Combining a swallowable gastric balloon with a weight loss drug may be a way to lose significant body weight, a new study suggests.
In about eight months of combination treatment, participants lost an average of 19% of their body weight, and significantly reduced their body mass index (BMI), researchers report.
"Combination therapy gives providers much flexibility and further options in managing obesity in patients who need additional weight loss or increased durability," said lead researcher Dr. Roberta Ienca, from the Nuova Villa Claudia Clinic in Rome, Italy.
"The ease of use and low rate of adverse events make it an ideal primary weight loss therapy that can be complemented by medications or other treatments," she added.
Gastric balloons for weight loss are not new, but they haven't been popular because they require an endoscopy for placement, the study authors said. This new swallowable balloon from Allurion Technologies eliminates the need for a medical procedure. (Ienca and her two co-authors are advisors for Allurion.)
In the noninvasive procedure, the balloon is swallowed as a capsule and is filled with liquid after it reaches the stomach. The outpatient procedure takes about 20 minutes. After about 16 weeks, the balloon is excreted naturally.
The balloon reduces the amount of food that can be ingested, which leads to weight loss. Taking the diabetes drug liraglutide (Saxenda) enhances feelings of fullness and suppresses appetite, adding to the weight loss, the researchers noted. Liraglutide is a glucagon like peptide-1 receptor agonist (GLP-1 RA).
Not all weight-loss experts believe gastric balloons are a solution to obesity, however, largely because they're temporary.
"I do not recommend a balloon to my patients unless they have a short-term need for something, say it's not safe to get a transplant or it's not safe to get a knee or hip replacement," said Dr. Jamie Kane, director of Northwell Health Center for Weight Management, in Great Neck, N.Y.
According to Kane, better options for the long term include bariatric surgery, newer drugs such as Ozempic and Wegovy (semaglutide), and, of course, lifestyle changes including a healthy diet, portion control and exercise.
"You should always be thinking long term — that's the main advice," added Kane, who played no role in the research.
Dr. Mitchell Roslin, director of bariatric surgery at Northern Westchester Hospital in Mount Kisco, N.Y., isn't a fan of the gastric balloon, either.
"By putting a balloon in people they lose a lot of weight early, but ultimately the thermostat or the energy regulation center in the brain isn't going to be reset," said Roslin, who wasn't involved in the study.
The prolonged weight loss is mostly due to the medication. "If you didn't have the medication, they'd regain all of their weight after the balloon is removed," Roslin said.
"The effective tools that we have are bariatric surgical procedures and the GLP analogs," he said. "What they both share in common is they change the energy regulation center in the brain."
"Temporary devices are just that, they're temporary," Roslin added. Weight loss is a "lifetime commitment no matter what you do."
The study included 181 obese men and women whose average weight was 209 pounds. All got the balloon and were also given liraglutide, which controls the release of insulin in the pancreas and causes weight loss. The drug was started one to four months after balloon placement.
After 16 weeks, participants lost an average of 29 pounds and 14% of their initial body weight. They also shed an average of 74% excess weight.
After the balloon passed from the body, patients were put on a Mediterranean diet and followed for at least six months.
Neither treatment was linked to serious side effects. Side effects from the balloon include nausea, vomiting and abdominal cramps. Four patients had the balloon removed due to intolerance, gastric dilation or early balloon deflation, the researchers noted.
Side effects from liraglutide included nausea, diarrhea, constipation and headache. Four participants discontinued the drug because of a fast heartbeat, chest pain or gastrointestinal symptoms.
The findings were scheduled for presentation Wednesday at the annual meeting of the European Congress on Obesity, in Dublin, Ireland. Research presented at medical meetings should be considered preliminary until published in a peer-reviewed journal.