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Safer steroid treatment depicted in news release is still in early trials

Study paves way for steroid treatments with fewer side effects

Our Review Summary

syringe with vialAdrenal gland disorders such as congenital adrenal hyperplasia are controlled by steroid treatments, usually cortisol, which can lead to weight gain, high blood pressure and diabetes. Researchers here are testing another of the body’s steroids, corticosterone, and find in basic studies that it may avoid some of those symptoms. This release does a nice job of explaining the outcomes of these studies and comparing them to typical outcomes of cortisol use. But it is less adept at reminding readers that the research to date is far shy of the clinical studies needed to determine the efficacy of this new treatment.

 

Why This Matters

We all want to avoid treatments that may fix one problem but produce others. The effort to come up with a safer steroid replacement for cortisol is worthwhile, if early in the game.

Identifying possible new treatments that reduce or eliminate debilitating drug side effects is a laudable goal and worthy of news coverage. But it is important to keep in mind that the road from promising early results in an animal model or in a small number of patients for a brief period of time is a difficult one.

Criteria

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

Not Satisfactory

Although this is basic research at the moment, the study does compare health outcomes between corticosterone and an existing treatment.  It could well have also offered a preliminary cost assessment.

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

Not Satisfactory

The release does a brief but nice job of explaining the effects of corticosterone on fat cells. We would have liked to have seen a bit of quantification of the differences between cortisol and corticosterone. The study demonstrated statistically significant differences on fat cells but the duration of the study in a small number of patients with Addison’s disease was 330 minutes.

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

Not Satisfactory

Although the research article from which this release stems notes that “adverse effects will need to be compared not only for metabolism and obesity but also for immune suppression and osteoporosis,” the release makes no mention of possible harms.

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

Not Satisfactory

On the one hand, the release mentions use of both mice and men (!) — well, patients with Addison’s disease — hinting at the multi-methodological nature of this study.  On the other, though, it fails to share the full nature of the study, which employed three targets — mice, human epithelial cells, and a small, blinded study of 12 men with Addison’s disease — which offered a nice, linear evidentiary trial. Data from just a 12-person cohort is far from what one might regard as strong clinical evidence on behalf of this new therapy.

The claims made appear out of line with the evidence.

‘These findings suggest that corticosterone could provide a safer alternative to traditional cortisol replacement therapy for conditions such as Addison’s disease and congenital adrenal hyperplasia.”

“The researchers say that, with further research, these findings may one-day lead to improved therapies for other conditions that respond to steroid treatment, including asthma and rheumatoid arthritis.”

“Dr Mark Nixon, of the BHF Centre for Cardiovascular Science at the University of Edinburgh, said: “The discovery of this selective corticosterone pump in fat cells could lead to a completely new approach in our search for safer steroid medications.”

There was almost no caution about the difficulty of translating these results into something clinically useful.  Where is the caution that these things might not come to pass?

Does the news release commit disease-mongering?

Satisfactory

The researchers make it clear that they are not trying to cure a health problem but, rather, seek to offer a safer treatment regimen for individuals with adrenal gland disorders.

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

Satisfactory

The text offers information about funding sources. The reader must infer that the two sources in the release were involved in the research, but their full identifications make that relatively easy to do. Possible conflicts of interest are nowhere to be found.

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

Satisfactory

The text offers an extended comparison of the side effects of the current use of cortisol and those of the possible new treatment.

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

Not Satisfactory

The research article is clear that corticosterone is available only for research purposes at this time, but the release is not specific about that, instead employing phrases such as “An improved therapy…is a step closer”) that suggest unavailability but also encourage the reader to conclude that the treatment is just around the corner.

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

Satisfactory

The text notes that scant attention has been paid to the use of corticosterone.

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

Satisfactory

We rate this borderline satisfactory. While the sources in the story are optimistic while somewhat guarded, often employing conditional tense verbs (“could provide a safer alternative”), and the release lead sentence makes it clear that this new treatment is not yet available, the release headline (“Study paves way for steroid treatments with fewer side effects”) seems overly optimistic about a new treatment that has not yet survived clinical testing.

It’s not until you read to the end of the release that you find more tempered language:

“The researchers say that, with further research, these findings may one-day lead to improved therapies for other conditions that respond to steroid treatment, including asthma and rheumatoid arthritis.”

Total Score: 5 of 10 Satisfactory

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