Horbach T, Meyer G, Morales-Conde S, Alarcón I, Favretti F, Anselmino M, Rovera G M, Dargent J, Stroh C, Susewind M, Torres A J
Department of Surgery, Schön Klinik, Adipositas Zentrum, Fürth, Nürnberg, Germany.
Department of Surgery, Wolfart Klinik, Adipositas Zentrum, München-Graefelfing, Germany.
Int J Obes (Lond). 2016 Dec;40(12):1891-1898. doi: 10.1038/ijo.2016.159. Epub 2016 Sep 16.
To compare the weight loss, change in quality of life (QOL) and safety of closed-loop gastric electrical stimulation (CLGES) versus adjustable gastric band (LAGB) in the treatment of obesity.
This multicenter, randomized, non-inferiority trial randomly assigned the patients in a 2:1 ratio to laparoscopic CLGES versus LAGB and followed them for 1 year. We enrolled 210 patients, of whom 50 were withdrawn preoperatively. Among 160 remaining patients (mean age=39±11 years; 75% women; mean body mass index=43±6 kg m) 106 received CLGES and 54 received LAGB. The first primary end point was non-inferiority of CLGES versus LAGB, ascertained by the proportion of patients who, at 1 year, fulfilled: (a) a ⩾20% excess weight loss (EWL); (b) no major device- or procedure-related adverse event (AE); and (c) no major, adverse change in QOL. Furthermore, ⩾50% of patients had to reach ⩾25% EWL. The incidence and seriousness of all AE were analyzed and compared using Mann-Whitney's U-test.
At 1 year, the proportions of patients who reached all components of the primary study end point were 66.7 and 73.0% for the LAGB and CLGES group, respectively, with a difference of -6.3% and an upper 95% CI of 7.2%, less than the predetermined 10% margin for confirming the non-inferiority of CLGES. The second primary end point was also met, as 61.3% of patients in the CLGES group reached ⩾25% EWL (lower 95% CI=52.0%; P<0.01). QOL improved significantly and similarly in both groups. AE were significantly fewer and less severe in the CLGES than in the LAGB group (P<0.001).
This randomized study confirmed the non-inferiority of CLGES compared with LAGB based on the predetermined composite end point. CLGES was associated with significantly fewer major AE.
比较闭环胃电刺激（CLGES）与可调节胃束带（LAGB）在治疗肥胖症时的体重减轻情况、生活质量（QOL）变化及安全性。
本多中心、随机、非劣效性试验按2:1的比例将患者随机分为腹腔镜CLGES组和LAGB组，并对其进行为期1年的随访。我们招募了210例患者，其中50例在术前退出。在其余160例患者（平均年龄=39±11岁；75%为女性；平均体重指数=43±6 kg/m²）中，106例接受CLGES治疗，54例接受LAGB治疗。第一个主要终点是CLGES相对于LAGB的非劣效性，通过1年后满足以下条件的患者比例来确定：（a）超重减轻⩾20%（EWL）；（b）无重大设备或手术相关不良事件（AE）；（c）生活质量无重大不良变化。此外，⩾50%的患者必须达到⩾25%的EWL。使用曼-惠特尼U检验分析和比较所有AE的发生率和严重程度。
1年后，LAGB组和CLGES组达到主要研究终点所有指标的患者比例分别为66.7%和73.0%，差异为-6.3%，95%置信区间上限为7.2%，小于预先确定的用于确认CLGES非劣效性的10%界限。第二个主要终点也得到满足，因为CLGES组61.3%的患者达到⩾25%的EWL（95%置信区间下限=52.0%；P<0.01）。两组的生活质量均有显著且相似的改善。CLGES组的AE明显少于LAGB组，且严重程度更低（P<0.001）。
这项随机研究基于预先确定的复合终点证实了CLGES与LAGB相比具有非劣效性。CLGES相关的重大AE明显更少。
