Skip to main content

Advertisement

Log in

Efficacy of First-Time Intragastric Balloon in Weight Loss: a Systematic Review and Meta-analysis of Randomized Controlled Trials

  • Original Contributions
  • Published:
Obesity Surgery Aims and scope Submit manuscript

Abstract

Background

The intragastric balloon (IGB) is an adjunctive treatment for obesity. This meta-analysis aimed to evaluate the efficacy and safety of IGB treatment by reviewing randomized controlled trials (RCTs).

Methods

A total of 20 RCTs involving 1195 patients were identified. Weight loss results before and after 3 months were analyzed separately. The weight loss results of patients with and without IGB treatment were compared.

Results

Our meta-analysis calculated the following significant effect sizes: 1.59 and 1.34 kg/m2 for overall and 3-month BMI loss, respectively; 14.25 and 11.16 % for overall and >3-month percentage of excess weight loss, respectively; 4.6 and 4.77 kg for overall and 3-month weight loss, respectively; and 2.81, 1.62, and 4.09 % for overall, 3-month, and >3-month percent of weight loss, respectively. A significant effect size was calculated that favored fluid-filled IGBs over air-filled IGBs. Flatulence (8.75 vs. 3.89 %, p = 0.0006), abdominal fullness (6.32 vs. 0.55 %, p = 0.001), abdominal pain (13.86 vs. 7.2 %, p = 0.0001), abdominal discomfort (4.37 vs. 0.55 %, p = 0.006), and gastric ulcer (12.5 vs. 1.2 %, p < 0.0001) were significantly more prevalent among IGB patients than among non-IGB control patients. No mortality was reported from IGB treatment.

Conclusion

IGB treatment, in addition to lifestyle modification, is an effective short-term modality for weight loss. However, there is not sufficient evidence confirming its safety or long-term efficacy.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. WHO. Global health risks: mortality and burden of disease attributable to selected major risks. Geneva, Switzerland: World Health Organization; 2009.

    Google Scholar 

  2. Loveman E, Frampton GK, Shepherd J, et al. The clinical effectiveness and cost-effectiveness of long-term weight management schemes for adults: a systematic review. Health Technol Assess. 2011;15(2):1–182.

    Article  CAS  Google Scholar 

  3. Ribaric G, Buchwald JN, McGlennon TW. Diabetes and weight in comparative studies of bariatric surgery vs conventional medical therapy: a systematic review and meta-analysis. Obes Surg. 2014;24(3):437–55.

    Article  CAS  PubMed  Google Scholar 

  4. Genco A, Lorenzo M, Baglio G, et al. Does the intragastric balloon have a predictive role in subsequent LAP-BAND((R)) surgery? Italian multicenter study results at 5-year follow-up. Surg Obes Relat Dis. 2014;10(3):474–8.

    Article  PubMed  Google Scholar 

  5. Paulus GF, de Vaan LE, Verdam FJ, Bouvy ND, Ambergen TA, van Heurn LW. Bariatric surgery in morbidly obese adolescents: a systematic review and meta-analysis. Obes Surg. 2015;25(5):860–78.

    Article  PubMed  PubMed Central  Google Scholar 

  6. Mathus-Vliegen EM, Tytgat GN, Veldhuyzen-Offermans EA. Intragastric balloon in the treatment of super-morbid obesity. Double-blind, sham-controlled, crossover evaluation of 500-milliliter balloon. Gastroenterology. 1990;99(2):362–9.

    Article  CAS  PubMed  Google Scholar 

  7. Hogan RB, Johnston JH, Long BW, et al. A double-blind, randomized, sham-controlled trial of the gastric bubble for obesity. Gastrointest Endosc. 1989;35(5):381–5.

    Article  CAS  PubMed  Google Scholar 

  8. Ramhamadany EM, Fowler J, Baird IM. Effect of the gastric balloon versus sham procedure on weight loss in obese subjects. Gut. 1989;30(8):1054–7.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  9. Geliebter A, Westreich S, Gage D. Gastric distention by balloon and test-meal intake in obese and lean subjects. Am J Clin Nutr. 1988;48(3):592–4.

    CAS  PubMed  Google Scholar 

  10. Benjamin SB, Maher KA, EL Jr C, et al. Double-blind controlled trial of the Garren-Edwards gastric bubble: an adjunctive treatment for exogenous obesity. Gastroenterology. 1988;95(3):581–8.

    Article  CAS  PubMed  Google Scholar 

  11. Meshkinpour H, Hsu D, Farivar S. Effect of gastric bubble as a weight reduction device: a controlled, crossover study. Gastroenterology. 1988;95(3):589–92.

    Article  CAS  PubMed  Google Scholar 

  12. Lindor KD, RW Jr H, Ilstrup DM, Jensen MD. Intragastric balloons in comparison with standard therapy for obesity—a randomized, double-blind trial. Mayo Clin Proc. 1987;62(11):992–6.

    Article  CAS  PubMed  Google Scholar 

  13. Garren M, Garren L, Giordano F. The Garren gastric bubble: an Rx for the morbidly obese. Endocr Rev. 1984;1:57–60.

    Google Scholar 

  14. Nieben OG, Harboe H. Intragastric balloon as an artificial bezoar for treatment of obesity. Lancet. 1982;1(8265):198–9.

    Article  CAS  PubMed  Google Scholar 

  15. Giardiello C, Borrelli A, Silvestri E, Antognozzi V, Iodice G, Lorenzo M. Air-filled vs water-filled intragastric balloon: a prospective randomized study. Obes Surg. 2012;22(12):1916–9.

    Article  PubMed  Google Scholar 

  16. De Castro ML, Morales MJ, Del Campo V, et al. Efficacy, safety, and tolerance of two types of intragastric balloons placed in obese subjects: a double-blind comparative study. Obes Surg. 2010;20(12):1642–6.

    Article  PubMed  Google Scholar 

  17. Mathus-Vliegen EM, Eichenberger RI. Fasting and meal-suppressed ghrelin levels before and after intragastric balloons and balloon-induced weight loss. Obes Surg. 2014;24(1):85–94.

    Article  CAS  PubMed  Google Scholar 

  18. Mohammed M, 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(2):58–80.

    Article  CAS  Google Scholar 

  19. Mathus-Vliegen EM, de Groot GH. Fasting and meal-induced CCK and PP secretion following intragastric balloon treatment for obesity. Obes Surg. 2013;23(5):622–33.

    Article  PubMed  Google Scholar 

  20. Fuller NR, Pearson S, Lau NS, et al. An intragastric balloon in the treatment of obese individuals with metabolic syndrome: a randomized controlled study. Obesity (Silver Spring). 2013;21(8):1561–70.

    Article  Google Scholar 

  21. Ponce J, Quebbemann BB, Patterson EJ. Prospective, randomized, multicenter study evaluating safety and efficacy of intragastric dual-balloon in obesity. Surg Obes Relat Dis. 2013;9(2):290–5.

    Article  PubMed  Google Scholar 

  22. Genco A, Maselli R, Frangella F, et al. Effect of consecutive intragastric balloon (BIB(R)) plus diet versus single BIB(R) plus diet on eating disorders not otherwise specified (EDNOS) in obese patients. Obes Surg. 2013;23(12):2075–9.

    Article  PubMed  Google Scholar 

  23. Lee YM, Low HC, Lim LG, et al. Intragastric balloon significantly improves nonalcoholic fatty liver disease activity score in obese patients with nonalcoholic steatohepatitis: a pilot study. Gastrointest Endosc. 2012;76(4):756–60.

    Article  PubMed  Google Scholar 

  24. Farina MG, Baratta R, Nigro A, et al. Intragastric balloon in association with lifestyle and/or pharmacotherapy in the long-term management of obesity. Obes Surg. 2012;22(4):565–71.

    Article  PubMed  Google Scholar 

  25. Dumonceau JM. Evidence-based review of the Bioenterics intragastric balloon for weight loss. Obes Surg. 2008;18(12):1611–7.

    Article  PubMed  Google Scholar 

  26. Fernandes M, Atallah AN, Soares BG, et al. Intragastric balloon for obesity. Cochrane Database Syst Rev. 2007(1):CD004931.

  27. Zheng Y, Wang M, He S, Ji G. Short-term effects of intragastric balloon in association with conservative therapy on weight loss: a meta-analysis. J Transl Med. 2015;13:246.

    Article  PubMed  PubMed Central  Google Scholar 

  28. Imaz I, Martinez-Cervell C, Garcia-Alvarez EE, Sendra-Gutierrez JM, Gonzalez-Enriquez J. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obes Surg. 2008;18(7):841–6.

    Article  PubMed  Google Scholar 

  29. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med. 2009;151(4):W65–94.

    Article  PubMed  Google Scholar 

  30. Mathus-Vliegen EM, Tygat GN. Gastro-oesophageal reflux in obese subjects: influence of overweight, weight loss and chronic gastric balloon distension. Scand J Gastroenterol. 2002;37(11):1246–52.

    Article  CAS  PubMed  Google Scholar 

  31. Mathus-Vliegen EM, Tytgat GN. Intragastric balloon for treatment-resistant obesity: safety, tolerance, and efficacy of 1-year balloon treatment followed by a 1-year balloon-free follow-up. Gastrointest Endosc. 2005;61(1):19–27.

    Article  PubMed  Google Scholar 

  32. 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. 2006;30(1):129–33.

    Article  CAS  Google Scholar 

  33. Ponce J, Woodman G, Swain J, et al. The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity. Surg Obes Relat Dis. 2015;11(4):874–81.

    Article  PubMed  Google Scholar 

  34. Genco A, Bruni T, Doldi SB, et al. BioEnterics intragastric balloon: the Italian experience with 2,515 patients. Obes0020Surg. 2005;15(8):1161–4.

    CAS  Google Scholar 

  35. Abu Dayyeh BK, Kumar N, Edmundowicz SA, et al. ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc. 2015;82(3):425–38 .e5

    Article  PubMed  Google Scholar 

  36. Rigaud D, Trostler N, Rozen R, Vallot T, Apfelbaum M. Gastric distension, hunger and energy intake after balloon implantation in severe obesity. Int J Obes Relat Metab Disord. 1995;19(7):489–95.

    CAS  PubMed  Google Scholar 

  37. Martinez-Brocca MA, Belda O, Parejo J, et al. Intragastric balloon-induced satiety is not mediated by modification in fasting or postprandial plasma ghrelin levels in morbid obesity. Obes Surg. 2007;17(5):649–57.

    Article  PubMed  Google Scholar 

  38. Genco A, Cipriano M, Bacci V, et al. Intragastric balloon followed by diet vs intragastric balloon followed by another balloon: a prospective study on 100 patients. Obes Surg. 2010;20(11):1496–500.

    Article  PubMed  Google Scholar 

Download references

Acknowledgment

We would like to express our appreciation to Anabela Rodrigues for her help in the preparation of this manuscript.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Alan A. Saber.

Ethics declarations

Informed Consent

Not applicable.

Statement of Human and Animal Rights

Not applicable.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Saber, A.A., Shoar, S., Almadani, M.W. et al. Efficacy of First-Time Intragastric Balloon in Weight Loss: a Systematic Review and Meta-analysis of Randomized Controlled Trials. OBES SURG 27, 277–287 (2017). https://doi.org/10.1007/s11695-016-2296-8

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11695-016-2296-8

Keywords

Navigation