Randomized clinical trials for psoriasis 1977-2000: the EDEN survey.
This study aims to describe the range of treatment comparisons, study designs and quality of reporting of randomized clinical trials (RCTs) in psoriasis published in a variety of medical and dermatological journals, and to analyze time trends with quality items. Hand-searching of clinical trials of psoriasis published from 1977 to 2000 in 13 medical or dermatological journals, selected as relevant to a European readership, was performed. A total of 249 trials published in 226 papers were classified as RCTs. Of these, 139 (55.8%) employed a parallel control group design, 107 (43.0%) studies adopted a self-control design and 3 (1.2%) a cross-over design. The median number of patients recruited per study was 40 (range 6-699). Overall, 55 different treatment modalities, including topical, ultraviolet-based, systemic, and other miscellaneous therapies were assessed. Only 31 (12.5%) RCTs were comparative studies of treatment modalities in different therapeutic classes. Most of the studies were short-term with a median study duration of 7 weeks (range 1-104), with only 18 studies (7.2%) lasting for more than four months. A variety of outcome measures including 44 different score systems were employed. According to the conclusions of the authors, 196 (78.7%) studies were judged to provide striking or definite observations in favor of one of the treatments examined. No important variations over time were documented for quality items. Based on our survey we have identified an enormous range of treatments that have been evaluated for psoriasis over the examined period. Most studies were short-term, and only a handful compared treatment options in different therapeutic classes. Since we did not examine all the relevant journals, the number of treatment options may be even greater than we have documented. There is an urgent need to reset the research agenda focusing on long-term comparative RCTs. Editors of major medical and dermatological journals are urged to take a role in improving the quality of RCT reporting.
Naldi
Luigi
L
Department of Dermatology, University of Geneva, Switzerland. luiginal@tin.it
Svensson
Ake
A
Diepgen
Thomas
T
Elsner
Peter
P
Grob
Jean-Jacques
JJ
Coenraads
Pieter-Jan
PJ
Bavinck
Jan Nico Bouwes
JN
Williams
Hywel
H
D002986:Clinical Trials as Topic; D018592:Cross-Over Studies; D006801:Humans; D011565:Psoriasis / Q000175:diagnosis / Q000628:therapy*; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic; D013997:Time Factors; D016896:Treatment Outcome