Creytens 1980.
Study characteristics | ||
Methods | Study design: parallel design Number of arms: 2 Experimental arm: piracetam (nootropic agent) Control arm: matched placebo |
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Participants | Geographical location: Belgium
Setting: inpatient (women's hospital)
Stroke criteria: all subtypes Method of stroke diagnosis: via clinical signs Time since stroke: not reported Inclusion criteria: not reported Exclusion criteria: not reported Total number randomised in this trial: 50 Number randomised to treatment group: 25 (0% men, mean age 73 years SD not reported) Number randomised to control group: 25 (0% men, mean age 69 years SD not reported) Total number included in final analysis: 42 Number included in treatment group for final analysis: unclear Number included in control group for final analysis: unclear |
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Interventions | Treatment: piracetam (nootropic agent), 6g IM daily for 7 days, 4.8 g (4 x 400 mg three times a day orally) daily for 30 days
Control: matched placebo
Treatment duration: treatment continued for 37 days Follow‐up: not reported |
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Outcomes | Primary outcomes
Secondary outcomes
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote: "Two independent groups of patients suffering a CVA (acute stage) were randomized…." pp. 23 Comments: method of sequence generation not reported |
Allocation concealment (selection bias) | Unclear risk | Comments: method of allocation concealment not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk |
Quote: "This study was double‐blind." pp. 23 Comments: no details of who was blinded was reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk |
Quote: "This study was double‐blind." pp. 23 Comments: no details of who was blinded was reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comments: per protocol analysis presented only. 8/50 participants were not included in the analysis |
Selective reporting (reporting bias) | Unclear risk | Comments: no trial protocol available to compare with the publication |
Other bias | Unclear risk | ‐ |