Intragastric balloon or diet alone? A retrospective evaluation

Background Very few studies have reported results of the BioEnterics Intragastnic Balloon (BIB (R)) at >= 12 months follow-up. The aim of this study is the retrospective evaluation of the results of BIB placement compared to diet regimen alone. Methods From January 2005 to June 2006, 130 outpatients, underwent a structured diet plan with simple behavioral modification at Our institutions. Controls (n=130) were selected from the charts of patients who, during the same period, underwent BIB treatment. Patients in the outpatient group were given a structured balanced diet with a caloric intake between 1,000 and 1,200. The approximate macronutrient distribution, according the "Mediterranean diet," was 25% protein (at least 60 g/day), 20-25% lipids, and 50-55%, carbohydrates. In the BIB group, patients received generic Counseling for eating behavior. In both groups, We considered weight loss parameters (kilograms, percentage of excess weight loss [%EWL], body mass index [BMI], percentage of excess BMI loss [ëL]) at 6 and 24 months from baseline and comorbidities at baseline and after 24 months. Results are expressed as mean standard deviation. Statistical analysis was done by Student's t-test and chi(2)- test or Fisher's exact test. p <.05 was considered significant. Results At the time of BIB removal (6 months), significantly better results in terms of weight loss in kilograms (16.7 +/- 4.7 vs. 6.6 +/- 2.6; p < 0.01), BMI (35.4 +/- 11.2 vs. 38.9 +/- 12.1; p < 0.01), ëL (38.5 +/- 16.1 Vs 18.6 +/- 14.3; p < 0.01), and %EWL (33.9 +/- 18 vs. 24.3 +/- 17.0; p < 0.01) were observed in patients treated by intragastric balloon as compared to diet-treated patients. At 24 months from baseline, patient dropout was 1/130 (0.7%) and 25/130 (19.2%) in the BIB and diet groups, respectively (p < 0.001). At this tirne, patients treated with intragastric balloon have tended to regain weight, whereas diet-treated patients have already regained most of lost weight. Conclusions Although the strength of this study may be limited by its retrospective design, the results indicate that, in the short-to-medium term, BIB is significantly superior to diet in terms of weight loss.