Rheumatology 2000; 39: 1095-1101
© 2000 British Society for Rheumatology
The long-term effects of non-steroidal anti-inflammatory drugs in osteoarthritis of the knee: a randomized placebo-controlled trial
Department of Rheumatology, King's College Hospital (Dulwich), East Dulwich Grove, London SE22 8PT,
1 Centre for Rheumatic Diseases, Royal Infirmary, Glasgow G4 0SF,
2 Department of Rheumatology, Coventry and Warwickshire Hospital, Stoney Stanton Road, Coventry CV1 4FH,
3 Department of Rheumatology, District General, Chester Road, Sunderland SR4 7TP,
4 Whipps Cross Hospital, Leytonstone, London E11 1NR,
5 Department of Rheumatology, Royal Sussex County Hospital, Eastern Road, Brighton BN2 5BE,
6 Department of Rheumatology, Addenbrooke's Hospital, Cambridge CB2 2QQ,
7 Gartnavel General Hospital, Great Western Road, Glasgow G12 0YN,
8 14a Milford House, 7 Queen Anne Street, London W1M 9FD,
9 Musculoskeletal Directorate, The Royal London Hospital (Mile End), 275 Bancroft Road, London E1 4DG,
10Department of Rheumatology, Selly Oak Hospital, Birmingham B29 6JB,
11Wirral Hospital NHS Trust, Upton, Wirral L49 5PE,
12Stobhill General Hospital, Balornock Road, Glasgow G21 3UW,
13Department of Rheumatology, Leicester Royal Infirmary, Leicester,
14Department of Rheumatology, Basildon Hospital, Nether Mayne, Basildon, Essex SS16 5NL,
15Stoke Mandeville Hospital, Aylesbury, Bucks HP21 8AL,
16Department of Rheumatology, Royal Cornwall Hospital, Truro, Cornwall TR1 2HZ and
17District General Hospital, Eastbourne, East Sussex BN21 2UD, UK
Background. Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used to treat osteoarthritis (OA), though their long-term efficacy is uncertain. We report a comparison of the symptomatic responses to therapy with tiaprofenic acid, indomethacin and placebo over 5 yr.
Methods. A parallel-group, randomized, single-blind trial of patients with knee OA recruited 812 patients from 20 centres; 307 patients received tiaprofenic acid (300 mg b.d.), 202 indomethacin (25 mg t.d.s.) and 303 matching placebo for up to 5 yr. At the end of the parallel-group study, patients receiving tiaprofenic acid or placebo entered a 4-week blinded cross-over study of tiaprofenic acid or placebo, both given for 2 weeks. Assessments were at baseline, 4 weeks, then at 6-month intervals for up to 5 yr in the parallel group study and at 2-week intervals in the cross-over study. They comprised pain scores, duration of morning stiffness, patients' global assessments, paracetamol consumption, adverse reactions, withdrawals and functional outcomes.
Results. There were significant falls in overall pain scores in patients receiving NSAIDs compared with placebo at 4 weeks in the parallel-group phase. Thereafter there were no advantages favouring active therapy. In the cross-over phase, pain scores were significantly lower in patients receiving tiaprofenic acid than placebo. Patients who had been receiving long-term tiaprofenic acid showed significant rises in their pain scores when receiving placebo therapy and vice versa. Adverse events were reported by 61% of patients receiving tiaprofenic acid, 63% on indomethacin and 51% on placebo. Potentially severe side-effects were rare; for example, there were only three cases of gastrointestinal bleeding on NSAIDs. The pattern of withdrawal was similar in patients taking NSAIDs and placebo in the parallel-group study; at 48 weeks 53% of the patients remained on tiaprofenic acid, 50% on indomethacin and 54% on placebo.
Conclusions. NSAIDs significantly reduce overall pain over 4 weeks. This short-term responsiveness is retained, and even after several years of therapy with tiaprofenic acid pain scores increased over 2 weeks when it was changed to placebo. Our results do not show long-term benefits from the use of NSAIDs in OA and the majority of patients had persisting pain and disability despite therapy.
KEY WORDS: NSAIDs, Osteoarthritis, Knee, Randomized controlled trial.
Correspondence to: D. L. Scott, Clinical and Academic Rheumatology, King's College Hospital (Dulwich), East Dulwich Grove, London SE22 8PT, UK
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