| Objective:To assess the efficacy and safety of Ruhening Tablets in treating hyperplasia of galactophore through Phase II clinical trial, compared with Ruhesanjie Tablets, and to provide recommendation for dose and treatment duration for Phase III study.Methods:This is a double blind double dummy, randomized, multicenter trial with paralleled ctive control.240 female subjects aged 18-50 years with hyperplasia of galactophore and liver and blood stasis syndrome were included, and randomized with 1:1 ration to experimental (Ruhening Tablets) and control (Ruhesanjie Tablets) groups. The treatment durations were 3 months. The scores of major and concomitant sysptoms/signs were collected to assess the efficacy. The adverse events and laboratory test (routine test of blood, urine and feces, liver function, kidney function; ECG) were collected to assess the safety. Overall efficacy was assessed with primary and accompanied symptoms/signs scores. Overall response rate was tested with CMH chi-square test, therapeutic index was tested with Wilcoxon rank sums test, and degree of improvement and cure rate of symptoms/signs were test with CMH chi-square and common chi-square tes, to compare the difference of efficacy between the experimental and control groups.Results:240 subjects were enrolled in this study,11 of them were excluded and 9 discontinued. All the subjects were included in Safety Set,229 subjects were valid for Full Analysis Set (113 subjects in experimental group,116 subjects in control group), 220 subjects were included in Per Protocol Set (109 subjects in experimental group, 111 subjects in control group). The demographics and baseline characteristics are comparable between the two groups.Overall Clincal EfficacyPPS analysis:Therapeutic index in the experimental group is 0.52±0.16, superior to that in the control group(0.47±0.22), the difference between the two groups is statistically significant (P=0.04). The overall response rate in the experimental group is 93.58%, larger than that in the conrol group (80.18%), the difference is statistically significant, (P=0.003)。The results of analyses based on FAS are confistent with those based on PPS, in the aspects of therapeutic index and overall respose rate, the experimental group is superior to the control group.Clinical svpmptoms/signs:In almost half of the subjects, breast pain (experimental 57.41% vs control 42.34%),beast tenderness disappered (experimental 53.70% vs control 42.34%), while breast lump disappeared in only less than 10% of subjects (experimental 8.26% vs control 9.91%)。The disappear rate of breast painis higher in experimental group than in the control group, the difference is statistically significant(P=0.03). In the aspects of disappear rate and improvement degree of other symptolms/signs, there is no statistically significant difference between the two groups (P>0.05)Laboratory test:In some of the subjects in both groups, there were abnormal results of routine tests of blood, urine and feces, and liver function, kidney funct and ECG, but without clinical significance and judged with not related to study drug.Adverse Events/Reactions:There were 5 (4.17%) subjects with adverse reactions in the experimental group, while 3(2.50%) in the control group. Both the experimental and control drug were safe.Conclusion:Ruhening Tablets are effective and safe used in treating Hyperplasia of Galactophore (liver and blood stasis syndrome), especially in alleviating breat pain. The overall response rate in the experimental group is superior to the control group. No serious adverse events occurred in this study, Ruhening Tablets (oral,4 tablets/dose, tid) were well tolerated. It is recommended that using the same dose in the Phase III study to confirm the efficacy and safety of Ruhening Tablets. |
PDF Full Text Request