Safety and efficacy of Eupatorium laevigatum paste as therapy for buccal aphthae: randomized, double-blind comparison with triamcinolone 0.1% orabase.

Eupatorium laevigatum Lam. is a plant common to the central region of Brazil, where it is a widely used remedy for lesions such as buccal aphthae. These painful inflammatory ulcers affect 50% of the general population. For the first part of this two-part study, a phytotherapeutic preparation from E. laevigatum extracts was formulated into an orabase paste appropriate for use on the buccal mucosa. The study evaluated the toxicologic safety of this paste in 20 healthy volunteers, as determined by changes in biochemical and hematologic values and on urinalysis and intrabuccal examination. The second part of the study was a randomized, double-blind comparison of efficacy with triamcinolone 0.1% orabase in 60 patients. The healthy volunteers tolerated the phytotherapeutic paste well, and no adverse effects could be attributed to its use. In the clinical comparison, after 5 days of treatment, 40% of the patients who used the paste and 26.7% of those who used triamcinolone obtained complete cure of the ulcers. Pain was alleviated in 70% of the phytotherapeutic group and in 33.3% of the triamcinolone group. The phytotherapeutic paste of E. laevigatum was a safe and effective treatment of buccal aphthae, the most common disease of the buccal mucosa.