Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial

Courcoulas, Anita P.; Dayyeh, Barham K. Abu; Eaton, Laura; Robinson, J. S.; Woodman, George; Fusco, M; Shayani, Vafa; Billy, Helmuth; Pambianco, Daniel J.; Gostout, Christopher J.

doi:10.1038/ijo.2016.229

Cited by 106 publications

(101 citation statements)

References 32 publications

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“…Some authors suggested that after three months of treatment, the volumes should be reset to a higher level, given that 80% of weight loss occurs during that interval, after which there is a heightened level of gastric compliance and a diminished effect of early satiety (19,30) . However, there is much divergence of opinion in the literature concerning readjustment (18,31) .…”

Section: Discussionmentioning

confidence: 99%

Assessment of Weight Loss After Non-Adjustable and Adjustable Intragastric Balloon Use

Schwaab

Usuy

Albuquerque

et al. 2020

Arq. Gastroenterol.

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BACKGROUND: Intragastric balloon (IGB) use is indicated for patients whose BMI precludes the option of bariatric surgery or who need to lose weight prior to undergoing surgery. It is a minimally invasive procedure and currently there are two main models of IGBs in use, the non-adjustable intragastric balloon (NIB), implanted for six months, and the adjustable intragastric balloon (AIB), implanted for up to 12 months. OBJECTIVE: Analyze clinical characteristics between patients receiving non-adjustable gastric balloon and the adjustable (prolonged implantation) intragastric balloon. METHODS: This was a cross-sectional study of 470 patients diagnosed as obese or overweight who had balloon implantation from October 2011 to July 2018. The associations between percentage excess weight loss versus clinical and demographic variables were calculated using the chi-squared test. Independent samples were submitted to the Student’s t test to determine the quantitative variables, with a confidence interval of 95%. Calculation of excess weight was based on an estimated ideal weight that would correspond to a BMI of 24.99 kg/m2. RESULTS: A total of 414 patients completed the treatment achieving an average total body weight loss (%TBWL) of 15.4±7 with the NIB and 15.5±9.6 with the AIB. Overweight patients achieved higher excess weight loss (%EWL) values using AIBs (157.2±82.5) and obese patients did so with NIB use (56±29.7). Women achieved higher %EWL values (65.6±62.2) than men (48±27.1). Individuals who attended >4 consultations with a nutritionist (60.8%) achieved TBWL >18%. All of those P-values were <0.001. CONCLUSION: Obese individuals and women registered the greatest weight losses. Overweight patients achieved greater losses using AIB and obese patients did so using NIBs. NIB use was associated with higher EWL percentages. Nutritional accompaniment had a positive impact on the %TBWL.

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Section: Discussionmentioning

confidence: 99%

Assessment of Weight Loss After Non-Adjustable and Adjustable Intragastric Balloon Use

Schwaab

Usuy

Albuquerque

et al. 2020

Arq. Gastroenterol.

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“…These balloon volume manipulations have produced an impressive percentage of patients that have a successful outcome-79% (297/376) had > 25% EWL in our retrospective series. This is a significant improvement over the results of 6-month, nonadjustable balloons which have reported response rates ( >25% EWL) of 48% and 46.4% in FDA studies [17,18] and 45.6%, 71.4%, 24%, 75%, and 63%,respectively, in several published studies [13,19,[26][27][28].…”

Section: Discussionmentioning

confidence: 67%

Spatz3 Adjustable Balloon: Weight Loss and Response Rates in Brazil

Almeida¹

2018

IGH

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Background: The degree of efficacy and duration of effect of Intragastric Balloons (IGBs) can be variable and unpredictable. The Spatz Adjustable Intragastric Balloon (AIGB) was developed to address these issues by extending implantation to 1 year, decreasing balloon volume for intolerance and increasing volume for decreased balloon effect.Aims: To determine the efficacy and response rate of the Spatz3 AIGB.Methods: Results of 379 consecutive patients (pts) implanted with the Spatz3 AIGB were retrospectively reviewed (3 lost to follow up). Mean BMI 35.5; mean weight (wt) 97.5 kg; mean excess wt 29.1 kg; mean balloon volume 600ml. Balloon volume adjustments were offered: Down adjustments for intolerance and up adjustments for decreased balloon effect.Results: The mean implantation time of 376 pts was 10.6 months yielding mean wt loss 14.9 kg; mean 15.1% Total Body Wt Loss (%TBL) and 58% Excess Wt Loss(%EWL). Response rate (> 25%EWL) was achieved in 79% (297/376) of pts. Down adjustments in 95 pts (mean 2.4 months; mean -152.4 ml) allowed 76/95 (80%) to continue IGB therapy for at least 6 months (mean 9.1 months). Up adjustments in 205/376 (54.5%) pts (mean 5.8 months; mean + 179.2 ml) yielded additional mean wt loss of 6.5 kg. There was 1 gastric ulcer (0.27%). One balloon deflated at 7.4 months and 4 others deflated after 1 year (13-23 months).Conclusions: In this retrospective review of 376 Spatz3 AIGB patients, up adjustments yielded a mean 6.5kg extra wt loss for those with wt loss plateau, and down adjustments alleviated early intolerance. These two adjustment functions may be instrumental in yielding a successful outcome (> 25% EWL) in 79% of pts.

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“…A total of 16 700 unique studies were initially identified through the database search, out of which 20 met our inclusion/exclusion criteria . These studies reported results of nine interventions: five pharmaceutical products (Alli [over‐the‐counter Orlistat], Xenical [Orlistat], Contrave [Naltrexone‐bupropion], Belviq [Lorcaserin]) and Saxenda [Liraglutide]), two lifestyle modification programmes (Weight Watchers Meetings and Weight Watchers Online), one food replacement and lifestyle programme (Jenny Craig) and one intragastric balloon system (Orbera) manufactured by Apollo Endosurgery, Inc., headquartered in Austin, Texas.…”

Section: Resultsmentioning

confidence: 99%

Incremental cost‐effectiveness of evidence‐based non‐surgical weight loss strategies

Finkelstein

Verghese

2019

Clinical Obesity

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Recent medical advancements have led to new modes of treatment for non-surgical weight loss, including several new medications. Our aim was to conduct an incremental cost-effectiveness analysis for all commercially available, evidence-based non-surgical weight loss interventions for people with excess weight. We identified interventions through a systematic review of randomized controlled trials that reported weight loss 12 months from baseline. We then metaanalysed the results, sourced costs and performed an incremental cost-effectiveness analysis from the payer perspective. Cost-effectiveness was presented in terms of cost per kilogram lost and quality-adjusted life years (QALY) gained. We further performed sensitivity analyses on costs and duration of benefits, and a probabilistic sensitivity analysis. Ten interventions were identified for inclusion: six pharmaceutical products (Alli, Xenical, Qsymia, Contrave, Belviq and Saxenda), two lifestyle modification programmes (Weight Watchers Meetings and Online), one food replacement and lifestyle programme (Jenny Craig) and one intragastric balloon system (Orbera). At an incremental cost-effectiveness ratio of $30 071 per additional QALY gained, only Weight Watchers Meetings was cost-effective. Sensitivity analyses revealed that for the medications to become incrementally cost-effective, costs would have to decrease by as much as 91%. Results are highly dependent on duration that benefits are maintained. Despite several newly available interventions, Weight Watchers Meetings is currently the only evidence-based, commercially available, cost-effective option for non-surgical weight loss. Other interventions, specifically medications, are more effective but priced too high to be cost-effective. K E Y W O R D Scost-effectiveness, obesity, overweight, weight loss medication, weight loss programmes

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Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial

Abstract: Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common.

Cited by 106 publications

References 32 publications

Assessment of Weight Loss After Non-Adjustable and Adjustable Intragastric Balloon Use

Assessment of Weight Loss After Non-Adjustable and Adjustable Intragastric Balloon Use

Spatz3 Adjustable Balloon: Weight Loss and Response Rates in Brazil

Incremental cost‐effectiveness of evidence‐based non‐surgical weight loss strategies

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