A Randomized, Double-Blind, Multicenter, Open Phase IV Clinical Trial to Evaluate The Efficacy and Safety of A Chinese Patent Medicine Combined With Mesalazine for Ulcerative Colitis

Background: Enteric-coated HuDi capsules（HuDi）have been approved for the treatment of ulcerative colitis (UC) in China. In this clinical trial, we objectively evaluated the clinical efficacy and safety of HuDi combined with enteric-coated mesalazine tablets in the treatment of active UC.Methods: A total of 355 patients from 18 hospitals in China were randomly divided into the HuDi group, enteric-coated mesalazine tablet group (mesalazine group) or combined group with randomized, controlled double-blinding and double-modeling methods. The patients were followed every two weeks and reexamined by endoscopy at the end of six weeks of treatment. The clinical response; clinical remission rate; endoscopic response rate; mucosal healing rate; erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP); and safety indicators were evaluated after treatment.Results: The clinical response rate was 58% in the HuDi group and 58.82% in the mesalazine group, while the clinical effective rate in the combined group was 82.46%. A total of 32% of the patients receiving the enteric-coated HuDi capsules and 29.41% of the patients receiving the enteric-coated mesalazine tablets achieved clinical remission. The clinical remission rate in the combined group was 52.63%, which was better than that in the mesalazine group (P = 0.0145)and HuDi group(P = 0.0315). Moreover, the endoscopic response rates were 50% in the HuDi group, 47.06% in the mesalazine group and 64.91% in the combined group, with no significant difference among the three groups (P > 0.05). Further, the mucosal healing rates in the three groups were 44%, 41.18% and 63.16%, respectively, the combined group was better than that in the HuDi group(P=0.0472) and mesalazine group (P=0.0223). Finally, there was no significant difference in the normalization rates of the ESR and CRP among the three groups (P > 0.05).There were no serious adverse events in the combined drug group. Conclusions: In patients with mild and moderate active UC, combined treatment with enteric-coated mesalazine tablets and enteric-coated HuDi capsules improved the Clinical response and induced clinical remission. However, further studies need extended follow-up periods to determine the efficacy.Trial registration: Chinese It was registered in Clinical Trial Registry on 2015-01-14.