Nazir Muhammad Hashir, Mehboob Uswa, Farhan Muhammad, Patel Tirath, Ahmad Muhammad, Nazir Saleha, Durrani Tooba Ahmed, Khafaja Mustafa, Sobhi Abdulaziz, Kuznetsova Mariyam, Ahmed Muhammad, Awosika Ayoola
Department of Internal Medicine, King Edward Medical University, Lahore, Pakistan.
Department of Internal Medicine, College of Medicine, Ajman University, Ajman, UAE.
Ann Med Surg (Lond). 2025 Mar 28;87(5):2928-2935. doi: 10.1097/MS9.0000000000003203. eCollection 2025 May.
Fibromyalgia is a chronic disorder characterized by pain and psychological symptoms in adults. Several randomized controlled trials (RCTs) have shown the effectiveness and safety of low-dose naltrexone (LDN) in the treatment of fibromyalgia in variable small settings. Hence the need to conducted a meta-analysis to evaluate the overall effect and the strength of evidence.
PUBMED, CENTRAL, and ClinicalTrials.gov were searched to retrieve RCTs comparing naltrexone with placebo in fibromyalgia patients for systematic review and meta-analysis. We conducted pairwise meta-analyses using DerSimonian and Laird random-effects model via RevMan 5.4. We reported dichotomous outcomes as relative risk (RR) and continuous outcomes as standardized mean difference (SMD) with 95% confidence intervals (CIs). Quality of included RCTs was assessed using revised Cochrane Risk of Bias Tool for RCTs (RoB 2.0). Heterogeneity was detected by Chi and values for each meta-analysis and if significant, sensitivity analysis was performed.
We included five RCTs in meta-analysis. Our results estimated that LDN is superior to placebo in alleviating pain both in primary (SMD -0.61; 95% CI -1.14, -0.08) and sensitivity analysis (SMD -0.87; 95% CI -1.28, -0.46) but not in raising mechanical pain threshold (SMD 0.24; 95% CI -0.09, 0.56) in fibromyalgia patients. Neither the primary (RR 1.68; 95% CI 0.84, 3.36) nor sensitivity analysis (RR 0.98; 95% CI 0.72, 1.34) could associate LDN use with the incidence of headache. The incidence of vivid dreams (RR 2.41; 95% CI 1.77, 3.28) was significantly higher in treatment group as compared to placebo.
LDN is considered to be effective in the treatment of fibromyalgia. No serious adverse effects were reported in treatment group. There is need for more RCTs to support the evidence.
纤维肌痛是一种以成体疼痛和心理症状为特征的慢性疾病。多项随机对照试验（RCT）已表明低剂量纳曲酮（LDN）在不同小规模环境下治疗纤维肌痛的有效性和安全性。因此，需要进行一项荟萃分析来评估总体效果和证据强度。
检索了PUBMED、CENTRAL和ClinicalTrials.gov，以获取比较纳曲酮与安慰剂治疗纤维肌痛患者的RCT，进行系统评价和荟萃分析。我们通过RevMan 5.4使用DerSimonian和Laird随机效应模型进行成对荟萃分析。我们将二分结果报告为相对风险（RR），连续结果报告为标准化均数差（SMD），并给出95%置信区间（CI）。使用修订的Cochrane随机对照试验偏倚风险工具（RoB 2.0）评估纳入RCT的质量。通过卡方检验和每个荟萃分析的I²值检测异质性，若有显著性，则进行敏感性分析。
我们在荟萃分析中纳入了5项RCT。我们的结果估计，在原发性（SMD -0.61；95% CI -1.14，-0.08）和敏感性分析（SMD -0.87；95% CI -1.28，-0.46）中，LDN在缓解纤维肌痛患者疼痛方面优于安慰剂，但在提高机械性疼痛阈值方面（SMD 0.24；95% CI -0.09，0.56）并非如此。原发性分析（RR 1.68；95% CI 0.84，3.36）和敏感性分析（RR 0.98；95% CI 0.72，1.34）均未发现使用LDN与头痛发生率相关。与安慰剂相比，治疗组生动梦境的发生率（RR 2.41；95% CI 1.77，3.28）显著更高。
LDN被认为对治疗纤维肌痛有效。治疗组未报告严重不良反应。需要更多的RCT来支持这一证据。
