Meshkinpour H, Hsu D, Farivar S
Department of Medicine, University of California, Irvine.
Gastroenterology. 1988 Sep;95(3):589-92. doi: 10.1016/s0016-5085(88)80002-7.
In spite of the widespread use of the Garren-Edwards gastric bubble as an adjuvant device in weight reduction, its efficacy has not been established. Therefore, our purpose was to conduct a randomized, double-blind, crossover study of this device in the management of exogenous obesity. The study group consisted of 23 patients, 21 women and 2 men, ranging in age from 21 to 53 yr. Patients were 25%-111% above their ideal body weight. They were studied for 24 wk, consisting of two separate 12-wk evaluation periods. Patients were randomly assigned either to receive the gastric bubble or to have a sham procedure. After the first 12-wk evaluation period, the gastric bubble and sham were administered in crossover fashion, so that those who had received the gastric bubble initially received the sham later and vice versa. The study coordinator remained blind to the kind of treatment, weighed each patient biweekly, enforced dietary counseling, and provided behavior modification. Those who had passed or were found to have a deflated bubble at the end of the treatment period were excluded from the study. Mean weight reduction in the two evaluation periods did not differ significantly. Patients lost 5.4 +/- 1.7 kg (mean +/- SE) during the gastric bubble period and 5.20 +/- 0.8 kg during the sham period. The order of administration of the gastric bubble and sham did not significantly affect the result. The time-course of mean biweekly values, however, revealed that with the gastric bubble, weight loss was significantly greater only during first (p less than 0.005) and second (p less than 0.025) 2-wk evaluation periods. This difference, however, disappeared after the initial 4 wk of treatment. These observations suggest that although gastric bubble implantation reduced weight significantly more than the sham procedure initially, the mean weight loss during 12 wk of evaluation was not different between the two periods. In our opinion, the gastric bubble is of no value as an adjuvant device in weight reduction.
尽管加伦-爱德华兹胃泡作为减肥辅助装置被广泛使用，但其疗效尚未得到证实。因此，我们的目的是对该装置在治疗外源性肥胖方面进行一项随机、双盲、交叉研究。研究组由23名患者组成，其中21名女性和2名男性，年龄在21至53岁之间。患者体重超出理想体重25%至111%。他们接受了为期24周的研究，包括两个独立的12周评估期。患者被随机分配接受胃泡植入或假手术。在第一个12周评估期后，胃泡和假手术以交叉方式进行，即最初接受胃泡植入的患者后来接受假手术，反之亦然。研究协调员对治疗类型不知情，每两周为每位患者称重一次，加强饮食咨询，并提供行为矫正。在治疗期结束时胃泡已通过或被发现已瘪掉的患者被排除在研究之外。两个评估期的平均体重减轻没有显著差异。在胃泡植入期患者体重减轻了5.4±1.7千克（平均±标准误），在假手术期体重减轻了5.20±0.8千克。胃泡和假手术的给药顺序对结果没有显著影响。然而，平均每两周数值的时间进程显示，使用胃泡时，仅在第一个（p<0.005）和第二个（p<0.025）2周评估期体重减轻明显更多。然而，这种差异在治疗最初4周后就消失了。这些观察结果表明，尽管胃泡植入最初比假手术显著减轻更多体重，但在12周评估期内两个阶段的平均体重减轻并无差异。我们认为，胃泡作为减肥辅助装置没有价值。
