Intragastric Balloon or Diet Alone? A Retrospective Evaluation

Background Very few studies have reported results of the BioEnterics Intragastric Balloon (BIB®) 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 [%EBL]) 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 χ 2 -test or Fisher’s exact test. p