Ulcerative colitis (UC) is a prevalent type of inflammatory bowel disease (IBD) characterized by inflammation and ulceration in the rectum and colon.1 The optimal therapeutic effect of current treatment strategies for UC may be unattainable; even surgery may be followed by ongoing morbidity. Pharmacological therapies, mainly including aminosalicylates, steroids, immunosuppressants, etc., are used to control the acute onset of UC, heal the mucosa, and prevent complications.2 In clinical practice, some patients, however, may experience a gradual loss of response to the therapy while others may show intolerance to the adverse effects of drugs.3 Consequently, an increasing number of UC patients (21%–60%) prefer to seek additional help from Chinese herbal medicine (CHM). While numerous clinical studies have demonstrated the efficacy of CHM therapies in relieving symptoms, enhancing the therapeutic effects of chemical drugs, and reducing side effects and recurrence rates in UC patients, recommending CHM interventions for UC treatment remains cautious due to significant issues related to the choice and reporting of outcome measures.4-7 The lack of agreed-upon and standardized evaluation criteria, such as tongue and pulses in Chinese medicine (CM), contributes to considerable variation in outcome measurement and reporting among studies, making comparisons challenging.8 Therefore, we aim to summarize existing endpoint definitions and measurement tools, and inspect the efficacy and safety outcomes reported in randomized controlled trials (RCTs) of CHM in adults with UC. Given that some UC patients in China receive integrative Chinese and Western Medicine (ICWM) therapy over CHM or Western Medicine (WM) alone, the development of a core outcome set (COS) for CHM studies of UC is crucial. Such a COS would help reduce outcome heterogeneity, enhance study quality, and contribute to generating robust evidence for innovative UC therapies, ultimately fostering international recognition in the field.
ContributorsXuan Zhang, Lin Zhang, Juan Wang, Lihan Hu, Xuanqi Zhang, Nana Wang, Hanzhi Tan, Chung Wah Cheng, Ji Li, Fei Han, Ping Wang, Aiping Lyu, Zhaoxiang Bian
Disease Category: Gastroenterology
Disease Name: Inflammatory bowel disease (IBD), Ulcerative colitis
Age Range: 0 - 100
Sex: Either
Nature of Intervention: Other
- Systematic review of outcomes measured in trials
- Systematic review