Balloon ‘Pill’ Helped Obese Patients Lose Weight
Obese patients who swallowed balloon capsules that helped them eat less lost an average of 15 pounds, roughly two times more weight than patients who just dieted and exercised, researchers report. The capsule was inflated with gas via a catheter when it reached the stomach. As many as three balloons were placed over three months, and all of the balloons were removed after six months. The balloons made patients feel full, the researchers explained.
In addition to the balloons, patients followed a moderate diet and behavior modification program. Whether the weight loss will last over the long term isn’t known, said lead researcher Dr. Aurora Pryor, director of the Bariatric and Metabolic Weight Loss Center at Stony Brook University in New York.
The study lasted a year, but “we don’t know what happens after that,” Pryor said.
“If they are able to stick to their newfound lifestyle with their diet and exercise program, they could maintain their weight loss,” she said. “The long-term results are dependent on patients keeping their motivation to stay with their diet and exercise programs.”
The balloon treatment will be available starting in January, but the cost hasn’t been announced, Pryor said. The device, called the Obalon Balloon System, was approved in September by the U.S. Food and Drug Administration. The Obalon Balloon System is specifically designed for people who need help jump-starting their weight loss program
An advantage of the balloons is that patients have no downtime and can go back to work the same day, the researchers said.
“There is no sedation or recovery time when the balloons are placed, but there is sedation when the balloons are removed, so you wouldn’t want to go back to work after that,” Pryor added.
Pryor believes balloons are a better option for patients who are candidates for weight loss surgery but don’t want 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,” she suggested.
The findings were to be presented at the annual meeting of the American Society for Metabolic and Bariatric Surgery and the Obesity Society in New Orleans. Research presented at meeting is considered preliminary until published in a peer-reviewed journal.
One weight-loss expert expressed some doubts about the findings.
“I still question the efficacy of balloons,” said Dr. Mitchell Roslin, chief of obesity surgery at Lenox Hill Hospital in New York City. “While there is potentially easier insertion that does not require sedation, I still doubt after removal there will be weight loss,” he said.
Roslin said patients who have other treatments that restrict their ability to eat — such as bands and bypass operations that reduce the size of the stomach — often regain lost weight over time. “As time goes on, weight loss will be about lifestyle changes,” he said.
For the study, Pryor and her colleagues randomly assigned nearly 400 obese patients to receive a real or sham device. All patients also had 25 minutes of lifestyle therapy every three weeks. After six months, patients with the Obalon balloons had them removed.
During the time patients had the balloons, and for six months after, the researchers monitored their weight loss. The investigators also followed those who had not received the balloon therapy.
People treated with the balloons lost an average of 7 percent of their weight, compared to less than 4 percent for those who received the sham device, the researchers found. Six months after the balloons were removed, nearly 90 percent maintained the weight loss they achieved during treatment, Pryor said.
As for side effects, one patient had a bleeding stomach ulcer while taking high doses of pain pills after a knee replacement. Most patients (91 percent) suffered from stomach cramps and nausea, which nearly 100 percent said were mild or moderate.
The results were also presented at a medical meeting in May.
One health and nutrition expert noted that a balloon does not equal a lifestyle change.
The role for such technology-based approaches to weight control should be a small one, he said.
“Such devices may be alternatives to bariatric surgery in some cases. But they should not distract us from the far better solution at the population level: practices, programs and policies that make eating well and being active a cultural norm,” Katz said.
What is Obalon Balloon System?
The Obalon Balloon System is a weight-loss system that uses gastric balloons to occupy space in the stomach. The balloons are delivered to the stomach inside of a swallowable capsule that is attached to a thin (1 mm) inflation catheter. Once in place, the capsule opens and the balloon is filled with air via the inflation catheter. Each inflated balloon occupies approximately 1 cup of volume (250 mL). Up to three (3) balloons can be placed over a 6-month treatment period. At the end of treatment, the balloons are deflated and removed with an endoscopic procedure.
How does it work?
The Obalon Balloon System occupies space in the stomach to help patients lose weight. The system is temporary and should be removed after 6 months.
When is it used?
The device is used to treat adults with obesity who have a Body Mass Index (BMI) of 30-40 kg/m2 and who have been unable to lose weight through diet and exercise. The Obalon Balloon System is intended to be used while a patient participates in a moderate intensity diet and exercise program.
What will it accomplish?
During the clinical study, the group of patients who used this device lost more weight than those who did not use it. The study included a total of 419 subjects, of whom 387 were able to successfully swallow the device. A total of 198 subjects received the Obalon device and 189 received a sham device (a capsule without a balloon). All study participants received diet and exercise counseling.
Patients with the Obalon Balloon System lost an average of 14.4 pounds (6.6% of their total body weight). The patients who received the sham device lost an average of 7.4 pounds (3.42% of their total body weight).
When should it not be used?
The Obalon Balloon System should not be used in patients who:
- have anatomical abnormalities or functional disorders that may affect swallowing.
- have had prior surgeries that may have led to a narrowing of the gastrointestinal tract.
- have had any bariatric surgery procedure.
- have inflammatory and other pathophysiological conditions of the GI tract.
- take medications known to be gastric irritants or those that alter function or integrity of any portion of the GI tract, including NSAIDs and aspirin.
- have an untreated Helicobacter pylori infection.
- are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
- have allergies to products/foods of porcine origin.
- have bulimia, binge eating, compulsive overeating, high liquid calorie intake habits or similar eating related psychological disorders.
- have a history of structural or functional disorders of the stomach including, gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2 cm), cancer or any other disorder of the stomach.
- require the use of anti-platelet drugs or other agents affecting the normal clotting of blood.
- are pregnant or lactating, or women with an intention to become pregnant.
- have a history of any obstructive disorder of the gastrointestinal tract.
- have a history of irritable bowel syndrome, radiation enteritis, or other inflammatory bowel disease, such as Crohn’s disease.
- are taking medications on specified hourly intervals that may be affected by changes in gastric emptying, such as anti-seizure or anti-arrhythmic medications.
- have untreated or unstable alcohol or illicit drug addiction.
The original article was published at WebMD and written by Steven Reinberg (HealthDay Reporter).