Department of Biomedical Sciences for Health, University of Milan, Via Mangiagalli 31, 20133, Milan, Italy.
Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Via Milanese 300, 20099, Sesto San Giovanni (MI), Italy.
Endocrine. 2021 Feb;71(2):331-343. doi: 10.1007/s12020-020-02496-x. Epub 2020 Sep 22.
Repetitive Transcranial Magnetic Stimulation (rTMS) has been demonstrated to be effective in body weight control in individuals with obesity. Most clinical trials on rTMS provided a reassuring safety profile. In the present work, we present an extensive analysis on both severe and mild Adverse Events (AEs) in obese individuals treated with rTMS.
We examined the intensity, duration, correlation with the treatment, up to 1 year after the end of rTMS treatment.
Descriptive analysis included a total of 63 subjects undergoing a 5-week deep rTMS experimental treatment for obesity (age 48.3 ± 10.4 years; BMI 36.3 ± 4.4 kg/m): 31 patients were treated with high-frequency rTMS (HF), 13 with low-frequency rTMS (LF), and 19 were sham treated (Sham). Thirty-two subjects (50.8%) reported a total of 52 AEs, including mainly moderate (51.9%) events. The most frequently reported side effects were headaches of moderate intensity (40.4%) and local pain/discomfort (19.2%) and resulted significantly more frequent in HF group compared to other groups (p < 0.05). No significant differences among groups were found for the other reported AEs: drowsiness, insomnia, paresthesia, vasovagal reactions, hypertensive crisis. No AEs potentially related to the rTMS arised up to 1 year from the end of the treatment.
This is the first comprehensive safety analysis in obese patients treated with rTMS. The analysis did not reveal any unexpected safety concerns. Only headaches and local pain/discomfort have been significantly more frequent in the HF group, confirming the good tolerability of rTMS even in the obese population potentially more susceptible to side effects of brain stimulation.
重复经颅磁刺激（rTMS）已被证明可有效控制肥胖个体的体重。大多数关于 rTMS 的临床试验均提供了令人安心的安全性概况。在本工作中，我们对接受 rTMS 治疗的肥胖个体的严重和轻度不良事件（AE）进行了广泛分析。
我们检查了强度、持续时间、与治疗的相关性，以及 rTMS 治疗结束后 1 年内的情况。
描述性分析共纳入 63 名接受 5 周肥胖深度 rTMS 实验治疗的受试者（年龄 48.3±10.4 岁；BMI 36.3±4.4kg/m²）：31 名患者接受高频 rTMS（HF）治疗，13 名接受低频 rTMS（LF）治疗，19 名接受假刺激（Sham）治疗。32 名受试者（50.8%）共报告了 52 例不良事件，主要为中度（51.9%）事件。报告的最常见副作用为中度强度的头痛（40.4%）和局部疼痛/不适（19.2%），HF 组明显比其他组更常见（p<0.05）。其他报告的不良事件在各组之间无显著差异：嗜睡、失眠、感觉异常、血管迷走神经反应、高血压危象。治疗结束后 1 年内未发生与 rTMS 相关的任何不良事件。
这是首次对接受 rTMS 治疗的肥胖患者进行的全面安全性分析。该分析未发现任何意外的安全性问题。仅头痛和局部疼痛/不适在 HF 组更为常见，证实了 rTMS 的良好耐受性，即使在更容易出现脑刺激副作用的肥胖人群中也是如此。
