A phase III randomized, double-blind, placebo-controlled trial of gabapentin in the management of hot flashes in men (N00CB)
- 1 March 2009
- journal article
- research article
- Published by Elsevier BV in Annals of Oncology
- Vol. 20 (3), 542-549
- https://doi.org/10.1093/annonc/mdn644
Abstract
Hot flashes represent a significant problem in men undergoing androgen deprivation therapy. Via a prospective, double-blind, placebo-controlled clinical trial, men with hot flashes, on a stable androgen deprivation therapy program for prostate cancer, received a placebo or gabapentin at target doses of 300, 600, or 900 mg/day. Hot flash frequencies and severities were recorded daily during a baseline week and for 4 weeks while the patients took the study medication. In the 214 eligible patients who began the study drug on this trial, comparing the fourth treatment week to the baseline week, mean hot flash scores decreased in the placebo group by 4.1 units and in the three increasing dose gabapentin groups by, 3.2, 4.6, and 7.0 units. Comparing the three combined gabapentin arms to the placebo arm did not result in significant hot flash differences. Wilcoxon rank-sum P values for change in hot flash scores and frequencies after 4 weeks of treatment were 0.10 and 0.02, comparing the highest dose gabapentin arm to the placebo arm, respectively. The gabapentin was well tolerated in this trial. These results support that gabapentin decreases hot flashes, to a moderate degree, in men with androgen ablation-related vasomotor dysfunction.Keywords
Funding Information
- Public Health Service (CA-25224, CA-37404, CA-35103, CA-63849, CA-63848, CA-35195, CA-35272, CA-35269, CA-35101, CA-60276, CA-52352, CA-37417, CA-35448)
- National Cancer Institute (U10CA037404)
This publication has 24 references indexed in Scilit:
- Gabapentin for the treatment of menopausal hot flashesMenopause, 2008
- Efficacy of gabapentin in the management of chemotherapy‐induced peripheral neuropathyCancer, 2007
- Paroxetine Is an Effective Treatment for Hot Flashes: Results From a Prospective Randomized Clinical TrialJournal of Clinical Oncology, 2005
- Gabapentin's effects on hot flashes in postmenopausal women: a randomized controlled trialPublished by Ovid Technologies (Wolters Kluwer Health) ,2003
- Pilot Evaluation of Gabapentin for Treating Hot FlashesMayo Clinic Proceedings, 2002
- Hot Flashes: The Old and the New, What Is Really True?Mayo Clinic Proceedings, 2002
- Phase III Evaluation of Fluoxetine for Treatment of Hot FlashesJournal of Clinical Oncology, 2002
- Megestrol Acetate for the Prevention of Hot FlashesNew England Journal of Medicine, 1994
- Diethylstilbestrol in treatment of postorchiectomy vasomotor symptoms and its relationship with serum follicle-stimulating hormone, luteinizing hormone, and testosteroneUrology, 1992
- Flushing long-term side effect of orchiectomy in treatment of prostatic carcinomaUrology, 1989