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. 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. 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. 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.
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Authors | Jarred Younger, Noorulain Noor, Rebecca McCue, Sean Mackey |
Journal | Arthritis and rheumatism
(Arthritis Rheum)
Vol. 65
Issue 2
Pg. 529-38
(Feb 2013)
ISSN: 1529-0131 [Electronic] United States |
PMID | 23359310
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2013 by the American College of Rheumatology. |
Chemical References |
- Narcotic Antagonists
- Placebos
- Naltrexone
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Topics |
- Adult
- Aged
- Cross-Over Studies
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Fibromyalgia
(drug therapy)
- Humans
- Middle Aged
- Naltrexone
(administration & dosage, therapeutic use)
- Narcotic Antagonists
(administration & dosage, therapeutic use)
- Pain
(drug therapy)
- Pain Measurement
(drug effects)
- Placebos
- Self Report
- Treatment Outcome
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