Active Ingredients: Gabapentin
Women aged 18 years or older who had breast cancer and were having an average of two or more hot flashes per day were eligible to take part in the study.
Acceptable non-steroidal contraceptive measures were required. Patients currently receiving chemotherapy were not eligible, although endocrine therapies were allowed. Most of the patients were taking adjuvant tamoxifen.
Patients taking venlafaxine, clonidine, or anticonvulsants were not eligible for the study, but use of other antidepressants including selective serotonin-reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors was allowed.
The other reasons for exclusion were: pregnancy; breastfeeding; use of steroidal contraception; coronary insufficiency; recent history of myocardial infarction, symptomatic cardiac disease, peripheral or cerebrovascular disease, stroke, syncope, or symptomatic hypotension; hepatic dysfunction aspartate aminotransferase concentration above twice the upper limit of normal, or bilirubin concentration above the upper limit of normal, as defined at each institution; renal dysfunction serum creatinine concentration above 1.
The Institutional Review Boards of the University of Rochester and each participating site approved the protocol.
Written informed consent was obtained from each participant. Design and procedures Patients were randomly assigned placebo, gabapentin 100 mg, or gabapentin 300 mg, each to be taken by mouth three times a day, for 8 weeks.
There was a 3-day titration period for all patients because the study was double-blind.
The study drugs were supplied as capsules of similar appearance in bottles. A block size of three was used to ensure that the treatment assignment was balanced after every three participants within each stratum.
The efficacy of gabapentin was assessed by three measures of hot-flash symptoms: frequency total number of mild, moderate, severe, and very severe hot flashes, severity score calculated by assigning scores of 1, 3, and 4, respectively, to mild, moderate, severe, and very severe hot flashes and adding the scores, and mean duration.
Each of these measures for the three treatment cycles was obtained by averaging of data collected over 1 week. Differences and percentage changes from baseline to week 4 or week 8 were calculated for each of the three measures.
A mixed-effect model was used for comparison of the treatment effect on these measures. The fixed effects in the model included treatment group three strata, time two strata, 4 weeks and 8 weeks and baseline measures.
A random effect for participants was also included in the model.
The assumptions made for mixed-effect models normality of error terms, mean, and covariance structure were checked thoroughly by use of residual plots. Outliers were identified and their influence on model estimation was examined.
For purposes of comparison, simpler analyses were also done on change scores and percentage change scores at week 4 and week 8 separately, by ANCOVA. The drug and placebo were provided by Pfizer, Inc.
The study was reviewed and approved by the National Cancer Institute, but not by Pfizer, and neither funding source had any role in study design; collection, analysis, or interpretation of data; or the writing of the report.
Demographic, clinical, and hot-flash characteristics at baseline are given in table 1.
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