title: Paroxetine for patients with undifferentiated somatoform disorder: A prospective, open-label, 8-week pilot study.
abstract: BACKGROUND
  Forty-eight percent of somatic symptoms encountered in the primary care setting are medically unexplained. Such symptoms have been associated with negative impact on quality of life and with functional impairment.
  
  
  OBJECTIVE
  The aim of this study was to assess the potential utility and tolerability of paroxetine for the treatment of undifferentiated somatoform disorder (USD), using the 15-item Patient Health Questionnaire (PHQ-15) to assess the severity of somatic symptoms.
  
  
  METHODS
  A prospective, open-label, 8-week pilot study of paroxetine was conducted in outpatients with USD. Data were collected at baseline and at weeks 1, 2, 4, and 8. The primary measure was the mean change in PHQ-15 total score from baseline to the end of treatment. Secondary effectiveness measures included mean changes in total scores on the Beck Depression Inventory (BDI) and the 12-item General Health Questionnaire from baseline to end of treatment. A physical examination, electrocardiography, complete blood count, blood chemistry, urinalysis, and pregnancy test (for women of childbearing potential) were performed at baseline and the end of treatment. Vital signs were measured during each visit. Adverse events (AEs) were recorded during the study and included those determined using the Systematic Assessment for Treatment Emergent Events-General Inquiry.
  
  
  RESULTS
  Forty-three Korean patients were screened for the study. Twenty-two patients (13 women, 9 men; mean [SD] age, 37.4 [12.4] years) were enrolled and 20 completed the study; 2 patients were lost to follow-up. The mean total score on the PHQ-15 from baseline to the end of treatment was significantly decreased (17.2 vs 4.3; P = 0.001), as was the mean total BDI score (12.8 vs. 6.3; P < 0.001). Overall, paroxetine was well-tolerated. Nausea and dry mouth were the most commonly reported treatment-emergent AEs (both, 5 [22.7%]); no serious AEs were reported. No abnormal laboratory results were observed.
  
  
  CONCLUSIONS
  This open-label pilot study found that paroxetine had potential utility in the treatment of USD and was generally well-tolerated. These results suggest that adequately-powered, double-blind, placebo-controlled trials are warranted to more fully assess the efficacy and safety of paroxetine in the treatment of USD.
authors.affiliation: Department of Psychiatry, College of Medicine, Korea University, Seoul, South Korea ; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.
authors.forename: Changsu
authors.initials: C
authors.lastname: Han
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.
authors.forename: David M
authors.initials: DM
authors.lastname: Marks
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina ; Department of Psychiatry, Kangnam St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, South Korea.
authors.forename: Chi-Un
authors.initials: CU
authors.lastname: Pae
authors.affiliation: Department of Psychiatry, College of Medicine, Korea University, Seoul, South Korea.
authors.forename: Bun Hee
authors.initials: BH
authors.lastname: Lee
authors.affiliation: Department of Psychiatry, College of Medicine, Korea University, Seoul, South Korea.
authors.forename: Young-Hoop
authors.initials: YH
authors.lastname: Ko
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.
authors.forename: Prakash S
authors.initials: PS
authors.lastname: Masand
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.
authors.forename: Ashwin A
authors.initials: AA
authors.lastname: Patkar
authors.affiliation: Department of Psychiatry, College of Medicine, Korea University, Seoul, South Korea.
authors.forename: In-Kwa
authors.initials: IK
authors.lastname: Jung
keywords: Patient Health Questionnaire; paroxetine; pilot study; undifferentiated somatoform disorder