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. 2017 Jan 27;2017(1):CD002854. doi: 10.1002/14651858.CD002854.pub4
Methods Design: randomised, placebo‐controlled, double‐blind study
Duration: 6 months
Participants Country: Spain
Number of centres: 1
Diagnosis: probable AD according to NINCDS‐ADRDA
Number of participants: 57 participants total randomised (completers: 19 in vitamin E group, 14 in placebo group), 18 healthy controls
Age: not described
Gender: not described
Ethnicity: not described
Cognitive status: severity of participants based on the Geriatric Dementia Scale ‐ mild (n = 25), moderate (n = 26) and severe (n = 6)
Inclusion criteria: not described
Exclusion criteria: people taking antioxidant supplements or any medication other than cholinesterase inhibitors
Interventions Treatment 1: vitamin E 800 IU/day
Treatment 2: placebo daily
Outcomes Clock Drawing Test (months 0 and 6)
BDS (months 0 and 6)
MMSE (months 0 and 6)
Blood total glutathione levels and oxidised glutathione (months 0 and 6)
Plasma malondialdehyde (months 0 and 6)
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Randomization was performed using a randomized list of numbers."
Allocation concealment (selection bias) Unclear risk No reference made to how allocation concealment was ensured.
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Study described as 'double blind' but authors did not describe how blinding was maintained and whether it was successful. It is unclear whether the placebo was identical in appearance to the vitamin E treatment.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Study described as 'double blind' but authors did not describe how blinding was maintained and whether it was successful.
Incomplete outcome data (attrition bias) All outcomes High risk 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 reasons for participant dropout were not described.
Selective reporting (reporting bias) Unclear risk Outcomes reported, though the level of detail lacking. For example, means and SDs not described.
Other bias Low risk No evidence of other bias.