Skip to main content
. 2012 Nov 14;2012(11):CD002854. doi: 10.1002/14651858.CD002854.pub3

Lloret 2009

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)
Interventions 6‐month intervention
1. Vitamin E (800 IU/day)
2. Placebo daily
Outcomes 1. Clock drawing
2. BDS
3. MMSE
4. Oxidative stress levels
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