Outcome Indexes in Randomized Controlled Trials of Chinese Medicine for Diabetic Kidney Disease / 中国实验方剂学杂志

ABSTRACT

ObjectiveTo analyze the utilization of outcome indexes and other trial design elements in randomized controlled trials （RCTs） of Chinese medicine for diabetic kidney disease （DKD） and provide a basis for the design of clinical trials and the development of core outcome index sets for Chinese medicine treatment of DKD. MethodSeven medical databases （CNKI， Wanfang Data， VIP， SinoMed， etc.） and two clinical trial registration centers （clinicaltrials.gov and chinadrugtrials.org.cn） were searched for RCTs of Chinese medicine for DKD published in the past 5 years. The included studies were assessed for risk of bias using the Cochrane Handbook for Systematic Reviews of Interventions， and the outcome indexes and other trial design elements were statistically analyzed. ResultNinety-seven RCTs were enrolled， including five trial registration protocols. The overall risk of bias was found to be high in the included studies. Stage Ⅲ DKD （36 studies， 41.38%） and the Qi-Yin deficiency with blood stasis syndrome （16 studies， 26.23%） were the top DKD stage and traditional Chinese medicine （TCM） syndrome， respectively. The treatment duration ranged from 2 weeks to 96 weeks， with 12 weeks being the most common duration （52 studies， 56.52%）. A total of 152 outcome indexes were used in 92 RCTs and five registered trials， with a frequency of 1 040 times. These indexes were classified into eight categories： Laboratory tests （blood）， laboratory tests （urine）， clinical efficacy， TCM syndrome score， quality of life scales， vital signs， other indexes， and other events. The most frequently used outcome indexes were serum creatinine （68 times， 70.10%）， clinical response rate （55 times， 56.70%）， fasting blood glucose （51 times， 52.58%）， blood urea nitrogen （48 times， 49.48%）， total cholesterol （47 times， 48.45%）， and 24-hour urinary protein excretion （43 times， 44.33%）. Safety indexes were used in 56 RCTs and two registered trials， with 53 different indexes and a frequency of 227 times. The most frequently used safety indexes were adverse reactions （49 times， 84.48%）， liver function （28 times， 48.28%）， complete blood count （24 times， 41.38%）， electrocardiogram （17 times， 29.31%）， and urinalysis （14 times， 24.14%）. Ten RCTs and five registered trials reported primary outcome indexes， and 54 RCTs reported clinical response rates. ConclusionThe current design of outcome indexes in RCTs of Chinese medicine for DKD is not standardized. In the future， efforts should be made to develop core outcome index sets that highlight the characteristics of TCM， improve the quality of clinical research， and enhance the applicability of trial results.