| Methods |
52‐week double‐blind, parallel study. Method of randomisation: random number table.
Results presented for each arm of the trial.
Per‐protocol data analysis.
Location: 1 centre (USA). |
| Participants |
81 patients, 8 drop‐outs.
Mean age of participants: no data.
Mean duration of disease: no data.
Inclusion criteria: HD (clinical diagnosis and positive family history), mild to moderate disease (mild to moderate dementia, MMSE>15, ambulatory care), reliable family member for information and medication compliance.
Exclusion criteria: none stated. |
| Interventions |
Oral Vitamin E 3000 UI/day (40 patients) and placebo, identical capsules (33 patients). No titration. |
| Outcomes |
Change in quality of life (ADL scale of the Baltimore HD project).
Change in motor abnormalities (QNE).
Change in cognitive function (MMSE, digit span, Controlled Oral Word Association Test, Design Fluency Test, Trail Making Test, CERAD Verbal Learning Test, Luria Sequential Hand Position Test, Wisconsin Card Sorting Test, Benton Visual Retention Test, Motor Go/No‐Go Test, Stroop Word Test). |
| Notes |
Negative for efficacy measures. Post‐hoc analysis produced positive results for patients with QNE<45.
All patients were given anti‐oxidants vitamin A and C. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
