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CME Released: 3/10/2008
Valid for credit through: 3/10/2009
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March 10, 2008 — Gabapentin at 900 mg/day was effective in treating hot flashes, according to the results of a randomized, double-blind, controlled trial published in the March issue of Menopause.
"Gabapentin, a γ-aminobutyric acid, has been shown to reduce hot flashes in breast cancer patients, in women with chemically and/or surgically induced menopause, and in a small sample of women in natural menopause," write Debra A. Butt, MSc, MD, CCFP, from the University of Toronto in Toronto, Ontario, Canada, and colleagues. "Despite the promising evidence, gabapentin has not been adequately studied in postmenopausal women who enter menopause naturally."
The goal of this study was to compare the effectiveness and tolerability of gabapentin vs placebo for the treatment of hot flashes in women who enter menopause naturally.
Between March 2004 and April 2006, this study took place in the community and primary care settings across the Greater Toronto Area. Eligibility criteria were natural menopause, ages 45 to 65 years, with at least 14 hot flashes per week.
Of 200 eligible women, 197 were randomized to receive gabapentin 300-mg oral capsules or placebo 3 times daily for 4 weeks, and 193 (98%) completed the study. The main endpoint was the mean percentage change from baseline to week 4 in daily hot flash score, which was calculated from the participants' diaries. Secondary endpoints included changes in weekly mean hot flash scores and frequencies, quality of life, and adverse events. Analysis was by intent-to-treat.
From baseline to week 4, hot flash scores decreased by 51% (95% confidence interval [CI],
43% - 58%) in the gabapentin group and by 26% (95% CI, 18% - 35%) in the placebo group
(P < .001). In the gabapentin group, the Menopause-Specific Quality-of-Life vasomotor score decreased by 1.7 (95% CI, 1.3 -
2.1; P < .001).
Compared with the placebo group, the gabapentin group had a higher proportion of women who reported dizziness (18%), unsteadiness (14%), and drowsiness (12%) at week 1, but these symptoms decreased by week 2 and returned to baseline by week 4.
"Gabapentin at 900 mg/day is an effective and well-tolerated treatment for hot flashes," the study authors write.
Limitations of the study include lack of data beyond treatment week 4; dosage data available only for 900 mg/day, although a higher dose might have had a greater benefit in the reduction of hot flashes; and study population highly educated, predominantly white, and not ethnically diverse, limiting generalizability to other populations.
"Gabapentin seems to be an effective treatment for hot flashes with few side effects in women who are moderately affected by such symptoms in the general population," the study authors conclude. "Longer term studies of at least 3 months are needed to determine whether gabapentin continues to have a beneficial effect over a longer period."
The Physicians' Services Incorporated Foundation and the University of Toronto, Faculty of Medicine Dean's Fund funded this study. Pfizer, Inc, donated the gabapentin capsules. The study authors have disclosed no relevant financial relationships.
Menopause. 2008;15:310-318.
Approximately half of postmenopausal women have hot flashes for 6 months to 5 years, or even longer, after natural menopause. In North America and Europe, only 1 approved treatment is available for hot flashes, namely hormone therapy (HT). Because risks associated with HT use have led to recommendations that HT be used at the lowest effective dose for the shortest duration possible, the number of HT prescriptions has markedly decreased.
Gabapentin has been shown to reduce hot flashes in women with breast cancer and in those with chemically or surgically induced menopause, or both, as well as in a small sample of women in natural menopause. Gabapentin seems to be a safe and well-tolerated drug, and it is currently licensed for use for the treatment of epilepsy. However, it has not been adequately studied in postmenopausal women who enter menopause naturally.
