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.
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.
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.
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.
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.