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Assessing the quality of reports about randomized controlled trials of scalp acupuncture combined with another treatment for stroke.

ABSTRACT: BACKGROUND:This study was designed to assess the quality of reporting on randomized controlled trials (RCTs) of scalp acupuncture for the treatment of stroke. METHODS:The following 8 databases were systematically investigated from their inception to December 2015: PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, National Institute of Informatics Scholarly and Academic Information Navigator, National Digital Science Library, Korean Traditional Knowledge Portal, and Korean Studies Information Service System. RCTs utilizing scalp acupuncture as an intervention for stroke were selected, and the quality of reports was assessed based on the Consolidated Standards of Reporting Trials 2010 statement (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture 2010 (STRICTA). For each study, the overall quality score (OQS) of 13 CONSORT items, a combined key methodological index score (MIS) of 5 CONSORT items, and the OQS of 17 STRICTA items were measured. RESULTS:The original reports of 63 RCTs were ultimately obtained, and the median CONSORT OQS was 7 (minimum 2, maximum 11). Particularly, the items 'trial design', 'sample size', 'ancillary analyses', and 'harms' had a positive rate of less than 10%. The median MIS was 1 (minimum 0, maximum 5), with 'allocation concealment and implementation' and 'intent-to-treat analysis (ITT) analysis' having a positive rate of less than 10%. The median STRICTA OQS was 11 (minimum 6, maximum 14), and only the items 'sample size' and 'intent-to-treat analysis' were reported, with a positive rate of less than 10%. The mean CONSORT OQS increased by approximately 0.81 for each 5-year period in which manuscripts were published (95% confidence interval: 0.43 to 1.19; p < 0.001). No variable was significantly associated with MIS in the ordinal regression model. CONCLUSION:The quality of reports on RCTs investigating scalp acupuncture treatment for stroke was moderate to low. Furthermore, reporting of some items was either insufficient or inadequate in the majority of studies. In order to improve and standardize the quality of RCTs investigating scalp acupuncture for stroke, CONSORT and STRICTA guidelines should be utilized more frequently.

SUBMITTER: You YN

PROVIDER: S-EPMC5588620 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Assessing the quality of reports about randomized controlled trials of scalp acupuncture combined with another treatment for stroke.

You Young-Nim YN Cho Myung-Rae MR Kim Jae-Hong JH Park Ju-Hyung JH Park Gwang-Cheon GC Song Min-Yeong MY Choi Jin-Bong JB Han Jae-Young JY

BMC complementary and alternative medicine 20170906 1

<h4>Background</h4>This study was designed to assess the quality of reporting on randomized controlled trials (RCTs) of scalp acupuncture for the treatment of stroke.<h4>Methods</h4>The following 8 databases were systematically investigated from their inception to December 2015: PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, National Institute of Informatics Scholarly and Academic Information Navigator, National Digital Science Library, Korean Traditional Knowledge Po ...[more]

PMID: 28877716

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Project description:BackgroundTo evaluate the reports' qualities which are about randomized controlled trials (RCTs) of acupuncture treatment on Diabetic Peripheral Neuropathy (DPN).Methodology/principal findingsEight databases including The Cochrane Library(1993-Sept.,2011), PubMed (1980-Sept., 2011), EMbase (1980-Sept.,2011), SCI Expanded (1998-Sept.,2011), China Biomedicine Database Disc (CBMdisc, 1978-Sept., 2011), China National Knowledge Infrastructure (CNKI, 1979-Sept., 2011 ), VIP (a full text issues database of China, 1989-Sept., 2011), Wan Fang (another full text issues database of China 1998-Sept., 2011) were searched systematically. Hand search for further references was conducted. Language was limited to Chinese and English. We identified 75 RCTs that used acupuncture as an intervention and assessed the quality of these reports with the Consolidated Standards for Reporting of Trials statement 2010 (CONSORT2010) and Standards for Reporting Interventions Controlled Trials of Acupuncture 2010(STRICTA2010). 24 articles (32%) applied the method of random allocation of sequences. No article gave the description of the mechanism of allocation concealment, no experiment applied the method of blinding. Only one article (1.47%) could be identified directly from its title as about the Randomized Controlled Trials, and only 4 articles gave description of the experimental design. No article mentioned the number of cases lost or eliminated. During one experiment, acupuncture syncope led to temporal interruption of the therapy. Two articles (2.94%) recorded the number of needles, and 8 articles (11.76%) mentioned the depth of needle insertion. None of articles reported the base of calculation of sample size, or has any analysis about the metaphase of an experiment or an explanation of its interruption. One (1.47%) mentioned intentional analysis (ITT).Conclusions/significanceThe quality of the reports on RCTs of acupuncture for Diabetic Peripheral Neuropathy is moderate to low. The CONSORT2010 and STRICTA2010 should be used to standardize the reporting of RCTs of acupuncture in future.

Project description:BackgroundSpastic paralysis is one of the most common sequelae of stroke, severely affecting patients' limb function and reducing their quality of life. Scalp acupuncture (SA) has been shown to significantly improve cerebral blood supply and reduce the severity of limb spasticity. This meta-analysis aims to systematically evaluate the clinical efficacy of SA in the treatment of post-stroke spastic paralysis, providing evidence-based medicine for clinical management of this condition.MethodsWe comprehensively searched databases including China National Knowledge Infrastructure, Wanfang Data, VIP Chinese Science and Technology Periodical Database, China Biomedical Literature Database, PubMed, Embase, and Cochrane Library. Randomized controlled trials investigating the efficacy of SA in post-stroke spastic paralysis were identified until July 28, 2023. Meta-analysis was conducted using RevMan 5.4 and Stata17.0.ResultsA total of 16 studies were included. Meta-analysis showed that the modified Ashworth spasticity assessment scale in the SA group was significantly higher than that in the rehabilitation group (mean difference [MD] = -0.56, 95% confidence interval [CI] [-0.75, -0.37], Z = 5.67, P < .00001). The simplified Fugl-Meyer motor function assessment scale in the SA group was significantly higher than that in the rehabilitation group (MD = 5.86, 95% CI [3.26, 8.46], Z = 4.41, P < .0001). The modified Barthel index assessment scale in the SA group was significantly higher than that in the rehabilitation group (MD = 5.79, 95% CI [4.73, 6.84], Z = 10.77, P < .00001). Additionally, the clinical effective rate in the SA group was significantly higher than that in the rehabilitation group (relative risk = 1.25, 95% CI [1.16, 1.36], Z = 5.42, P < .00001).ConclusionSA combined with rehabilitation therapy has certain advantages in reducing limb spasticity, improving limb function, and enhancing activities of daily living in patients with post-stroke spastic paralysis. This study provides reference and theoretical support for the promotion of SA in the treatment of this condition.

Project description:BackgroundBlinding is a cornerstone of therapeutic evaluation because lack of blinding can bias treatment effect estimates. An inventory of the blinding methods would help trialists conduct high-quality clinical trials and readers appraise the quality of results of published trials. We aimed to systematically classify and describe methods to establish and maintain blinding of patients and health care providers and methods to obtain blinding of outcome assessors in randomized controlled trials of pharmacologic treatments.Methods and findingsWe undertook a systematic review of all reports of randomized controlled trials assessing pharmacologic treatments with blinding published in 2004 in high impact-factor journals from Medline and the Cochrane Methodology Register. We used a standardized data collection form to extract data. The blinding methods were classified according to whether they primarily (1) established blinding of patients or health care providers, (2) maintained the blinding of patients or health care providers, and (3) obtained blinding of assessors of the main outcomes. We identified 819 articles, with 472 (58%) describing the method of blinding. Methods to establish blinding of patients and/or health care providers concerned mainly treatments provided in identical form, specific methods to mask some characteristics of the treatments (e.g., added flavor or opaque coverage), or use of double dummy procedures or simulation of an injection. Methods to avoid unblinding of patients and/or health care providers involved use of active placebo, centralized assessment of side effects, patients informed only in part about the potential side effects of each treatment, centralized adapted dosage, or provision of sham results of complementary investigations. The methods reported for blinding outcome assessors mainly relied on a centralized assessment of complementary investigations, clinical examination (i.e., use of video, audiotape, or photography), or adjudication of clinical events.ConclusionsThis review classifies blinding methods and provides a detailed description of methods that could help trialists overcome some barriers to blinding in clinical trials and readers interpret the quality of pharmacologic trials.

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Assessing the quality of reports about randomized controlled trials of scalp acupuncture combined with another treatment for stroke.

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Assessing the quality of reports about randomized controlled trials of scalp acupuncture combined with another treatment for stroke.

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