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Fecal transplant via a pill? Newsweek’s coverage points out possible selection bias of study participants

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4 Star

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Fecal transplant via a pill? Newsweek’s coverage points out possible selection bias of study participants

Our Review Summary

This Newsweek story reports on the results of a small study published in the Journal of the American Medical Association. The study compared two methods of delivering a fecal microbiota transplant (FMT), via a colonoscopy or with an oral pill, to treat Clostridium difficile infection. An FMT involves taking feces from a healthy person and transplanting it into a sick person, to see if that can help eradicate unwanted microbes.

Both approaches were equally successful and the oral pill — as might be expected — was perceived as less objectionable by patients. The story covers most of the bases we require, though it was unclear on the availability of the pill-based treatment, and what role standard antibiotics play in treatment and research outcomes.

 

Why This Matters

As the story points out, Clostridium difficile infections in hospital patients is a serious public health problem, infecting “half a million people in the United States per year and killing 15,000 people” annually.  Fecal microbiota transplant (FMT) is fast becoming the treatment of choice in these cases and any improvement to facilitate this approach would obviously be welcome.  The pill approach diminishes the “yuck factor” with this treatment, based on the study results.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story does a good job of pointing out one advantage of the pill approach compared to delivery via colonoscopy–the reduced cost. “There was a significant difference in cost. Though the procedures were done in a Canadian hospital, the FMTs delivered by colonoscopy cost nearly $500 USD more than the capsules, which cost about $300.”

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

Satisfactory

This was a close call. Early on, it says the pill was 90% effective for treating recurrent Clostridium difficile infections. Later on, the story explains that both were equally successful in treating the Clostridium difficile infections. It would take a bit of deduction to figure out that the 90% treatment rate applies to both the pills and colonoscopies. And the study puts this figure close to 96%.

But we’ll give the benefit of the doubt and rate it satisfactory.

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

Satisfactory

The story gets a satisfactory here for including the differences between the two methods of delivery: One source is quoted saying, “colonoscopies and the anesthesia required for the procedure can put a lot of stress on a person’s body and can be complicated for the people most at risk for C. difficile infections.”  It could have gone a step further and reminded readers that a colonoscopy is an invasive procedure with the inherent risks of infection and perforation that obviously aren’t there when taking a pill. The story did not mention the other adverse events described in the paper such as nausea and vomiting, though.

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

Satisfactory

The story comments on the size of the study and quotes a researcher about strengths (a randomized, controlled trial) and limitations (selection bias) of the study. Selection bias, in this case, means many people were excluded from the clinical trial if they had any number of issues (patients with severe or complicated cases were excluded, for example), potentially biasing the results. In a more real-world setting, the effectiveness rate may drop once it’s tried on a wider range of people.

Does the story commit disease-mongering?

Satisfactory

No disease mongering here.

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

Not Satisfactory

The story does include comments from an independent source unaffiliated with the research. But, it doesn’t specify that the source has received research money from a drug company that’s developing microbiome drugs.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Standard treatment for C. diff is antibiotics. This should have been mentioned.

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

Not Satisfactory

Unfortunately, the story doesn’t spell out whether the pill form FMT is now, or soon will be, available to the public. The story does mention that numerous other clinical trials are using FMT as a possible treatment for various diseases but it is unclear whether the pill form is an option for physicians at this point.

Does the story establish the true novelty of the approach?

Satisfactory

What’s new here is that a pill form for delivery of a fecal transplant is being tested against a colonoscopy. The story established this.

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

Satisfactory

It does not appear to rely on a news release.

 

Total Score: 7 of 10 Satisfactory

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