Reporting of corticosteroid use in systemic disease trials: evidence from a systematic review of the potential impact on treatment effect.
OBJECTIVE
To study how corticosteroid therapy is planned and described in reports of systemic disease trials and estimate the impact of the between-arm difference in corticosteroid dose on treatment effect.


METHODS
We performed a systematic review of PubMed and Cochrane databases on all reports of randomized systemic disease trials with corticosteroids as a cointervention. Data were extracted on the trial characteristics and results, planning of corticosteroid use, and dose. Success rates were adjusted for corticosteroid use for studies with available data and a binary outcome. Because the exact impact of between-arm differences in corticosteroid dose on success rates is unknown, we tested different values for the impact of a difference of 1 unit (1 mg for daily dosage or 250 mg for cumulative dose at the end of the trial).


RESULTS
A total of 139 trials were identified, including 79 investigating lupus and 30 investigating vasculitis. Planned management of corticosteroid use was specified in 101 reports (72.7%), with a fully described tapering scheme in 33 (23.7%). Corticosteroid consumption for each arm was given in 60 reports (43.2%), with a comparison of daily or cumulative dosage at the end of the trial in 32 (23.0%). An attempt to adjust for corticosteroid use was described in 2 (1.5%). With a value of 2.5% for the impact of a 1-unit difference in corticosteroid dose, adjustment yielded changes in success rate differences exceeding 10% in 11 (46%) of the 24 reports analyzed.


CONCLUSIONS
For systemic disease trials, use of corticosteroids as a cointervention is often inadequately planned and reported and could affect treatment effect.
Pagnoux
Christian
C
INSERM U738, Université Paris-Diderot, Hôpital Bichat-Claude Bernard, Assistance Publique Hôpitaux de Paris, Université Paris-Descartes, Paris, France. christian.pagnoux@cch.aphp.fr
Dechartres
Agnès
A
Giraudeau
Bruno
B
Seror
Raphaèle
R
Guillevin
Loïc
L
Ravaud
Philippe
P
D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D014657:Vasculitis / Q000188:drug therapy*
D000305:Adrenal Cortex Hormones