ABSTRACT
Objective:To investigate the efficacy of Sishen pill compound combined with mesalazine in the treatment of mild to moderate ulcerative colitis and its effect on the circadian rhythm of symptoms. Methods:A total of 136 patients with mild to moderate ulcerative colitis who received treatment in Hospital of Chengdu University of Traditional Chinese Medicine from January 2018 to December 2020 were included in this prospective randomized controlled trial. These patients were divided into a treatment group ( n = 68) and a control group ( n = 68). The treatment group was treated with Sishen pill compound combined with mesalazine. The control group was treated with mesalazine alone. All patients were treated for 12 weeks. Clinical efficacy, as well as morning abdominal pain grade, morning diarrhea score, fecal trait score, Mayo score, hemoglobin, and hypersensitive C-reactive protein pre- and post-treatment, were compared between the two groups. Results:Total response rate in the treatment group was significantly higher than that in the control group [91.18% (62/68) vs. 72.06% (49/68), χ2 = 8.28, P < 0.05]. After treatment, morning diarrhea score, morning abdominal pain score, fecal trait score, Mayo score, hemoglobin, and hypersensitive C-reactive protein in the treatment group were (0.47 ± 0.56) points, (0.53 ± 0.56) points, (3.01 ± 0.72) points, (7.13 ± 1.38) points, (108.04 ± 12.21) g/L, (4.00 ± 2.19) mg/L, respectively, and they were (0.84 ± 0.56) points, (1.12 ± 0.56) points, (4.40 ± 0.76) points, (3.25 ± 1.44) points, (102.15 ± 12.61) g/L, and (6.07 ± 3.66) mg/L respectively in the control group. There were significant differences in these indexes between the treatment and control groups ( t = 3.59, 5.95, 10.06, 9.62, 2.78, 3.99, all P < 0.05). Conclusion:Sishen pill compound combined with mesalazine can effectively reduce clinical symptoms of active ulcerative colitis, increase hemoglobin level, decrease C-reactive protein level, improve the efficiency of treatment, reduce symptoms and the number of diarrhea rhythms, and improve stool symptoms of mild to moderate ulcerative colitis patients.