Objective To observe the efficacy of self-made Koumixiao Granules for recurrent oral ulcers（ ROU）.Methods Totally 142 cases of ROU were randomized into the Koumixiao Granules group

western medicine group and integrative medicine group

with 48

46 and 48 in each.The Koumixiao Granules group was given self-made Koumixiao Granules one dose daily for 6 months.The western medicine group was given 0.6 g of Total Glucosides of Peony Capsules 3 times daily for 6 months

6 mg of Transfer Factor Capsules 3 times daily for one month

and 0.25 mg of Dequalinium Buccal Tablets 4 times daily for 10 days.The integrative medicine group was given self-made Koumixiao Granules

Total Glucosides of Peony Capsules

Transfer Factor Capsules and Dequalinium Buccal Tablets.The pain scores and ulcer sizes were evaluated before treatment and on the 5th and 10th day after treatment.The clinical efficacy was evaluated in the 3rd and 6th month after treatment and in the 12th month of follow-up.Results The pain scores were significantly decreased and the ulcer sizes were significantly reduced in all groups on the 5th and 10th day after treatment（ P < 0.05）

especially pain scores on the 10th day after treatment（ P <0.05） and pain scores and ulcer sizes in the integrative medicine group and Koumixiao Granules group on the 10th day after treatment as compared with the western medicine group（ P < 0.05）.The total efficacy in the integrative medicine group and Koumixiao Granules group was significantly higher than that in the western medicine group in the 3rd

6th and 12th month after treatment（ P < 0.05）.Conclusion Self-made Koumixiao Granules is effective for ROU and it can reduce the mucosal congestion

quickly remove pain and promote healing of ulcers.