TY - JOUR
T1 - Efficacy and safety of Fufangkushen colon-coated capsule in the treatment of ulcerative colitis compared with mesalazine
T2 - A double-blinded and randomized study
AU - Gong, Yang
AU - Zha, Qinglin
AU - Li, Li
AU - Liu, Yan
AU - Yang, Bo
AU - LIU, Liang
AU - LYU, Aiping
AU - Lin, Yifan
AU - Jiang, Miao
N1 - Funding Information:
This study was supported jointly by the National Eleventh Five Year Support Project of China ( 2006BAI04A10 ) and National Science Foundation of China (No. 30902003 ).
PY - 2012/6/1
Y1 - 2012/6/1
N2 - 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.
AB - 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.
KW - Clinical trials
KW - Fufangkushen colon-coated capsule (FCC)
KW - Mesalamine
KW - Traditional Chinese medicine
KW - Ulcerative colitis
UR - http://www.scopus.com/inward/record.url?scp=84861197356&partnerID=8YFLogxK
U2 - 10.1016/j.jep.2011.08.057
DO - 10.1016/j.jep.2011.08.057
M3 - Journal article
C2 - 21911045
AN - SCOPUS:84861197356
SN - 0378-8741
VL - 141
SP - 592
EP - 598
JO - Journal of Ethnopharmacology
JF - Journal of Ethnopharmacology
IS - 2
ER -