OBJECTIVETo observe the effect of Shugan Liangxue Compound (SLC) for relieving hot flashes in breast cancer patients medicated with tamoxifen.

METHODSA randomized, double blind clinical trial for observing the therapeutic effects of SLC was carried out on 73 breast cancer patients hospitalized from October 2004 to November 2006, who were treated with tamoxifen, and revealed hot flashes. They were randomly assigned to two groups, the 37 in the treated group treated by SLC, and the 36 in the control group treated with placebo. Taking the improvement of hot flashes as an end point index and that of sleep as a secondary index, the effects of treatment were compared by Kupperman scoring with the average times of hot flashes per day and condition of sleep within 1 week before treatment as baseline.

RESULTSThe effects on 66 patients (33 in the treated group and 33 in the control group) were evaluable. In the treated group hot flashes disappeared in 5 patients (15.2%), relieved in 14 (42.4%) and unchanged in 14 (42.4%); while in the control group, it disappeared in none, relieved in 10 (30.3%) and unchanged in 23 (69.7%), comparison between groups showed significant difference (P = 0.012). As for the condition of sleep, it was improved in 21 (63.6%) and unchanged in 12 (36.4%) in the treated group; while the condition of sleep in the control group was improved in 13 (39.4%) and unchanged in 20 (60.6%), also with significant difference between the two groups (P = 0.002).

CONCLUSIONSLC is effective in alleviating tamoxifen-induced hot flashes and improving the condition of sleep.