Balloon capsules, swallowed then inflated, produce weight loss in nearly 65%

SAN DIEGO — Nearly 65% of participants who swallowed three capsules then filled with gas lost 5% or more of their total body weight, according to a presentation at Digestive Disease Week 2016.

“Individuals in the Obalon balloon treatment group also saw improvement in systolic blood pressure, fasting glucose, LDL cholesterol and triglycerides — outcomes that were not observed in the control group,” Shelby Sullivan, MD, director of bariatric endoscopy at Washington University School of Medicine in St. Louis, Mo., said during a press conference.

Sullivan presented data on 366 people included in the per protocol analysis. These people were randomized to either the treatment group (n = 185) or the control group (n = 181). In the treatment group, patients received a balloon capsule at 3, 6 and 9 or 12 weeks. Immediately after each capsule was swallowed, the physician used a catheter to fill it to 250 cm³, which Sullivan said is approximately one U.S. cup.

In the control group, this process was mimicked with the same capsule schedule and a faux inflation procedure, she said.

All patients also underwent 18 weeks of lifestyle therapy with a registered dietician, meeting that dietician every 3 weeks for 25 minutes. The dietician was blinded to the treatment protocols.

At 24 weeks, researchers removed the balloons via endoscopy and measured weight and other health parameters, Sullivan explained.

“We found that within the Obalon balloon treatment group, the average loss of total body weight was 6.81% while the control group’s average total body weight loss was 3.59%. Significantly, 64.3% of individuals who received the Obalon balloon achieved at least a 5% total body weight loss compared to only 32% in the control group,” Sullivan said.

As the FDA requires at least 35% of patients achieve at least 5% weight loss, Sullivan touted this study as “pivotal.”

While many patients reported discomfort with the inflated balloons, the side effects were classified as mild or moderate and treated with over-the-counter or homeopathic remedies, she added.

“While patients in our study who used the balloon system had nearly a 7% total body weight loss, I believe that once the system is used in the real world, patients may experience more weight loss than that. This projection is based on the fact that we’ve seen other weight loss interventions help people lose more weight than they lost during sham-controlled clinical trials,” Sullivan said.

Researchers are following both the treatment group after removal and the control patients who chose to cross over to treatment, she said. – Katrina Altersitz

Reference:

Sullivan S. Abstract #812d. Presented at Digestive Disease Week; May 21-24, 2016. San Diego.

Disclosures: Sullivan reports financial relationships with Aspire Bariatrics, Baranova, GI Dynamics, Obalon, Takeda and USGI Medical.