The Safety and Efficacy of Low-Dose Naltrexone in Patients with Fibromyalgia: A Systematic Review

Juan Yang,1 Kyung-Min Shin,2 Alex Do,1 Dennis M Bierle,1 Abd Moain Abu Dabrh,3 Ziying Yin,4 Brent A Bauer,1 Arya B Mohabbat1 1Division of General Internal Medicine, Mayo Clinic, Rochester, MN, 55905, USA; 2KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, 34054, South Kore...

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Main Authors: Yang J, Shin KM, Do A, Bierle DM, Abu Dabrh AM, Yin Z, Bauer BA, Mohabbat AB
Format: Article
Language:English
Published: Dove Medical Press 2023-03-01
Series:Journal of Pain Research
Subjects:
Online Access:https://www.dovepress.com/the-safety-and-efficacy-of-low-dose-naltrexone-in-patients-with-fibrom-peer-reviewed-fulltext-article-JPR
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author Yang J
Shin KM
Do A
Bierle DM
Abu Dabrh AM
Yin Z
Bauer BA
Mohabbat AB
author_facet Yang J
Shin KM
Do A
Bierle DM
Abu Dabrh AM
Yin Z
Bauer BA
Mohabbat AB
author_sort Yang J
collection DOAJ
description Juan Yang,1 Kyung-Min Shin,2 Alex Do,1 Dennis M Bierle,1 Abd Moain Abu Dabrh,3 Ziying Yin,4 Brent A Bauer,1 Arya B Mohabbat1 1Division of General Internal Medicine, Mayo Clinic, Rochester, MN, 55905, USA; 2KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea; 3Division of General Internal Medicine, Mayo Clinic, Jacksonville, FL, 32224, USA; 4Department of Radiology, Mayo Clinic, Rochester, MN, 55905, USACorrespondence: Arya B Mohabbat, Division of General Internal Medicine, Mayo Clinic, 200 First Street SW, RO_GO_17_102GIM, Rochester, MN, 55905, USA, Tel +1-507-284-2511, Email Mohabbat.Arya@mayo.eduAbstract: Fibromyalgia (FM) is a chronic pain sensitivity syndrome characterized by diffuse musculoskeletal pain and many other systemic manifestations. Low-dose naltrexone (LDN) has been increasingly used as an off-label treatment option in FM. However, current evidence on the safety and efficacy of LDN in patients with FM is not well known. To systematically assess the current evidence on the safety and efficacy of LDN use in the treatment of FM. A comprehensive bibliographic search was conducted on EBM Reviews – Cochrane Central Register of Controlled Trials, EBM Reviews – Cochrane Database of Systematic, Embase, Ovid MEDLINE(R) and Epub Ahead of Print, In-Process, In-Data-Review & Other Non-Indexed Citations, Daily and Versions and Scopus databases in September 2022. Inclusion criteria were articles that were published in English, focusing on clinical trials involving LDN for the treatment of FM. Two reviewers independently screened and extracted the data. A qualitative analysis was used due to the high methodological heterogeneity between studies. The electronic search produced 805 articles. After applying the inclusion criteria, 9 articles (one RCT, two case reports, two case series, and four pilot trials) were selected for evaluation. LDN intervention protocols, study designs, and follow-up periods were different among the included studies. Overall, LDN was found to be effective in the symptomatic management of FM, and of the 78% of included studies that evaluated for safety, no severe adverse events were reported. Proving the efficacy and safety of low-dose naltrexone is a future possibility based on current study data, but the level of scientific evidence is limited. Future well-designed trials with large sample sizes are required.Keywords: fibromyalgia, naltrexone, low-dose naltrexone, chronic pain, review
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spelling doaj.art-e2c366c41ee4466696d60647e9c0c03b2023-03-21T18:11:20ZengDove Medical PressJournal of Pain Research1178-70902023-03-01Volume 161017102382434The Safety and Efficacy of Low-Dose Naltrexone in Patients with Fibromyalgia: A Systematic ReviewYang JShin KMDo ABierle DMAbu Dabrh AMYin ZBauer BAMohabbat ABJuan Yang,1 Kyung-Min Shin,2 Alex Do,1 Dennis M Bierle,1 Abd Moain Abu Dabrh,3 Ziying Yin,4 Brent A Bauer,1 Arya B Mohabbat1 1Division of General Internal Medicine, Mayo Clinic, Rochester, MN, 55905, USA; 2KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea; 3Division of General Internal Medicine, Mayo Clinic, Jacksonville, FL, 32224, USA; 4Department of Radiology, Mayo Clinic, Rochester, MN, 55905, USACorrespondence: Arya B Mohabbat, Division of General Internal Medicine, Mayo Clinic, 200 First Street SW, RO_GO_17_102GIM, Rochester, MN, 55905, USA, Tel +1-507-284-2511, Email Mohabbat.Arya@mayo.eduAbstract: Fibromyalgia (FM) is a chronic pain sensitivity syndrome characterized by diffuse musculoskeletal pain and many other systemic manifestations. Low-dose naltrexone (LDN) has been increasingly used as an off-label treatment option in FM. However, current evidence on the safety and efficacy of LDN in patients with FM is not well known. To systematically assess the current evidence on the safety and efficacy of LDN use in the treatment of FM. A comprehensive bibliographic search was conducted on EBM Reviews – Cochrane Central Register of Controlled Trials, EBM Reviews – Cochrane Database of Systematic, Embase, Ovid MEDLINE(R) and Epub Ahead of Print, In-Process, In-Data-Review & Other Non-Indexed Citations, Daily and Versions and Scopus databases in September 2022. Inclusion criteria were articles that were published in English, focusing on clinical trials involving LDN for the treatment of FM. Two reviewers independently screened and extracted the data. A qualitative analysis was used due to the high methodological heterogeneity between studies. The electronic search produced 805 articles. After applying the inclusion criteria, 9 articles (one RCT, two case reports, two case series, and four pilot trials) were selected for evaluation. LDN intervention protocols, study designs, and follow-up periods were different among the included studies. Overall, LDN was found to be effective in the symptomatic management of FM, and of the 78% of included studies that evaluated for safety, no severe adverse events were reported. Proving the efficacy and safety of low-dose naltrexone is a future possibility based on current study data, but the level of scientific evidence is limited. Future well-designed trials with large sample sizes are required.Keywords: fibromyalgia, naltrexone, low-dose naltrexone, chronic pain, reviewhttps://www.dovepress.com/the-safety-and-efficacy-of-low-dose-naltrexone-in-patients-with-fibrom-peer-reviewed-fulltext-article-JPRfibromyalgianaltrexonelow-dose naltrexonechronic painreview
spellingShingle Yang J
Shin KM
Do A
Bierle DM
Abu Dabrh AM
Yin Z
Bauer BA
Mohabbat AB
The Safety and Efficacy of Low-Dose Naltrexone in Patients with Fibromyalgia: A Systematic Review
Journal of Pain Research
fibromyalgia
naltrexone
low-dose naltrexone
chronic pain
review
title The Safety and Efficacy of Low-Dose Naltrexone in Patients with Fibromyalgia: A Systematic Review
title_full The Safety and Efficacy of Low-Dose Naltrexone in Patients with Fibromyalgia: A Systematic Review
title_fullStr The Safety and Efficacy of Low-Dose Naltrexone in Patients with Fibromyalgia: A Systematic Review
title_full_unstemmed The Safety and Efficacy of Low-Dose Naltrexone in Patients with Fibromyalgia: A Systematic Review
title_short The Safety and Efficacy of Low-Dose Naltrexone in Patients with Fibromyalgia: A Systematic Review
title_sort safety and efficacy of low dose naltrexone in patients with fibromyalgia a systematic review
topic fibromyalgia
naltrexone
low-dose naltrexone
chronic pain
review
url https://www.dovepress.com/the-safety-and-efficacy-of-low-dose-naltrexone-in-patients-with-fibrom-peer-reviewed-fulltext-article-JPR
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