I am always a fan of evidence supporting treatments that are safe, efficacious, and massively less expensive than conventional care. Even if multiple sclerosis flares are infrequently seen in the Emergency Department setting compared with, say, sepsis or chest pain, their care is part of the spectrum of our purview.
We’ve known all along oral steroids are just as useful as intravenous steroids for asthma. However, multiple sclerosis flares are typically treated with 1000mg of intravenous methylprednisolone. When’s the last time you gave that dose – or equivalent with another steroid – orally?
So, this is the COPOUSEP trial, and it is a non-inferiority investigation comparing three days of high-dose oral administration of methylprednisolone with intravenous. Enrolling 199, and reporting outcomes on 90 and 93 patients in the oral and IV groups, respectively, the authors find functional improvement in the most disabling aspect persisting at 28 days in 81% for oral and 80% of IV. Adverse effects tended to favor the intravenous cohort, with agitation and insomnia troubling the oral cohort in greater fashion than IV. Despite these adverse effects, given the costs and inconvenience of inpatient or infusion center treatment, it is certainly reasonable to encourage patients to pursue the oral option.
Oddly, the authors omit their intention-to-treat results from the paper, and provide only the per-protocol. The ITT results, supposedly, are available in a supplementary appendix – not yet available, apparently – and are similar to the per-protocol outcomes. Thus, I see no particular reason to omit the ITT, as such better reflects the efficacy and safety profile of pragmatic use; the authors should either present both together, or defer the per-protocol analysis to the appendix.
Nearly all individuals involved in the study declared conflicts of interest with multiple pharmaceutical companies, although I do not see how any would have untoward effect on the work in question.
“Oral versus intravenous high-dose methylprednisolone for treatment of relapses in patients with multiple sclerosis (COPOUSEP): a randomised, controlled, double-blind, non-inferiority trial”
http://www.ncbi.nlm.nih.gov/pubmed/26135706