Campbell 1975.
Study characteristics | ||
Methods | Cross‐over RCT | |
Participants |
Setting: Diabetic and Dietetic Department, University Department of Medicine, The Royal Infirmary, Edinburgh Number of participants: 6 Unit of randomization: individual Age (mean): 50 Diagnostic criteria of orthostatic hypotension: symptomatic postural hypotension with a fall of systolic BP of 30 mmHg or greater immediately on changing from the lying to standing position Severity of OH: see “diagnostic criteria of orthostatic hypotension” Severity of underlying illness: severe diabetic neuropathy Inclusion/exclusion criteria: see “diagnostic criteria of orthostatic hypotension” |
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Interventions |
Intervention: 0.1 mg of fludrocortisone twice a day for 3 weeks Comparator: placebo twice a day for 3 weeks |
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Outcomes |
Time points reported: baseline, 3 weeks Primary outcome: mean systolic and diastolic BP in lying and tilted position at 1‐min increments Secondary outcomes: orthostatic symptoms |
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Notes | Conflicts of interest not reported. Fludrocortisone and placebo tablets were supplied by ER Squibb and Son, Ltd | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details provided |
Allocation concealment (selection bias) | Unclear risk | No details provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Low for BP; unclear for symptoms |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Low for BP; unclear for symptoms |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Low for BP; unclear for symptoms, 16% attrition while taking active drug for reason of "defaulted" |
Selective reporting (reporting bias) | Unclear risk | No protocol |
Other bias | Unclear risk | First period data not available. No assessment for period effect |