Wald 2012.
Methods | Individual-level randomised double-blind placebo-controlled cross-over trial | |
Participants | 86 individuals (43 Polypill then placebo; 43 placebo then Polyp ill) aged 50 years or over without history of cardiovascular disease who were previously taking simvastatin and blood pressure lowering drugs; limited to participants living in London or could travel easily to London | |
Interventions | Intervention: fixed-dose combination (amlodipine 2.5mg, losartan 25mg, hydrochlorothiazide 12.5mg, simvastatin 40mg) daily for 12 weeks Control: placebo |
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Outcomes | SBP, DBP, total cholesterol, LDL-C, HDL-C, triglycerides, apoB, adherence | |
Notes | Control: inactive/placebo | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated block randomisation |
Allocation concealment (selection bias) | Low risk | Computer generated block randomisation with sequential identical blister packs |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo controlled |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors reported as being blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Primary outcomes reported |
Selective reporting (reporting bias) | Unclear risk | Adverse event data not clearly described; only proportion of individuals with “symptom”, which was assumed to be an adverse event |
Other bias | Low risk | No need for intention-to-treat analysis as cross-over design. Any losses to follow-up clear |