Objective
Prior studies of hypochondriasis demonstrate benefit for pharmacotherapy and for cognitive-behavioral therapy (CBT). This study examines whether joint treatment offers additional benefit.
Method
195 patients with DSM-IV hypochondriasis were randomly assigned to one of 4 treatments – placebo, fluoxetine, CBT, or joint treatment with both fluoxetine and CBT. Evaluations assessed hypochondriasis, other psychopathology, adverse events, functional status, and quality of life. The primary analysis assessed outcome at week 24 among the intent-to-treat sample, with responders defined as having a 25% or greater improvement over baseline on both the Whiteley Index and the H-YBOCS-M. The Cochran-Armitage Trend test assessed the hypothesized pattern of response: joint treatment>CBT or fluoxetine treatment>placebo treatment.
Results
The response rate was greater with combined therapy than either fluoxetine or CBT alone; all three were more effective than placebo. Responder rates for each active treatment were not significantly different compared to placebo. Secondary analyses of the Whiteley Index as a continuous measure revealed that, compared to placebo, fluoxetine (but not CBT) was significantly more effective at week 24 in reducing hypochondriasis and had a significantly faster rate of improvement over 24 weeks. The fluoxetine group also had significantly less anxiety and an improved quality of life compared to placebo. Drop-out rates did not differ between groups and treatment emergent adverse events were evenly distributed.
Conclusions
This study supports the safety, tolerance, and efficacy of fluoxetine for hypochondriasis. Joint treatment provided a small incremental benefit. Because approximately 50% of patients did not respond to the study treatments, new or more intensive approaches are needed.
ClinicalTrials.gov Identifier: NCT00339079