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. 2020 May 11;2020(5):CD003689. doi: 10.1002/14651858.CD003689.pub4

Creytens 1980.

Study characteristics
Methods Study design: parallel design
Number of arms: 2
Experimental arm: piracetam (nootropic agent)
Control arm: matched placebo
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
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
Outcomes Primary outcomes
  • Depression measured using the BOP scale (depressive behaviour sub scale)


Secondary outcomes
  • Leaving the study early

  • Adverse events

  • Death

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