Ruzengxiaotong Tiemo In Treating Hyperplasia Of Galactophore (Qi And Blood Stasis Sydrome) Multicenter Trial

Objective: To study the efficacy security and side effect of ruzengxiaotong tiemo in treating hyperplasia of galactophore. Methods: this is a single blind ,randomized, controlled, multicenter trial. 240 cases were included, there were 237 cases in intention-to-treat (ITT),had 212 cases in per-protocol population (PP).The study group (ITT:n=120, PP: n=107) received ruzengxiaotong tiemo and the controlled group(ITT:n=117, PP: n=105) were given sanjiezhitong plaster. Results: The vaule of synthesis curative effecy:in ITT,the total effective percentage in the study group was 20.83% and 14.53% in the controlled group, in PP,the numbers were 18.69% and 16.19%,they don't show the statistical difference(ITT:CMH=1.5802 P=0.2087; PP:CMH= 0.1788 P=0.6724.there was no significant electrocardiogram difference(P>0.05) between two groups before treatment. Conclusion: ruzengxiaotong tiemo is effective and safety in the treatment ofhyperplasia of mammary gland,the Conclusion is awaiting to be confirmed by the third periord clinical trail.