Intragastric balloon followed by diet vs intragastric balloon followed by another balloon: a prospective study on 100 patients.

Aim of this study is to compare the efficacy of BioEnterics Intragastric Balloon (BIB®) followed by diet with BIB followed by another BIB. A prospective study was designed: a homogeneous group of 100 obese patients (age range 25-35, BMI range 40.0-44.9, M/F ratio 1/4) was allocated into two groups according to procedure: BIB (6 months) followed by diet therapy (7 months; group A = 50 pts), BIB positioning followed by another BIB after 1 month (group B = 50 pts). Baseline demographics were similar in both groups (Group A 10M/40F; mean age 31.4 ± 2.6; range 25-35; mean weight 106.3 ± 12.5 Kg; range 88-150; mean BMI 42.6±2.7 Kg/m(2); range 40.2-43.8; Group B 10M/40F; mean age 32.1 ± 2.1; range 25-35; mean weight 107.1 ± 11.9 Kg; range 90-150; mean BMI 42.9 ± 2.3; range 40.2-43.9). In both groups, weight loss parameters (Kg, BMI, and % EBL) were considered. Statistics were by Fisher's exact test (p < 0.05 was considered significant). At the time of 1st BIB removal, weight loss parameters in both groups were not significantly different: Group A: mean weight was 83.7±19.1 (range 52-151); mean BMI 34.2 ± 3.9 (range 32.4-43.8); and mean %EBL 43.5 ± 21.1 (range 0-68). Group B: mean weight was 84.9 ± 18.3 (range 50-148); mean BMI 34.8 ± 3.3 (range 32.4-43.8); and mean % EBL 45.2 ± 22.5% (range 0-68). At the study end, weight loss parameters were significantly lower in patients who underwent consecutive BIB (p < 0.05): mean BMI was 30.9 ± 7.2 Kg/m(2) (range 24-40), and 35.9 ± 9.7 Kg/m(2) (range 34-42); mean % EBL was 51.9 ± 24.6% (range 0-100) and 25.1 ± 26.2% (range 0-100) in group B and A, respectively. As compared with diet, a second intragastric balloon can be positioned without difficulties, achieving good results with continuous weight loss.

RCT Entities:   Population Interventions Outcomes