| Methods |
Randomized
Double blind
Placebo controlled
Crossover design |
| Participants |
N=41 patients with primary RP.
26 female, 15 male.
Mean age = 46, ranging from 15 to 74.
All patients experienced vasospastic attacks induced by cold or emotion.
Mean duration of symptoms was 7 years.
21 patients were smokers.
1 patient dropped out. |
| Interventions |
Additional vasoactive drugs prohibited for the trial period, other medications continued.
16 weeks long, divided into patients introduction placebo runin period of 4 weeks, and the 12 week study with crossover after 6 weeks.
For the next 4 weeks patients in the active group recieved Ketanserin BID. |
| Outcomes |
Patients asked to keep a diary of duration and frequency of attacks. Existence of edema was examined and checked by body weight.
Patients were asked about side effects.
Diary contained details of cold sensation, numbness, parasthesia, pain, and smoking habits.
Non‐invasive vascular measurements included a study of digital skin temperature, digital cystolic blood pressure, and doppler spectral analysis.
All measurements performed on each visit to the vascular laboratory before and after instant provocation on the left hand. |
| Notes |
Quality Score = 3 |
