Ulcerative colitis (UC) is a prevalent type of Inflammatory Bowel Disease (IBD) that characterized as inflammation and ulceration in rectum and colon, which may eventually affect the whole colon if left untreated. The treatment strategies are based on the conventional step-up approach in which oral 5-aminosalicylic acid (5-ASA) and corticosteroids are the first-line standard therapies for mild to moderately active UC patients. However, UC is deemed as an incurable disease despite plenty of therapeutic options are available depending on the disease severity. This is because even under medical intervention UC patients are often suffering from alternating conditions of clinical relapse and remission that severely deteriorate their quality of life. Consequently, an increasing number of UC patients (ranging between 21% and 60%) seek helps from complementary and alternative medicine (CAM), especially Chinese medicine (CM), which has been practiced in eastern Asia for thousands of years. In mainland China, most UC patients preferred Integrative Chinese and Western Medicine (ICWM) over TCM or WM alone. Several reviews supported the promising effect and few side effects of ICWM for UC, but most of the included trials had high risk of bias and major methodological deficiencies, particular in the considerable heterogeneity identified in the selection, definition and measurement of outcomes among these studies. Therefore, this study aims to develop a core outcome set (COS) for use in UC clinical trials with ICWM interventions.
ContributorsDr Xuan Zhang, Prof Zhaoxiang Bian, Miss Nana Wang, Ms Chungwah Cheng, Miss Juan Wang, Chinese Clinical Trial Registry (Hong Kong), Hong Kong Chinese Medicine Clinical Study Centre, Chinese EQUATOR Centre, Centre for Chinese Herbal Medicine Drug Development Limited, Hong Kong Baptist University, HKSAR, China.
Prof Ping Wang, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Disease Category: Gastroenterology
Disease Name: Inflammatory bowel disease (IBD), Ulcerative colitis
Age Range: 0 - 100
Sex: Either
Nature of Intervention: Other
- Clinical experts
- Conference participants
- Epidemiologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Regulatory agency representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Systematic review