OBJECTIVE： To investigate the clinical efficacy and safety of Shugan granule in the adjunctive treatment of melasma with irregular menstruation. METHODS： 140 cases of melasma with irregular menstruation were divided into observation group and control group according to random number table method， with 70 cases in each group. Control group was given vitamin C， vitamin E and compound retinoic acid and other routine medicines； observation group was additionally given Shugan granule 10 g，bid. A treatment course lasted for 21 d， and both groups received 2 courses of treatment. The area of melasma， irregular menstruation integral， clinical efficacy of melasma and irregular menstruation were observed in 2 groups， and the occurrence of ADR was recorded. RESULTS： There was no statistical significance in the area of melasma and irregular menstruation integral between 2 groups before treatment （P＞0.05）； after treatment， the area of melasma decreased significantly in 2 groups， and the observation group was significantly lower than the control group； irregular menstruation integral decreased significantly， and the observation group was significantly lower than the control group， with statistical significance （P＜0.05）. Total effective rates of melasma and irregular menstruation were 61.86％ and 61.43％， which were significantly higher than those of control group （45.71％and 44.29％）， with statistical significance （P＜0.05）. There was no statistical significance in the incidence of ADR between 2 groups （P＞0.05）. CONCLUSIONS： Shugan granule shows significant therapeutic efficacy in adjunctive treatment of melasma with irregular menstruation， and can decrease the area of melasma and improve irregular menstruation significantly.