16 The primary efficacy analysis of the study at week 24 did not succeed at demonstrating superiority of the add-on over the switch strategy, suggesting that switching to tocilizumab monotherapy might be a valuable treatment strategy for patients for whom methotrexate is contraindicated or poorly tolerated.
This study does not aim at exploring superiority of participants between cultures.
With regard to behaviour therapy alone, some secondary endpoints hinted at the superiority of the combination during the acute phase treatment (frequency of panic attack, social functioning).
The study was conducted in 2003 and 2004 as a multicenter, randomized, double blind, controlled parallel group clinical field trial with client-owned animals in compliance with Good Clinical Practice (GCP), aimed at demonstrating superiority of imepitoin 30 mg/kg BID over a low-dose of 1 mg/kg imepitoin administered BID for 12 weeks.
With respect to combination therapy versus benzodiazepines alone, secondary endpoints representing continuous measures also hint at the superiority of the combination during the acute phase treatment, in that the combination was significantly superior to benzodiazepines in terms of the global severity, phobic avoidance, and social functioning.
It was inspired by Winston Churchill, drafted by Tory politician Sir David Mandell-Fyfe and ratified by a Tory government, and was part of the cold war ideological battles aimed at showing the superiority of the western way of life.
The pragmatically-oriented RCT aims at establishing the superiority of a treatment over another, the goal being to maximize the external validity of the trial (that is, its application in current practice).
At present the superiority of one regimen over the other in terms of treatment efficacy remains unknown.
As the study did not succeed at demonstrating the superiority of the add-on versus the switch strategy, we discuss here factors that could potentially have biased the study outcome, before rejecting the clinical study hypothesis.
