Department of Medicine, Neurological Unit and Service of Clinical Neurophysiology, Garibaldi Hospital, Catania, Italy.
Department of Biomedical and Biotechnological Sciences, Section of Physiology, University of Catania, Catania, Italy.
Ann Neurol. 2018 Nov;84(5):674-682. doi: 10.1002/ana.25340. Epub 2018 Oct 16.
Muscle cramps occur in >50% of diabetic patients and reduce the quality of life. No effective treatment is available. We evaluated the clinical effectiveness of botulinum toxin A (BTX-A) injections for treating cramps in diabetic patients with neuropathy.
This single-center, double-blind, placebo-controlled perspective study investigated the efficacy and safety of BTX-A intramuscular injection for treating calf or foot cramps refractory to common pharmacological drugs. Fifty diabetic patients with peripheral neuropathy and cramps were randomly assigned to 2 matched groups. BTX-A (100 or 30 units) or saline was injected on each side into the gastrocnemius or the small flexor foot muscles. Changes in pain intensity (primary outcome) and cramp frequency were evaluated over the course of 20 weeks after BTX-A administration. Cramp interference in daily life and the electrophysiological cramp threshold frequency were also measured. The treatment was repeated 5 months after first injection in 19 responders.
All outcome measures improved significantly after BTX-A compared with placebo. The changes with respect to baseline were already significant after 1 week and persisted up to week 14. Only 5 of 25 (20%) patients were nonresponders (<50% decrease of the primary outcome). The responses to a second BTX-A injection provided results similar to the first administration. Mild pain at the injection site (4/25 cases) was the only adverse event, and it disappeared within 2 to 3 days.
Local BTX-A infiltration is an efficacious and safe procedure for obtaining a sustained amelioration of muscle cramps associated with diabetic neuropathy. Ann Neurol 2018;84:682-690.
肌肉痉挛在>50%的糖尿病患者中发生，并降低生活质量。目前尚无有效的治疗方法。我们评估了肉毒毒素 A（BTX-A）注射治疗伴有神经病变的糖尿病患者痉挛的临床疗效。
这项单中心、双盲、安慰剂对照的前瞻性研究调查了 BTX-A 肌内注射治疗对常规药物治疗抵抗的小腿或足部痉挛的疗效和安全性。50 例伴有周围神经病变和痉挛的糖尿病患者被随机分为 2 个匹配组。BTX-A（100 或 30 单位）或生理盐水分别注射到腓肠肌或小屈趾肌的每一侧。在 BTX-A 给药后 20 周内评估疼痛强度（主要结局）和痉挛频率的变化。还测量了日常生活中痉挛的干扰以及电生理痉挛阈值频率。在首次注射后 5 个月，在 19 名应答者中重复治疗。
与安慰剂相比，所有结局指标在 BTX-A 治疗后均显著改善。与基线相比，变化在 1 周后即具有统计学意义，并持续至第 14 周。仅有 25 例患者中的 5 例（20%）为无应答者（主要结局的减少<50%）。第二次 BTX-A 注射的反应与首次给药相似。仅 4/25 例（16%）出现注射部位轻度疼痛（2-3 天内消失）。
局部 BTX-A 渗透是一种有效且安全的方法，可持久改善与糖尿病性神经病变相关的肌肉痉挛。Ann Neurol 2018;84:682-690。
