A Randomized Controlled Trial of Fluvoxamine in Prostatodynia, a Male Somatoform Pain Disorder
J Clin Psychiatry 2002;63:778-781
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: Prostatodynia is a common
and often disabling condition that affects males
and has the characteristics of a somatoform pain
disorder. It presents with urogenital pain and
urinary symptoms. Failure of conventional treatment
and a successful uncontrolled pilot study with
fluvoxamine in this condition prompted this study.
Method: In a randomized double-blind
trial, 42 patients with prostatodynia were assigned
to receive either fluvoxamine (N=21) or placebo (N=21) for up to 8 weeks. Doses were
adjusted according to therapeutic need. The median
dose of fluvoxamine was 150 mg (range, 50-300 mg). Self-rated pain scores, urinary flow rates,
and depression and anxiety scores were measured at baseline and several times throughout the
Results: The groups were similar at
baseline, and the results were examined by
intent-to-treat analysis either using the last observation
carried forward or, in the case of dichotomous
measures, counting treatment dropouts as treatment
failures. Fluvoxamine was significantly more likely
to reduce pain intensity (p=.01) and normalize urinary flow rates (p=.03) with a clinically
significant number needed to treat value of 1.5
(confidence interval=1.12 to 5.50). This
therapeutic effect could not be attributed to change in
mood, as the 2 groups did not differ with respect to
affective ratings at the end of the study. The fluvoxamine-treated group had significantly
lower (p=.02) final scores on the General Health
Questionnaire, indicating an overall benefit from
Conclusion: Fluvoxamine is a viable
treatment for prostatodynia. Dose-ranging studies
and longer trials are needed to evaluate this agent