Clinical trial of silicone-rubber gastric balloon to treat obesity
Geliebter, A.; Melton, P.M.; McCray, R.S.; Gage, D.; Heymsfield, S.B.; Abiri, M.; Hashim, S.A.
International Journal of Obesity 15(4): 259-266
1991
ISSN/ISBN: 0307-0565 PMID: 2071316 Document Number: 375927
The efficacy and safety of a silicone-rubber gastric balloon 300 ml for weight reduction was investigated in 86 obese subjects divided into 4 groups: gastric balloon only; gastric balloon and prescribed 1000 kcal/day (239 kJ) diet; 1000 kcal/day diet only; and no treatment. The intervention period was 3 months. The balloon only group lost 3.2 kg+or-0.9 (s.e.), the balloon and diet group lost 5.1+or-1.0 kg, the diet group lost 6.9+or-1.4 kg and the control group gained 0.6+or-0.5 kg. The 3 intervention groups each lost significantly more weight than the control group. The diet only group lost significantly more weight than the balloon only group. Body densitometry showed that the treatment groups lost a significant amount of body fat. Gastroscopy revealed 3 ulcers and 2 superficial erosions at balloon removal. The gastric balloons were well tolerated despite gastric spasms and nausea which abated after the initial 24-48 h. Gastric capacity was estimated in a subset of 19 subjects from the 2 balloon groups before the intervention by distending the stomach with a balloon and calculating the volume required to produce an increase in intragastric pressure of 5 cm H2O. Subjects with a smaller gastric capacity lost more weight with the balloon than those with a large capacity (r = 0.45, P<0.05). It is suggested that for improved efficacy, balloon volume may need to be larger than 300 ml or adjusted to the individual's gastric capacity. The pattern of weight loss remained similar after 6-months, although the difference between the diet and the balloon group was not significant. The 300 ml balloon itself caused significant but modest weight loss. Combining diet and balloon improved weight loss with the balloon, but was still not different than diet only.