Chinara M Tate1, Allan Geliebter2,3. 1. Department of Psychiatry, Mt. Sinai St. Luke's, Icahn School of Medicine at Mt. Sinai, New York, NY, USA. chinara.tate@mountsinai.org. 2. Department of Psychiatry, Mt. Sinai St. Luke's, Icahn School of Medicine at Mt. Sinai, New York, NY, USA. 3. Department of Psychology, Touro College and University System, New York, NY, USA.
Abstract
INTRODUCTION: The FDA recently approved three intragastric balloon (IGB) devices, ReShape, ORBERA™, and Obalon for treatment of obesity. Given the high cost, complication risk, and invasiveness of bariatric surgery, IGB treatment may present a safer and lower cost option for weight reduction. IGBs are generally placed in the stomach endoscopically for up to 6 months to reduce gastric capacity, enhance feelings of fullness, and induce weight loss. The mechanism of action likely involves stimulation of gastric mechanoreceptors triggering short-acting vagal signals to brain regions implicated in satiety. Balloon efficacy may be influenced by balloon volume, patient gastric capacity, and treatment duration. METHODS: This review focused on eight recent (2006-present) randomized controlled trials (RCTs) comparing percentage total body weight loss (%TBWL) between IGB and control groups including three reviewed by the FDA. %TBWL based on the reviewed studies was also compared with bariatric surgery and pharmacotherapy. RESULTS: Of the eight IGB studies, five had balloon treatment duration of 6 months. Efficacy at 6 months, based on a pooled weighted-mean %TBWL, was 9.7%, and the control-subtracted %TBWL was 5.6%. When one study without SDs was removed, the weighted mean %TBWL was 9.3 ± 5.7% SD, and control-subtracted %TBWL was 5.5 ± 7.8%, which was statistically greater than controls. IGB showed lower efficacy than bariatric surgery (median weight loss of 27% for Rouen-Y gastric bypass (RYGB). The control-subtracted %TBWL over 6 months of 5.5-5.6% is less than the most efficacious FDA-approved weight loss drug, Qsymia. At the recommended dose, Qsymia has a placebo-subtracted %TBWL at 6 months of approximately 6.6%. The weighted mean reported incidence of serious adverse events (SAEs) in the IGB group across all eight studies was 10.5%. Only six of the eight reviewed studies reported adverse events (AEs) in the IGB group, with a pooled reported incidence of 28.2%. Recently, the FDA reported new AEs including acute pancreatitis with ReShape and ORBERA™. CONCLUSION: Based on the available evidence, it is unlikely that IGB use will supplant other forms of obesity treatment. The estimated cost of endoscopic balloon implantation and retrieval is US $8,150. Collectively, a relatively small control-subtracted %TBWL and the potential for serious complications makes IGB unlikely to become widely adopted. Given the recent FDA warning, IGB longevity on the market is questionable.
INTRODUCTION: The FDA recently approved three intragastric balloon (IGB) devices, ReShape, ORBERA™, and Obalon for treatment of obesity. Given the high cost, complication risk, and invasiveness of bariatric surgery, IGB treatment may present a safer and lower cost option for weight reduction. IGBs are generally placed in the stomach endoscopically for up to 6 months to reduce gastric capacity, enhance feelings of fullness, and induce weight loss. The mechanism of action likely involves stimulation of gastric mechanoreceptors triggering short-acting vagal signals to brain regions implicated in satiety. Balloon efficacy may be influenced by balloon volume, patient gastric capacity, and treatment duration. METHODS: This review focused on eight recent (2006-present) randomized controlled trials (RCTs) comparing percentage total body weight loss (%TBWL) between IGB and control groups including three reviewed by the FDA. %TBWL based on the reviewed studies was also compared with bariatric surgery and pharmacotherapy. RESULTS: Of the eight IGB studies, five had balloon treatment duration of 6 months. Efficacy at 6 months, based on a pooled weighted-mean %TBWL, was 9.7%, and the control-subtracted %TBWL was 5.6%. When one study without SDs was removed, the weighted mean %TBWL was 9.3 ± 5.7% SD, and control-subtracted %TBWL was 5.5 ± 7.8%, which was statistically greater than controls. IGB showed lower efficacy than bariatric surgery (median weight loss of 27% for Rouen-Y gastric bypass (RYGB). The control-subtracted %TBWL over 6 months of 5.5-5.6% is less than the most efficacious FDA-approved weight loss drug, Qsymia. At the recommended dose, Qsymia has a placebo-subtracted %TBWL at 6 months of approximately 6.6%. The weighted mean reported incidence of serious adverse events (SAEs) in the IGB group across all eight studies was 10.5%. Only six of the eight reviewed studies reported adverse events (AEs) in the IGB group, with a pooled reported incidence of 28.2%. Recently, the FDA reported new AEs including acute pancreatitis with ReShape and ORBERA™. CONCLUSION: Based on the available evidence, it is unlikely that IGB use will supplant other forms of obesity treatment. The estimated cost of endoscopic balloon implantation and retrieval is US $8,150. Collectively, a relatively small control-subtracted %TBWL and the potential for serious complications makes IGB unlikely to become widely adopted. Given the recent FDA warning, IGB longevity on the market is questionable.
Authors: Shailendra Singh; Diogo Turiani Hourneaux de Moura; Ahmad Khan; Mohammad Bilal; Michele B Ryan; Christopher C Thompson Journal: Surg Obes Relat Dis Date: 2019-12-10 Impact factor: 4.734
Authors: Shailendra Singh; Diogo Turiani Hourneaux de Moura; Ahmad Khan; Mohammad Bilal; Monica Chowdhry; Michele B Ryan; Ahmad Najdat Bazarbashi; Christopher C Thompson Journal: Obes Surg Date: 2020-08 Impact factor: 4.129