This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention.
In this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30–40 kg m−2 were treated and outcomes were assessed up to 12 months. Participants were randomized to endoscopic placement of an intragastric balloon plus lifestyle or lifestyle intervention alone. Balloons were removed at 6 months and lifestyle intervention continued for both groups through 12 months. At 9 months, coprimary end points were two measures of weight loss.
At 6 months, weight loss was −3.3% of total body weight (−3.2 kg) in the lifestyle arm vs −10.2% (−9.9 kg) in the balloon plus lifestyle arm (P<0.001); at 9 months (3 months postballoon removal), weight loss was −3.4% (−3.2 kg) vs −9.1% (−8.8 kg, P⩽0.001); and at 12 months, −3.1% (−2.9 kg) vs −7.6% (−7.4 kg, P⩽0.001). For the primary end points, at 9 months, mean percent loss of weight in excess of ideal body weight (s.d.) at 9 months was 26.5% (20.7) (P=0.32) and 9.7% (15.1) in the balloon and control groups, respectively. Also, 45.6% (36.7, 54.8) of the subjects randomized to the balloon achieved at least 15% loss of weight in excess of ideal body weight greater than the control group (P<0.001). The majority of balloon subjects experienced adverse events; 86.9% nausea, 75.6% vomiting, 57.5% abdominal pain and 18.8% had their device removed before 6 months because of an adverse event or subject request. Five subjects (3.1%) in the balloon group had a gastric abnormality at the time of device removal, and no ulcers were found.
Conclusions and relevance:
Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common.
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Ogden CL, Carroll MD, Kit BK, Flegal KM . Prevalence of childhood and adult obesity in the United States, 2011–2012. JAMA 2014; 311: 806–814.
Berrington de Gonzalez A, Hartge P, Cerhan JR, Flint AJ, Hannan L, MacInnis RJ et al. Body-mass index and mortality among 1.46 million white adults. N Engl J Med 2010; 363: 2211–2219.
Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol 2014; 63 (Part B): 2985–3023.
Mechanick JI, Garber AJ, Handelsman Y, Garvey WT . American Association of Clinical Endocrinologists' position statement on obesity and obesity medicine. Endocr Pract 2012; 18: 642–648.
The Practical Guide: Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. National Institutes of Health: Bethesda, MD, USA; 2000. NIH publication 00-4084.
Ryan DH, Johnson WD, Myers VH, Prather TL, McGlone MM, Rood J et al. Nonsurgical weight loss for extreme obesity in primary care settings: results of the Louisiana Obese Subjects Study. Arch Intern Med 2010; 170: 146–154.
Mechanick JI, Youdim A, Jones DB, Timothy Garvey W, Hurley DL, Molly McMahon M et al. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient—2013 update: cosponsored by American Association of Clinical Endocrinologists, the Obesity Society, and American Society for Metabolic & Bariatric Surgery. Surg Obes Rel Dis 2013; 9: 159–191.
Arterburn DE, Courcoulas AP . Bariatric surgery for obesity and metabolic conditions in adults. BMJ 2014; 349: g3961.
Diabetes Prevention Program Research G Diabetes Prevention Program Research G Knowler WC Diabetes Prevention Program Research G Fowler SE Diabetes Prevention Program Research G Hamman RF Diabetes Prevention Program Research G Christophi CA Diabetes Prevention Program Research G Hoffman HJ et al. 10-Year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet 2009; 374: 1677–1686.
Look ARG . Eight-year weight losses with an intensive lifestyle intervention: the look AHEAD study. Obesity 2014; 22: 5–13.
Yanovski SZ, Yanovski JA . Long-term drug treatment for obesity: a systematic and clinical review. JAMA 2014; 311: 74–86.
Buchwald H, Oien DM . Metabolic/bariatric surgery worldwide 2011. Obes surg 2013; 23: 427–436.
Fact Sheet Metabolic and Bariatric Surgery. American Society for Metabolic and Bariatric Surgery. Available at:http://www.asbs.org/Newsite07/media/asmbs_fs_surgery.pdf (last accessed 8 August).
Sallet JA, Marchesini JB, Paiva DS, Komoto K, Pizani CE, Ribeiro MLB et al. Brazilian multicenter study of the intragastric balloon. Obes Surg 2004; 14: 991–998.
Herve J, Wahlen CH, Schaeken A, Dallemagne B, Dewandre JM, Markiewicz S et al. What becomes of patients one year after the intragastric balloon has been removed? Obes Surg 2005; 15: 864–870.
Angrisani L, Lorenzo M, Borrelli V, Giuffre M, Fonderico C, Capece G . Is bariatric surgery necessary after intragastric balloon treatment? Obes Surg 2006; 16: 1135–1137.
Ganesh R, Rao AD, Baladas HG, Leese T . The Bioenteric Intragastric Balloon (BIB) as a treatment for obesity: poor results in Asian patients. Singap Med J 2007; 48: 227–231.
Genco A, Balducci S, Bacci V, Materia A, Cipriano M, Baglio G et al. Intragastric balloon or diet alone? A retrospective evaluation. Obes Surg 2008; 18: 989–992.
Crea N, Pata G, Della Casa D, Minelli L, Maifredi G, Di Betta E et al. Improvement of metabolic syndrome following intragastric balloon: 1 year follow-up analysis. Obes Surg 2009; 19: 1084–1088.
Genco A, Cipriano M, Materia A, Bacci V, Maselli R, Musmeci L et al. Laparoscopic sleeve gastrectomy versus intragastric balloon: a case–control study. Surg Endosc 2009; 23: 1849–1853.
Ohta M, Kitano S, Kai S, Shiromizu A, Eguchi H, Endo Y et al. Initial Japanese experience with intragastric balloon placement. Obes Surg 2009; 19: 791–795.
Al Kahtani K, Khan MQ, Helmy A, Al Ashgar H, Rezeig M, Al Quaiz M et al. Bio-enteric intragastric balloon in obese patients: a retrospective analysis of King Faisal Specialist Hospital experience. Obes Surg 2010; 20: 1219–1226.
Mui WL-M, Ng EK-W, Tsung BY-S, Lam CH, Yung MY . Impact on obesity-related illnesses and quality of life following intragastric balloon. Obes Surg 2010; 20: 1128–1132.
Genco A, Cipriano M, Bacci V, Maselli R, Paone E, Lorenzo M et al. Intragastric balloon followed by diet vs intragastric balloon followed by another balloon: a prospective study on 100 patients. Obes Surg 2010; 20: 1496–1500.
Kotzampassi K, Grosomanidis V, Papakostas P, Penna S, Eleftheriadis E . 500 intragastric balloons: what happens 5 years thereafter? Obes Surg 2012; 22: 896–903.
Nikolic M, Boban M, Ljubicic N, Supanc V, Mirosevic G, Pezo Nikolic B et al. Morbidly obese are ghrelin and leptin hyporesponders with lesser intragastric balloon treatment efficiency: ghrelin and leptin changes in relation to obesity treatment. Obes Surg 2011; 21: 1597–1604.
Bozkurt S, Coskun H . The early results of intragastric balloon application of different BMI groups. Eur Surg Acta Chirurg Austr 2012; 44: 383–387.
Farina MG, Baratta R, Nigro A, Vinciguerra F, Puglisi C, Schembri R et al. Intragastric balloon in association with lifestyle and/or pharmacotherapy in the long-term management of obesity. Obes Surg 2012; 22: 565–571.
Dogan UB, Gumurdulu Y, Akin MS, Yalaki S . Five percent weight lost in the first month of intragastric balloon treatment may be a predictor for long-term weight maintenance. Obes Surg 2013; 23: 892–896.
Fuller NR, Pearson S, Lau NS, Wlodarczyk J, Halstead MB, Tee HP et al. An intragastric balloon in the treatment of obese individuals with metabolic syndrome: a randomized controlled study. Obesity 2013; 21: 1561–1570.
Genco A, Cipriano M, Bacci V, Cuzzolaro M, Materia A, Raparelli L et al. BioEnterics Intragastric Balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients. Int J Obes 2006; 30: 129–133.
Mohammed MA, Anwar R, Mansour AH, Elmasry E, Othman G . Effects of intragastric balloon versus conservative therapy on appetite regulatory hormones in obese subjects. Trends Med Res 2014; 9: 58–80.
Force ABET, Committee AT Force ABET, Committee AT Abu Dayyeh BK Force ABET, Committee AT Edmundowicz SA Force ABET, Committee AT Jonnalagadda S Force ABET, Committee AT Kumar N et al. Endoscopic bariatric therapies. Gastrointest Endosc 2015; 81: 1073–1086.
Therapy AATFoEB. A pathway to endoscopic bariatric therapies. Surg Obes Rel Dis 2011; 7: 672–682.
Therapy AATFoEB Therapy AATFoEB Ginsberg GG Therapy AATFoEB Chand B Therapy AATFoEB Cote GA Therapy AATFoEB Dallal RM Therapy AATFoEB Edmundowicz SA et al. A pathway to endoscopic bariatric therapies. Gastrointest Endosc 2011; 74: 943–953.
The IB-005 Study Investigators included Nicholas Berth, MD (New Jersey), Helmuth Billy, MD (California), Anita Courcoulas, MD (Pennsylvania), Timothy Ehrlich, MD (Connecticut), Mark Fusco, MD (Florida), Daniel Pambianco, MD (Virginia), Michael Snyder, MD (Colorado), George Woodman, MD (Tennessee), Colin Powers, MD (New York), Hans Joseph Schmidt, MD (New Jersey), Vafa Shayani, MD (Illinois), Peter Billing, MD (Washington), Thomas Chua, MD (Wisconsin), Lee Grossbard, MD (Florida) and Adam Smith, DO (Texas). The study was designed, funded and conducted by Allergan Medical, which was acquired by Apollo Endosurgery—the sponsor. The specific role of the sponsor for each of the following was: design and conduct of the study—sponsor initiated and led; data collection—study sites collected data that was then transmitted to sponsor; data management and study monitoring—sponsor led; statistical analysis—sponsor led, statistical analysis was provided by SimulStat Inc. and North American Science Associates (NAMSA), investigator and writing group input to analyses; interpretation of the data—study investigators and writing group members; preparation of manuscript—writing group; review of manuscript—writing group; approval of the manuscript—writing group; decision to submit the manuscript for publication—writing group.
AC has received research grants from the NIH-NIDDK, Nutrisystem, Ethicon J & J Healthcare, Covidien, is a consultant for Apollo Endosurgery for this project and was a project consultant for Ethicon J & J Healthcare. BAD is a consultant for Apollo Endosurgery and Xlumina. He has research agreements with Aspire Bariatrics and GI Dynamics. LE was a consultant to Allergan Medical while the study was being conducted. She currently serves as a consultant to Apollo Endosurgery and is the principal consultant for UltaMed Corporation. JR was an employee of Allergan Medical during the close of the study but did not work on the trial, and currently serves as a consultant to Apollo Endosurgery. He currently is an employee of Simulstat. GW is a clinical trial investigator with USGI, ReShape and Obalon. MF is a former Allergan consultant and proctor. VS is a consultant for Apollo Endosurgery. He has research agreements with Apollo Endosurgery and Obalon as well as a clinical trial investigator for Obalon. HB is a consultant for Transenterix and speaker for Ethicon and Apollo Endosurgery. DP has nothing to disclose. CG is a consultant for Apollo Endosurgery and Olympus Corporation. He has performed sponsored research for Olympus Corporation and GI Supply. AC and JR had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
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Courcoulas, A., Abu Dayyeh, B., Eaton, L. et al. Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial. Int J Obes 41, 427–433 (2017). https://doi.org/10.1038/ijo.2016.229
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