中国大陆地区中医药治疗2型糖尿病安慰剂对照随机试验报告质量的评估：一项遵循PRISMA的系统评价
Assessment of the Reporting Quality of Placebo-controlled Randomized Trials on the Treatment of Type 2 Diabetes With Traditional Chinese Medicine in Mainland China: A PRISMA-Compliant Systematic Review.
作者信息
Zhao Xiyan, Zhen Zhong, Guo Jing, Zhao Tianyu, Ye Ru, Guo Yu, Chen Hongdong, Lian Fengmei, Tong Xiaolin
机构信息
From the Department of Endocrinology, China Academy of Chinese Medical Sciences, Guang'anmen Hospital (XZ, ZZ, JG, RY, HC, FL, XT); Graduate School, Beijing University of Chinese Medicine, Beijing (XZ, RY); Department of Endocrinology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin (TZ); and Department of Endocrinology, Dongzhimen Hospital Eastern Affiliated to Beijing University of Chinese Medicine, Beijing, China (YG).
出版信息
Medicine (Baltimore). 2016 Jan;95(3):e2522. doi: 10.1097/MD.0000000000002522.
Placebo-controlled randomized trials are often used to evaluate the absolute effect of new treatments and are considered gold standard for clinical trials. No studies, however, have yet been conducted evaluating the reporting quality of placebo-controlled randomized trials. The current study aims to assess the reporting quality of placebo-controlled randomized trials on treatment of diabetes with Traditional Chinese Medicine (TCM) in Mainland China and to provide recommendations for improvements.China National Knowledge Infrastructure database, Wanfang database, China Biology Medicine database, and VIP database were searched for placebo-controlled randomized trials on treatment of diabetes with TCM. Review, animal experiment, and randomized controlled trials without placebo control were excluded. According to Consolidated Standards of Reporting Trials (CONSORT) 2010 checklists items, each item was given a yes or no depending on whether it was reported or not.A total of 68 articles were included. The reporting percentage in each article ranged from 24.3% to 73%, and 30.9% articles reported more than 50% of the items. Seven of the 37 items were reported more than 90% of the items, whereas 7 items were not mentioned at all. The average reporting for "title and abstract," "introduction," "methods," "results," "discussion," and "other information" was 43.4%, 78.7%, 40.1%, 49.9%, 71.1%, and 17.2%, respectively. The percentage of each section had increased after 2010. In addition, the reporting of multiple study centers, funding, placebo species, informed consent forms, and ethical approvals were 14.7%, 50%, 36.85%, 33.8%, and 4.4%, respectively.Although a scoring system was created according to the CONSORT 2010 checklist, it was not designed as an assessment tool. According to CONSORT 2010, the reporting quality of placebo-controlled randomized trials on the treatment of diabetes with TCM improved after 2010. Future improvements, however, are still needed, particularly in methods sections.
安慰剂对照随机试验常用于评估新治疗方法的绝对疗效，被视为临床试验的金标准。然而，尚未有研究对安慰剂对照随机试验的报告质量进行评估。本研究旨在评估中国大陆中医药治疗糖尿病的安慰剂对照随机试验的报告质量，并提出改进建议。通过检索中国知网数据库、万方数据库、中国生物医学数据库和维普数据库，查找中医药治疗糖尿病的安慰剂对照随机试验。排除综述、动物实验以及无安慰剂对照的随机对照试验。根据《报告试验的统一标准》（CONSORT）2010清单项目，依据是否报告对每个项目给予“是”或“否”的判定。共纳入68篇文章。每篇文章的报告率在24.3%至73%之间，30.9%的文章报告了超过50%的项目。37个项目中有7个项目的报告率超过90%，而有7个项目完全未被提及。“标题和摘要”“引言”“方法”“结果”“讨论”及“其他信息”的平均报告率分别为43.4%、78.7%、40.1%、49.9%、71.1%和17.2%。2010年后各部分的报告率均有所提高。此外，多研究中心、资金资助、安慰剂种类、知情同意书及伦理批准的报告率分别为14.7%、50%、36.85%、33.8%和4.4%。尽管根据CONSORT 2010清单创建了一个评分系统，但它并非作为评估工具设计。根据CONSORT 2010，2010年后中医药治疗糖尿病的安慰剂对照随机试验的报告质量有所提高。然而，未来仍需改进，特别是在方法部分。
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