Clinical Randomized Controlled Study Of Kuikeling For The Treatment In Patients With Ulcerative Colitis

Aims:The aim of this study was to observe the efficacy and safety of Kuikeling (KKL), a Traditional Chinese Medicine (TCM), for the treatment in patients with ulcerative colitis (UC) and to provide the basis for guiding therapy of ulcerative colitis.Methods:In the clinical randomized controlled study,132 patients with active ulcerative colitis were randomized into two treatment groups:KKL versus west medicine as control for 4 weeks.The KKL group with 66 cases was then divided into three groups of KKL treatment alone (KKL), KKL combined with 5-ASA (sulfasalazine) or aminosalicylates (SASP) (KKL+ASA) and KKL combined with 5-ASA or SASP and prednisolone (KKL+ASA+P) respectively. The control group with 66 cases was divided into two groups of 5-ASA treatment alone (ASA), ASA combined with prednisolone (ASA+P).The primary recording items were the clinical features such as diarrhea and bloody stool, the mucosa feature in colonoscopy and Sutherland disease activity index (DAI).The lab test such as routine blood test, liver and kidney function, erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) were also checked. The primary effect evaluation indicators were including each symptom score, DAI score and their value difference.The safety indicators were the liver or kidney function and other side effects.Results:1 The onset age of UC was common in the period of 31 to 40 years.2 The main type of UC patients were of proctosigmoiditis (34.1%) and total colitis (32.6%).3 The indicator score and the value of DAI in each group were significantly decreased after treatment (P<0.001). 4 The therapeutic effect of diarrhea in KKL was better than in ASA and ASA+P group (P<0.05). 5 The proving effect on intestinal mucosa in KKL and KKL+ASA+P is better than in ASA. The similar result was also seen in ASA+P comparing to ASA group.6 The value difference of DAI in all groups with KKL was higher than that in ASA group (P<0.05).The value difference of DAI in KKL+ASA+P group was significantly higher than that in ASA+P group (P=0.01).7 The rate of clinical complete remission was 27.3% in KKL,15.8% in KKL+ASA,22.2% in KKL+ASA+P,12% in ASA and 9.1% in ASA+P group,respectively. There was a trend with a higher clinical complete remission rate in combined treatment with KKL.8 In each group after treatment, there were significantly increased in the value of hemoglobin and decreased in the level of ESR and CRP. But the liver and kindy function was not obviously changed in each group.Conclusions:1 Study results indicated that the symptom such as diarrhea and bloody stool and DAI could be improved after treatment in different schemes with KKL alone or combined with western medicine on patients with UC.2 The TCM of Kuikeling had a good effect on diarrhea improvement.3 KKL could improve some results of lab test such as hemoglobin, ESR and CRP and it had no effects on the liver and kidney function.4 The total therapeutic effect of KKL on patients with mild and moderate active UC was better than west medicine.KKL combined with western medicine.5 The clinical symptoms of UC patients could be improved more comprehensively after the treatment combined KKL with western medicine.