Abstract

Background: Fibromyalgia presents a significant challenge in clinical management, particularly among women who are disproportionately affected. Traditional treatment modalities often provide inadequate relief and may entail adverse effects. This meta-analysis aimed to evaluate the safety and efficacy of naltrexone in fibromyalgia management specifically among women.
Methods: A systematic review and meta-analysis were conducted following PRISMA guidelines. Studies assessing naltrexone's efficacy in female participants with fibromyalgia were included. Outcome measures included pain severity, physical function, fatigue, mood disturbances, and adverse events. Data were synthesized narratively, and quantitative analysis was performed using random-effects or fixed-effects models.
Results: Four trials met the inclusion criteria, The analysis revealed that the naltrexone group exhibited a statistically significant reduction in pain intensity compared to the placebo group (MD: –0.46, 95% CI [–0.85, -0.06], P = 0.02). Additionally, participants in the naltrexone group experienced a higher incidence of dizziness compared to those in the placebo group (RR: 1.99, 95% CI [1.07, 3.70], P = 0.03). However, no statistically significant differences were observed between the naltrexone and placebo groups regarding abdominal pain (RR: 0.80, 95% CI [0.43, 1.49], P = 0.48) or nausea (RR: 0.97, 95% CI [0.59, 1.61], P = 0.92).
Conclusion: While naltrexone shows promise in fibromyalgia management, the current evidence does not support its significant efficacy in reducing pain severity or alleviating associated symptoms among women. Further research is warranted to elucidate optimal dosing regimens, treatment durations, and patient selection criteria to enhance its therapeutic potential in this population.

Key words: Fibromyalgia, naltrexone, chronic pain, women, meta-analysis, randomized controlled trials, pain intensity, adverse events.