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June 26, 2002
A DGReview of:"A randomized, placebo-controlled, double-blind, flexible-dose study of fluoxetine in the treatment of women with fibromyalgia"
Source: American Journal of Medicine
By Robert Short
The SSRI fluoxetine is effective and generally well tolerated in women with fibromyalgia.
A randomized, placebo-controlled, double-blind flexible-dose study of fluoxetine in 60 women with fibromyalgia was carried out by Dr Lesley Arnold and colleagues. Dr Arnold is based at the Women's Health Research program, Department of Psychiatry, University of Cincinnati Medical Center, Cincinnati, Ohio, United States.
The intent-to-treat analysis in women who had received fluoxetine showed significant improvement in the Fibromyalgia Impact Questionnaire (FIQ) total score, compared with women who received placebo (difference of -12). The FIQ pain score was also 2.2 points lower in fluoxetine-treated women compared with the control group. Similarly, the FIQ fatigue and depression scores were lower in the treated group compared with women who received placebo. Fluoxetine-treated women also showed significant improvement in the McGill Pain Questionnaire, relative to the placebo group of women.
The effects of fluoxetine on tender points and myalgic scores were not so clear-cut. Said Dr Arnold, "Although counts for the number of tender points and total myalgic scores improved more in the fluoxetine group than in the placebo group, these differences were not statistically significant."
Dr Arnold concluded, "Fluoxetine was found to be effective on most outcome measures and generally well tolerated in women with fibromyalgia."
The American Journal of Medicine 2002;112(3):191-197 "A randomized, placebo-controlled, double-blind, flexible-dose study of fluoxetine in the treatment of women with fibromyalgia"
The Study Abstract:
A randomized, placebo-controlled, double-blind, flexible-dose study of fluoxetine in the treatment of women with fibromyalgia
Lesley M. Arnold MD, Evelyn V. Hess MD, James I. Hudson MD, SM, Jeffrey A. Welge PhD, Sarah E. Berno BPh, and Paul E. Keck Jr MD.
Received: 3/19/2001. Revised: 9/19/2001. Accepted: 10/29/2001.
Purpose
To assess the efficacy of fluoxetine in the treatment of patients with fibromyalgia.
Subjects and methods
Sixty outpatients (all women, aged 21–71 years) with fibromyalgia were randomly assigned to receive fluoxetine (10–80 mg/d) or placebo for 12 weeks in a double-blind, parallel-group, flexible-dose study. The primary outcome measures were the Fibromyalgia Impact Questionnaire total score (score range, 0 [no impact] to 80) and pain score (score range, 0–10). Secondary measures included the McGill Pain Questionnaire, change in the number of tender points, and total myalgic score.
Results
In the intent-to-treat analysis, women who received fluoxetine (mean [± SD] dose, 45 ± 25 mg/d) had significant (P = 0.005) improvement in the Fibromyalgia Impact Questionnaire total score compared with those who received placebo, with a difference of –12 (95% confidence interval [CI]: –19 to –4). They also had significant (P = 0.002) improvement in the Fibromyalgia Impact Questionnaire pain score (difference, –2.2 [95% CI: –3.6 to –0.9]), as well as in the Fibromyalgia Impact Questionnaire fatigue (P = 0.05) and depression (P = 0.01) scores and the McGill Pain Questionnaire (P = 0.01), when compared with subjects who received placebo. Although counts for the number of tender points and total myalgic scores improved more in the fluoxetine group than in the placebo group, these differences were not statistically significant.
Conclusion
In a 12-week, flexible-dose, placebo-controlled trial, fluoxetine was found to be effective on most outcome measures and generally well tolerated in women with fibromyalgia.
Supported by an investigator-initiated grant from Eli Lilly and Company, Indianapolis, Indiana.Affiliations:
a Women's Health Research Program (LMA, SEB), Department of Psychiatry, University of Cincinnati Medical Center, Cincinnati, Ohio, USA. b Department of Internal Medicine (EVH), Division of Immunology, University of Cincinnati Medical Center, Cincinnati, Ohio, USA. c Biological Psychiatry Laboratory (JIH), McLean Hospital, Belmont, Massachusetts, USA. d Department of Psychiatry (JIH), Harvard Medical School, Boston, Massachusetts, USA. e Department of Biostatistics and Epidemiology (JIH), Harvard School of Public Health, Boston, Massachusetts, USA. f Biological Psychiatry Program (JAW, PEK), Department of Psychiatry, University of Cincinnati Medical Center, Cincinnati, Ohio, USA.
Copyright © 2002 Excerpta Medica Inc. All rights reserved.
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