Randomized, placebo controlled trial of withdrawal of slow-acting antirheumatic drugs and of observer bias in rheumatoid arthritis

P C Gøtzsche, M Hansen, M Stoltenberg, Anders Jørgen Svendsen, J Beier, K L Faarvang, M Wangel, L Rydgren, P Halberg, P Juncker, V Andersen, T M Hansen, L Endahl

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Abstrakt

Patients with rheumatoid arthritis, in stable treatment with methotrexate, penicillamine, or sulfasalazine, were randomized in a double-blind fashion either to continuation of their usual treatment or to placebo. 112 patients were included; 52 patients who refused participation had no more severe disease than the others. The patients felt worse on placebo than on active drug (p = 0.002). The mean differences in number of tender, painful and swollen joints after one month were 2.4 (p = 0.08), 3.0 (p = 0.12) and 2.2 (p = 0.03), respectively. Treatment failure occurred for 42 patients of whom 33 received placebo (p = 0.000,001). There was no difference in the severity of side effects (p = 0.91). The patients guessed their treatment correctly more often than expected (p = 0.02) because of the perceived effect. None of the two observers guessed better than chance, and there were no differences between the observers' evaluations of the joints. The effect of slow-acting antirheumatic drugs was unequivocal and no observer bias occurred.
OriginalsprogEngelsk
TidsskriftScandinavian Journal of Rheumatology
Vol/bind25
Udgave nummer4
Sider (fra-til)194-9
Antal sider6
ISSN0300-9742
StatusUdgivet - 1996

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Citationsformater

Gøtzsche, P. C., Hansen, M., Stoltenberg, M., Svendsen, A. J., Beier, J., Faarvang, K. L., Wangel, M., Rydgren, L., Halberg, P., Juncker, P., Andersen, V., Hansen, T. M., & Endahl, L. (1996). Randomized, placebo controlled trial of withdrawal of slow-acting antirheumatic drugs and of observer bias in rheumatoid arthritis. Scandinavian Journal of Rheumatology, 25(4), 194-9.