Efficacy and safety of the Chinese herbal formula Hewei Jiangni recipe for NERD with cold-heat complex syndrome: study protocol for a double-blinded randomized controlled trial.
Efficacy and safety of the Chinese herbal formula Hewei Jiangni recipe for NERD with cold-heat complex syndrome: study protocol for a double-blinded randomized controlled trial.
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中药和胃降逆方治疗冷热复合型NERD的疗效和安全性：双盲随机对照试验研究方案
DOI：
10.1186/s13063-021-05471-7
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发表时间：
2021-08-18
期刊：
影响因子：
2.5
通讯作者：
Li J
中科院分区：
文献类型：
--
作者：
Zhang X;Cheng Y;Li X;Tan X;Shi L;Shi X;Zhang X;Xie C;Li J
研究背景质子泵抑制剂（PPI）对非糜烂性胃食管反流（NERD）的治疗有效，但长期使用PPI易出现并发症，且停药后易复发。中药（TCM）可以缓解反流症状，提高生活质量。本研究旨在评价和胃降逆方（HWJNR）治疗冷热复合证NERD的安全性和有效性，并基于肠道菌群与代谢物的相关性分析，阐明和胃降逆方治疗NERD的作用机制。方法本研究是一项单中心、随机对照、双盲、安慰剂对照临床试验，将72名符合条件的NERD和中医寒热错杂证受试者随机分配到研究组。按1：1的比例分为两组：中药组和西药组。中药组给予和WJNR联合奥美拉唑肠溶片安慰剂，西药组给予奥美拉唑肠溶片和和WJNR安慰剂。每组将接受8周的治疗。主要结局是胃食管反流病（GERD）健康相关生活质量问卷（GERD-Q）的评分。次要结局包括SF-36生活质量量表（SF-36）、患者报告结局（PRO）自评量表评分、中医证候评分和不良事件。机制结局是分别对健康个体和NERD参与者治疗前后的肠道菌群和代谢物进行相关性分析。讨论本试验的目的是探讨活络健脾治疗冷热复合综合征NERD的有效性和安全性，并通过粪便菌群的16SrRNA测序和代谢组学相关性分析来研究NERD患者肠道菌群的组成结构和代谢物表达谱，从而明确治疗的主导环节。并揭示了HWJNR.ChiCTR2000041225的潜在机制。注册日期：2020年12月22日
BackgroundProton pump inhibitor (PPI) is effective for the treatment of nonerosive gastroesophageal reflux (NERD), but long-term use of PPI is prone to have complications and recurrence after withdrawal. Traditional Chinese medicine (TCM) can relieve the symptoms of reflux and improve the quality of life. The purpose of this study is to evaluate the safety and efficacy of Hewei Jiangni recipe (HWJNR) in the treatment of NERD with cold-heat complex syndrome, and clarify the mechanism of HWJNR on NERD based on the correlation analysis of intestinal flora and metabolites.MethodsThis is a single-center, randomized controlled, double-blind, placebo-controlled clinical trial in which 72 eligible participants with NERD and TCM syndrome of intermingled heat and cold will be randomly allocated in the ratio of 1:1 to two groups: TCM group and western medicine group. The TCM group will receive HWJNR with omeprazole enteric-coated tablets placebo, while the western medicine group will receive omeprazole enteric-coated tablets with HWJNR placebo. Each group will be treated for 8 weeks. The primary outcome is the score of gastroesophageal reflux disease (GERD) health-related quality of life questionnaire (GERD-Q). Secondary outcomes include SF-36 quality of life scale (SF-36), patient-reported outcomes (PRO) self-rating scale score, syndrome score of TCM, and adverse events. Mechanistic outcome is the correlation analysis of intestinal flora and metabolites from healthy individuals and NERD participants before and after the treatment respectively.DiscussionThe goal of this trial is to investigate the efficacy and safety of HWJNR in the treatment of NERD with cold-heat complex syndrome, and to study the composition structure and metabolite expression profile of intestinal flora in patients with NERD through 16SrRNA sequencing and metabolomic correlation analysis of fecal flora, which makes us identify the dominant links of treatment and reveal the potential mechanism of HWJNR.ChiCTR2000041225 . Registered on 22 December 2020
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影响因子：
15.3
作者：
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