Abstract
Psoriatic arthropathy is a relatively uncommon arthritis that exists in a wide variety of clinical forms. These two features of the disease cause problems in the design of clinical trials.
In a comparison of two non-steroidal anti-inflammatory agents in this condition we attempted to overcome the difficulties by using a run-in period during which the dosage of one of the trial drugs was adjusted to suit the individual patient. After two weeks on indomethacin (75 mg or 150 mg/day) patients were allocated to four-week periods of indomethacin in the chosen dosage or diclofenac (75 mg or 150 mg/day) in a double-blind randomized crossover trial that used double dummy packaging.
Of the 35 patients that entered the study, 19 completed both study groups. No significant differences were observed between the clinical improvements due to both drugs during the course of the study. In general more side-effects were seen during indomethacin treatment, though the study design precluded exact comparison. In a study biased against diclofenac, patient preference was 9/19 for indomethacin, 4/19 for diclofenac and 7/19 expressing no choice.
Advantages and disadvantages of the study design are discussed.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
O.L. Meyers, O.P. Quantock, P.G. Joubert, D.F. du P. Louw, D.F. Marais, W.A. McDonald Scott andF.O. Muller,A multi-centre trial of Voltaren in the treatment of rheumatoid arthritis, S. Afr. Med. J.48, 2013–2017 (1974).
T. Durrigl, M. Vitaus, L. Pucar andM. Miko,Diclofenac sodium (Voltaren): Results of a multicentre comparative trial in adult-onset rheumatoid arthritis, J. Int. Med. Res.3, 139–144 (1975).
M.S. Doreen, P.L. Boardman, P.D. Fowler andP.H. Poole,Diclofenac (Voltarol) in rheumatoid arthritis: A report of a double-blind trial, Rheum. Rehab.17, 95–102 (1978).
N. Cardoe andP.D. Fowler,Diclofenac sodium (Voltarol): A double-blind comparative study with ibuprofen in patients with rheumatoid arthritis, Rheum Rehab. Suppl.2, 89–97 (1979).
P.H. Joubert, A.R. Kushlick, W.G. McNeil, F.O. Muller andE.S.C. Sheard,South African multicentre trial with Voltaren in osteoarthritis of the knee, S. Afr. Med. J.48, 1973–1978 (1974).
F.A. Rossi andL. Baroni,A double-blind comparison between diclofenac sodium and ibuprofen in osteoarthritis, J. Int. Med. Res.3, 267–274 (1975).
C.G. Barnes, H. Berry, M.E. Carter, W.W. Downie, P.D. Fowler, J.M.H. Moll, J.D. Perry, M.S. Sawaf andV. Wright,Diclofenac sodium (Voltarol) and indomethacin: A multi-centre comparative study in rheumatoid arthritis and osteoarthritis, Rheum. Rehab. Suppl. 2, 135–143 (1979).
K. Reinberger,Efficacy and tolerance of Voltaren and indomethacin in patients with ankylosing spondylitis, Therapiewoche26, 2916–2920 (1976).
M.E.T. Roberts, V. Wright, A.G.S. Hill andA.C. Mehra,Psoriatic arthritis — Follow-up study, Ann. Rheum. Dis.35, 206–212 (1976).
M. Zbojanova, K. Trnavsky andF. Ulcek,Indocid in the treatment of psoriatic arthritis, CESK Dermatol.49, 129–132 (1974).
N.O. Rothermich,An extended study of indomethacin II. Clin. Ther. J.A.M.A.195, 1102–1106 (1966).
W.M. O'Brien,Indomethacin: A survey of clinical trials, Clin. Pharm. Ther.9, 94–107 (1968).
D.M. Ritchie, J.A. Boyle, J.M. McInnes, M.K. Jasani, T.G. Dalakos, P. Grieveson andW.W. Buchanan,Clinical studies with an articular index for the assessment of joint tenderness in patients with rheumatoid arthritis. Q. J. Med.37, 393–406 (1968).
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Leatham, P.A., Bird, H.A., Wright, V. et al. The run-in period in trial design: A comparison of two non-steroidal anti-inflammatory agents in psoriatic arthropathy. Agents and Actions 12, 221–224 (1982). https://doi.org/10.1007/BF01965150
Received:
Issue Date:
DOI: https://doi.org/10.1007/BF01965150