A capsule pill that releases a balloon in the gut has proved an effective means of losing weight in a randomised trial.
Gastric balloons are not new, but the novelty of the Obalon balloon is that it doesn’t require invasive surgery to put it in place.
Instead, the person swallows a capsule the size of a vitamin pill, attached to a micro-catheter. Once in place, the capsule is gas-inflated to the size of an apple and the catheter is then released.
People can progressively receive a second or third balloon as their body adjusts to the therapy.
At the end of treatment period the balloons are deflated and removed endoscopically, in an outpatient procedure that takes around 15 minutes, with no anaesthesia required.
The trial, presented last week at Digestive Diseases Week in San Diego, randomised 400 people with a BMI of 30 to 40 to either Obalon balloon treatment or to a sham treatment with an identical catheter procedure.
All patients also followed a lifestyle program given by a registered dietitian.
By the end of the 6-month trial, those who had had the treatment had lost nearly 7% of their body weight, around double that lost by people who had dummy treatment (placebo).
Around two-thirds of balloon patients lost weight over the study period, compared with only a third who had the dummy treatment.
The balloon patients also scored significant improvements in systolic blood pressure, fasting glucose, LDL cholesterol (‘bad’ cholesterol) and triglycerides, compared with placebo.
Lead researcher Dr Shelby Sullivan, director of bariatric endoscopy at Washington University School of Medicine, says he expects people to lose even more weight with the device out in the real world.
“This projection is based on the fact that we’ve seen other weight loss interventions help people lose more weight than what occurred in clinical trials for those treatments,” he says.
The device is already available in a number of European countries, but is yet to receive TGA approval.