Abstract
Background Ulcerative colitis (UC), a chronic inflammatory bowel disease, is characterized by abdominal pain, diarrhea, and mucopurulent bloody stool. In recent years, the incidence and prevalence of UC have been increasing consistently. Five-flavor Sophora falvescens enteric-coated capsule (FSEC), a licensed Chinese patent medicine, was specifically used to treat UC. This review was aimed to assess the effectiveness and safety of FSEC for the treatment of UC. Methods Six electronic databases were searched from inception to March 2021. Randomized clinical trials (RCTs) comparing FSEC or FSEC plus conventional Western medicine with conventional Western medicine in participants with UC were included. Two authors screened all references, assessed the risk of bias, and extracted data independently. Binary data were presented as risk ratios (RRs) with 95% confidence intervals (CIs) and metric data as mean difference (MD) with 95% CI. The overall certainty of the evidence was assessed by GRADE. Results We included 15 RCTs (1194 participants, 763 in the FSEC group and 431 in the control group). The treatment duration ranged from 42 to 64 days. Twelve trials compared FSEC with conventional Western medicine, and two trials compared FSEC plus conventional medicine with conventional medicine. Another trial compared FSEC plus mesalazine with compound glutamine enteric capsules plus mesalazine. FSEC showed a higher clinical effective rate (improved clinical symptoms, colonoscopy results, and stools) (RR 1.12, 95% CI 1.05 to 1.20; 729 participants; 8 trials; low-quality evidence) as well as the effective rate of traditional Chinese medicine (TCM) syndromes (RR 1.10, 95% CI 1.01 to 1.20; 452 participants; 5 trials; low-quality evidence) compared to mesalazine. There was no significant difference in the adverse events between FSEC and control groups. Conclusions FSEC may show effectiveness in UC treatment compared to conventional medicine, and the use of FSEC may not increase the risk of adverse events. Due to the limited number of clinical trials and low methodological quality of the included trials, our findings must be interpreted with discretion.
Highlights
Ulcerative colitis (UC), a chronic inflammatory bowel disease, is characterized by abdominal pain, diarrhea, and mucopurulent bloody stool
One Randomized clinical trials (RCTs) compared the clinical efficacy of falvescens enteric-coated capsule (FSEC) combined with mesalazine versus mesalazine, and there was no significant difference (RR 1.17, 95% confidence intervals (CIs) 1.00 to 1.37; 86 participants; 1 trial; low-quality evidence)
One trial compared FSEC plus mesalazine with compound glutamine enteric capsules plus mesalazine. e result showed that the FSEC group had worse clinical efficacy than the compound glutamine group (RR 0.79, 95% CI 0.67 to 0.95; 80 participants; 1 trial; lowquality evidence)
Summary
Ulcerative colitis (UC), a chronic inflammatory bowel disease, is characterized by abdominal pain, diarrhea, and mucopurulent bloody stool. FSEC may show effectiveness in UC treatment compared to conventional medicine, and the use of FSEC may not increase the risk of adverse events. UC is characterized by a prolonged disease course and high risk of cancer and is challenging to cure and easy to relapse, which seriously affects the quality of patients’ lives [2, 3]. It has been listed as one of the intractable diseases by the World Health Organization and recently became a hotbutton issue in digestive diseases. A German study showed that the average annual treatment cost for patients with UC was 8772.03 euros, and the number of absentee days due to UC was about 16.1 days [11]
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