Читать книгу Randomised Clinical Trials - David Machin - Страница 21

Meggitt, Gray and Reynolds (2006) randomised 63 patients with moderate‐to‐severe atopic eczema to receive either Azathioprine or Placebo in a double‐blind formulation to ascertain the relative reduction in disease activity determined by the six‐area six‐sign atopic dermatitis (SASSAD) score between the groups. One patient in each group subsequently withdrew from the trial before treatment was initiated. The investigators reported a 5.4 unit advantage with Azathioprine. In this trial, patients were randomised using a minimisation procedure, in the ratio of 2 to 1 in favour of Azathioprine in order to.

… encourage recruitment, to reduce the numbers receiving pharmacologically inactive systemic treatment, and to increase the likelihood of identifying infrequent adverse events.

Key features include the following:

 Design: Single‐centre, randomised double‐blind, placebo‐controlled, randomised 2 : 1 allocation ratio using minimisation,

 Endpoint: SASSAD,

 Size: 63 patients with moderate‐to‐severe atopic eczema,

 Analysis: Comparison of mean group regression slopes over a 12‐week period,

 Conclusion: Azathioprine produces a clinically relevant improvement.