Bested Kirsten, Jensen Lotte M, Andresen Trine, Tarp Grete, Skovbjerg Louise, Johansen Torben S D, Schmedes Anne V, Storgaard Ida K, Madsen Jonna S, Werner Mads U, Bendiksen Anette
Multidisciplinary Pain Clinic, Friklinikken, Grindsted, Denmark.
Molecular Diagnostics and Clinical Research Unit, Hospital Sonderjylland, Aabendraa, Denmark.
Pain Rep. 2023 Jun 15;8(4):e1080. doi: 10.1097/PR9.0000000000001080. eCollection 2023 Jul-Aug.
Fibromyalgia (FM) is a chronic fluctuating, nociplastic pain condition. Naltrexone is a µ-opioid-receptor antagonist; preliminary studies have indicated a pain-relieving effect of low-dose naltrexone (LDN) in patients with FM. The impetus for studying LDN is the assumption of analgesic efficacy and thus reduction of adverse effects seen from conventional pharmacotherapy.
, to examine if LDN is associated with analgesic efficacy compared with control in the treatment of patients with FM. , to ascertain the analgesic efficacy of LDN in an experimental pain model in patients with FM evaluating the competence of the descending inhibitory pathways compared with controls. to examine the pharmacokinetics of LDN.
The study used a randomized, double-blind, placebo-controlled, crossover design and had a 3-phase setup. The first phase included baseline assessment and a treatment period (days -3 to 21), the second phase a washout period (days 22-32), and the third phase a baseline assessment followed by a treatment period (days 33-56). Treatment was with either LDN 4.5 mg or an inactive placebo given orally once daily. The primary outcomes were Fibromyalgia Impact Questionnaire revised (FIQR) scores and summed pain intensity ratings (SPIR).
Fifty-eight patients with FM were randomized. The median difference (IQR) for FIQR scores between LDN and placebo treatment was -1.65 (18.55; effect size = 0.15; = 0.3). The median difference for SPIR scores was -0.33 (6.33; effect size = 0.13; = 0.4).
Outcome data did not indicate any clinically relevant analgesic efficacy of the LDN treatment in patients with FM.
纤维肌痛（FM）是一种慢性波动性的神经病理性疼痛病症。纳曲酮是一种μ-阿片受体拮抗剂；初步研究表明低剂量纳曲酮（LDN）对纤维肌痛患者有止痛效果。研究LDN的动力在于其止痛效果的假设，以及由此减少传统药物治疗中所见的不良反应。
该研究采用随机、双盲、安慰剂对照、交叉设计，分为三个阶段。第一阶段包括基线评估和治疗期（第-3天至21天），第二阶段为洗脱期（第22 - 32天），第三阶段为基线评估后接着治疗期（第33 - 56天）。治疗采用每日口服一次4.5毫克LDN或无活性安慰剂。主要结局指标为修订的纤维肌痛影响问卷（FIQR）评分和疼痛强度总和评分（SPIR）。
58名纤维肌痛患者被随机分组。LDN与安慰剂治疗之间FIQR评分的中位数差异（IQR）为-1.65（18.55；效应大小 = 0.15；P = 0.3）。SPIR评分的中位数差异为-0.33（6.33；效应大小 = 0.13；P = 0.4）。
结果数据未表明LDN治疗对纤维肌痛患者有任何临床相关的止痛效果。
