[Efficacy of Yunnan Baiyao as an adjuvant treatment for active ulcerative colitis: an open-label randomized controlled study].

Objective: To investigate the efficacy of Yunnan Baiyao (YNBY)as an adjuvant treatment of active ulcerative colitis.

Methods: A total of 221 patients with active ulcerative colitis were randomized into YNBY group (78 cases) and control group (143 cases). The patients were followed up for 26 weeks and time of remission and serological data (WBC, HGB, PLT, and CRP) were recorded.

Results: The patients receiving YNBY as an adjuvant therapy had a median remission time of 9 weeks (95% CI: 8.293-9.707), significantly shorter than that of 13 weeks (95% CI: 11.855-14.145) in the control patients (P<0.001). According to the extent of the lesion, both YNBY group and control group were classified into E1, E2 and E3 subgroups, and the median remission time was 7 versus 11 weeks in E1 subgroups (P=0.09), 10 versus 13 weeks in E2 subgroups (P=0.04), and 9 versus 14 weeks in E3 subgroups (P<0.001). According to the disease severity, the patients in YNBY group and control group had a median remission time of 9 versus 10 weeks in mild cases (P=0.568), 9 versus 14 weeks in moderate cases (P<0.001), and 11 versus 20 weeks in severe cases (P=0.001). According to the standard treatment received, the median remission time in YNBY group and control group was 9 versus 12 weeks in those receiving mesalazine (P<0.001), 9 versus 13 weeks in those receiving corticosteroid (P=0.001), and 7 versus 14 weeks in those receiving infliximab (P=0.04). Cox proportional hazards regression analysis showed that YNBY was a protective factor for disease remission. The remission time was shortened by 2.283 times (95% CI: 1.69-3.070, P<0.001) in patients having YNBY as an adjuvant treatment compared to the control group.

Conclusion: Patients with active ulcerative colitis can benefit from YNBY as an adjuvant treatment, which shortens the time of disease remission, relieves the symptoms and improves the quality of life of the patients.