The Therapeutic Effect of Herbal Composition of Scutellaria baicalensis and Eleutherococcus senticosus in Patients with Recurrent Aphthous Stomatitis: A Randomized Controlled Trial

Abstract

Objective: This study aimed at assessing the therapeutic effect of herbal composition of Scutellaria baicalensis and Eleutherococcus senticosus (SB-ES drug) on recurrent aphthous stomatitis (RAS). Methods and materials: The study was a placebo-controlled, double blind, randomized trial with one year follow-up after the treatment. 68 subjects (36 in study group, 32 in placebo group) attended the final follow-up. The active and placebo drugs were administered for 20 consecutive days to study group and placebo group, respectively. After a year, the responses of the patients to treatment efficacy (subjective changes at the end of study, adverse effect), the reductions in ulcer symptoms (frequency, pain score, size, duration of ulcers) were assessed. Results: Many patients (78%) from study group reported that their RAS was better than before the treatment. The adverse effects (diarrhea, constipation) were also reported in most of the patients in study group, and these were improved by combined use of antacids or laxatives during the period of treatment or cessation of taking drugs. And after a year, there were marked reductions (more than 50%) in frequency, pain score, size and duration of ulcers in study group and the differences between groups or between before and after study were statistically significant (p<0.001). Conclusion: According to 1-year study we conducted, the use of SB-ES drug can markedly improve the main symptoms of RAS (frequency and pain of ulcers) when used at a dose of 5 tablets, trice daily for 20 consecutive days in RAS patients.