Zhang 2003.
Methods | Randomised: enrolled participants were allocated randomly by drawing lots, but the method of allocation concealment was not described. Double‐blind: it was stated that participants and investigators were blinded during the interventions and evaluations. Blank‐controlled Duration: 3 years ITT analysis: no participants were lost to follow‐up. |
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Participants | Country: single centre in China. Number of participants: 29 (3 female and 26 male). Age: average: 70.80 ± 6.69 years in the Cere group, 69.51 ± 7.02 years in the control group. Inclusion: mild to moderately severe VaD according to DSM‐IV criteria, with a Hachinski score of ≥ 7. Dementia occurred within 3 months after the onset of confirmed cerebral vascular disease, and the manifestations persisted for more than 3 months. Exclusion: patients with evidence of other kinds of dementia, with severe cardiac, cerebral, or renal dysfunction, severe psychiatric disorders or diabetes mellitus, and patients who had recently received other treatments for dementia. Baseline: the study groups had similar baseline characteristics. |
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Interventions | Cere group: Cere 20 mL + Xuesaitong (a traditional Chinese patent medicine) 0.4 g + physiological saline 250 mL or 50 g/L glucose solution 250 mL Control group: Xuesaitong (a traditional Chinese patent medicine) 0.4 g + physiological saline 250 mL or 50 g/L glucose solution 250 mL i.v. infusions 60 to 120 min once daily, 10 days for each course and 1 course in each spring and autumn; in total 6 courses for the whole 3 years. |
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Outcomes | MMSE WAIS‐RC |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were allocated randomly by drawing lots. |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment was not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Stated that participants and investigators were blinded during the interventions. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Stated that participants and investigators were blinded during the evaluations. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None of the 29 enrolled participants were lost to the study or follow‐up. |
Selective reporting (reporting bias) | Unclear risk | The study protocol is unavailable, so information was insufficient information to make a definitive judgement. |
Other bias | Low risk | No other potential bias was found. |
ADAS‐cog+: Alzheimer's Disease Assessment Scale Cognitive Subpart, Extended Version; ADCS‐ADL: Alzheimer's Disease Cooperative Study – Activities of Daily Living; Cere: Cerebrolysin; CIBIC+: Clinician's Interview‐Based Impression of Change plus Caregiver Input; CIBIS+: Clinician's Interview‐Based Impression of Severity; DSM: Diagnostic and Statistical Manual of Mental Disorders; EEG: electroencephalogram; GDS: Global Deterioration Scale; HDS: Hasegawa Dementia Scale; ICD: International Classification of Disease; ITT: intention‐to‐treat; i.v.: intravenous injection; LOCF: last observation carried forward; MMSE: Mini‐Mental State Examination; NaCl: sodium chloride; NINDS‐AIREN: National Institute of Neurologic Disorders and Stroke – Association Internationale pour la Recherche et l'Enseignement en Neurosciences; PR: power ratio; qEEG: quantitative electroencephalogram; VaD: vascular dementia; WAIS‐RC: Wechsler Adult Intelligence Scale ‐ Revised for Chinese.