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In a randomized, multicenter, therapeutic trial of 379 patients with Guillain-Barré syndrome (GBS) comparing standard regimens of plasma exchange ([PE], n = 121), intravenous immunoglobulin ([IVIG], n = 130), or PE followed by IVIG (n = 128), no significant difference between any of the groups was found with respect to mean improvement four weeks following randomization, as measured on a seven-point disability scale. Secondary end point criteria, including time to come off ventilator, time to walk unaided, and average rate of recovery over 48 weeks, were likewise not significantly different between the treatment groups. Death rates (n = 5, n = 6, n = 8, respectively), time to hospital discharge, time to return to work, relapse rates (n = 7, n = 4, n = 9, respectively), number of side effects, and incidence of complications requiring termination of therapy (n = 3, n = 2, n = 3 during PE and 5 during IVIG, respectively) were similarly comparable between treatment groups.
The verdict is in, and treatment preference may now be dictated by factors other than efficacy. Given similar cost, the simplicity of IVIG argues in its favor, but be prepared for elevated liver function and sedimentation rates during the first few months following treatment (Oomes PG, et al. Neurology 1996;46:96-100). Functional deterioration during the first two weeks of therapy occurs in up to 25% of IVIG-treated patients (and 33% of PE-treated GBS) but does not warrant altering treatment (van der Meche FGA, et al. Ann Neurol 1995;37(S1):S14-S31). Roughly 10% of patients may require another round of therapy when secondary deterioration follows initial stabilization or improvement, presumably due to the disease course outlasting the treatment course (Kleyweg RP, van der Meche FGA. J Neurol Neurosurg Psychiatry 1991;54:957-960). IVIG has also proven beneficial for pediatric GBS (Shahar E, et al. J Pediatr 1990;116:141-144; Vallee L, et al. Neuropediatrics 1993;24:235-236), as well as for Miller-Fisher syndrome (Arakawa Y, et al. Brain Dev 1993;15:231-233; Zifko U, et al. J Neurol 1994;241:178-179). Although no additional benefit is accrued by adding high-dose methylprednisolone to PE (GBS Steroid Trial Group. Lancet 1993;341:586-590), an ongoing multicenter European trial is examining the role of high-dose methylprednisolone combined with IVIG (van der Meche FGA, van Doorn PA. Muscle Nerve 1997;20:136-147). We await the results with interest. mr