The Safety and Efficacy of Low-Dose Naltrexone in Patients with Fibromyalgia: A Systematic Review.
The Safety and Efficacy of Low-Dose Naltrexone in Patients with Fibromyalgia: A Systematic Review.
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DOI：
10.2147/jpr.s395457
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发表时间：
2023
影响因子：
2.7
通讯作者：
Mohabbat AB
中科院分区：
文献类型：
--
作者：
Yang J;Shin KM;Do A;Bierle DM;Abu Dabrh AM;Yin Z;Bauer BA;Mohabbat AB
纤维肌痛（FM）是一种慢性疼痛敏感性综合征，其特征是弥漫性肌肉骨骼疼痛和许多其他全身表现。低剂量纳洛酮（LDN）已越来越多地用作FM的标签外治疗选择。然而，目前关于LDN在FM患者中的安全性和有效性的证据尚不清楚。系统评估LDN治疗FM的安全性和有效性的现有证据。于2022年9月对EBM Reviews-科克伦对照试验中心注册库、EBM Reviews-科克伦系统数据库、Embase、奥维德MEDLINE（R）和Epub Ahead of Print、In-Process、In-Data-Review & Other Non-Indexed Citations、Daily和Versions以及Scopus数据库进行了全面的文献检索。纳入标准为以英语发表的文章，重点是涉及LDN治疗FM的临床试验。两名评审员独立筛选和提取数据。由于研究之间的方法学异质性较高，因此使用了定性分析。电子检索产生了805篇文章。在应用纳入标准后，选择了9篇文章（1篇RCT，2篇病例报告，2篇病例系列和4项先导试验）进行评价。LDN干预方案、研究设计和随访期在纳入的研究中不同。总体而言，LDN被发现在FM的症状管理中是有效的，并且在78%的评估安全性的纳入研究中，没有报告严重的不良事件。根据目前的研究数据，证明低剂量纳洛酮的有效性和安全性是未来的可能性，但科学证据水平有限。未来需要设计良好的大样本量试验。
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.