This study assessed the efficacy, durability, and tolerability of fluoxetine for hypochondriasis, a disorder for which controlled pharmacological trials are scarce.
Fifty-seven patients with hypochondriasis were enrolled: 12 discontinued during the placebo run-in, and 45 were randomized to either fluoxetine or placebo for 12 weeks (acute treatment). Responder status was defined as a Clinical Global Impression rating for hypochondriasis of much or very much improved. Secondary outcome measures included severity of hypochondriasis, somatization, anxiety, and depression. Responders to acute treatment entered a 12-week maintenance phase to week 24. Sustained responders at week 24 entered a 12-week double-masked discontinuation phase. Primary analysis used the intent-to-treat sample.
More patients responded with improvement in hypochondriasis when given fluoxetine compared with placebo, starting at week 8 (50.0% vs 19.0%, P = 0.03) and continuing to week 12 (62.5% vs 33.3%, P = 0.05). Mean dose at week 12 dose was 51.4 mg (SD, ±23 mg). The acute treatment response was maintained to week 24 with more responders in the fluoxetine compared with the placebo group (54.2% vs 23.8%, P = 0.04). Significant improvement was not noted on the continuous secondary outcomes measures of hypochondriasis, with the exception of the Clinical Global Impression hypochondriasis severity scale at week 24. Likelihood of response was not associated with severity of psychiatric comorbidity. Durability of response after controlled drug discontinuation could not be reasonably assessed, given the small sample size of patients who entered the discontinuation phase (n = 10). Fluoxetine was well tolerated, with no significant differences in discontinuation due to side effects between treatment groups.
Fluoxetine is a moderately effective and well-tolerated treatment for hypochondriasis.
Departments of *Psychiatry and †Biostatistics, Columbia University, New York, NY.
Received February 23, 2008; accepted after revision September 2, 2008.
This study was supported by a "First Award" (R29 MH49409) from NIHM to Dr Fallon.
This study was presented at the International Congress on Somatoform Disorders, Marburg, Germany, February 21-24, 2002.
Location of work: New York State Psychiatric Institute in Manhattan, NY (main site), and the Freedom From Fear Clinic, Brooklyn, NY, and St Joseph's Medical Center, Stamford, CT (secondary).
Fluoxetine was provided at no cost by Eli Lilly, Co.
Address correspondence and reprint requests to Brian A. Fallon, MD, MPH, Department of Psychiatry, Columbia University, 1051 Riverside Dr, Unit 69, New York, NY 10032. E-mail: email@example.com.