This article is more than 5 years old. Information may no longer be current.
Vagal nerve block improved weight loss for patients with morbid obesity
Click Here to Manage Email Alerts
Patients with morbid obesity lost weight with a device that blocks the vagal nerve, according to research published in JAMA.
Although the device did not meet efficacy objectives compared with no treatment in the ReCharge Study, it was well tolerated and met safety objectives, according to the paper.
“Randomized placebo-controlled trials have been the standard in obesity trials involving medication and lifestyle intervention, but up to this time, obesity device trials have rarely included a sham comparator or a 10%-point superiority margin,” the researchers wrote. “Consequently, the trial used an unusually strong design to study this obesity-treatment device.”
Sayeed Ikramuddin, MD, of the University of Minnesota, and colleagues from other institutions conducted a randomized, double blind trial involving 239 participants at 10 sites in the United States and Australia from May to December 2011, with 12-month visits completed in January 2013.
Sayeed Ikramuddin
Patients with a BMI between 40 and 45 or 35 and 40 with at least one obesity-related condition were assigned to either an active vagal nerve block device (n=162) or a sham device (n=77); they also received weight-management education.
Vagal nerve block resulted in a mean 24.4% excess weight loss, or 9.2% of initial body weight loss, compared with a mean 15.9% excess weight loss, or 6% initial body weight loss, with the sham device.
Excess weight loss between groups showed a mean difference of 8.5 percentage points (95% CI, 3.1-13.9), falling short of the 10-point target (P=.71). In a post-hoc analysis, weight loss was statistically greater in the vagal nerve block group (P=.002 for treatment difference).
At the end of 12 months, 52% of patients achieved 20% or more excess weight loss with vagal nerve block and 38% achieved 25% or more. In the sham group, 32% achieved 20% or more excess weight loss and 23% achieved 25% or more.
Serious adverse events with vagal nerve block were significantly lower than the 15% goal rate, with event rates for device, procedure or therapy at 3.7% (95% CI, 1.4-7.9).
Heartburn and abdominal pain attributed to therapy, reported as mild or moderate in severity, were more frequent in the vagal nerve block group.
“Additional studies are needed to compare effectiveness of vagal nerve block with other obesity treatments and to assess long-term durability of weight loss and safety,” the researchers wrote.
Disclosure: Please see the study for a full list of the researchers’ financial disclosures.
Click Here to Manage Email Alerts