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Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial

BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h6544 (Published 23 December 2015) Cite this as: BMJ 2015;351:h6544

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Re: Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial

1. Why did you choose a 10^2 cfu/mL cutoff to determine status of microbiological culture? Generally speaking, the norm in practice is to use 10^5 cfu/mL, as does the IDSA in defining significant bacteriuria. If you had done so, I suspect that status of microbiological culture would have consisted in an even more accurate predictor of women who can benefit from antibiotic treatment.
2. I also question your decision to transpose bioequivalence accepted margins to your definition of non-inferiority. Bioequivalence margins define a range of pharmacokinetic parameters within which the clinical effect of a single drug is deemed to be equivalent. However, in the case of non-inferiority, we seek to define the range of a clinical parameter (outcome) within which two drugs would be considered equivalent. In this case, the range of non-inferiority is very difficult to estimate, considering the lack of evidence.

Competing interests: No competing interests

18 March 2016
Justin Panasci
Pharmacy student
Université de Montréal
2900 Boulevard Edouard-Montpetit, Montréal, QC H3T 1J4