Researchers at Perelman School of Medicine at the University of Pennsylvania compared about 38,000 records from women treated for acne with two different drugs. They found those who used the diuretic drug spironolactone switched to a different drug within one year at almost the same rate as those who began with antibiotics. Authors of the study viewed the prescription change as a proxy for ineffectiveness, and suggest that switching is often the result of treatment failure due to lack of efficacy or other factors.
The release sends a mixed message. It calls twice for a change in prescribing practices but then states that “the findings of this study should be confirmed by a randomized controlled trial that directly compares the two treatment options.”
Another problem with the release is that it doesn’t discuss any of the harms associated with spironolactone.
The overuse of antibiotics is a public health problem and has been identified by the World Health Organization as a major threat. This study explored an antibiotic alternative for dermatologists, who write more antibiotic prescriptions per provider than any other specialty. The news release gives only a slight nod to the study’s main limitation — it was not a randomized controlled trial comparing different therapies — while making a strong push for dermatologists to prescribe a drug for acne that is not FDA approved for acne treatment. The evidence gathered so far is not strong enough to warrant a change in practice.
The news release doesn’t provide the cost for either antibiotics or spirinolactone. It only suggests that using spirinolactone could be “less expensive” than the antibiotic course.
This criterion rates a Not Satisfactory because the study did not set out to quantify benefits of a specific drug or drugs and yet the release makes numerous claims about one drug’s benefits while calling for a change in practice. The study that was undertaken can not tell us how well the drug worked or which factors contributed to discontinuance of any of the drugs. The release provided the absolute numbers of women who stopped taking a drug and switched to an alternative drug but the measurement of switching drug therapies was only a proxy for effectiveness.
The release does not discuss harms of the drug other than to say it “may have a better safety profile” than oral antibiotics. Then again, it may not. Safety was not part of the study. There should be some language about spironolactone’s known side effects, which include an allergic reaction and vomiting, among others listed by the National Library of Medicine.
In addition, there can be long-term consequences of lower androgens, such as decreased bone mass following continued use.
The study does not provide any data on the drug’s effectiveness, and isn’t that what patients most want to know? We need much more detail about the analysis of the prescription rates, duration, and reasons for discontinuation, as well as the improvement of acne. It’s interesting but perhaps not really useful to compare how many people switched from one drug to an alternative.
The release erroneously refers to acne as “one of the most common diseases in the world.” It’s not a disease. It’s a common skin condition and an annoyance for most people that have it, and can often be treated with careful cleansing and over-the-counter products.
The release does not provide the name of the study funders.
The release is comparing two alternatives. It would have been helpful to mention that there are other ways of dealing with acne besides just these two methods. There are a number of prudent approaches to treating acne before turning to prescription medications.
The release explains that both methods are currently available and in use. It states that while some dermatologists already prescribe spironolactone for acne, the FDA has not approved it for that use. Without FDA approval, most insurers will not cover the cost of treatment.
The release doesn’t make a claim of novelty, nor should it. It is not about a new drug, but a call for a new application for an old drug.
There was no sensational language employed in the release.