Venlafaxine in management of hot flashes in survivors of breast cancer: a randomised controlled trial

Background Hot flashes can be troublesome, especially when hormonal therapy is contraindicated. Preliminary data have suggested that newer antidepress ants, such as venlafaxine, can diminish hot flashes. We undertook a double- blind, placebo-controlled, randomised trial to assess the efficacy of venla faxine in women with a history of breast cancer or reluctance to take hormo nal treatment because of fear of breast cancer. Methods Participants were assigned placebo (n=56) or venlafaxine 37.5 mg da ily (n=56), 75 mg daily (n=55), or 150 mg daily (n=54). After a baseline as sessment week, patients took the study medication for 4 weeks. All venlafax ine treatment started at 37.5 mg daily and gradually increased in the 75 mg and 150 mg groups. Patients completed daily hot-flash questionnaire diarie s. The primary endpoint was average daily hot-flash activity (number of fla shes and a score combining number and severity). Analyses were based on the women who provided data throughout the baseline and study weeks. Findings 191 patients had evaluable data for the whole study period (50 pla cebo, 49 venlafaxine 37.5 mg, 43 venlafaxine 75 mg, 49 venlafaxine 150 mg), After week 4 of treatment, median hot flash scores were reduced from basel ine by 27% (95% CI 11-34), 37% (26-54), 61% (50-68), and 61% (48-75) in the four groups. Frequencies of some side-effects (mouth dryness, decreased ap petite, nausea, and constipation) were significantly higher in the venlafax ine 75 mg and 150 mg groups than in the placebo group. Interpretation Venlafaxine is an effective non-hormonal treatment for hot f lashes, though the efficacy must be balanced against the drug's side-effect s. Confirmation of the results of this 4-week study awaits the completion o f three ongoing randomised studies to assess the effects of other related a ntidepressants for the treatment of hot flashes.