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Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels.
- Source :
-
Arthritis and rheumatism [Arthritis Rheum] 2013 Feb; Vol. 65 (2), pp. 529-38. - Publication Year :
- 2013
-
Abstract
- Objective: To determine whether low dosages (4.5 mg/day) of naltrexone reduce fibromyalgia severity as compared with the nonspecific effects of placebo. In this replication and extension study of a previous clinical trial, we tested the impact of low-dose naltrexone on daily self-reported pain. Secondary outcomes included general satisfaction with life, positive mood, sleep quality, and fatigue.<br />Methods: Thirty-one women with fibromyalgia participated in the randomized, double-blind, placebo-controlled, counterbalanced, crossover study. During the active drug phase, participants received 4.5 mg of oral naltrexone daily. An intensive longitudinal design was used to measure daily levels of pain.<br />Results: When contrasting the condition end points, we observed a significantly greater reduction of baseline pain in those taking low-dose naltrexone than in those taking placebo (28.8% reduction versus 18.0% reduction; P = 0.016). Low-dose naltrexone was also associated with improved general satisfaction with life (P = 0.045) and with improved mood (P = 0.039), but not improved fatigue or sleep. Thirty-two percent of participants met the criteria for response (defined as a significant reduction in pain plus a significant reduction in either fatigue or sleep problems) during low-dose naltrexone therapy, as contrasted with an 11% response rate during placebo therapy (P = 0.05). Low-dose naltrexone was rated equally tolerable as placebo, and no serious side effects were reported.<br />Conclusion: The preliminary evidence continues to show that low-dose naltrexone has a specific and clinically beneficial impact on fibromyalgia pain. The medication is widely available, inexpensive, safe, and well-tolerated. Parallel-group randomized controlled trials are needed to fully determine the efficacy of the medication.<br /> (Copyright © 2013 by the American College of Rheumatology.)
- Subjects :
- Adult
Aged
Cross-Over Studies
Dose-Response Relationship, Drug
Double-Blind Method
Female
Humans
Middle Aged
Naltrexone administration & dosage
Narcotic Antagonists administration & dosage
Placebos
Self Report
Treatment Outcome
Fibromyalgia drug therapy
Naltrexone therapeutic use
Narcotic Antagonists therapeutic use
Pain drug therapy
Pain Measurement drug effects
Subjects
Details
- Language :
- English
- ISSN :
- 1529-0131
- Volume :
- 65
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Arthritis and rheumatism
- Publication Type :
- Academic Journal
- Accession number :
- 23359310
- Full Text :
- https://doi.org/10.1002/art.37734