Treatment of Bulimia Nervosa With Topiramate in a Randomized, Double-Blind, Placebo-Controlled Trial, Part 1: Improvement in Binge and Purge Measures
J Clin Psychiatry 2003;64(11):1335-1341
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Background: This randomized, double-blind,
placebo-controlled trial was designed to assess the efficacy and
safety of topiramate in bulimia nervosa.
Method: Patients with DSM-IV bulimia nervosa
were randomly assigned in equal proportions to receive topiramate
(N = 35) or placebo (N = 34) for 10 weeks (between April 1999 and
Dec. 2000). Topiramate treatment was started at 25 mg/day and
titrated by 25 to 50 mg/week to a maximum of 400 mg/day. The
primary efficacy measure was mean weekly number of binge and/or
purge days. Related outcome measures included mean weekly number
of binge days and binge frequency, as well as mean weekly number
of purge days and purge frequency.
Results: Sixty-four outpatients (33 placebo, 31
topiramate) were included in the intent-to-treat analysis. The
median topiramate dose was 100 mg/day (range, 25-400 mg/day).
Mean ± SD baseline number of weekly binge and/or purge days was
5.0 ± 1.6 for topiramate patients and 5.1 ± 1.5 for placebo
patients. The primary efficacy measure, mean weekly number of
binge and/or purge days, decreased 44.8% from baseline with
topiramate versus 10.7% with placebo (p = .004). The mean weekly
number of binge days decreased 48.2% with topiramate versus 17.7%
with placebo (p = .015), and mean binge frequency decreased 49.2%
with topiramate versus 28.0% with placebo (p = .071). The mean
weekly number of purge days decreased 43.4% with topiramate
versus 16.6% with placebo (p = .016), and mean purge frequency
decreased 49.8% with topiramate versus 21.6% with placebo (p =
.016). Three patients (2 placebo, 1 topiramate) discontinued from
the trial due to adverse events.
Conclusion: Topiramate was associated with
significant improvements in both binge and purge symptoms in this
study population and represents a potential treatment for bulimia