Gilron Ian, Robb Sylvia, Tu Dongsheng, Holden Ronald, Towheed Tanveer, Ziegler Dan, Wang Louie, Milev Roumen, Gray Christopher
Department of Anesthesiology and Perioperative Medicine, Kingston Health Sciences Centre, Queen's University, Kingston, ON, Canada.
Department of Biomedical and Molecular Sciences, Queen's University, Kingston, ON, Canada.
Pain. 2021 Feb 1;162(2):561-568. doi: 10.1097/j.pain.0000000000002028.
Fibromyalgia is a common and challenging chronic pain disorder with few, if any, highly effective and well-tolerated treatments. Alpha-lipoic acid (ALA) is a nonsedating antioxidant with evidence of efficacy in the treatment of symptomatic diabetic neuropathy that has not been evaluated in the setting of fibromyalgia treatment. Thus, we conducted a single-centre, proof-of-concept, randomized, placebo-controlled, crossover trial of ALA for the treatment of fibromyalgia. Twenty-seven participants were recruited, and 24 participants completed both treatment periods of the trial. The median maximal tolerated dose of ALA in this trial was 1663 mg/day. Treatment-emergent adverse events with ALA were infrequent and not statistically different from placebo. For the primary outcome of pain intensity, and for several other validated secondary outcomes, there were no statistically significant differences between placebo and ALA. A post hoc exploratory subgroup analysis showed a significant interaction between gender and treatment with a significant favourable placebo-ALA difference in pain for men, but not for women. Overall, the results of this trial do not provide any evidence to suggest promise for ALA as an effective treatment for fibromyalgia, which is predominantly prevalent in women. This negative clinical trial represents an important step in a collective strategy to identify new, better tolerated and more effective treatments for fibromyalgia.
纤维肌痛是一种常见且具有挑战性的慢性疼痛疾病，几乎没有（即便有也极少）高效且耐受性良好的治疗方法。α-硫辛酸（ALA）是一种无镇静作用的抗氧化剂，有证据表明其在治疗症状性糖尿病神经病变方面有效，但尚未在纤维肌痛治疗背景下进行评估。因此，我们开展了一项单中心、概念验证性、随机、安慰剂对照、交叉试验，以研究ALA治疗纤维肌痛的效果。招募了27名参与者，24名参与者完成了试验的两个治疗阶段。本试验中ALA的最大耐受剂量中位数为1663毫克/天。ALA治疗中出现的不良事件不常见，且与安慰剂在统计学上无差异。对于疼痛强度这一主要结局以及其他几个经过验证的次要结局，安慰剂与ALA之间在统计学上无显著差异。一项事后探索性亚组分析显示，性别与治疗之间存在显著交互作用，男性在疼痛方面安慰剂与ALA之间存在显著的有利差异，而女性则不然。总体而言，该试验结果并未提供任何证据表明ALA有望成为治疗纤维肌痛的有效方法，而纤维肌痛在女性中更为普遍。这项阴性临床试验是确定纤维肌痛新的、耐受性更好且更有效治疗方法的集体策略中的重要一步。
