Herrschaft 1988.
Methods | Randomised prospective double blind controlled trial. No details of the randomisation process are available in the report. | |
Participants | The setting was a single hospital in Germany. 44 people entered the study, who had been admitted to one clinic in this hospital. 40 were assessable at the end of the study. Participants were aged between 29 and 80 years, with an average age of 56.5, with acute cerebral ischaemic cerebral infarct that had existed from zero to maximum of 5 days before the beginning of the treatment. 23 patients (17 male) were assessable in the treatment group, 17 patients (10 male) were assessable in the placebo group. Exclusion criteria: Severe accompanying diseases, in particular cardiac, pulmonary, liver or renal insufficiency, insulin dependant diabetes mellitus, fixed hypertonia, neoplasia, haematological and systemic diseases Earlier neurological diseases of a different nature A history of alcohol or drug abuse Participants were not significantly different at baseline regarding sex, age, duration of illness before start of therapy, risk factors, or test scores. | |
Interventions | Piracetam 3x4 g/20 ml in bolus, or placebo from first to fourteenth day, followed by either 4.8 g piracetam orally, or placebo in identical formulation for further 14 days. No other medication allowed during the 28 day treatment period. Participants were given remedial exercises five times weekly and, if necessary, speech therapy 3 times a week. No note is available in the report of who was thought to be in need of this therapy, in either of the two groups. All were treated with 1000 ml Dextran 40 as continuous infusion plus 2x150 ml Sorbit 40% daily during first three days, then 500 ml Dextran 40 (duration of infusion 4‐6 hours) from fourth to fourteenth day. |
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Outcomes | Aphasia was graded from 0 to 4 in severity. This was measured on the day of reception into the study, then on days 7, 14, and 28 thereafter. One person receiving piracetam and 3 receiving the placebo developed complications which led to them being withdrawn from the study. They were lost to follow up and have been treated as having suffered an adverse effect for the purposes of this review. The authors did not believe that the complications experienced were connected to the treatment. | |
Notes | It is not made explicit in the report whether the tablets containing piracetam tasted the same as those which were a placebo. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |