IS THERE A SPECIAL AWARD FOR THE EXPERIMENTAL DRUG IN RANDOMIZED CONTROLLED TRIALS?
Fabio A. Tin, MD1, Luigi Pagliaro, MD1, and Massimo Attanasio, PhD2. (1) V. Cervello Hospital, Gastroenterology, Palermo, Italy, (2) University of Palermo, Metodi Quantitativi per le Scienze Umane, Palermo, Italy Purpose: an association between the experimental drug and benefit has been reported from RCTs of Fluoxetine. We searched for the same relationship 69 RCTs of Interferon alpha for Chronic Hepatitis C (CHC) that used the same dose of 9 MU/week at least in one of the arms. Methods: ALT normalization sustained for at least 6 months was the abstracted measure of benefit; such effect was analysed in experimental vs control group for association with a set of variables of design and reporting. A fixed effects, arm level, logistic meta-regression accounted for the sources of heterogeneity reported in the individual studies (PROC LOGISTIC-SAS Institute, Cary, NC). Results: main characteristics of arms were mean age 46 years, male 65%, cirrhotics 21%, genotype-1 61%, yearly schedule 28%
