Li Feng, Yuan Yali, Wu Di, Li Junxiang, Han Haixiao, Li Xiaohong, Hu Liming, Chen Runhua, Yao Yupu, Jiao Yao, Chen Huihui, Mao Tangyou, Xie Chune
Beijing University of Chinese Medicine, Beijing, China.
Shenzhen Hospital, Beijing University of Chinese Medicine, Shenzhen, China.
Evid Based Complement Alternat Med. 2022 Sep 22;2022:9647003. doi: 10.1155/2022/9647003. eCollection 2022.
Conventional approaches for patients with nonerosive gastroesophageal reflux disease (NERD) were not satisfactory. This study aimed to evaluate the effectiveness and mechanisms of Chinese herbal medicine Hewei Jiangni Decoction (HWJND) as a novel and promising regimen for NERD.
A total of 128 patients with NERD were randomly assigned to the Treatment group and Control group. The patients from the Treatment group were administered HWJND (81 g) plus dummy omeprazole (20 mg) daily for 8 weeks, and the others were given dummy HWJND granules (81 g) plus omeprazole (20 mg). The clinical efficacy was assessed using the gastroesophageal reflux disease questionnaire (GERD-Q) scale, patient reported outcomes (PRO) scale, and short form health survey 36 (SF-36) scale at week 4. Moreover, its pharmacological and molecular mechanisms were elucidated based on network pharmacology and molecular docking.
Due to case shedding and other reasons, 109 patients, including 56 in the Treatment group and 53 in the Control group completed this study. Our results showed that HWJND significantly improved heartburn, regurgitation, epigastric pain, nausea, and sleep disturbance, which led to a significant reduction of GERD-Q scores in NERD patients. In addition, PRO scores of NERD patients with HWJND administration were improved, and sufficient relief of physical role, body pain, general health, social function, and mental health on the SF-36 scale was also observed in patients after HWJND treatment. We further showed that the curative effect of HWJND was close to that of omeprazole, except for the better improvement of general health and social function. What's more, the main active ingredients of HWJND included quercetin, beta-sitosterol, naringenin, baicalein, and kaempferol were retrieved, and the protective effects of HWJND against NERD may be closely related to targets such as TNF, IL6, IL1B, MMP9, CXCL8, and EGFR, which were mainly enriched in IL-17 signaling pathway and TNF signaling pathway.
Our findings demonstrate that HWJND is noninferior to oral omeprazole for the treatment of patients with NERD, plays a therapeutic role through multiple targets and diverse pathways, and holds promise for complementary and alternative therapy for the treatment of NERD. This trial is registered with http://www.chictr.org.cn, Chinese Clinical Trials Registry [ChiCTR2200055960].
传统治疗非糜烂性胃食管反流病（NERD）患者的方法并不令人满意。本研究旨在评估中药和胃降逆汤（HWJND）作为一种新型且有前景的NERD治疗方案的有效性及作用机制。
128例NERD患者被随机分为治疗组和对照组。治疗组患者每日服用HWJND（81克）加安慰剂奥美拉唑（20毫克），持续8周，其余患者服用安慰剂HWJND颗粒（81克）加奥美拉唑（20毫克）。在第4周时，使用胃食管反流病问卷（GERD-Q）量表、患者报告结局（PRO）量表和健康调查简表36（SF-36）量表评估临床疗效。此外，基于网络药理学和分子对接阐明其药理及分子机制。
由于病例脱落等原因，109例患者完成了本研究，其中治疗组56例，对照组53例。我们的结果表明，HWJND显著改善了烧心、反流、上腹痛、恶心和睡眠障碍，这导致NERD患者的GERD-Q评分显著降低。此外，服用HWJND的NERD患者的PRO评分得到改善，并且在HWJND治疗后的患者中，还观察到SF-36量表上身体功能、身体疼痛、总体健康、社会功能和心理健康的充分缓解。我们进一步表明，HWJND的疗效与奥美拉唑相近，除了在总体健康和社会功能方面改善更好。此外，检索到HWJND的主要活性成分包括槲皮素、β-谷甾醇、柚皮素、黄芩素和山奈酚，HWJND对NERD的保护作用可能与TNF、IL6、IL1B、MMP9、CXCL8和EGFR等靶点密切相关，这些靶点主要富集在IL-17信号通路和TNF信号通路中。
我们的研究结果表明，HWJND在治疗NERD患者方面不劣于口服奥美拉唑，通过多个靶点和多种途径发挥治疗作用，有望成为NERD治疗的补充和替代疗法。本试验已在中国临床试验注册中心（http://www.chictr.org.cn）注册[ChiCTR2200055960]。
