Objective: To investigate the interrelationships between satiety feelings, abdominal perception, energy intake and weight loss, related to the presence of an intragastric balloon.
Design: Randomized double blind study.
Subjects: 20 severely obese subjects, BMI > 40 kg/m2, randomly assigned either to receive an air filled balloon (n = 11) or to have a sham procedure (n = 9). All subjects had dietary counselling to help them follow a relatively low energy diet (60% of individual spontaneous intake).
Measurements: During biweekly visits, body weight was recorded, visual analogic scales for stomach distension, hunger and feeling of balloon presence were completed. Blood chemistry profiles were monitored once every 4 weeks.
Results: In the balloon group, the sensations related to the presence of the balloon and to abdominal distension dramatically increased after insertion, and plateaued during the next 4 weeks. Both feelings of presence and distension decreased thereafter, and after 10 weeks they were not significantly different from those of the sham balloon group. Hunger dramatically decreased to about 30% of initial rating in the first week, but slowly returned to the initial value by the 12th week. Hunger feelings were highly and negatively correlated with feelings of distension. During the same period, the sham balloon group continued to maintain the low energy intake, and did not register any feelings of distension or presence; hunger level did not differ from initial levels throughout the whole study. The energy intake and the rate of weight loss (8-9 kg) was similar in the two groups during the study, and were not correlated with the feelings of distension.
Conclusion: This study showed that in severely obese subjects submitted to a restrictive diet, an intragastric balloon has a measurable but transient effect on the sensation of epigastric distension and is able to decrease feelings of hunger. Unfortunately, these effects were not associated with a lower energy intake or a higher rate of weight loss than the sham situation. Thus, the present study does not support the interest of such a balloon (500 ml, air filled) in the treatment of severe obesity.