Chen Xiaofan, Yan Dongmei, Fang Jianhe, Liu Wenjun, Nie Heyun, Lv Nonghua, Fang Nian, Gong Jinhua, Yu Jianwei, Jiang Yiping, Liu Zhijun, Gan Huihu, Fu Ying, Yang Deping, Xiong Yan, Liu Dunju, Chen Ming, Wang Yanping, Wang Yang, Sun Xin, Zhou Xu, Zhu Weifeng
Evidence-based Medicine Research Center, Jiangxi University of Traditional Chinese Medicine, Nanchang, Jiangxi.
School of Food Science and Engineering, Inner Mongolia Agricultural University, Hohhot, Inner Mongolia.
Medicine (Baltimore). 2019 Jul;98(29):e16561. doi: 10.1097/MD.0000000000016561.
Peptic 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.
This multicenter, double-blind, randomized controlled trial will assess efficacy and safety of HGMX in patients with PUD.
Three 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.
The 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.
The 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.
The protocol of this trial was approved in all research hospitals and was registered in ClinicalTrials.gov at October 25, 2017(No. NCT03320538).
消化性溃疡病（PUD）是全球的一项重大负担。PUD的标准西医治疗仍存在一些挑战，如持续虚弱、疲劳和复发。一种饮食中药配方厚朴米昔（HGMX）已被开发作为PUD的辅助治疗方法。
这项多中心、双盲、随机对照试验将评估HGMX治疗PUD患者的疗效和安全性。
360名符合条件的患者将在接受2周标准西医治疗后，被分配接受HGMX、安慰剂、HGMX+雷贝拉唑或安慰剂+雷贝拉唑治疗4周。第一步采用2×2析因设计，将重点评估HGMX和雷贝拉唑对溃疡愈合的主要和交互作用。然后，停用雷贝拉唑，继续使用HGMX长达1年。第二步采用安慰剂对照设计，将比较HGMX和安慰剂的长期效果。无治疗的延长随访将持续长达2年。将使用独立样本和配对t检验、Pearsonχ检验和秩和检验来比较组间差异。将使用O'Brien&Fleming方法对P值进行多重比较调整。
主要结果是PUD治疗的总有效率、溃疡愈合质量和脾气虚症状的变化。次要结果包括溃疡面积、PUD复发、幽门螺杆菌根除率、胃功能、体重和体重指数。将记录不良事件（AE）、严重AE、治疗相关AE以及因AE导致的停药情况，以评估治疗安全性。
试验结果将为HGMX作为PUD长期管理的辅助疗法提供高质量证据，并将对相关指南和法规的制定具有重要价值。
本试验方案在所有研究医院均获批准，并于2017年10月25日在ClinicalTrials.gov注册（编号NCT03320538）。
