PMID- 36258217
OWN - NLM
STAT- MEDLINE
DCOM- 20221024
LR  - 20221024
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 23
IP  - 1
DP  - 2022 Oct 18
TI  - 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.
PG  - 879
LID - 10.1186/s13063-022-06811-x [doi]
LID - 879
AB  - 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 (TJ) 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. TRIAL REGISTRATION: Clinicaltrials.gov 
      NCT04340297. Registered on April 9, 2020.
CI  - (c) 2022. The Author(s).
FAU - Li, Xia
AU  - Li X
AUID- ORCID: 0000-0002-7121-7958
AD  - Department of Spleen and Stomach Diseases of Traditional Chinese Medicine, 
      China-Japan Friendship Hospital, Beijing, 100029, China.
FAU - Wu, Haomeng
AU  - Wu H
AD  - The Second Clinical College of Guangzhou University of Chinese Medicine, 
      Guangzhou, 510120, China.
FAU - Zhang, Beihua
AU  - Zhang B
AD  - Department of Gastroenterology, Xiyuan Hospital Affiliated to China Academy of 
      Traditional Chinese Sciences, Beijing Institute of Spleen and Stomach Disease of 
      Traditional Chinese Medicine, Beijing, 100091, China.
FAU - Chen, Ting
AU  - Chen T
AD  - Department of Gastroenterology, Xiyuan Hospital Affiliated to China Academy of 
      Traditional Chinese Sciences, Beijing Institute of Spleen and Stomach Disease of 
      Traditional Chinese Medicine, Beijing, 100091, China.
FAU - Shi, Xiaoshuang
AU  - Shi X
AD  - Department of Gastroenterology, The Third Affiliated Hospital of Beijing 
      University of Chinese Medicine, Beijing, 100020, China.
FAU - Ma, Jinxin
AU  - Ma J
AD  - Department of Gastroenterology, Peking University Traditional Chinese Medicine 
      Clinical Medical School (Xiyuan), Beijing, 100091, China.
FAU - Zhang, Jiaqi
AU  - Zhang J
AD  - Department of Gastroenterology, Xiyuan Hospital Affiliated to China Academy of 
      Traditional Chinese Sciences, Beijing Institute of Spleen and Stomach Disease of 
      Traditional Chinese Medicine, Beijing, 100091, China.
FAU - Tang, Xudong
AU  - Tang X
AD  - China Academy of Traditional Chinese Sciences, Beijing Institute of Spleen and 
      Stomach Disease of Traditional Chinese Medicine, Beijing, 100091, China. 
      txdly@sina.com.
FAU - Wang, Fengyun
AU  - Wang F
AD  - Department of Gastroenterology, Xiyuan Hospital Affiliated to China Academy of 
      Traditional Chinese Sciences, Beijing Institute of Spleen and Stomach Disease of 
      Traditional Chinese Medicine, Beijing, 100091, China. wfy811@163.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT04340297
GR  - 2019YFC1709600/National Key Research and Development Project/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20221018
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Proton Pump Inhibitors)
RN  - 0 (tongjiang)
SB  - IM
MH  - Humans
MH  - *Gastroesophageal Reflux/drug therapy
MH  - *Medicine, Chinese Traditional/methods
MH  - Multicenter Studies as Topic
MH  - *Proton Pump Inhibitors/therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Combined Modality Therapy
PMC - PMC9580143
OTO - NOTNLM
OT  - Nonerosive reflux disease (NERD)
OT  - PPI
OT  - Protocol
OT  - Randomized controlled trial (RCT)
OT  - TCM granules
COIS- The authors declare that they have no competing interests.
EDAT- 2022/10/19 06:00
MHDA- 2022/10/21 06:00
PMCR- 2022/10/18
CRDT- 2022/10/18 23:40
PHST- 2021/08/18 00:00 [received]
PHST- 2022/10/03 00:00 [accepted]
PHST- 2022/10/18 23:40 [entrez]
PHST- 2022/10/19 06:00 [pubmed]
PHST- 2022/10/21 06:00 [medline]
PHST- 2022/10/18 00:00 [pmc-release]
AID - 10.1186/s13063-022-06811-x [pii]
AID - 6811 [pii]
AID - 10.1186/s13063-022-06811-x [doi]
PST - epublish
SO  - Trials. 2022 Oct 18;23(1):879. doi: 10.1186/s13063-022-06811-x.