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Gastric balloon for weight loss: HealthDay avoids hot air by balancing PR spin with skepticism from independent sources

Rating

4 Star

Categories

Balloon-in-a-pill helped obese patients lose weight

Our Review Summary

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Credit: FDA safety materials on Obalon

This story about a balloon swallowed by people with obesity to help them diet and lose weight is more informative than the associated conference news release we also reviewed.

The overall tone of the story balances the positive spin from a researcher with skeptical comments from independent sources. It alerts readers that this sort of medical conference presentation does not go through the peer review process that major journals use.

However, the story should have noted that the research was sponsored by the company that makes the device. It could have done a better job pointing out that the main difference between this device and other intragastric balloons already on the market is that this one doesn’t require patients to be sedated during placement. The story also didn’t point out that this type of device could cause life-threatening complications, and that the fact none were reported in this trial could be because fewer than 200 participants received the balloons.

 

Why This Matters

Patients want help comparing treatment options. Rather than highlighting results of a trial that merely compared this new weight loss balloon to a placebo, this story could have made more clear that there is no evidence yet that this device is any better or worse than similar products already on the market. It also could have helped readers by explaining that these results need to be weighed against intensive behavioral weight loss programs (like the LookAHEAD trial, where one-year outcomes were better than balloon).

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

While the story notes that the U.S. price of the Obalon intragastric balloon has yet to be announced, the story could have reported that the device and related care typically cost $2,500 to $4,000 in Europe, where it has been available for almost three years. Costs are also likely markedly higher than working with a behavioral team.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The story quantified benefits by stating:

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.

and:

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.

In addition to reporting the weight loss results announced by researchers and that, unlike other balloons, this device doesn’t require patients to be sedated during placement, the story adds important context by including comments from independent sources who are skeptical that many patients will maintain their lower weight long after the device is removed.

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

The story mentions these harms:

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 story would have been stronger if it had warned readers that a study that puts a device in only a couple of hundred people may miss problems that could appear after the device is placed in hundreds of thousands or even millions of patients. The documentation that the manufacturer will give patients lists several serious, even life-threatening, potential side effects, including intestinal and airway blockages. These potential risks should have been noted.

Does the story seem to grasp the quality of the evidence?

Satisfactory

The story reports the key features of the trial. It also notes that, “Research presented at meetings is considered preliminary until published in a peer-reviewed journal.”

The story would have been stronger if it clearly reported that the trial does not provide any evidence about whether the Obalon device is any better or worse than other options, because it did not compare it to similar balloons or to other weight loss interventions, other than the lifestyle counseling offered to all study participants.

Does the story commit disease-mongering?

Satisfactory

The researcher quoted in the story notes that this device could be an option for people who are leery of surgery. Independent sources quoted in the story predict a small role for such devices.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

One of the strongest aspects of this story is the ample use of independent sources to provide context and point out limitations of the device. However, this criterion demands that sponsors of research be identified, and this story does not tell readers that the trial was sponsored by Obalon Therapeutics.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story includes discussion of weight loss surgery and lifestyle interventions. It includes a quote noting that the Obalon device does not require patients to be sedated during insertion, which implies there are other similar balloon devices, though the story would have been better if it specifically noted that there are already two very similar devices available in the U.S. as well as other balloon devices that are for sale in other countries. It also could have pointed out that these results don’t appear more effective than an intensive behavioral program.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story reports that the Obalon balloon was approved by the FDA in September and will be available in January 2017.

Does the story establish the true novelty of the approach?

Satisfactory

As noted above, the story reports that the Obalon device does not require patients to be sedated during insertion, which appears to be the main difference between this device and other similar balloons. It would have been better if it had more clearly informed readers that there are other intragastric balloon devices already on the market.

The story notes that these study results also were presented back in May.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story includes several quotes from independent sources, as well as important details that were not included in a news release from the organizers of the the medical meeting where these results were presented. (We also reviewed the news release.)

Total Score: 8 of 10 Satisfactory

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