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Fluid-Filled Versus Gas-Filled Intragastric Balloons as Obesity Interventions: a Network Meta-analysis of Randomized Trials

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Abstract

Background

Four commercially available intragastric balloons have been used for the management of obesity and underwent randomized controlled trials (RCTs), and we aimed to compare them using a network meta-analysis approach.

Methods

Several databases were queried from inception to May 26, 2017, and we included RCTs enrolling patients treated with Orbera, Heliosphere, ReShape Duo, and Obalon compared with another balloon, sham, or open-label control group. Two investigators independently abstracted data. A random effects frequentist network meta-analysis and relative ranking of agents using surface under the cumulative ranking probabilities were performed.

Results

We included 15 trials at low risk of bias (only two were head-to-head). Compared to control groups, the two fluid-filled devices were associated with significant outcome (% total body weight loss) at 6 months: Orbera, 6.72% (95% CI, 5.55, 7.89) and ReShape Duo 4% (95% CI 2.69, 5.31). Only one of the two gas-filled devices was associated with significant outcome at 6 months: Obalon 3.3% (95% CI 2.30, 4.30), and not the second: Heliosphere 6.71% (95% CI − 0.82, 14.23). Fluid-filled devices had the highest likelihood of superiority in achieving the outcome at 6 months (96.8%) and at 12 months (96.6%). The quality of evidence was high for comparisons against control.

Conclusions

Fluid-filled balloons are more likely to produce weight loss compared to gas-filled balloons or lifestyle intervention. However, they may be associated with a higher rate of intolerance and early removal. This information will aid clinicians in device selection and engaging patients in shared decision-making.

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Abbreviations

BMI:

Body mass index

CI:

Confidence interval

EBTs:

Endoscopic bariatric therapies

EWL:

Excess weight loss

FDA:

Food and Drug Administration

IGBs:

Intragastric balloons

RCT:

Randomized controlled trial

SAE:

Serious adverse events

US:

United States

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Author notes

  1. Fateh Bazerbachi and Samir Haffar contributed equally to this work.

Authors and Affiliations

  1. Division of Gastroenterology and Hepatology, Mayo Clinic, 200 First Street SW, Rochester, MN, USA

    Fateh Bazerbachi, Tarek Sawas, Eric J. Vargas, Ravinder Jeet Kaur & Barham K. Abu Dayyeh

  2. Digestive Center for Diagnosis and Treatment, 29 Ayar Street, Damascus, Syrian Arab Republic

    Samir Haffar

  3. Mayo Clinic Evidence-based Practice Center, Mayo Clinic, Rochester, MN, USA

    Zhen Wang & M. Hassan Murad

  4. Department of Library Services, Mayo Clinic, Rochester, MN, USA

    Larry J. Prokop

Authors
  1. Fateh Bazerbachi
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Contributions

Fateh Bazerbachi MD, Samir Haffar MD, M. Hassan Murad MD, MPH, and Barham K. Abu Dayyeh MD, MPH, contributed to the study concept and design, interpretation of data, drafting of the manuscript, critical revision of the manuscript for important intellectual content, and study supervision. Tarek Sawas, Ravinder Jeet Kaur, and Eric J. Vargas contributed to the data acquisition and critical revision of the manuscript for important intellectual content. Larry J. Prokop contributed to the librarian search and critical revision of the manuscript for important intellectual content. Zhen Wang contributed to the statistical analysis and critical revision of the manuscript for important intellectual content.

Corresponding author

Correspondence to Barham K. Abu Dayyeh.

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Conflict of Interest

Fateh Bazerbachi: none, Samir Haffar: none, Tarek Sawas: none, Eric J. Vargas: none, Ravinder Jeet Kaur: none, Zhen Wang: none, Larry Prokop: none, M. Hassan Murad: none, Barham K. Abu Dayyeh received research grants by Spatz Medical and Apollo Endosurgery.

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Bazerbachi, F., Haffar, S., Sawas, T. et al. Fluid-Filled Versus Gas-Filled Intragastric Balloons as Obesity Interventions: a Network Meta-analysis of Randomized Trials. OBES SURG 28, 2617–2625 (2018). https://doi.org/10.1007/s11695-018-3227-7

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  • DOI: https://doi.org/10.1007/s11695-018-3227-7

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