Quantitative study of the effects of Ketanserin in patients with primary Raynaud's phenomenon. A randomized, double blind, placebo controlled investigation and an additional long term open trial.

In 41 patients with primary Raynaud's phenomenon (PRP) the effectiveness of the serotonin receptor blocker Ketanserin has been studied in a double-blind cross-over investigation and during an additional long-term open study. Objective assessments of the severity of PRP in the patients were obtained by measuring Digital Skin Temperature (DST), Digital systolic Blood Pressure (DBP) and Doppler Spectral Analysis (DOSA) of the radial and ulnar artery. All measurements were performed both before and after cold provocation. Thirty one (78%) of the patients clinically improved on Ketanserin, while only 1 patient (2.3%) improved on placebo. DST significantly increases on Ketanserin treatment. On Ketanserin treatment DBP measurements show a significant increase in the digit to brachial systolic blood pressure index (DBI) after cold provocation. DOSA showed a significant decrease of the downslope of the spectra of both radial and ulnar artery on treatment. This downslope is indicative for peripheral resistance. Neither blood chemistry nor systemic blood pressure showed any change during Ketanserin treatment. The results of the study suggest that orally administered Ketanserin can be an effective and well tolerated treatment for minimizing subjective complaints in PRP patients. Ketanserin results in an increased DST and DBP combined with a decreased peripheral resistance as measured on the radial and ulnar artery. After treatment, Ketanserin does not show any side effects.

RCT Entities:   Population Interventions Outcomes