Hong Kong Chinese Medicine Clinical Study Centre, Chinese EQUATOR Centre, School of Chinese Medicine, Chinese Clinical Trial Registry (Hong Kong), Hong Kong Baptist University, HKSAR, China.
Centre for Chinese Herbal Medicine Drug Development, Hong Kong Baptist University, HKSAR, China.
Syst Rev. 2023 Dec 8;12(1):228. doi: 10.1186/s13643-023-02402-2.
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.
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.
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.
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.
中西医结合（ICWM）在溃疡性结肠炎（UC）的临床治疗中被广泛应用。然而，ICWM 干预措施的细节，如选择原理、实施设计和潜在的相互作用，是否得到充分报告尚不清楚。因此，本研究旨在评估 UC 的 ICWM 干预随机对照试验（RCT）的报告质量，并确定是否存在常见问题。
通过检索 10 个国际电子数据库，我们从每个数据库的创建日期到 2023 年 6 月 16 日，识别出以英文或中文发表的 UC 的 ICWM 干预 RCT。文献筛选严格按照人群、概念和背景（PCC）框架的纳入和排除标准进行。描述了纳入研究的一般特征。根据 CONSORT（临床试验报告统一标准）36 项（除了关于摘要的 1b 项）、CONSORT 摘要（17 项）和自行设计的 ICWM 相关清单（涵盖设计原理、干预措施细节、结果评估和分析的 27 项），评估报告质量。比较了 2010 年前和 2010 年后发表的 RCT 的报告得分。
共纳入 1458 项符合条件的 RCT。关于报告合规性，CONSORT（总分 72 分）、CONSORT 摘要（34 分）和 ICWM 相关（54 分）项目的中位数得分（四分位间距）分别为 21（18-25）、13（12-15）和 18（15-21）。尽管时间周期比较表明，在 CONSORT 2010 发布后，纳入出版物的报告质量显著提高（P < 0.01），但每个清单中仍有超过 50%的项目被评估为质量差（报告率<65%），尤其是在 CONSORT 摘要和 ICWM 特定项目中。
尽管 CONSORT 似乎提高了 UC 的 RCT 报告质量，但 ICWM 具体内容的质量参差不齐，需要改进。应制定 ICWM 建议的报告指南，以提高其质量。
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