The story provides good information about the potential benefits of the procedure. We wish it had done the same in regard to costs and the potential harms. The story could have benefited from a good independent source who was not tied to the study or to the procedure itself. Such an independent source could have provided a critical analysis of the potential limitations in a review of a series of case studies – which is what this study was.
Another significant gap in the story was the issue of quality control. How do we make sure the donor is the right donor? Is a family member always the right choice? It seems this type of treatment will require more compelling evidence to make this “gross” sounding option one that is widely supported and available.
C. difficile is a serious infection that is increasing as a result of the widespread use of potent antibiotics. Some individuals who develop C. diff. may never have needed the antibiotic that caused the problem in the first place. Once one has C. diff., the standard treatment is another antibiotic that specifically targets the C. diff. Eradicating C. diff in some cases is tough to do, especially individuals who are chronically ill and debilitated, such as individuals in nursing facilities. Recurrence can occur after the antibiotic is stopped. This study addresses such individuals who have had recurrences or are otherwise failing standard therapy. Fecal transplants have been marketed for a wide variety of disorders, which is one of the reasons the story refers to them as “fringe”. In a very good Slate piece earlier this year, the reporter notes that “true believers have even bigger plans. They hope fecal transplants might be used to treat other gut-related conditions, such as ulcerative colitis and even obesity. Some very overweight people, for example, are thought to have more of a certain type of bacteria in their intestines, which causes them to extract extra calories from complex carbohydrates. With this in mind, researchers found that fat mice would lose weight if transplanted with feces from thin ones.” That’s what makes it so important to talk about the science in measured tones and to show people where the evidence truly sits. While a bunch of case reports is intriguing, only studies that compare this novel treatment to established ones and that carefully follow-up patients can answer whether this treatment should be more widely available.
The story did not discuss costs. Given that the story at one point describes them as “regarded as something of a fringe treatment,” we wonder whether they are often covered by insurance. So both cost and insurability were issues that should have been addressed in our view.
The story does quantify the benefits in one sense. It says, “A new review of more than two dozen scientific reports involving 317 patients, some dating back 50 years, finds that fecal bacteriotherapy, commonly known as fecal transplant, cured the problem in 92 percent of the cases.” There should have been a mention of how shaky this result is. As previously cited, this is a compliation of case series. So one should have questions about how meaningful this number is. We know from many studies that when rigorously studied, the results of case series are almost alway less impressive than initially reported. One can only “quantify” the potential benefits by studying this treatment in a scientific manner. That hasn’t been done here.
We didn’t think it was right to ding the story in both the “evidence” and “benefits” criteria for the same problem, so, given that we ruled “evidence” unsatisfactory, we’ll give the story the benefit of the doubt here.
No harms were mentioned in the story. This seems like a significant oversight. One of the reasons the transplants work is because fecal matter carries so much bacteria, but this is also what can make them dangerous because diseases can be transmitted. How do you know which donor to use? Do you need to test their stool to make sure it’s ok? There are a lot of quality control problems that may affect the safety of this procedure. What if you ask someone who doesn’t want to let on that they have gastrointestinal problems? Would they feel pressured to donate? This is an issue that occurs on organ donation programs.
The story calls the study “the most comprehensive evidence so far” but we would have expected at least a little more critical analysis of the potential holes in such a review.
We would have liked to have seen more discussion of the study’s limitations, particularly the fact that this is a retrospective review, not a clinical trial comparing fecal transplants to other procedures or to a placebo. This level of evidence represents a lower rung on the evidence ladder. In case series, there is no control group and one always worries about bias in reporting. It’s interesting to report patients responding to a new treatment but not always so interesting to to report when it doesn’t work. We could have gone either way with this score, but we’ll give the story the benefit of the doubt.
Not only does the story avoid disease-mongering, it does a very nice job describing exactly who would be the target for these treatments. The story says, “Rates of C. diff acquired in health care settings have skyrocketed in recent years, climbing more than 200 percent in people older than 65 between 1996 and 2009, according to the Centers for Disease Control and Prevention. Between 20 percent and 50 percent of those patients may wind up with hard-to-treat recurrent infections, Rubin said.” The story could have done a better job saying that antibiotics are used for C. diff with generally good results. This treatment refers to those individuals who have already been on antibiotics and are having recurrences or other problems.
The story fell down a little here. It starts and ends with anecdotes from a woman who is described as essentially an evangelist for fecal transplants. Then it quotes the lead author of the review. And it quotes “Dr. Tim Rubin, a gastroenterologist with Essentia Health in Duluth, Minn., whose team performed its 119th fecal transplant last week.” No one is brought in to independently evaluate the evidence or to give an assessment of the safety or efficacy of these treatments.
The story does not provide an in-depth comparison, but it does at least mention the other options. It says that the transplants have “a better record than other treatments, including probiotics, toxin-binding molecules and an experimental vaccine.”
The story does not make it clear that this is not a widely available therapy. It cites one Duluth gastroenterologist who has done over 100 of the procedures. But we don’t all live in Duluth. Our medical editor reviewing this piece – a physician in Boston – didn’t know about availability of the approach in that medical Mecca.
There is a confusing sentence in this piece: “For most of the last decade, fecal transplants have been regarded as something of a fringe treatment by outsiders, but as a viable treatment by doctors who see desperate C. diff patients every day.” We are not experts in fecal transplantation, but our understanding is that it has been around for much longer than a decade, as evidenced by the fact that some of the studies included in this review are 50 years old. We thought that the lead researcher put it best in saying, “It’s considered a treatment of last resort.”
The story does not rely on a news release.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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