Bentham 2008.
| Methods | Open‐label randomised controlled trial, 3 years | |
| Participants | 310 participants (156 intervention, 154 control) who had a DSM‐4 diagnosis of probable dementia of AD without a coexisting diagnosis of vascular dementia, aged 46‐90, were out‐patient in the UK. 75% took Donepezil. | |
| Interventions | Intervention: aspirin 75 mg oral once Control: avoid aspirin |
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| Outcomes | Cognition (MMSE 0‐30 higher score = improvement) at 12 wk, 1,2,3 years (NPI 0‐144 lower score = improvement) at 12 wk, 1,2,3 years Activity of daily living (BALDS 0‐60 higher score = improvement ) at 12 wk, 1,2,3 years Caregiver burden (GHQ for care give 0‐30 lower score = improvement) at 12 wk, 1,2,3 years |
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| Notes | funding from research and development directorate of the west midlands region or national health service executive | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Quote: Eligible patients were randomly assigned to take open‐label aspirin or to take no aspirin. Treatment allocation was obtained by telephone from the central trial office and used minimised randomisation generated by a computer program to balance allocations by age, severity of dementia, the presence of absence of vascular dementia, parkinsonian and psychotic symptoms. Comment: done |
| Allocation concealment (selection bias) | Unclear risk | No statement Comment: Probably not done |
| Blinding (performance bias and detection bias) All outcomes | High risk |
Quote 1: No blinding and the outcome or outcome measurement is likely to be influenced by lack of blinding. This is an open‐label study Quote 2: The potential for biased assessment by patients or raters was judged insufficient to justify the cost of packaging aspirin and placebo for this long‐term study. Comment: Not done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk |
Quote 1 Comment: Reasons for missing outcome data unlikely to be related to true outcome Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups |
| Selective reporting (reporting bias) | Low risk |
Comment: The study protocol is not available, but all of the study’s pre‐specified outcomes have been reported in the pre‐specified way in methodology |
| Other bias | High risk |
Comment: Had a potential source of bias related to the specific study design used |