Quality of reporting of integrative Chinese and Western medicine intervention in randomized controlled trials of ulcerative colitis: a review.

BACKGROUND: Integrative Chinese and Western medicine (ICWM) is commonly used for the treatment of ulcerative colitis (UC) in clinical practice. However, it is unclear whether the details of ICWM interventions, such as selection rationale, implementation design, and potential interactions, were adequately reported. Therefore, this study aimed to assess the quality of reporting in the ICWM interventional randomized controlled trials (RCTs) of UC and to identify the common problems if any. METHODS: Through a search of 10 international electronic databases, we identified RCTs of UC with ICWM interventions published in English or Chinese from the inception date of each database up to 16 June 2023. Literature screening was strictly conducted based on the inclusion and exclusion criteria of the Population, Concept, and Context (PCC) framework. The general characteristics of the included studies were described. The quality of reporting was assessed according to three checklists, including the CONSORT (Consolidated Standards of Reporting Trials) with 36 items (except for one item 1b about abstract), the CONSORT for Abstracts (17 items), and a self-designed ICWM-related checklist (27 items covering design rationale, intervention details, outcome assessments, and analysis). The reporting scores of RCTs published before and after 2010 were compared. RESULTS: A total of 1458 eligible RCTs were included. For the reporting compliance, the median score (interquartile ranges) of the CONSORT (72 score in total), the CONSORT for Abstract (34 score), and ICWM-related (54 score) items was 21 (18-25), 13 (12-15), and 18 (15-21), respectively. Although the time period comparisons showed that reporting quality of included publications improved significantly after the CONSORT 2010 issued (P < 0.01), more than 50% of items were evaluated as poor quality (reporting rate < 65%) among each checklist, especially in the CONSORT for Abstract and ICWM-specific items. CONCLUSION: Although CONSORT appears to have enhanced the reporting of RCTs in UC, the quality of ICWM specifics is variable and in need of improvement. Reporting guidelines of the ICWM recommendations should be developed to improve their quality.

Reporting quality of randomized controlled trials of angina pectoris with integrated traditional Chinese and western medicine interventions: a cross-sectional study.

BACKGROUND AND OBJECTIVE: Integrated traditional Chinese and western medicine (ITCWM), as a representative type of complex intervention, is commonly used for the treatment of angina pectoris (AP) in clinical practice. However, it is unclear whether the details of ITCWM interventions, such as rationale for selection and design, implementation and potential interactions for different therapies, were adequately reported. Therefore, this study aimed to describe the reporting characteristics and quality in randomized controlled trials (RCTs) of AP with ITCWM interventions. METHODS: Through a search of 7 electronic databases, we identified RCTs of AP with ITCWM interventions published in both English and Chinese from 1st Jan 2017 to 6th Aug 2022. The general characteristics of included studies were summarized, further, the quality of reporting was assessed based on three Checklists, including the CONSORT with 36 items (except for one item 1b about abstract), the CONSORT for abstracts (17 items), and a self-designed ITCWM-related checklist (21 items covering rationale and details of interventions, outcome assessment and analysis). The quality of RCTs published in English and Chinese, as well as journals and dissertations were also compared. RESULTS: A total of 451 eligible RCTs were included. For the reporting compliance, the mean score (95% Confidence Interval) of the CONSORT (72 scores in total), CONSORT for abstract (34 scores in total), and ITCWM-related (42 scores in total) checklists was 27.82 (27.44-28.19), 14.17 (13.98-14.37) and 21.06 (20.69-21.43), respectively. More than half items were evaluated as poor quality (reporting rate < 50%) among each Checklist. Moreover, the reporting quality of publications in English journals was higher than that in Chinese journals in terms of the CONSORT items. The reporting of published dissertations was better than that in journal publications regarding both the CONSORT and ITCWM-specific items. CONCLUSION: Although the CONSORT appears to have enhanced the reporting of RCTs in AP, the quality of ITCWM specifics is variable and in need of improvement. Reporting guideline of the ITCWM recommendations should be developed thus to improve their quality.

STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM): Extending the CONSORT statement.

OBJECTIVES: Massage is a common therapy of nonpharmacological treatments, particularly in Tuina (Chinese massage) as its most common style, detailed guidance in reporting the intervention is warranted for its evaluation and replication. Based on the CONSORT (Consolidated Standards of Reporting Trials), we aimed to develop an Extension for Tuina/Massage, namely "The STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM)." METHODS: A group of professional clinicians, trialists, methodologists, developers of reporting guidelines, epidemiologists, statisticians, and editors has developed this STRICTOTM checklist through a standard methodology process recommended by the EQUATOR (Enhancing the QUAlity and Transparency of Health Research) Network, including prospective registration, literature review, draft of the initial items, three rounds of the Delphi survey, consensus meeting, pilot test, and finalization of the guideline. RESULTS: A checklist of seven items (namely Tuina/Massage rationale, details of Tuina/Massage, intervention regimen, other components of the intervention, Tuina/Massage provider background, control or comparator interventions, and precaution measures), and 16 subitems were developed. Explanations and examples (E&E) for each item are also provided. CONCLUSIONS: The working group hopes that the STRICTOTM, in conjunction with both the CONSORT statement and extension for nonpharmacologic treatment, can improve the reporting quality and transparency of Tuina/Massage clinical research.

Chinese herbal medicine for previous cesarean scar defect: A protocol for systematic review and meta-analysis.

BACKGROUND: Previous cesarean scar defect (PCSD) is a gynecological disease that can cause bleeding after intercourse, prolonging menstrual period, intermenstrual bleeding, dysmenorrhea, and even lead to infertility. Chinese herbal medicine plays an important role in the treatment of gynecological diseases in China and East Asia. This study aims to assess the efficacy and safety of Chinese herbal medicine for PCSD. METHODS: We search the following databases: PubMed, the Cochrane Library, Chinese Biomedical Literature Database (CB), Chinese Science and Technique Journals Database (VIP), EMBASE, Chinese National Knowledge Infrastructure Database (CNKI), and the Wanfang Database. Other sources will also be searched like Google Scholar and gray literature. All databases mentioned above are searched from the start date to the latest version. Randomized controlled trials will be included which recruiting PCSD participants to assess the efficacy and safety of Chinese herbal medicines against controls (placebo or other therapeutic agents). Primary outcomes will include the size of PCSD, menstrual cycle, menstrual phase, menstrual volume, duration of disease, security index. Two authors will independently scan the searched articles, extract the data from attached articles, and import them into Endnote X8 and use Microsoft Excel 2013 to manage data and information. We will assess the risk of bias by Cochrane tool of risk of bias. Disagreements will be resolved by consensus or the participation of a third party. All analysis will be performed based on the Cochrane Handbook for Systematic Reviews of Interventions. The meta-analysis in this review will use RevMan 5.3 software. RESULTS: The study aims to evaluate the efficacy and safety of the treatment that Chinese herbal medicine for PCSD. CONCLUSION: This study of the meta-analysis could provide evidence for clinicians and help patients to make a better choice. INPLASY REGISTRATION NUMBER: INPLASY202090080.

Warming yang method in traditional Chinese medicine for depression: A protocol for systematic review and meta-analysis.

BACKGROUND: Depression is a chronic psychological disease with low emotion, interest, cognition, thinking and disorder of physiological function, even numbness, or hallucination, delusion and other psychotic symptoms. Traditonal Chinese medicine plays an important role in the treatment of mental diseases in China and East Asia. The aim of this study is to assess the efficacy and safety of warming yang method in traditional Chinese medicine for depression. METHODS: We search the following databases: PubMed, the Cochrane Library, Chinese Science and Technique Journals Database, Chinese Biomedical Literature Database, Excerpt Medica Database, MEDLINE, Chinese National Knowledge Infrastructure Database, and the Wanfang Database. Other sources will also be searched like Google Scholar and gray literatures. All databases mentioned above are searched from the start date to November 2020. Randomised controlled trials will be included which recruiting depression participants to assess the efficacy and safety of warming yang method in traditional Chinese medicines against controls (placebo or other therapeutic agents). Primary outcomes will include the reduction ratio of Hamilton Depression Rating Scale and security index. Secondary outcomes include the Yang deficiency improves. Two authors will independently scan the searched articles, extract the data from attached articles and import them into Endnote X8 and use Microsoft Excel 2013 to manage data and information. We will assess the risk of bias by Cochrane tool of risk of bias. Disagreements will be resolved by consensus or the participation of a third party. All analysis will be performed based on the Cochrane Handbook for Systematic Reviews of Interventions. The meta-analysis in this review will use RevMan 5.3 software. RESULTS: The study is aim to evaluate the efficacy and safety of warming yang method in traditional Chinese medicine for depression. CONCLUSION: This study of the meta-analysis could provide evidence for clinicians and help patients to make a better choice. INPLASY REGISTRATION NUMBER: INPLASY2020110129.

Jingui Shenqi pill for nocturia due to nocturnal polyuria: A protocol for systematic review and meta-analysis.

BACKGROUND: The incidence of nocturia is high and will seriously affect patients' physical and mental health. Nocturnal polyuria is the most critical cause of nocturia, There are few drugs currently used to treat nocturia due to Nocturnal Polyuria (NP). The guide highly recommends only Desmopressin. There is an urgent need to find new drugs. Jingui Shenqi pill (JSP) is a Chinese patent medicine, it is widely used in China to treat NP. However, there is no evidence-based medical evidence to prove its safety and effectiveness. The purpose of this systematic review is to evaluate the efficacy and safety of JSP in the treatment of NP. METHODS: We will search the randomized controlled trials (RCTs) including JSP for NP and published from the inception of the database to Oct 2020 by the following eight databases: Embase, Cochrane Library, PubMed, MEDLINE, the China National Knowledge Infrastructure, Cqvip Database, and Wanfang Data, the Chinese Biomedical Literature Database. There is no language and publication status restriction. The primary outcomes will include Nocturnal urine volume, the number of nocturnal voids, Nocturnal polyuria index (Nocturnal total urine volume /24 h total urine volume). We will perform the data synthesis, sensitivity analysis, subgroup analysis, and bias assessment risk using RevMan V.5.3. The reporting bias will be assessed using a funnel plot and Egger test. RESULTS: This study may provide additional evidence of JSP for NP in the effectiveness and safety and alternative therapy for NP. CONCLUSIONS: In this systematic review, we will assess whether JSP is an effective and safe medicine for nocturia.