Efficacy evaluation of prostaglandin E1 against placebo in patients with progressive systemic sclerosis and significant Raynaud's phenomenon

Minerva Cardioangiol. 1999 May;47(5):137-43.
[Article in English, Italian]


Background: Raynaud's phenomenon, due to connective tissue diseases, is difficult to treat successfully. Symptomatic improvement has been reported using nifedipine or iloprost, but adverse side effects may limit their use. The purpose of this study was to examine the effects of PGE1 (Alprostadil) in patients with scleroderma and severe Raynaud's disease.

Methods: Twelve females, aged 50-67 years, were included in the study with six of them receiving a 3-hour infusion of alprostadil at the standard dosage of 60 micrograms in 250 cc of physiological infusion for six consecutive days and the remaining six receiving placebo (250 cc of physiological infusion administered in the same manner).

Results: After infusion, blood flow, digitally measured by telethermography was increased only in patients treated with alprostadil. The number, frequency and severity of attacks recorded were reduced only in patients treated with alprostadil. No side effects were recorded during and after the infusion.

Conclusion: In conclusion, alprostadil is effective in the management of Raynaud's phenomenon, due to scleroderma.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Alprostadil / administration & dosage
  • Alprostadil / therapeutic use*
  • Dose-Response Relationship, Drug
  • Female
  • Fibrinolytic Agents / therapeutic use
  • Humans
  • Middle Aged
  • Placebos
  • Raynaud Disease / complications
  • Raynaud Disease / drug therapy*
  • Scleroderma, Systemic / complications
  • Scleroderma, Systemic / drug therapy*
  • Treatment Outcome


  • Fibrinolytic Agents
  • Placebos
  • Alprostadil