Ibuprofen, paracetamol, and steam for patients with respiratory tract infections in primary care: pragmatic randomised factorial trial.

Although the finding of increased reconsultation could have been caused by chance, there was a similar effect of borderline significance in the combined group and adjustment for possible confounders did not modify the effect, so the possibility of modest harm with ibuprofen should probably not be dismissed.

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Type I error is a possibility, particularly for the subgroup analyses that were not specified at study inception, but subgroups were defined before we performed the analysis, and there were highly significant interactions for two significant subgroups.

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