Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending...

Journal of Evidence-Based Medicine ISSN 1756-5383

METHODOLOGY

Revised STandards for Reporting Interventions in ClinicalTrials of Acupuncture (STRICTA): Extending the CONSORTStatementHugh MacPherson1, Douglas G. Altman2, Richard Hammerschlag3, Li Youping4, Wu Taixiang4,Adrian White5 and David Moher6, on behalf of the STRICTA Revision Group

1 Department of Health Sciences, University of York, York, United Kingdom2 Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom3 Department of Research, Oregon College of Oriental Medicine, Portland, Oregon, United States of America4 Chinese Cochrane Centre, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, China5 Primary Care Research, Peninsula Medical School, Universities of Exeter and Plymouth, Plymouth, United Kingdom6 Ottawa Methods Centre, Ottawa Hospital Research Institute; Department of Epidemiology and Community Medicine, Faculty of Medicine,University of Ottawa, Ottawa, Canada

CorrespondenceHugh MacPherson, Department of HealthSciences, University of York, York, UnitedKingdom.Tel: +44-1904-321394Fax: +44-1904-321388Email: [email protected]

Membership of the STRICTA Revision Groupis provided in the Acknowledgements.

Reproduced by permission of the Authors.

Received 14 June 2010; accepted 14June 2010.

doi: 10.1111/j.1756-5391.2010.01086.x

Abstract

The STandards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA) were published in five journals in 2001 and 2002. These guidelines,in the form of a checklist and explanations for use by authors and journal ed-itors, were designed to improve reporting of acupuncture trials, particularly theinterventions, thereby facilitating their interpretation and replication. Subsequentreviews of the application and impact of STRICTA have highlighted the value ofSTRICTA as well as scope for improvements and revision. To manage the revisionprocess a collaboration between the STRICTA Group, the CONSORT Group, andthe Chinese Cochrane Centre was developed in 2008. An expert panel with 47participants was convened that provided electronic feedback on a revised draft ofthe checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 par-ticipants further revised the STRICTA checklist and planned dissemination. Thenew STRICTA checklist, which is an official extension of CONSORT, includessix items and 17 sub-items. These set out reporting guidelines for the acupuncturerationale, the details of needling, the treatment regimen, other components of treat-ment, the practitioner background, and the control or comparator interventions. Inaddition, and as part of this revision process, the explanations for each item havebeen elaborated, and examples of good reporting for each item are provided. Inaddition, the word “controlled” in STRICTA is replaced by “clinical,” to indicatethat STRICTA is applicable to a broad range of clinical evaluation designs, includ-ing uncontrolled outcome studies and case reports. It is intended that the revisedSTRICTA, in conjunction with both the main CONSORT Statement and extensionfor nonpharmacologic treatment, will raise the quality of reporting of clinical trialsof acupuncture.

Introduction

The STandards for Reporting Interventions in Clinical Trialsof Acupuncture (STRICTA) reporting guidelines, first pub-

lished in 2001 (1–9), were designed to improve the complete-ness and transparency of reporting of interventions in con-trolled trials of acupuncture, in order that such trials may bemore accurately interpreted and readily replicated. STRICTA

140JEBM 3 (2010) 140–155 c© 2010 the Authors.

c© 2010 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University

H MacPherson et al. STRICTA: extending the CONSORT statement

comprised a checklist that expanded the generic content ofItem 5 of the CONSORT statement (10,11), which relates tothe reporting of the intervention.

A survey of authors of clinical trials and systematic re-views was subsequently conducted to determine the useful-ness of STRICTA in helping them write their reports (12). Inaddition, a survey of 90 acupuncture trials was undertakento assess whether use of the STRICTA checklist was asso-ciated with improved reporting over time (13). The resultsof these initiatives led to conclusions that most STRICTAitems were found to be necessary and easy-to-use, thoughsome were seen as poorly reported, ambiguous or possi-bly redundant, and a number of suggestions were madefor additional items. A revision of STRICTA was thereforeproposed.

Meanwhile, extensions to CONSORT have been devel-oped to cover the reporting of nonpharmacological treat-ments (14,15) and pragmatic trials (16). Since there areacupuncture specific aspects to reporting not covered by theseextensions, it was decided that STRICTA should be revisedin a manner congruent with CONSORT and its extensionsfor nonpharmacological treatments and pragmatic trials.

The combination of these developments led to an agree-ment between the CONSORT Group and the STRICTAGroup, in collaboration with the Chinese Cochrane Cen-tre and the Chinese Centre for Evidence-based Medicine, torevise STRICTA as a formal extension to CONSORT. Therevision processes have been described in more detail else-where (17). This paper describes the outcome in terms of anew checklist, updated explanations, and published examplesof good reporting.

Methods

In the summer of 2008, a group of 47 experts from the orig-inal STRICTA Group, the CONSORT Group, the WorldFederation of Acupuncture and Moxibustion Societies, theAcupuncture Trialists’ Collaboration (18), the Society forAcupuncture Research (19), and clinical trial authors weresurveyed (12). The experts were from 15 countries, 41 hadacademic positions, 31 were acupuncturists, 18 were in-volved with journals, such as board members, 15 were physi-cians, and 11 had been involved previously in developingreporting guidelines. These experts were consulted in re-gard to a draft of revised STRICTA items that had evolvedfrom previous research (12,13). Feedback was collated andforwarded (with permission) to those invited to a consen-sus development workshop, the next phase of the revisionprocess.

Twenty-one individuals attended a workshop in Freiburg,Germany, in October 2008. The attendees included expertsin epidemiology, trial methodology, statistics, and medicaljournal editing. Just over half the participants were acupunc-

turists from a variety of backgrounds, including physicianand nonphysician. All attendees received collated feedbackfrom the 47 experts, along with a draft revised STRICTAchecklist for consideration.

The workshop comprised presentations about the historyof STRICTA, CONSORT, and the then new CONSORT non-pharmacological treatments extension (14,15). The resultsof two investigations into the utility and acceptability ofSTRICTA (12,13), and the subsequent consultation with the47 experts, were also presented. A general discussion andagreement on generic issues relating to STRICTA were fol-lowed by a discussion of each nominated checklist item. Theaim was to agree, where possible, on the content of the up-dated draft checklist as well as to develop a revised set ofexplanations for each included item.

Subsequent to the workshop, a small writing group editeddrafts of the revised STRICTA checklist, identifying for eachitem one or more exemplars of good reporting, and devel-oped text explaining the rationale and discussing relevantevidence. Taking into account further feedback from thoseattending the Freiburg workshop, the writing group finalizedthe STRICTA checklist, the explanations and the examplesof good reporting.

Results

[Note: In the Examples that follow, the embedded terms (ref)and (refs) refer to sources that are reported in the originalpublished studies, but the details of these sources are notprovided in this article for reasons of brevity.]

There was agreement that STRICTA should continue tofunction as a stand-alone guideline for reporting acupuncturestudies, and be an official extension of CONSORT for report-ing randomized controlled trials. There was also consensuson a minor change of name, in that the word “controlled”in STRICTA should be replaced by “clinical,” to indicatethat it was applicable for reporting a broad range of clinicalevaluation designs, including uncontrolled outcome studiesand case reports. The group agreed that the rationale behindreporting should be to provide the information needed to al-low replication of a study, reduce ambiguity, and enhancetransparency. The group recognized that acupuncture trialsinevitably differ in the degree of individualization of care thatis permitted, and agreed that the reporting guideline shouldacknowledge this and be applicable across the whole range ofdesigns. The group also suggested that the revised STRICTAstatement, when published, should be presented as embed-ded within the two-group parallel trial CONSORT checklist(10) and its nonpharmacological treatment extension check-list (14).

The revised STRICTA checklist comprises six items bro-ken out into 17 sub-items (Table 1). Table 2 presents howthe revised STRICTA checklist fits within the CONSORT

JEBM 3 (2010) 140–155 c© 2010 the Authors.c© 2010 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University 141

STRICTA: extending the CONSORT statement H MacPherson et al.

Table 1 STRICTA 2010 checklist of information to include when reporting interventions in a clinical trial of acupuncture

Item Detail

1. Acupuncture rationale (a) Style of acupuncture (eg, TCM, Japanese, Korean, Western medical, Five Element, ear acupuncture, etc)(b) Reasoning for treatment provided, based on historical context, literature sources, and consensus methods,

with references where appropriate(c) Extent to which treatment was varied

2. Details of needling (a) Number of needle insertions per subject per session (mean and range where relevant)(b) Names (or location if no standard name) of points used (uni/bilateral)(c) Depth of insertion, based on a specified unit of measurement, or on a particular tissue level(d) Response sought (eg, de qi or muscle twitch response)(e) Needle stimulation (eg, manual, electrical)(f) Needle retention time(g) Needle type (diameter, length, and manufacturer or material)

3. Treatment regimen (a) Number of treatment sessions(b) Frequency and duration of treatment sessions

4. Other components oftreatment

(a) Details of other interventions administered to the acupuncture group (eg, moxibustion, cupping, herbs,exercises, lifestyle advice)

(b) Setting and context of treatment, including instructions to practitioners, and information and explanations topatients

5. Practitionerbackground

Description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice,other relevant experience)

6. Control or comparatorinterventions

(a) Rationale for the control or comparator in the context of the research question, with sources that justify thischoice

(b) Precise description of the control or comparator. If sham acupuncture or any other type of acupuncture-likecontrol is used, provide details as for Items 1 to 3 above.

Note: This checklist, which should be read in conjunction with the explanations of the STRICTA items provided in the main text, is designed toreplace CONSORT 2010’s item 5 when reporting an acupuncture trial.

checklist (10) and its extension for nonpharmacological treat-ments (14). Further we provide the checklist text for each ofthe six items and their sub-items, as well as explanations onthe need for their adequate reporting and examples of goodreporting from the published literature.

STRICTA Item 1: AcupunctureRationaleItem 1a

Style of acupuncture (eg, Traditional Chinese Medicine,Japanese, Korean, Western medical, Five Element, earacupuncture, etc.).

Explanation

Acupuncture has a long history in many cultures and is char-acterized by a broad diversity of styles and approaches inboth East Asia and the West (20). In order for the readersto contextualize the trial within the range of current clin-ical practices, researchers should state the overall style orapproach on which they have based the treatments. If the re-searcher believes the treatment approach is completely novel,then this should be clearly stated.

Examples

(1) We based the acupuncture point selections on TraditionalChinese Medicine (TCM) meridian theory to treat kneejoint pain, known as the “Bi” syndrome (21).

(2) Participants were randomized to two styles of acupunc-ture: Japanese style (Kiiko-Matsumoto’s Form) and TCMstyle (22).

(3) Four out of five of the acupuncturists primarily practisedthe Five Element style with a diagnostic focus on indi-vidual “Causative Factors,” (ref) and one used the TCMstyle with diagnosis primarily based on syndrome pat-terns.(ref) Both styles are rooted in traditional acupunc-ture theory, and they are the most common traditionalapproaches used by professional acupuncturists in theUK today(ref) (23).

(4) Each patient was treated with nonlocal needle acupunc-ture (according to the theory of channels of TCM) atdistant points, and dry needling of local myofascial trig-ger points (24).

Item 1b

Reasoning for treatment provided, based on historical con-text, literature sources, and consensus methods, with refer-ences where appropriate.




Table 2 CONSORT 2010 checklist with the Nonpharmacological Trials Extension to CONSORT (with STRICTA 2010 extending CONSORT Item

5 for acupuncture trials).

CONSORT 2010 Statement∗: checklist Additional items from the nonpharmacologicalSection/Topic Item # item (10). Describe: trials extension to CONSORT (14). Add:

Title and abstract1a Identification as a randomized trial in the title In the abstract, description of the experimental

treatment, comparator, care providers, centresand blinding status.

1b Structured summary of trial design, methods,results, and conclusions; for specific guidancesee CONSORT for Abstracts (58,59)

IntroductionBackground and

objectives2a Scientific background and explanation of rationale

2b Specific objectives or hypothesesMethodsTrial design 3a Description of trial design (eg, parallel, factorial)

including allocation ratio3b Important changes to methods after trial

commencement (eg, eligibility criteria), withreasons

Participants 4a Eligibility criteria for participants When applicable, eligibility criteria for centers andthose performing the interventions.4b Settings and locations where the data were

collectedInterventions 5 The interventions for each group with sufficient

details to allow replication, including how andwhen they were actually administered

Precise details of both the experimental treatmentand comparator, see Table 1 for details

Outcomes 6a Completely defined pre-specified primary andsecondary outcome measures, including howand when they were assessed

6b Any changes to trial outcomes after the trialcommenced with reasons

Sample size 7a How sample size was determined When applicable, details of whether and how theclustering by care providers or centers wasaddressed.7b When applicable, explanation of any interim

analyses and stopping guidelinesRandomizationSequence generation 8a Method used to generate the random allocation

sequenceWhen applicable, how care providers were

allocated to each trial group.8b Type of randomization; details of any restriction

(eg, blocking and block size)Allocation

concealment9 Mechanism used to implement the random

allocation sequence (eg, sequentially numberedcontainers), describing any steps taken toconceal the sequence until interventions wereassigned

Implementation 10 Who generated the random allocation sequence,who enrolled participants, and who assignedparticipants to interventions

Blinding 11a If done, who was blinded after assignment tointerventions (eg, participants, care providers,those assessing outcomes) and how

Whether or not those administeringco-interventions were blinded to groupassignment. If blinded, method of blinding anddescription of the similarity of interventions.11b If relevant, description of the similarity of

interventionsStatistical methods 12a Statistical methods used to compare groups for

primary and secondary outcomesWhen applicable, details of whether and how the

clustering by care providers or centers wasaddressed.

12b Methods for additional analyses, such assubgroup analyses and adjusted analyses



Table 2 Continued

CONSORT 2010 Statement∗: checklist Additional items from the nonpharmacologicalSection/Topic Item # item (10). Describe: trials extension to CONSORT (14). Add:

ResultsParticipant flow (A

diagram is stronglyrecommended)

13a For each group, the numbers of participants whowere randomly assigned, received intendedtreatment, and were analyzed for the primaryoutcome

The number of care providers or centersperforming the intervention in each group andthe number of patients treated by each careprovider or in each center.

13b For each group, losses and exclusions afterrandomization, together with reasons

Implementation ofintervention

Details of the experimental treatment andcomparator as they were implemented.

Recruitment 14a Dates defining the periods of recruitment andfollow up

14b Why the trial ended or was stoppedBaseline data 15 A table showing baseline demographic and clinical

characteristics for each groupWhen applicable, a description of care providers

(case volume, qualification, expertise, etc.) andcenters (volume) in each group.

Numbers analyzed 16 For each group, number of participants(denominator) included in each analysis andwhether the analysis was by original assignedgroups

Outcomes andestimation

17a For each primary and secondary outcome, resultsfor each group, and the estimated effect sizeand its precision (eg, 95% confidence interval)

17b For binary outcomes, presentation of bothabsolute and relative effect sizes isrecommended

Ancillary analyses 18 Results of any other analyses performed, includingsubgroup analyses and adjusted analyses,distinguishing pre-specified from exploratory

Harms 19 All important harms or unintended effects in eachgroup; for specific guidance see CONSORT forHarms (60)

DiscussionLimitations 20 Trial limitations, addressing sources of potential

bias, imprecision, and, if relevant, multiplicity ofanalyses

Generalizability 21 Generalizability (external validity, applicability) ofthe trial findings

Generalizability (external validity) of the trialfindings according to the intervention,comparators, patients and care providers andcenters involved in the trial.

Interpretation 22 Interpretation consistent with results, balancingbenefits and harms, and considering otherrelevant evidence

In addition, take into account the choice of thecomparator, lack of or partial blinding, unequalexpertise of care providers or centers in eachgroup.

Other informationRegistration 23 Registration number and name of trial registryProtocol 24 Where the full trial protocol can be accessed, if

availableFunding 25 Sources of funding and other support (eg, supply

of drugs); role of funders

∗We strongly recommend reading this Statement in conjunction with the CONSORT 2010 explanation and elaboration (11) for importantclarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomized trials (61), noninferiority,and equivalence trials (62), herbal interventions (63), and pragmatic trials (16). Moreover, additional extensions are forthcoming. For those andfor up-to-date references relevant to this checklist, see http://www.consort-statement.org.




Explanation

The author(s) should provide the reasoning for the chosentreatment, including rationale for diagnosis, point selection,and treatment procedures. The “rules” that were used inproviding treatments should be described. When treatmentswere selected that have roots in traditional practice, it isrecommended that the historical and cultural context be sup-plied. This is relevant for interventions within styles suchas “TCM,” where the broad diversity of approaches requirescareful identification of where and when the treatment pa-rameters were developed. Where consensus methods, expertclinical panels, practitioner surveys or some combination ofsources have been used to define the treatment protocol, it isrecommended that full details of the methodology be given.Literature and other sources should be provided where rel-evant, in order that others can replicate the trial by consult-ing these source(s) and developmental methods on whichtreatment was based. Authors are encouraged to referencepublished works that are easily obtainable, such as a bookor journal article. If the reference is a thesis, nonpublishedwork, written material only available in a different languagefrom the journal article, or a verbal communication, authorsare encouraged to present or summarize the information inan appendix or make it otherwise generally available (eg, ona website). For fully individualized trials where the goal isto have representative practitioners who are encouraged topractice as they normally do, it is appropriate to specify theselection process for the practitioners, providing details ofcriteria for their inclusion. It is important to note that wheredetails of the intended intervention are defined in advance,it is possible that what was actually administered may havediffered. In such cases, precise details of the treatments thatwere provided are also necessary.

Examples

(i) This study employed a style of Japanese acupuncturedeveloped by Shima and Chace (ref) and Manaka (ref),and follows the Japanese acupuncture training curricu-lum at the New England School of Acupuncture. In com-parison to typical TCM acupuncture, Japanese acupunc-ture uses smaller needles and inserts needles less deeplyand with less manipulation.(ref) For these reasons, webelieved Japanese acupuncture would be less invasivethan TCM, and thus better received by our adolescentpopulation. Japanese acupuncture has been shown tobe effective in treating certain pain conditions.(ref) Thespecific acupuncture protocols employed in this studyare briefly described later and discussed in greater detailin a companion paper(ref) (25).

(ii) We based point selection on individualized Westernacupuncture techniques by using a list of points pre-

viously reported as being effective in neck pain (refs)and by reaching a consensus according to our own clin-ical and teaching practice.(ref) The specific points foreach individual were defined at each treatment session,depending on the patient’s pain distribution and palpa-tion of the neck and thorax to determine ah-shi points,or local tender points, for acupuncture. At least one dis-tal point was used. Point location and depth of insertionwere as described in traditional texts(ref) (26).

(iii) We developed the treatment strategies for acupunc-ture and minimal acupuncture in a consensus processwith three acupuncture specialists (names provided)representing two major German societies for medicalacupuncture: the German Medical Acupuncture As-sociation (Deutsche Arztegesellschaft fur Akupunk-tur, DAGfA) and the International Society for ChineseMedicine (Societas Medicinae Sinensis, SMS). The firststep involved three specialists (names provided) and thestudy team developing a proposal, which was followedby a discussion including more than 30 acupuncture ex-perts from both acupuncture societies. The final inter-vention strategies were defined by the aforementionedthree specialists together with the study team and sub-sequently were communicated to the external advisors(27).

Item 1c

Extent to which treatment was varied.

Explanation

The extent to which the treatment was individualized, bothbetween patients and between practitioners, should be de-scribed. Trial protocols choose one of three broad levels ofindividualization, ranging from none at all (all patients re-ceiving the same treatment at all sessions), through partiallyindividualized treatments (eg, use of a fixed set of pointsto be combined with a set of points to be used flexibly), tofully individualized treatment protocols within which eachpatient receives a unique and evolving diagnosis and treat-ment. Additionally, the practitioners may have to apply astandardized theoretical framework, or may be allowed toapply their own. Many styles of acupuncture, whether basedon traditional theories or Westernized concepts such as trig-ger points, are individualized in routine practice. Trials thatare more pragmatic (28) in their aim, and designed to repli-cate routine settings and patient groups, have more of anemphasis on fully individualized treatment. In such casesstandardization may consist of a protocol that instructs prac-titioners to provide treatments as they normally do. Trialsthat are more explanatory (mechanistic) in their aim tend toneed a tighter definition of specific components in order tominimize variation across treatments.



Examples

(i) Each patient received individualized acupuncture treat-ments that focused on specific needs and symptoms thatthe individual was experiencing. The rationale for thisintervention was to test acupuncture as it is typicallyperformed in practice. Point selection was based on thegeneral principles of acupuncture and TCM (ref). Thetreatment was modified over the course of the study toaccommodate the individual’s changing pattern of pain,sleep, or other health issues (29).

(ii) The verum points consisted of obligatory points andadditional points individually chosen by the physicianson the basis of TCM diagnosis for syndromes (includ-ing tongue diagnosis), acupuncture channels related tothe individual headache area, and Ah Shi points (locusdolendi points) (30).

(iii) The acupuncture protocol was based on the conceptof adequacy of treatment,(ref) survey results,(ref) aconsensus workshop, and recommendations from tra-ditional Chinese protocols. We did not allow moxibus-tion, cupping, herbs, or electroacupuncture. For eachindividualized treatment session between six and 10acupuncture points from 16 commonly used local anddistal points were selected. Local points were Sp 9, Sp10, St 34, St 35, St 36, Xiyan, Gb 34, and trigger points.Distal points were LI 4, TH5, Sp 6, Liv 3, St 44, Ki 3,BI 60, and Gb 41 (31).

STRICTA Item 2: Details of NeedlingItem 2a

Number of needle insertions per subject per session (meanand range where relevant).

Explanation

It is recommended that the reporting of this item shouldinclude a total of needle insertions per subject per session.This item is relevant to all designs of randomized controlledtrials, from pragmatic to explanatory. For more explanatorydesigns where a formula of points is prescribed, the numberof needle insertions should be reported as a simple total. Formore pragmatic designs, with individualized treatments, themean and range should be reported. Clearly, full details ofindividualized treatment cannot be reported in every sectionof Item 2 below. However, each item should be consideredand as much information given as possible.

Examples

(i) The protocol allowed for up to 10 treatments per patient,the precise number being agreed between patient and

practitioner. A total of 1269 treatments were provided,an average of 8.6 treatments per patient (range 1–10)and 9.6 needles per treatment (range 6–12). See (table)for variations between practitioners (32).

(ii) Disposable stainless steel needles (0.2 × 50 mm, Seirin)were inserted into the skin over the trigger point to adepth of 10–30 mm, appropriate to the muscle targeted,attempting to elicit a local muscle response using the“sparrow pecking” technique. After the local twitch re-sponse was elicited or a reasonable attempt made, theneedle was retained for a further 10 minutes. The meannumber of insertions was 3.3 (33).

(iii) In the real acupuncture group, the acupuncture pointsHegu (LI 4), Jiache (St 6), Xiaguan (St 7), and Yifeng(SJ 17) were used unilaterally on the tooth extractionside (34).

Item 2b

Names (or location if no standard name) of points used(uni/bilateral).

Explanation

The point descriptions in the seminal classic texts, such asthe Huangdi Neijing (Inner Canon of the Yellow Emperor)are rare and vague. The depiction of acupuncture pointsin relation to precise anatomical structures dates back only100 years. Since the mid 1950s a process of standardizationhas been taking place, and the acupuncture point descriptionsbased on anatomical locations and proportional cun measure-ment systems have served as a blueprint for many Westerntranslations. It should be noted that these locations have notbeen universally adopted. Given this historical context, itremains important to know which acupuncture points havebeen used in clinical trials, with as accurate descriptions aspossible of the location of these points, and where relevantthe method used to identify the points.

The specific point locations used in treatments where stan-dardized should be described in terms of an accepted nomen-clature (eg, GB21) (35) or in terms of anatomical locationwhere there is no accepted name. Whether the needles areinserted unilaterally or bilaterally should be stated. For proto-cols with partially individualized prescriptions, list any pre-scribed essential or optional points, and describe (in the Re-sults section) both the points used at every visit, and all thepoints used on an ad hoc basis. If the list is extensive, themost commonly used points (with percentages) should bereported. Where protocols specify using fully individualizedpoint prescriptions, authors should consider the best way toreport the points used, for example, by listing all points acrossall subjects, or by identifying the most commonly used pointsif the list is extensive.




Examples

(1) We based the acupuncture point selections on TCMmeridian theory to treat knee joint pain, known as the“Bi” syndrome. These points consisted of five localpoints (Yanglinquan [gall bladder meridian point 34],Yinlinquan [spleen meridian point 9], Zhusanli [stomachmeridian point 36], Dubi [stomach meridian point 35],and extra point Xiyan) and four distal points (Kunlun[urinary-bladder, meridian point 60], Xuanzhong [gallbladder meridian point 39], Sanyinjiao [spleen meridianpoint 6], and Taixi [kidney meridian point 3]) on meridi-ans that traverse the area of pain (refs). The same pointswere treated for each affected leg. If both knees wereaffected, nine needles were inserted in each leg (21).

(2) The verum acupuncture (VA) group received acupunc-ture with a 0.25 × 40-mm stainless steel needle (AsiaMed, Munich, Germany) at LI4, which is situated be-tween the first two metacarpal bones on the dorsal side ofboth hands at the top of the muscle belly (figure provided)(36).

(3) The most frequently treated local points were Bl 23, Bl25, Gb 30, DU 4, Bl 26, and the extra point Huatuoji-aji (table provided). . . . . . . The most frequently treateddistant points were Bl 40, Kid 3, Gb 34, Bl 60, SI 3,and DU 20. In most cases, 8 to 12 local points and 4to 6 distant points were used. Physicians used additionalacupuncture points in 565 of the treatment sessions. Themost frequently used additional local points were Li 4,St 40, Bl 17, Sp 6, and St 36 (27).

Item 2c

Depth of insertion, based on a specified unit of measurement,or on a particular tissue level.

Explanation

The depth of insertion should be expressed using the Chinesemeasurement of the cun; in terms of anatomical depth, forexample, of subcutaneous tissue, fascia, muscle or perios-teum; or in millimetres. For some trials, the protocol mightspecify the angle and direction of insertion along with depthof insertion, in which case these should also be reported.

Examples

(1) All needle placements were performed by an experiencedacupuncturist at a premarked depth of 4 mm from the tipof the needle (37).

(2) The depth of needle insertion varied with thickness ofthe skin and subcutaneous fatty tissues at the site of theacupuncture points; it was usually 1 to 1.5 cm (38).

(3) Shallow and light needling stimulation (1–2 mm) usingfine needles (0.18–0.16 mm) inserted with the aid ofinsertion tubes was emphasized. Points were needled ata 10◦–20◦ angle with a two-hand needling technique,generally in the direction of the flow of the channel (39).

Item 2d

Responses sought (eg, de qi or muscle twitch response).

Explanation

If the study protocol requires that specific responses toneedling be elicited, for example the de qi sensation in tradi-tional Chinese acupuncture, the muscle twitch in trigger pointtreatment or muscle contraction in electro-acupuncture, theseelicited responses should be reported. Where relevant, the au-thors should differentiate between the responses required inthe protocol and those actually obtained (which should bereported in the Results section).

Examples

(1) The trigger point (TRP) group received treatment at trig-ger points. The correct application of the technique re-quires experience in palpation and localization of tautmuscle bands and myofascial trigger points. Preciseneedling of myofascial trigger points provokes a briefcontraction of the muscle fibres. This local twitch re-sponse must be elicited for successful therapy but it maybe painful and post-treatment soreness is frequent (33).

(2) In contrast with TCM style acupuncture, we did not em-ploy vigorous manipulation in order to elicit a strong deqi sensation (defined as a feeling of heaviness around theacupuncture point).(ref) Practitioners focused instead onfeeling the response to stimulation as an “echo” sensationexperienced on the receiving hand, while the active handperformed the actual needling. Attention was placed onreactivity or change in diagnostic areas, especially thepulse and abdomen. By carefully assessing changes inpalpatory findings, the treatment was adjusted continu-ously based on the patient’s response. Before needling,the “live” points were identified by palpation, that is, sub-tle changes at the skin level, or upon touch or pressure,for that particular patient (39).

Item 2e

Needle stimulation (eg, manual or electrical).

Explanation

Needle stimulation techniques, where used, should be clearlydescribed for all points. For manual stimulation, such



techniques include lifting, thrusting or rotating the needleto manipulate the de qi sensation. For electrical stimula-tion, the current, amplitude, and frequency settings shouldbe recorded.

Examples

(1) This mode of (manual) stimulation was provided via theacupuncture needles, which were placed in the premarkeddepth at the marked sites. The needle was rotated byan experienced acupuncturist with the index finger andthumb in an alternating clockwise and counterclockwisefashion at the rate of three to five rotations per second(37).

(2) Electrical stimulation was given to the anterior part ofthe knee for 10 minutes and then 10 minutes for theposterior part using a battery-operated, four-channel, “ASSuper 4” Electrostimulator (RDG Medical, Surrey, UK)which generated low frequency, square-wave (2–10 Hz)pulses of 1 millisecond duration for 10 minutes.(ref) Inboth groups, the apparatus was attached to needles at thetwo Xiyan points, SP9 and GB34, and BL40 and BL57.Electrical stimulation was delivered at 6Hz at a constantcurrent. Voltage was set at a level just above the painthreshold (38).

Item 2f

Needle retention time.

Explanation

Needle retention times should be reported as either a stan-dard or a mean and range. Authors should make it clear thatthey are reporting the time elapsed between the insertion andremoval of needles (retention time) and distinguish it fromtreatment time, which may include other procedures, such ashistory taking, discussion, and preparation for treatment.

Examples

(1) Each participant was treated bilaterally and had a totalof six needles inserted for the duration of the treatment.A draining technique was used and the needles were leftfor a period of 30 minutes. The practitioner returned tocheck on the participant at regular intervals during theintervention (40).

(2) Needles were withdrawn immediately for tonification,and retained for up to 20 minutes for the evens technique(23).

(3) Therapists allow 25 (min) to 35 (max) minutes betweeninsertion of the last needle and cessation of treatmentand during that time they are to revisit the needles asappropriate (41).

(4) The patients in group A were dry needled for a few sec-onds. For trigger point inactivation by dry needling. . . itis especially important not to apply too strong a stimu-lus because this may produce a flare-up of the patient’ssymptoms (42).

Item 2g

Needle type (diameter, length, and manufacturer ormaterial).

Explanation

Details should be given of the types of needles used, includingthe diameter and length as well as the manufacturer and/or thematerial. This information is of importance since the effectof different metals or needle sizes on the body is not known.For trials using a variety of different types of needles, theranges of diameters and lengths as well as types of materialshould be reported.

Examples

(1) Seirin 36 gauge 2.5 inches long unused sterile L-typeneedles were used for the study (37).

(2) The VA (verum acupuncture) group received acupunc-ture with a 0.25 × 40-mm stainless steel needle (AsiaMed, Munich, Germany) at LI4 (36).

STRICTA Item 3: Treatment RegimenItem 3a

Number of treatment sessions.

Explanation

The planned number of sessions and frequency of treatmentshould be clearly documented. The actual number of treat-ments received by participants should be reported in the Re-sults section. If there is variation between patients, then themean and range should be reported.

Examples

(1) The true acupuncture (experimental) group underwent26 weeks of gradually tapering treatment according tothe following schedule: eight weeks of two treatmentsper week followed by two weeks of one treatment perweek, four weeks of one treatment every other week, and12 weeks of one treatment per month (21).

(2) In all groups, participants were asked to attend treat-ment sessions twice weekly for 12 weeks (24 treatments).We considered participants who attended 80% or more




(≥19 of 24) of acupuncture sessions to have completed afull course of treatment (43).

Item 3b

Frequency and duration of treatment sessions.

Explanation

The frequency and duration of sessions should be docu-mented, with mean and range to be reported where thereis variation across patients. Any variation in frequency oftreatment (eg, if subjects are to be treated twice weekly inthe first two weeks then once a week for the next six weeks)should be clearly reported.

Examples

(1) Acupuncture was administered a maximum of eighttimes, twice during each of the first three weeks and onceduring each of the following two weeks, for 30 minutesat each session. One month after this series of treatmentshad been completed and evaluated, the patients were of-fered a maximum of two follow-up treatments of the samekind, one week apart (44).

STRICTA Item 4: Other Componentsof TreatmentItem 4a

Details of other interventions administered to the acupunc-ture group (eg, moxibustion, cupping, herbs, exercises,lifestyle advice).

Explanation

Additional components of treatment refer to the auxiliarytechniques, prescribed self-treatment and lifestyle adviceprovided by the practitioner. All additional components,whether carried out by the practitioner or patient and whetherintegral or adjunctive to the acupuncture needling, shouldbe described clearly. For acupuncture related interventions,such as moxibustion or cupping, detail should be providedequivalent to that recommended for acupuncture needling.If the protocol specifies the options of prescribed self-helptreatments such as qigong or muscle stretching exercises,and/or lifestyle advice such as dietary changes based onacupuncture-related diagnostic criteria, then these too mustbe reported. The frequency with which the advice was given,and participants’ compliance with this advice, should be re-ported. “Other components of treatment” should be distin-guished from “co-interventions,” that is interventions that are

provided additionally to both groups, which should be fullyreported as described in STRICTA Item (6b) further.

Examples

(1) In addition to needling, moxibustion or thermal stimu-lation of the acupoints was used forming very fine woolof mugwort (Artemisa vulgaris) into minute, thread-sizepunks (okyu) and placing them on a thin layer of an herbalcream (shiunko). The moxa was lit with an incense stickand the process was repeated several times until warmthwas felt by the patient (39).

(2) Following application of the studs, patients were in-structed to apply pressure to the stud by making smallcircular movements with the fingers of the opposite hand,2–3 cycles per second for 1–2 minutes per point. As istypical for self-administered acupressure, patients wereencouraged to apply acupressure this way on waking, inthe early afternoon and during any exacerbation of symp-toms. Initial instruction was provided verbally, at whichtime patients were asked to confirm their understandingby demonstrating the procedure. Patients also were giveneasy-to-read written materials describing the acupressureprocedure (45).

(3) Chinese herbal medicine was to be taken three times perday over a period of six weeks and parallel to acupunc-ture treatment. . . All herbs used in the present study wereimported from China by a single TCM herbal medicineimport company (Sinores, Lueneberg, Germany). . . Allherbs were prepared in dried, minced pieces and thensealed in generic paper sachets by a pharmacist in or-der to render the herbal formulation nonidentifiable forpatients. . . In addition to the basic formula, every patientreceived a second additional formula tailored to his orher individual TCM diagnosis (46).

Item 4b

Setting and context of treatment, including instructionsto practitioners and information and explanations topatients.

Explanation

The setting and context of treatment can also provide im-portant additional components to treatment (47). Context in-cludes instructions to practitioners that might modify theirnormal practice, for example, prescribing or proscribing ex-planations to patients about their diagnosis. For patients,the context includes the information they have been givenabout the trial that might be expected to modify outcomes.Therefore, the information that the patient receives regard-ing the treatment and control intervention should be re-ported, including any relevant wording on consent forms and



information leaflets designed to influence beliefs or expec-tations. For example, describing a sham acupuncture controlas “a type of acupuncture” may have a different effect onoutcome than saying it is “not acupuncture, but will involvea similar experience to acupuncture.”

Examples

(1) The first acupuncturist was the “diagnosing acupunctur-ist” (DA), whom the patient saw for the initial consul-tation, and before and after each treatment. A full casehistory was taken by the DA, together with tongue andpulse examination, to arrive at an individual diagnosisin accordance with the principles of TCM, with an ad-ditional lesser emphasis on Five Element Acupuncture(refs). Although all patients in the study had IBS, this cor-responded to a wide range of TCM patterns, making in-dividual diagnosis essential. Dietary and lifestyle advice(important in treatment according to TCM principles)was given to all patients by the DA, who then selectedacupuncture points. The second “treating acupuncturist”(TA) opened the randomization envelope, and for the du-ration of the study remained the only individual aware oftreatment allocation. The TA carried out the treatment—either according to instructions issued by the DA orusing sham points, depending on the randomization(48).

(2) Patients were informed about acupuncture and minimalacupuncture in the study as follows: “In this study, dif-ferent types of acupuncture will be compared. One typeis similar to the acupuncture treatment used in China.The other type does not follow these principles, but hasalso been associated with positive outcomes in clinicalstudies” (27).

STRICTA Item 5: PractitionerBackgroundItem 5

Description of participating acupuncturists (qualification orprofessional affiliation, years in acupuncture practice, otherrelevant experience).

Explanation

Characteristics of the acupuncturists providing treatmentshould be reported, including qualification or affiliation,years in acupuncture practice, as well as any other experiencethat may be relevant to the trial. Relevant differences (if any)in the qualification, training and experience of the participat-ing acupuncturists should be highlighted. The recent surveyof authors of acupuncture trials and reviews reinforced theneed for these characteristics to be reported well (12), es-

pecially since the actual level of reporting has historicallybeen poor (13). In trials where different acupuncturists pro-vide treatment to different treatment arms, the backgroundof both groups should be reported. The eligibility criteriafor acupuncturists should be explained, as these will influ-ence generalisability of the trial results. Where there areknown to be potential variations between practitioners, se-lecting a random sample of practitioners will reduce exper-tise bias and help improve the applicability of the results(49).

Examples

(1) Physicians had a median of 350 hours (range 140–2508hours) of acupuncture training before participating in thetrial; 33 (73%) had the B-Diploma. Seventeen (17; 38%)trial physicians taught acupuncture in accredited post-graduate courses. The physicians had used acupuncturein their practices for an average of 11 years (median 10,range 0–25) and had treated 346 patients (range 22–1200)with acupuncture in the year before the trial. Forty-onephysicians (92%) indicated that they frequently or alwaysmake a Chinese syndrome diagnosis before starting treat-ment (27).

(2) Eight US-trained and licensed acupuncturists with amedian of 10 years of experience (range 4–18 years)provided study treatments in their private offices. Oneinvestigator trained the acupuncturists in the study pro-cedures to increase their comfort with delivering all fourtreatments and monitored compliance with the protocolthroughout the study (43).

(3) Of the 11 midwives participating in the study, six hadbeen taught acupuncture for midwives at the Norwe-gian School of Acupuncture/NFKA. These six gave realand false acupuncture, whereas the others, who had beentrained in acupuncture by the six, were allowed only togive false acupuncture (50).

STRICTA Item 6: Control andComparator InterventionsItem 6a

Rationale for the control or comparator in the context of theresearch question, with sources that justify the choice(s).

Explanation

The rationale for choice of control or comparator should bepresented and justified in relation to the research questionand the methodology. In studies in which a group receivingacupuncture is compared with another group, the control orcomparator can be sham acupuncture, usual care, an activetreatment, a waiting list or no treatment. Whereas “control”




is sometimes used for a group that receives no intervention,the term “comparator” may be more appropriate for an activeintervention, such as physiotherapy, for which the intendedaction of the comparator is expected to be therapeutic. If us-ing an acupuncture-like control in a participant-blinded trialthen one of the following terms: active acupuncture control;penetrating needle control; or nonpenetrating sham needlingcontrol might be helpful descriptors. Control procedures in-volving invasive or noninvasive sham needling techniquesmay be therapeutically active, evoking neurophysiologicaland localized immune and circulatory responses. The ex-tent that sham acupuncture needling, whether penetrating ornot, might elicit acupuncture-specific physiological mech-anisms is not known, and is in part a consequence of ourlack of knowledge of the mechanism(s) of true acupuncture.There are also variations in assumptions about the precisionrequired for point location, as for some clinicians and in-vestigators, acupuncture points are considered as areas ofreactivity rather than points of action. Such assumptionshave a bearing on the integrity of the sham as an appro-priate control. Some non-needling control procedures canbe assumed to be physiologically inert, such as an inac-tivated transcutaneous electrical nerve stimulation (TENS)machine; however, these procedures may not have the sametotal psychophysiological credibility as acupuncture, therebycompromising the interpretation of the results. Sources thatled to the choice of control, such as literature or expertopinion, should also be reported and referenced. The au-thor should reference prior work that supports the use ofthe selected comparator, such as from the conclusion of asystematic review or from another randomised controlledtrial.

Examples

(1) “Sham” acupuncture points were chosen from three dif-ferent areas on the body (the anterior thigh distally,the posterior thigh, and the lateral aspect of the lowerback), which do not correspond to recognized acupunc-ture points and are deemed to have no therapeutic value(48).

(2) International guidelines suggest that the best package ofcare for this patient group is one that includes patienteducation, advice and exercise (ref). . . . . Randomisedclinical trials consistently show the benefit of exercisefor knee pain in older adults (refs). Recent studies alsohighlight the need to provide adequate instruction, feed-back and practice in order to ensure that the key musclegroups around the knee, such as the quadriceps, are acti-vated (ref). The European League Against Rheumatism(EULAR) recommendations have recently been updatedand in particular, advocate exercise for knee pain relatedto osteoarthritis (ref). In line with this evidence base, the

current trial was designed so that all participants receivea package of care that includes education, advice, andexercise (41).

(3) For this study a special “placebo needle” was designedby Streitberger. The needle body is not fixed inside thecopper handle. Its tip is blunt and when it touches theskin, a small pricking sensation is felt by the patient,simulating the puncture of the skin. The handle of theneedle moves over the needle, the needle is shortened.Patients “see” the needle moving inside their body. . .

This needle was tested in 60 volunteers and proved to besufficiently credible to be used in our clinical trial as acontrol(ref) (51).

Item 6b

Precise description of the control or comparator. If shamacupuncture or any other type of acupuncture-like control isused, provide details as for Items 1 to 3 above.

Explanation

A precise description of the components of the control orcomparator should be presented. If the control treatment isan acupuncture-like intervention, such as a form of shamacupuncture, then it should be specified whether the shamis invasive (penetrating the skin) or noninvasive (nonpene-trating). The theoretical basis, needling details and regimenof an acupuncture-like control need to be reported in thesame way as is set out in STRICTA Items 1 to 3 above.The lack of a world-wide consensus on the location andsize of acupuncture points reinforces the importance of ac-curate documentation of the sham points actually used, theirprecise location and the method used to locate them. If usualcare or another active treatment is the comparator, all thecomponents should be reported in full detail. This will en-able readers to compare usual care as provided in the trialwith what is usually provided to participants in another set-ting. Where usual care is also provided to those receivingacupuncture, these data will also allow readers to comparethe intensity of usual care in the comparator arm with that ofthe experimental arm. If it is a waitlist arm, then the periodof waiting needs to be specified. While precise descriptionof the control or comparator is fairly straightforward in prin-ciple, the more complex the components, the more care isrequired to specify them precisely.

Examples

(1) Acupuncturists inserted 2 needles into the sham pointsin the abdominal area, approximately 3 cm lateral to andslightly above the umbilicus bilaterally, and then immedi-ately applied 2 pieces of adhesive tape next to the needles.



In addition, they tapped a mock plastic needle guidingtube on the surface of each of the 9 true points in theleg to produce some discernible sensation and then im-mediately applied a needle with a piece of adhesive tapeto the dermal surface, without needle insertion, of eachpoint for a total of 20 minutes. The sham acupunctureprocedure was given on the same schedule as the exper-imental group and used the same active needle place-ments, except actual insertion did not occur at these ninepoints. Although electrical stimulation did not occur, amock transelectrical stimulation unit (which emitted asound and possessed a blinking light) was attached tothe sham needles at the knee. To facilitate blinding, weused screens in both treatment and sham groups that wereplaced below the abdomen to prevent participants fromactually observing the true or sham procedures at theknee area but to allow them to observe the procedurebeing performed in the abdomen area (21).

(2) In each session, at least 5 out of 10 predefined distantnonacupuncture points (ref) were needled bilaterally (atleast 10 needles) and superficially using fine needles (ie,minimal acupuncture). “De Qi” and manual stimulationof the needles were avoided. All acupuncturists receivedoral instructions, a videotape, and a brochure with de-tailed information on sham acupuncture (52).

(3) Conservative therapy involved 10 visits to practitionerswith consultation and a prescription for diclofenac, up to150 mg/d, or rofecoxib, 25 mg/d, as needed until week23 (53).

(4) Patients received the same treatment as in the standardgroup but in addition did stabilising exercises modifiedbecause of the pregnancy.(refs) The training programmestarted by emphasizing activation and control of localdeep lumbopelvic muscles. Training of more superfi-cial muscles in dynamic exercises to improve mobility,strength, and endurance capacity was gradually included.Patients received treatments individually for a total of sixhours during six weeks. They were told to integrate theexercises in daily activities and to exercise in short ses-sions on several occasions during the day (54).

Discussion

This revised STRICTA Statement has been designed to helpimprove the reporting of interventions in clinical trials ofacupuncture, with the intention that it will help authors ofacupuncture trials provide readers with a clear, accurate andtransparent account of their acupuncture protocols as wellas their control and/or comparator procedures. In additionto revising the STRICTA checklist, we have improved theexplanations of each item and provided examples of goodreporting. To enhance awareness, endorsement and adher-ence, the revised STRICTA Statement has been developed

as an extension to CONSORT. Authors of clinical trials ofacupuncture should use the STRICTA recommendations forthe acupuncture intervention (Item 5 in the CONSORT 2010Statement) in conjunction with the other 25 items of thechecklist in the main CONSORT guidelines (10,11). The ex-tension to CONSORT for nonpharmacological interventionsis also highly relevant to acupuncture trials (14,15). Thereare other extensions to CONSORT that may be relevant, de-pending on the type of trial design, including extensions forcluster trials, equivalence and noninferiority trials, and prag-matic trials, and the reporting of abstracts and of harms (eg,adverse events) associated with the intervention. The mostrecent versions of all CONSORT guidance documents canbe found on the CONSORT website (http://www.consort-statement.org).

A complete, accurate and transparent trial report facili-tates dissemination, interpretation, translation and replica-bility. There continues to be a need for better reporting gen-erally, as has been highlighted in a recent study of what ismissing from descriptions of treatments in trials and reviews(55). The authors found that elements of the intervention weremissing in half of the published articles that they reviewed,giving insufficient detail, for example, with practitioners un-able to use the treatments as described and researchers un-able to replicate studies. This finding is similar to that froma review of authors of acupuncture trials (12). Improved re-porting reduces reader ambiguity in interpretation, is likelyto increase credibility and application of the results by pro-viding better evidence on which to base decisions on patientcare.

Reporting guidelines do help improve the quality of re-porting randomized trials (56) although it is difficult toobserve their maximal benefit because too few journals en-dorse reporting guidelines (57) and fewer adhere to them(57). To maximize this potential, we encourage journalsto unambiguously endorse the revised STRICTA reportingguidelines. This can be most readily achieved by updatingjournal Instructions to Authors, thereby alerting prospectiveauthors. In addition, we encourage journals to implementstrategies to improve author adherence to reporting guide-lines. These efforts might also help peer reviewers and jour-nal editors in deliberating the merits of such trials.

Acknowledgements

This revision to STRICTA has benefited from contributionsfrom many people. Support and administrative help in man-aging the process of revising STRICTA has come fromAnne Burton, Ann Hopton, Suzanne Jenna, Stephanie Prady,and Tracy Stuardi. The Steering Group comprised DougAltman and David Moher (CONSORT), Hugh MacPhersonand Richard Hammerschlag (STRICTA), and Li Youping andWu Taixiang (Chinese Cochrane Centre).




The initial consultation with experts, which was pi-loted with the help of Mark Bovey, Val Hopwood andAdrian White, involved a panel consisting of: Joyce Anas-tasi, Stephen Birch, Joao Bosco, Claudia Citkovitz, RemyCoeytaux, Misha Cohen, Agatha Colbert, Helen Elden,Reginaldo de Carvalho Silva Filho, Alastair Forbes, Na-dine Foster, Joel Gagnier, Mark Goldby, Marita Gronlund,Richard Harris, Dominik Irnich, Helene Langevin, LaoLixing, Anna Lee, Lee Hyangsook, Lee Myeongsoo, LeeSanghoon, George Lewith, Klaus Linde, Liu Jianping, RyanMilley, Scott Mist, Dieter Melchart, Albrecht Molsberger, Vi-taly Napadow, Richard Niemtzow, Park Jongbae, MahmoodSaghaei, Koosnadi Saputra, Rosa Schnyer, Charles Shang,Karen Sherman, Shin Byung-Cheul, Caroline Smith, Elisa-bet Stener-Victorin, Kien Trinh, Jorge Vas, Andrew Vickers,Peter White, Claudia Witt, Hitoshi Yamashita, ChristopherZaslawski.

The STRICTA Revision Group, who participated in theconsensus-building workshop in Freiburg, comprised thesix members of the Steering Group and Stephen Birch,Isabelle Boutron, Mark Bovey, Fei Yutong, Joel Gagnier,Sally Hopewell, Val Hopwood, Susanne Jena, Klaus Linde,Liu Jianping, Kien Trinh, Emma Veitch, Adrian White, andHitoshi Yamashita.

References

1. MacPherson H, White A, Cummings M, Jobst K, Rose K,Niemtzow R. Standards for reporting interventions in controlledtrials of acupuncture: the STRICTA recommendations.Complement Therapies in Medicine 2001; 9: 246–9.

2. MacPherson H, White A, Cummings M, Jobst K, Rose K,Niemtzow R. Standards for reporting interventions in controlledtrials of acupuncture: the STRICTA statement. Acupuncture in

Medicine 2002; 20: 22–5.3. MacPherson H, White A, Cumming M, Jobst K, Rose K,

Niemtzow R. Standards for reporting interventions in controlledtrials of acupuncture: the STRICTA statement. Clinical

Acupuncture and Oriental Medicine 2002; 3: 6–9.4. MacPherson H, White A, Cumming M, Jobst K, Rose K,

Niemtzow R. Standards for reporting interventions in controlledtrials of acupuncture: the STRICTA statement. Medical

Acupuncture 2002; 13: 9–11.5. MacPherson H, White A, Cummings M, Jobst KA, Rose K,

Niemtzow R. Standards for Reporting Interventions inControlled Trials of Acupuncture: the STRICTArecommendations. Journal of Alternative and Complementary

Medicine 2002; 8: 85–9.6. Hyangsook L., Jongbae P., Jungchul S., Hijoon P., Hyejung L.

Standards for Reporting Interventions in Controlled Trials ofAcupuncture: the STRICTA recommendations. Journal of

Korean Society for Acupuncture and Moxibustion 2002; 19:134–54.

7. Liu J. Standards for Reporting Interventions in Controlled Trials

of Acupuncture: the STRICTA recommendations. Zhongguo

Zhong Xi Yi Jie He Za Zhi 2005; 25: 556–8.8. Liu X., Zhang M., Liu H. Improving the Quality of Reports in

controlled trials of acupuncture by using CONSORT andSTRICTA. Zhongguo Zhen Jiu 2003; 23: 699–701.

9. Kawakita K. (2010) Standards for Reporting Interventions inControlled Trials of Acupuncture: the STRICTArecommendations. http://jsam.jp/activity/checklist.html(Accessed 16 July 2010)

10. Schulz KF, Altman DG, Moher D., for the CONSORT Group.CONSORT 2010 Statement: updated guidelines for reportingparallel group randomised trials. British Medical Journal 2010;340: 698–792.

11. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010Explanation and Elaboration: updated guidelines for reportingparallel group randomised trials. British Medical Journal 2010;340: c869. doi: 10.1136/bmj.c869

12. Prady SL, MacPherson H. Assessing the utility of the standardsfor reporting trials of acupuncture (STRICTA): a survey ofauthors. Journal of Alternative and Complementary Medicine

2007; 13: 939–43.13. Prady SL, Richmond SJ, Morton VM, MacPherson H.

A systematic evaluation of the impact of STRICTA andCONSORT recommendations on quality of reporting foracupuncture trials. Public Library of Science ONE 2008; 3:e1577. doi: 10.1371/journal.pone.0001577

14. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P.Extending the CONSORT statement to randomized trials ofnonpharmacologic treatment: explanation and elaboration.Annals of Internal Medicine 2008; 148: 295–309.

15. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P.Methods and processes of the CONSORT Group: example of anextension for trials assessing nonpharmacologic treatments.Annals of Internal Medicine 2008; 148: W60–6.

16. Zwarenstein M, Treweek S, Gagnier JJ, et al. Improving thereporting of pragmatic trials: an extension of the CONSORTstatement. British Medical Journal 2008; 337: a2390.doi:10.1136/bmj.a2390

17. MacPherson H, Altman DG. Improving the quality of reportingacupuncture interventions: describing the collaboration betweenSTRICTA, CONSORT and the Chinese Cochrane Centre.Journal of Evidence-Based Medicine 2009; 2: 1–4.

18. Acupuncture Trialists Collaboration. (2010) Home page.http://www.acupuncturetrialistscollaboration.org/ (Accessed 16July 2010)

19. Society for Acupuncture Research (2010) Home page.http://www.acupunctureresearch.org (Accessed 16 July 2010)

20. Birch S, Felt R (1999) Understanding Acupuncture. Edinburgh:Churchill Livingstone.

21. Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM,Hochberg MC. Effectiveness of acupuncture as adjunctivetherapy in osteoarthritis of the knee: a randomized, controlledtrial. Annals of International Medicine 2004; 141: 901–10.

22. Ahn AC, Bennani T, Freeman R, Hamdy O, Kaptchuk TJ. Twostyles of acupuncture for treating painful diabetic neuropathy—a



pilot randomised control trial. Acupuncture in Medicine 2007;25: 11–17.

23. Reynolds JA, Bland JM, MacPherson H. Acupuncture forirritable bowel syndrome an exploratory randomised controlledtrial. Acupuncture in Medicine 2008; 26: 8–16.

24. Irnich D, Behrens N, Gleditsch JM, et al. Immediate effects ofdry needling and acupuncture at distant points in chronic neckpain: results of a randomized, double-blind, sham-controlledcrossover trial. Pain 2002; 99: 83–9.

25. Wayne PM, Kerr CE, Schnyer RN, Legedza ATR,Savetsky-German J, et al. Japanese-style acupuncture forendometriosis-related pelvic pain in adolescents and youngwomen: results of a randomized sham-controlled trial. Journal

of Pediatric and Adolescent Gynecology 2008; 21: 247–57.26. White P, Lewith G, Prescott P, Conway J. Acupuncture versus

placebo for the treatment of chronic mechanical neck pain: arandomized, controlled trial. Annals of Internal Medicine 2004;141: 911–9.

27. Brinkhaus B, Witt CM, Jena S, et al. Interventions and physiciancharacteristics in a randomized multicenter trial of acupuncturein patients with low-back pain. Journal of Alternative and

Complementary Medicine 2006; 12: 649–57.28. MacPherson H. Pragmatic clinical trials. Complementary

Therapies in Medicine 2004; 12: 136–40.29. Phillips KD, Skelton WD, Hand GA. Effect of acupuncture

administered in a group setting on pain and subjective peripheralneuropathy in persons with human immunodeficiency virusdisease. Journal of Alternative and Complementary Medicine

2004; 10: 449–55.30. Diener HC, Kronfeld K, Boewing G, et al. Efficacy of

acupuncture for the prophylaxis of migraine: a multicentrerandomised controlled clinical trial. Lancet Neurology 2006; 5:310–6.

31. Foster NE, Thomas E, Barlas P, et al. Acupuncture as an adjunctto exercise based physiotherapy for osteoarthritis of the knee:randomised controlled trial. British Medical Journal 2007; 335:436–40.

32. MacPherson H, Thorpe L, Thomas K, Campbell M.Acupuncture for low back pain: traditional diagnosis andtreatment of 148 patients in a clinical trial. Complementary

Therapies in Medicine 2004; 12: 38–44.33. Itoh K, Hirota S, Katsumi Y, Ochi H, Kitakoji H. Trigger point

acupuncture for treatment of knee osteoarthritis—a preliminaryRCT for a pragmatic trial. Acupuncture in Medicine 2008; 26:17–26.

34. Lao L, Bergman S, Hamilton GR, Langenberg P, Berman B.Evaluation of acupuncture for pain control after oral surgery: aplacebo-controlled trial. Archives of Otolaryngology-Head and

Neck Surgery 1999; 125: 567–72.35. World Health Organisation (1991) A Proposed Standard

International Acupuncture Nomenclature: Report of a WHOScientific Group. http://apps.who.int/medicinedocs/en/d/Jh2947e/ (accessed 31 December 2009).

36. Streitberger K, Steppan J, Mater C, Hill H, Backs J, Plaschke K.Effects of verum acupuncture compared to placebo acupuncture

on quantitative EEG and heart rate variability in healthyvolunteers. Journal of Alternative and Complementary Medicine

2008; 14: 505–13.37. Leung AY, Park J, Schulteis G, Duann JR, Yaksh T. The

electrophysiology of de qi sensations. Journal of Alternative and

Complementary Medicine 2006; 12: 743–50.38. Jubb RW, Tukmachi ES, Jones PW, Dempsey E, Waterhouse L,

Brailsford S. A blinded randomised trial of acupuncture (manualand electroacupuncture) compared with a non-penetrating shamfor the symptoms of osteoarthritis of the knee. Acupuncture

Medicine 2008; 26: 69–78.39. Schnyer RN, Iuliano D, Kay J, Shields M, Wayne P.

Development of protocols for randomized sham-controlled trialsof complex treatment interventions: Japanese acupuncture forendometriosis-related pelvic pain. Journal of Alternative and

Complementary Medicine 2008; 14: 515–22.40. Gibson D, Bruton A, Lewith GT, Mullee M. Effects of

acupuncture as a treatment for hyperventilation syndrome: apilot, randomized crossover trial. Journal of Alternative and

Complementary Medicine 2007; 13: 39–46.41. Hay E, Barlas P, Foster N, Hill J, Thomas E, Young J. Is

acupuncture a useful adjunct to physiotherapy for older adultswith knee pain?: the “Acupuncture, Physiotherapy andExercise” (APEX) study. BMC Musculoskeletal Disorders 2004;5: 31–42.

42. Hesse J, Mogelvang B, Simonsen H. Acupuncture versusmetoprolol in migraine prophylaxis: a randomized trial of triggerpoint inactivation. Journal of Internal Medicine 1994; 235:451–6.

43. Assefi NP, Sherman KJ, Jacobsen C, Goldberg J, Smith WR,Buchwald D. A randomized clinical trial of acupuncture

compared with sham acupuncture in fibromyalgia. Annals of

Internal Medicine 2005; 143: 10–9.44. Hansson Y, Carlsson C, Olsson E. Intramuscular and periosteal

acupuncture for anxiety and sleep quality in patients withchronic musculoskeletal pain—an evaluator blind, controlledstudy. Acupuncture Medicine 2007; 25: 148–57.

45. Vickers AJ, Feinstein MB, Deng GE, Cassileth BR.Acupuncture for dyspnea in advanced cancer: a randomized,placebo-controlled pilot trial [ISRCTN89462491]. BMC Palliat

Care 2005; 4: 5–12.46. Brinkhaus B, Hummelsberger J, Kohnen R, et al. Acupuncture

and Chinese herbal medicine in the treatment of patients withseasonal allergic rhinitis: a randomized-controlled clinical trial.Allergy 2004; 59: 953–60.

47. Di Blasi Z, Kleijnen J. Context effects. Powerful therapies ormethodological bias? Evaluation and Health Professions 2003;26: 166–79.

48. Forbes A, Jackson S, Walter C, Quraishi S, Jacyna M, Pitcher M.Acupuncture for irritable bowel syndrome: a blindedplacebo-controlled trial. World Journal of Gastroenterology

2005; 11: 4040–4.49. Devereaux PJ, Bhandari M, Clarke M, et al. Need for expertise

based randomised controlled trials. British Medical Journal

2005; 330: 88–92.




50. Skilnand E, Fossen D, Heiberg E. Acupuncture in themanagement of pain in labor. Acta Obstetricia et Gynecologica

Scandinavica 2002; 81: 943–8.51. Kleinhenz J, Streitberger K, Windeler J, Gussbacher A, Mavridis

G, Martin E. Randomised clinical trial comparing the effects ofacupuncture and a newly designed placebo needle in rotator cufftendinitis. Pain 1999; 83: 235–41.

52. Linde K, Streng A, Jurgens S, et al. Acupuncture for patientswith migraine: a randomized controlled trial. Journal of the

American Medical Association 2005; 293: 2118–25.53. Scharf H, Mansmann U, Streitberger K, et al. Acupuncture and

knee osteoarthritis. Annals of Internal Medicine 2006; 145:12–20.

54. Elden H, Ladfors L, Olsen MF, Ostgaard H-C, Hagberg H.Effects of acupuncture and stabilising exercises as adjunct tostandard treatment in pregnant women with pelvic girdle pain:randomised single blind controlled trial. British Medical Journal

2005; 330: 761–4.55. Glasziou P, Meats E, Heneghan C, Shepperd S. What is missing

from descriptions of treatment in trials and reviews? British

Medical Journal 2008; 336: 1472–4.56. Plint AC, Moher D, Morrison A, et al. Does the CONSORT

checklist improve the quality of reports of randomised controlledtrials? A systematic review. Medical Journal of Australia 2006;185: 263–7.

57. Hopewell S, Altman DG, Moher D, Schulz KF. Endorsement ofthe CONSORT Statement by high impact factor medicaljournals: a survey of journal editors and journal ‘Instructions toAuthors’. Trials 2008; 9: 20–6.

58. Hopewell S, Clarke M, Moher D, et al. CONSORT for reportingrandomised trials in journal and conference abstracts. Lancet

2008; 371: 281–3.59. Hopewell S, Clarke M, Moher D, et al. CONSORT for reporting

randomized controlled trials in journal and conference abstracts:explanation and elaboration. Public Library of Science Medicine

2008; 5: e20. doi: 10.1371/journal.pmed.005002060. Ioannidis JP, Evans SJ, Gotzsche PC, et al. Better reporting of

harms in randomized trials: an extension of the CONSORTstatement. Annals of Internal Medicine 2004; 141: 781–8.

61. Campbell MK, Elbourne DR, Altman DG. CONSORTstatement: extension to cluster randomised trials. British

Medical Journal 2004; 328: 702–8.62. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ.

Reporting of noninferiority and equivalence randomized trials:an extension of the CONSORT statement. Journal of the

American Medical Association 2006; 295: 1152–60.63. Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier

C. Reporting randomized, controlled trials of herbalinterventions: an elaborated CONSORT statement. Annals of

Internal Medicine 2006; 144: 364–7.


Date post:	30-Sep-2016
Category:	Documents
Upload:	hugh-macpherson
View:	212 times
Download:	0 times

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending...

Documents