ABSTRACT
Objective To observe the effect and safety of modified Yishen Zhuyang Huoxue Huazhuo Formula for polycystic ovarian syndrome (PCOS) in the TCM pattern of deficiency of spleen and kidney with phlegm-dampness. Methods Totally 123 cases were recruited into this study and randomized to two groups by central random approach, 64 cases in the observation group and 59 cases in the control group. Patients in the observation group were given the modified Yishen Zhuyang Huoxue Huazhuo Formula, while those in the control group were given compound cyproterone acetate tablet, for two treatment courses, three months for one course. The changes of ovarian volume and the number of follicles before and after treatment were observed. Adverse reactions were also evaluated. Results Bilateral ovarian volumes in both groups decreased after treatment (P0.05). The rate of adverse reaction in the observation group was lower than the control group. Conclusion Modified Yishen Zhuyang Huoxue Huazhuo Formula is effective for PCOS patient by reducing the ovarian volume with a low incidence of side effect.