PMID- 28707286
OWN - NLM
STAT- MEDLINE
DCOM- 20180201
LR  - 20181202
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Linking)
VI  - 34
IP  - 8
DP  - 2017 Aug
TI  - Intragastric Balloon Treatment for Obesity: Review of Recent Studies.
PG  - 1859-1875
LID - 10.1007/s12325-017-0562-3 [doi]
AB  - INTRODUCTION: The FDA recently approved three intragastric balloon (IGB) devices, 
      ReShape, ORBERA, and Obalon for treatment of obesity. Given the high cost, 
      complication risk, and invasiveness of bariatric surgery, IGB treatment may 
      present a safer and lower cost option for weight reduction. IGBs are generally 
      placed in the stomach endoscopically for up to 6 months to reduce gastric 
      capacity, enhance feelings of fullness, and induce weight loss. The mechanism of 
      action likely involves stimulation of gastric mechanoreceptors triggering 
      short-acting vagal signals to brain regions implicated in satiety. Balloon 
      efficacy may be influenced by balloon volume, patient gastric capacity, and 
      treatment duration. METHODS: This review focused on eight recent (2006-present) 
      randomized controlled trials (RCTs) comparing percentage total body weight loss 
      (%TBWL) between IGB and control groups including three reviewed by the FDA. %TBWL 
      based on the reviewed studies was also compared with bariatric surgery and 
      pharmacotherapy. RESULTS: Of the eight IGB studies, five had balloon treatment 
      duration of 6 months. Efficacy at 6 months, based on a pooled weighted-mean 
      %TBWL, was 9.7%, and the control-subtracted %TBWL was 5.6%. When one study 
      without SDs was removed, the weighted mean %TBWL was 9.3 +/- 5.7% SD, and 
      control-subtracted %TBWL was 5.5 +/- 7.8%, which was statistically greater than 
      controls. IGB showed lower efficacy than bariatric surgery (median weight loss of 
      27% for Rouen-Y gastric bypass (RYGB). The control-subtracted %TBWL over 6 months 
      of 5.5-5.6% is less than the most efficacious FDA-approved weight loss drug, 
      Qsymia. At the recommended dose, Qsymia has a placebo-subtracted %TBWL at 6 
      months of approximately 6.6%. The weighted mean reported incidence of serious 
      adverse events (SAEs) in the IGB group across all eight studies was 10.5%. Only 
      six of the eight reviewed studies reported adverse events (AEs) in the IGB group, 
      with a pooled reported incidence of 28.2%. Recently, the FDA reported new AEs 
      including acute pancreatitis with ReShape and ORBERA. CONCLUSION: Based on the 
      available evidence, it is unlikely that IGB use will supplant other forms of 
      obesity treatment. The estimated cost of endoscopic balloon implantation and 
      retrieval is US $8,150. Collectively, a relatively small control-subtracted %TBWL 
      and the potential for serious complications makes IGB unlikely to become widely 
      adopted. Given the recent FDA warning, IGB longevity on the market is 
      questionable.
FAU - Tate, Chinara M
AU  - Tate CM
AUID- ORCID: 0000-0002-7033-5821
AD  - Department of Psychiatry, Mt. Sinai St. Luke's, Icahn School of Medicine at Mt. 
      Sinai, New York, NY, USA. chinara.tate@mountsinai.org.
FAU - Geliebter, Allan
AU  - Geliebter A
AD  - Department of Psychiatry, Mt. Sinai St. Luke's, Icahn School of Medicine at Mt. 
      Sinai, New York, NY, USA.
AD  - Department of Psychology, Touro College and University System, New York, NY, USA.
LA  - eng
GR  - R01 DK080153/NH/NIH HHS/United States
PT  - Journal Article
PT  - Review
DEP - 20170713
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
MH  - Bariatric Surgery/*adverse effects
MH  - Gastric Balloon/*adverse effects
MH  - Gastric Bypass
MH  - Gastric Emptying
MH  - Humans
MH  - Obesity/therapy
MH  - Obesity, Morbid/*surgery
MH  - Weight Loss
OTO - NOTNLM
OT  - Bariatric surgery
OT  - Endoscopy
OT  - Gastric capacity
OT  - Gastric distension
OT  - Obesity
OT  - Obesity treatment
OT  - Qsymia
OT  - Weight loss
EDAT- 2017/07/15 06:00
MHDA- 2018/02/02 06:00
CRDT- 2017/07/15 06:00
PHST- 2016/10/12 00:00 [received]
PHST- 2017/07/15 06:00 [pubmed]
PHST- 2018/02/02 06:00 [medline]
PHST- 2017/07/15 06:00 [entrez]
AID - 10.1007/s12325-017-0562-3 [pii]
AID - 10.1007/s12325-017-0562-3 [doi]
PST - ppublish
SO  - Adv Ther. 2017 Aug;34(8):1859-1875. doi: 10.1007/s12325-017-0562-3. Epub 2017 Jul 
      13.