Randomized Double-blind Placebo-controlled Trial of Modified Zuojinwan Granules in Treating Reflux Esophagitis and Functional Dyspepsia with Same Syndrome with Disharmony Between Liver and Stomach
10.13422/j.cnki.syfjx.20241498
- VernacularTitle:加味左金丸颗粒剂治疗反流性食管炎及功能性消化不良不同疾病相同证候肝胃不和证的随机双盲安慰剂对照试验
- Author:
Guangming WANG
1
;
Wanli LIU
2
;
Lu YANG
1
;
Hao WU
1
;
Yuzhen HUANG
1
Author Information
1. Nanjing Hospital of combination of Chinese traditional and western medicine，Nanjing 210014，China
2. Nanjing Hospital （Nanjing First Hospital） affiliated to Nanjing Medical University，Nanjing 210006，China
- Publication Type:Journal Article
- Keywords:
reflux esophagitis;
functional dyspepsia;
disharmony between liver and stomach;
modified Zuojinwan granules;
treating different diseases with the same method
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2024;30(12):112-120
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo observe the clinical efficacy of modified Zuojinwan granules in treating reflux esophagitis （RE） and functional dyspepsia （FD） with the same syndrome with disharmony between liver and stomach）. MethodA randomized double-blind placebo-controlled clinical trial was conducted to enroll 144 patients with disharmony between liver and stomach， including 72 patients with RE and 72 patients with FD. These patients were then randomly divided into observation and control groups， with 36 patients in each group. The observation group was given modified Zuojinwan granules orally， and the control group was given placebo granules orally. They both were treated with two packs each time， twice a day， for four weeks. The traditional Chinese medicine （TCM） syndrome scores， cerebrointestinal peptides ［calcitonin gene-associated titanium （CGRP）， vasoactive intestinal peptide （VIP）， 5-hydroxytryptamine （5-HT）， and substance P （SP）］， inflammatory factors ［tumor necrosis factor-α （TNF-α） and interleukin-6 （IL-6）］， common gastrointestinal related hormones ［gastrin （GAS） and motilin （MTL）］， and other indicators in the two groups were compared before and after treatment， and the curative effect of TCM syndromes and the occurrence of adverse reactions were determined. At the same time， the changes in the above indicators and the curative effect of TCM syndromes in the two groups of patients with the same disease were analyzed. ResultAfter treatment， CGRP， VIP， 5-HT， SP， TNF-α， IL-6， GAS， MTL， and TCM syndrome scores in the observation group and control group were significantly improved （P<0.05）. After treatment， the improvement of CGRP， VIP， 5-HT， SP， TNF-α， IL-6， GAS， MTL， and TCM syndrome scores in the observation group was better than that in the control group （P<0.05）. After treatment， CGRP， VIP， 5-HT， SP， TNF-α， IL-6， GAS， MTL， and TCM syndrome scores in both groups of RE patients and FD patients were significantly improved （P<0.05）. After treatment， the improvement of CGRP， VIP， 5-HT， SP， TNF-α， IL-6， GAS， MTL， and TCM syndrome scores in RE patients and FD patients in the observation group were better than that in the control group （P<0.05）. In the observation group and the control group， the incidence of nausea， vomiting， fatigue， dry mouth， and other adverse reactions was lower， and there was no statistical significance. ConclusionModified Zuojinwan granules can effectively improve the TCM syndromes of disharmony between liver and stomach of RE and FD， brain and intestinal peptide， gastrointestinal hormone， and inflammatory factors and provide evidence for the clinical application of TCM theory of "treating different diseases with the same method".
