A Cochrane review [Abstract] 1 included 5 studies with a total of 3838 patients with acute ischemic or hemorrhagic stroke. All participants were included within 12 hours after stroke onset. Four trials (n=2909) measured death and dependency at 3 months in chlormethiazole vs. placebo without significant difference (RR 1.03, 95% CI 0.95 to 1.11). One trial (n=849) measured this outcome between diazepam and placebo without differences (RR 0.94, 95% CI 0.82 to 1.07). In the subgroup analysis of total anterior circulation syndrome (TACS, n=545), a higher percentage of functional independence was found in the chlormethiazole group (RR 1.33, 95% CI 1.09 to 1.64). The frequent adverse events related to chlormethiazole were somnolence (RR 4.56, 95% CI 3.50 to 5.95) and rhinitis (RR 4.75, 95% CI 2.67 to 8.46).
Comment: The quality of the evidence is downgraded by study quality (unclear allocation concealment).
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