Low-dose naltrexone for the treatment of fibromyalgia: Findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels.Color me unconvinced.
Younger J, Noor N, McCue R, Mackey S.
Stanford University School of Medicine, Palo Alto, California.
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.
The results may be "significant" in the statistical sense – and then even barely, just look at the p-values and the small sample size. To me however they don't look significant in the common sense of the word.
LDN may help some patients, a bit – so I won't blame you if you do give it a try. A cure or significant help, LDN is not.
If the (small) benefits of LDN outweigh the side-effects, that can this study not answer.
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