BMJ Open...Korean databases is lacking despite the fact that acupuncture is regularly practiced in...

For peer review only

Assessment of the quality of reporting in randomized controlled trials of acupuncture in the Korean literature

using the CONSORT and STRICTA statements

Journal: BMJ Open

Manuscript ID: bmjopen-2014-005068

Article Type: Research

Date Submitted by the Author: 17-Feb-2014

Complete List of Authors: Kim, Kun Hyung; School of Korean Medicine, Pusan National University, Department of Acupuncture and Moxibustion Kang, Jung Won; College of Korean Medicine, Kyung Hee University,

Department of Acupuncture and Moxibustion Lee, Myeong Soo; Korea Institute of Oriental Medicine, Lee, Jae Dong; College of Korean Medicine, Kyung Hee University, Department of Acupuncture and Moxibustion

<b>Primary Subject Heading</b>:

Complementary medicine

Secondary Subject Heading: Complementary medicine, Medical publishing and peer review, Research methods

Keywords: COMPLEMENTARY MEDICINE, EPIDEMIOLOGY, EDUCATION & TRAINING (see Medical Education & Training)

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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Assessment of the quality of reporting in randomized controlled

trials of acupuncture in the Korean literature using the

CONSORT and STRICTA statements

Kun Hyung Kim1, Jung Won Kang2, Myeong Soo Lee,3 Jae-Dong Lee2

1School of Korean Medicne, Pusan National University, Yangsan, South Korea

2Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University,

Seoul, South Korea

3Korea Institute of Oriental Medicine

Running Title: CONSORT and STRICTA for Korean acupuncture trials

Source of support: None

Financial Disclosure: None

Keywords: acupuncture, randomized controlled trial, CONSORT, STRICTA, reporting

guideline

Corresponding author :

Jae Dong Lee, KMD., PhD.

Department of Acupuncture & Moxibustion,

College of Korean Medicine,

Kyung Hee University,

Seoul, 130-872, South Korea

Tel : 82-(0) 2-958-9207

Fax: 82-(0) 2-958-9211

E-mail:[email protected]

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Abstract

Objectives: Adequate reporting quality of randomized controlled trials (RCTs) is a

prerequisite for comprehensive understanding and optimal utilization of research results. This

study aims to assess the reporting quality of RCT of acupuncture in the Korean literature.

Design: Systematic review

Methods: Twelve Korean databases and seven Korean journals were searched to identify

eligible RCTs of acupuncture published from 1996 to July 2011. The Consolidated Standards

of Reporting Trials (CONSORT) checklist for parallel RCTs and the revised STandards for

Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were used to assess the

quality of reporting in Korean RCTs. The completeness of reporting of CONSORT and

STRICTA items in papers published in two time periods (1996-2004 as pre-CONSORT and

2005-2011 as post-CONSORT) were compared.

Results: In total, 146 eligible RCTs were identified and analysed using CONSORT (n=146)

and STRICTA (n=90). Information related to randomisation sequence generation, allocation

concealment and implementation, participant flow, recruitment and reporting of adverse

events were significantly more completely reported in the post-CONSORT trials; however,

the absolute reporting rate was suboptimal (ranged from 5.8 to 54.4 % in 103 post-

CONSORT trials). The acupuncture rationale, number of needles, depth of insertion, response

to needle stimulation, needle stimulation methods and description of acupuncture

practitioners were significantly more completely reported in the post-CONSORT trials.

Although most of the 15 STRICTA items were reported in 50% of post-STRICTA trials, the

reporting of setting/context (24.6%) and practitioner background (27.9%) items remained

incomplete.

Conclusion: The reporting quality of Korean acupuncture RCTs was suboptimal with regard

to the CONSORT and revised STRICTA statements. The inclusion of the CONSORT and

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revised STRICTA statements in author instructions and the use of those statements in writing

as well as editorial and peer review processes are necessary to enhance reporting quality in

Korean acupuncture RCTs.

Strengths and limitations of this study

• This is the first study that investigated the incompleteness of quality of reporting in Korean

RCTs of acupuncture with regard to the CONSORT and STRICTA recommendations and

their changes over time.

• Our findings demonstrate that most of core components of trials remained substantially

under-reported in Korean RCTs of acupuncture.

• The assessment criteria for completeness of reporting in each item may be different with

other relevant studies. Future periodical updates of the results are also needed.

Keywords: acupuncture, CONSORT, STRICTA, reporting quality, randomised controlled

trial

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Background

Rigorous randomised controlled trials (RCTs) can minimise bias and thus contribute to the

establishment of gold-standard evidence for medical interventions. Well-designed and

properly conducted RCTs can also provide raw data for systematic reviews and meta-analyses

to supply reliable information to clinicians, patients and policymakers. A complete, accurate

and transparent report of RCTs also facilitates dissemination, interpretation, translation and

replicability, whereas poorly conducted or reported RCTs impede the improvement of

evidence.1 Given these concerns, the Consolidated Standards of Reporting Trials (CONSORT)

statement was established to improve the reporting of RCTs and thus enable readers to

understand the study design, conduct, analysis and interpretation through complete

transparency.2 The CONSORT statement was revised in 2001 and 2010, and the revised

STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) serves

as an official extension of the statement for descriptions of acupuncture treatments.1

Previous studies revealed that adherence to the CONSORT statement improved the reporting

quality of trials.3 4

Recent studies assessing the reporting quality of RCTs published in

languages other than English identified low adherence to the CONSORT statement and

suggested the need to improve the quality of RCT reports in China and Japan.5 6

In Korea,

RCTs for conventional medicine demonstrated very low adherence to the CONSORT

statement.7 However, a study assessing the quality of the reporting of acupuncture RCTs in

Korean databases is lacking despite the fact that acupuncture is regularly practiced in Korea,

and many clinical trials assessing the effects of acupuncture have been published in Korean

databases.8 A previous study assessing the reporting quality of acupuncture trials reported in

English suggested that future research should investigate the reporting quality of acupuncture

trials in languages other than English.9 Hence, we aimed to evaluate the reporting quality of

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acupuncture RCTs published in Korean databases using the CONSORT and revised

STRICTA statements.

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Methods

Study design

The quality of reporting in eligible Korean RCTs of acupuncture was compared before and

after publication of the revised CONSORT 2001 statements and the first STRICTA

recommendation, which was also published in 2001. Before-and-after comparisons were

made to investigate whether the reporting quality of Korean acupuncture RCTs was altered

after the publication of the CONSORT and STRICTA statements in 2001. In this study, we

compared Korean RCTs published before 2005 with those published after 2005, which

represents the four-year period spanning the publication of the revised CONSORT and the

original STRICTA statements.

Type of studies

Parallel group RCTs reported in Korean databases were eligible for this study. We decided

not to include Korean RCTs reported in English databases given that the primary aim of this

study was to assess adherence to the CONSORT statement among trials reported in Korean

databases that might be unknown due to language restriction. Studies reported in English but

recorded in Korean databases were eligible. Crossover or cluster RCTs were excluded

because we employed the CONSORT guidelines for parallel RCTs as the main analysis tool

for this study.

CONSORT and STRICTA statements

The revised version of the CONSORT statement for parallel RCTs published in 2001 was

used to compare the reporting quality of Korean trials before and after the publication of the

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statement. Although the CONSORT initiatives recommend the use of the most recently

released version of CONSORT when reporting and analysing RCTs,2 the revised CONSORT

version published in 2010 was not used to avoid potential systematic disadvantages for RCTs

that were published prior to CONSORT publication in 2010.9

The revised version of STRICTA published in 2010 was used to compare the reporting

quality of acupuncture intervention components before and after the publication of the

original STRICTA recommendation. We did not use the original STRICTA recommendation

for this comparison based on the following reasons. First, we found sufficient consistency

among the STRICTA components recommendation for this review between the original and

revised STRICTA statements, thereby justifying use of the latest STRICTA version.10 Second,

the ultimate aim of the STRICTA statement in this review is not to simply score studies for

each STRICTA item but to identify the extent to which Korean RCTs comprehensively report

the essential components of acupuncture treatment that are considered to best represent

consensus among international acupuncture experts.10

STRICTA items were not analysed for

non-acupuncture control group interventions because our primary interest is to assess the

reporting quality of acupuncture treatment components. The original statements were

transformed into data extraction checklists for the CONSORT statement with 22 items and

the revised STRICTA statement with 15 items.

Type of participants

RCTs of patients with any health problems or diseases were eligible. RCTs of healthy

individuals were excluded. No study was excluded based on its outcome measures.

Type of interventions and comparisons

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For the CONSORT analyses, acupuncture was defined as a stimulation of the body or

auricular points regardless of the type of stimulation. Studies using acupuncture-like

techniques that stimulate acupuncture points (i.e., acupuncture point injection or acupressure)

were also included when classified and reported as a type of acupuncture in an RCT. Studies

testing moxibustion as a primary intervention were excluded. Any types of control groups

were eligible for this analysis.

For the STRICTA analyses, acupuncture was defined as needle penetration of the body or

auricular points with manual or/and electrical stimulation given that STRICTA was originally

developed to assess the components of these interventions. Studies comparing acupuncture as

a control group with non-acupuncture interventions were also eligible for this study, and only

acupuncture-related information was extracted for the STRICTA analysis. With regard to

studies that compare different types of needle-penetration acupuncture interventions, the most

comprehensively described acupuncture intervention was selected for the STRICTA analysis.

Searching methods

The studies included herein were selected from the dataset of Korean RCTs described as

previously published.11 In the article, 12 Korean databases (i.e., NANET, RISS4U, KISS,

DBpia, KMbase, KoreaMed, KISTI, NDSL, OASIS, DLlibrary, KoreanTK, and RICHIS)

were searched from their inception to July 2011. The search terms included “acupuncture”

and “clinical trials” (Table 1). Theses and dissertations were also included if they met the

eligibility criteria.

Data extraction and assessment

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General characteristics of the included RCTs were extracted. Two reviewers performed data

extraction for the assessment of reporting quality independently, and any disagreements were

resolved with discussion. Each item was assessed as ‘yes’ or ‘no’ based on whether it was

reported in the study. If an item has more than one concept to be assessed, item reporting was

considered complete when at least one concept was reported in a given trial. For example,

item #8 on the CONSORT 2011 checklist assesses the random sequence generation with two

concepts (i.e., method used to generate the random allocation sequence, including details of

any restrictions). The reporting of the item was considered complete when the sequence

generation method was reported regardless of information of restriction method provided in a

given RCT. Explanation and elaboration documents of the CONSORT12

and revised

STRICTA1 statements were used as assessment references.

For item #4 on the CONSORT 2001 checklist (i.e., details of intervention intended for each

group and how and when they were actually administered), the rating criteria of Hoffmann et

al. were adopted with slight modification.13

We selected four items (i.e., procedure, materials,

intensity and schedule) from the checklist that was developed to assess reports of non-

pharmacological interventions in RCTs13 because we considered these items to be most

relevant for the replication of acupuncture interventions. If all four items were assessed as

‘yes’, item #4 on the CONSORT 2001 statement was rated as ‘yes’. Table 2 presents detailed

assessment criteria for item #4 (Table 2). Item #11 on the CONSORT 2001 checklist (i.e.,

blinding of participants, intervention providers and outcome assessors) was modified to only

include outcome assessor blinding. Participant and intervention provider blinding are often

not feasible in complex interventions, such as acupuncture14

, whereas outcome assessors can

be blinded without interfering with the acupuncture treatment process.

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Statistical analysis

For each time period (i.e., before and after 2005), general publication details (e.g., sample

size, type of journals, acupuncture/non-acupuncture trials, etc.) were compared using t-tests

or Chi-Square tests. For each CONSORT and STRICA item, the number and percentage of

trials that successfully reported the item as well as the percentage differences between two

time periods with binomial 95% confidence intervals are reported. Multiple linear regression

analysis was used to investigate potential predictors of better reporting. Independent variables

included year of publication, type of journal (TKM-related or other), sample size and type of

acupuncture stimulation (penetration needling or other), and the dependent variable was the

CONSORT index score (i.e., aggregate of 22 checklist items). The same independent

variables other than the type of acupuncture stimulation and the STRICTA index score (i.e.,

aggregate of 15 checklist items) as a predictor variable were analysed in the same manner.

STATA version 13.0 (Stata-Corp, College Station, Texas) was used for statistical analyses.

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Results

Search results and characteristics of included RCTs

In total, 227 studies were screened during the initial process, of which 146 RCTs met the

eligibility criteria and were included in the analyses (Figure 1). The primary interventions of

needle acupuncture and non-needle acupuncture were used in 90 and 56 RCTs, respectively.

Non-needle acupuncture stimulation consisted of pharmacopuncture (i.e., the injection of

hernal medicine on acupuncture points), bee venom acupuncture (i.e., the injection of diluted

bee venom on acupuncture points), acupressure (by hand or device) or electrostimulation of

acupuncture points. Additional general characteristics of the included RCTs are provided in

Table 3.

Differences in completeness of reporting for CONSORT items between pre- and post-

CONSORT statements

Among the 43 pre-CONSORT and 103 post-CONSORT trials, 10 and 11 of 22 items were

reported in greater than 50% of trials, respectively. The remainder of the items were reported

in less than 35% of included pre- and post-CONSORT trials regardless of the statistical

significance of the differences of reporting quality between two time periods. Items regarding

random sequence generation, allocation concealment, implementation of randomisation, flow

of participants, dates of participant recruitment and adverse events displayed significantly

more complete reporting in post-CONSORT trials; however, only two items (random

sequence generation and dates of participant recruitment) achieved greater than 50%

reporting rates in post-CONSORT trials. The reporting rates of the remaining five items that

showed statistically significant improvement in post-CONSORT trials remained markedly

incomplete (less than 25.2 %). The most significant improvement in reporting quality was

identified in random sequence generation (mean difference: 42.7%, 95% CI: 29.2 to 56.3%),

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although the reporting rate was only 54.4% in the post-CONSORT trials. Detailed

information regarding the reporting of each item is provided in Table 4. The CONSORT

Index score was significantly increased in post-CONSORT trials compared with pre-

CONSORT trials (p=0.0082). (Table 6)

Differences in completeness of reporting for STRICTA items between pre- and post-

STRICTA statements

Among the 29 pre-STRICTA and 61 post-STRICTA trials, 10 and 13 of 15 items were

reported in greater than 50% of trials, respectively. The percentage of trials that showed

complete reporting in the remaining items ranged from 0.0 to 48.3 % in pre-STRICTA trials

and 24.6 to 27.9% in post-STRICTA trials. Items regarding reasoning of acupuncture

treatments (item 1b), number of needles (item 2a), depth of insertion (item 2c), response to

needle (item 2d), needle stimulation methods (item 2e) and description of acupuncture

practitioners (item 5) displayed significantly more complete reporting in post-CONSORT

trials. Greater than 50% of trials achieved complete reporting of these items with the

exception of the item related to the description of acupuncture practitioners, which

maintained a low reporting rate (27.9%) in post-STRICTA trials. The most significant

improvement in reporting quality was identified in needling depth (item 2c) (mean difference:

36.2%, 95% CI: 15.6 to 56.7%), achieving a 67.2% reporting rate in the post-STRICTA trials.

Although most of 15 STRICTA items were reported in 50% of post-STRICTA trials,

reporting of items for setting/context (24.6%) and practitioner background (27.9%) remained

incomplete. Detailed information regarding the reporting of each item is provided in Table 5.

The STRICTA Index score was significantly increased in post-STRICTA trials compared with

pre-STRICTA trials (p<0.0001) (Table 6).

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Predictors of better reporting for the CONSORT and STRICTA statements

The variables we examined (year of publication, type of journal, sample size and type of

acupuncture stimulation) accounted for minimal variance in the regression model (0.1415 and

0.2194 adjusted R-squared values in the CONSORT and STRICTA regression models,

respectively). Year of publication showed significantly modest positive correlation with

increased CONSORT and STRICTA indices (both p<0.0001; correlation coefficients: 0.25

and 0.31, respectively). The journal type displayed significantly negative correlation with the

CONSORT index (correlation coefficient: 1.8 point), indicating that RCTs in TKM-related

journals displayed CONSORT indices 1.8 points lower than RCTs not published in TKM-

related journals. Types of intervention and sample size did not significantly correlate with the

CONSORT index scores. In the STRICTA analysis, the sample size demonstrated a

statistically significant but minimal positive correlation with the STRICTA index (correlation

coefficient: 0.02), indicating that RCTs with 10 more samples display a 0.2 point increase in

STRICTA index score. Type of journals did not significantly correlate with the STRICTA

index scores. The regression model showed a good fit.

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Discussion

We identified a considerable number of items that were incompletely reported, which may

limit the internal validity and applicability of the trial results. Reporting of items that are core

components of assessing the risk of bias, such as randomization, concealment of allocation,

and outcome assessor blinding, were particularly incomplete. The number of participants at

each stage of the trial was not explicitly reported, which suggests high risk of attrition bias of

the results of the RCTs. None of the Korean RCTs reported the critical criteria of subgroup

analyses including the use of subgroup variables measured at baseline, prespecification of

subgroup hypotheses, and statistical significance of interaction tests; inappropriately claimed

subgroup effect is not credible and can lead to the misuse of information by researchers,

clinicians and policymakers.15 Harms of study interventions were reported in less than one-

quarter of the included RCTs, which does not permit the investigation of the safety of

acupuncture in the context of trials. Discussions regarding the generalisability of trial

findings was lacking in most Korean RCTs, which may interfere with the application of trial

results to real clinical situations. Overall, the reporting quality of Korean RCTs was

suboptimal as assessed by the CONSORT statement, which could serve as a significant

obstacle to the establishment of a sound evidence base.

Regarding the reporting quality of intervention details based on the revised STRICTA

statement, the theoretical background and some details of the needling processes showed

moderate to good quality reporting, whereas items related to contextual factors were

markedly under-reported. The inconsistent reporting quality between items may imply that

certain items are perceived as more important by investigators or journal editors,18 although

there is no evidence to justify such inference in the Korean context. Practitioner qualifications

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were also incompletely reported, which may increase the uncertainty with regard to treatment

quality and safe implementation of interventions. Observed incompleteness of the reporting

of practitioner qualifications may have been influenced by the exclusive government registry

system for Korean medicine doctors (KMDs) and the possible assumption that trial

interventions were conducted by qualified KMDs. Collectively, the reporting quality of

intervention details was inconsistent, which may be problematic for the replication of

acupuncture treatments in other contexts.

Intervention item #4 (details of intervention) was completely reported in more than two-thirds

of the included RCTs when assessed by the criteria in this study. However, practitioner

information was not included in the criteria based on the following reasons. First, we found

that practitioner information was lacking in most RCTs from our initial search. We considered

that including practitioner information as a mandatory component for adequate intervention

reporting would result in the exclusion of most RCTs regardless of the completeness of

additional components, ultimately causing the assessment to be less meaningful. Second, only

KMDs can practice acupuncture in South Korea according to the unique dual healthcare

qualification system in South Korea (Western medicine doctors and KMDs).17 This

contextual background may have caused the authors of Korean acupuncture RCTs to assume

that the acupuncture practitioner was a KMD and omit the practitioner information. However,

this hypothesis may not be supported in other contexts. We conducted a sensitivity analysis

by including the practitioner information in the criteria for assessing item #4, and found that

the complete reporting of the respective item in one (2%) and 17 (16%) Korean RCTs

published before and after 2005, respectively. This result is substantially lower than results

based on our primary criteria. Because practitioner information can be crucial for the

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replication of trial interventions in research and clinical contexts, this information should be

clearly reported in future Korean acupuncture RCTs.

In our study, the STRICTA items were generally more completely reported than CONSORT

items. This may be because the subject of included studies was acupuncture. Another possible

explanation refers to the fact that the Korean translations of the original and revised

STRICTA statements were published in a Korean acupuncture-related journal (i.e., Journal of

Acupuncture and Moxibustion Society)22 23

; however, an official Korean CONSORT was

never published to our knowledge. Although no direct evidence supports the assumption that

translated CONSORT statements in published in languages other than English (LOE) are

associated with more transparent reporting in trials reported by LOE, attempts have been

made to translate and endorse CONSORT statements in domestic journals to assist local

authors in comprehensive reporting of the recommended trial components according to

international standards (i.e., CONSORT).24 25

Consistent with these international efforts, the

official Korean translation of the CONSORT statements is expected to be a useful resource

for Korean authors and journal editors.

Our findings are consistent with previous studies investigating the adherence of RCTs to

CONSORT and STRICTA statements in various clinical fields, including acupuncture.5-7 9 19

20 The quality of reporting was relatively incomplete in this study compared with others,

especially for items related to randomisation, allocation concealment, outcome assessor

blinding and the method of analysis (per protocol or intent-to-treatment analysis). Several

factors may be potentially related to the poor reporting quality identified in this study. First, a

lack of understanding of the need for comprehensive trial reporting to enable the assessment

of internal and external validity in the design and implementation of trials may result in

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incomplete reporting. This factor was the primary motivation for international initiatives to

develop the CONSORT statement.2 However, the uptake of the CONSORT statement at the

author level was not investigated in this study due to resource limitations, and this issue

should be addressed by future research. Second, the lack of utilisation of the CONSORT and

STRICTA checklists by journal editors and peer reviewers may impede the improvement of

the quality of trial reporting through the publication process. The utilisation of reporting

guidelines by biomedical journals during the peer review process improves the quality of

publication in terms of general methodological issues.21 Hwang et al. found that none of the

conventional Korean medical journals endorsed the CONSORT statement as part of the

author instructions, which may be responsible for the incomplete reporting quality of Korean

RCTs of conventional medicine.7 Little is known as to whether Korean acupuncture or

traditional medicine journals have used reporting guidelines (e.g., CONSORT and STRICTA)

for editorial or peer-review processes. To date, only one acupuncture-related journal (i.e.,

Journal of Acupuncture and Moxibustion Society) endorses the CONSORT and STRICTA

guidelines in the author instructions (unpublished communication). To improve the quality of

reporting for acupuncture trials in Korean, collective efforts of journal editors, authors and

peer-reviewers to utilise the CONSORT and the STRICTA statements during each stage of

manuscript preparation and submission as well as the peer-review process are urgently

needed. Barriers related to the incompleteness of reporting by Korean authors of RCTs should

also be investigated.

One strength of this study is that it is the first systematic investigation to assess the reporting

quality of Korean RCTs of acupuncture based on the CONSORT statements. Given that the

quality of reporting in RCTs of traditional Chinese medicine (TCM), which employ

interventions similar to acupuncture, has already been reported,6 this study complements

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current data regarding the reporting quality of acupuncture RCTs in Korean databases. We

also attempted to evaluate the best available dataset of Korean acupuncture RCTs by

employing extensive search strategies that targeted 17 Korean databases; however, the

possibility of undetected studies could not be completely excluded. Two recent studies

analysed study characteristics and bibliographic information using updated search results and

database information.26 27

The results of this review should also be updated periodically to

monitor whether recommended components of trials by the CONSORT and STRICTA

statements are transparently and completely reported in Korean RCTs of acupuncture.

Several weaknesses of our study should be mentioned. First, the cut-off year of the

CONSORT and STRICTA analysis was arbitrarily defined because no standard criteria exist

regarding sufficient period for dissemination and implementation of the CONSORT and

STRICTA recommendations. Although we assumed that local authors would require at least

four years to reflect the CONSORT and STRICTA recommendations into design and writing

of trial, no concrete evidence justifies our assumption. Second, we considered the partial

reporting of CONSORT and STRICTA items as complete despite the fact that the recent

Cochrane review regarded only full descriptions of the required content for a given item as

complete.4 Consequently, our assessment may have reported inflated scores, and this

possibility should be recognised when interpreting our results. Third, time may serve as a

potential confounder of quality of reporting because the completeness of reporting may have

naturally changed over time regardless of CONSORT and STRICTA endorsements.4 The

publication year displayed significant positive correlation with CONSORT and STRICTA

index scores in the regression analyses; however, the correlation magnitude was modest. Thus,

the potential influence of the natural improvement of completeness of reporting on the

observed results remains unclear and should be acknowledged as limitation of this study.

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Implications for future research

Endorsement of the CONSORT and STRICTA checklist should be encouraged among editors

of relevant Korean medical journals, and potential barriers need to be tackled. Collective

efforts to increase compliance with the CONSORT and STRICTA statements during design,

implementation and reporting of clinical trials are needed to improve the quality of reporting

in Korean RCTs of acupuncture. The need to appropriately address core items relevant to

assessments of internal and external trial validity should also be impressed upon trial authors,

journal editors and peer reviewers. In particular, items related to randomisation, concealment

of allocation, blinding of outcome assessors, flow of participants, subgroup analyses and

harms of acupuncture should be more completely reported in future Korean RCTs of

acupuncture. Practitioner- and context-related STRICTA items should also be better reported.

The authors, editors and peer-reviewers of Korean RCTs of acupuncture should be properly

educated to aid in the complete reporting of these items.

Conclusions

The quality of reporting in Korean RCTs of acupuncture remained suboptimal over time. The

CONSORT and STRICTA statements should be thoroughly utilised by trial authors and

journal editors to improve the quality of reporting.

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Acknowledgements

The study was supported by the Korea Institute of Oriental Medicine. The views expressed

are not necessarily those of the funding body.

Authors’ contributions

KHK conceived the research. KHK and JWK performed data collection, analysis and wrote

the first draft of the paper. KHK, JWK, MSL and JDL were all involved in the development

and refinement of subsequent drafts. KHK is the guarantor for the study. All authors read and

approved the final manuscript.

Competing Interests

None

Data Sharing Statement

Authors adhere to the data sharing statement of BMJ

Open. Please send an email to the first author (KHK) to obtain additional unpublished data.

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References

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Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT

statement. PLoS Med 2010;7(6):e1000261.

2. www.consort-statement.org.

3. Moher D, Jones A, Lepage L, CONSORT Group (Consolitdated Standards for Reporting of

Trials). Use of the CONSORT statement and quality of reports of randomized trials: a

comparative before-and-after evaluation. JAMA 2001;285:1992-5.

4. Turner L, Shamseer L, Altman DG, et al. Consolidated standards of reporting trials

(CONSORT) and the completeness of reporting of randomised controlled trials (RCTs)

published in medical journals. Cochrane Database Syst Rev 2012;11:MR000030.

5. Uetani K, Nakayama T, Ikai H, et al. Quality of reports on randomized controlled trials

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6. Wang G, Mao B, Xiong ZY, et al. The quality of reporting of randomized controlled trials

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China. Clin Ther 2007;29(7):1456-67.

7. Hwang YW, Lee KW, Hwang IH, et al. The quality of reporting of randomized controlled

trials in Korean Medical Journals Indexed in KoreaMed: Survey of Items of the revised

CONSORT statement. J Korean Acad Fam Med 2008;29:276-82.

8. Kong JC, Lee MS, Shin BC. Randomized clinical trials on acupuncture in Korean literature:

a systematic review. Evid Based Complement Alternat Med 2009;6(1):41-8.

9. Prady SL, Richmond SJ, Morton VM, et al. A systematic evaluation of the impact of

STRICTA and CONSORT recommendations on quality of reporting for acupuncture trials.

PLoS One 2008;3(2):e1577.

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10. Kim KH, Kang JW, Lee MS, et al. Assessment of the quality of reporting for treatment

components in Cochrane reviews of acupuncture. BMJ Open 2014;4:e004136.

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trials in cochrane reviews of acupuncture. PLoS One 2012;7(10):e47619.

12. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration:

updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869.

13. Hoffmann TC, Erueti C, Glasziou PP. Poor description of nonpharmacological

interventions: analysis of consecutive sample of randomised trials. BMJ 2013;347:f3755.

14. Paterson C, Dieppe P. Characteristic and incidental (placebo) effects in complex

interventions such as acupuncture. BMJ 2005;330(7501):1202-5.

15. Sun X, Briel M, Busse JW, et al. Credibility of claims of subgroup effects in randomised

controlled trials: systematic review. BMJ 2012;344:e1553.

16. Sun X, Briel M, Busse JW, et al. The influence of study characteristics on reporting of

subgroup analyses in randomised controlled trials: systematic review. BMJ 2011;342:d1569.

17. Na SS. East Asian medicine in South Korea. Harvard Asia Quarterly 2012;14(4):44-56.

18. Prady SL, Macpherson H. Assessing the utility of the standards for reporting trials of

acupuncture (STRICTA): a survey of authors. J Altern Complement Med 2007;13(9):939-43.

19. Han C, Kwak KP, Marks DM, et al. The impact of the CONSORT statement on reporting

of randomized clinical trials in psychiatry. Contemp Clin Trials 2009;30(2):116-22.

20. Lu X, Hongcai S, Jiaying W, et al. Assessing the quality of reports about randomized

controlled trials of acupuncture treatment on mild cognitive impairment. PLoS One

2011;6(2):e16922.

21. Cobo E, Cortés J, Ribera JM, et al. Effect of using reporting guidelines during peer

review on quality of final manuscripts submitted to a biomedical journal: masked randomised

trial. BMJ 2011;343:d6783.

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22. Lee H-S, Cha S-J, Park H-J, et al. Revised STandards for Reporting Interventions in

Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT statement. Korean

Journal of Acupuncture 2010;27(3):1-23.[In Korean]

23. Lee H-S, Park J-B, Seo J-C, et al. Standards for Reporting Interventions in Controlled

Trials of Acupuncture: The STRICTA recommendations. Journal of Korean Acupuncture and

Moxibustion Society 2002;19(6):135-54.[In Korean]

24. Costa LO, Maher CG, Moseley AM, et al. Endorsement of trial registration and the

CONSORT statement by the Revista Brasileira de Fisioterapia. Rev Bras Fisioter

2010;14(3):5-6.

25. MacPherson H, Altman DG. Improving the quality of reporting acupuncture interventions:

describing the collaboration between STRICTA, CONSORT and the Chinese Cochrane

Centre. J Evid Based Med 2009;2(1):57-60.

26. Choi J, Lee JA, Yun K-J, et al. Online databases and journals of Traditional Medicine and

Complementary and Alternative Medicine in Korea. Eur J Integr Med Published Online First:

18 November 2013. doi: 10.1016/j.eujim.2013.10.001

27. Kim S, Sagong HS, Kong JC, et al. Randomised clinical trials on acupuncture in the

Korean literature: bibliometric analysis and methodological quality. Acupunct Med Published

Online First: 23 January 2013. doi: 10.1136/acupmed-2013-010470

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Table 1. Search terms used in titles and abstracts

English search term

# 1 acupuncture

# 2 clinical

# 3 controlled OR random

# 4 #1 AND #2 AND #3

Korean search term

#1

# 2

# 3 OR

# 4 # 1 AND # 2 AND #3

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Table 2. Assessment criteria of the item #4 of the CONSORT 2001 statement

Criteria item Components of respective STRICTA items

1) Procedure At least one item should be reported for the ‘yes’ assessment

De-qi response sought (item 2d)

Needle stimulation methods (item 2e)

Names of points (item 2b)

2) Materials Needle specification (item 2g)

3) Intensity Needle retention time (item 2f)

4) Schedules At least one item should be reported for the ‘yes’ assessment

Duration (item 3b)

Frequency (item 3b)

Total or average number of sessions (3a)

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Table 3. General characteristics of included RCTs

Before 2005

(1996~2004)

(n=43)

After 2005

(2005-2013)

(n=103)

Total number of included studies

CONSORT analysis 43 103

STRICTA analysis 29 61

Journals

Peer-review journals 43 (100.0%) 97 (94.2%)

Unpublished (Master dissertation or PhD Thesis)a 0 (0.0%) 6 (5.8%)

Sample sizeb 45.6 (49.5) 41.3 (19.4)

Publication yearc 2002 (1996-2004) 2007 (2005-2011)

Type of intervention

Needle acupuncture 29 (67.4%) 61 (59.2%)

Non-needling acupunctured 14 (32.6%) 42 (40.8%)

Type of control

Active treatment 35 (81.4%) 70 (68.0%)

Sham or placebo 5 (11.6%) 31 (30.1%)

Waitlist 3 (7.0%) 2 (1.9%)

Number of arms

2 arms 39 (90.7%) 92 (89.3%)

3 or 4 arms 4 (9.3%) 11 (10.7%)

aUnpublished articles were obtained from the NANET database (www.nanet.go.kr).

bValues are presented as mean (standard deviation).

cValues are presented as median (range).

dNon-needling acupuncture includes pharmacopuncture, bee venom acupuncture and other acupuncture point

stimulation using non-penetrating techniques.

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Table 4. CONSORT checklist for Korean RCTs of acupuncture

Item no Summarized descriptor Before 2005 (1996~2004) After 2005 (2005~2011) Mean difference [95% CI]

N=43 % [95% CI] N=103 % [95% CI]

1 Title / Abstract How participants were allocated to interventions 26 60.4 [45.9, 75.1] 60 58.3[48.7, 67.8] -2.2 [-19.7, 15.2]

2 Introduction / background Scientific background / explanation of rationale 39 90.7 [82.0, 99.4] 98 95.1[91.0, 99.3] 4.4 [-5.2, 14.1]

Methods

3 Participants Eligibility criteria for participants 43 100.0 [100.0, 100.0] 98 95.1 [91.0, 99.3] -4.9 [-9.0, -0.7]

4 Interventions Precise details of the interventions 30 69.8 [56.0, 83.5] 75 72.8 [64.2, 81.4] 3.0 [-13.1, 19.2]

5 Objectives Specific objectives and hypotheses 36 83.7 [72.9, 94.8] 85 82.5 [75.2, 89.9] -1.2 [-14.4, 12.1]

6 Outcomes Clearly defined primary / secondary outcome measures 6 13.9 [3.6, 24.3] 16 15.5 [8.5, 22.5] 1.6 [-10.9, 14.1]

7 Sample size How sample size was determined 1 2.3 [-2.2, 6.8] 3 2.9 [-0.3, 6.2] 0.6 [-5.0, 6.1]

Randomization

8 Sequence generation Method used to generate the random allocation sequence 5 11.6 [2.0, 21.2] 56 54.4[44.7, 64.0] 42.7 [29.2, 56.3]

9 Allocation

concealment

Method used to implement the random allocation

sequence 0 0.0 [0.0, 0.0] 6 5.8 [1.3, 10.3] 5.8 [1.3, 10.3]

10 Implementation Who generated the allocation sequence / enrolled

participants / assigned participants to their groups 0 0.0 [0.0, 0.0] 12 11.7 [5.5, 17.8] 11.7 [5.5, 17.8]

11 Blinding Outcome assessor blinding 6 13.9 [3.6, 24.3] 21 20.3 [12.6, 28.2] 6.4 [-6.5, 19.4]

12 Statistical Methods Methods used to compare groups for primary outcomes 42 97.6 [93.2, 102.2] 99 96.1 [92.4, 98.8] -1.6 [-7.4, 4.3]

Results

13 Participant flow Flow of participants through each stage 2 4.7 [-1.6, 10.9] 26 25.2 [16.9, 33.6] 20.6 [10.1, 31.1]

14 Recruitment Dates defining the periods of recruitment/follow-up 30 69.7 [56.0, 83.5] 90 87.4 [81.0, 93.8] 17.6 [2.5, 32.8]

15 Baseline data Baseline demographic/clinical characteristics of each

group 40 93.0 [85.4, 100.6] 97 94.1 [89.7, 98.7] 1.2 [-7.7, 10.0]

16 Numbers Analysed Number of participants (denominator) in each group

included in each analysis 11 25.5 [12.5, 38.6] 20 19.4 [11.8, 27.1] -6.2 [-21.3, 8.9]

17 Outcomes / estimation For each primary and secondary outcome, a summary of results for each group

43 100.0 [100.0, 100.0] 102 99.0 [97.1, 100.9] -1.0 [-2.9, 0.9]

18 Ancillary analyses Address multiplicity by reporting any other analyses

performed 0/6 0.0 [0.0, 0.0] 0/19 0.0 [0.0, 0.0] 0.0 [0.0, 0.0]

19 Adverse events All important adverse events or side effects in each

intervention group 3 6.9 [-0.6, 14.6] 25 24.3 [16.0, 32.6] 17.3 [6.0, 28.5]

Discussion

20 Interpretation Interpretation of the results 30 69.7 [56.0, 83.5] 78 75.7 [67.4, 84.0] 6.0 [-10.1, 22.0]

21 Generalizability Generalizability (external validity) of the trial findings 4 9.3 [6.2, 18.0] 2 1.9 [-0.7, 4.6] -7.4 [-16.4, 1.7]

22 Overall evidence General interpretation of the results in the context of

current evidence 15 34.9 [20.6, 49.1] 33 32.0 [23.0, 41.1] -2.8 [-19.7, 14.0]

aValues are presented as number of reported RCTs divided by the total number of eligible RCTs assessed for each item and percentage.

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Table 5. The number of Korean RCTs reporting each STRICTA Item

Before STRICTA (~ 2004) After STRICTA (2005~2011)

Item no N=29 % [95% CI] N=61 % [95% CI] Mean difference [95% CI]

1. Acupuncture Rationale

1a) Style of acupuncture 26 89.7 [78.6, 100.7] 59 96.7 [92.3, 101.2] 7.1 [-4.9, 19.0]

1b) Reasoning of treatments 18 62.1 [44.4, 79.7] 52 85.2 [76.3, 94.1] 23.1 [3.4, 43.0]

1c) Acupuncture regimen variation 25 86.2 [73.7, 98.8] 60 98.4 [95.2, 101.5] 12.2 [-0.8, 25.1]

2. Needling details

2a) Number of needles 20 69.0 [52.1, 85.8] 55 90.2 [82.7, 97.6] 21.2 [2.8, 39.6]

2b) Names of points 26 89.7 [78.6, 100.7] 59 96.7 [92.3, 101.2] 7.0 [-4.8, 19.0]

2c) Depth of insertion 9 31.0 [14.2, 47.9] 41 67.2 [55.4, 79.0] 36.2 [15.6, 56.7]

2d) Response to needle 7 24.1 [8.6, 39.7] 31 50.8 [38.3, 63.4] 26.7 [6.7, 46.7]

2e) Needle stimulation methods 16 55.2 [37.1, 73.3] 48 78.7 [68.4, 89.0] 23.5 [2.7, 44.3]

2f) Retention time 26 89.7 [78.6, 100.7] 56 91.8 [84.9, 98.7] 2.1 [-10.9, 15.2]

2g) Type of needles 24 82.8 [69.0, 96.5] 52 85.2 [76.3, 94.1] 2.5 [-13.9, 18.9]

3. Treatment regimen

3a) Number of sessions 19 65.5 [48.2, 82.8] 51 83.6 [74.3, 93.0] 18.1 [-1.5, 37.7]

3b) Frequency / duration 23 79.3 [64.6, 94.1] 56 91.8 [84.9, 98.7] 12.5 [-3.8, 28.8]

4. Treatment context

4a) Details of other treatments 14 48.3 [30.1, 66.5] 32 52.5 [39.9, 65.0] 4.2 [-17.9, 26.3]

4b) Setting and context 4 13.8 [1.2, 26.3] 15 24.6 [13.8, 35.4] 10.8 [-5.8, 27.4]

5. Practitioner background

5) Description of acupuncturists 0 0.0 [0.0, 0.0] 17 27.9 [16.6, 39.1] 27.9 [16.6, 39.1]

aValues are presented as number of reported RCTs divided by the total number of eligible

RCTs assessed for each item and percentage.

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Table 6. Comparison of the CONSORT/STRICTA index between pre- and post-

CONSORT/STRICTA trials

N Mean 95% CI P-value

Pre-CONSORT (1996-2004) 43 9.5 8.9 to 10.2

Post-CONSORT (2005-2011) 103 10.6 10.2 to 11.1

Difference 1.1 0.2 to 1.9 0.0082

Pre-STRICTA (1996-2004) 29 8.8 7.9 to 9.7

Post-STRICTA (2005-2011) 61 11.2 10.5 to 11.8

Difference 2.3 1.2 to 3.4 <0.0001

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Figure 1: Flow chart of the trial selection process

RCT; randomized controlled trial.

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Potentially relevant articles identified

and retrieved for more detailed

evaluation (n=869)

Reasons for exclusion (n=642)

• uncontrolled clinical trial (n=189)

• case-control study (n=4)

• duplicated article (n=1)

• protocol (n=4)

• review (n=20)

• animal study (n=29)

• non- randomized controlled trial (n=303)

• RCTs but excluded because of

not being related to acupuncture (n= 92)

Full-texts screened for primary

analysis (n=227)

Korean RCTs contributed to the final

primary analysis (n=146)

by analyses:

- CONSORT checklist (n=146)

- STRICTA checklist (n=90)

by year:

- before 2005 (n=43)

- from 2005 (n=103)

Exclusions (n=81)

• No acupuncture study (n=5)

• Healthy participants (n=57)

• Non-parallel RCT (n=11)

• Duplication (n=7)

• Not in a domestic journal (n=1)

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Assessment of the quality of reporting in randomised controlled trials of acupuncture in the Korean literature

using the CONSORT and STRICTA statements

Journal: BMJ Open

Manuscript ID: bmjopen-2014-005068.R1


Date Submitted by the Author: 02-Jun-2014






Keywords: COMPLEMENTARY MEDICINE, EDUCATION & TRAINING (see Medical Education & Training), EPIDEMIOLOGY




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CONSORT statement and the STRICTA guidelines

Kun Hyung Kim1, Jung Won Kang2, Myeong Soo Lee3, Jae-Dong Lee2



Seoul, South Korea






guideline







Tel : 82-(0) 2-958-9207

Fax: 82-(0) 2-958-9211


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Abstract

Objectives: This study aimed to assess the completeness of reporting of randomised

controlled trials (RCTs) of acupuncture in the Korean literature.

Design: Systematic review.

Methods: We searched 12 Korean databases and 7 Korean journals to identify eligible RCTs

of acupuncture published from 1996 to July 2011. We used the Consolidated Standards of

Reporting Trials (CONSORT) checklist for parallel RCTs and the revised STandards for

Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) to assess the quality of

reporting in Korean RCTs. We compared the completeness of reporting of CONSORT and

STRICTA items in RCTs published in two time periods (1996-2004 referred to as the early

period and 2005-2011 referred to as the late period).

Results: We analysed 146 eligible RCTs using the CONSORT statement concerning RCTs of

both needling and non-needling acupuncture and the STRICTA guidelines for 90 trials of

needling acupuncture. Among the 103 RCTs in the late period, the proportion of RCTs that

completely reported the CONSORT items of outcome definition (15.5%), sample size

calculation (2.9%), randomisation (56%), allocation concealment (5.8%), implementation of

allocation (11.7%), outcome assessor blinding (20.3%), flow of participants (25.2%), number

of participants analysed (19.4%), ancillary analyses (0.0%), adverse events (24.3%),

generalisability of findings (1.9%) and overall evidence (32.0%) remained small. Among the

61 RCTs of needling acupuncture in the late period, the STRICTA items of setting/context

(24.6%) and practitioner background (27.9%) showed incomplete reporting. The

completeness of reporting improved over time in several CONSORT and STRICTA items.

Conclusion: The completeness of reporting of Korean RCTs of acupuncture was suboptimal

according to the CONSORT and revised STRICTA statements. Trial authors and journal

editors should use the CONSORT statement and the STRICTA guidelines for transparent

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reporting in Korean RCTs of acupuncture. The endorsement of the CONSORT and revised

STRICTA statements in author instructions is also required.


• This study is the first to investigate the completeness of reporting in Korean RCTs of

acupuncture with regard to the CONSORT and STRICTA recommendations and their

changes over time.

•Our findings indicate that the majority of the core components of trials remained

substantially under-reported in Korean RCTs of acupuncture.

• The assessment criteria for the completeness of reporting in each item may differ from other

relevant reviews. Future periodical updates of the results are warranted.


trial

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Background

Rigorous randomised controlled trials (RCTs) can reduce bias and thus contribute to the

establishment of gold-standard evidence for medical interventions. A complete, accurate and

transparent report of RCTs facilitates dissemination, interpretation, translation and

replicability, whereas incomplete reporting of RCTs impedes the reliability of evidence.1 An

international group of clinical trialists, statisticians, epidemiologists and biomedical journal

editors developed the Consolidated Standards of Reporting Trials (CONSORT) statement to

improve the reporting of RCTs, thus enabling readers to understand the study design, conduct,

analysis and interpretation through complete transparency.2,3 The STandards for Reporting

Interventions in Clinical Trials of Acupuncture (STRICTA), which were developed by the

international experts of acupuncture and trialists in 2001 and revised in 2010, serves as an

official extension of the statement for descriptions of acupuncture treatments.1 Although

these statements aimed to improve the reporting of RCTs, a recent Cochrane review

suggested that the completeness of reporting remained suboptimal.3 There was also the

incompleteness of reporting of treatment details based on STRICTA checklist items in RCTs

of acupuncture published in English, which suggests that future research should investigate

the completeness of reporting in acupuncture trials in languages other than English.4 To the

best of our knowledge, no study has investigated the completeness of reporting of Korean

RCTs based on CONSORT and STRICTA checklist items in acupuncture research fields,

although acupuncture is regularly practised in Korea and many clinical trials assessing the

effects of acupuncture have been published in the Korean language.5 Hence, we aimed to

evaluate the completeness of reporting of RCTs of acupuncture indexed in the Korean

literature based on the CONSORT and revised STRICTA statements. We anticipate that this

study will reveal the current status of the completeness of reporting in RCTs of acupuncture

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indexed in the Korean literature. This study will thus provide information for facilitating

transparent and more complete reporting in RCTs of acupuncture.

Methods

Study design

The primary aim of this study was to identify the current weakest components of reporting

based on the CONSORT statement and the STRICTA guidelines. Another aim was to

investigate whether the completeness of reporting of RCTs had improved over time. We

stratified the RCTs based on the publication year. Trials that were published before 2005 and

from 2005 were grouped as those published in the ‘early’ period or the ‘late’ period,

respectively. We set the cut-off year as 2005 because we expected that it would take at least

four years for trial authors to be aware of and use the revised CONSORT statement and the

first STRICTA guidelines that were both published in 2001. The RCTs published in the ‘late’

period were used to identify the current status of reporting. We compared the RCTs in the

‘early’ period with those in the ‘late’ period to assess the changes of completeness of

reporting over time.

Type of studies

Parallel group RCTs of acupuncture listed in Korean databases and published either in

Korean or in English languages were eligible for inclusion in the present study. The Korean

RCTs listed in English databases were not eligible because the primary aim of this study was

to assess adherence to the CONSORT statement among trials in the Korean literature that

might be unknown due to language restriction or inaccessibility to the databases. We

excluded crossover or cluster RCTs because we employed the CONSORT guidelines for

parallel RCTs.

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We used RCTs that comprised patients who had any type of health problems or diseases. We

excluded RCTs that comprised healthy individuals.


For the CONSORT analyses, we defined acupuncture as a stimulation of the body or auricular

points regardless of the type of stimulation. We included studies using acupuncture-related

interventions that stimulate acupuncture points (i.e., acupuncture point injection or

acupressure) when classified and reported as a type of acupuncture in an RCT. We included

such studies because there is a diverse range of methods for acupuncture point stimulation

that is classified as a subtype of acupuncture in Korea.6 Studies testing moxibustion as a

primary intervention were excluded. Any type of control group interventions was eligible.


auricular points using manual and electrical stimulation because the STRICTA guidelines

were originally developed to report the components of needling acupuncture. RCTs

comparing acupuncture as a control group intervention with other types of treatments were

also eligible; only acupuncture-related information was extracted for the STRICTA analysis.

Studies that compared different types of needle-penetration acupuncture interventions were

also eligible; the most comprehensively described acupuncture intervention was extracted for

the STRICTA analysis.

Search methods

The studies included in this study were selected from the dataset of Korean RCTs previously

described.7 In that published study, 12 Korean databases (i.e., NANET, RISS, KISS, DBpia,

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KMbase, KoreaMed, KISTI, NDSL, OASIS, Dlibrary, KoreanTK and RICHIS) were

searched from their inception to July 2011. Simple search terms and strategies were used

(Table 1). Theses and dissertations that were accessible from four databases (NANET, RISS,

Dlibrary and RICHIS) were included if they met the eligibility criteria.

Data extraction

One author (K.H.K.) extracted general characteristics of the included RCTs, such as

publication year, type of acupuncture and control intervention, type and scope of journals,

number of arms and sample size. We used the CONSORT statement for parallel RCTs revised

in 2001 to assess the completeness of reporting of RCTs. Although the CONSORT initiatives

recommended the use of the most recently released version of CONSORT when reporting and

analysing RCTs,2 we did not use the revised CONSORT published in 2010 to avoid potential

systematic disadvantages for RCTs that were published before 2010.4 We used the revised

version of STRICTA guidelines published in 2010 to analyse the completeness of reporting of

treatment components of acupuncture in RCTs. We believe there was sufficient consistency

among the STRICTA guidelines between the original and revised versions, thereby justifying

the use of the latest version.8 We did not extract the data regarding non-acupuncture

interventions of a control group because our primary interest was to assess the completeness

of reporting of acupuncture treatment. Two authors (K.H.K. and J.W.K.) converted the

CONSORT statement and the STRICTA guidelines into 22 and 11 checklist items for data

extraction and assessment, respectively. The checklists of each statement provided in the

CONSORT and the STRICTA webpages served as the primary sources of data extraction and

assessment sheets.2,9 Each item had equal weight. Two authors (K.H.K. and J.W.K.)

independently assessed the completeness of reporting in each item. Any disagreements were

resolved with discussion.

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Two authors (K.H.K. and J.W.K.) rated each item as ‘yes’ or ‘no’ based on whether it was

reported in the study. For an item that contained multiple sub-items, the reporting of the item

was considered to be complete when at least one sub-item was completely reported. For

example, item #8 in the CONSORT statement assesses the random sequence generation with

two sub-items (i.e., the method used for generating the random allocation sequence, including

details of any restrictions). The reporting of the item was considered to be complete when the

sequence generation method was reported regardless of the information of restriction method

provided in a given RCT. We used the explanation and elaboration documents of the

CONSORT10 and the revised STRICTA

1 as assessment references. For item #4 in the

CONSORT statement (i.e., details of the intervention intended for each group and how and

when they were actually administered), we adopted and slightly modified the rating criteria of

Hoffmann et al.11 We selected four items (i.e., procedure, materials, intensity and schedule)

from the checklist11 that was developed to assess the reports of non-pharmacological

interventions in RCTs because we considered these items to be most relevant for the

replication of acupuncture interventions. If all of the four items were assessed as ”yes”, we

rated item #4 as ”yes”. Table 2 presents the detailed assessment criteria for item #4. Item #11

in the CONSORT statement (i.e., blinding of participants, intervention providers and outcome

assessors) was modified to include only the outcome assessor blinding. Participant and

intervention provider blinding is often not feasible in complex interventions, such as

acupuncture,12 whereas outcome assessors can be blinded without interfering with the

acupuncture treatment process. We rated item #18 (i.e., reporting of ancillary analyses) as

“yes” only if a RCT reported the results of ancillary analyses (e.g., subgroup analyses) with

the notion whether those analyses were prespecified, based on the elaboration document of

the CONSORT statement.10 Otherwise, the item was rated as “no”.

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The STRICTA guidelines recommended reporting acupuncture treatments that were actually

provided because what was in fact administered may likely have differed from the pre-

defined treatment protocol.1 We assumed the reporting of acupuncture interventions in RCTs

as performed because the distinctions were not clear in most cases.8 We calculated the

CONSORT and the STRICTA index scores to summarise the overall completeness of

reporting in one item by summing the scores of 22 items of the CONSORT checklist and 15

items of the STRICTA.13


For each time period (i.e., early and late), general publication details (e.g., sample size, type

of journals, acupuncture/non-acupuncture trials) were compared using t-tests or chi-square

tests. For each CONSORT and STRICA item, the number and the percentage of trials that

completely reported the item and the mean differences of percentages between two time

periods with binomial 95% confidence interval (CI) were reported. The STATA version 13.0

(Stata-Corp, College Station, TX, USA) was used for statistical analyses.

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Results


In total, 146 of 227 screened RCTs were included (Figure 1). Forty-three and 103 RCTs were

published in the early period (1996-2004) and the late period (2005-2011), respectively. The

primary interventions were needle acupuncture and non-needle acupuncture point stimulation

in 90 RCTs and 56 RCTs, respectively. The types of non-needle acupuncture point

stimulation were pharmacopuncture (i.e., the injection of herbal medicine), bee venom

acupuncture (i.e., the injection of diluted bee venom), and acupressure (by hand or device) or

non-penetrating electrostimulation to the acupuncture points. General characteristics of the

included RCTs are shown in Table 3.

Completeness of reporting for the CONSORT items

Of 103 RCTs published in the late period, there was considerable incompleteness of reporting

in items related to the study design, implementation, reporting and interpretation (Figure 2).

Items with markedly incomplete reporting were allocation concealment (item #9; 5.8%),

implementation of allocation process (item #10; 11.7%), definition of primary/secondary

outcomes (item #6; 15.5%), methods of sample size calculation (item #7; 2.9%), blinding of

outcome assessors (item #11; 20.3%), participant flow (item #13; 25.2%), number of

participants analysed (item #16; 19.4%), ancillary analyses (item #18; 0%), adverse events

(item #19; 24.3%), generalisability of the study findings (item #21; 1.9%) and overall

evidence (item #22; 32.0%).

Item #8 (random sequence generation) showed the most salient improvement over time

(mean difference 42.7%; 95% CI, 29.2% to 56.3%), although the completeness of reporting

remained modest in the late period (54.4%). The CONSORT Index score was significantly

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increased in the late period RCTs compared with the early period RCTs (p=0.0082) (Table 4).

The detailed information regarding the reporting of each item is shown in Appendix 1.

Completeness of reporting for the STRICTA items

We found that 61 RCTs of needle acupuncture interventions published in the late period

completely reported 9 of 15 items, with more than 70% of reporting rates (Figure 3). The

reporting of items for setting/context (24.6%) and practitioner background (27.9%), however,

remained incomplete in the late period. In all of the items, the completeness of reporting had

improved over time; the most prominent improvements of the completeness of reporting were

evident in items related to depth of needle insertion (item #6; mean difference 36.2%; 95% CI,

15.6% to 56.7% ), response to needle stimulation (item #7; mean difference 26.7%; 95%

CI,6.7% to 46.7%) and the methods of acupuncture stimulation (item #8; mean difference

23.5%; 95% CI, 2.7% to 44.3%). The STRICTA Index score was significantly increased in

the late period RCTs compared with the early period RCTs (p<0.0001) (Table 4). The detailed

information regarding the reporting of each item is provided in Appendix 2.

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Discussion


limit the assessment of internal validity and applicability of the trial results. Our findings are

consistent with those of previous studies that investigated the adherence of RCTs to

CONSORT and STRICTA statements in various clinical fields, including acupuncture.13-18

The reporting of the CONSORT items that are core components for assessing the risk of bias,

such as random sequence generation (item #8), concealment of allocation (item #9), outcome

assessor blinding (item #11), and flow of participants through each stage of trials (item #13),

were particularly incomplete. None of the Korean RCTs reported the critical criteria of

subgroup analyses (item #18) including the use of subgroup variables measured at baseline,

the prespecification of subgroup hypotheses, and the statistical significance of interaction

tests. The side effects of study interventions (item # 19) were reported in less than 25% of the

included RCTs, which does not permit the investigation of acupuncture safety in the context

of trials. Discussions regarding the generalisability of trial findings (item #21) were lacking

in the majority of the Korean RCTs, which may interfere with the application of trial results

to actual clinical situations. Overall, the completeness of reporting of Korean RCTs of

acupuncture was suboptimal, which could represent a significant obstacle to the

establishment of a sound evidence base.

Regarding the completeness of reporting of intervention details based on the revised

STRICTA statements, the theoretical background (items #1 to #3) and several details of the

needling processes (items #4, #5 and #9 to #12) showed relative completeness of reporting,

whereas the items related to contextual factors (items #13 and #14) were markedly under-

reported. The inconsistent completeness of reporting among items may imply that certain

items are perceived to be less important by researchers or journal editors,19 although there is

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no evidence to justify such inference in the Korean context. Practitioner qualifications were

also incompletely reported (item #15), which may increase the uncertainty with regard to

treatment quality and safe implementation of interventions. Collectively, the completeness of

reporting of acupuncture details was inconsistent, which may be problematic for replicating


Our findings indicate that the STRICTA items were generally more completely reported than

the CONSORT items because the subject of included studies was acupuncture. Another likely

explanation refers to the advantages from the translated Korean version of STRICTA

guidelines,20,21

whereas no official Korean translation of the CONSORT statement exists.

Currently, the official translated version of the CONSORT statement is available in 11

different languages22 to assist local authors in the comprehensive reporting of the

recommended trial components according to international standards.23,24

Consistent with

these international efforts, the official Korean translation of the CONSORT statement is

expected to be a useful resource for Korean authors and journal editors.

In a study that is being prepared separately, only one of 36 traditional Korean medical

journals (i.e., Journal of Acupuncture and Moxibustion Society) endorsed the CONSORT

statement and the STRICTA guidelines as a component of the author instructions

(unpublished). A recent Cochrane review found that four CONSORT items (i.e., allocation

concealment, introduction, sample size, and random sequence generation) and a total sum

score of 22 CONSORT items were significantly more completely reported in RCTs favouring

CONSORT-endorsing journals over the non-endorsers.3 The results are consistent with our

findings that the most incomplete reporting was in items related to allocation concealment,

sample size and random sequence generation. The absence of endorsement of the CONSORT

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statement and the STRICTA guidelines in the majority of Korean journals may be a potential

factor of incompleteness of reporting in Korean RCTs of acupuncture.

Strengths and limitations

The present study is the first systematic investigation to assess the completeness of reporting

of Korean RCTs of acupuncture based on the CONSORT statements. We attempted to

evaluate the best available dataset of Korean RCTs of acupuncture by employing extensive

search strategies that targeted 17 Korean databases; however, the likelihood of undetected

studies could not be completely excluded. Two recent articles analysed study characteristics

and bibliographic information using updated search results and database information.25,26

Our

finding needs periodic updates to monitor whether the items of the CONSORT statement and

the STRICTA guidelines are transparently and completely reported in Korean RCTs of

acupuncture. The weaknesses in our study should be mentioned. First, the cut-off year of the

CONSORT and STRICTA analysis was arbitrarily defined because there are no standard

criteria regarding a sufficient period for disseminating and implementing the CONSORT and


four years to implement the CONSORT and STRICTA recommendations into the design and

writing of a trial, no concrete evidence justifies our assumption. Second, we considered the

partial reporting of CONSORT and STRICTA items that had multiple sub-items as complete

despite the fact that the recent Cochrane review considered only full descriptions of the

required content for a given item as complete.3 Consequently, our assessment may have

reported inflated scores and our findings should be considered as results under the best-case

scenario. Third, time may serve as a potential confounder for the completeness of reporting,

which may have naturally changed over time regardless of the use of the CONSORT

statement and the STRICTA guidelines by trial authors.3 Whether trial authors referred to the

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CONSORT statement and the STRICTA guidelines was not investigated in this study; thus,

we do not know that more complete reporting in several items and the higher aggregate

scores might be related either to the natural improvement over time or to the influences of

these resources on the trial reporting by Korean researchers.


Collective efforts for increasing adherence to the CONSORT statement and the STRICTA

guidelines during design, implementation and reporting of clinical trials are needed to

improve the completeness of reporting in Korean RCTs of acupuncture. In particular, the

items related to randomisation, concealment of allocation, blinding of outcome assessors,

flow of participants, subgroup analyses and harms of acupuncture should be more completely

reported in future Korean RCTs of acupuncture. There should be improved reporting of

practitioner- and context-related STRICTA items. Barriers related to the incompleteness of

reporting by Korean authors of RCTs should also be investigated. The endorsement of the

CONSORT statement and the STRICTA guidelines in the relevant Korean medical journals is

urgently required. All of the stakeholders (editors, peer-reviewers and authors) should

promote the use of these resources during the manuscript preparation, submission and peer-

review processes. Relevant education is necessary. The official version of the Korean

translation of the CONSORT statement is required to increase the accessibility of

international trial reporting guidelines by Korean researchers.

Conclusions

The completeness of reporting in Korean RCTs of acupuncture has remained suboptimal over

time. Trial authors and journal editors should use the CONSORT statement and the STRICTA

guidelines for transparent reporting of Korean RCTs of acupuncture.

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Contributorship statement





Competing interests

There are no competing interests.

Funding

The study was supported by the Korea Institute of Oriental Medicine (K14400). The views

expressed are not necessarily those of the funding body.

Data sharing

Extra data is available by e-mailing the first author (K.H.K; [email protected]).

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References




2. The CONSORT Group. www.consort-statement.org (Accessed 20 May).






PLoS One 2008;3(2):e1577.



6. Textbook publication committee of the Korean Acupuncture and Moxibustion Medicine

Society. Textbook of the Acupuncture and Moxibustion Medicine. Seoul: Jipmoondang,

2012:143-254.

7. Kim KH, Kong JC, Choi JY, et al. Impact of including korean randomized controlled trials

in cochrane reviews of acupuncture. PLoS One 2012;7(10):e47619.

8. Kim KH, Kang JWL, M S, Lee JD. Assessment of the quality of reporting for treatment


9. The STRICTA checklist. http://http://www.stricta.info/checklist.html (Accessed 26 May

2014).

10. Altman DG, Schulz KF, Moher D, et al. The revised CONSORT statement for reporting

randomized trials: explanation and elaboration. Ann Intern Med 2001;134(8):663-94.

11. Hoffman TC, Erueti C, Glasziou PP. Poor description of non-pharmacological

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2011;6(2):e16922.



2009;48(5):307-13.



China. Clin Ther 2007;29(7):1456-67.

18. Hammerschlag R, Milley R, Colbert A, et al. Randomized Controlled Trials of

Acupuncture (1997-2007): An Assessment of Reporting Quality with a CONSORT- and

STRICTA-Based Instrument. Evid Based Complement Alternat Med 2011;2011.





Journal of Acupuncture 2010;27(3):1-23.

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Moxibustion Society 2002;19(6):135-54.

22. CONSORT translations. http://www.consort-statement.org/downloads/translations

(Accessed 24 May 2014).



2010;14(3):5-6.





Complementary and Alternative Medicine in Korea. Eur J Integr Med 2014;6(1):64-73.


Korean literature: bibliometric analysis and methodological quality. Acupunct Med

2014;32(2):160-6.

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English search term

#1 Acupuncture related acupuncture OR acupressure OR acupoint OR meridian OR

acup*

#2 Design related Random OR control OR group OR divide

#3 #1 AND #2

Korean search term

#1 침 OR 경혈 OR 경락

# 2 대조군 OR 무작위

# 3 # 1 AND # 2

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Duration (item 3b)

Frequency (item 3b)


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Early period

(1996~2004)

(n=43)

Late period

(2005-2013)

(n=103)




Type of journals


Unpublished (Master dissertation or PhD Thesis) 0 (0.0%) 6 (5.8%)

Scope of journals

Acupuncture-related 34 (79.1%) 93 (90.3%)

Othersa 9 (20.9%) 10 (9.7%)

Sample sizeb 45.6 (49.5) 41.3 (19.4)





Type of control


Sham or placebo 5 (11.6%) 31 (30.1%)

Waitlist 3 (7.0%) 2 (1.9%)

Number of arms

2 arms 39 (90.7%) 92 (89.3%)

3 or 4 arms 4 (9.3%) 11 (10.7%)

aOthers refer to journals that are not related with acupuncture and unpublished dissertion/thesis.





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Table 4. Comparison of the CONSORT/STRICTA index between early and late periods


CONSORT

Early period (1996-2004) 43 9.5 8.9 to 10.2

Late period (2005-2011) 103 10.6 10.2 to 11.1

Difference 1.1 0.2 to 1.9 0.0082

STRICTA

Early period (1996-2004) 29 8.8 7.9 to 9.7

Late period (2005-2011) 61 11.2 10.5 to 11.8

Difference 2.3 1.2 to 3.4 <0.0001

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Figure 2: Percentage of RCTs with complete reporting of the CONSORT items

RCT; randomized controlled trial

# and number in the parentheses refers to the item number.

Green dash in the figure indicates a reference line of 50%.

Blue and red bar represent the percentages of RCTs with complete reporting in early and late

period, respectively.

Figure 3: Percentage of RCTs with complete reporting of the STRICTA items






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Seoul, South Korea






guideline







Tel : 82-(0) 2-958-9207

Fax: 82-(0) 2-958-9211


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Abstract

























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changes over time.






trial

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Background
























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Methods

Study design












Type of studies







parallel RCTs.

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that is classified as a subtype of acupuncture in Korea.6 Studies testing moxibustion as a

primary intervention were excluded. Any type of control group interventions was eligible.









Search methods



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Data extraction




















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Results























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Discussion
























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guidelines,20,21





Consistent with












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Our
















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Conclusions




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Competing interests


Funding



Data sharing


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References










PLoS One 2008;3(2):e1577.





2012:143-254.






2014).




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2011;6(2):e16922.



2009;48(5):307-13.



China. Clin Ther 2007;29(7):1456-67.









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2010;14(3):5-6.








2014;32(2):160-6.

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English search term


acup*


#3 #1 AND #2

Korean search term



# 3 # 1 AND # 2

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Duration (item 3b)

Frequency (item 3b)


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Early period

(1996~2004)

(n=43)

Late period

(2005-2013)

(n=103)




Type of journals



Scope of journals


Othersa 9 (20.9%) 10 (9.7%)

Sample sizeb 45.6 (49.5) 41.3 (19.4)





Type of control


Sham or placebo 5 (11.6%) 31 (30.1%)

Waitlist 3 (7.0%) 2 (1.9%)

Number of arms

2 arms 39 (90.7%) 92 (89.3%)

3 or 4 arms 4 (9.3%) 11 (10.7%)






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CONSORT

Early period (1996-2004) 43 9.5 8.9 to 10.2

Late period (2005-2011) 103 10.6 10.2 to 11.1

Difference 1.1 0.2 to 1.9 0.0082

STRICTA

Early period (1996-2004) 29 8.8 7.9 to 9.7

Late period (2005-2011) 61 11.2 10.5 to 11.8

Difference 2.3 1.2 to 3.4 <0.0001

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90x100mm (300 x 300 DPI)

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108x79mm (300 x 300 DPI)

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108x79mm (300 x 300 DPI)

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Appendix 1. The number of Korean RCTs reporting each CONSORT item

Item no Summarized descriptor Early period (1996~2004) Late period (2005~2011) Mean difference [95% CI]

N=43 % [95% CI] N=103 % [95% CI]



Methods






Randomization


9 Allocation

concealment


sequence 0 0.0 [0.0, 0.0] 6 5.8 [1.3, 10.3] 5.8 [1.3, 10.3]





Results




group 40 93.0 [85.4, 100.6] 97 94.1 [89.7, 98.7] 1.2 [-7.7, 10.0]




43 100.0 [100.0, 100.0] 102 99.0 [97.1, 100.9] -1.0 [-2.9, 0.9]


performed 0 0.0 [0.0, 0.0] 0 0.0 [0.0, 0.0] 0.0 [0.0, 0.0]



Discussion






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Appendix 2. The number of Korean RCTs reporting each STRICTA item

Early period (~ 2004) Late period (2005~2011)



1) Style of acupuncture 26 89.7 [78.6, 100.7] 59 96.7 [92.3, 101.2] 7.1 [-4.9, 19.0]

2) Reasoning of treatments 18 62.1 [44.4, 79.7] 52 85.2 [76.3, 94.1] 23.1 [3.4, 43.0]

3) Acupuncture regimen variation 25 86.2 [73.7, 98.8] 60 98.4 [95.2, 101.5] 12.2 [-0.8, 25.1]

2. Needling details

4) Number of needles 20 69.0 [52.1, 85.8] 55 90.2 [82.7, 97.6] 21.2 [2.8, 39.6]

5) Names of points 26 89.7 [78.6, 100.7] 59 96.7 [92.3, 101.2] 7.0 [-4.8, 19.0]

6) Depth of insertion 9 31.0 [14.2, 47.9] 41 67.2 [55.4, 79.0] 36.2 [15.6, 56.7]

7) Response to needle 7 24.1 [8.6, 39.7] 31 50.8 [38.3, 63.4] 26.7 [6.7, 46.7]

8) Needle stimulation methods 16 55.2 [37.1, 73.3] 48 78.7 [68.4, 89.0] 23.5 [2.7, 44.3]

9) Retention time 26 89.7 [78.6, 100.7] 56 91.8 [84.9, 98.7] 2.1 [-10.9, 15.2]

10) Type of needles 24 82.8 [69.0, 96.5] 52 85.2 [76.3, 94.1] 2.5 [-13.9, 18.9]


11) Number of sessions 19 65.5 [48.2, 82.8] 51 83.6 [74.3, 93.0] 18.1 [-1.5, 37.7]

12) Frequency / duration 23 79.3 [64.6, 94.1] 56 91.8 [84.9, 98.7] 12.5 [-3.8, 28.8]


13) Details of other treatments 14 48.3 [30.1, 66.5] 32 52.5 [39.9, 65.0] 4.2 [-17.9, 26.3]

14) Setting and context 4 13.8 [1.2, 26.3] 15 24.6 [13.8, 35.4] 10.8 [-5.8, 27.4]





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Assessment of the quality of reporting in randomized controlled trials of acupuncture in the Korean literature

using the CONSORT statement and the STRICTA guidelines

Journal: BMJ Open

Manuscript ID: bmjopen-2014-005068.R2


Date Submitted by the Author: 01-Jul-2014






Keywords: COMPLEMENTARY MEDICINE, EDUCATION & TRAINING (see Medical Education & Training), EPIDEMIOLOGY




jopen.bmj.com

/B

MJ O


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Seoul, South Korea






guideline







Tel : 82-(0) 2-958-9207

Fax: 82-(0) 2-958-9211


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Abstract

























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changes over time.






trial

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Background
























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Methods

Study design












Type of studies







parallel RCTs.

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that is classified as a subtype of acupuncture in Korea.6 Studies that combined acupuncture

with moxibustion were eligible when they used moxibustion as one of co-interventions of

acupuncture. Studies testing moxibustion as a primary intervention were excluded. Any type

of control group interventions was eligible.









Search methods

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Data extraction


















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Results























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Discussion
























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guidelines,20,21





Consistent with












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Our
















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Conclusions




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Competing interests


Funding



Data sharing


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References










PLoS One 2008;3(2):e1577.





2012:143-254.






2014).




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2011;6(2):e16922.



2009;48(5):307-13.



China. Clin Ther 2007;29(7):1456-67.









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2010;14(3):5-6.








2014;32(2):160-6.

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English search term


acup*


#3 #1 AND #2

Korean search term



# 3 # 1 AND # 2

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Duration (item 3b)

Frequency (item 3b)


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Early period

(1996~2004)

(n=43)

Late period

(2005-2013)

(n=103)




Type of journals



Scope of journals


Othersa 9 (20.9%) 10 (9.7%)

Sample sizeb 45.6 (49.5) 41.3 (19.4)





Type of control


Sham or placebo 5 (11.6%) 31 (30.1%)

Waitlist 3 (7.0%) 2 (1.9%)

Number of arms

2 arms 39 (90.7%) 92 (89.3%)

3 or 4 arms 4 (9.3%) 11 (10.7%)






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CONSORT

Early period (1996-2004) 43 9.5 8.9 to 10.2

Late period (2005-2011) 103 10.6 10.2 to 11.1

Difference 1.1 0.2 to 1.9 0.0082

STRICTA

Early period (1996-2004) 29 8.8 7.9 to 9.7

Late period (2005-2011) 61 11.2 10.5 to 11.8

Difference 2.3 1.2 to 3.4 <0.0001

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Seoul, South Korea






guideline







Tel : 82-(0) 2-958-9207

Fax: 82-(0) 2-958-9211


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Abstract

























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changes over time.






trial

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Background
























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Methods

Study design












Type of studies







parallel RCTs.

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that is classified as a subtype of acupuncture in Korea.6 Studies that combined acupuncture

with moxibustion were eligible when they used moxibustion as one of co-interventions of

acupuncture. Studies testing moxibustion as a primary intervention were excluded. Any type

of control group interventions was eligible.









Search methods

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Data extraction


















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Results























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Discussion
























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guidelines,20,21





Consistent with












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Our
















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Conclusions




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Competing interests


Funding



Data sharing


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References










PLoS One 2008;3(2):e1577.





2012:143-254.






2014).




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2011;6(2):e16922.



2009;48(5):307-13.



China. Clin Ther 2007;29(7):1456-67.









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2010;14(3):5-6.








2014;32(2):160-6.

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English search term


acup*


#3 #1 AND #2

Korean search term



# 3 # 1 AND # 2

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Duration (item 3b)

Frequency (item 3b)


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Early period

(1996~2004)

(n=43)

Late period

(2005-2013)

(n=103)




Type of journals



Scope of journals


Othersa 9 (20.9%) 10 (9.7%)

Sample sizeb 45.6 (49.5) 41.3 (19.4)





Type of control


Sham or placebo 5 (11.6%) 31 (30.1%)

Waitlist 3 (7.0%) 2 (1.9%)

Number of arms

2 arms 39 (90.7%) 92 (89.3%)

3 or 4 arms 4 (9.3%) 11 (10.7%)






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CONSORT

Early period (1996-2004) 43 9.5 8.9 to 10.2

Late period (2005-2011) 103 10.6 10.2 to 11.1

Difference 1.1 0.2 to 1.9 0.0082

STRICTA

Early period (1996-2004) 29 8.8 7.9 to 9.7

Late period (2005-2011) 61 11.2 10.5 to 11.8

Difference 2.3 1.2 to 3.4 <0.0001

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90x100mm (300 x 300 DPI)

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108x79mm (300 x 300 DPI)

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108x79mm (300 x 300 DPI)

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Appendix 1. The number of Korean RCTs reporting each CONSORT item

Item no Summarized descriptor Early period (1996~2004) Late period (2005~2011) Mean difference [95% CI]

N=43 % [95% CI] N=103 % [95% CI]



Methods






Randomization


9 Allocation

concealment


sequence 0 0.0 [0.0, 0.0] 6 5.8 [1.3, 10.3] 5.8 [1.3, 10.3]





Results




group 40 93.0 [85.4, 100.6] 97 94.1 [89.7, 98.7] 1.2 [-7.7, 10.0]




43 100.0 [100.0, 100.0] 102 99.0 [97.1, 100.9] -1.0 [-2.9, 0.9]


performed 0 0.0 [0.0, 0.0] 0 0.0 [0.0, 0.0] 0.0 [0.0, 0.0]



Discussion






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Appendix 2. The number of Korean RCTs reporting each STRICTA item

Early period (~ 2004) Late period (2005~2011)



1) Style of acupuncture 26 89.7 [78.6, 100.7] 59 96.7 [92.3, 101.2] 7.1 [-4.9, 19.0]

2) Reasoning of treatments 18 62.1 [44.4, 79.7] 52 85.2 [76.3, 94.1] 23.1 [3.4, 43.0]

3) Acupuncture regimen variation 25 86.2 [73.7, 98.8] 60 98.4 [95.2, 101.5] 12.2 [-0.8, 25.1]

2. Needling details

4) Number of needles 20 69.0 [52.1, 85.8] 55 90.2 [82.7, 97.6] 21.2 [2.8, 39.6]

5) Names of points 26 89.7 [78.6, 100.7] 59 96.7 [92.3, 101.2] 7.0 [-4.8, 19.0]

6) Depth of insertion 9 31.0 [14.2, 47.9] 41 67.2 [55.4, 79.0] 36.2 [15.6, 56.7]

7) Response to needle 7 24.1 [8.6, 39.7] 31 50.8 [38.3, 63.4] 26.7 [6.7, 46.7]

8) Needle stimulation methods 16 55.2 [37.1, 73.3] 48 78.7 [68.4, 89.0] 23.5 [2.7, 44.3]

9) Retention time 26 89.7 [78.6, 100.7] 56 91.8 [84.9, 98.7] 2.1 [-10.9, 15.2]

10) Type of needles 24 82.8 [69.0, 96.5] 52 85.2 [76.3, 94.1] 2.5 [-13.9, 18.9]


11) Number of sessions 19 65.5 [48.2, 82.8] 51 83.6 [74.3, 93.0] 18.1 [-1.5, 37.7]

12) Frequency / duration 23 79.3 [64.6, 94.1] 56 91.8 [84.9, 98.7] 12.5 [-3.8, 28.8]


13) Details of other treatments 14 48.3 [30.1, 66.5] 32 52.5 [39.9, 65.0] 4.2 [-17.9, 26.3]

14) Setting and context 4 13.8 [1.2, 26.3] 15 24.6 [13.8, 35.4] 10.8 [-5.8, 27.4]





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