Methods |
Single blind
Placebo controlled
Randomized
Crossover design |
Participants |
N = 10 patients, aged 18‐60 years, 5 male, 5 female
Typical RP and related connective tissue disorders.
No patients dropped out. |
Interventions |
Patients recieved no drugs other than ketanserin, nifedipine, or placebo.
Initially recieved orally in the washout period placebo for 4 weeks. Then randomly assigned to recieve either nifedipine orally or ketanserin for four weeks.
After this a 2 week lasting placebo phase interconnected with a crossover to the final 4 week lasting therapy phase. |
Outcomes |
Patients recorded possible adverse effects, frequency, duration, and severity of attacks.
Severity assessed using a 3 point scale.
Patients rated treatment on a 3 point scale.
Laboratory parameters including blood cell count, ESR, and a biochemical analysis of renal and hepatic function was performed.
Plethysmography, skin temperature recordings, and video microscopy were performed, thereby flowmetry, a standard cold provocation test, and typical morphological changes of skin capillaries were monitored. |
Notes |
Quality Score = 2 |