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Management of Postmenopausal Hot Flushes With Venlafaxine Hydrochloride: A Randomized, Controlled Trial

Michele L. Evans, MD^*, Elizabeth Pritts, MD^*, Eric Vittinghoff, PhD, MPH, Karen McClish^*, Kevin S. Morgan^* and Robert B. Jaffe, MD^*

From the *Center for Reproductive Sciences, Department of Obstetrics, Gynecology, and Reproductive Sciences, and Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.

Address reprint requests to: Robert B. Jaffe, MD, Center for Reproductive Sciences, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, 505 Parnassus Avenue, San Francisco, CA 94143–0556; e-mail: jaffer{at}obgyn.ucsf.edu.

OBJECTIVE: To examine the efficacy of extended-release venlafaxine for the treatment of postmenopausal hot flushes.

METHODS: Eighty postmenopausal women with more than 14 hot flushes per week were randomized to receive treatment with extended-release venlafaxine or placebo. Participants received 37.5 mg daily for 1 week, followed by 75 mg daily for 11 weeks. Daily hot flush severity scores and adverse effects were recorded by subjects. Baseline and monthly follow-up questionnaires assessed patient-perceived hot flush score, quality of life, and sexual function. Participants were treated for 12 weeks.

RESULTS: Of the 80 subjects who enrolled in the study, 40 were in the treatment group and 40 in the control group. Of these, 61 completed the study (treatment, n = 29; control, n = 32). Subjective assessment at monthly visits of the effects of hot flush symptoms on daily living were significantly improved in the treatment group (P < .001). Hot flush severity scores based on daily diaries were somewhat lower in the treatment group, but the between-group difference did not reach statistical significance (P = .25). Three side effects, dry mouth, sleeplessness, and decreased appetite, were significantly more frequent in the venlafaxine group, but others, including dizziness, tremors, anxiety, diarrhea, and rash, were significantly less frequent. Ninety-three percent of participants in the venlafaxine group chose to continue treatment at the conclusion of the study.

CONCLUSION: Extended-release venlafaxine, 75 mg per day, is an effective treatment for postmenopausal hot flushes in otherwise healthy women, based on a significant decrease in patient-perceived hot flush score.

LEVEL OF EVIDENCE: I

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