A double-blind, randomized, sham-controlled trial of the gastric bubble for obesity. Intragastric balloon for treatment-resistant obesity: safety, tolerance, and efficacy of 1-year balloon treatment followed by a 1-year balloon-free follow-up. Double-blind controlled trial of the Garren-Edwards gastric bubble: an adjunctive treatment for exogenous obesity. Intragastric balloon in the treatment of super-morbid obesity. Double-blind, sham-controlled, crossover evaluation of 500-milliliter balloon. Effect of the gastric balloon versus sham procedure on weight loss in obese subjects. Effect of gastric bubble as a weight reduction device: a controlled, crossover study.
We investigated the effect of an endoscopically placed gastric balloon, the Garren-Edwards gastric bubble (GEGB), on weight loss in obese patients. Fifty-nine obese patients were entered into a prospective double-blind study and randomized into two groups. In one group (34 patients) the GEGB was inserted, and in the other group (25 patients) a sham insertion was done. All patients participated in a standard weight loss program consisting of dietary therapy, behavior modification, and physical exercise. The bubble was removed endoscopically after 3 months from both groups. Patients were followed for an additional 9 months after bubble removal and weight loss was monitored. Weight loss was the same in both groups at 3 months (18.7 lb vs. 17.2 lb). This was true whether determined by change in pounds, percentage of body weight, or body mass index. We concluded that the GEGB was of no added benefit as compared with sham insertion, when combined with a standard weight loss program. Because of the lack of proven efficacy and the relatively high cost, we recommend that such devices be restricted to controlled studies until significant benefits are proven. Prior efforts to treat obesity with intragastric balloons were thwarted by high complication rates. Therefore, fundamental requirements for optimal balloon designs were defined. The aim of the present study was to investigate the effectiveness, the safety, and the tolerance of a new intragastric balloon.
                Adults with treatment-resistant obesity and no GI contraindications to balloon placement were invited to participate in a randomized, double-blind trial of balloon or sham treatment of 3 months' duration. Patients (sham- and balloon-treated groups) in whom a preset weight-loss goal was achieved were given an additional 9 months of balloon treatment. After removal of the balloon at year 1, patients were followed for a second year without the balloon.
                Forty-three treatment-resistant patients (mean body mass index 43.3 kg/m 2) were enrolled. Five patients did not meet the preset weight-loss goal (nonresponse 11.6%). Three patients did not tolerate the balloon (7.0%), with endoscopy demonstrating severe esophagitis. Three other patients developed esophagitis that was related to use of nonsteroidal anti-inflammatory drugs, albeit prohibited (2 patients), or substantial weight loss with balloon treatment (1). In intention-to-treat analysis, sham- and balloon-treated groups had a similar mean weight loss of 11.2 kg (9.0%) and 12.9 kg (10.4%), respectively, during the first 3 months. During months 3 to 6, patients who had sham therapy in months 0 to 3 lost 8.8 kg (7.9%) during the first 3 months of balloon treatment. In contrast, patients in the balloon-treatment group lost 3.9 kg (3.5%) during months 3 to 6 (their second balloon treatment period). The overall weight loss was 20 kg (16.1%) and 16.7 kg (13.4%) after 6 months in the sham/balloon and in the balloon/balloon treated groups (not significant), respectively. After 1-year of balloon treatment, a mean weight loss of 21.3 kg (17.1%) was achieved in all patients, of which 12.6 kg (9.9%) was maintained at the end of the second balloon-free year; 47% of patients sustained a greater than 10% weight loss, with considerably reduced comorbidity. In 33 patients who completed the study per protocol, weight loss was 25.6 kg (20.5%) after 1 year and 14.6 kg (11.4%) after 2 years; 55% maintained a weight loss of greater than 10%. Interventional complications occurred in 1.6% (2/128) and balloon deflations in 2.3% (3/128).
                For patients with treatment-resistant obesity, the intragastric balloon appeared to be safe but was not a treatment option in a fifth of patients. Although an independent benefit of balloon treatment beyond diet, exercise, and behavioral therapy could not be demonstrated in the first 3 months, balloon treatment for 1 year resulted in substantial weight loss, the greater part of which was maintained during the balloon-free second year. 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. A prolonged randomized, prospective, double-blind, crossover study, including a sham-sham-treated group, was undertaken to evaluate the efficacy and safety of a 500-mL gastric bubble (Ballobes; DOT ApS, Rödovre, Denmark) as an adjunct to diet, physical training, and behavioral modification. Only supermorbidly obese patients who fulfilled the usual criteria for surgery were admitted. A weight loss of 38 kg in the first 17 weeks and another 12 kg in the second 18 weeks could be achieved. The body mass index, the percentage of overweight and the loss in percentage of initial weight, paralleled this impressive weight loss. In the second period, a plateau effect occurred after the massive changes in the first period, and only one third of the changes in all parameters was seen. Stratification into a sham-sham, sham-balloon, balloon-sham, and balloon-balloon group did not show any statistical difference for all parameters between the four groups. The double-blind nature of the study was affirmed by the patient's correct judgment of the presence or absence of a balloon in only 21% of the balloon and 44% of the sham procedures. Gastrointestinal complications were infrequent and consisted of erosions (three patients), asymptomatic reflux oesophagitis (one patient), and asymptomatic gastric ulcer (one patient). Only the latter patient had elevated gastrin levels. One patient could not tolerate the balloon. All balloons remained airtight during both parts of the study for a mean of 123 days. This study confirmed the safety of the balloon, but no additional benefit could be ascribed to the balloon compared with a very low-calorie diet and medical and dietary support. The mechanism by which intragastric balloons induce weight loss is not known, although they may act simply by reducing the amount of food needed to induce satiety. The knowledge that a balloon is present may influence the patients' eating patterns and reduce caloric intake and weight. In order to test whether the balloon or the secondary psychological effect caused weight loss, a double blind balloon versus sham procedure was devised with both groups receiving identical outpatient dietary advice (800 kcal/day). Twenty four obese women with body mass index greater than 30 kg/m2 from an obesity clinic were studied. Twelve had the balloon and 12 the sham procedure. The balloon was removed after three months and the patients were followed for a further three months. There was significantly greater weight loss in the balloon group, mean weight loss (SD) of 7.33 (6.12) kg compared with the sham group, mean weight loss (SD) of 3.33 (3.9) kg (p less than 0.05). Weight loss was not maintained in all patients after balloon removal. Side effects were more common in the balloon group (abdominal pain, nausea, and vomiting) but resolved by the second week. We conclude that the intragastric balloon is a safe and effective method of inducing weight loss in well motivated obese patients. 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.
Evidence from this review is limited for decision making, since there was large heterogeneity in IGB trials, regarding both methodological and clinical aspects. However, a co-adjuvant factor described by some authors in the loss and maintenance of weight has been the motivation and the encouragement to changing eating habits following a well-organized diet and a program of behavioural modification. The IGB alone and the technique of positioning appear to be safe. Despite the evidence for little additional benefit of the intragastric balloon in the loss of weight, its cost should be considered against a program of eating and behavioural modification.