Methods | Randomised, placebo‐controlled, double‐blind study | |
Participants | Country: Spain Single centre Diagnosis: probable AD according to NINCDS‐ADRDA Number of participants: 57 patients, 18 healthy controls Age: not stated Inclusion criteria: not stated Exclusion criteria: patients taking antioxidant supplements, patients taking any medication other than cholinesterase inhibitors Severity of patients based on the Geriatric Dementia Scale ‐ mild (N = 25), moderate (N = 26) and severe (N = 6) |
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Interventions | 6‐month intervention 1. Vitamin E (800 IU/day) 2. Placebo daily |
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Outcomes | 1. Clock drawing 2. BDS 3. MMSE 4. Oxidative stress levels |
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Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Patients were randomly assigned to groups using a randomised list of numbers |
Allocation concealment (selection bias) | Unclear risk | No reference was made to allocation concealment was ensured |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Though it is a double‐blinded study, and random assignment occurred before the trial, there is no mention of how/if participants and personnel were blinded throughout |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Although it states it is a double‐blinded study, there is no indication to whether the assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | A total of 24/57 AD participants did not complete the research. "Of the patients who finished the study, 14 had been treated with placebo and 19 with vitamin E." The reason for participant drop‐out was not described |
Selective reporting (reporting bias) | Unclear risk | All outcomes reported sufficiently |
Other bias | Low risk | No evidence of additional bias |