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Paroxetine is an effective treatment for hot flashes: results from a prospective randomized clinical trial.
J Clin Oncol. 2005 Oct 01; 23(28):6919-30.JC

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+Show Affiliations

Lombardi Comprehensive Cancer Center at Georgetown University, Washington, DC, USA. vstearn1@jhmi.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16192581

Citation

Stearns, Vered, et al. "Paroxetine Is an Effective Treatment for Hot Flashes: Results From a Prospective Randomized Clinical Trial." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 23, no. 28, 2005, pp. 6919-30.
Stearns V, Slack R, Greep N, et al. Paroxetine is an effective treatment for hot flashes: results from a prospective randomized clinical trial. J Clin Oncol. 2005;23(28):6919-30.
Stearns, V., Slack, R., Greep, N., Henry-Tilman, R., Osborne, M., Bunnell, C., Ullmer, L., Gallagher, A., Cullen, J., Gehan, E., Hayes, D. F., & Isaacs, C. (2005). Paroxetine is an effective treatment for hot flashes: results from a prospective randomized clinical trial. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 23(28), 6919-30.
Stearns V, et al. Paroxetine Is an Effective Treatment for Hot Flashes: Results From a Prospective Randomized Clinical Trial. J Clin Oncol. 2005 Oct 1;23(28):6919-30. PubMed PMID: 16192581.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Paroxetine is an effective treatment for hot flashes: results from a prospective randomized clinical trial. AU - Stearns,Vered, AU - Slack,Rebecca, AU - Greep,Nancy, AU - Henry-Tilman,Ronda, AU - Osborne,Michael, AU - Bunnell,Craig, AU - Ullmer,Lynda, AU - Gallagher,Ann, AU - Cullen,Jennifer, AU - Gehan,Edmund, AU - Hayes,Daniel F, AU - Isaacs,Claudine, PY - 2005/9/30/pubmed PY - 2005/11/3/medline PY - 2005/9/30/entrez SP - 6919 EP - 30 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J Clin Oncol VL - 23 IS - 28 N2 - 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. SN - 0732-183X UR - https://www.unboundmedicine.com/medline/citation/16192581/Paroxetine_is_an_effective_treatment_for_hot_flashes:_results_from_a_prospective_randomized_clinical_trial_ L2 - https://ascopubs.org/doi/10.1200/JCO.2005.10.081?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -