Background: Gabapentin (GPT), a widely used drug in neurology, has been proposed as a non-hormonal option for the management of hot flushes in menopausal women with contraindications for estrogen therapy.
Objective: To compare GPT versus low-dose transdermal estradiol (E(2)) for treating post-menopausal women with moderate to very severe hot flushes.
Methods: A total of 45 post-menopausal women with moderate to very severe hot flushes were prospectively and single-blinded randomised to receive oral GPT 600 mg/night or transdermal 25 microg/day E(2) per week. Hot flush intensity and frequency were assessed with the Menopause Rating Scale and a numeric scale respectively at baseline and at 1, 4 and 8 weeks. Side effects were also assessed.
Results: Hot flush intensity and frequency significantly decreased for both groups at 1, 4 and 8 weeks of treatment as compared to baseline; however, this decrease was statistically more evident for the E(2) group. Although the percentage of hot flush intensity and frequency reduction at the end of the treatment was higher for E2, this was not statistically significant (68.2% vs. 60.6% for intensity and 70.1% vs. 58.9% for frequency, respectively, p > 0.05, NS). Encountered side effects included: drowsiness, dizziness, fatigue (GPT group) and mastodynia, vaginal spotting and a local allergic reaction (E(2) group). Compliance to treatment was 95.6% (GPT group) as compared to 90.9% for the E(2) group.
Conclusion: Despite statistical significant differences, from a clinical point of view oral GPT 600 mg was as effective as low-dose transdermal E(2) in controlling moderate to severe hot flushes in post-menopausal women, and should be recommended as an alternative option in those with contraindications to estrogen therapy. More research is warranted in this regard.