High dose immunoglobulins and plasma exchange in the Guillain-Barré Syndrome

ABSTRACT

The background, design and preliminary results of the Dutch Guillain-Barré trial comparing high-dose immunoglobulins (IgIV) with plasma-exchange (PE) are described. This randomized trial was conservative in that the main aim was to show equal effect of both treatments within certain predefined limits. This approach was appropriate since IgIV is quickly and easily applicable, whereas PE is much more combersome leading to treatment delays and a considerable dropout rate. Moreover PE is not available in all hospitals. For these reasons IgIV would be preferable if the two treatments have a similar effect. We originally estimated that 200 patients would be needed to demonstrate a comparable effect of IgIV and PE (type I error = 0.05 and type II error = o.2). At the interim analysis after 150 patients the stopping criterion has been met. Four weeks after randomization 52.7 per cent in the IgIV group was functionally improved and 34.2 per cent in the PE-group, and advantage of 18.5 per cent for IgIV (p = 0.024)