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Clinical trial registration, and publication in acupuncture studies: A systematic review.

ABSTRACT: Background:To research 1) how many acupuncture clinical trials are registered with the WHO International Clinical Trial Registry Platform (ICTRP) and what patterns they demonstrate, 2) publication of the articles of acupuncture clinical trials which were registered with ICTRP. Methods:The search strategy using the ICTRP: Intervention: acupuncture; Recruitment status: All; Date of registration; from 1 Jan 1990 to 31 Dec 2018. We searched the indexed articles in PubMed using trial IDs on 25 Feb 2019. When the paper was published, we indicated the number of weeks from the date of registration with ICTRP to the date of publication in order to define time till the publication. We divided the whole period we analyzed into 6 periods of every 3 years and measured the proportion of publication and the time from the date of registration of each trial till its publication in each period by the Kaplan-Meier method. Results:Forty-three countries/areas conducted at least one acupuncture clinical trial. The total number of registrations was 1758. China, the USA, and the Republic of Korea accounted for 61% of those registrations. The proportion of publication was 178/1758 10% for the fully published papers and 141/1758 8% for the protocol papers. Conclusions:The substantial increase of registrations by China, the Republic of Korea, Iran, Brazil, Japan was observed which may be attributed to improved awareness of the CONSORT statement. However, the fully published papers rate is low at 10%. The publication of results of acupuncture clinical trials should also be rigorously mandated.

SUBMITTER: Matsuura Y

PROVIDER: S-EPMC7021548 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Clinical trial registration, and publication in acupuncture studies: A systematic review.

Matsuura Yuto Y Takazawa Wlch Naomi N Sakai Tomomi T Tsutani Kiichiro K

Integrative medicine research 20200120 1

<h4>Background</h4>To research 1) how many acupuncture clinical trials are registered with the WHO International Clinical Trial Registry Platform (ICTRP) and what patterns they demonstrate, 2) publication of the articles of acupuncture clinical trials which were registered with ICTRP.<h4>Methods</h4>The search strategy using the ICTRP: Intervention: acupuncture; Recruitment status: All; Date of registration; from 1 Jan 1990 to 31 Dec 2018. We searched the indexed articles in PubMed using trial I ...[more]

PMID: 32082988

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Project description:Previously, we reviewed 1052 randomized-controlled trial abstracts presented at the American Society of Anesthesiologists annual meetings from 2001-2004. We found significant positive publication bias in the period examined, with the odds ratio for abstracts with positive results proceeding to journal publication over those with null results being 2.01 [95% confidence interval: 1.52, 2.66; P < 0.001]. Mandatory trial registration was introduced in 2005 as a required standard for publication. We sought to examine whether mandatory trial registration has decreased publication bias in the anesthesia and perioperative medicine literature. We reviewed all abstracts from the 2010-2016 American Society of Anesthesiologists meetings that reported on randomized-controlled trials in humans. We scored the result of each abstract as positive or null according to a priori definitions. We systematically searched for any subsequent publication of the studies and calculated the odds ratio for journal publication, comparing positive vs null studies. We compared the odds ratio from the 2010-2016 abstracts (post-mandatory trial registration) with the odds ratio from the 2001-2004 abstracts (pre-mandatory trial registration) as a ratio of odds ratios. We defined a 33% decrease in the odds ratio as significant, corresponding to a new odds ratio of 1.33. We reviewed 9789 abstracts; 1049 met inclusion criteria as randomized-controlled trials, with 542 (51.7%) of the abstracts going on to publication. The odds ratio for abstracts with positive results proceeding to journal publication was 1.28 [95% CI: 0.97, 1.67; P = 0.076]. With adjustment for sample size and abstract quality, the difference in publication rate between positive and null abstracts was statistically significant (odds ratio 1.34; 95% CI: 1.02, 1.76; P = 0.037). The ratio of odds ratios, comparing the odds ratio from the 2010-2016 abstracts (post-mandatory trial registration) to the odds ratio from the 2001-2004 abstracts (pre-mandatory trial registration), was 0.63 (95% CI: 0.43, 0.93); P = 0.021). We present the first study in the anesthesia and perioperative medicine literature that examines and compares publication bias over two discrete periods of time, prior to and after the implementation of mandatory trial registration. Our results suggest that the amount of publication bias has decreased markedly following implementation of mandatory trial registration. However, some positive publication bias in the anesthesia and perioperative medicine literature remains.

Project description:ObjectiveOverview on risks of acupuncture-related adverse events (AEs).DesignSystematic review and meta-analyses of prospective studies.Data sourcesPubMed, Scopus and Embase from inception date to 15 September 2019.Eligibility criteria for selecting studiesProspective studies assessing AEs caused by needle acupuncture in humans as primary outcome published in English or German.Data extraction and synthesisTwo independent researchers selected articles, extracted the data and assessed study quality. Overall risks and risks for different AE categories were obtained from random effects meta-analyses.Main outcomesOverall risk of minor AEs and serious adverse events (SAEs) per patients and per treatments.ResultsA total of 7679 publications were identified. Twenty-two articles reporting on 21 studies were included. Meta-analyses suggest at least one AE occurring in 9.31% (95% CI 5.10% to 14.62%, 11 studies) of patients undergoing an acupuncture series and in 7.57% (95% CI 1.43% to 17.95%, 5 studies) of treatments. Summary risk estimates for SAEs were 1.01 (95% CI 0.23 to 2.33, 11 studies) per 10 000 patients and 7.98 (95% CI 1.39 to 20.00, 14 studies) per one million treatments, for AEs requiring treatment 1.14 (95% CI 0.00 to 7.37, 8 studies) per 1000 patients. Heterogeneity was substantial (I2 >80%). On average, 9.4 AEs occurred in 100 treatments. Half of the AEs were bleeding, pain or flare at the needle site that are argued to represent intended acupuncture reaction. AE definitions and assessments varied largely.ConclusionAcupuncture can be considered among the safer treatments in medicine. SAEs are rare, and the most common minor AEs are very mild. AEs requiring medical management are uncommon but necessitate medical competence to assure patient safety. Clinical and methodological heterogeneity call for standardised AE assessments tools, clear criteria for differentiating acupuncture-related AEs from therapeutically desired reactions, and identification of patient-related risk factors for AEs.Prospero registration numberCRD42020151930.

Project description:ImportancePrimary outcome change could threaten the validity of a clinical trial; however, evidence about the consequences on the reported intervention effect size is unclear.ObjectivesTo examine the status of randomized clinical trials whose primary outcome changed between trial registration and publication and to quantify the association of this change with the reported intervention effect size.Design, setting, and participantsIn this cross-sectional study on the primary report of randomized clinical trials with clear prospectively registered primary outcomes, PubMed and Embase were searched for articles published between January 1, 2011, and December 31, 2015. The search was conducted in January 2016, identifying randomized clinical trials and the combination of keywords and text words related to registry.Main outcomes and measuresBased on the developed approach, trials were classified as having primary outcome change when there was a major discrepancy between the registered and published primary outcomes. Intervention effect was estimated or recalculated using the odds ratio (OR) for each comparison. Each component OR is structured so that an OR is less than 1 if the intervention group has a more favorable result than the control group. The ratio of ORs (ROR), which is the summary OR for trials with primary outcome change divided by those without, and its 95% CI were calculated, with a value less than 1 indicating a larger reported intervention effect size in trials with primary outcome change than those without.ResultsAmong 29 749 searched articles (28 810 MEDLINE and 939 Embase), 1488 articles were randomly selected for review. Of 389 trials with clear primary outcomes prospectively described in the registry (416 outcomes reported), 33.4% (130 of 389) of trials had at least 1 primary outcome change. Most (66 of 130) of the changes were either not reporting or omitting the primary outcome. In total, 338 trials (365 outcomes and 487 comparisons) were available for quantitative analysis on the reported intervention effect size bias assessment. Compared with those without primary outcome change, trials with primary outcome change showed a 16% (pooled ROR, 0.84; 95% CI, 0.73-0.96) larger reported intervention effect size. The result persisted after adjustment for potential confounders (ROR, 0.81; 95% CI, 0.71-0.93) and other sensitivity and subgroup analyses.Conclusions and relevanceResults of this study suggest that inconsistencies between registered and published primary outcomes of clinical trials are common, and trials with primary outcome change are likely to have a larger intervention effect than those without.

Project description:BackgroundClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.Methods and findingsWe examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515), nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46%) of trials were published, among which 96 (31%) provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357) were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001), but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22). Among trials that reported an end date, 75 of 123 (61%) completed prior to 2004, 50 of 96 (52%) completed during 2004, and 62 of 149 (42%) completed during 2005 were published (p = 0.006).ConclusionsReporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data elements, the potential for ClinicalTrials.gov to address selective publication of clinical trials will be limited. Please see later in the article for the Editors' Summary.

Project description:Acupuncture clinical practice guidelines are authoritative medical recommendations developed by evaluating and integrating acupuncture-related evidence. However, their synthesis and dissemination are not integrated, and clinical practitioners require more credible effective evidence. The study aim was to systematically review problems disseminating acupuncture clinical practice guidelines to clinical practitioners, to facilitate evidence dissemination. This systematic review included searches of PubMed, EBSCO, Web of Science, and four major Chinese electronic databases (CNKI, VIP, Wanfang Database, and SinoMed) from inception to October 26, 2021. Two independent reviewers screened the literature, extracted information, and evaluated the quality of included studies. A systematic review was subsequently performed. Eleven studies were reviewed: nine (81.8%) cross-sectional surveys and two (18.2%) systematic reviews. The evaluated clinical practice guidelines differed across studies; seven studies (63.6%) evaluated guidelines for a specific disease, one (9.1%) evaluated guidelines for acupuncture therapies (e.g., moxibustion and fire acupuncture), one (9.1%) evaluated US acupuncture guidelines and recommendations, and two (18.2%) did not describe the guideline content. The included studies used different evaluation indicators. Guideline dissemination problems included lack of guideline standardization, unclear target population, mismatch between guidelines and application environment, lack of reliable health economics evaluation, poor quality content of the recommendations, lack of linkage between recommendations and evidence, and disassociation of recommendations from clinical practice et al. The development and publishing of credible acupuncture clinical practice guidelines is urgently needed to improve the usability of guidelines and standardize and disseminate tools for analysing information to clinical practitioners and to help the domestic and international acupuncture community to apply evidence to practice. Recommendations for promoting the dissemination of acupuncture clinical practice guidelines are to define clinical events suitable for the target population, to develop recommendations relevant to clinical practice, to improve the evidence evaluation index system, and to further standardize the method and process of formulating guidelines.

Project description:ObjectiveThe registration of clinical trials is required by law in Switzerland. We investigated (1) the proportion of registered and prospectively registered clinical trials, (2) the availability of results for ethically approved trial protocols, (3) factors associated with increased registration, and (4) reasons for non-registration.Design and settingWe included all clinical trials with mandatory prospective registration, which were approved by the ethics committee of Northwestern and Central Switzerland between January 1, 2016, and December 31, 2020.MethodsWe extracted relevant trial characteristics from the Swiss Business Administration System for Ethics Committees and systematically searched the International Clinical Trials Registry Platform and primary trial registries for corresponding registry entries. We used multivariable logistic regression to examine the association between trial characteristics and registration. We qualitatively assessed reasons for non-registration of trials through an email questionnaire for trial investigators.ResultsOf 473 included clinical trials, 432 (91%) were registered at all and 326 (69%) were prospectively registered. While the percentages of registration and prospective registration of investigator-sponsored trials increased from 85 to 93% and from 59 to 70% over 5 years, respectively, industry-sponsored trials consistently remained at a high level of prospective registration (92 to 100%). Trials with multiple centres, higher risk category, or methodological support from the local clinical trials unit were independently associated with increased registration rates. Of 103 clinical trials completed before August 2020, results were available for 70% of industry-sponsored trials and 45% of investigator-sponsored trials as peer-reviewed journal publications or in trial registries. Most common reasons for non-registration provided by investigators were lack of time or resources (53%), lack of knowledge (22%), and lack of reminders by the ethics committee (36%).ConclusionsIn Northwestern and Central Switzerland about 10% of clinical trials remained unregistered despite the obligation by law. More support for investigators and stricter enforcement by regulators are needed to improve the transparency of investigator-sponsored trials in particular.

Project description:BackgroundAcupuncture effectively improves cognitive function in Alzheimer's disease (AD). Many neuroimaging studies have found significant brain alterations after acupuncture treatment of AD, but the underlying central modulation mechanism is unclear.ObjectiveThis review aims to provide neuroimaging evidence to understand the central mechanisms of acupuncture in patients with AD.MethodsRelevant neuroimaging studies about acupuncture for AD were retrieved from eight English and Chinese medicine databases (PubMed, Embase, Cochrane Library, Web of Science, SinoMed, CNKI, WF, VIP) and other resources from inception of databases until June 1, 2022, and their methodological quality was assessed using RoB 2.0 and ROBINS - I. Brain neuroimaging information was extracted to investigate the potential neural mechanism of acupuncture for AD. Descriptive statistics were used for data analysis.ResultsThirteen neuroimaging studies involving 275 participants were included in this review, and the overall methodological quality of included studies was moderate. The approaches applied included task-state functional magnetic resonance imaging (ts-fMRI; n = 9 studies) and rest-state functional magnetic resonance imaging (rs-fMRI; n = 4 studies). All studies focused on the instant effect of acupuncture on the brains of AD participants, including the cingulate gyrus, middle frontal gyrus, and cerebellum, indicating that acupuncture may regulate the default mode, central executive, and frontoparietal networks.ConclusionThis study provides evidence of the neural mechanisms underlying the effect of acupuncture on AD involving cognitive- and motor-associated networks. However, this evidence is still in the preliminary investigation stage. Large-scale, well-designed, multimodal neuroimaging trials are still required to provide comprehensive insight into the central mechanism underlying the effect of acupuncture on AD. (Systematic review registration at PROSPERO, No. CRD42022331527).

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Clinical trial registration, and publication in acupuncture studies: A systematic review.

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Clinical trial registration, and publication in acupuncture studies: A systematic review.

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