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- W3199661329 abstract "Abstract Background: Non-erosive reflux disease (NERD) is characterized by typical gastroesophageal reflux symptoms, such as heartburn and regurgitation, but an absence of oesophageal 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 PPIs de-escalation therapy for NERD patients who did not respond to PPIs alone. Method: This multicentred, double-blinded, RCT with two parallel groups will recruit 174 participants who will be randomized into the TCM granules combined with PPIs de-escalation group (n=87) and the TCM granules placebo combined with PPIs de-escalation 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 Analogue 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 number: Clinicaltrials.gov: NCT04340297" @default.
- W3199661329 created "2021-09-27" @default.
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- W3199661329 date "2021-09-14" @default.
- W3199661329 modified "2023-10-17" @default.
- W3199661329 title "Traditional Chinese Medicine Based On Tongjiang Methodology Combined With Proton Pump Inhibitors (PPIs) De-Escalation In Treating Non-Erosive Reflux Disease: A Study Protocol For A Multicentred, Randomized Controlled Clinical Trial" @default.
- W3199661329 doi "https://doi.org/10.21203/rs.3.rs-826755/v1" @default.
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