A randomized, placebo-controlled, double-blind study was performed as a pil
ot study to examine the benefit of the administration of magnesium sulfate
given intravenously as a protective substance during the first 24 hours fol
lowing a stroke. Patients who had cortical infarction in the middle cerebra
l artery territory with moderate to severe neurologic deficits lasting for
more than 15 minutes with onset less than 24 hours were included. The patie
nts were treated with magnesium sulfate or placebo for 5 days and examined
by a blinded investigator. Patients had follow-up for 30 days. The primary
efficacy variable was the proportion of patients reaching mild to moderate
neurologic deficit on the Orgogozo scale (80 points) and relative functiona
l independence on the Barthel index (60 points). Orgogozo scale and Mathew
scale values were obtained on admission and days 2, 4, 8, and 30 after stro
ke. Barthel activities of daily living index and Rankin disability score we
re obtained on day 30. Forty-one patients (22 given treatment and 19 given
placebo) demonstrated significant beneficial effects on the Orgogozo scale
(84 +/- 11 vs. 64 +/- 10, p < 0.0001) and (83 +/- 14 vs. 70 +/- 15, p < 0.0
09), respectively. At the end of 1-month follow-up, the Barthel ADL index w
as nonsignificantly higher and the Rankin disability score was marginally s
ignificantly lower in the magnesium-treated group (84 +/- 26 vs. 71.8 +/- 2
6, p < 0.143) than in control subjects (2.3 +/- 1.1 vs. 3 +/- 1.3, p < 0.07
7). Intravenous magnesium sulfate had significant positive effect on the ou
tcome in patients with acute stroke. Further studies on a larger scale are
needed to confirm these findings.