RESUMEN
OBJECTIVE: To assess the efficacy and safety of Xiaozheng pills in treating mastoplasia. METHOD: Clinical trials were carried out by five hospitals. In each hospital, patients were divided into two groups with one group 24 patients (trial group) and the other 24 patients (control group). Total 240 patients were included in the study. According to randomized, double-blinded and placebo-controlled clinical study, the trial groups were treated by Xiaozheng pills with Rujiekang mimetic (placebo) and the control groups were treated by Rujiekang with Xiaozheng pills mimetic (placebo). Symptoms, laboratory test results as well as ADR were evaluated after 1 period of treatment. RESULT: The overall response rates of trial group and control group were 93.8% and 88.6% respectively, no statistic difference between the two groups. No deleterious effect in both groups and the indexes of safety were normal. CONCLUSION: These results suggest that Xiaozheng pills are effective and safe in treating mastoplasia caused by qi stagnation, blood stasis or/and stagnation of phlegm.