To evaluate the application status of outcomes in the randomized controlled trials (RCTs) on traditional Chinese medicine for hyperplasia of mammary glands (HMG). Four Chinese databases and four English databases were searched to screen RCTs of TCM in the treatment of HMG according to the pre-established selection criteria. Cochrane risk of bias tool was used for methodological evaluation. The outcomes in RCTs were categorized and calculated for frequency. A total of 7210 articles were initially retrieved, and finally, 67 articles were included. As revealed by the results, 67 RCTs involving 17 outcome indicators with the frequency of 247 times. The outcomes of the included RCTs were classified into 6 categories. Five symptom and sign outcomes with frequency of 67 times (100%), two safety outcomes with frequency of 25 times (37.31%), six types of physicochemical inspection outcomes with frequency of 20 times (29.85%), two types of TCM syndrome outcomes with frequency of 6 times (8.96%), one long-term prognosis index with frequency of 5 times (7.46%), one quality of life index with frequency of 1 time (1.49%). Many problems were found in the selection of outcomes of RCTs on TCM for HMG at present. Such as large differences in the choice of outcome indicators, inconsistent evaluation standards, unclear definition of primary and secondary outcomes, lack of TCM outcomes, inconsistent measurement methods, and irregular reporting. It is recommended to strengthen the trial design and actively construct the core outcomes set on the treatment of HMG with TCM in order to improve the quality of clinical trials on TCM.
ContributorsXiaohua Pei, Liuyan Xu, Xuan Wang, Baoyong Lai, Xinyan Jin, Yingyi Fan
Disease Category: Other
Disease Name: Hyperplasia of Mammary Glands
Age Range: 14 - 53
Sex: Female
Nature of Intervention: Traditional Chinese Medicine
- None
- Systematic review of outcomes measured in trials
- Literature review
Four Chinese databases and four English databases were searched to screen RCTs of TCM in the treatment of HMG according to the pre-established selection criteria. Cochrane risk of bias tool was used for methodological evaluation. The outcomes in RCTs were categorized and calculated for frequency. A total of 7210 articles were initially retrieved, and finally, 67 articles were included.