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Oral Prednisolone in the Treatment of Acute Gout: A Pragmatic, Multicenter, Double-Blind, Randomized Trial.

Journal Club Summary


Methodology Score: 4/5                 
Usefulness Score: 4/5

Rainer TH, et al. Ann Intern Med. 2016 Feb 23. doi: 10.7326/M14-2070.
Abstract Link

This multicenter, double-blind, randomized equivalence trial enrolled 416 patients in 4 EDs in Hong Kong found that oral prednisolone and indomethacin had similar analgesic effectiveness among patients with acute gout, with patients on prednisolone having significantly fewer minor side effects. While the group felt that this rigorous study supports the use of a systemic steroid as an alternate first line for acute gout, their preference was still colchicine or naproxen unless there were contraindications.


Epi lesson 

Most RCTs aim to determine whether one intervention is superior to another (superiority trials). Often a non-significant test of superiority is wrongly interpreted as proof of no difference between the two treatments. By: contrast, equivalence trials aim to determine whether one (typically new) intervention is therapeutically similar to another (usually existing) treatment. A non-inferiority trial seeks to determine whether a new treatment is no worse than a reference treatment. Because proof of exact equality is impossible, a pre-stated margin of non-inferiority (delta) for the treatment effect in a primary patient outcome must be defined a priori. Equivalence trials are very similar, except that equivalence is defined as being within pre-stated a two-sided treatment effect. True (2-sided) equivalence therapeutic trials are rare. 

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