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Paroxetine Is an Effective Treatment for Hot Flashes: Results From a Prospective Randomized Clinical Trial

Lombardi Comprehensive Cancer Center at Georgetown University, Washington, DC; Strang-Cornell Breast Center, New York, NY; Dana-Farber Cancer Institute, Boston, MA; John Wayne Cancer Institute, Santa Monica, CA; Arkansas Cancer Research Center, Little Rock, AR; and the University of Michigan Comprehensive Cancer Center, Ann Arbor, MI

Address reprint requests to Vered Stearns, MD, Assistant Professor of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, 1650 Orleans St, CRB 1M53, Baltimore, MD 21230; e-mail: vstearn1{at}jhmi.edu

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.

Supported in part by a grant from the Fashion Footwear Foundation/QVC Presents Shoes on Sale and by a collaborative research grant from GlaxoSmithKline Pharmaceuticals.

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

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