BACKGROUND: The BioEnterics intragrastric balloon (BIB) has been successfully used for treatment with BMI >35 or BMI >40. Gastroesophageal reflux (GER) symptoms are sometimes reported to occur and/or to worsen in patients with BIB, with a variable onset of erosive esophagitis (EE). The aim of this study was to investigate the prevalence and the severity of esophagitis after BIB placement. METHODS: 121 patients (93 F, 28 M, mean age 45 (19-65), mean BMI 41.5 (30-63.5) were studied. Patients with severe esophagitis (grade C-D Los Angeles (LA) classification), gastric or duodenal ulcers were excluded from the BIB treatment. After BIB placement, proton-pump inhibitors (PPI) were administered in the first month to each patient. The BIB was removed after 6 months. The presence of EE and related severity by LA classification were recorded RESULTS: Before BIB insertion, 18 patients (15%) showed mild EE (16 grade A and 2 grade B). After BIB removal, EE was observed in 22 patients (18.2%): 11 grade A, 7 grade B, 4 grade C-D. The difference in the prevalence of EE after BIB was statistically significant (Wilcoxon's test P =0.030). CONCLUSION: EE prevalence was significantly increased after BIB placement. We suggest that EE due to enhanced GER could be considered as an adverse effect of such treatment. We therefore recommend maintaining intragastric acid suppression with PPIs during the 6 months of BIB placement.
BACKGROUND: The BioEnterics intragrastric balloon (BIB) has been successfully used for treatment with BMI >35 or BMI >40. Gastroesophageal reflux (GER) symptoms are sometimes reported to occur and/or to worsen in patients with BIB, with a variable onset of erosive esophagitis (EE). The aim of this study was to investigate the prevalence and the severity of esophagitis after BIB placement. METHODS: 121 patients (93 F, 28 M, mean age 45 (19-65), mean BMI 41.5 (30-63.5) were studied. Patients with severe esophagitis (grade C-D Los Angeles (LA) classification), gastric or duodenal ulcers were excluded from the BIB treatment. After BIB placement, proton-pump inhibitors (PPI) were administered in the first month to each patient. The BIB was removed after 6 months. The presence of EE and related severity by LA classification were recorded RESULTS: Before BIB insertion, 18 patients (15%) showed mild EE (16 grade A and 2 grade B). After BIB removal, EE was observed in 22 patients (18.2%): 11 grade A, 7 grade B, 4 grade C-D. The difference in the prevalence of EE after BIB was statistically significant (Wilcoxon's test P =0.030). CONCLUSION: EE prevalence was significantly increased after BIB placement. We suggest that EE due to enhanced GER could be considered as an adverse effect of such treatment. We therefore recommend maintaining intragastric acid suppression with PPIs during the 6 months of BIB placement.
Authors: D Armstrong; J R Bennett; A L Blum; J Dent; F T De Dombal; J P Galmiche; L Lundell; M Margulies; J E Richter; S J Spechler; G N Tytgat; L Wallin Journal: Gastroenterology Date: 1996-07 Impact factor: 22.682