Journal of Obesity Study Recommends Pacemaker Type Device for Weight Loss
A new study reveals promising results that show losing weight with a pacemaker-like device may exceed expectations from earlier reports.
According to a new study published in the Journal of Obesity, researchers report that their latest data showed that when patients were implanted with either a Vagal block therapy (vBloc) device or a sham device as a control, that the vBloc patients lost significantly more weight and kept the weight off as opposed to the sham device patients who loss less weight and regained a significant portion of it afterward.
This vBloc device--more precisely known as the “vBloc neurometabolic therapy"--is delivered by a pacemaker-like device called the Maestro Rechargeable System developed by EnteroMedics, Inc. The vBloc therapy system consists of an electrical pulse generator and wire leads with electrodes that are implanted surgically around the abdominal vagus nerve. The concept of the device is that by sending intermittent electrical pulses to the abdominal vagus nerve―which is involved in sending messages to the brain indicating whether the stomach is empty or full―will help obese dieters feel full rather than hungry and thereby eat less and lose weight more easily than just by dieting using willpower alone.
This study is part of ongoing research by the makers of the device per instructions by the FDA following its approval for patient use that additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity-related conditions must be collected as part of the approval.
The new study dubbed “The ReCharge trial” was a double-blind, randomized controlled clinical trial consisting of 239 participants with body mass index (BMI) of 40 to 45 kg/m or 35 to 40 kg/m with one or more obesity-related conditions such as type 2 diabetes, hypertension, dyslipidemia, sleep apnea syndrome, or obesity-induced cardiomyopathy.
The participants were divided into two groups of which one group received the vBloc device and the other group a sham device that would not be expected to cause weight loss. The two groups were periodically followed during an 18-month long test period. Both groups were provided with educational interaction discussing healthy food choices, physical fitness, and social support. No specific diet or exercise program was prescribed.
At the end of the 18-month long study, what the researchers found was that the vBloc patients were more successful with their weight loss efforts than those observed in previous studies when the vBloc was viewed as being only marginally effective for weight loss by some health experts. The current study’s data showed that:
• At 18 months, 142 (88%) vBloc and 64 (83%) Sham patients remained enrolled in the study.
• For vBloc participants, weight loss was 23% percent excess weight loss (EWL) and 8.8% total weight loss (TWL).
• For the sham device participants, weight loss was 10% percent excess weight loss (EWL) and 3.8% total weight loss (TWL).
However, more significant was the fact that the vBloc participants largely maintained their weight loss whereas the sham participants regained much of their lost weight.
The data also showed that the most common side effects of vBloc were heartburn/dyspepsia and abdominal pain, of which 98% were reported as mild or moderate and 79% had eventually resolved.
The researchers concluded that the ReCharge study showed sustained weight loss with a low rate of serious complications from intermittent vagal nerve block with the vBloc device, but did not show sustained weight loss with Sham surgery and device intervention.
Reference: “Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial,” Journal of Obesity, vol. 2015, Article ID 365604, 8 pages, 2015. doi:10.1155/2015/365604; Scott A. Shikora, Bruce M. Wolfe, Caroline M. Apovian, et al.