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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.

AbstractOBJECTIVE:
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.
AuthorsJarred Younger, Noorulain Noor, Rebecca McCue, Sean Mackey
JournalArthritis and rheumatism (Arthritis Rheum) Vol. 65 Issue 2 Pg. 529-38 (Feb 2013) ISSN: 1529-0131 [Electronic] United States
PMID23359310 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2013 by the American College of Rheumatology.
Chemical References
  • Narcotic Antagonists
  • Placebos
  • Naltrexone
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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