Current Status of Outcome Indexes in Randomized Controlled Trials of Traditional Chinese Medicine for Functional Dyspepsia
Objective To analyze the research status of outcome indexes in randomized controlled trials(RCTs)of traditional Chinese medicine(TCM)treatment of functional dyspepsia(FD),to facilitate the construction of core index set for TCM treatment of FD.Methods The RCTs of TCM treatment of FD were retrieved from China National Knowledge In-frastructure(CN KI),Wanfang Data,VIP Chinese Science and Technology Periodicals Database(VIP),SinoMed,EMbase,PubMed and Cochrane Library.The retrieval time was from January 01,2017 to January 01,2022.Two researchers inde-pendently screened the literature and extracted the data according to the inclusion and exclusion criteria.Results A total of 285 RCTs were included,involving 28 061 patients,117 outcome indexes and 28 TCM syndromes.The maximum and minimum numbers of single RCT indexes was 12 and 1,respectively,with an average of 5.The indexes were used for 1 275 times in total.The top five indexes by frequency of use were total clinical effective rate(81.40%),TCM syndrome score(54.04%),adverse reaction(47.02%),motilin(MTL,30.18%),and symptom score(23.1%).According to the func-tional attributes of the outcome indexes,they were divided into six major domains.Among them,symptoms/signs(38.51%)and physical and chemical tests(28.94%)were more widely used.Conclusion At present,there are some problems in the RCTs of TCM treatment of FD,such as large difference in selecting outcome indexes,regardless of primary and second-ary outcome indexes,inconsistent evaluation indexes of TCM efficacy,lack of standardization in total effective rate indexes,large difference in index measurement time points,lack of long-term prognosis indexes,various index measurement tools and poor applicability,failing to include economic evaluation index and simple safety event reports.Therefore,it is urgent to standardize the core index set in TCM treatment of FD and solve the existing problems.
Traditional Chinese medicineFunctional dyspepsiaCore outcome setOutcome indexRandomized controlled trial