Benjamin S B, Maher K A, Cattau E L, Collen M J, Fleischer D E, Lewis J H, Ciarleglio C A, Earll J M, Schaffer S, Mirkin K
Department of Medicine, Georgetown University Hospital, Washington, D.C.
Gastroenterology. 1988 Sep;95(3):581-8. doi: 10.1016/s0016-5085(88)80001-5.
Since its approval by the Food and Drug Administration in September 1985, the Garren-Edwards gastric bubble has been extensively used as an adjunct to diet and behavioral modification in the treatment of exogenous obesity. In an attempt to evaluate the efficacy of the Garren-Edwards gastric bubble, a double-blind crossover study was undertaken. Ninety patients were randomized into three groups: bubble-sham, sham-bubble, and bubble-bubble in two successive 12-wk periods. Sixty-one patients completed the entire 24-wk study. All groups participated in ongoing diet and behavioral modification therapy in a free-standing obesity program, the members of which were blinded to randomization arms. All patient groups lost weight during this study. The mean cumulative weight loss in pounds at 12 wk was as follows: bubble-sham = 19, sham-bubble = 12, and bubble-bubble = 8; and at 24 wk: bubble-sham = 23, sham-bubble = 16, and bubble-bubble = 18. The mean cumulative change in body mass index (kg/m2) at 12 wk was as follows: bubble-sham = -3.1, sham-bubble = -2.3, and bubble-bubble = -2.9; and at 24 wk: bubble-sham = -3.1, sham-bubble = -3.0, and bubble-bubble = -3.3. Although weight loss occurred more consistently in patients with a Garren-Edwards gastric bubble, there were no significant differences between any of the three groups at 12 or 24 wk with respect to weight loss or change in body mass index. The major part of the weight loss noted during this study occurred during the first 12-wk period, irrespective of therapy (bubble or sham). Side effects observed during this study included gastric erosions (26%), gastric ulcers (14%), small bowel obstruction (2%), Mallory-Weiss tears (11%), and esophageal laceration (1%). We conclude that, in this study, the use of a Garren-Edwards gastric bubble did not result in significantly more weight loss than diet and behavioral modification alone in the management of exogenous obesity, and it may result in significant morbidity.
自1985年9月获得美国食品药品监督管理局批准以来，加伦 - 爱德华兹胃泡已被广泛用作饮食和行为矫正的辅助手段，用于治疗外源性肥胖症。为了评估加伦 - 爱德华兹胃泡的疗效，开展了一项双盲交叉研究。90名患者被随机分为三组：胃泡 - 假手术组、假胃泡 - 手术组和胃泡 - 胃泡组，分两个连续的12周阶段进行。61名患者完成了整个24周的研究。所有组都参与了一个独立的肥胖症项目中正在进行的饮食和行为矫正治疗，该项目的成员对随机分组情况不知情。在这项研究中，所有患者组体重都有所减轻。12周时平均累计体重减轻磅数如下：胃泡 - 假手术组 = 19，假胃泡 - 手术组 = 12，胃泡 - 胃泡组 = 8；24周时：胃泡 - 假手术组 = 23，假胃泡 - 手术组 = 16，胃泡 - 胃泡组 = 18。12周时体重指数（kg/m²）的平均累计变化如下：胃泡 - 假手术组 = -3.1，假胃泡 - 手术组 = -2.3，胃泡 - 胃泡组 = -2.9；24周时：胃泡 - 假手术组 = -3.1，假胃泡 - 手术组 = -3.0，胃泡 - 胃泡组 = -3.3。尽管使用加伦 - 爱德华兹胃泡的患者体重减轻更为持续，但在12周或24周时，三组在体重减轻或体重指数变化方面均无显著差异。在这项研究中观察到的体重减轻主要发生在最初的12周内，与治疗方式（胃泡或假手术）无关。在这项研究中观察到的副作用包括胃糜烂（26%）、胃溃疡（14%）、小肠梗阻（2%）、马-魏二氏撕裂（11%）和食管撕裂（1%）。我们得出结论，在这项研究中，在治疗外源性肥胖症方面，使用加伦 - 爱德华兹胃泡与单纯的饮食和行为矫正相比，并没有导致显著更多的体重减轻，而且它可能会导致显著的发病率。
