Study designs of evaluations included in the review
Randomised controlled trials (RCTs) with at least 40 patients per treatment arm and a study period of at least 4 weeks were eligible for inclusion in the review.
Specific interventions included in the review
Studies that evaluated exposure to bromfenac, benoxaprofen or ibufenac over at least 4 weeks were eligible for inclusion. The included studies evaluated benoxaprofen (600 mg/day) for 4 weeks or 4 months and bromfenac (50 to 200 mg/day) for between 4 and 36 weeks. The control interventions, where reported, included ibuprofen (1,200 to 1,800 mg/day), naproxen (1,000 mg/day), diclofenac (150 mg/day) and placebo.
Participants included in the review
Studies of patients with osteoarthritis or rheumatoid arthritis were eligible for inclusion. The review did not present further information about the participants in the included studies.
Outcomes assessed in the review
Studies that assessed the following measures were eligible for inclusion: alanine aminotransferase (ALT) elevations greater than three times the upper limit of normal (ULN); bilirubin elevations at least 1.5 times greater than the ULN; discontinuation of study because of elevation of transaminase; liver-related clinical events; hospitalisation for liver diagnoses; and death due to liver disease. The included studies reported the number of patients with ALT elevations between 1.2 and 3 times the ULN, between 3 and 8 times the ULN, and over 8 times the ULN, as well as liver-related hospitalisations and deaths and withdrawal due to elevated liver tests.
How were decisions on the relevance of primary studies made?
The authors did not state how the papers were selected for the review, or how many reviewers performed the selection.