OBJECTIVE： To compare the efficacy and safety of Leonurus artemisia cream and Dan’e fukang cream in the treatment of primary dysmenorrhea. METHODS： 80 patients with primary dysmenorrheal were randomly divided into L. artemisia cream group （40 cases） and Dan’e fukang cream group （40 cases）. L. artemisia cream group received L. artemisia cream 10 g， orally， twice a day. Dan’e fukang cream group received Dan’e fukang cream 10 g， orally， twice a day. The treatment was stated before 10 days of menstruation. 10 days was regarded as 1 treatment course， and it lasted for 6 courses. Cold drink and food were forbid during medication， washing face and feet with warm water， soaking feet with hot water if they can， paying attention to keep the lower abdomen and legs warm. If patients felt unbearable pain in menstruation， 0.3 g Ibuprofen sustained release capsule was given， orally twice a day. Clinical efficacy， symptom score （dysmenorrhea degree，abdominal pain，lumbosacral pain）before and after treatment， dysmenorrhea duration， frequency of taking painkillers and the incidence of adverse reactions in 2 groups were observed. RESULTS： There were no significant differences in the total effective rate and the incidence of adverse reactions in 2 groups （P＞0.05）. Before treatment， there were no significant differences in dysmenorrhea degree， abdominal pain， lumbosacral pain score， dysmenorrheal duration and frequency of taking painkillers in 2 groups （P＞0.05）. After treatment， the dysmenorrhea degree， abdominal pain， lumbosacral pain score in 2 groups were significantly lower than before， and Dan’e fukang cream group was lower than L. artemisia cream group with statistical sighificance（P＜0.05），and dysmenorrheal duration and frequency of taking painkillers were significantly lower than before， with statistical significance （P＜0.05）， while there was no significant difference in 2 groups （P＞0.05）. CONCLUSIONS： Both L. artemisia cream and Dan’e fukang cream have good efficacy and safety in the treatment of primary dysmenorrhea， while Dan’e fukang cream is superior to L. artemisia cream in terms of improving clinical symptoms.