Low‐dose naltrexone for the treatment of fibromyalgia: Findings of a small, randomized, double‐blind, placebo‐controlled, counterbalanced, crossover trial assessing daily pain levels

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, placebocontrolled, 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.

Reactive Astrogliosis in an Experimental Model of Fibromyalgia: Effect of Dexmedetomidine

“…Degos et al [2013] mentioned that macrophages play a pivotal role in the development of neuroinflammation; they noticed that when blood-brain barrier permeability allows their migration into the hippocampus concomitant with proinflammatory cytokines, the inflammatory cascade is promoted. Younger et al [2013] reported that low-dose naltrexone has a beneficial effect on FMS pain, and they attributed this effect to the transient opioid blockade which causes a compensatory increase in endogenous opioid activity.…”

A control systems engineering approach for adaptive behavioral interventions: illustration with a fibromyalgia intervention

“…We illustrate how control engineering can accomplish this vision for behavioral interventions with the treatment of fibromyalgia (FM), a complex, multisymptom illness [10][11][12]. The approach is based on a secondary analysis of intensive longitudinal data collected in a previously conducted clinical trial that relied on low-dose naltrexone for the treatment of FM.…”

“…There is good evidence to suggest that naltrexone, an opioid antagonist, has a neuroprotective role and may be a potentially effective treatment for diseases like FM [11,35]. The data for this paper has been taken from clinical trials of a low-dose naltrexone (LDN) intervention [11,12].…”

The (putative) pathological impact of fibromyalgia on the orofacial system

“…Een recent getest medicament is de opioïd-antagonist naltrexon die in een lage dosis van 4,5 mg per dag bij fi bromyalgiepatiënten statistisch signifi cant meer pijnreductie bewerkstelligde dan een placebo, respectievelijk 28,8% en 18%. Het medicament had geen eff ect op vermoeidheid en slaapproblemen (Younger et al, 2013).…”