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. 2021 May 17;2021(5):CD012868. doi: 10.1002/14651858.CD012868.pub2

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”
Interventions Intervention: 0.1 mg of fludrocortisone twice a day for 3 weeks
Comparator: placebo twice a day for 3 weeks
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
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