Recurrent aphthous stomatitis unresponsive to topical corticosteroids: a study of the comparative therapeutic effects of systemic prednisone and systemic sulodexide

Int J Dermatol. 2003 May;42(5):394-7. doi: 10.1046/j.1365-4362.2003.01853.x.


Background: Recurrent aphthous stomatitis (RAS) is a common oral condition, the etiology of which remains largely unclear. Numerous therapeutic protocols have been tried. Apart from immunomodulators, no therapy is unequivocally effective, and many systemic therapies have potential adverse effects.

Objective: To compare, in patients with frequent RAS unresponsive to conventional therapies, the therapeutic effectiveness of systemic prednisone with that of systemic sulodexide, a low-molecular-weight heparin with immunosuppressive activity but few adverse effects.

Methods: The study involved a group of 30 patients suffering from frequent minor RAS over >or= 4 months unresponsive to topical corticosteroids. Patients were randomly assigned to one of three study groups: blind therapy with systemic sulodexide or systemic prednisone and control (no treatment). The outcomes were assessed blind on the basis of the days to recovery from pain and days to recovery from ulceration (epithelialization) during the first month of therapy; the number of aphthae appearing during the second month of therapy; and the number of aphthae appearing in the 2 months after the end of the 2-month treatment cycle.

Results and conclusions: The effectiveness of systemic sulodexide was almost comparable with that of systemic prednisone in patients with frequent RAS, without significant adverse effects.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Adrenal Cortex Hormones / therapeutic use
  • Adult
  • Anti-Inflammatory Agents / therapeutic use*
  • Female
  • Glycosaminoglycans / therapeutic use*
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Male
  • Middle Aged
  • Prednisone / therapeutic use*
  • Recurrence
  • Stomatitis, Aphthous / drug therapy*
  • Treatment Outcome


  • Adrenal Cortex Hormones
  • Anti-Inflammatory Agents
  • Glycosaminoglycans
  • Immunosuppressive Agents
  • glucuronyl glucosamine glycan sulfate
  • Prednisone