[Comparative study of misoprostol and nifedipine in the treatment of Raynaud's phenomenon secondary to systemic diseases. Hemodynamic assessment with Doppler duplex]

Abstract

Objective: To evaluate the mid-term efficiency and therapeutic safety at a mid term of the orally administered misoprostol, a synthetic PGE1, analogue, compared with nifedipine for the treatment of RP secondary to autoimmune systemic diseases.

Methods: A double blind, crossover study was designed. Patients were randomly distributed to receive either retard nifedipine (20 mg/12 hourly) and misoprostol (200 micrograms/12 hourly) in 10-day periods (washing period with placebo for 10 days). At the end of each period a clinical assessment was obtained on the frequency and severity of symptoms as well as on secondary drug reactions. Simultaneously, blood flow changes in radial artery were Doppler-duplex investigated (pulsatility index, resistance index).

Results: Twenty patients were studied (15 women and 5 men). The mean basal daily frequency of attacks was 4.8 +/- 2.0 compared with 2.4 +/- 1.4 with nifedipine (p < 0.001) and 2.6 +/- 1.2 with misoprostol (p < 0.001). The mean basal severity of attacks, according to a pre-established scale decreased from 3.7 +/- 0.6 to 1.9 +/- 0.9 with nifedipine (p < 0.001) and to 2.0 +/- 1.0 with misoprostol (p < 0.001). The mean basal value of blood flow in radial artery was 24.9 +/- 14.4 ml/min; with nifedipine it increased to 43.0 +/- 19.2 ml/min (p < 0.001) and with misoprostol to 46.9 +/- 19.2 ml/min (p < 0.001). Five patients (25%) had secondary effects with nifedipine and three (15%) with misoprostol; in no case had therapy to be discontinued.

Conclusions: Misoprostol was similar to nifedipine for the treatment of Raynaud phenomenon secondary to systemic diseases and can be a therapeutic alternative for these patients.