Topical steroids such as Betnesol mouthwash are the standard therapy for Recurrent Aphthous Stomatitis (RAS). In addition systemic therapy such as Colchicine can be considered in severe cases, but to date there are no clinical trials reporting efficacies for either. In this clinical trial the efficacy of Colchicine with or without Betnesol mouthwash in the management of RAS was compared.
Method:
106 patients with RAS (major, minor) were randomized in this trial into 3 groups: (1): 36 patients on Colchicine 500mcg OD and Betnesol mouthwash QDS (C+B), (2): 35 patients on Colchicine 500mcg OD (C), (3): 35 patients on Betnesol mouthwash QDS during ulcers attacks and BD in between (B). An Ulcer Severity Score (USS) established in the department (Tappuni et al 2005) was used for assessing the initial severity and monitoring any response to the treatment, using six parameters including number, size, site, duration of ulcers, ulcer free periods and pain.
Result:
106 patients have completed 12 months of the trial. The severities of the ulcers were scored on the first visit and at 3 monthly intervals thereafter for 12 months. The (USS) mean of the whole group before any treatment was 34.8±7.3 (SD) and after 12 months of treatment (n= 86) was 17.5±8.9. The USS mean score changed in each sub-group (C+B) 37.4±6.7 to 19.2±7.8, (C) 33±6.9 to 17.7±9.7 and (B) 34.2±7.6 to 15.7±9.3 (SD).
Conclusion:
Significant reductions in the USS were found with all three modes of therapy, with reductions in the size, number, duration of ulcers and pain and an increase in the ulcer-free period. Colchicine with or without Betnesol was effective. USS offers a powerful aid in research and clinical trials for continuous monitoring of therapeutic responses.