Semplicini 2000.
| Study characteristics | ||
| Methods |
Study design: double‐blind, randomised, parallel study Total duration of study: 3 months Details of any 'run‐in' period: 4‐week single‐blind placebo period Number of study centres and location: no details given, Italy Study setting and date of study: outpatients; no details given |
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| Participants |
Number randomised: 15 participants Number lost to follow‐up/withdrawn: no details given Number analysed: 15 participants Number of interest: 15 participants Mean age: no details given Age range: 55 to 75 years Gender: 13 men and 2 women Severity of condition: essential hypertension Diagnostic criteria: "at least one stenosis (50% to 70%) of an internal carotid artery." Smoking history: no details given Inclusion criteria: "essential hypertensive were selected from the outpatient clinic database because of the presence of at least one moderate (30% to 60%) stenosis of the internal carotid arteries at echocolor Doppler examination." Exclusion criteria: "secondary hypertension was excluded by means of standard biochemical and radiological imaging tests, all had a negative history of cerebrovascular diseases." |
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| Interventions |
Intervention: lacidipine (4 to 6 mg once daily, orally) Comparison: hydrochlorothiazide (HCTZ, 25 to 50 mg once daily orally) Concomitant medications: no details given Excluded medications: no details given |
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| Outcomes |
Primary outcome: "measure of mean relative perfusion (MRP) in the cortical and subcortical areas (thalami and basal ganglia)." Secondary outcome: clinical (blood pressure) measurement Time points reported: regional cerebral perfusion was assessed at baseline and at the end of the treatment period with HMPAO‐SPECT (12 weeks) |
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| Notes |
Funding for trial: "the study was made possible by a research grant from GlaxoWellcome." 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 | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The patients were enrolled for a double‐blind, parallel study" and "The examination was carried out by the same sonographer who was not aware of the patient’s clinical data and treatment." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "CT scans were examined twice by a single observer (C.C.) unaware of the patient identity." |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number lost to follow‐up/withdrawn not reported |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported |
| Other bias | Low risk | No other source of bias detected |