A clinical trial of prostaglandin E2 in recurrent aphthous ulceration

Thirty-five patients suffering from minor recurrent aphthous ulceration (RAU) entered a single-phase double-blind clinical trial of treatment with topical prostaglandin E2 (PGE2). The PGE2 was applied as a gel at a dose of 0.3 mg twice daily for 10 days. The vehicle alone acted as control. Patients were examined on days 1, 3, 5, 7 and 10 and also maintained daily diary cards. Of the 33 patients (94%) who completed the study, 18 had been allocated the active PGE2 and 15 the placebo. The two volunteers who failed to complete were excluded on technical grounds related to the strict study design and did not withdraw on the basis of adverse reactions to the trial preparation. Patients using the active PGE2 gel experienced significantly fewer new lesions than those on placebo (P < 0.05) over the 10-day trial period. There were no significant differences between the PGE2 and placebo gels in terms of speed of healing or pain relief of established aphthous ulcers. Prostaglandin E2 may, therefore, have useful prophylactic activity in RAU.