Paroxetine is an effective treatment for hot flashes: results from a prospective randomized clinical trial.

Abstract

PURPOSE:

In an open-label trial we have previously demonstrated that paroxetine reduces hot flashes. We initiated a stratified, randomized, double-blind, cross-over, placebo-controlled trial to investigate the efficacy of paroxetine 10 mg and 20 mg compared to placebo in reducing hot flash frequency and composite score. A secondary objective was to evaluate quality of life (QOL) parameters.

PATIENTS AND METHODS:

Women who suffered at least two hot flashes a day for 1 month or longer were eligible. Women were randomly assigned to 4 weeks of paroxetine 10 mg or 20 mg followed by placebo for 4 weeks, or placebo for 4 weeks followed by paroxetine 10 mg or 20 mg for 4 weeks. Participants completed baseline daily hot flash diaries for one week prior to the start of the study and throughout the study, and QOL questionnaires at baseline, week 5 and week 9.

RESULTS:

279 women were screened, and 151 were randomly assigned. Paroxetine 10 mg reduced hot flash frequency and composite score by 40.6% and 45.6%, respectively, compared to 13.7% and 13.7% for placebo (P = .0006 and P = .0008, respectively). Paroxetine 20 mg reduced hot flash frequency and composite score by 51.7% and 56.1%, respectively, compared with 26.6% and 28.8% for placebo (P = .002 and P = .004, respectively). Efficacy was similar between the two doses, but women were less likely to discontinue low-dose paroxetine. Paroxetine 10 mg was associated with a significant improvement in sleep compared with placebo (P = .01).

CONCLUSION:

Paroxetine is an effective treatment for hot flashes in women with or without a prior breast cancer.

• Authors: Vered Stearns, Rebecca Slack, Nancy Greep, Ronda Henry-Tilman, Michael Osborne, Craig Bunnell, Lynda Ullmer, Ann Gallagher, Jennifer Cullen, Edmund Gehan, Daniel F Hayes, Claudine Isaacs
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 23 Issue 28 Pg. 6919-30 (Oct 01 2005) ISSN: 0732-183X [Print] United States
• PMID: 16192581 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Placebos
• Serotonin Uptake Inhibitors
• Paroxetine

Topics

• Adult
• Aged
• Breast Neoplasms (drug therapy)
• Cross-Over Studies
• Double-Blind Method
• Female
• Hot Flashes (drug therapy, etiology)
• Humans
• Middle Aged
• Paroxetine (therapeutic use)
• Patient Compliance
• Placebos
• Quality of Life
• Selective Serotonin Reuptake Inhibitors (therapeutic use)