To investigate the clinical effect of Honghua Ruyi pill with catgut embedding therapy in treating irregular menstruation and its safety evaluation. Methods： To select 120 cases of patients with irregular menstruation who came to the gynecological department in our hospital between June 2012—2014 December and then randomly divided them into two groups with 60 cases in each. The control group was given estrogen and progesterone cycle therapy and the observation group was treated with Honghua Ruyi pill with catgut embedding therapy. The treatment course was one month and the treatment went on for 2 courses. After treatment， curative effect， serum sex hormones(FSH， LH， E2)levels and adverse reactions were observed. Results： The effective rate of the observation group was 88.1%， which was significantly higher than that of the control group(74.6%)， and the difference was statistically significant(P<0.05). In the aspect of peripheral serum hormone levels： after treatment， both of the peripheral serum FSH levels in the two groups were decreased(P<0.05)， while the observation group decreased more significantly(P<0.01)with a statistically significant difference. In both of the two groups， serum E2 levels increased in varying degrees(all P<0.05)， which was observed more significantly in the observation group(P<0.01)， and the difference was statistically significant. While in terms of serum LH levels(P>0.05)， there are no significant change on both of the groups and the difference was not statistically significant. Adverse reactions have not been seen in both of the two groups. Conclusion： The effect of catgut embedding therapy combined with Honghua Ruyi pill was more significant that hormone therapy， and it is of high safety value and good compliance. It should be promoted to the market.