Skip to main content

Advertisement

SpringerLink
Log in

Safety and Effectiveness of the Intragastric Balloon for Obesity. A Meta-Analysis

  • Research Article
  • Published:
Obesity Surgery Aims and scope Submit manuscript

Abstract

Background

Intragastric balloons have been used since 1985 to treat obesity, but an evidence-based systematic review had not been previously performed. The objective of this study is to determine the safety, efficacy, and effectiveness of the most widely used balloon, BioEnterics Intragastric Balloon (BIB®), to treat obesity.

Methods

Systematic literature review of Medline, Embase, and other information sources from inception to March 2006. The quality of selected studies was assessed. Meta-analysis of weighted mean difference was made using the inverse variance method.

Results

We pooled 15 articles (3,608 patients) to estimate BIBs® effectiveness. The estimates for weight lost at balloon removal for BIB® were the following: 14.7 kg, 12.2% of initial weight, 5.7 kg/m2, and 32.1% of excess weight. However, data were scant after balloon removal. Yet, efficacy at balloon removal was estimated with a meta-analysis of two randomized controlled trials (75 patients) that compared balloon versus placebo, indicating the balloon group lost more weight than the placebo group. These differences in weight lost were 6.7 kg, 1.5% of initial weight, 3.2 kg/m2, and 17.6% of excess weight. Regarding BIB® safety, the majority of complications were mild and the early removal rate was 4.2%.

Conclusion

The use of the BIB®, within a multidisciplinary weight management program, is a short-term effective treatment to lose weight, but it is not yet possible to verify its capacity to maintain the weight lost over a long period of time.

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

Access this article

Log in via an institution

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

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Fernandes M, Atallah AN, Soares BGO, et al. Baloes Intragástricos para pessoas com obesidade. Cochrane Library. Oxford: Update Software Ltd.; 2006.

    Google Scholar 

  2. National Institutes of Health, National Heart Lung and Blood Institute, North American Association for the Study of Obesity. Practical Guide to the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. NIH Publication no. 00-4084. Bethesda: NIH; 2000. p. 94.

    Google Scholar 

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

    PubMed  CAS  Google Scholar 

  4. Schapiro M, Benjamin S, Blackburn G, et al. Obesity and the gastric balloon: a comprehensive workshop. Tarpon Springs, Florida, March 19–21, 1987. Gastrointest Endosc. 1987;33:323–7.

    Article  PubMed  CAS  Google Scholar 

  5. Allison C. Intragastric balloons: a temporary treatment for obesity. Issues in emerging health technologies, no. 79. Canadian Coordinating Office for Health Technology Assessment, Ottawa; 2006.

  6. Forestieri P, De Palma GD, Formato A, et al. Heliosphere(R) bag in the treatment of severe obesity: preliminary experience. Obes Surg. 2006;16:635–7.

    Article  PubMed  CAS  Google Scholar 

  7. Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions. 4.2.6. In: The Cochrane Library. Issue 4, ed. Chichester, UK: John Wiley and Sons, Ltd.; 2006.

  8. Jadad AR. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1–12.

    Article  PubMed  CAS  Google Scholar 

  9. Khan KS, Riet G, Glanville J, et al. Undertaking systematic reviews of research on effectiveness. CRD’s guidance for those carrying out or commissioning reviews. no. 4. York: NHS Center for Reviews and Dissemination, University of York; 2001.

    Google Scholar 

  10. Oxford Centre for Evidence-based Medicine. Quality filters [On line]. Web of the centre for evidence-based medicine, 23-10-2006. http://www.cebm.net/levels_of_evidence.asp.

  11. Schwartz D. Métodos estadísticos para médicos y biólogos. Barcelona: Editorial Herder; 1991. p. 385.

    Google Scholar 

  12. Furukawa TA, Barbui C, Cipriani A, et al. Imputing missing standard deviations in meta-analyses can provide accurate results. J Clin Epidemiol. 2006;59:7–10.

    Article  PubMed  Google Scholar 

  13. Angrisani L, Lorenzo M, Borrelli V, et al. Is bariatric surgery necessary after intragastric balloon treatment. Obes Surg. 2006;16:1135–7.

    Article  PubMed  Google Scholar 

  14. Busetto L, Segato G, De Luca M, et al. Preoperative weight loss by intragastric balloon in super-obese patients treated with laparoscopic gastric banding: a case-control study. Obes Surg. 2004;14:671–6.

    Article  PubMed  Google Scholar 

  15. Busetto L, Enzi G, Inelmen EM, et al. Obstructive sleep apnea syndrome in morbid obesity: effects of intragastric balloon. Chest. 2005;128:618–23.

    Article  PubMed  Google Scholar 

  16. Doldi SB, Micheletto G, Perrini MN, et al. Intragastric balloon: another option for treatment of obesity and morbid obesity. Hepatogastroenterology. 2004;51:294–7.

    PubMed  CAS  Google Scholar 

  17. Francica G, Giardiello C, Iodice G, et al. Ultrasound as the imaging method of choice for monitoring the intragastric balloon in obese patients: normal findings, pitfalls and diagnosis of complications. Obes Surg. 2004;14:833–7.

    Article  PubMed  Google Scholar 

  18. Galloro G, De Palma GD, Catanzano C, et al. Preliminary endoscopic technical report of a new silicone intragastric balloon in the treatment of morbid obesity. Obes Surg. 1999;9:68–71.

    Article  PubMed  CAS  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

  20. Krakamp B, Leidig P, Gehmlich D, et al. Der Magenvolumen-Reduzierungsballon zur Gewichtsreduktion: Welche Berechtigung hat diese umstrittene Methode? Zentralbl Chir. 1997;122:349–56.

    PubMed  CAS  Google Scholar 

  21. Rydzewska G, Milewski J. Balony dozoladkowe-nowa nadzieja w leczeniu otylosci? Pol Merkuriusz Lek. 2004;17 Suppl 1:114–6.

    Google Scholar 

  22. Bonazzi P, Petrelli MD, Lorenzini I, et al. Gastric emptying and intragastric balloon in obese patients. Eur Rev Med Pharmacol Sci. 2005;9:15–21.

    PubMed  CAS  Google Scholar 

  23. Alfalah H, Philippe B, Ghazal F, et al. Intragastric balloon for preoperative weight reduction in candidates for laparoscopic gastric bypass with massive obesity. Obes Surg. 2006;16:147–50.

    Article  PubMed  Google Scholar 

  24. Al Momen A, El Mogy I. Intragastric balloon for obesity: a retrospective evaluation of tolerance and efficacy. Obes Surg. 2005;15:101–5.

    Article  PubMed  Google Scholar 

  25. Carbonelli MG, Fusco MA, Cannistra F, et al. Body composition modification in obese patients treated with intragastric balloon. Acta Diabetol. 2003;40 Suppl 1:S261–2.

    Article  PubMed  CAS  Google Scholar 

  26. Evans JD, Scott MH. Intragastric balloon in the treatment of patients with morbid obesity. Br J Surg. 2001;88:1245–8.

    Article  PubMed  CAS  Google Scholar 

  27. Genco A, Bruni T, Doldi SB, et al. BioEnterics intragastric balloon: the italian experience with 2,515 patients. Obes Surg. 2005;15:1161–4.

    Article  PubMed  CAS  Google Scholar 

  28. Herve J, Wahlen CH, Schaeken A, et al. What becomes of patients one year after the intragastric balloon has been removed? Obes Surg. 2005;15:864–70.

    Article  PubMed  CAS  Google Scholar 

  29. Hodson RM, Zacharoulis D, Goutzamani E, et al. Management of obesity with the new intragastric balloon. Obes Surg. 2001;11:327–9.

    Article  PubMed  CAS  Google Scholar 

  30. Loffredo A, Cappuccio M, De Luca M, et al. Three years experience with the new intragastric balloon, and a preoperative test for success with restrictive surgery. Obes Surg. 2001;11:3.

    Article  Google Scholar 

  31. Mion F, Napoleon B, Roman S, et al. Effects of intragastric balloon on gastric emptying and plasma ghrelin levels in non-morbid obese patients. Obes Surg. 2005;15:510–6.

    Article  PubMed  Google Scholar 

  32. Roman S, Napoleon B, Mion F, et al. Intragastric balloon for “non-morbid” obesity: a retrospective evaluation of tolerance and efficacy. Obes Surg. 2004;14:539–44.

    Article  PubMed  Google Scholar 

  33. Sallet JA, Marchesini JB, Paiva DS, et al. Brazilian multicenter study of the intragastric balloon. Obes Surg. 2004;14:991–8.

    Article  PubMed  Google Scholar 

  34. Sánchez B, Espinós J, Turró J, et al. Tratamiento y seguimiento nutricional en pacientes con balón intragástrico. Revista Española de Nutrición Comunitaria. 2005;11:152–5.

    Google Scholar 

  35. Totté E, Hendrickx L, Pauwels M, et al. Weight reduction by means of intragastric device: experience with the bioenterics intragastric balloon. Obes Surg. 2001;11:519–23.

    Article  PubMed  Google Scholar 

  36. Weiner R, Gutberlet H, Bockhorn H. Preparation of extremely obese patients for laparoscopic gastric banding by gastric-balloon therapy. Obes Surg. 1999;9:261–4.

    Article  PubMed  CAS  Google Scholar 

  37. 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;30:129–33.

    Article  CAS  Google Scholar 

  38. 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;61:19–27.

    Article  PubMed  Google Scholar 

  39. Maggard MA, Shugarman LR, Suttorp M, et al. Meta-analysis: surgical treatment of obesity. Ann Intern Med. 2005;142:547–59.

    PubMed  Google Scholar 

  40. Goldstein DJ. Beneficial health effects of modest weight loss. Int J Obes Relat Metab Disord. 1992;16:397–415.

    PubMed  CAS  Google Scholar 

  41. Li Z, Maglione M, Tu W, et al. Meta-analysis: pharmacologic treatment of obesity. Ann Intern Med. 2005;142:532–46.

    PubMed  CAS  Google Scholar 

  42. McTigue KM, Hess R, Ziouras J. Obesity in older adults: a systematic review of the evidence for diagnosis and treatment. Obesity. 2006;14:1485–97.

    Article  PubMed  Google Scholar 

  43. Tosetti C, Corinaldesi R, Stanghellini V, et al. Gastric emptying of solids in morbid obesity. Int J Obes Relat Metab Disord. 1996;20:200–5.

    PubMed  CAS  Google Scholar 

  44. Geliebter A, Melton PM, McCray RS, et al. Clinical trial of silicone-rubber gastric balloon to treat obesity. Int J Obes. 1991;15:259–66.

    PubMed  CAS  Google Scholar 

Download references

Acknowledgment

We thank David Peck for his structural review of this manuscript.

Author information

Authors and Affiliations

  1. Agencia de Evaluación de Tecnologías Sanitarias, Instituto de Salud “Carlos III”, Ministry of Health and Consumer Affairs, C/ Sinesio Delgado, 6, 28029, Madrid, Spain

    Iñaki Imaz, Juan Manuel Sendra-Gutiérrez & Jesús González-Enríquez

  2. Preventative Medicine Department, Hospital Clínico “San Carlos”, Health Service of Madrid, Madrid, Spain

    Carmen Martínez-Cervell

  3. Evidence-Based Medicine Department, Health Sciences Institute of Aragon, Aragon, Spain

    Elvira Elena García-Álvarez

Authors
  1. Iñaki Imaz
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Carmen Martínez-Cervell
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Elvira Elena García-Álvarez
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Juan Manuel Sendra-Gutiérrez
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Jesús González-Enríquez
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Iñaki Imaz.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Imaz, I., Martínez-Cervell, C., García-Álvarez, E.E. et al. Safety and Effectiveness of the Intragastric Balloon for Obesity. A Meta-Analysis. OBES SURG 18, 841–846 (2008). https://doi.org/10.1007/s11695-007-9331-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11695-007-9331-8

Keywords

Search

Navigation