Fluoxetine versus sertraline in the treatment of patients with undifferentiated somatoform disorder: a randomized, open-label, 12-week, parallel-group trial.

Abstract

The present study was conducted to compare the effectiveness and tolerability of fluoxetine and sertraline in the treatment of undifferentiated somatoform disorder (USD), using the Patient Health Questionnaire (PHQ-15), which was specifically designed for assessing the severity of somatic symptoms. A randomized, 12-week, open-label trial of fluoxetine (10-60 mg/d) and sertraline (25-350 mg/d) in patients with USD was conducted. Six visits, at baseline and weeks 1, 2, 4, 8, and 12, were scheduled. Assessments for effectiveness and tolerability were conducted at each visit. The primary effectiveness measure was the mean change in PHQ-15 total score, from baseline to the end of treatment. Secondary effectiveness measures were the mean changes in total scores on the Beck Depression Inventory (BDI) and the 12-item General Health Questionnaire (GHQ-12), from baseline to the end of treatment. A total of 45 subjects were enrolled; of them, 28 were randomly assigned to receive fluoxetine and 17 to receive sertraline. The total score on the PHQ-15 from baseline to the end of treatment significantly decreased in the fluoxetine (-10.7, p<0.0001) and sertraline (-10.3, p<0.0001) treatment groups, with no between-group difference (F=0.0701, p=0.7924). Overall, both treatments were well tolerated and no serious adverse event was reported. This study suggests that both agents may have a potential role in the treatment of USD. A double-blind, placebo-controlled trial and/or head-to-head comparison study with larger samples are required to draw more definite conclusions.

• Authors: Changsu Han, Chi-Un Pae, Bun Hee Lee, Young-Hoon Ko, Prakash S Masand, Ashwin A Patkar, In-Kwa Jung
• Journal: Progress in neuro-psychopharmacology & biological psychiatry (Prog Neuropsychopharmacol Biol Psychiatry) Vol. 32 Issue 2 Pg. 437-44 (Feb 15 2008) ISSN: 0278-5846 [Print] England
• PMID: 17950970 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Serotonin Uptake Inhibitors
• Fluoxetine
• Sertraline

Topics

• Adult
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Fluoxetine (adverse effects, therapeutic use)
• Health Status
• Humans
• Male
• Personality Inventory (statistics & numerical data)
• Selective Serotonin Reuptake Inhibitors (adverse effects, therapeutic use)
• Sertraline (adverse effects, therapeutic use)
• Severity of Illness Index
• Somatoform Disorders (diagnosis, drug therapy, psychology)
• Surveys and Questionnaires
• Treatment Outcome