Current issues of ACP Journal Club are published in Annals of Internal Medicine


Therapeutics

Immunoglobulin led to better functional improvement than plasma exchange for the Guillain-Barré syndrome

ACP J Club. 1992 Sept-Oct;117:33. doi:10.7326/ACPJC-1992-117-2-033


Source Citation

van der Meché FG, Schmitz PI, and the Dutch Guillain-Barré Study Group. A randomized trial comparing intravenous immune globulin and plasma exchange in Guillain-Barré syndrome. N Engl J Med. 1992 Apr 23;326:1123-9.


Abstract

Objective

To determine whether intravenous immunoglobulin (lg) therapy and plasma exchange (PE) produce similar improvement in motor function in patients with the Guillain-Barré syndrome.

Design

6-month randomized controlled trial.

Setting

17 centers in The Netherlands.

Patients

Patients with acute Guillain-Barré syndrome who could not walk 10 meters independently and who entered the study within 2 weeks of onset of neuropathy were eligible. Exclusion criteria were age < 4 years; a previous episode of the syndrome; allergy to blood products; selective IgA deficiency; pregnancy; treatment with an immunosuppressive agent; severe concurrent disease; or unavailability for follow-up. 46 of 193 patients evaluated were ineligible. 146 patients (99%) completed the trial.

Intervention

74 patients were assigned to intravenous lg (0.4 g/kg body weight per d for 5 d). 73 patients were assigned to PE (200 to 250 mL of plasma/ kg body weight in 5 sessions within 7 to 14 d). Therapy was started as soon as possible after randomization and could be repeated if the patient deteriorated > 1 week after responding to treatment.

Main outcome measure

Improvement of motor function by ≥ 1 point on a 7-point ("healthy" to "dead") scale of motor function.

Main results

The study was stopped early because the 4-week rate of improvement by ≥ 1 point was 53% in the lg group compared with 34% in the PE group (95% CI for a difference of 19%, 3% to 34%, P = 0.024). The direction of the treatment effect remained the same after adjustment for age, Campylobacter infection, presence of GM-1 antibodies, and treatment center. The median times to improvement and to the recovery of independent function were 27 days compared with 41 days (P = 0.05) and 55 days compared with 69 days (P = 0.07) for lg and PE, respectively. Fewer patients assigned to lg than to PE had complications (39 vs 68 complications) including multiple complications (7% vs 22%, P < 0.01). {The absolute risk reduction of 15% means that 7 patients would need to be treated with Ig (rather than PE) to prevent 1 additional multiple complication, CI 4 to 24; the relative risk reduction was 69%, CI 24% to 88%.}*

Conclusion

Patients with the acute Guillain-Barré syndrome had greater functional improvement after treatment with intravenous immunoglobulin than with plasma exchange.

Sources of funding: Baxter Healthcare Corporation and the American Red Cross.

Address for article reprint: Dr. F.G. van der Meché, Ee2222, Academic Hospital Rotterdam, P.O. Box 1738, 3000 DR Rotterdam, The Netherlands.

*Numbers calculated from data in article.


Commentary

To understand the study by van der Meché and colleagues that compared plasma exchange with intravenous immunoglobulin infusion in the treatment of the Guillain-Barré syndrome, it is necessary to know that plasma exchange has previously been shown to be effective. What is being tested now is how intravenous immunoglobulin compares with plasma exchange in preventing or ameliorating weakness. Using the criteria of functional weakness and rate of complications, patients assigned to immunoglobulin did at least as well as, perhaps even better than, those having plasma exchange. Because of the large size of the study, the obvious care in its design, and the attention to assessing for bias, the results do give us confidence that intravenous immunoglobulin is effective in the treatment of acute inflammatory polyradiculo- neuropathy. It is, however, unfortunate that the neurologists doing the evaluations were not blinded to the treatment used because this would have lessened potential observer bias. Nevertheless, I agree with the conclusion of the investigators that immunoglobulin is at least as effective (but not definitely more effective) than plasma exchange. Assuming that immunoglobulin is as effective as plasma exchange, immunoglobulin might become the preferred treatment for acute inflammatory polyradiculo-neuropathy. Intravenous immunoglobulin is not as invasive as plasma exchange and expensive equipment and specialized hospital facilities are not required. Because the procedure can be done in an outpatient facility or in the home, patients prefer it. At this time, immunoglobulin treatment appears to be as safe as plasma exchange. A comparison of the cost effectiveness of immunoglobulin treatment and plasma exchange would be very timely.

Peter J. Dyck, MD
Mayo Medical SchoolRochester, Minnesota, USA

Peter J. Dyck, MD
Mayo Medical School
Rochester, Minnesota, USA