MEGESTROL-ACETATE FOR THE PREVENTION OF HOT FLASHES

Background. Vasomotor hot flashes are a common symptom in women during menopause and in men who have undergone androgen-deprivation therapy for prostate cancer. Although treatment with estrogens in women and an drogens in men can attenuate these symptoms, these hormones may be con traindicated in women with breast cancer and in men with prostrate can cer. Pilot trials have suggested that the progestational agent megestr ol acetate can ameliorate hot flashes in both groups of patients. Meth ods. The patients included 97 women with a history of breast cancer an d 66 men with prostate cancer who had undergone androgen-deprivation t herapy. All patients had experienced bothersome hot flashes (median nu mber per day at base line, 6.1 for the women and 8.4 for the men). Aft er a one-week pretreatment observation period, the patients received m egestrol acetate (20 mg twice dally) for four weeks, followed by place bo for four weeks, or vice versa in a double-blind manner as determine d by pretreatment randomization. The patients documented the frequency and severity of hot flashes in daily symptom diaries. Results. After four weeks, hot flashes were reduced by 21 percent in the group receiv ing placebo first and by 85 percent in the group receiving megestrol a cetate first (P<0.001). An intention-to-treat analysis of data for all eligible treated patients showed that 74 percent of the megestrol ace tate group, as compared with 20 percent of the placebo group, had a de crease of 50 percent or more in the frequency of hot flashes during th e first four weeks (P<0.001). The degree of efficacy was similar in me n and women. The only side effect was withdrawal menstrual bleeding in women, generally occurring one to two weeks after the megestrol aceta te had been discontinued.