David H. Hickam, MD, MPH
Is ibuprofen plus acetaminophen (paracetamol) at nonprescription doses more effective and safer than either drug alone for chronic knee pain in adults living in the community?
Randomized controlled trial. Current Controlled Trials ISRCTN77199439.
Unclear allocation concealment.*
10 days and 3 months.
8 recruiting centers in England, UK.
892 patients ≥ 40 years of age (mean age 61 y, 51% men) who had knee pain for ≥ 4 days in the past week and most of the past 3 months, were not under medical supervision for knee pain, were willing to discontinue current analgesics, had Steinbrocker functional capacity classification I to III, and had knee pain without analgesics of 30 to 80 mm on a 100-mm visual analogue scale over the past 48 hours for everyday activities. Exclusion criteria were malignant, gastrointestinal, renal, hepatic, or rheumatic conditions; recent use of drugs for modifying joint structure or function; and current use of anticoagulants other than aspirin, ≤ 325 mg/d.
2 fixed-dose combination tablets of ibuprofen, 200 mg, and acetaminophen, 500 mg (n = 224); 1 fixed-dose combination tablet of ibuprofen and acetaminophen plus 1 placebo tablet (n = 222); 2 ibuprofen tablets, 200 mg each (n = 224); or 2 acetaminophen tablets, 500 mg each (n = 222). All were taken 3 times/d.
Western Ontario McMaster Universities Osteoarthritis Index pain subscale score and adverse events (AEs).
88% at 10 days (intention-to-treat analysis). Follow-up at 13 weeks was < 80% and is not reported here.
At 10 days, higher-dose combination treatment was better than acetaminophen but not ibuprofen for reducing knee pain (Table). Range of AEs at 10 days was 44% for ibuprofen to 50% for acetaminophen. Treatment-related AEs were more frequent in the higher-dose combination treatment group than in the ibuprofen group (31% vs 21%, P = 0.018); other groups did not differ for treatment-related AEs.
Ibuprofen plus acetaminophen given in 2 fixed-dose combination tablets was better than acetaminophen but not ibuprofen for reducing knee pain at 10 days.
†WOMAC = Western Ontario McMaster Universities Osteoarthritis Index. Normalized scale range 0 to 100 mm; lower score = less pain.
‡No significant difference for 1 combination tablet vs acetaminophen or 2 combination tablets vs ibuprofen; no other comparisons were in the prespecified analysis.
Hickam DH. Ibuprofen plus acetaminophen reduced knee pain in the short-term more than acetaminophen but not ibuprofen. Ann Intern Med. ;156:JC3–12. doi: 10.7326/0003-4819-156-6-201202210-02012
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Published: Ann Intern Med. 2012;156(6):JC3-12.
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