Efficacy and safety of Fufangkushen colon-coated capsule in the treatment of ulcerative colitis compared with mesalazine: a double-blinded and randomized study

Abstract

Ethnopharmacological relevance Fufangkushen colon-coated capsule (FCC) was a newly developed herbal drug for treating ulcerative colitis (UC) patients with traditional Chinese medicine (TCM) pattern of damp-heat accumulating in the interior. Objective To explore the efficacy and safety of FCC in the treatment of active UC compared with Huidi (HD, mesalazine enteric-coated tablets) were evaluated in a double-blinded and randomized clinical trial. Materials and Methods In the double-blind, double-dummy, multicenter, randomized and controlled study, 320 active UC patients with TCM pattern of damp-heat accumulating in the interior were assigned to two groups: 240 treated with FCC plus HD placebo treatment, 80 with HD plus FCC placebo. The drugs and their corresponding placebos were administrated at advised dosage for 8 weeks. The primary endpoint was a positive clinical response at week 8, and Mayo scoring system was employed for assessment of UC activity. Results At the 8th week, 72.50 % of patients in FCC group (170 of 234) and 65.00 % of patients in HD group (52 of 80) had achieved a clinical response. There was no statistically significance between the 2 groups (P > 0.05). The proportions of patients who had a clinical remission was similar in 2 groups (41.50 % in FCC group, 41.25 % in HD group, P > 0.05), mucosal healing rate at week 8 in the two groups were also without significant difference (55.13 % in FCC group, 55.00 % in HD group, P > 0.05). Mayo scores at week 8 showed no statistically difference in the two groups. No significant differences were observed between the safety profiles of the 2 groups (P > 0.05). No severe AEs were reported in either group. The latent class analysis indicated that FCC was superior applicable for the left hemicolon involved patients than HD. Conclusions Compared with HD, a mesalamine enteric-coated tablet, FCC is similarly effective and safe in the treatment of active UC with TCM pattern of damp-heat accumulation interior pattern. In addition, FCC indicates superior effect in the treatment of UC with inflamed area of the left hemicolon than HD.