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*
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.
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.
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.
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
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
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.
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.
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
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.
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 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
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
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.
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.
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.
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.
Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gøtzsche
PC, Lang T, for the CONSORT Group. The Revised CONSORT statement for
reporting randomized controlled trials: Explanation and elaboration.
Ann Intern Med 2001;134:663-694.
Begg CB, Cho MK, Eastwood S, et al. Improving the quality of reporting
of randomized controlled trials: The CONSORT statement. JAMA 1996;276:637-639.
Jobst KA, Eskinazi D, eds. United States National Institutes of Health
Report for the FDA on the status of Acupuncture in the USA. J Altern
Complement Med 1996;2:1-353.
Moher D, Jones A, Lepege L, for the CONSORT Group. Use of the CONSORT
statement and quality of reports of randomized trials: A comparative
before-and-after evaluation. JAMA 2001a;285:1992-1995.
Moher D, Schulz KF, Altman DG, for the CONSORT Group. The CONSORT
statement: Revised recommendations for improving the quality of reports
of parallel-group randomized trials. Lancet 2001b;357:1191-2001.
Ter Riet G, Kleijnen J, Knipschild P. Acupuncture and chronic pain:
A criteria-based meta-analysis. J Clin Epidemiol 1990;43:1191-1199.
White AR, Ernst E. A trial method for assessing the adequacy of acupuncture
treatments. Altern Ther Health Med 1998;4(6):66-71.
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