Background: Piracetam has neuroprotective and antithrombotic effects which may help to reduce death and disability in people with acute stroke.
Objectives: The objective of this review was to assess the effects of piracetam in acute presumed ischaemic stroke.
Search strategy: We searched the Cochrane Stroke Review Group Trials Register (last searched April 2001). In addition we searched the Cochrane Controlled Trials Register (Cochrane Library 2001, issue 2), MEDLINE (1966-April 2001), EMBASE (1980-April 2001), and ISI Science Citation Index (1981- April 2001). We also handsearched 15 journals and contacted the manufacturer to identify further published and unpublished studies.
Selection criteria: Randomised trials comparing piracetam with control, with at least mortality reported and entry to the trial within approximately 48 hours of stroke onset.
Data collection and analysis: Two reviewers extracted data and assessed trial quality and this was checked by the other two reviewers. Study authors were contacted for missing information.
Main results: Three trials involving 1002 people were included, with one trial contributing 93% of the data. Participants' ages ranged from 40 to 85, and both sexes were equally represented. Piracetam was associated with a statistically non significant increase in death at one month (approximately 31% increase, 95% confidence interval 81% increase to 5% reduction). This trend was no longer apparent in the large trial after correction for imbalance in stroke severity. Limited data showed no difference between the treatment and control groups for functional outcome, dependency or proportion of patients dead or dependent. Adverse effects were not reported.
Reviewer's conclusions: There is some suggestion (but no statistically significant result) of an unfavourable effect of piracetam on early death, but this may have been caused by baseline differences in stroke severity in the trials. There is not enough evidence to assess the effect of piracetam on dependency.