Abstract

Objectives To critically appraise the efficacy and safety of Kangfuxinye enema combined with mesalamine for the ulcerative colitis (UC) patients and in addition to grade the quality of evidence by using the GRADE (grading of recommendations, assessment, development, and evaluation) approach. Methods A literature search was performed in the Cochrane Library, MEDLINE, EMBASE, CBM, CNKI, VIP, and WanFang Databases. The search restrictions were patients with UC and RCTs. Studies including other treatments except Kangfuxinye with mesalamine were excluded. Results Nineteen studies met the inclusion criteria. We found significant benefits of Kangfuxinye combined with mesalamine against mesalamine alone in improving response rate as well as reducing the recurrence rate and inflammation rate; meanwhile, the increase of the adverse events rate was not observed. Furthermore, the symptoms remission rate and the cure time were insignificant statistically. Additionally, GRADE results indicated that the quality of evidence regarding the above 6 outcomes was rated from very low to moderate quality. Conclusions Although Kangfuxinye enema seems effective and safe for treating UC patients in this systematic review, Kangfuxinye enema combined with mesalamine was weakly recommended due to very low to moderate quality of available evidence by the GRADE approach.

Highlights

  • Ulcerative colitis (UC) is one of the 2 major types of inflammatory bowel disease (IBD), along with Crohn disease but 3 times more common compared to it [1, 2]

  • The results in our study showed that, compared to mesalamine alone, Kangfuxinye enema combined with mesalamine appeared to be more effective either in reducing recurrence rate or in improving response rate and the inflammation reduction rate

  • The present study indicated that P. americana extract can increase the levels of prostaglandin E2 (PGE2) [52]

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Summary

Introduction

Ulcerative colitis (UC) is one of the 2 major types of inflammatory bowel disease (IBD), along with Crohn disease but 3 times more common compared to it [1, 2]. The incidence of UC is 1.2–20.3 cases per 100,000 per year, and the developed countries, such as Northern Europe and North America, have the highest incidence of the disease [1, 3]. In combination with the change of environment and other unknown reasons, UC has become a global emergence disease with increasing incidence and prevalence worldwide [5]. Typical symptoms of UC include abdominal pain, tenesmus, bloody diarrhea, passage of pus, mucus, or both, urgency, weight loss, and fever [6], which causes a miserable influence on the quality of life of the UC patients. UC often requires life-long maintenance therapy for relieving symptoms and/or to attenuate the inflammation while there is lack of curative treatment

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