The Obalon Balloons aren't designed as standalone weight loss aids

Would YOU Swallow ‘Balloon Pills’?

posted by Paul Fiddian | 09.11.2016

Newly-Approved Weight Loss Treatment Clears Trial

FDA-approved intragastric balloon system proves its mettle under trial conditions. US patients who qualify should start being able to use it within coming weeks.

Swallowed pills that are inflated in the stomach are two times better weight loss aids than other more traditional methods, according to newly-published trial results.

Recently approved by US health regulators, the Obalon Balloon System has been shown as doubly effective for obese patients than calorie-controlled diets and exercise can manage to be alone.

Details of the Obalon Balloon System’s performance were presented by its developers (Obalon Therapeutics) during ObesityWeek 2016 – an annual event co-staged by TOS (The Obesity Society) and the ASMBS (American Society for Metabolic and Bariatric Surgery).

Based in San Diego, Obalon Therapeutics specialises in novel weight loss products. FDA-approved two months ago (September 2016), the firm’s newest one is an intragastric balloon system for short-term use by obese adult patients, with a minimum BMI (Body Mass Index) of 30, who haven’t managed to lose weight via diet and exercise.

Obalon Balloon System

The Obalon Balloon System is designed to give patients a ‘full-up’ sensation, to the extent that they don’t eat as much. Treatment courses last 12 months and involve up to three balloons. They’re not intended to be a standalone weight loss aid but, rather, enhance ‘moderate intensity diets’.

These courses start with a single swallowed capsule. Once this capsule has reached the stomach – X-rays being taken to ensure it’s where it should be – it open ups and its balloon contents are released. Next, the balloon fills with gas supplied through a catheter. Once fully expanded, the balloon becomes around tangerine-sized and weighs six grams.

Up to two more balloons can subsequently join this balloon in any one adult’s stomach (so long as they meet the FDA’s treatment/use criteria) but they all must be removed within six months of the first insertion. That’s a state achieved via endoscopic surgery.

“For people who want to lose some weight but don't feel they are heavy enough for surgery or they're afraid of surgery, this is a really good next step to help them jump start their weight loss”, Obalon Balloon System trial study co-author and Bariatric and Metabolic Weight Loss Center Director, Aurora Pryor, tells ‘Healthday’.

“The Obalon Balloon System, coupled with lifestyle modification, provides a new low risk option for patients struggling with obesity”, she continues. “The significant weight loss achieved with the Obalon Balloon System is typically maintained at 12 months, providing patients with an opportunity to maintain a healthier lifestyle.”

Balloon Pill Weight Loss

The balloon pill weight loss trial itself was conducted at 15 sites and involved 387 patients, all of them being US residents. They were given either three Obalon balloons or three sugar-filled placebo pills, without knowing which one they were getting. Monitoring then took place for six months alongside regular diet counselling sessions.

Ultimately, circa 65 per cent of the Obalon balloon patients lost five or more per cent of their body weight: twice the placebo group’s five/five-plus per cent weight loss percentage. Average weight losses were seven per cent (equating to 15 pounds) and sub-four per cent, respectively.

12 months on, nearly 90 per cent of those who’d lost weight thanks to the Obalon balloons hadn’t put any back on. "If they are able to stick to their newfound lifestyle with their diet and exercise program, they could maintain their weight loss”, Prior comments. "The long-term results are dependent on patients keeping their motivation to stay with their diet and exercise programs.”

The side effects most often experienced were mild-to-moderate stomach cramps and nausea feelings. In just one case, a stomach ulcer occurred.

The Obalon Balloon System will be available to US patients from January 2017 onwards. The cost of it is not yet known.

 

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