Skip to main content
. 2017 Dec 13;2017(12):CD000467. doi: 10.1002/14651858.CD000467.pub2

Kirch 1987.

Methods Single‐blind placebo‐controlled randomized trial
 Cross‐over design
Participants N = 10 patients ‐ 5 male, 5 female
Age 18 to 60 years
 Typical Raynaud's phenomenon and related connective tissue disorders
 No dropouts
Interventions Participants given no drugs other than ketanserin, nifedipine, or placebo
 Initially received placebo orally during washout period of 4 weeks, then randomly assigned to receive either nifedipine or ketanserin orally for 4 weeks
 Then, a 2‐week lasting placebo phase interconnected with a cross‐over to the final 4‐week lasting therapy phase
 Total study duration 14 weeks
Outcomes Participant diary used to record possible adverse effects and frequency, duration, and severity of attacks
 Severity assessed on a 3‐point scale
 Patient treatment rating on a 3‐point scale
 Laboratory parameters performed including blood cell count, erythrocyte sedimentation rate, and biochemical analysis of renal and hepatic function
 Skin temperature recordings and videomicroscopy performed, thereby monitoring flowmetry, a standard cold provocation test, and typical morphological changes in skin capillaries
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Evidence insufficient for judgement of risk
Allocation concealment (selection bias) Unclear risk Evidence insufficient for judgement of risk
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Single‐blind study ‐ patients unaware of their treatment arm
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Participant diary used to record attack frequency and duration and adverse effects
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No losses to follow‐up
Selective reporting (reporting bias) Low risk None detected
Other bias Low risk Washout period of 2 weeks separating cross‐over periods