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Hospital says its ‘good bacteria’ cream treats eczema. Where’s the data?

Rating

2 Star

Clinical Trial Offers Natural Eczema Treatment, Using Good Bacteria to Fight the Bad

Our Review Summary

The news release highlights a new clinical trial using a twice daily lotion containing what we’re told is “good bacteria” used to fight “bad bacteria” in order to restore the “natural microbial balance” of patients with eczema, or atopic dermatitis.

The premise of this research is that introducing “good bacteria” might decrease the population of Staphlococcus aureus —  a bacterium that’s part of the normal flora of our skin and respiratory tract, and speculated to play a role in making eczema worse.

But as with many treatments based on the microbiome, the benefits are touted with language that — although it sounds reasonable and appealing — is not backed by existing research. In fact, here there is no research. The sponsors are still recruiting volunteers for the trial. That should have been made more clear.

The news release does explain why a less toxic alternative might have advantages over existing therapies such as antibiotics and corticosteroids.

 

Why This Matters

Eczema is a very common skin disorder that is notoriously difficult to treat. Finding an effective and non-toxic treatment alternative would be a boon to both patients and those who might develop such a treatment.

But it’s important to note that the cause of eczema is unknown; it’s thought to be triggered by a combination of genetic and environmental factors. That’s why treatment is focused on minimizing  possible triggers and symptoms. It’s also a disease that can repeatedly flare up and significantly compromise people’s quality of life.

A non-toxic therapy — as this approach promises to be — could have a major impact on the lives of these people, some of whom are quite incapacitated by this disease. Promising them a long-term solution based on very preliminary, unpublished results is unwarranted. It is very unlikely that one approach, such as altering the microbiome, will yield results for a majority of eczema sufferers.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Applicable

This lotion is still in clinical trials. Pricing is most likely unavailable.

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

Not Satisfactory

We’re told the lotion contains “beneficial bacteria to fight harmful bacteria,” and the lead investigator is quoted as saying that this will “help the skin gain back it’s natural balance and create that barrier needed to keep it healthy.”

But we’re given no data from the trials to support this. We’re also not given any context regarding what good bacteria, natural balance, or “that barrier” are.

The only example of a “bad” bacteria mentioned is Staphylococcus aureus. The news release informs us that Staph. aureus makes eczema worse. Previous studies have shown that high levels of Staph. aureus do correlate with increasing severity of eczema.

The lead investigator suggests that applying the lotion twice a day will “eliminate all staph aureus.” But there’s no evidence included to show that this lotion actually improves the eczema.

It should have been acknowledged that staph aureas colonization might be associated with eczema severity and not a cause of it. For example, if people with more severe eczema scratch more, they are more likely to colonize themselves with bacteria they pick up in the environment around them.  This does not indicate that reducing the staph will result in improvement of the underlying disorder.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

No potential harms from using the lotion are mentioned.

Could there be allergic reactions? If the lotion does, indeed, reduce the amount of Staph. aureus on the skin, are there consequences to that? Or consequences to changing the skin’s microbial balance in general?

Also, many eczema patients are acutely aware that their skin is not just fragile, but also may have open sores; should a bacterial lotion be applied to broken skin? And does this put them at risk of a bacterial infection that can spread?

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

It’s mentioned that “there is more research to be done” but it’s unclear whether any people have thus far been tested. The release also alludes to a future safety trial and a larger study “to see if the benefits of bacterial cream can truly provide a permanent solution for eczema patients.” This is a far cry from the claims that this cream “restores the natural balance of healthy skin,” and has the potential to be “a long-term solution.”

There’s no indication that any preliminary results have been peer-reviewed, published, or presented at medical conferences. We’re only given the anecdote of one woman, but nothing about her response to the treatment.

The news release is clearly jumping to describing a new treatment that sounds beneficial without any evidence at all.

Does the news release commit disease-mongering?

Satisfactory

No disease mongering. Atopic dermatitis is very common and difficult to treat.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

Funding sources for this clinical trial are not mentioned. Potential conflicts of interest are also not addressed and this could be relevant since a quick check of the lead author on Dollars for Docs reveals multiple sources of industry funding in the past.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The article does well in mentioning two alternative treatments for eczema that can often prove problematic: antibiotics and corticosteroids.

There are a host of other treatment options as listed here.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The release suggests the benefit of the cream was already proven and hints that the treatment would be available soon.

It would have been helpful to note for readers something like, “because this lotion is in clinical trials, it is not currently available on the market; furthermore the preliminary results have not been published or peer-reviewed.”

Does the news release establish the true novelty of the approach?

Not Satisfactory

There are a number of probiotic creams for sale, according to a quick search of Amazon.  What is different about the one being tested?

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The release doesn’t rely on sensational terms so we’ll give it a Satisfactory.

The unwarranted claims, such as alluding to a possible “long-term solution” for eczema without providing any evidence, are addressed under other criteria.

Total Score: 3 of 9 Satisfactory

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