Evidence map›Paper›PMID 28017964›Full record

Trial reportInternational journal of obesity (2005)2017

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

A Courcoulas, B K Abu Dayyeh, L Eaton, J Robinson, G Woodman, M Fusco, V Shayani, H Billy, D Pambianco, C Gostout

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of obesity (2005), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 58 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 9 pooled it
12.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03473938 completednot on this map

Adjustable Balloons for Weight Loss: A Higher Yield of Responders Compared With Non-Adjustable Balloons

TypeobservationalSponsorUniversity Hospital OstravaRan2015 to 2016Enrolled227ConditionsObesityArmsSpatz3 AIGB
NCT04306445 naterminatednot on this mapstarted 2020, after this paper: background citation

The Effect of a Gas-filled Intragastric Balloon or Endoscopic Sleeve Gastroplasty for Weight Loss Compared With a Meal Replacement Weight Loss Program on Gastric Emptying, Hormonal Adaptation to Weight Loss, and Hunger

TypeinterventionalSponsorUniversity of Colorado, DenverRan2020 to 2024Enrolled3ConditionsObesityArmsGF-IGB: Obalon Balloon, Medically Supervised Meal Replacement Program: My New Weigh, Endoscopic sleeve gastroplasty: (ESG)
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 9 syntheses or guidelines pooled it, 161 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 1 country.

A CourcoulasDepartment of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
B K Abu DayyehMayo Clinic, Rochester, MN, USA.
L EatonUltaMed Corporation, Huntington Beach, CA, USA.
J RobinsonSimulstat Incorporated, San Diego, CA, USA.
G WoodmanGeorge Woodman, MD, PC, Memphis, TN, USA.
M FuscoHealth First Medical Group, Melbourne, FL, USA.
V ShayaniSt James Hospital, Olympia Fields, IL, USA.
H BillyVentura Advanced Surgical Associates, Ventura, CA, USA.
D PambiancoCharlottesville Medical Research, Charlottesville, VA, USA.
C GostoutMayo Clinic, Rochester, MN, USA.
Mayo Clinic in Arizona · USCharlottesville Medical Research · USHealth First · USSt. James Hospital and Health Centers · USUniversity of Pittsburgh Medical Center · USUniversity Surgical Associates · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectivesThis trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention. SUBJECTS/

methodsIn this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30-40 kg m

resultsAt 6 months, weight loss was -3.3% of total body weight (-3.2 kg) in the lifestyle arm vs -10.2% (-9.9 kg) in the balloon plus lifestyle arm (P<0.001); at 9 months (3 months postballoon removal), weight loss was -3.4% (-3.2 kg) vs -9.1% (-8.8 kg, P⩽0.001); and at 12 months, -3.1% (-2.9 kg) vs -7.6% (-7.4 kg, P⩽0.001). For the primary end points, at 9 months, mean percent loss of weight in excess of ideal body weight (s.d.) at 9 months was 26.5% (20.7) (P=0.32) and 9.7% (15.1) in the balloon and control groups, respectively. Also, 45.6% (36.7, 54.8) of the subjects randomized to the balloon achieved at least 15% loss of weight in excess of ideal body weight greater than the control group (P<0.001). The majority of balloon subjects experienced adverse events; 86.9% nausea, 75.6% vomiting, 57.5% abdominal pain and 18.8% had their device removed before 6 months because of an adverse event or subject request. Five subjects (3.1%) in the balloon group had a gastric abnormality at the time of device removal, and no ulcers were found. CONCLUSIONS AND RELEVANCE: Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common.

Indexed as

Gastric BalloonGastroscopyRisk Reduction BehaviorAbdominal PainAdultBody Mass IndexDevice RemovalDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleNauseaObesity, MorbidPostoperative ComplicationsProspective Studies

Identifiers

PMID28017964
OpenAlexW2566106089

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.