Weight-loss balloons which can be swallowed rather than surgically inserted in the stomach have been found safe and effective at combating obesity, according to a new study unveiled today.
Intragastric balloons (IGBs) have been used as weight loss devices for decades. Inflated with water, these devices make it easier to adhere to a low calorie diet by inducing feelings of fullness.
However, all IGBs have historically required endoscopy and anaesthesia resulting in a low adoption rate and high cost.
The new study, presented today at European Congress on Obesity (ECO) in Portugal, evaluated the efficacy and safety of a new swallowable IGB which does not need endoscopy or anaesthesia.
These IGBs are optimised to reduce risk and discomfort in combination with a very low calorie ketogenic diet (VLCKD) in the final month of therapy. A VLCKD diet comprises of low calories and less carbohydrates.
"The Elipse Balloon appears to be a safe and effective weight loss method. Furthermore, the introduction of a VLCKD improves weight loss," said Roberta Ienca from Sapienza University of Rome in Italy.
The study involved 50 obese individuals who had failed to lose weight by diet alone and refused other IGB treatment, because of the need of an endoscopy and/or anaesthesia, and were offered the Elipse Balloon.
The balloon was swallowed under fluoroscopy, an imaging technique that uses X-rays to obtain real-time moving images of the interior of an object, and then filled with 550 millilitres (mL) of liquid.
The balloon remains in the stomach for 16 weeks after which it spontaneously opens, empties, and is excreted. Follow-up was performed every two weeks.
In the last four weeks of treatment, a ketogenic diet (700 kilocalories/day) was introduced to enhance weight loss and maximise the results to increase patient satisfaction.
Once the balloon was excreted, patients were transitioned to a Mediterranean diet for weight maintenance.
A Mediterranean diet consists of high consumption of vegetables and olive oil and moderate intake of protein.
A total of 42 patients (29 men and 13 women) patients were enrolled.
Mean age was 46 years, mean initial weight was 110 kilogrammes (kg), and mean initial Body mass index (BMI) was 39 kilogrammes per millimetre square (kg/m2).
After 16 weeks, the mean weight loss was 15.2 kg, mean percentage excess weight loss was 31 per cent, and mean BMI reduction was 4.9 kg/m2.
At four, eight and 12 weeks a mean weight loss of 5.4 kg, 8.9 kg and 11.5 kg was observed, respectively.
In the VLCKD period (the final four weeks), a mean weight loss of 3.7 kg, was observed, similar to that seen between weeks 4 and 8.
There were no serious adverse events recorded. All other adverse events including nausea, vomiting, and abdominal pain were either self-limiting or resolved with medication.
Significant reductions were also observed in diabetes, high blood pressure, high cholesterol, and metabolic syndrome.
"Because the Elipse Balloon does not require endoscopy, surgery or anaesthesia, this may make it suitable for a larger population of obese patients not responding to diet/lifestyle treatment," Ienca added.