Effectiveness of external Sanjierupi Gao on mastalgia caused by mammary gland hyperplasia: a placebo controlled trial.

OBJECTIVE: To evaluate the curative effect of external application of the Chinese drug, Sanjierupi Gao, on mastalgia caused by mammary gland hyperplasia. METHODS: This randomized, double-blinded, and placebo controlled study enrolled 260 patients with mammary gland hyperplasia from five hospitals. Patients were randomly and equally divided into a Sanjierupi Gao treatment group and a placebo control group. An adhesive plaster was applied to the most painful area on either breast for 7 h a day. Treatment lasted for two menstrual cycles without application during menstruation. Mastalgia was used as the main index of curative effect. The change before and after treatment in days of mastalgia, the time to alleviate pain, pain extent, and severe pain scores were observed. RESULTS: Compared to the control group, the treatment group had significantly fewer days of mastalgia (P < 0.01), a significantly lower severe pain score (P < 0.01), and significantly less subjective pain and tenderness (P < 0.05 and P < 0.01, respectively). Three days before the follow-up visit, the pain score in the treatment group was significantly lower than that in the control group (P < 0.05). A non-parametric test was used to compare the time to alleviate mastalgia between the two groups and found no statistical difference (Z = -0.313, P = 0.754). CONCLUSION: Application of Sanjierupi Gao can decrease mastalgia duration in patients with mammary gland hyperplasia during menstruation and alleviate the extent of mastalgia. The time to alleviate pain is psychologically influenced.