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.