101. Mo1549 Meta-Analysis of the Orbera Intragastric Balloon for the Endoscopic Management of Obesity
- Author
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Saurabh Mukewar, Erik B. Wilson, Natan Zundel, Manoel Galvao Neto, Sohail N. Shaikh, Badr Al-Bawardy, Nitin Kumar, Gontrand Lopez-Nava, Alfred Genco, Barham K. Abu Dayyeh, Christopher C. Thompson, and Christopher J. Gostout
- Subjects
medicine.medical_specialty ,business.industry ,Nausea ,Perforation (oil well) ,Gastroenterology ,Publication bias ,Management of obesity ,law.invention ,Randomized controlled trial ,Weight loss ,law ,Meta-analysis ,Internal medicine ,medicine ,Radiology, Nuclear Medicine and imaging ,medicine.symptom ,business ,Body mass index - Abstract
Mo1549 Meta-Analysis of the Orbera Intragastric Balloon for the Endoscopic Management of Obesity Badr Al-Bawardy*, Saurabh S. Mukewar, Alfred Genco, Manoel P. Galvao Neto, Gontrand Lopez-Nava, Nitin Kumar, Christopher C. Thompson, Erik B. Wilson, Sohail Shaikh, Natan Zundel, Christopher J. Gostout, Barham K. Abu Dayyeh Mayo Clinic, Rochester, MN; Sapienza University of Rome, Rome, Italy; Gastro Obesity Center, Sao Paulo, Brazil; Bariatric Endoscopy Unit, Madrid Sanchinarro University Hospital, Madrid, Spain; Brigham and Women’s Hosptial, Boston, MA; Univesrity of Texas, Houston, TX; FIU Herbert Wertheim College of Medicine, Miami, FL Background and Aims: The Orbera Intragastric Balloon (IGB) System has been widely used outside the United States (US) as an effective adjunct to life-style modification in the management of mild to moderate obesity. We performed a systematic review and meta-analysis to summarize the out of the US safety and efficacy experience with this IGB system in anticipation of its possible use in the US after regulatory approval. Methods: A comprehensive search of Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, Scopus, and Web of Science was conducted. The search strategy was designed and conducted by an experienced librarian with input from the study’s team. Two independent reviewers reviewed all citation and identify full-length clinical studies, published in English, investigating use of the Orbera IGB system for obesity. A random-effect meta-analysis and meta-regression were performed. Results: Eighty studies including 8506 patients were included in this meta-analysis. The pooled percent total body weight (%TBW) lost after a single six-months IGB insertion was 12.7% [95% CI 8.5-16.9], 13% [95% CI 11.7-14.7], 10 [95% CI 6.6-13.6], and 6.2 [95% CI 1.4-10.9] at 3, 6, 12, and 36 months respectively. The pooled incidences of side-effects were as following: pain 33.7%, nausea 29%, GERD 18.5%, early removal 7.5%, gastric ulcers 2%, migration 1.4%, small bowel obstruction 0.3%, perforation 0.1%, and death 0.08%. Five included studies were randomized controlled trials (RCTs) that compared the Orbera IGB system to sham or life-style interventions. The mean extra weight lost after Orbera over that in the control arm at 6 months was -8.5kg [95% CI -13 -4.23] (p!0.001). Three different RCTs evaluated the efficacy sequential use of the Orbera IGB system compared to single use. The mean decrease in body mass index (BMI) after two sequential treatments with Orbera IGB was -4 [95% CI -7.7 -0.04] (pZ 0.047) over that seen with single treatment at 12 months after insertion. A meta-regression showed that higher IGB fill volumes are associated with greater weight loss at six months (p % 0.001) (figure). A funnel plot did not reveal any evidence of publication bias. Conclusions: The Orbera IGB system seems to produce predictable and significant weight loss with a favorable safety profile that should make it a valuable tool for the management of obesity once approved for use in the United States.
- Published
- 2015