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2026, Vol: 10, Issue: 1
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Review Article
Online Published: 19 Jan 2026
 


Safety and Efficacy of Naltrexone in the Treatment of Chronic Pain: A Meta-Analysis and Systematic Review of Randomized Controlled Trials

Saja Abdulmajeed Saif, Mohammed Saad Alwarhi, Mariam Radhi Al-umran, Saleh Mohammed Almaymuni, Ali Abed Alsakhairi, Eman Saud Alkhaldi, Rayan Fahad Alanazi, Ahmad Hassan Aljazir, Norah Sattam H. Alruwaili, Joud Dhaifullah Alghamdi, Emtnan Mohseen Ahmed Robidiy, Ayman Mohammed Kharaba.


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.


 
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How to Cite this Article
Pubmed Style

Saif SA, Alwarhi MS, Al-umran MR, Almaymuni SM, Alsakhairi AA, Alkhaldi ES, Alanazi RF, Aljazir AH, Alruwaili NSH, Alghamdi JD, Robidiy EMA, Kharaba AM. Safety and Efficacy of Naltrexone in the Treatment of Chronic Pain: A Meta-Analysis and Systematic Review of Randomized Controlled Trials. IJMDC. 2026; 10(1): 526-531. doi:10.24911/IJMDC.51-1766177666

Web Style

Saif SA, Alwarhi MS, Al-umran MR, Almaymuni SM, Alsakhairi AA, Alkhaldi ES, Alanazi RF, Aljazir AH, Alruwaili NSH, Alghamdi JD, Robidiy EMA, Kharaba AM. Safety and Efficacy of Naltrexone in the Treatment of Chronic Pain: A Meta-Analysis and Systematic Review of Randomized Controlled Trials. https://www.ijmdc.com/?mno=303821 [Access: January 25, 2026]. doi:10.24911/IJMDC.51-1766177666

AMA (American Medical Association) Style

Saif SA, Alwarhi MS, Al-umran MR, Almaymuni SM, Alsakhairi AA, Alkhaldi ES, Alanazi RF, Aljazir AH, Alruwaili NSH, Alghamdi JD, Robidiy EMA, Kharaba AM. Safety and Efficacy of Naltrexone in the Treatment of Chronic Pain: A Meta-Analysis and Systematic Review of Randomized Controlled Trials. IJMDC. 2026; 10(1): 526-531. doi:10.24911/IJMDC.51-1766177666


Vancouver/ICMJE Style

Saif SA, Alwarhi MS, Al-umran MR, Almaymuni SM, Alsakhairi AA, Alkhaldi ES, Alanazi RF, Aljazir AH, Alruwaili NSH, Alghamdi JD, Robidiy EMA, Kharaba AM. Safety and Efficacy of Naltrexone in the Treatment of Chronic Pain: A Meta-Analysis and Systematic Review of Randomized Controlled Trials. IJMDC. (2026), [cited January 25, 2026]; 10(1): 526-531. doi:10.24911/IJMDC.51-1766177666


Harvard Style

Saif, S. A., Alwarhi, . M. S., Al-umran, . M. R., Almaymuni, . S. M., Alsakhairi, . A. A., Alkhaldi, . E. S., Alanazi, . R. F., Aljazir, . A. H., Alruwaili, . N. S. H., Alghamdi, . J. D., Robidiy, . E. M. A. & Kharaba, . A. M. (2026) Safety and Efficacy of Naltrexone in the Treatment of Chronic Pain: A Meta-Analysis and Systematic Review of Randomized Controlled Trials. IJMDC, 10 (1), 526-531. doi:10.24911/IJMDC.51-1766177666


Turabian Style

Saif, Saja Abdulmajeed, Mohammed Saad Alwarhi, Mariam Radhi Al-umran, Saleh Mohammed Almaymuni, Ali Abed Alsakhairi, Eman Saud Alkhaldi, Rayan Fahad Alanazi, Ahmad Hassan Aljazir, Norah Sattam H. Alruwaili, Joud Dhaifullah Alghamdi, Emtnan Mohseen Ahmed Robidiy, and Ayman Mohammed Kharaba. 2026. Safety and Efficacy of Naltrexone in the Treatment of Chronic Pain: A Meta-Analysis and Systematic Review of Randomized Controlled Trials. International Journal of Medicine in Developing Countries, 10 (1), 526-531. doi:10.24911/IJMDC.51-1766177666


Chicago Style

Saif, Saja Abdulmajeed, Mohammed Saad Alwarhi, Mariam Radhi Al-umran, Saleh Mohammed Almaymuni, Ali Abed Alsakhairi, Eman Saud Alkhaldi, Rayan Fahad Alanazi, Ahmad Hassan Aljazir, Norah Sattam H. Alruwaili, Joud Dhaifullah Alghamdi, Emtnan Mohseen Ahmed Robidiy, and Ayman Mohammed Kharaba. "Safety and Efficacy of Naltrexone in the Treatment of Chronic Pain: A Meta-Analysis and Systematic Review of Randomized Controlled Trials." International Journal of Medicine in Developing Countries 10 (2026), 526-531. doi:10.24911/IJMDC.51-1766177666


MLA (The Modern Language Association) Style

Saif, Saja Abdulmajeed, Mohammed Saad Alwarhi, Mariam Radhi Al-umran, Saleh Mohammed Almaymuni, Ali Abed Alsakhairi, Eman Saud Alkhaldi, Rayan Fahad Alanazi, Ahmad Hassan Aljazir, Norah Sattam H. Alruwaili, Joud Dhaifullah Alghamdi, Emtnan Mohseen Ahmed Robidiy, and Ayman Mohammed Kharaba. "Safety and Efficacy of Naltrexone in the Treatment of Chronic Pain: A Meta-Analysis and Systematic Review of Randomized Controlled Trials." International Journal of Medicine in Developing Countries 10.1 (2026), 526-531. Print. doi:10.24911/IJMDC.51-1766177666


APA (American Psychological Association) Style

Saif, S. A., Alwarhi, . M. S., Al-umran, . M. R., Almaymuni, . S. M., Alsakhairi, . A. A., Alkhaldi, . E. S., Alanazi, . R. F., Aljazir, . A. H., Alruwaili, . N. S. H., Alghamdi, . J. D., Robidiy, . E. M. A. & Kharaba, . A. M. (2026) Safety and Efficacy of Naltrexone in the Treatment of Chronic Pain: A Meta-Analysis and Systematic Review of Randomized Controlled Trials. International Journal of Medicine in Developing Countries, 10 (1), 526-531. doi:10.24911/IJMDC.51-1766177666




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