Hormonal
Reversible intermittent intra-abdominal vagal nerve blockade produces statistically greater weight loss than a sham device in patients with morbid obesity, though it failed to meet pre-specified superiority margins for excess weight loss.
This therapy involves implanting a device that blocks stomach signals to reduce hunger. In this study, patients using the device lost significantly more weight than those with a sham device, though not enough to meet the study's strict success criteria. The device requires daily recharging and periodic programming adjustments. It is an option for those with severe obesity who want a less invasive alternative to surgery but are willing to manage a medical device.
In the intent-to-treat analysis, the vagal nerve block group had a mean 24.4% excess weight loss (9.2% of their initial body weight loss) vs 15.9% excess weight loss (6.0% initial body weight loss) in the sham group. The mean difference in the percentage of the excess weight loss between groups was 8.5 percentage points (95% CI, 3.1-13.9), which did not meet the 10-point target (P = .71), although weight loss was statistically greater in the vagal nerve block group (P = .002 for treatment difference in a post hoc analysis).
Why this rating
Randomized, double-blind, sham-controlled clinical trial (high quality design), but failed primary endpoints.
Source
Effect of Reversible Intermittent Intra-abdominal Vagal Nerve Blockade on Morbid Obesity
Sayeed Ikramuddin et al. · JAMA · 2014
DOI 10.1001/jama.2014.10540
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