Methods |
Design: randomised, placebo‐controlled, double‐blind study Duration: 6 months |
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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 |
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Interventions |
Treatment 1: vitamin E 800 IU/day Treatment 2: placebo daily |
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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) |
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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. |