Kruse 1993.
| Methods |
Study design: prospective, randomised trial
Setting/location: not reported.Country: Germany
Period of study: not reported (published in 1993)
Unit of randomisation: participant
Unit of analysis: participant Trial test: not reported Analysis strategy: intention‐to‐treat |
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| Participants |
Inclusion criteria: outpatients with familiar hypercholesterolaemia Exclusion criteria: not reported Randomised: 24 (M‐DG: n = 12, E‐DG: n = 12) Participants assessed: 24 participants Withdrawals: no withdrawals Definition of hyperlipidaemia: not reported Baseline characteristics: Female (%): M‐DG: 25, E‐DG: 33 Age (years) (mean (SD)): M‐DG: 48.4 (11.4), E‐DG: 45 (9.7) Total cholesterol (TC) (mg/dL) (mean (SD)): M‐DG: 424.6 (129.9), E‐DG: 450.9 (87.0) LDL‐C (mg/dL) (mean (SD)): M‐DG: 338.8 (111), E‐DG: 379.7 (80.1) HDL‐C (mg/dL) (mean (SD)): M‐DG: 36.4 (10.8), E‐DG: 40.2 (8.1) Triglycerides (mg/dL) (mean (SD)): M‐DG: 178.9 (92.1), E‐DG: 130.2 (52.3) |
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| Interventions | Type of interventions: morning vs evening doses of lovastatin M‐DG: 20 mg daily dose of lovastatin in the morning (regime 6:00 am‐10:00 am) E‐DG: 20 mg daily dose of lovastatin in the evening (regime 5:00 pm‐9:00 pm) Duration of intervention: 8 weeks. Quote: "The patients received placebo first in order to achieve stable baseline lipid values (washout period)... and all patients were randomly assigned to receive placebo...for 4 weeks. The washout period was followed by a second period of 4 weeks during which the patients were to take lovastatin 20 mg" (page 211 trial report) | |
| Outcomes | Drug compliance (consumption and time compliance) Change in lipid levels: TC, LDL‐C, HDL‐C and triglycerides levels (mg/dL) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "..and all patients were randomly assigned to receive placebo.." (page 211 trial report) Comment: insufficient information to make a judgement |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding of participants and study personnel not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessors not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Did not report number of withdrawals Comment: denominator values suggested complete follow‐up |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement of ‘low risk’ or ‘high risk’ |
| Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias existed |