JianpiQinghua granule reduced PPI dosage in patients with nonerosive reflux disease: A multicenter, randomized, double-blind, double-dummy, noninferiority study

Zhang, Jiaqi; Hui, Chi Man; Zhang, Beihua; Zhang, Chang; Zhou, Bin; Ji, Haijie; Xie, Jingyi; Shi, Xiaoshuang; Li, Xia; Wang, Fengyun; Tang, Xudong

doi:10.1016/j.phymed.2021.153584

Cited by 6 publications

(5 citation statements)

References 27 publications

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“…In several randomized, double-blind, and double-placebo controlled trials, CHM is noninferior to omeprazole for the treatment of patients [23,32]. In another multicenter, randomized, doubleblind, double-placebo study, the results show the superior clinical e cacy of CHM combined with omeprazole (10 mg) vs. omeprazole (20 mg) [33]. CHM signi cantly improves heartburn, regurgitation, epigastric pain, nausea, and sleep disturbance, which can lead to a signi cant reduction of GERD-Q scores [23].…”

Section: Discussionmentioning

confidence: 98%

“…Esophageal manometry shows that participants with lower esophageal sphincter pressure reduction and the proportion of ineffective swallowing (more than 50%) improve especially in the CHM treatment group [23]. In addition, the improvement of PRO scores, Anxiety score of HAD, Depression score of HAD, and SF-36 are observed in CHM treatment group [32,33]. Several studies investigated the possible mechanisms of CHM.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy and safety of Chinese Herbal Medicine (Shugan-Hewei Decoction) combined with vonoprazan for refractory gastroesophageal reflux disease: A study protocol for a Double-Blind Randomized controlled trial

Zheng,

Han,

Zhang

et al. 2023

Preprint

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Introduction: Refractory gastroesophageal reflux disease (rGERD) therapy is always lack of effective treatment in recent medical procedures. The potassium-competitive acid blocker (PCAB) vonoprazan has greater potency of acid inhibition than PPIs. The Chinese herbal medicine (CHM) Shugan-Hewei Decoction (SHD) has also demonstrated its efficacy in relieving symptoms and improving quality of life, but data on its efficacy combined with vonoprazan for rGERD are limited. This trial aims to evaluate the efficacy and safety of SHD combined with vonoprazan in the treatment of rGERD. Methods and analysis: This is a pilot, randomized, parallel-arm, placebo-controlled, multi-center clinical trial. A total of 124 participants will be allocated to the SHD group and control group randomly. The SHD group will receive SHD granules with vonoprazan (20mg/day). The control group will receive vonoprazan (20mg/day) plus an SHD granule placebo. Each group will be treated for 8 weeks. The primary outcome of the study is the score of the gastroesophageal reflux disease health-related quality of life questionnaire (GERD-Q). Secondary outcomes include healing rate, Acid exposure time (AET), oesophageal high-resolution manometry (HRM), frequency scale for the symptoms of GERD (FSSG), evaluation criteria of TCM syndrome efficacy, SF-36 quality of life scale (SF-36) and somatization symptom checklist (SSS). This trial aims to investigate the efficacy and safety of SHD combined with vonoprazan in the treatment of rGERD. Ethics and dissemination: This study has been approved by the Institutional Review Board of Human Research of Yueyang Hospital (approval number:2022-050). We will report the results of this study in a peer-reviewed journal and academic conference. Trial registration: ChiCTR2200061651, Registered 30 June 2022, https://www.chictr.org.cn/showproj.html?proj=171492

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Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of Chinese Herbal Medicine (Shugan-Hewei Decoction) combined with vonoprazan for refractory gastroesophageal reflux disease: A study protocol for a Double-Blind Randomized controlled trial

Zheng,

Han,

Zhang

et al. 2023

Preprint

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“…However, due to the complex pathophysiological mechanism of GERD, the use of PPIs does not achieve the expected effect [ 6 – 8 ]. As a result, complementary and alternative therapies are gradually gaining interest [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

Molecular Mechanism of the Effect of Zhizhu Pill on Gastroesophageal Reflux Disease Based on Network Pharmacology and Molecular Docking

Huang

Wang

Peng

et al. 2022

Evidence-Based Complementary and Alternative Medicine

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Background. To investigate the pharmacological mechanism of Zhizhu pill (ZZP) against gastroesophageal reflux disease (GERD), network pharmacology in combination with molecular docking was applied in this study. Methods. Active compounds of ZZP and target genes related to GERD were identified through public databases. Subsequently, the obtained data were used as a basis for further network pharmacological analysis to explore the potential key active compounds, core targets, and biological processes involved in ZZP against GERD. Finally, the results predicted by network pharmacology were validated by molecular docking. Results. Twenty active components of ZZP were identified to act on 59 targets related to GERD. Enrichment analysis revealed that multiple biological processes including response to oxygen levels, response to oxidative stress, and response to reactive oxygen species were involved in the GERD ZZP treatment with ZZP. ZZP had an impact on the prognosis of GERD mainly through the HIF-1 signaling pathway, PI3K-Akt signaling pathway, and pathways in cancer. Further analysis identified the key components and core targets of ZZP against GERD, of which nobiletin, didymin, luteolin, and naringenin were key components, and PPARG, MMP9, JUN, TP53, PTGS2, EGFR, MAPK3, CASP3, AKT1, and VEGFA were the core targets. Molecular docking verified the stable bonds formed between the key components and the core targets. Conclusions. The results of this study predict that the therapeutic effects of ZZP in GERD are mediated at least in part via PPARG, MMP9, JUN, TP53, PTGS2, EGFR, MAPK3, CASP3, AKT1, and VEGFA. These results may be useful in providing an experimental basis and new ideas for further research on ZZP in GERD.

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“…Moreover, some patients require surgical treatment when conventional treatment is ineffective [ 4 ]. As a result, patients often seek complementary and alternative therapies to alleviate their symptoms [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

Treatment of the Gastroesophageal Reflux Disease with Chinese Herbal Medicine (BanxiaXiexin Decoction): Evidence from Meta-Analysis

Liu

Huang

Zhang

et al. 2022

Evidence-Based Complementary and Alternative Medicine

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Objectives. Systematic reviews/meta-analyses (SRs/MAs) are still controversial on the effectiveness of Banxia Xiexin decoction (BXD) to treat gastroesophageal reflux disease (GERD). To assess the evidence reliability and inform the clinical use of BXD, we performed a meta-analysis from previous SRs/MAs to collate, critically appraise, and synthesize the effectiveness of BXD treatment in GERD. Methods. SRs/MAs were collected by searching major medical databases. The included studies were evaluated in terms of methodological quality and quality of evidence using criteria from the Assessment of Multiple Systematic Reviews 2 (AMSTAR-2) tool, and the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system, respectively. Results. Six SRs/MAs were included in this study. The methodological quality of SRs/MAs was generally unsatisfactory. Unregistered protocols, failure to provide a list of excluded trials, and lack of a comprehensive search strategy were the main limitations of previous SRs/MAs. No high-quality evidence was found to support the effect of BXD on GERD patients. The qualitative data synthesis relied on low-quality trials with a small sample size, which was the main factor for evidence degradation. Conclusions. BXD seems to have promising efficacy to treat GERD patients. Although the quality of SRs/MAs was generally low and defects were frequent, our study highlights areas where methodologies need to be improved.

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JianpiQinghua granule reduced PPI dosage in patients with nonerosive reflux disease: A multicenter, randomized, double-blind, double-dummy, noninferiority study

Cited by 6 publications

References 27 publications

Efficacy and safety of Chinese Herbal Medicine (Shugan-Hewei Decoction) combined with vonoprazan for refractory gastroesophageal reflux disease: A study protocol for a Double-Blind Randomized controlled trial

Efficacy and safety of Chinese Herbal Medicine (Shugan-Hewei Decoction) combined with vonoprazan for refractory gastroesophageal reflux disease: A study protocol for a Double-Blind Randomized controlled trial

Molecular Mechanism of the Effect of Zhizhu Pill on Gastroesophageal Reflux Disease Based on Network Pharmacology and Molecular Docking

Treatment of the Gastroesophageal Reflux Disease with Chinese Herbal Medicine (BanxiaXiexin Decoction): Evidence from Meta-Analysis

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