A randomized, double-blind multicentre clinical trial comparing the efficacy and safety of Caffeic acid for the treatment of immune thrombocytopenia in China

Chinese Caffeic Acid Multicenter Study Group

doi:10.19538/jnk2017090108

Abstract：Objective To evaluate the effectiveness and safety of Caffeic acid tablets (CA) in the treatment of immune thrombocytopenia (ITP).Method 120 patients with ITP were randomly divided into two groups:trial group and control group with 60 patients in each group.Trial group A receives(0.3 g CA 3 times daily) and Control group B receives(placebo 3 times daffy for 4 weeks.Safety indicators:(1) Vital signs,blood routine tests,liver & kidney function assays,electrocardiogram (ECG) and the incidence of adverse events (AE).(2)Therapeutic indexes:(1) Major response effects:the platelet count,platelet transfusion amount,platelet recovery reaction time,effectiveness (complete response rate (CR) + response rate (R)) were compared between two groups.(2) Minor response effects:to use Kaplan Meier method was used to describe process of platelet count recovery to up to 80 × 109/L,and 100 × 109/L,and platelet count increase time needed for reaching to absolute value 50 × 109/L or higher (per day) in two groups.(3) Data analysis:EP 13.0 was used.For comparison of incidence of adverse events between two groups,Fisher's exact probability method was used.AE and lab tests before and after study were also listed.Results Comparison beween group A and group B shows,the major response effects (CR + R) were 41.82％ and 14.81％ (FAS) or 44.00％ and 15.35％ (PPS);P =0.001.There was significant difference in platelet response with 95％ confidence interval (95％ CI) is 27％ [10.89％～43.12％] (FAS),or28％ [11.72％～45.51％] (PPS).Both group A and group B had no platelet transfusion.Platelet recovery reaction time (median time) in group A and group B were 17.00 and 34.00 (FAS) or 15.00 and 34.00 (PPS).Comparison between two groups of patients shows,the CR rate + R rate had statistically significant difference (P＜0.05).Group A had no obvious adverse event.Conclusion In ITP CA resulted in good response effect,low adverse events rate and reliable safety.