Reid 2005.
| Study characteristics | ||
| Methods |
Study design: randomised, double‐blind trial Total duration of study: no details given Details of any 'run‐in' period: no details given Number of study centres and location: Vascular Surgery Unit of Belfast City Hospital Study setting and date of study: outpatients; August 2001 to February 2003 |
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| Participants |
Number randomised: 28 participants Number lost to follow‐up/withdrawn: no details given Number analysed: 28 participants Number of interest: 28 participants Mean age: 70 (1.5) years in placebo group and 71 (1.3) years in pravastatin group Age range: no details given Gender: no details given Severity of condition: carotid artery disease Diagnostic criteria: no details given Smoking history: 35 smokers Inclusion criteria: "people with carotid artery disease not undergoing surgery and with cholesterol concentration less than 5.5 mmol/L." Exclusion criteria: "patients were excluded if they were already on a cholesterol‐lowering drug or had previous carotid endarterectomy." |
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| Interventions |
Intervention: pravastatin 40 mg daily Comparison: placebo Concomitant medications: no details given Excluded medications: no details given |
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| Outcomes |
Primary outcome: combined measure of IMT of the right and left CCAs Secondary outcome: serological measurements of cholesterol concentration Time points reported: 3, 6, and 9 months following randomisation |
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| Notes |
Funding for trial: Bristol‐Myers Squibb and Northern Ireland Chest Heart and Stroke Association Notable conflicts of interest of trial authors: no details given Protocol: no details given |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Patients were randomly assigned in blocks of four but not described how it was done |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Patients were randomly assigned in blocks of four in a blinded fashion to receive treatment with either pravastatin 40 mg daily or placebo"; and "One operator, blinded to patient treatment or randomisation performed all the scans." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The IMT was calculated using a computer program removing any observer bias." |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number of lost to follow‐up/withdrawn not reported |
| Selective reporting (reporting bias) | Low risk | All outcome measures have been reported in the results section |
| Other bias | Low risk | No other source of bias detected |