Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial.
Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial.
复制标题
DOI：
10.1155/2015/365604
复制
发表时间：
2015
影响因子：
3.3
通讯作者：
Billington CJ
中科院分区：
文献类型：
--
作者：
Shikora SA;Wolfe BM;Apovian CM;Anvari M;Sarwer DB;Gibbons RD;Ikramuddin S;Miller CJ;Knudson MB;Tweden KS;Sarr MG;Billington CJ
背景/目标。迷走神经阻滞疗法（vBloc）在一年内对中度至重度肥胖有效。主题/方法。ReCharge试验是一项双盲、随机对照临床试验，有239名体重指数（BMI）为40至45 kg/m2或35至40 kg/m2的受试者，伴有一种或多种肥胖相关疾病。干预措施包括植入vBloc或Sham器械和体重管理咨询。在意向治疗分析中，混合模型评估了过量体重减轻百分比（%EWL）和总体重减轻（%TWL）。18个月时，142例（88%）vBloc和64例（83%）假手术患者仍入组研究。结果18-vBloc组和Sham组的体重减轻分别为23%EWL（8.8%TWL）和10%EWL（3.8%TWL）（P <0.0001）。vBloc患者在很大程度上维持了12个月体重减轻26% EWL（9.7% TWL）。18个月时，假手术组恢复了17% EWL的40%以上（6.4% TWL）。大多数体重恢复发生在揭盲之前。18个月内vBloc的常见不良事件为烧心/消化不良和腹痛; 98%的事件报告为轻度或中度，79%已消退。结论. vBloc的体重减轻持续了18个月，而Sham在12至18个月之间恢复了体重。vBloc有效，严重并发症发生率低。
Background/Objectives. Vagal block therapy (vBloc) is effective for moderate to severe obesity at one year. Subjects/Methods. The ReCharge trial is a double-blind, randomized controlled clinical trial of 239 participants with body mass index (BMI) of 40 to 45 kg/m or 35 to 40 kg/m with one or more obesity-related conditions. Interventions were implantation of either vBloc or Sham devices and weight management counseling. Mixed models assessed percent excess weight loss (%EWL) and total weight loss (%TWL) in intent-to-treat analyses. At 18 months, 142 (88%) vBloc and 64 (83%) Sham patients remained enrolled in the study. Results. 18-month weight loss was 23% EWL (8.8% TWL) for vBloc and 10% EWL (3.8% TWL) for Sham (P < 0.0001). vBloc patients largely maintained 12-month weight loss of 26% EWL (9.7% TWL). Sham regained over 40% of the 17% EWL (6.4% TWL) by 18 months. Most weight regain preceded unblinding. Common adverse events of vBloc through 18 months were heartburn/dyspepsia and abdominal pain; 98% of events were reported as mild or moderate and 79% had resolved. Conclusions. Weight loss with vBloc was sustained through 18 months, while Sham regained weight between 12 and 18 months. vBloc is effective with a low rate of serious complications.