Hot flashes may be a significant clinical problem in men undergoing androgen deprivation therapy with gonadotropin releasing hormone analogues, oral antiandrogens and/or surgical bilateral orchiectomy. Anecdotal information suggests that a low dose of the relatively new antidepressant venlafaxine may abrogate this clinical problem. We developed the current pilot trial to investigate further whether venlafaxine alleviates hot flashes in such men.

The study included men in whom substantial hot flashes were associated with androgen deprivation therapy. Hot flash data were collected by daily diary questionnaires during a 1-week baseline period when no therapy was given for hot flashes, as well as for the next 4 weeks when study participants received 12.5 mg. venlafaxine orally twice daily. Questionnaires completed during the 4 weeks ofvenlafaxine therapy also documented data on potential drug toxicity.

Of the 16 evaluable patients who completed the study 10 (63%) had a greater than 50% decrease in hot flash score, as determined using the formula, frequency x severity, by week 4 of treatment versus the baseline week. Median weekly hot flash scores decreased 54% from baseline during week 4 of venlafaxine therapy. Average incidence of severe and very severe hot flashes was reduced from 2.3 daily at baseline to 0.6 daily at study end (p = 0.003). Therapy was generally well tolerated.

Venlafaxine hydrochloride appears to represent an efficacious new method for alleviating hot flashes in men undergoing androgen ablation therapy. Further evaluation of this compound for alleviating hot flashes is indicated.