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BioEnterics® Intragastric Balloon (BIB®): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients

Abstract

Background:

The BioEnterics® Intragastric Balloon (BIB®) System in association with restricted diet has been used for the short-term treatment of morbid obesity. Aim of this study was to evaluate the real, short term, efficacy of the BIB for weight reduction in morbidly obese patients by using a prospective, double-blind, randomised, sham-controlled, crossover study.

Methods:

Patients were recruited from January 2003 to December 2003. After selection, they were randomly allocated into two groups: BIB followed by sham procedure after 3 months (Group A), and sham procedure followed by BIB after 3 months (Group B). All endoscopic procedures were performed under unconscious intravenous sedation. The BioEnterics Intragastric Balloon (Inamed Health; Santa Barbara, CA, USA) was filled by using saline (500 ml) and methylene blue (10 ml). Patients were discharged with omeprazole therapy and diet (1000 kcal). Patients were followed up weekly by a physician blinded to randomisation. In both groups mortality, complications, BMI, BMI reduction and %EWL were considered. Data were expressed as mean±s.d., except as otherwise indicated. Statistical analysis was performed by means of Student's t-test, Fisher's exact test or χ2 with Yates correction; P<0.05 was considered significant.

Results:

A total of 32 patients were selected and entered the study (8M/24F; mean age: 36.2±5.6 years, range 25–50 years; mean BMI 43.7±1.5 kg/m2, range 40–45 kg/m2; mean %EW: 43.1±13.1, range: 35–65). All patients completed the study. Mortality was absent. Complications related to endoscopy, balloon placement and removal were absent. Mean time of BIB positioning was 15±2 min, range 10–20 min. After the first 3 months of the study, in Group A patients the mean BMI significantly (P<0.001) lowered from 43.5±1.1 to 38.0±2.6 kg/m2, while in Group B patients the decrease was not significant (from 43.6±1.8 to 43.1±2.8 kg/m2). The mean %EWL was significantly higher in Group A than in Group B (34.0±4.8 vs 2.1±1%; P<0.001). After crossover, at the end of the following 3 months, the BMI lowered from 38.0±2.6 to 37.1±3.4 kg/m2 and from 43.1±2.8 to 38.8±3.1 kg/m2 in Groups A and B, respectively.

Conclusions:

The results of this study show that treatment of obese patients with BioEnterics Intragastric Balloon is a safe and effective procedure. In association with appropriate diet it is significantly effective in weight reduction when compared to sham procedure plus diet. The BIB® procedure can play a role in weight reduction in morbidly obese patients or in the preoperative treatment of bariatric patients.

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References

  1. Yanovski SZ, Yanovski JA . Obesity. N Engl J Med 2002; 346 (8): 591–602.

    Article  CAS  Google Scholar 

  2. Calle EE, Thun MJ, Petrelli JM, Rodriguez C, Heath Jr CW . Body mass index and mortality in a prospective cohort of US adults. N Engl J Med 1999; 341 (15): 1097–1115.

    Article  CAS  Google Scholar 

  3. Steinbrook R . Surgery for severe obesity. N Engl J Med 2004; 350 (11): 1075–1079.

    Article  CAS  Google Scholar 

  4. National Institute of Health Conference. Gastrointestinal surgery for severe obesity. Consensus development conference panel. Ann Intern Med 1991; 115: 956–961.

  5. De Waele B, Reynaert H, Urbain D, Willelms G . Intragastric balloons for preoperative weight reduction. Obes Surg 2000; 10 (1): 58–60.

    Article  CAS  Google Scholar 

  6. Weiner A, Gutberlet H, Bockhorn H . Preparation of extremely obese patients for laparoscopic gastric banding by gastric balloon therapy. Obes Surg 1999; 9 (3): 261–264.

    Article  CAS  Google Scholar 

  7. Ramhamadany EM, Fowler J, Baird IM . Effect of the gastric balloon versus sham procedure on weight loss in obese subjects. Gut 1989; 30: 1054–1057.

    Article  CAS  Google Scholar 

  8. Busetto L, Segato G, De Luca M, Bortolozzi E, MacCari T, Magon A et al. Preoperative weight loss by intragastric balloon in super-obese patients treated with laparoscopic gastric banding: a case control study. Obes Surg 2004; 14: 671–676.

    Article  Google Scholar 

  9. Doldi SB, Micheletto G, Perrini MN, Librenti MC, Rella S . Treatment of morbid obesity with intragastric balloon in association with diet. Obes Surg 2002; 12 (4): 583–587.

    Article  CAS  Google Scholar 

  10. McFarland RJ, Grundy A, Gazet JC, Pilkinton TRE . The intragastric ballon: a novel idea proved ineffective. Br J Surg 1987; 74: 137–139.

    Article  CAS  Google Scholar 

  11. Nieben OG, Harboe H . Intragastric balloon as an artificial bezoar for treatment of obesity. Lancet 1982; 1 (8265): 198–199.

    Article  CAS  Google Scholar 

  12. Benjamin SB, Maher KA, Cattau EL, Collen MJ, Flcisher DE, Lewis JH et al. Double blind controlled trial of the Garren–Edward gastric bubble: an adjunctive treatment for exogenous obesity. Gastroenterology 1988; 95: 581–588.

    Article  CAS  Google Scholar 

  13. Mathus-Vliegen EMH, Tytgat GNJ . Intragastric balloons for morbid obesity: results, patient tolerance and balloon life span. Br J Surg 1990; 77 (1): 77–79.

    Article  Google Scholar 

  14. Hogan RB, Johnston JH, Long BW, Sones JQ, Ardell Hinton L, Dunge J et al. A double blind, randomised, sham controlled trial of the gastric bubble for obesity. Gastrointest Endosc 1989; 35 (5): 381–385.

    Article  CAS  Google Scholar 

  15. Meshkinpour H, Hsu D, Farivar S . Effect of gastric bubble as a weight reduction device: a controlled, crossover study. Gastroenterology 1988; 95: 589–592.

    Article  CAS  Google Scholar 

  16. Totté E, Hendrickx L, Pauwels M, Van Hee R . Weight reduction by means of intragatric device: experience with the bioenterics intragastric balloon. Obes Surg 2001; 11: 519–523.

    Article  Google Scholar 

  17. Al-Momen A, El-Mogy I . Intragastric balloon for obesity: a retrospective evaluation of tolerance and efficacy. Obes Surg 2005; 15: 101–105.

    Article  Google Scholar 

  18. Sallet JA, Marchesini JB, Paiva DK, Komoto K, Pizani CE, Ribeiro MLB . Brazilian multicenter study of the intragastric balloon. Obes Surg 2004; 14: 991–998.

    Article  Google Scholar 

  19. Loffredo A, Cappuccio M, De Luca M, de Werra C, Galloro G, Naddeo M et al. Three years experience with the new intragastric balloon, and a preoperative test for success with restrictive surgery. Obes Surg 2001; 11: 330–333.

    Article  CAS  Google Scholar 

  20. Hodson RM, Zacharoulis D, Goutzamani E, Slee P, Wood S, Wedgwood KR . Management of obesity with the new intragastric balloon. Obes Surg 2001; 11: 327–329.

    Article  CAS  Google Scholar 

Download references

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Genco, A., Cipriano, M., Bacci, V. 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 30, 129–133 (2006). https://doi.org/10.1038/sj.ijo.0803094

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