• Xiaofan Chen, Dongmei Yan, Jianhe Fang, Wenjun Liu, Heyun Nie, Nonghua Lv, Nian Fang, Jinhua Gong, Jianwei Yu, Yiping Jiang, Zhijun Liu, Huihu Gan, Ying Fu, Deping Yang, Yan Xiong, Dunju Liu, Ming Chen, Yanping Wang, Yang Wang, Xin Sun, Xu Zhou, and Weifeng Zhu.
• Evidence-based Medicine Research Center, Jiangxi University of Traditional Chinese Medicine, Nanchang, Jiangxi.
• Medicine (Baltimore). 2019 Jul 1; 98 (29): e16561e16561.

BackgroundPeptic ulcer disease (PUD) is a major burden worldwide. Several challenges remain with standard Western treatment of PUD, such as persistent weakness, fatigue, and relapse. A dietary traditional Chinese medicine (TCM) formula, Hou Gu Mi Xi (HGMX), has been developed as a complementary treatment for PUD.AimsThis multicenter, double-blind, randomized controlled trial will assess efficacy and safety of HGMX in patients with PUD.MethodsThree hundred sixty eligible patients will be assigned to receive HGMX, placebo, HGMX + rabeprazole or placebo + rabeprazole for 4 weeks after 2 weeks of standard Western treatment. This first step, with a 2 × 2 factorial design, will focus on assessing the main and interaction effects of HGMX and rabeprazole on ulcer healing. Then, rabeprazole will be stopped, and HGMX will be continued for up to 1 year. The second step, with a placebo-controlled design, will compare the long-term effects of HGMX and placebo. Extended follow-up with no treatment will continue for up to 2 years. Independent and paired t tests, Pearson χ test and the rank-sum test will be used to compare between-group differences. The P value will be adjusted using the O'Brien & Fleming method for multiple comparisons.Expected OutcomesThe primary outcomes are total efficacy rate of PUD treatment, quality of ulcer healing, and changes in spleen qi deficiency symptoms. The secondary outcomes include ulcer area, PUD recurrence, Helicobacter pylori eradication rate, gastric function, body weight, and body mass index. Adverse events (AEs), severe AEs, treatment-related AEs, and withdrawal owing to AEs will be recorded to assess treatment safety.DiscussionThe trial results will provide high-quality evidence for HGMX, as a complementary therapy, for the long-term management of PUD and will be valuable for the development of related guidelines and regulations.Trial RegistrationThe protocol of this trial was approved in all research hospitals and was registered in ClinicalTrials.gov at October 25, 2017(No. NCT03320538).

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