Yang Juan, Shin Kyung-Min, Do Alex, Bierle Dennis M, Abu Dabrh Abd Moain, Yin Ziying, Bauer Brent A, Mohabbat Arya B
Division of General Internal Medicine, Mayo Clinic, Rochester, MN, 55905, USA.
KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea.
J Pain Res. 2023 Mar 21;16:1017-1023. doi: 10.2147/JPR.S395457. eCollection 2023.
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.
纤维肌痛（FM）是一种慢性疼痛敏感性综合征，其特征为弥漫性肌肉骨骼疼痛及许多其他全身表现。低剂量纳曲酮（LDN）已越来越多地被用作FM的一种非适应证治疗选择。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明确。为了系统地评估目前关于LDN用于治疗FM的安全性和有效性的证据。于2022年9月在循证医学评价 - 考克兰对照试验中央注册库、循证医学评价 - 考克兰系统评价数据库、Embase、Ovid MEDLINE(R)及印刷版之前的Epub、在研、数据审核及其他未索引引文、每日更新版和Scopus数据库中进行了全面的文献检索。纳入标准为以英文发表的、聚焦于涉及LDN治疗FM的临床试验的文章。两名评审员独立筛选并提取数据。由于各研究之间方法学异质性较高，因此采用了定性分析。电子检索共得到805篇文章。应用纳入标准后，选取了9篇文章（1篇随机对照试验、2篇病例报告、2篇病例系列和4篇试点试验）进行评估。纳入研究中的LDN干预方案、研究设计和随访期各不相同。总体而言，发现LDN在FM的症状管理方面有效，在评估安全性的纳入研究中，78%未报告严重不良事件。根据目前的研究数据，证明低剂量纳曲酮的有效性和安全性是未来有可能实现的，但科学证据水平有限。未来需要设计良好的大样本量试验。
