Wang Ren-Yuan, Tang Xin-Yue, Han Qiang, Zeng Yin, Wang He-Tian, Guo Jun
Department of Andrology, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing 100010, China.
Department of Nephrology， Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing 100010, China.
Zhonghua Nan Ke Xue. 2024 Feb;30(2):167-173.
To systematically evaluate the methodological quality and reporting quality of randomized controlled trials (RCT) on the treatment of BPH with traditional Chinese medicine (TCM), in order to provide some methodological reference for clinical practice and research.
We searched CNKI, VIP, Wanfang Data and PubMed for RCTs on the treatment of BPH with TCM published in China from January 2013 to November 2023. Two researchers screened the literature separately, and evaluated the methodological and reporting quality of the RCTs based on the Cochrane bias risk assessment tool and CONSORT TCM compound.
Totally, 88 RCTs were included in this study. In terms of methodological quality, according to the Cochrane bias risk assessment tool, 27 biases in the process of randomization were identified as of low-risk and the other 61 of a certain risk. Among the allocation-related biases deviating from the established interventions, 76 were of low risk, 10 of a certain risk and 2 of high risk; among the compliance-related biases deviating from the established interventions, 76 were of low risk and 12 of a certain risk; among the biases due to missing outcome data, 86 were of low risk and 2 of a certain risk, while all the biases due to outcome measurement were of low risk; and among the biases from selective reporting, 65 were of low-risk, 2 of a certain risk and 21 of high-risk. In terms of reporting quality, according to the evaluation criteria of consort TCM compound, appropriate key words were used in 1 RCT (0.01%), the random assignment sequence method described in 27 (30.68%), the details of assignment limitation given in 5 (5.68%), assignment concealment mentioned in 3 (3.41%), the blind method and assignment concealment employed in 3 (3.41%), fall-offs recorded in 10 (11.36%), adverse events reported in 38 (43.18%), and limitations of the trials analyzed in 18 (20.45%). All the RCTs lacked complete intervention measures, subject flow chart, clinical trial registration and research schemes.
At present, the methodological quality and reporting quality of RCTs on the treatment of BPH with TCM are generally low, with the main problems of incomplete experimental designs, lack of detailed description of randomized and blind methods, and insufficient TCM symptom evaluation of outcome indicators. Researchers should be cautious in adopting and applying the results reported, follow the CONSORT statement in design, registration, implement and reporting of the scheme, fully consider the clinical characteristics of TCM in the treatment of BPH, and reasonably design and report the evaluation indicators.
系统评价中医药治疗良性前列腺增生症（BPH）随机对照试验（RCT）的方法学质量和报告质量，为临床实践及研究提供方法学参考。
检索中国知网、维普、万方数据和PubMed中2013年1月至2023年11月在中国发表的中医药治疗BPH的RCT。两名研究者分别进行文献筛选，并依据Cochrane偏倚风险评估工具和CONSORT TCM复合物对RCT的方法学和报告质量进行评价。
本研究共纳入88项RCT。在方法学质量方面，依据Cochrane偏倚风险评估工具，随机化过程中27个偏倚被判定为低风险，另外61个存在一定风险。在偏离既定干预措施的分配相关偏倚中，76个为低风险，10个存在一定风险，2个为高风险；在偏离既定干预措施的依从性相关偏倚中，76个为低风险，12个存在一定风险；在因结局数据缺失导致的偏倚中，86个为低风险，2个存在一定风险，而所有因结局测量导致的偏倚均为低风险；在选择性报告导致的偏倚中，65个为低风险，2个存在一定风险，21个为高风险。在报告质量方面，依据CONSORT TCM复合物的评价标准，1项RCT（0.01%）使用了恰当的关键词，27项（30.68%）描述了随机分配序列方法，5项（5.68%）给出了分配限制细节，3项（3.41%）提及了分配隐藏，3项（3.41%）采用了盲法和分配隐藏，10项（11.36%）记录了脱落情况，38项（43.18%）报告了不良事件，18项（20.45%）分析了试验的局限性。所有RCT均缺乏完整的干预措施、受试者流程图、临床试验注册和研究方案。
目前，中医药治疗BPH的RCT方法学质量和报告质量普遍较低，主要问题为实验设计不完整、随机和盲法描述欠缺、结局指标的中医症状评价不足。研究者在采用和应用所报告的结果时应谨慎，在方案设计、注册、实施和报告过程中遵循CONSORT声明，充分考虑中医药治疗BPH的临床特点，合理设计和报告评价指标。
