, MB, ChB, DipMedAc,3
Kim A. Jobst, MA, DM, MRCP, MFHom,4 Ken Rose,5
Richard C. Niemtzow, MD, PhD, MPH6 for the STRICTA Group*

ABSTRACT
Acupuncture treatment and control group interventions in parallel-group randomized trials of acupuncture are not always precisely reported. In an attempt to improve standards, an international group of experienced acupuncturists and researchers devised a set of recommendations, designating them STRICTA: Standards for Reporting Interventions in Controlled Trials of Acupuncture. In a further consensus-building round, the editors of several journals helped redraft the recommendations. These follow the Consolidated Standards for Reporting Trials (CONSORT) format, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies. Participating journals are publishing the STRICTA recommendations and requesting prospective authors to adhere to them when preparing reports for publication. Other journals are invited to adopt these recommendations. The intended outcome is that interventions in controlled trials of acupuncture will be more adequately reported, thereby facilitating an improvement in critical appraisal, analysis, and replication of trials.

INTRODUCTION
The need for more precise standards of reporting of interventions in controlled trials of acupuncture is evident from the difficulties associated with their interpretation and analysis (Ter Riet et al., 1990). Many of the more general problems have been addressed by the recently revised Consolidated Standards for Reporting Trials (CONSORT) statement (Altman et al., 2001; Moher et al., 2001b). Within acupuncture research, however, there remain specific aspects of controlled trials that are poorly documented, in particular those aspects that relate to interventions, for the treatment and control groups. These are not sufficiently covered by CONSORT.

An international group of acupuncture researchers met at Exeter University, England, from July 2-4, 2001, to discuss the design of clinical trials of acupuncture. This group also drafted a set of recommendations for improved reporting of the interventions in parallel-group trials of acupuncture. These recommendations were designated Standards for Reporting Interventions in Controlled Trials of Acupuncture or STRICTA. They are intended for use in conjunction with CONSORT, as an extension to the CONSORT checklist item on intervention.

The editors of several key journals that publish clinical trials of acupuncture were invited to participate in redrafting the recommendations. The overall aim was to achieve a broad set of recommendations that would cover the most common approaches to acupuncture and research design. The recommendations had to be appropriate for a range of styles, from Western trigger point treatment to traditional Chinese acupuncture and from electroacupuncture to auricular acupuncture. They also had to cover the spectrum of randomized controlled trial designs, from explanatory trials evaluating the specific effects of needling, to pragmatic trials evaluating the broader effects of acupuncture in routine practice.

The recommendations are being published by the editors of Acupuncture in Medicine, Clinical Acupuncture and Oriental Medicine, Complementary Therapies in Medicine, The Journal of Alternative and Complementary Medicine, and Medical Acupuncture as part of their Instructions to Authors. It is intended that implementation of the STRICTA recommendations will reduce inadequate reporting of acupuncture trials, facilitating an improvement in their critical appraisal and interpretation (Jobst and Eskinazi, 1996). It may also help with some specific challenges, such as developing criteria for assessing the adequacy of acupuncture treatment in earlier studies (White and Ernst, 1998). It is hoped that over time, use of the STRICTA recommendations will lead to more rigorous trial design, more robust conclusions, and better data to determine future policy and practice.

THE STRICTA RECOMMENDATIONS
Acupuncture rationale
The acupuncture rationale, the first item on the STRICTA checklist, should include a statement about the style of acupuncture used, whether, for example, Traditional Chinese Medicine or a Western medical approach. It should also include an explicit rationale for the chosen treatment, including diagnosis, point selection, and treatment procedures.

Where a trial protocol includes individualization of treatment, the rationale for the treatments should be documented. Whatever the active intervention, the sources that justify the underlying rationale must be explicit, whether these are from the literature, expert clinical and research panels, practitioner surveys, or any combination of sources.

Needling details
The specific point locations, and whether unilateral or bilateral, should be described in terms of a standard nomenclature or in terms of anatomical location. The number of needle insertions should be reported as either a simple total where a formula of points is used, or as the mean and range where the number of needles varies between patients. The depth of insertion, and whether standardized or individualized, should be expressed using the Chinese measurement of the cun; in terms of anatomic depth, for example subcutaneous tissue, fascia, muscle, or periosteum; or in millimeters. If the study protocol requires that specific responses to needling be elicited, for example the de qi sensation in traditional Chinese acupuncture, the muscle twitch in trigger point treatment, or muscle contraction in electroacupuncture, these responses should be documented. Needle stimulation techniques, when used, should be clearly described. For manual stimulation such techniques include lifting, thrusting, or rotating the needle to manipulate the de qi sensation. For electrical stimulation the current, amplitude, and frequency settings should be recorded. Needle retention times should be reported, as either a standard or a mean and range. Details should be given of the types of needles used, including the gauge and length as well as the manufacturer and/or the material.

Treatment regimen
The treatment regimen, which is the number of sessions and frequency of treatment, should be clearly documented. If there is variation in the regimen between patients, then the mean and range should be reported.

Cointerventions
Cointerventions refer to the auxiliary techniques and prescribed self-treatment and lifestyle advice carried out by the patient as an adjunct to the acupuncture needling itself. All cointerventions should be reported clearly. Examples of auxiliary techniques include moxibustion, cupping, plum-blossom needling, and use of Chinese herbs. If the protocol specifies the option of prescribed self-help treatments such as qigong or muscle stretching exercises, and lifestyle advice such as dietary changes based on diagnostic criteria, then these too must be reported.

Practitioner background
The background of acupuncture practitioners will influence the nature of the acupuncture treatment given and is therefore a variable that may significantly affect the outcome. For this reason reporting should include the duration of relevant training, length of clinical experience, and details of expertise in treating the specific condition being evaluated, as well as any other experience that may be relevant to the trial.

Control intervention(s)
The choice of control and its intended effect should be presented and justified in relation to the research question and the methodology. Sources that led to the choice of control, such as literature, should be provided. In particular, where the control is intended to mimic acupuncture in all but the specific needle puncture effect, care must be taken to describe precisely what the sham acupuncture is intended to control for, e.g., for point specificity or for the type and duration of stimulation. Control procedures may involve an active comparator, such as physiotherapy, for which the intended action is therapeutic. However control procedures involving invasive or noninvasive sham needling techniques may be minimally active, evoking a neurophysiologic and/or neurochemical response. Other control procedures can be assumed to be inert, such as an inactivated transcutaneous electrical nerve stimulation (TENS) machine; however, these procedures may not have the same total psychologic impact as acupuncture, thereby compromising outcome. The information that the patient receives regarding the treatment and control intervention should be provided, including relevant wording on the information leaflet. Describing a sham acupuncture control as "a type of acupuncture" may affect outcome differently than saying it is "not acupuncture, but will involve a similar experience to acupuncture." The credibility of the control, which often depends on the inclusion of acupuncture-naïve patients, needs to be tested and reported. Finally, a precise description of the control intervention itself should be presented, including needling details and regimen if different from those used in the acupuncture group.

DISCUSSION
The CONSORT statement was first published in 1996 (Begg et al., 1996) and subsequent evidence has shown it to be associated with a positive influence on the quality of trial reporting (Moher et al., 2001a). It is intended that these STRICTA recommendations will have a similarly positive influence on the reporting of acupuncture trials and thus help critical appraisal, analysis, and interpretation of future controlled trials.

The STRICTA recommendations have been adopted by several participating journals that regularly publish in the field of acupuncture research. They all have agreed to recommend the STRICTA guidelines in their Instructions for Authors. Journals that have not yet adopted STRICTA may do so by registering with the lead author who is the coordinator of the STRICTA group. A full list of journals that have adopted STRICTA is available at www.stricta.info.

Similar to CONSORT, the STRICTA recommendations are a work-in-progress that will be updated. As with the CONSORT checklist, ad hoc modifications to the STRICTA criteria are not encouraged because the process of generating consensus may differ from that used by the STRICTA participants. To help improve these guidelines, readers are invited to comment on the STRICTA checklist directly to the STRICTA group coordinator, identifying gaps or areas of ambiguity and suggesting improvements and additions. These contributions will be fed into the next round of redrafting.

ACKNOWLEDGMENTS
The authors would like to thank Professor J.W. Thompson for his useful comments on the STRICTA checklist and Dr. Jaqueline Filshie for her contribution to this paper.

MEMBERS OF THE STRICTA GROUP
An international group of experienced acupuncturists and researchers met July 2-4, 2001, at Exeter University, Exeter, England, U.K. This group first drafted these recommendations, designating them STRICTA, and initiated the plan to encourage journals in the field to adopt them. Participating in this group were Steven Birch, L.Ac., Ph.D., Foundation for Traditional East Asian Medicine, Amsterdam, The Netherlands; Mark Bovey, B.Sc., Lic.Ac., B.Ac., University of Exeter, U.K.; Sarah Budd, S.R.N., S.C.M., Dip.Ac., B.Phil., University of Exeter, U.K.; Richard Hammerschlag, Ph.D., Oregon College of Oriental Medicine, Portland, OR; Val Hopwood, M.Sc., F.C.S.P., S.R.P., Dip.Ac., University of Coventry, U.K; Kenji Kawakita, Ph.D., Meiji University of Oriental Medicine, Japan; Lixing Lao, Ph.D., Lic.Ac., University of Maryland, Baltimore; George T. Lewith, M.B., D.M., F.R.C.P., Royal South Hants Hospital, Southampton, Hampshire, U.K.; Hugh MacPherson, B.S.C., Ph.D., M.B.Ac.C., Foundation for Traditional Chinese Medicine, York, U.K.; Simon Mills, University of Exeter, U.K.; Marco Romoli, M.D., Federazione Italiana Società di Agopuntura, Prato, Italy; Karen J. Sherman, Ph.D., M.P.H., Center for Health Studies, Seattle, WA; Sonya Pancucci, M.Ed., KST Health Services, Hamilton, Ontario, Canada; Kien Trinh, M.D., M.Sc., McMaster University, Hamilton, Ontario, Canada; Adrian White, M.A., B.M., B.Ch., Dip.Med.Ac., University of Exeter, U.K.; and Chris Zaslawski, Dip.Ac., Dip.C.H.M., B.App.Sc., M.Hlth.Sc.Ed., University of Technology, Sydney, Australia.

REFERENCES
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Address reprint requests to:
Hugh MacPherson, B.Sc., Ph.D., M.B.Ac.C.
Coordinator for the STRICTA group
c/o Foundation for Traditional Chinese Medicine
122A Acomb Road
York, YO24 4EY
United Kingdom
E-mail: hugh(at)ftcm.org.uk