Biglia, N., Sgandurra, P., Peano, E., Marenco, D., Moggio, G., Bounous, V., … Sismondi, P. (2009). Non-hormonal treatment of hot flushes in breast cancer survivors: Gabapentin vs. vitamin E. Climacteric, 12, 310–318.
DOI Link
Study Purpose
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Assess efficacy and tolerability of gabapentin 900 mg/day compared to vitamin E for the control of vasomotor symptoms.
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Secondary objective to evaluate effect of the treatments on quality of sleep and other aspects of quality of life (QOL).
Intervention Characteristics/Basic Study Process
Patients were randomized to gabapentin 900 mg/day or vitamin E 800 IU/day for 12 weeks.
Sample Characteristics
The study population included 115 adult postmenopausal women with history of breast cancer experiencing eight or more hot flushes per day. Sixty women completed the study.
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Median age: 50 years
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Inclusion: Previous breast cancer surgically treated one year prior; no evidence of systemic disease; eight or more hot flushes per day; postmenopausal status; adjuvant tamoxifen, aromatase inhibitors or gonadotropin releasing hormone (GnRH) analogs allowed if started at least two months prior.
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Exclusion: Use of any antidepressant treatment, progestagens, or other medication to treat hot flashes within three months; concomitant chemotherapy; uncontrolled hypertension; impaired renal or hepatic function or diabetes.
Setting
Oncology Department University of Turin, Italy
Study Design
Non–placebo-controlled, non-blinded trial
Measurement Instruments/Methods
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Hot flush diary completed daily
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Pittsburgh Sleep Quality Index (PSQI)
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Menopause Rating Scale (MRS)
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SF-36 Health Survey
Results
Hot flush frequency and score decreased by 57.05% and 66.87%, respectively (p < 0.05) in the gabapentin group. Hot flush frequency and score were reduced by 10.02% and 7.28% respectively (p > 0.05) in the vitamin E group. Gabapentin improved the quality of sleep (PSQI score reduction: 21.33%, p < 0.05).
Limitations
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Small sample size
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High dropout rate