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

2005; Lippincott Williams & Wilkins; Volume: 23; Issue: 28 Linguagem: Inglês

10.1200/jco.2005.10.081

1527-7755

Vered Stearns, Rebecca Slack, Nancy Greep, Ronda Henry-Tilman, Michael T. Osborne, Craig A. Bunnell, L. Ullmer, Ann Gallagher, Jennifer Cullen, Edmund A. Gehan, Daniel F. Hayes, Claudine Isaacs,

Cancer Risks and Factors

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