The EMPOWER Study: Randomized, Prospective, Double-Blind, Multicenter Trial of Vagal Blockade to Induce Weight Loss in Morbid Obesity
The EMPOWER Study: Randomized, Prospective, Double-Blind, Multicenter Trial of Vagal Blockade to Induce Weight Loss in Morbid Obesity
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DOI：
10.1007/s11695-012-0751-8
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发表时间：
2012-11-01
期刊：
影响因子：
2.9
通讯作者：
Rosenthal, Raul
中科院分区：
文献类型：
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作者：
Sarr, Michael G.;Billington, Charles J.;Rosenthal, Raul
间歇性、可逆性腹腔内迷走神经阻滞（VBLOCA（R）疗法）在可行性试验中显示了临床上重要的体重减轻。EMPOWER是在美国和澳大利亚进行的一项随机、双盲、前瞻性、对照试验，在15个中心入组了503例受试者。知情同意后，294名受试者植入迷走神经阻滞系统，并随机分配至治疗组（n = 192）或对照组（n = 102）。主要结果指标是12个月时的体重减轻百分比（EWL百分比）和严重不良事件。受试者使用外部电源控制治疗持续时间;治疗涉及向小脑下迷走神经输送电能的编程算法，以抑制传入/传出迷走神经传输。两组中的设备都进行了定期的低能量安全检查。数据为平均值+/- SEM。研究对象包括90%的女性，体重指数为41 +/- 1 kg/m2，年龄为46 +/- 1岁。3%的受试者发生了器械相关并发症。无死亡。12-月百分比EWL对于治疗组为17 +/-2%，对于对照组为16 +/-2%。体重减轻与器械使用时间呈线性关系;使用12小时/天的千分之一日元的治疗组和对照组分别达到30 +/- 4和22 +/-8%EWL。VBLOCA（R）治疗病态肥胖是安全的，但治疗组的体重减轻并不比对照组大;然而，临床上重要的体重减轻与器械使用时间有关。研究后分析表明，系统电气安全检查（通过系统输送的低电荷用于电阻抗、安全性和诊断检查）可能导致对照组的体重减轻。
Intermittent, reversible intraabdominal vagal blockade (VBLOCA (R) Therapy) demonstrated clinically important weight loss in feasibility trials. EMPOWER, a randomized, double-blind, prospective, controlled trial was conducted in USA and Australia.Five hundred three subjects were enrolled at 15 centers. After informed consent, 294 subjects were implanted with the vagal blocking system and randomized to the treated (n = 192) or control (n = 102) group. Main outcome measures were percent excess weight loss (percent EWL) at 12 months and serious adverse events. Subjects controlled duration of therapy using an external power source; therapy involved a programmed algorithm of electrical energy delivered to the subdiaphragmatic vagal nerves to inhibit afferent/efferent vagal transmission. Devices in both groups performed regular, low-energy safety checks. Data are mean +/- SEM.Study subjects consisted of 90 % females, body mass index of 41 +/- 1 kg/m(2), and age of 46 +/- 1 years. Device-related complications occurred in 3 % of subjects. There was no mortality. 12-month percent EWL was 17 +/- 2 % for the treated and 16 +/- 2 % for the control group. Weight loss was related linearly to hours of device use; treated and controls with a parts per thousand yen12 h/day use achieved 30 +/- 4 and 22 +/- 8 % EWL, respectively.VBLOCA (R) therapy to treat morbid obesity was safe, but weight loss was not greater in treated compared to controls; clinically important weight loss, however, was related to hours of device use. Post-study analysis suggested that the system electrical safety checks (low charge delivered via the system for electrical impedance, safety, and diagnostic checks) may have contributed to weight loss in the control group.