The efficacy and safety of thalidomide on the recurrence interval of continuous recurrent aphthous ulceration: A randomized controlled clinical trial.

Abstract

Recurrent aphthous ulceration (RAU) is the most common oral mucosal disease. Some patients have almost continuous oral ulcers which influence the quality of life. The aim of this study was to observe the efficacy and safety of thalidomide on the recurrence interval of continuous RAU. A randomized controlled clinical trial was designed, and 60 continuous RAU patients were randomly assigned to the experimental group (n=32, taking thalidomide before bed at a dose of 100mg/d for 10days, then 50mg/d for 10days, and 25mg/d for 10days) and the control group (n=28, taking 0.4mg/kg/d prednisone every morning for 15days and then 0.2mg/kg/d for 15days). The clinical outcomes consisted of the primary outcome (recurrence interval) and the secondary outcomes (pain level, number of ulcers, and days for ulcer healing), and they were measured at every visit. Adverse reactions were recorded. A total of 54 and 51 patients presented at the first and second return visit, respectively. After 1month, the increase in the recurrence interval was not shown to differ between the two groups (P=.12). However, the improvement in the recurrence interval was significantly greater in the experimental group (P<.001) at the second return visit. The improvement in the secondary outcomes was identical between two groups at each return visit (P>.05). The incidence of adverse reactions was similar between two groups (P=.50). Thalidomide had a long-term effect of extending the recurrence interval of continuous RAU.