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Traditional Chinese medicine combination therapy for patients with steroid-dependent ulcerative colitis: study protocol for a randomized controlled trial

Overview of attention for article published in Trials, January 2017
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Title
Traditional Chinese medicine combination therapy for patients with steroid-dependent ulcerative colitis: study protocol for a randomized controlled trial
Published in
Trials, January 2017
DOI 10.1186/s13063-016-1763-9
Pubmed ID
Authors

Kai Zheng, Hong Shen, Jia, Yuelin Lu, Lei Zhu, Lu Zhang, Zhaofeng Shen

Abstract

Approximately 20% of patients with ulcerative colitis become steroid dependent. Azathioprine is recommended in steroid-dependent ulcerative colitis, but its side effects limit its use. Chinese herbal medicine has been widely used to treat ulcerative colitis in China. However, its effectiveness in steroid-dependent patients has not been evaluated. This study aims to investigate the efficacy of traditional Chinese medicine combination therapy with 5-aminosalicylic acid in patients with steroid-dependent ulcerative colitis. This is a parallel, multicenter, randomized controlled trial. One hundred and twenty eligible patients will be randomly assigned to a traditional Chinese medicine group or azathioprine group. All patients will be given basic treatment, which includes steroids and 5-aminosalicylic acid. Patients allocated to the traditional Chinese medicine group will receive basic treatment plus Chinese herbal medicine granules, while patients in the azathioprine group will receive basic treatment plus azathioprine. The whole study will last 24 weeks. The primary outcome measure is the steroid-free remission rate. Secondary outcome measures are health-related quality of life, efficacy of endoscopic response, degree of mucosal healing, and inflammation indicators. Results from this study may provide evidence for the effectiveness of traditional Chinese medicine combined with 5-aminosalicylic acid in patients with steroid-dependent ulcerative colitis. The findings will provide a basis for further confirmatory studies. Chinese Clinical Trial Register, ChiCTR-IPR-15005760 . Registered on 2 January 2015.

Mendeley readers

The data shown below were compiled from readership statistics for 24 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 24 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 4 17%
Student > Postgraduate 3 13%
Professor 2 8%
Student > Bachelor 2 8%
Student > Doctoral Student 1 4%
Other 3 13%
Unknown 9 38%
Readers by discipline Count As %
Medicine and Dentistry 4 17%
Pharmacology, Toxicology and Pharmaceutical Science 2 8%
Biochemistry, Genetics and Molecular Biology 2 8%
Psychology 2 8%
Computer Science 1 4%
Other 1 4%
Unknown 12 50%