A double-blind, randomized, placebo-controlled trial of paroxetine controlled-release in irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disease that causes significant impairment in quality of life and accounts for $8 billion per year to the healthcare system and loss of productivity in the workplace. OBJECTIVE: The authors examined the efficacy and safety of paroxetine controlled-release (paroxetine-CR) in patients with IBS. METHOD: Seventy-two patients with IBS participated in a 12-week, double-blind, randomized, placebo-controlled study of paroxetine-CR (12.5 mg-50 mg/day). Efficacy was measured by Composite Pain Scores (primary outcome) and the Clinical Global Impression-Improvement (CGI-I) and Severity (CGI-S) ratings. RESULTS: In intent-to-treat analyses, there were no significant differences between paroxetine-CR (N=36) and placebo (N=36) on reduction in Composite Pain Scores, although the proportion of responders on CGI-I was significantly higher in the paroxetine-CR group. The treatment was well tolerated. CONCLUSION: The study did not demonstrate a statistically significant benefit for paroxetine-CR over placebo on the primary outcome measure, although there was improvement in secondary outcome measures. Overall, paroxetine-CR seems to have potential benefit in IBS. Studies with adequate samples may clarify the role of paroxetine-CR in IBS.

Treatment of social anxiety disorder with citalopram.

Selective serotonin reuptake inhibitors (SSRIs) are used as treatment for generalized and specific social phobias (social anxiety disorders). The efficacy of citalopram, an SSRI, for the treatment of social anxiety disorders has not yet been fully evaluated. These cases suggest that citalopram may be an effective treatment for social anxiety disorder (social phobia). These cases are consistent with two other published reports with citalopram from outside the US. Randomized controlled studies are warranted.

Effect of Bupropion SR on the Quality of Life of Elderly Depressed Patients With Comorbid Medical Disorders.

BACKGROUND: There is a need for additional studies of the quality of life (QOL) of elderly depressed subjects with medical comorbidity. METHOD: We conducted an 8-week, open trial of bupropion sustained release (SR) in 18 elderly (60-81 years) subjects with DSM-IV major depressive disorder and one or more serious medical illnesses (e.g., congestive heart failure, type 1 diabetes mellitus, irritable bowel syndrome) with a week-12 follow-up interview. The intent-to-treat method with the last observation carried forward was used to analyze depression and QOL measures. Dosing was initiated at 100 mg once daily and increased at weekly intervals to a maximum of 150 mg twice daily as clinically indicated. RESULTS: Bupropion SR treatment was associated with reductions in Clinical Global Impressions-Severity of Illness scale (p <.0001) score and in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score (p <.0001). QOL as measured by the Medical Outcomes Study Short Form-36 (SF-36) also tended to improve with treatment. The SF-36 "mental health" (p <.01) and "social functioning" (p <.0006) domains improved significantly by week 4. "Vitality" (p <.03) improved significantly by week 12. On the HAM-D, statistically significant improvement was noted on "depressed mood" (p <.0001), "feelings of guilt" (p <.01), "work and activities" (p <.001), "hypochondriasis" (p <.02), and "insomnia" (p <.01) at week 8. The mean dose of bupropion SR at endpoint was 222 mg/day, and the drug was relatively well tolerated. Two subjects dropped out owing to adverse events and 2 owing to other reasons. No drug-drug interactions occurred. CONCLUSION: These data suggest that bupropion SR is well tolerated and may improve depression, insomnia, somatic symptoms, work functioning, and certain quality-of-life measures in elderly depressed subjects with medical disorders. A randomized, placebo-controlled study is warranted to confirm these promising findings.