title: Efficacy, safety, and tolerance of two types of intragastric balloons placed in obese subjects: a double-blind comparative study.
abstract: The intragastric balloon is a temporary treatment for obese patients. Fluid-filled devices have shown efficacy and safety, and are widely used. Recently, although there are no comparative studies between them, an air-filled balloon, Heliosphere® bag, has been proposed. Prospective, double-blind study in 33 patients with morbid and type 2 obesity: 23 female, 43.9±10 years, 120.3±17 kg, and body mass index (BMI) of 44.2±5 kg/m2, placing 18 gastric balloons filled with 960 cm3 of air (Heliosphere® bag) or 15 balloons filled with 700 ml of saline (Bioenterics-BIB®). Both balloons were placed with conscious sedation and removed under general anesthesia 6 months later. Intravenous drugs were given to control symptoms for 48 h. Patients were sent home on a 1000-kcal diet, multivitamin supplements, and oral proton pump inhibitors, and were followed monthly. Complications, symptoms, weight, and quality of life evaluated by the Gastrointestinal Quality of Life Index (GIQLI) scale were recorded. At 6 months, mean weight loss (12.8±8 vs 14.1±8 kg), BMI loss (4.6±3 vs 5.5±3 kg/m2) and percent excess weight loss (27±16 vs.30.2±17) showed no significant differences between both groups. At removal, two Heliosphere® bags were not found in the stomach, and four patients required extraction of the balloon by rigid esophagoscopy or surgery (p=0.02). Tolerance was good in both groups, but early removal occurred in three BIB® (20%) due to vomits and dehydration. The GIQLI total scores remained unchanged. Both balloons achieve a significant weight loss with good tolerance in obese patients. Nevertheless, Heliosphere® bag has severe technical problems that need to be solved before recommending it.
authors.affiliation: Department of Gastroenterology, Universitary Hospital of Vigo (CHUVI), Vigo, Galicia, Spain. luisadecastroparga@mundo-r.com
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: De Castro
authors.forename: María José
authors.initials: MJ
authors.lastname: Morales
authors.forename: Víctor
authors.initials: V
authors.lastname: Del Campo
authors.forename: Juan R
authors.initials: JR
authors.lastname: Pineda
authors.forename: Eduardo
authors.initials: E
authors.lastname: Pena
authors.forename: José M
authors.initials: JM
authors.lastname: Sierra
authors.forename: María José
authors.initials: MJ
authors.lastname: Arbones
authors.forename: Ignacio R
authors.initials: IR
authors.lastname: Prada
mesh_terms: D000328:Adult; D015992:Body Mass Index; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D015905:Gastric Balloon / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000628:therapy*; D011446:Prospective Studies; D011788:Quality of Life; D012449:Safety; D016896:Treatment Outcome; D015431:Weight Loss
references.citation: Obes Surg. 1999 Feb;9(1):68-71
references.pmid: 10065589
references.citation: Aliment Pharmacol Ther. 2007 Jun 15;25(12):1451-9
references.pmid: 17539985
references.citation: Obes Surg. 2004 Apr;14(4):539-44
references.pmid: 15130235
references.citation: Br J Surg. 1995 Feb;82(2):216-22
references.pmid: 7749697
references.citation: Gastroenterology. 1988 Sep;95(3):589-92
references.pmid: 3294080
references.citation: Obes Surg. 2005 Sep;15(8):1161-4
references.pmid: 16197790
references.citation: Br J Surg. 1987 Feb;74(2):137-9
references.pmid: 3815032
references.citation: Br J Surg. 1990 Jan;77(1):76-9
references.pmid: 2302519
references.citation: Obes Surg. 2010 Sep;20(9):1227-30
references.pmid: 19082675
references.citation: Gastrointest Endosc. 1987 Aug;33(4):323-7
references.pmid: 3653653
references.citation: Obes Surg. 2001 Aug;11(4):519-23
references.pmid: 11501367
references.citation: Gut. 1989 Aug;30(8):1054-7
references.pmid: 2767500
references.citation: Am J Surg. 2002 Dec;184(6B):4S-8S
references.pmid: 12527343
references.citation: Obes Surg. 2006 May;16(5):635-7
references.pmid: 16687034
references.citation: Obes Res. 1998 Sep;6 Suppl 2:51S-209S
references.pmid: 9813653
references.citation: Obes Surg. 2004 Aug;14(7):991-8
references.pmid: 15329191
references.citation: Gastrointest Endosc. 1989 Sep-Oct;35(5):381-5
references.pmid: 2792672
references.citation: Obes Surg. 2007 Jun;17(6):764-9
references.pmid: 17879576