Nonerosive Reflux Disease Clinical Trial
Official title:
Randomized Double-Blind Clinical Trial of Tongjiang Theory and Syndrome Differentiation Serial Prescriptions Combined With Proton Pump Inhibitors(PPIs)Descending Ladder Withdrawal for the Treatment of Nonerosive Reflux Disease.
Nonerosive Reflux Disease (NERD) is a common refractory gastrointestinal disease. Proton Pump Inhibitors (PPIs), the preferred drug, have poor response, single target and poor acid inhibition effect in some patients in clinical application. Long-term use of PPI can lead to many side effects, even dependency. The main Traditional Chinese Medicine (TCM)syndrome types of NERD are liver-stomach depression-heat syndrome, spleen deficiency damp-heat syndrome and cold-heat complicated syndrome. TCM syndrome differentiation treatment has the advantages of overall regulation and individualized treatment. The purpose of this study is to evaluate the safety and efficacy advantages of syndrome differentiation series prescription combined with PPIs descending ladder withdrawal in the treatment of patients who use PPIs for a long time that can not stop, and to solve the problems of multiple side effects and dependency caused by long-term use of PPIs.
Nonerosive Reflux Disease (NERD) accounts for about 70% of Gastroesophageal Reflux Disease (GERD), which is a common refractory gastrointestinal disease. Proton Pump Inhibitors (PPIs), the preferred treatment, have the following problems in clinical use: about 50% of patients respond to PPIs only partially or not at all; PPIs has a single target, and the effect of acid suppression alone is poor; long term use of PPIs can lead to dyspepsia, fundic gland polyp, atrophic gastritis, intestinal flora disorders, and even dependency. Liver-stomach depression-heat syndrome, spleen deficiency damp-heat syndrome and cold-heat complicated syndrome account for 80%-91% of NERD's Traditional Chinese Medicine (TCM) syndrome. TCM syndrome differentiation treatment has the advantages of overall regulation and individualized treatment, but it lacks high-level evidence-based medicine evidence. On the basis of previous work, the project plans to establish sub centers in 6 Chinese hospitals, including 180 patients with NERD who meet the requirements to carry out a multicenter, randomized, double-blind, placebo-controlled clinical study, in which 90 subjects in the experimental group received the treatment of syndrome differentiation series of prescriptions combined with PPIs descending ladder withdrawal, and 90 subjects in the control group received the treatment of placebo combined with PPIs descending ladder withdrawal. The therapeutic effects were evaluated from the following aspects: the VAS score of reflow and heartburn, the rate of discontinuation of antacids, the rate of recurrence of NERD symptoms, the score of TCM syndromes and the improvement of gastrointestinal function. The purpose of this study is to evaluate the efficacy advantage and safety of Tongjiang series prescription combined with PPIs descending ladder withdrawal compared with PPIs descending ladder withdrawal alone for patients who use PPIs for a long time that can not stop, so as to obtain evidence-based medical evidence of high-quality TCM syndrome differentiation treatment of NERD, and form an effective and popularized treatment plan to solve the problems of various side effects and dependency caused by long-term use of PPIs. ;
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