Study designs of evaluations included in the review
Randomised, double-blind placebo controlled parallel group clinical trials (RCTs).
Specific interventions included in the review
Multiple doses of a marketed formulation of racemic ibuprofen, within over the counter (OTC) limits - up to 1200mg/day for a maximum of 10 days, for conditions appropriate for a non-prescription analgesic/antipyretic. Six studies used 1200mg/day and 2 used 800mg/day.
Participants included in the review
Participants were aged 12-97 with a mean age of 47, 43% male and 86% Caucasian, 9% black, 1% Asian and 4% Hispanic.
Outcomes assessed in the review
Spontaneously reported adverse effects in the treatment groups. Adverse effects were mapped to the most clinically appropriate COSTART (Coding Symbol Thesaurus for Adverse Reaction Terms) term and then classified according to the COSTART dictionary-assigned body system.
How were decisions on the relevance of primary studies made?
The authors do not state how the papers were selected for the review, or how many of the authors performed the selection.