Stroke, Vol 23, 967-971, Copyright © 1992 by American Heart Association
YL Yu, CR Kumana, IJ Lauder, YK Cheung, FL Chan, M Kou, CM Chang, RT Cheung and KY Fong
BACKGROUND AND PURPOSE: Hitherto, treatment of acute cerebral hemorrhage
with intravenous glycerol has not been evaluated in rigorous clinical
studies with sufficient patient numbers. METHODS: We undertook a
double-blind, stratified and randomized, placebo-controlled clinical trial.
Only patients with a first stroke admitted to the hospital within 24 hours
after onset of symptoms were recruited, provided computed tomography
confirmed hemorrhage and informed consent was obtained. After
stratification into alert, semicoma, and coma subgroups using the Glasgow
Coma Scale, 107 patients received active treatment (500 ml of 10% glycerol
in saline by intravenous infusion over 4 hours on 6 consecutive days) and
109 were given corresponding saline treatment. Using a variety of objective
scoring systems, patients were followed up for up to 6 months. RESULTS: At
follow-up, all measures of outcome in the treated and control groups were
very similar. At 6 months, respective mortality rates were 37 of 107 and 33
of 109. Corresponding mean +/- SD improvements in Scandinavian Stroke Study
Group scores were 8.35 +/- 16.9 versus 11.55 +/- 15.6 (long-term) and 0.64
+/- 7.3 versus 2.40 +/- 6.9 (prognostic), and improvements in the Barthel
Index ratings were 10.72 +/- 24.7 versus 13.95 +/- 23.3, respectively.
Glasgow Coma Scale score improvements in the survivors were 0.81 +/- 1.5
and 1.16 +/- 1.7 in the treated and control groups, respectively. Hemolysis
(generally subclinical) was the only adverse effect of glycerol noted.
CONCLUSIONS: In the absence of any clinically or statistically significant
difference in outcome between the treated and control groups, this trial
provides no justification for glycerol therapy following acute cerebral
hemorrhage.
ARTICLES
Treatment of acute cerebral hemorrhage with intravenous glycerol. A double-blind, placebo-controlled, randomized trial
Department of Medicine, University of Hong Kong.
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