Beruflich Dokumente
Kultur Dokumente
METHODOLOGY
Correspondence
Abstract
Hugh MacPherson, Department of Health
Sciences, University of York, York, United The STandards for Reporting Interventions in Clinical Trials of Acupuncture
Kingdom. (STRICTA) were published in five journals in 2001 and 2002. These guidelines,
Tel: +44-1904-321394
in the form of a checklist and explanations for use by authors and journal ed-
Fax: +44-1904-321388
itors, were designed to improve reporting of acupuncture trials, particularly the
Email: hm18@york.ac.uk
interventions, thereby facilitating their interpretation and replication. Subsequent
Membership of the STRICTA Revision Group reviews of the application and impact of STRICTA have highlighted the value of
is provided in the Acknowledgements. STRICTA as well as scope for improvements and revision. To manage the revision
process a collaboration between the STRICTA Group, the CONSORT Group, and
Reproduced by permission of the Authors. the Chinese Cochrane Centre was developed in 2008. An expert panel with 47
participants was convened that provided electronic feedback on a revised draft of
the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 par-
Received 14 June 2010; accepted 14
ticipants further revised the STRICTA checklist and planned dissemination. The
June 2010.
new STRICTA checklist, which is an official extension of CONSORT, includes
doi: 10.1111/j.1756-5391.2010.01086.x six items and 17 sub-items. These set out reporting guidelines for the acupuncture
rationale, the details of needling, the treatment regimen, other components of treat-
ment, the practitioner background, and the control or comparator interventions. In
addition, and as part of this revision process, the explanations for each item have
been elaborated, and examples of good reporting for each item are provided. In
addition, the word “controlled” in STRICTA is replaced by “clinical,” to indicate
that STRICTA is applicable to a broad range of clinical evaluation designs, includ-
ing uncontrolled outcome studies and case reports. It is intended that the revised
STRICTA, in conjunction with both the main CONSORT Statement and extension
for nonpharmacologic treatment, will raise the quality of reporting of clinical trials
of acupuncture.
comprised a checklist that expanded the generic content of turists from a variety of backgrounds, including physician
Item 5 of the CONSORT statement (10,11), which relates to and nonphysician. All attendees received collated feedback
the reporting of the intervention. from the 47 experts, along with a draft revised STRICTA
A survey of authors of clinical trials and systematic re- checklist for consideration.
views was subsequently conducted to determine the useful- The workshop comprised presentations about the history
ness of STRICTA in helping them write their reports (12). In of STRICTA, CONSORT, and the then new CONSORT non-
addition, a survey of 90 acupuncture trials was undertaken pharmacological treatments extension (14,15). The results
to assess whether use of the STRICTA checklist was asso- of two investigations into the utility and acceptability of
ciated with improved reporting over time (13). The results STRICTA (12,13), and the subsequent consultation with the
of these initiatives led to conclusions that most STRICTA 47 experts, were also presented. A general discussion and
items were found to be necessary and easy-to-use, though agreement on generic issues relating to STRICTA were fol-
some were seen as poorly reported, ambiguous or possi- lowed by a discussion of each nominated checklist item. The
bly redundant, and a number of suggestions were made aim was to agree, where possible, on the content of the up-
for additional items. A revision of STRICTA was therefore dated draft checklist as well as to develop a revised set of
proposed. explanations for each included item.
Meanwhile, extensions to CONSORT have been devel- Subsequent to the workshop, a small writing group edited
oped to cover the reporting of nonpharmacological treat- drafts of the revised STRICTA checklist, identifying for each
ments (14,15) and pragmatic trials (16). Since there are item one or more exemplars of good reporting, and devel-
acupuncture specific aspects to reporting not covered by these oped text explaining the rationale and discussing relevant
extensions, it was decided that STRICTA should be revised evidence. Taking into account further feedback from those
in a manner congruent with CONSORT and its extensions attending the Freiburg workshop, the writing group finalized
for nonpharmacological treatments and pragmatic trials. the STRICTA checklist, the explanations and the examples
The combination of these developments led to an agree- of good reporting.
ment between the CONSORT Group and the STRICTA
Group, in collaboration with the Chinese Cochrane Cen-
Results
tre and the Chinese Centre for Evidence-based Medicine, to
revise STRICTA as a formal extension to CONSORT. The [Note: In the Examples that follow, the embedded terms (ref)
revision processes have been described in more detail else- and (refs) refer to sources that are reported in the original
where (17). This paper describes the outcome in terms of a published studies, but the details of these sources are not
new checklist, updated explanations, and published examples provided in this article for reasons of brevity.]
of good reporting. There was agreement that STRICTA should continue to
function as a stand-alone guideline for reporting acupuncture
studies, and be an official extension of CONSORT for report-
Methods
ing randomized controlled trials. There was also consensus
In the summer of 2008, a group of 47 experts from the orig- on a minor change of name, in that the word “controlled”
inal STRICTA Group, the CONSORT Group, the World in STRICTA should be replaced by “clinical,” to indicate
Federation of Acupuncture and Moxibustion Societies, the that it was applicable for reporting a broad range of clinical
Acupuncture Trialists’ Collaboration (18), the Society for evaluation designs, including uncontrolled outcome studies
Acupuncture Research (19), and clinical trial authors were and case reports. The group agreed that the rationale behind
surveyed (12). The experts were from 15 countries, 41 had reporting should be to provide the information needed to al-
academic positions, 31 were acupuncturists, 18 were in- low replication of a study, reduce ambiguity, and enhance
volved with journals, such as board members, 15 were physi- transparency. The group recognized that acupuncture trials
cians, and 11 had been involved previously in developing inevitably differ in the degree of individualization of care that
reporting guidelines. These experts were consulted in re- is permitted, and agreed that the reporting guideline should
gard to a draft of revised STRICTA items that had evolved acknowledge this and be applicable across the whole range of
from previous research (12,13). Feedback was collated and designs. The group also suggested that the revised STRICTA
forwarded (with permission) to those invited to a consen- statement, when published, should be presented as embed-
sus development workshop, the next phase of the revision ded within the two-group parallel trial CONSORT checklist
process. (10) and its nonpharmacological treatment extension check-
Twenty-one individuals attended a workshop in Freiburg, list (14).
Germany, in October 2008. The attendees included experts The revised STRICTA checklist comprises six items bro-
in epidemiology, trial methodology, statistics, and medical ken out into 17 sub-items (Table 1). Table 2 presents how
journal editing. Just over half the participants were acupunc- the revised STRICTA checklist fits within the CONSORT
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 of (a) Details of other interventions administered to the acupuncture group (eg, moxibustion, cupping, herbs,
treatment exercises, lifestyle advice)
(b) Setting and context of treatment, including instructions to practitioners, and information and explanations to
patients
5. Practitioner Description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice,
background other relevant experience)
6. Control or comparator (a) Rationale for the control or comparator in the context of the research question, with sources that justify this
interventions choice
(b) Precise description of the control or comparator. If sham acupuncture or any other type of acupuncture-like
control 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 to
replace CONSORT 2010’s item 5 when reporting an acupuncture trial.
Table 2 CONSORT 2010 checklist with the Nonpharmacological Trials Extension to CONSORT (with STRICTA 2010 extending CONSORT Item
5 for acupuncture trials).
Table 2 Continued
Results
Participant flow (A 13a For each group, the numbers of participants who The number of care providers or centers
diagram is strongly were randomly assigned, received intended performing the intervention in each group and
recommended) treatment, and were analyzed for the primary the number of patients treated by each care
outcome provider or in each center.
13b For each group, losses and exclusions after
randomization, together with reasons
Implementation of Details of the experimental treatment and
intervention comparator as they were implemented.
Recruitment 14a Dates defining the periods of recruitment and
follow up
14b Why the trial ended or was stopped
Baseline data 15 A table showing baseline demographic and clinical When applicable, a description of care providers
characteristics for each group (case volume, qualification, expertise, etc.) and
centers (volume) in each group.
Numbers analyzed 16 For each group, number of participants
(denominator) included in each analysis and
whether the analysis was by original assigned
groups
Outcomes and 17a For each primary and secondary outcome, results
estimation for each group, and the estimated effect size
and its precision (eg, 95% confidence interval)
17b For binary outcomes, presentation of both
absolute and relative effect sizes is
recommended
Ancillary analyses 18 Results of any other analyses performed, including
subgroup analyses and adjusted analyses,
distinguishing pre-specified from exploratory
Harms 19 All important harms or unintended effects in each
group; for specific guidance see CONSORT for
Harms (60)
Discussion
Limitations 20 Trial limitations, addressing sources of potential
bias, imprecision, and, if relevant, multiplicity of
analyses
Generalizability 21 Generalizability (external validity, applicability) of Generalizability (external validity) of the trial
the trial findings findings according to the intervention,
comparators, patients and care providers and
centers involved in the trial.
Interpretation 22 Interpretation consistent with results, balancing In addition, take into account the choice of the
benefits and harms, and considering other comparator, lack of or partial blinding, unequal
relevant evidence expertise of care providers or centers in each
group.
Other information
Registration 23 Registration number and name of trial registry
Protocol 24 Where the full trial protocol can be accessed, if
available
Funding 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 important
clarifications 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 and
for up-to-date references relevant to this checklist, see http://www.consort-statement.org.
Examples (3) Shallow and light needling stimulation (1–2 mm) using
fine needles (0.18–0.16 mm) inserted with the aid of
(1) We based the acupuncture point selections on TCM
insertion tubes was emphasized. Points were needled at
meridian theory to treat knee joint pain, known as the
a 10◦ –20◦ angle with a two-hand needling technique,
“Bi” syndrome. These points consisted of five local
generally in the direction of the flow of the channel (39).
points (Yanglinquan [gall bladder meridian point 34],
Yinlinquan [spleen meridian point 9], Zhusanli [stomach
meridian point 36], Dubi [stomach meridian point 35], Item 2d
and extra point Xiyan) and four distal points (Kunlun
Responses sought (eg, de qi or muscle twitch response).
[urinary-bladder, meridian point 60], Xuanzhong [gall
bladder meridian point 39], Sanyinjiao [spleen meridian
point 6], and Taixi [kidney meridian point 3]) on meridi- Explanation
ans that traverse the area of pain (refs). The same points If the study protocol requires that specific responses to
were treated for each affected leg. If both knees were needling be elicited, for example the de qi sensation in tradi-
affected, nine needles were inserted in each leg (21). tional Chinese acupuncture, the muscle twitch in trigger point
(2) The verum acupuncture (VA) group received acupunc- treatment or muscle contraction in electro-acupuncture, these
ture with a 0.25 × 40-mm stainless steel needle (Asia elicited responses should be reported. Where relevant, the au-
Med, Munich, Germany) at LI4, which is situated be- thors should differentiate between the responses required in
tween the first two metacarpal bones on the dorsal side of the protocol and those actually obtained (which should be
both hands at the top of the muscle belly (figure provided) reported in the Results section).
(36).
(3) The most frequently treated local points were Bl 23, Bl Examples
25, Gb 30, DU 4, Bl 26, and the extra point Huatuoji-
aji (table provided). . . . . . . The most frequently treated (1) The trigger point (TRP) group received treatment at trig-
distant points were Bl 40, Kid 3, Gb 34, Bl 60, SI 3, ger points. The correct application of the technique re-
and DU 20. In most cases, 8 to 12 local points and 4 quires experience in palpation and localization of taut
to 6 distant points were used. Physicians used additional muscle bands and myofascial trigger points. Precise
acupuncture points in 565 of the treatment sessions. The needling of myofascial trigger points provokes a brief
most frequently used additional local points were Li 4, contraction of the muscle fibres. This local twitch re-
St 40, Bl 17, Sp 6, and St 36 (27). sponse must be elicited for successful therapy but it may
be painful and post-treatment soreness is frequent (33).
(2) In contrast with TCM style acupuncture, we did not em-
Item 2c ploy vigorous manipulation in order to elicit a strong de
qi sensation (defined as a feeling of heaviness around the
Depth of insertion, based on a specified unit of measurement, acupuncture point).(ref) Practitioners focused instead on
or on a particular tissue level. feeling the response to stimulation as an “echo” sensation
experienced on the receiving hand, while the active hand
Explanation performed the actual needling. Attention was placed on
reactivity or change in diagnostic areas, especially the
The depth of insertion should be expressed using the Chinese pulse and abdomen. By carefully assessing changes in
measurement of the cun; in terms of anatomical depth, for palpatory findings, the treatment was adjusted continu-
example, of subcutaneous tissue, fascia, muscle or perios- ously based on the patient’s response. Before needling,
teum; or in millimetres. For some trials, the protocol might the “live” points were identified by palpation, that is, sub-
specify the angle and direction of insertion along with depth tle changes at the skin level, or upon touch or pressure,
of insertion, in which case these should also be reported. for that particular patient (39).
Examples Item 2e
(1) All needle placements were performed by an experienced Needle stimulation (eg, manual or electrical).
acupuncturist at a premarked depth of 4 mm from the tip
of the needle (37).
Explanation
(2) The depth of needle insertion varied with thickness of
the skin and subcutaneous fatty tissues at the site of the Needle stimulation techniques, where used, should be clearly
acupuncture points; it was usually 1 to 1.5 cm (38). described for all points. For manual stimulation, such
techniques include lifting, thrusting or rotating the needle (4) The patients in group A were dry needled for a few sec-
to manipulate the de qi sensation. For electrical stimula- onds. For trigger point inactivation by dry needling. . . it
tion, the current, amplitude, and frequency settings should is especially important not to apply too strong a stimu-
be recorded. lus because this may produce a flare-up of the patient’s
symptoms (42).
Examples
(1) This mode of (manual) stimulation was provided via the Item 2g
acupuncture needles, which were placed in the premarked
Needle type (diameter, length, and manufacturer or
depth at the marked sites. The needle was rotated by
material).
an experienced acupuncturist with the index finger and
thumb in an alternating clockwise and counterclockwise
fashion at the rate of three to five rotations per second Explanation
(37). Details should be given of the types of needles used, including
(2) Electrical stimulation was given to the anterior part of the diameter and length as well as the manufacturer and/or the
the knee for 10 minutes and then 10 minutes for the material. This information is of importance since the effect
posterior part using a battery-operated, four-channel, “AS of different metals or needle sizes on the body is not known.
Super 4” Electrostimulator (RDG Medical, Surrey, UK) For trials using a variety of different types of needles, the
which generated low frequency, square-wave (2–10 Hz) ranges of diameters and lengths as well as types of material
pulses of 1 millisecond duration for 10 minutes.(ref) In should be reported.
both groups, the apparatus was attached to needles at the
two Xiyan points, SP9 and GB34, and BL40 and BL57.
Examples
Electrical stimulation was delivered at 6Hz at a constant
current. Voltage was set at a level just above the pain (1) Seirin 36 gauge 2.5 inches long unused sterile L-type
threshold (38). needles were used for the study (37).
(2) The VA (verum acupuncture) group received acupunc-
ture with a 0.25 × 40-mm stainless steel needle (Asia
Item 2f
Med, Munich, Germany) at LI4 (36).
Needle retention time.
(≥19 of 24) of acupuncture sessions to have completed a provided additionally to both groups, which should be fully
full course of treatment (43). reported as described in STRICTA Item (6b) further.
Examples
Item 3b
(1) In addition to needling, moxibustion or thermal stimu-
Frequency and duration of treatment sessions. lation of the acupoints was used forming very fine wool
of mugwort (Artemisa vulgaris) into minute, thread-size
Explanation punks (okyū) and placing them on a thin layer of an herbal
cream (shiunko). The moxa was lit with an incense stick
The frequency and duration of sessions should be docu- and the process was repeated several times until warmth
mented, with mean and range to be reported where there was felt by the patient (39).
is variation across patients. Any variation in frequency of (2) Following application of the studs, patients were in-
treatment (eg, if subjects are to be treated twice weekly in structed to apply pressure to the stud by making small
the first two weeks then once a week for the next six weeks) circular movements with the fingers of the opposite hand,
should be clearly reported. 2–3 cycles per second for 1–2 minutes per point. As is
typical for self-administered acupressure, patients were
Examples encouraged to apply acupressure this way on waking, in
the early afternoon and during any exacerbation of symp-
(1) Acupuncture was administered a maximum of eight
toms. Initial instruction was provided verbally, at which
times, twice during each of the first three weeks and once
time patients were asked to confirm their understanding
during each of the following two weeks, for 30 minutes
by demonstrating the procedure. Patients also were given
at each session. One month after this series of treatments
easy-to-read written materials describing the acupressure
had been completed and evaluated, the patients were of-
procedure (45).
fered a maximum of two follow-up treatments of the same
(3) Chinese herbal medicine was to be taken three times per
kind, one week apart (44).
day over a period of six weeks and parallel to acupunc-
ture treatment. . . All herbs used in the present study were
imported from China by a single TCM herbal medicine
STRICTA Item 4: Other Components
import company (Sinores, Lueneberg, Germany). . . All
of Treatment herbs were prepared in dried, minced pieces and then
Item 4a sealed in generic paper sachets by a pharmacist in or-
der to render the herbal formulation nonidentifiable for
Details of other interventions administered to the acupunc-
patients. . . In addition to the basic formula, every patient
ture group (eg, moxibustion, cupping, herbs, exercises,
received a second additional formula tailored to his or
lifestyle advice).
her individual TCM diagnosis (46).
Explanation
Item 4b
Additional components of treatment refer to the auxiliary
Setting and context of treatment, including instructions
techniques, prescribed self-treatment and lifestyle advice
to practitioners and information and explanations to
provided by the practitioner. All additional components,
patients.
whether carried out by the practitioner or patient and whether
integral or adjunctive to the acupuncture needling, should
be described clearly. For acupuncture related interventions, Explanation
such as moxibustion or cupping, detail should be provided The setting and context of treatment can also provide im-
equivalent to that recommended for acupuncture needling. portant additional components to treatment (47). Context in-
If the protocol specifies the options of prescribed self-help cludes instructions to practitioners that might modify their
treatments such as qigong or muscle stretching exercises, normal practice, for example, prescribing or proscribing ex-
and/or lifestyle advice such as dietary changes based on planations to patients about their diagnosis. For patients,
acupuncture-related diagnostic criteria, then these too must the context includes the information they have been given
be reported. The frequency with which the advice was given, about the trial that might be expected to modify outcomes.
and participants’ compliance with this advice, should be re- Therefore, the information that the patient receives regard-
ported. “Other components of treatment” should be distin- ing the treatment and control intervention should be re-
guished from “co-interventions,” that is interventions that are ported, including any relevant wording on consent forms and
information leaflets designed to influence beliefs or expec- pecially since the actual level of reporting has historically
tations. For example, describing a sham acupuncture control been poor (13). In trials where different acupuncturists pro-
as “a type of acupuncture” may have a different effect on vide treatment to different treatment arms, the background
outcome than saying it is “not acupuncture, but will involve of both groups should be reported. The eligibility criteria
a similar experience to acupuncture.” for acupuncturists should be explained, as these will influ-
ence generalisability of the trial results. Where there are
Examples known to be potential variations between practitioners, se-
lecting a random sample of practitioners will reduce exper-
(1) The first acupuncturist was the “diagnosing acupunctur- tise bias and help improve the applicability of the results
ist” (DA), whom the patient saw for the initial consul- (49).
tation, and before and after each treatment. A full case
history was taken by the DA, together with tongue and
Examples
pulse examination, to arrive at an individual diagnosis
in accordance with the principles of TCM, with an ad- (1) Physicians had a median of 350 hours (range 140–2508
ditional lesser emphasis on Five Element Acupuncture hours) of acupuncture training before participating in the
(refs). Although all patients in the study had IBS, this cor- trial; 33 (73%) had the B-Diploma. Seventeen (17; 38%)
responded to a wide range of TCM patterns, making in- trial physicians taught acupuncture in accredited post-
dividual diagnosis essential. Dietary and lifestyle advice graduate courses. The physicians had used acupuncture
(important in treatment according to TCM principles) in their practices for an average of 11 years (median 10,
was given to all patients by the DA, who then selected range 0–25) and had treated 346 patients (range 22–1200)
acupuncture points. The second “treating acupuncturist” with acupuncture in the year before the trial. Forty-one
(TA) opened the randomization envelope, and for the du- physicians (92%) indicated that they frequently or always
ration of the study remained the only individual aware of make a Chinese syndrome diagnosis before starting treat-
treatment allocation. The TA carried out the treatment— ment (27).
either according to instructions issued by the DA or (2) Eight US-trained and licensed acupuncturists with a
using sham points, depending on the randomization median of 10 years of experience (range 4–18 years)
(48). provided study treatments in their private offices. One
(2) Patients were informed about acupuncture and minimal investigator trained the acupuncturists in the study pro-
acupuncture in the study as follows: “In this study, dif- cedures to increase their comfort with delivering all four
ferent types of acupuncture will be compared. One type treatments and monitored compliance with the protocol
is similar to the acupuncture treatment used in China. throughout the study (43).
The other type does not follow these principles, but has (3) Of the 11 midwives participating in the study, six had
also been associated with positive outcomes in clinical been taught acupuncture for midwives at the Norwe-
studies” (27). gian School of Acupuncture/NFKA. These six gave real
and false acupuncture, whereas the others, who had been
trained in acupuncture by the six, were allowed only to
STRICTA Item 5: Practitioner give false acupuncture (50).
Background
Item 5 STRICTA Item 6: Control and
Description of participating acupuncturists (qualification or Comparator Interventions
professional affiliation, years in acupuncture practice, other
Item 6a
relevant experience).
Rationale for the control or comparator in the context of the
Explanation research question, with sources that justify the choice(s).
is sometimes used for a group that receives no intervention, current trial was designed so that all participants receive
the term “comparator” may be more appropriate for an active a package of care that includes education, advice, and
intervention, such as physiotherapy, for which the intended exercise (41).
action of the comparator is expected to be therapeutic. If us- (3) For this study a special “placebo needle” was designed
ing an acupuncture-like control in a participant-blinded trial by Streitberger. The needle body is not fixed inside the
then one of the following terms: active acupuncture control; copper handle. Its tip is blunt and when it touches the
penetrating needle control; or nonpenetrating sham needling skin, a small pricking sensation is felt by the patient,
control might be helpful descriptors. Control procedures in- simulating the puncture of the skin. The handle of the
volving invasive or noninvasive sham needling techniques needle moves over the needle, the needle is shortened.
may be therapeutically active, evoking neurophysiological Patients “see” the needle moving inside their body. . .
and localized immune and circulatory responses. The ex- This needle was tested in 60 volunteers and proved to be
tent that sham acupuncture needling, whether penetrating or sufficiently credible to be used in our clinical trial as a
not, might elicit acupuncture-specific physiological mech- control(ref) (51).
anisms is not known, and is in part a consequence of our
lack of knowledge of the mechanism(s) of true acupuncture.
There are also variations in assumptions about the precision Item 6b
required for point location, as for some clinicians and in- Precise description of the control or comparator. If sham
vestigators, acupuncture points are considered as areas of acupuncture or any other type of acupuncture-like control is
reactivity rather than points of action. Such assumptions used, provide details as for Items 1 to 3 above.
have a bearing on the integrity of the sham as an appro-
priate control. Some non-needling control procedures can
be assumed to be physiologically inert, such as an inac- Explanation
tivated transcutaneous electrical nerve stimulation (TENS) A precise description of the components of the control or
machine; however, these procedures may not have the same comparator should be presented. If the control treatment is
total psychophysiological credibility as acupuncture, thereby an acupuncture-like intervention, such as a form of sham
compromising the interpretation of the results. Sources that acupuncture, then it should be specified whether the sham
led to the choice of control, such as literature or expert is invasive (penetrating the skin) or noninvasive (nonpene-
opinion, should also be reported and referenced. The au- trating). The theoretical basis, needling details and regimen
thor should reference prior work that supports the use of of an acupuncture-like control need to be reported in the
the selected comparator, such as from the conclusion of a same way as is set out in STRICTA Items 1 to 3 above.
systematic review or from another randomised controlled The lack of a world-wide consensus on the location and
trial. size of acupuncture points reinforces the importance of ac-
curate documentation of the sham points actually used, their
Examples precise location and the method used to locate them. If usual
care or another active treatment is the comparator, all the
(1) “Sham” acupuncture points were chosen from three dif- components should be reported in full detail. This will en-
ferent areas on the body (the anterior thigh distally, able readers to compare usual care as provided in the trial
the posterior thigh, and the lateral aspect of the lower with what is usually provided to participants in another set-
back), which do not correspond to recognized acupunc- ting. Where usual care is also provided to those receiving
ture points and are deemed to have no therapeutic value acupuncture, these data will also allow readers to compare
(48). the intensity of usual care in the comparator arm with that of
(2) International guidelines suggest that the best package of the experimental arm. If it is a waitlist arm, then the period
care for this patient group is one that includes patient of waiting needs to be specified. While precise description
education, advice and exercise (ref). . . . . Randomised of the control or comparator is fairly straightforward in prin-
clinical trials consistently show the benefit of exercise ciple, the more complex the components, the more care is
for knee pain in older adults (refs). Recent studies also required to specify them precisely.
highlight the need to provide adequate instruction, feed-
back and practice in order to ensure that the key muscle
Examples
groups around the knee, such as the quadriceps, are acti-
vated (ref). The European League Against Rheumatism (1) Acupuncturists inserted 2 needles into the sham points
(EULAR) recommendations have recently been updated in the abdominal area, approximately 3 cm lateral to and
and in particular, advocate exercise for knee pain related slightly above the umbilicus bilaterally, and then immedi-
to osteoarthritis (ref). In line with this evidence base, the ately applied 2 pieces of adhesive tape next to the needles.
In addition, they tapped a mock plastic needle guiding as an extension to CONSORT. Authors of clinical trials of
tube on the surface of each of the 9 true points in the acupuncture should use the STRICTA recommendations for
leg to produce some discernible sensation and then im- the acupuncture intervention (Item 5 in the CONSORT 2010
mediately applied a needle with a piece of adhesive tape Statement) in conjunction with the other 25 items of the
to the dermal surface, without needle insertion, of each checklist in the main CONSORT guidelines (10,11). The ex-
point for a total of 20 minutes. The sham acupuncture tension to CONSORT for nonpharmacological interventions
procedure was given on the same schedule as the exper- is also highly relevant to acupuncture trials (14,15). There
imental group and used the same active needle place- are other extensions to CONSORT that may be relevant, de-
ments, except actual insertion did not occur at these nine pending on the type of trial design, including extensions for
points. Although electrical stimulation did not occur, a cluster trials, equivalence and noninferiority trials, and prag-
mock transelectrical stimulation unit (which emitted a matic trials, and the reporting of abstracts and of harms (eg,
sound and possessed a blinking light) was attached to adverse events) associated with the intervention. The most
the sham needles at the knee. To facilitate blinding, we recent versions of all CONSORT guidance documents can
used screens in both treatment and sham groups that were be found on the CONSORT website (http://www.consort-
placed below the abdomen to prevent participants from statement.org).
actually observing the true or sham procedures at the A complete, accurate and transparent trial report facili-
knee area but to allow them to observe the procedure tates dissemination, interpretation, translation and replica-
being performed in the abdomen area (21). bility. There continues to be a need for better reporting gen-
(2) In each session, at least 5 out of 10 predefined distant erally, as has been highlighted in a recent study of what is
nonacupuncture points (ref) were needled bilaterally (at missing from descriptions of treatments in trials and reviews
least 10 needles) and superficially using fine needles (ie, (55). The authors found that elements of the intervention were
minimal acupuncture). “De Qi” and manual stimulation missing in half of the published articles that they reviewed,
of the needles were avoided. All acupuncturists received giving insufficient detail, for example, with practitioners un-
oral instructions, a videotape, and a brochure with de- able to use the treatments as described and researchers un-
tailed information on sham acupuncture (52). able to replicate studies. This finding is similar to that from
(3) Conservative therapy involved 10 visits to practitioners a review of authors of acupuncture trials (12). Improved re-
with consultation and a prescription for diclofenac, up to porting reduces reader ambiguity in interpretation, is likely
150 mg/d, or rofecoxib, 25 mg/d, as needed until week to increase credibility and application of the results by pro-
23 (53). viding better evidence on which to base decisions on patient
(4) Patients received the same treatment as in the standard care.
group but in addition did stabilising exercises modified Reporting guidelines do help improve the quality of re-
because of the pregnancy.(refs) The training programme porting randomized trials (56) although it is difficult to
started by emphasizing activation and control of local observe their maximal benefit because too few journals en-
deep lumbopelvic muscles. Training of more superfi- dorse reporting guidelines (57) and fewer adhere to them
cial muscles in dynamic exercises to improve mobility, (57). To maximize this potential, we encourage journals
strength, and endurance capacity was gradually included. to unambiguously endorse the revised STRICTA reporting
Patients received treatments individually for a total of six guidelines. This can be most readily achieved by updating
hours during six weeks. They were told to integrate the journal Instructions to Authors, thereby alerting prospective
exercises in daily activities and to exercise in short ses- authors. In addition, we encourage journals to implement
sions on several occasions during the day (54). strategies 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.
Discussion
This revised STRICTA Statement has been designed to help
Acknowledgements
improve the reporting of interventions in clinical trials of
acupuncture, with the intention that it will help authors of This revision to STRICTA has benefited from contributions
acupuncture trials provide readers with a clear, accurate and from many people. Support and administrative help in man-
transparent account of their acupuncture protocols as well aging the process of revising STRICTA has come from
as their control and/or comparator procedures. In addition Anne Burton, Ann Hopton, Suzanne Jenna, Stephanie Prady,
to revising the STRICTA checklist, we have improved the and Tracy Stuardi. The Steering Group comprised Doug
explanations of each item and provided examples of good Altman and David Moher (CONSORT), Hugh MacPherson
reporting. To enhance awareness, endorsement and adher- and Richard Hammerschlag (STRICTA), and Li Youping and
ence, the revised STRICTA Statement has been developed Wu Taixiang (Chinese Cochrane Centre).
The initial consultation with experts, which was pi- of Acupuncture: the STRICTA recommendations. Zhongguo
loted with the help of Mark Bovey, Val Hopwood and Zhong Xi Yi Jie He Za Zhi 2005; 25: 556–8.
Adrian White, involved a panel consisting of: Joyce Anas- 8. Liu X., Zhang M., Liu H. Improving the Quality of Reports in
tasi, Stephen Birch, Joao Bosco, Claudia Citkovitz, Remy controlled trials of acupuncture by using CONSORT and
Coeytaux, Misha Cohen, Agatha Colbert, Helen Elden, STRICTA. Zhongguo Zhen Jiu 2003; 23: 699–701.
Reginaldo de Carvalho Silva Filho, Alastair Forbes, Na- 9. Kawakita K. (2010) Standards for Reporting Interventions in
dine Foster, Joel Gagnier, Mark Goldby, Marita Gronlund, Controlled Trials of Acupuncture: the STRICTA
Richard Harris, Dominik Irnich, Helene Langevin, Lao recommendations. http://jsam.jp/activity/checklist.html
Lixing, Anna Lee, Lee Hyangsook, Lee Myeongsoo, Lee (Accessed 16 July 2010)
10. Schulz KF, Altman DG, Moher D., for the CONSORT Group.
Sanghoon, George Lewith, Klaus Linde, Liu Jianping, Ryan
CONSORT 2010 Statement: updated guidelines for reporting
Milley, Scott Mist, Dieter Melchart, Albrecht Molsberger, Vi-
parallel group randomised trials. British Medical Journal 2010;
taly Napadow, Richard Niemtzow, Park Jongbae, Mahmood
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Saghaei, Koosnadi Saputra, Rosa Schnyer, Charles Shang,
11. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010
Karen Sherman, Shin Byung-Cheul, Caroline Smith, Elisa-
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consensus-building workshop in Freiburg, comprised the authors. Journal of Alternative and Complementary Medicine
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Isabelle Boutron, Mark Bovey, Fei Yutong, Joel Gagnier, 13. Prady SL, Richmond SJ, Morton VM, MacPherson H.
Sally Hopewell, Val Hopwood, Susanne Jena, Klaus Linde, A systematic evaluation of the impact of STRICTA and
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14. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P.
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