ArticlesRandomised trial of plasma exchange, intravenous immunoglobulin, and combined treatments in Guillain-Barré syndrome
Introduction
Plasma exchange (PE) shortened the duration of disability in Guillain-Barré syndrome in comparison with standard supportive treatment in two large, open, controlled trials.1, 2 In a comparative open trial of intravenous immunoglobulin (IVIg) and PE, the two treatments had similar effects on recovery time.3 IVIg is potentially a safer and more convenient treatment, but it has not been universally accepted as the preferred treatment because of reports of continued disease progression or relapse after IVIg4, 5 and the fact that the IVIg trial (150 patients)3 was smaller than the PE trials (2421 and 2202). Although PE (and probably IVIg) shortens the average duration of disease, about 20% of patients are left with substantial disability after either treatment. 1, 2, 3 The mechanisms by which IVIg has a beneficial effect may include anti-idiotypic suppression of autoantibodies.6, 7, 8 After the removal of immunoglobulin and antibodies by PE, rebound synthesis of antibodies to myelin of peripheral nerves may be stimulated.9 The administration of IVIg immediately after PE might prevent this rebound synthesis. We have undertaken a multicentre, randomised controlled trial to find out whether IVIg is equivalent to or superior to PE in the treatment of Guillain-Barré syndrome, and whether PE followed by IVIg is superior to the better single treatment.
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Patients
Patients with Guillain-Barré syndrome were recruited in 38 centres in 11 countries. Inclusion criteria were: diagnosis by a qualified neurologist; satisfaction of accepted clinical and cerebrospinal-fluid diagnostic criteria;1 severe disease (requiring aid to walk or worse); age over 16 years; and onset of neuropathic symptoms within the previous 14 days. We excluded patients with atypical forms of Guillain-Barré syndrome, serious pre-existing other disease, or contraindications to PE or IVIg.
Randomisation
Between Jan 30, 1993, and April 30, 1995, 383 patients were enrolled and assigned randomised treatment. During the same period, 268 patients were seen at the trial centres but not entered into randomisation (figure 1). The commonest reasons for non-randomisation were disease severity less than grade 3 (70 patients), onset to diagnosis/referral delay more than 14 days (58), other active medical disorders (35), and atypical forms of Guillain-Barré syndrome, such as Miller Fisher syndrome (27).
Discussion
This trial showed that IVIg is equivalent to PE in reducing the amount of disability at 4 weeks after treatment in Guillain-Barré syndrome. This conclusion is strengthened by the absence of significant differences in any of the secondary outcome measures. Moreover, there was no difference in time to hospital discharge or time to return to work. These findings confirm the conclusion of the first comparative trial of PE and IVIg in Guillain-Barré syndrome.3 The results are also consistent with a
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Members of trial group listed at end of paper