Originally published as JCO Early Release 10.1200/JCO.2008.19.6253 on March 30 2009

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Newer Antidepressants and Gabapentin for Hot Flashes: An Individual Patient Pooled Analysis

From the Mayo Clinic, Rochester, MN; Johns Hopkins School of Medicine, Baltimore, MD; Lombardi Comprehensive Cancer Center, Washington, DC;GlaxoSmithKline, King of Prussia, PA; Duke University Medical Center, Durham; Wake Forest University, Winston-Salem, NC; University of Arizona College of Medicine, Tucson AZ; University of Rochester James P. Wilmot Cancer Center, Rochester; and University of New York at Buffalo, Buffalo, NY.

Corresponding author: Charles L. Loprinzi, MD, Division of Medical Oncology, Mayo Clinic, 200 First St Southwest, Rochester MN 55905; e-mail: cloprinzi{at}mayo.edu.

Purpose Nonhormonal treatment options have been investigated as treatments for hot flashes, a major clinical problem in many women. Starting in 2000, a series of 10 individual double-blind placebo-controlled studies has evaluated newer antidepressants and gabapentin for treating hot flashes. This current project was developed to conduct an individual patient pooled analysis of the data from these published clinical trials.

Patients and Methods Individual patient data were collected from the various study investigators who published their study results between 2000 and 2007. Between-study heterogeneity for study characteristics and patient populations was tested via ² tests before a pooled analysis. The primary end point, the change in hot flash activity from baseline to week 4, for each agent was calculated via both weighted and unweighted approaches, using the size of the study as the weight. Basic summary statistics were produced for hot flash score and frequency using the following three statistics: raw change, percent reduction, and whether or not a 50% reduction was achieved.

Results This study included seven trials of newer antidepressants and three trials of gabapentin. The optimal doses (defined by individual study results) of the newer antidepressants paroxetine, venlafaxine, fluoxetine, and sertraline decreased hot flash scores by 41%, 33%, 13%, and 3% to 18% compared with the corresponding placebo arms, respectively. The three gabapentin trials decreased hot flashes by 35% to 38% compared with the corresponding placebo arms.

Conclusion Some newer antidepressants and gabapentin, within 4 weeks of therapy initiation, decrease hot flashes more than placebo.

Supported by the North Central Cancer Treatment Group (Public Health Service Grant No. CA-37404) and the Mayo Clinic Foundation.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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