This release describes a new type of gastric balloon being developed that is inserted via a pill rather than through endoscopy. The interim study on the device was presented at an obesity medical conference and has not been peer-reviewed. The approach appears to be novel; a capsule containing a collapsed balloon is swallowed, then filled with water via a small attached catheter that remains outside the patient’s mouth. After four months, a valve on the balloon opens and the balloon deflates and is excreted by the body. The small patient group (34 volunteers) in the study lost an average of 22 pounds after four months. The device’s main advantage is that it is non-invasive (except for a small catheter which some could find uncomfortable) but the release is based on data that has not been peer-reviewed or published. The release played down the limited evidence base and possible harms and neglected costs.
Obesity appears to be a problem that isn’t going anywhere anytime soon. The Centers for Disease Control and Prevention says America, at least, appears stuck in unhealthy lifestyle paterns. One-in-three Americans is obese. Obesity is a leading contributor to dozens of other health conditions. As a result, millions of people turn to gastric bypass, and the less intrusive (and less effective) gastric balloon and other medical procedures to try to lose weight when other methods fail. It seems the more effective the procedure is in taking off the weight, the more complications arise. The Eprise gastric balloon pill described in the release claims to be as effective but less intrusive as current methods. If it proves effective, it could be a welcome addition to the weight-loss arsenal.
The release doesn’t suggest what the procedure might cost. It could be more than the gastric balloons already on the market due to the use of new technology or it could be less since it is less invasive than surgery. It would be useful to provide readers with some idea of how the procedure will be priced in comparison to similar procedures. A web search found prices for gastric balloon procedures ranging from $6,000 to $10,000 across the United States.
Whereas the Eprise gastric balloon pill would be available to those with a BMI of 27 and above, according to the release, it is not a permanent weight-loss solution. Not exactly a bargain then?
The release presents the benefits in extremely vague terms. We’re told 34 patients took part in a multi-center study and that they lost an average of 22 pounds or 37 percent of their excess weight. We aren’t told whether all patients lost weight, what the average starting weight was, what the age range was, and other useful demographic information.
We’re also told that patients “saw improvements in triglycerides and hemoglobin A1c (HgbA1c) levels, risk factors for heart disease and diabetes.” What sorts of improvements might these be?
Unfortunately, there is no published paper or accessible conference abstract to read to find more details and so the meaning remains unclear.
The release gives only a very brief mention of harms, citing nausea and vomiting as the most common adverse events reported. However, with a catheter patients might experience irritation in their esophagus or stomach (which could lead to bleeding or ulcers) or infection from bacteria surrounding the balloon. A concern for this type of balloon, which is intended to deflate, would be improper deflating and obstruction of the intestine — a potentially serious complication.
The release doesn’t link to a published abstract or study results so it’s not possible to compare the study methodology with what’s presented in the release. It’s pretty clear that this interim report from this study provides limited evidence of the device’s effectiveness, but there are few words of caution in the release. Generally speaking, results presented at scientific conferences should be interpreted very carefully because they haven’t undergone peer review. And news releases that present such results should alert readers to this fact.
The release doesn’t engage in disease mongering.
The release states that the manufacturer is “studying what it says is the first procedureless gastric balloon.'” It isn’t exactly clear what role the the manufacturer had in the study but the release does disclose that one of the quoted study co-authors “holds an equity position in Allurion Technologies,” the manufacturers of the device. This means he has an ownership interest in the company and will profit if the device is approved and adopted.
The release makes several mentions of alternative therapies including traditional gastric balloon surgery, other newly approved gastric balloon devices, bariatric surgery, weight-loss drugs and diet and exercise.
The release also suggests the gastric balloon pill would be an option filling a treatment gap between weight-loss drugs and surgery.
While the release doesn’t offer data on how the gastric balloon pill compared with all these alternative methods, we’ll give it a pass for the frequent mentions of alternatives.
The release makes it clear that the device is not yet commercially available.
The device manufacturer claims to be the first to deliver a gastric balloon via capsule.
At just 34 patients, and with the results unpublished, the study is just too small to be making claims like this: “Our findings demonstrate that Elipse provides individuals and their caregivers with a safe, effective, and non-invasive weight loss intervention that does not require surgery,endoscopy, or anesthesia.”