Schmieder 2009.
| Methods | Allocation: randomized, "Randomization by center was performed by the interactive voice response system provider with the use of a validated system that automates the random assignment of patients to randomization numbers. Randomization data were kept strictly confidential until the time of unblinding." Blinding: double‐blinded Duration: 1 year Funding: Novartis Pharmaceuticals Corporation, East Hanover, NJ |
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| Participants | Diagnosis: hypertension, mean sitting DBP > 90 mmHg and < 110 mmHg at the single‐blind placebo run‐in visit N = 962 Age: Aliskiren group 56.1 ± 10.9 years; HCTZ group 55.7 ± 10.9 years Sex: 36% women; 64% men History: mean duration of hypertension was 7.1 years. 35.2% of participants were classified as obese (body mass index 30 kg/m2), and 10.9% had DM (according to medical history) Inclusion criteria: outpatients aged 18 years or over with essential hypertension Exclusion criteria: not reported |
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| Interventions | RAS inhibitor: aliskiren; thiazide: HCTZ Aliskiren 150 mg 300 mg daily HCTZ 12.5 mg 25 mg daily Amlodipine was added when needed |
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| Outcomes | Mean sitting DBP and SBP were measured by a mercury sphygmomanometer. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomization by center was performed by the interactive voice response system provider with the use of a validated system that automates the random assignment of patients to randomization numbers." |
| Allocation concealment (selection bias) | Low risk | Quote: "Randomization data were kept strictly confidential until the time of unblinding." |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Method of blinding was not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data were unlikely to have an impact on the results of the trial |
| Selective reporting (reporting bias) | Low risk | Outcomes listed in the methods were all reported |
| Other bias | Unclear risk | Insufficient information was found to evaluate the risk as either high or low |