Tolerance and efficacy of an air-filled balloon in non-morbidly obese patients: results of a prospective multicenter study.

BACKGROUND: Intragastric balloons have been proposed to induce body weight loss in obese subjects. Most studies were performed using liquid-filled balloons. Air-filled balloons may increase digestive tolerance. Our goal was to study the tolerance and efficacy of a new air-filled intragastric balloon in nonmorbidly obese patients. METHODS: 32 patients were included, with a mean BMI of 35.0 (range 30.1-40.0). The balloon was inserted under general anaesthesia, inflated with 800 ml of air, and removed 4 months later. Tolerance and body weight were monitored until 12 months after removal. Ghrelin levels were measured before balloon insertion, 1 and 4 weeks after, and before removal. RESULTS: Weight loss was significant at 1, 2 and 4 months after balloon insertion (6, 7 and 10 kg, respectively, P<0.001). Early removal of the balloon occurred in 3 cases. 28 patients were contacted 12 months after balloon removal: 2 had undergone gastric banding; among the 26 remaining, the mean weight loss was 7 kg. 9 patients (30%) remained with a weight loss >10%, and satisfaction with the method was 87% for these 9 patients, and 22% for the other patients who had weight loss <10% (P<0.04). Fasting plasma ghrelin levels increased at week 1 and 4 after balloon insertion, and decreased at week 16 (P<0.001). CONCLUSIONS. The air-filled intragastric balloon was safe. Its effect on weight loss appeared equivalent to other balloons. 12 months after balloon removal, 30% of the patients maintained a weight loss >10%.

Effects of intragastric balloon on gastric emptying and plasma ghrelin levels in non-morbid obese patients.

BACKGROUND: Intragastric balloons have been proposed to induce weight loss in obese subjects. The consequences of the balloon on gastric physiology remain poorly studied. We studied the influence of an intragastric balloon on gastric emptying and ghrelin secretion in non-morbid obese patients. PATIENTS AND METHODS: 17 patients were included in the study, with mean BMI of 34.4 (range 30.1-40.0). The balloon was inserted under general anaesthesia and endoscopic control, inflated with 600 ml saline, and removed 6 months later. Body weight and gastric emptying (13C-octanoic acid breath test) were monitored while the balloon was in place and 1 month after removal. Ghrelin levels were measured just before balloon insertion and removal. RESULTS: Mean weight loss was 8.7 kg (range 0-21). Gastric emptying rates were significantly decreased with the balloon in place, and returned to pre-implantation values after balloon removal. Plasma ghrelin levels were significantly decreased (95% CI: -3.8 to -20.7 ng/ml), despite concomitant weight loss. Weight reduction was not correlated to the effect of the balloon on gastric emptying, but was significantly correlated to the ghrelin variations (r=0.668, 95% CI: 0.212-0.885). CONCLUSIONS: Gastric emptying rates and plasma ghrelin levels are decreased in the presence of intragastric balloon. Weight loss induced by the intragastric balloon is related to ghrelin variations, but not to gastric emptying. Ghrelin inhibition may explain part of the effect of the balloon on satiety.

Intragastric balloon for "non-morbid" obesity: a retrospective evaluation of tolerance and efficacy.

BACKGROUND: One potential indication for intra-gastric balloon is weight reduction for mild to moderate obesity. The authors evaluated retrospectively the tolerance and efficacy of the BioEnterics intragastric balloon (BIB). METHODS: From February 1998 to July 2001, an intragastric balloon was placed under endoscopic control in 176 patients (mean BMI 31 kg/m(2)). It was filled with 500 ml saline in the first 142 patients and with 600 ml in the last 34. Removal was proposed between 4 and 6 months after balloon insertion. RESULTS: Balloon placement was uneventful. 13 patients were lost of follow-up (7.4%). Removal was performed endoscopically in 113 patients (64.2%), with 1 case of tracheal aspiration. Balloon evacuation was spontaneous in 49 cases. 1 BIB was removed at laparoscopic surgery for small bowel obstruction. Side-effects were: vomiting during the first week (90%), occasional vomiting for >3 weeks (18%), hypokalemia (8.5%), functional renal failure (1.1%), abdominal pain (12.5%), gastro-esophageal reflux (11.5%). There were 2 gastric ulcers, 1 sub-occlusion treated endoscopically and the 1 small bowel obstruction treated surgically, occurring after the theoretical date of removal in all cases. Mean excess weight loss was 38 +/- 28.5 % (35.4 +/- 27.3 % for 500-ml balloons and 48.8 +/- 31.0 % for 600-ml balloons (P <0.02)). CONCLUSIONS: The BIB appears to be safe provided that it is removed within the period specified by the manufacturer. Its efficacy to reduce weight in patients with non-morbid obesity may depend in part on the filling volume.