Gastric balloon to treat obesity: a double-blind study in nondieting subjects

Abstract

To determine its efficacy and safety in treating obesity, a silicone-rubber balloon was passed into the stomach of 10 nondieting, obese subjects. In a counterbalanced sequence, the balloon was inflated with 400 mL for 1 mo and deflated for 1 mo. Lower intakes of solid and liquid test meals (NS), significantly slower gastric emptying, and concomitant changes in glucose, insulin, glucagon, and cholecystokinin concentrations consistent with slower emptying resulted during balloon inflation. After balloon inflation, one small gastric ulcer developed, which subsequently healed. Significant weight loss occurred during the second and third week of the inflation period (F[1,9] = 5.0, p less than 0.05). However, the weight loss was small and the significant effect did not continue through the fourth week.

Critical review of sham surgery clinical trials: Confounding factors analysis

“…5) The presence of inter-study variability between sham and not sham studies was not ascribable to mean or median age of patients but possibly to other factors. 6) The absence of psychological and psychiatric profile that is relevant for studies were the placebo effect have to be evaluated represents a very important confounding factor [10], [22], [24], [25], [26], [27], [28], [29], [30], [31], [32], [33], [34], [35], [36], [37], [38], [39], [40], [41], [42], [43], [44], [45], [46], [47], [48], [49], [50], [51], [52], [53], [54], [55], [56], [57], [58], [59], [60], [61], [62], [63], [64], [65], [66], [67], [68], [69], [70], [71], [72], [73], [78], [79]. 7) A percentage of 5% of participants lost to the follow-up has been extracted from 30 on the 52 studies examined (ref.).…”

Proximal gastric distension modifies ingestion rate in pigs

“…Similarly, balloons occupying about 30% of the rat gastric capacity (Geliebter et al, 1986) had a relatively large impact on food intake, reducing it by more than 25% (Geliebter et al, 1987). Surprisingly, in man, a 400 mL balloon occupying 30% of the stomach was unable to trigger a significant reduction in food intake (Geliebter et al, 1990). Similar inconclusive data have been obtained in dogs (Share et al, 1952).…”

Safety of the Ullorex® Oral Intragastric Balloon for the Treatment of Obesity

“…10,11 The Dow-Corning silicon gastric balloon was fashioned from a breast implant and was inflated with 300-400 ml of air, but, like the Ballobes balloon, gave minimal weight loss compared to control. 12,13 Pear-shaped gastric balloons were also used, inflated with either air or fluid, and resulted in weight loss in uncontrolled trials. 14,15 One of the most widely utilized gastric balloons, however, is the BioEnterics intragastric balloon (BIB).…”