Mixed
Endoscopic gastric plication (pose procedure) produces statistically significant but clinically modest weight loss (mean 4.95% TBWL) compared to sham, failing to meet pre-specified superiority margins, while demonstrating a manageable safety profile with transient adverse events.
This procedure involves placing sutures inside the stomach to reduce its capacity. It is a single, minimally invasive procedure followed by basic lifestyle counseling. While the average weight loss is modest (around 5% of body weight), it is statistically better than a sham procedure and can significantly improve conditions like diabetes and high blood pressure. It is an option for those with Class I or II obesity who want more than lifestyle changes but are not candidates for or willing to undergo traditional surgery. Most side effects like pain and nausea resolve within a week.
The pose procedure was safe and resulted in statistically significant and clinically meaningful weight loss over sham through 1 year... mean TBWL 4.95 ± 7.04% in active... differences observed between the active and sham groups for co-primary end points were statistically significant (P < 0.0001); however, super superiority margin as set forth in the study design was not met.
Why this rating
Randomized, sham-controlled, blinded trial with large sample size (n=332), though funded by device manufacturer.
Source
Randomized sham‐controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial
Shelby Sullivan et al. · Obesity · 2016
DOI 10.1002/oby.21702
Related findings · Mixed
- Bariatric surgery (VSG and RYGB) is the most effective and sustainable treatment for obesity, producing marked and sustained weight loss that non-surgical interventions cannot match.Strong
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- For patients with Class III obesity (BMI >39.9 kg/m2), metabolic bariatric surgery (MBS) is significantly more effective than any currently approved medication, with BilioPancreatic Diversion (BPD) showing the highest estimated weight loss.Strong
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