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Phase III evaluation of fluoxetine for treatment of hot flashes.
J Clin Oncol. 2002 Mar 15; 20(6):1578-83.JC

Abstract

PURPOSE

Hot flashes can be a prominent problem in women with a history of breast cancer. Given concerns regarding the use of hormonal therapies in such patients, other nonhormonal means for treating hot flashes are required. Based on anecdotal information regarding the efficacy of fluoxetine and other newer antidepressants for treating hot flashes, the present trial was developed.

PATIENTS AND METHODS

This trial used a double-blinded, randomized, two-period (4 weeks per period), cross-over methodology to study the efficacy of fluoxetine (20 mg/d) for treating hot flashes in women with a history of breast cancer or a concern regarding the use of estrogen (because of breast cancer risk). Eligible patients had to have reported that they averaged at least 14 hot flashes per week; they could have received tamoxifen or raloxifene as long as they were on a stable dose. The major outcome measure was a bivariate construct representing hot flash frequency and hot flash score, analyzed by a classic sums and differences cross-over analysis.

RESULTS

Eighty-one randomized women began protocol therapy. By the end of the first treatment period, hot flash scores (frequency x average severity) decreased 50% in the fluoxetine arm versus 36% in the placebo arm. Cross-over analysis demonstrated a significantly greater marked hot flash score improvement with fluoxetine than placebo (P =.02). The results were not adjusted for potential confounding influences, including age and tamoxifen use. The fluoxetine was well tolerated.

CONCLUSION

This dose of fluoxetine resulted in a modest improvement in hot flashes.

Authors+Show Affiliations

Division of Medical Oncology, Mayo Clinic and Foundation, Rochester, MN 55905, USA. cloprinzi@mayo.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 available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

11896107

Citation

Loprinzi, Charles L., et al. "Phase III Evaluation of Fluoxetine for Treatment of Hot Flashes." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 20, no. 6, 2002, pp. 1578-83.
Loprinzi CL, Sloan JA, Perez EA, et al. Phase III evaluation of fluoxetine for treatment of hot flashes. J Clin Oncol. 2002;20(6):1578-83.
Loprinzi, C. L., Sloan, J. A., Perez, E. A., Quella, S. K., Stella, P. J., Mailliard, J. A., Halyard, M. Y., Pruthi, S., Novotny, P. J., & Rummans, T. A. (2002). Phase III evaluation of fluoxetine for treatment of hot flashes. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 20(6), 1578-83.
Loprinzi CL, et al. Phase III Evaluation of Fluoxetine for Treatment of Hot Flashes. J Clin Oncol. 2002 Mar 15;20(6):1578-83. PubMed PMID: 11896107.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase III evaluation of fluoxetine for treatment of hot flashes. AU - Loprinzi,Charles L, AU - Sloan,Jeff A, AU - Perez,Edith A, AU - Quella,Susan K, AU - Stella,Phillip J, AU - Mailliard,James A, AU - Halyard,Michele Y, AU - Pruthi,Sandhya, AU - Novotny,Paul J, AU - Rummans,Teresa A, PY - 2002/3/16/pubmed PY - 2002/4/18/medline PY - 2002/3/16/entrez SP - 1578 EP - 83 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J Clin Oncol VL - 20 IS - 6 N2 - PURPOSE: Hot flashes can be a prominent problem in women with a history of breast cancer. Given concerns regarding the use of hormonal therapies in such patients, other nonhormonal means for treating hot flashes are required. Based on anecdotal information regarding the efficacy of fluoxetine and other newer antidepressants for treating hot flashes, the present trial was developed. PATIENTS AND METHODS: This trial used a double-blinded, randomized, two-period (4 weeks per period), cross-over methodology to study the efficacy of fluoxetine (20 mg/d) for treating hot flashes in women with a history of breast cancer or a concern regarding the use of estrogen (because of breast cancer risk). Eligible patients had to have reported that they averaged at least 14 hot flashes per week; they could have received tamoxifen or raloxifene as long as they were on a stable dose. The major outcome measure was a bivariate construct representing hot flash frequency and hot flash score, analyzed by a classic sums and differences cross-over analysis. RESULTS: Eighty-one randomized women began protocol therapy. By the end of the first treatment period, hot flash scores (frequency x average severity) decreased 50% in the fluoxetine arm versus 36% in the placebo arm. Cross-over analysis demonstrated a significantly greater marked hot flash score improvement with fluoxetine than placebo (P =.02). The results were not adjusted for potential confounding influences, including age and tamoxifen use. The fluoxetine was well tolerated. CONCLUSION: This dose of fluoxetine resulted in a modest improvement in hot flashes. SN - 0732-183X UR - https://www.unboundmedicine.com/medline/citation/11896107/Phase_III_evaluation_of_fluoxetine_for_treatment_of_hot_flashes_ L2 - https://ascopubs.org/doi/10.1200/JCO.2002.20.6.1578?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -