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A randomized, controlled, trial of controlled release paroxetine in fibromyalgia.
Am J Med. 2007 May; 120(5):448-54.AJ

Abstract

PURPOSE

We investigated the efficacy and tolerability of paroxetine controlled release, a selective serotonin reuptake inhibitor in fibromyalgia.

METHODS

After excluding patients with current major depression and anxiety disorders, 116 subjects with fibromyalgia were enrolled in a 12-week, randomized, double-blind, placebo-controlled, trial of paroxetine controlled release (12.5-62.5 mg/day). The primary outcome measure was proportion of responders as defined as a> or =25% reduction in scores on the Fibromyalgia Impact Questionnaire (FIQ) from randomization to end of treatment. Secondary outcome measures included changes in FIQ scores, Clinical Global Impression -Improvement (CGI-I) and Severity (CGI-S) scores, Visual Analogue Scale for pain scores, number of tender points, and scores on the Sheehan Disability Scale (SDS).

RESULTS

Significantly more patients in paroxetine controlled release group (57%) showed a> or =25% reduction in FIQ compared to placebo (33%) (P=.016). Paroxetine controlled release was significantly superior to placebo in reducing the FIQ total score (P =.015). The CGI-I ratings significantly favored the drug over placebo (P<.005). The improvements on other secondary outcome measures between the 2 groups were not statistically significant. Drowsiness, dry mouth, blurred vision, genital disorders, and anxiety were reported more frequently with paroxetine controlled release. The mean dose of paroxetine controlled release was 39.1 mg/day.

CONCLUSIONS

Paroxetine controlled release appears to be well-tolerated and improve the overall symptomatology in patients with fibromyalgia without current mood or anxiety disorders. However, its effect on pain measures seems to be less robust.

Authors+Show Affiliations

Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27704, USA. ashwin.patkar@duke.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17466657

Citation

Patkar, Ashwin A., et al. "A Randomized, Controlled, Trial of Controlled Release Paroxetine in Fibromyalgia." The American Journal of Medicine, vol. 120, no. 5, 2007, pp. 448-54.
Patkar AA, Masand PS, Krulewicz S, et al. A randomized, controlled, trial of controlled release paroxetine in fibromyalgia. Am J Med. 2007;120(5):448-54.
Patkar, A. A., Masand, P. S., Krulewicz, S., Mannelli, P., Peindl, K., Beebe, K. L., & Jiang, W. (2007). A randomized, controlled, trial of controlled release paroxetine in fibromyalgia. The American Journal of Medicine, 120(5), 448-54.
Patkar AA, et al. A Randomized, Controlled, Trial of Controlled Release Paroxetine in Fibromyalgia. Am J Med. 2007;120(5):448-54. PubMed PMID: 17466657.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, controlled, trial of controlled release paroxetine in fibromyalgia. AU - Patkar,Ashwin A, AU - Masand,Prakash S, AU - Krulewicz,Stan, AU - Mannelli,Paolo, AU - Peindl,Kathleen, AU - Beebe,Katherine L, AU - Jiang,Wei, PY - 2006/03/14/received PY - 2006/06/05/revised PY - 2006/06/06/accepted PY - 2007/5/1/pubmed PY - 2007/5/23/medline PY - 2007/5/1/entrez SP - 448 EP - 54 JF - The American journal of medicine JO - Am J Med VL - 120 IS - 5 N2 - PURPOSE: We investigated the efficacy and tolerability of paroxetine controlled release, a selective serotonin reuptake inhibitor in fibromyalgia. METHODS: After excluding patients with current major depression and anxiety disorders, 116 subjects with fibromyalgia were enrolled in a 12-week, randomized, double-blind, placebo-controlled, trial of paroxetine controlled release (12.5-62.5 mg/day). The primary outcome measure was proportion of responders as defined as a> or =25% reduction in scores on the Fibromyalgia Impact Questionnaire (FIQ) from randomization to end of treatment. Secondary outcome measures included changes in FIQ scores, Clinical Global Impression -Improvement (CGI-I) and Severity (CGI-S) scores, Visual Analogue Scale for pain scores, number of tender points, and scores on the Sheehan Disability Scale (SDS). RESULTS: Significantly more patients in paroxetine controlled release group (57%) showed a> or =25% reduction in FIQ compared to placebo (33%) (P=.016). Paroxetine controlled release was significantly superior to placebo in reducing the FIQ total score (P =.015). The CGI-I ratings significantly favored the drug over placebo (P<.005). The improvements on other secondary outcome measures between the 2 groups were not statistically significant. Drowsiness, dry mouth, blurred vision, genital disorders, and anxiety were reported more frequently with paroxetine controlled release. The mean dose of paroxetine controlled release was 39.1 mg/day. CONCLUSIONS: Paroxetine controlled release appears to be well-tolerated and improve the overall symptomatology in patients with fibromyalgia without current mood or anxiety disorders. However, its effect on pain measures seems to be less robust. SN - 1555-7162 UR - https://www.unboundmedicine.com/medline/citation/17466657/A_randomized_controlled_trial_of_controlled_release_paroxetine_in_fibromyalgia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9343(06)00685-1 DB - PRIME DP - Unbound Medicine ER -