高级检索
当前位置: 首页 > 详情页

Traditional Chinese medicine based on Tongjiang methodology combined with proton pump inhibitor (PPI) step-down in treating non-erosive reflux disease: a study protocol for a multicentered, randomized controlled clinical trial

文献详情

资源类型:
WOS体系:

收录情况: ◇ SCIE

单位: [1]Department of Spleen and Stomach Diseases of Traditional Chinese Medicine, China-Japan Friendship Hospital, Beijing 100029, China. [2]The Second Clinical College of Guangzhou University of Chinese Medicine,Guangzhou 510120, China. [3]Department of Gastroenterology, Xiyuan Hospital Afliated to China Academy of Traditional Chinese Sciences, Beijing Institute of Spleen and Stomach Disease of Traditional Chinese Medicine,Beijing 100091, China. [4]Department of Gastroenterology, The Third Afliated Hospital of Beijing University of Chinese Medicine, Beijing 100020, China. [5]Department of Gastroenterology, Peking University Traditional Chinese Medicine Clinical Medical School (Xiyuan), Beijing 100091, China. [6]China Academy of Traditional Chinese Sciences, Beijing Institute of Spleen and Stomach Disease of Traditional Chinese Medicine, Beijing 100091, China.
出处:
ISSN:

关键词: Nonerosive reflux disease (NERD) TCM granules PPI Randomized controlled trial (RCT) Protocol

摘要:
Background: Non-erosive reflux disease (NERD) is characterized by typical gastroesophageal reflux symptoms, such as heartburn and regurgitation but an absence of esophageal mucosal damage during upper gastrointestinal endoscopy. Although proton pump inhibitors (PPIs) are the first line therapy, almost 50% of patients with NERD fail to respond to this treatment. Traditional Chinese medicine (TCM) can better relieve the symptoms of NERD. Therefore, a randomized controlled trial (RCT) was designed to investigate the efficiency of TCM granules based on Tongjiang (Ti) methodology combined with PPI step-down therapy for NERD patients who did not respond to PPIs alone. Method: This multicentered, double-blinded, RCT with two parallel groups will recruit 174 participants who will be randomized into the TCM granules combined with PPI step-down group (n = 87) and the TCM granules placebo combined with PPI step-down group (n = 87). Both groups of participants will receive 6 weeks of treatment and 4 weeks of follow-up, and all participants will be assessed for related symptoms, mental health status, and quality of life at each visit. The primary outcome measurements include visual analog scale (VAS) for heartburn and regurgitation and the major symptoms scale. The secondary outcome measurements include PPI withdrawal rate, symptom recurrence rate, minor symptoms scale, SF-36, PRO, SAS, SDS, GERD-HRQL, and TCM syndromes scales. Discussion: Previous research has shown that TCM is capable to alleviate NERD symptoms. This trial will help to provide a better understanding of the synergistic efficiency of the combination of TCM and PPIs, to explore whether the dosage of PPIs can be reduced after the supplement of TCM granules and to provide a feasible plan to reduce dependencies or withdraw NERD patients from PPIs. The outcome of this trial is expected to reduce the symptom recurrence rates, lessen patients'physical and psychological burdens, and achieve good social benefits.

基金:
语种:
WOS:
中科院(CAS)分区:
出版当年[2021]版:
大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
JCR分区:
出版当年[2020]版:
Q4 MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版:
Q3 MEDICINE, RESEARCH & EXPERIMENTAL

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2020版] 出版当年五年平均[2016-2020] 出版前一年[2019版] 出版后一年[2021版]

第一作者:
第一作者单位: [1]Department of Spleen and Stomach Diseases of Traditional Chinese Medicine, China-Japan Friendship Hospital, Beijing 100029, China.
共同第一作者:
通讯作者:
推荐引用方式(GB/T 7714):
APA:
MLA:

资源点击量:1320 今日访问量:0 总访问量:816 更新日期:2025-04-01 建议使用谷歌、火狐浏览器 常见问题

版权所有:重庆聚合科技有限公司 渝ICP备12007440号-3 地址:重庆市两江新区泰山大道西段8号坤恩国际商务中心16层(401121)