Dong Yue, Liu Lin, Zhang Xiaowen, Gong Yijia, Yan Shiyan, Li Wei, Li Shunping, Rong Hongguo, Liu Jianping
School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Front Pharmacol. 2023 May 11;14:1159906. doi: 10.3389/fphar.2023.1159906. eCollection 2023.
Patient-reported outcomes (PROs) provide a global perspective of patient health status which plays an enormous role in evaluating clinical efficacy. However, the application of PROs in traditional Chinese medicine (TCM) was still insufficiently studied in mainland China. This cross-sectional study was performed based on interventional clinical trials of TCM that were conducted in mainland China from 1 January 2010, to 15 July 2022. Data was retrieved from the ClinicalTrials.gov and Chinese Clinical Trial Registry. We included interventional clinical trials of TCM for which the country of the primary sponsors or recruitment settings in mainland China. For each included trial, data including clinical trial phases, study settings, participant's age, sex, diseases, and the patient-reported outcome measures (PROMs) were extracted. Trials were categorized into four categories according to 1) listed PROs as primary endpoints, 2) listed PROs as secondary endpoints, 3) listed PROs as coprimary outcomes (both primary and secondary endpoints), and 4) did not mention any PROMs. Among a total of 3,797 trials, 680 (17.9%) trials listed PROs as primary endpoints, 692 (18.2%) trials listed PROs as secondary endpoints, and 760 (20.0%) trials listed PROs as coprimary endpoints. Among 675,787 participants included in the registered trials, 448,359 (66.3%) patients' data were scientifically collected by PRO instruments. Neurological diseases (11.8%), musculoskeletal symptoms (11.5%), mental health conditions (9.1%) were the most common conditions evaluated by PROMs. Disease-specific symptoms related concepts were used most frequently (51.3%), followed by health-related quality of life concepts. Visual analog scale, 36-item Short-Form Health Questionnaire, and TCM symptom score were the most common PROMs in these trials. In this cross-sectional study, the use of PROs increased in the past decades according to clinical trials of TCM conducted in mainland China. Considering that the application of PROs in clinical trials of TCM has some existing issues including uneven distribution and lack of normalized PROs of TCM, further study should be focused on the standardization and normalization of TCM-specific scales.
患者报告结局（PROs）提供了患者健康状况的整体视角，在评估临床疗效方面发挥着巨大作用。然而，在中国大陆，PROs在中医药（TCM）中的应用仍研究不足。本横断面研究基于2010年1月1日至2022年7月15日在中国大陆进行的中医药干预性临床试验开展。数据从ClinicalTrials.gov和中国临床试验注册中心检索。我们纳入了主要申办方所在国家或招募地点在中国大陆的中医药干预性临床试验。对于每项纳入的试验，提取包括临床试验阶段、研究地点、参与者年龄、性别、疾病以及患者报告结局指标（PROMs）等数据。试验根据以下情况分为四类：1）将PROs列为主要终点；2）将PROs列为次要终点；3）将PROs列为共同主要结局（主要和次要终点均有）；4）未提及任何PROMs。在总共3797项试验中，680项（17.9%）试验将PROs列为主要终点，692项（18.2%）试验将PROs列为次要终点，760项（20.0%）试验将PROs列为共同主要终点。在注册试验纳入的675787名参与者中，448359名（66.3%）患者的数据通过PRO工具进行了科学收集。神经疾病（11.8%）、肌肉骨骼症状（11.5%）、心理健康状况（9.1%）是PROMs评估最常见的疾病。特定疾病症状相关概念使用最为频繁（51.3%），其次是健康相关生活质量概念。视觉模拟量表、36项简明健康调查问卷和中医症状评分是这些试验中最常见的PROMs。在这项横断面研究中，根据在中国大陆进行的中医药临床试验，过去几十年PROs的使用有所增加。鉴于PROs在中医药临床试验中的应用存在一些现有问题，包括分布不均和缺乏标准化的中医PROs，未来研究应聚焦于中医特定量表的标准化和规范化。
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