Kim Sul-Ki, Joung Jin-Yong, Ahn Yo-Chan, Jung In-Chul, Son Chang-Gue
Liver and Immunology Research Center, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.
Department of Health Service Management, Daejeon University, Daejeon, Republic of Korea.
Front Pharmacol. 2021 Apr 20;12:636752. doi: 10.3389/fphar.2021.636752. eCollection 2021.
Functional dyspepsia (FD) is a highly complex pathophysiologic disease, which shows low recovery and high relapse rates. Therefore, a growing number of clinicians and patients are looking for alternative herbal medicine. (BST) is an herbal prescription for treating a wide range of dyspepsia in traditional Korean medicine (TKM). This study aimed to evaluate the efficacy of BST on FD in patients with psychological stress-related symptoms and to investigate the involvement of ghrelin. This study is registered at https://cris.nih.go.kr/with the identification number KCT 0002811. A total of 31 participants with FD who met the Rome IV criteria and the psychological stress-related pattern were enrolled in a double-blind, randomized, and controlled study. Participants were randomly assigned to the BST group (10 g twice daily for 4 weeks) or placebo group. The primary endpoint was a change in the Nepean Dyspepsia Index-Korean (NDI-K) score. The secondary endpoints were changes in the Visual Analog Scale (VAS) scores and plasma ghrelin level. All participants completed the study ( = 15 for BST, = 16 for placebo). BST decreased NDI-K scores compared with placebo, but the difference was not statistically significant (37.40 ± 27.40 22.50 ± 23.85, = 0.12). VAS scores and plasma total ghrelin levels were significantly improved in patients who were treated with BST (3.19 ± 1.60 1.38 ± 2.85, = 0.03 for VAS and 105.69 ± 287.89 -142.31 ± 314.32, = 0.03 for total ghrelin). No BST-related adverse effects were observed during the trial. Our results indicate the clinical potential of BST for FD patients and are the first study to show the modulation of plasma ghrelin as one of its corresponding mechanisms. https://cris.nih.go.kr/, identifier KCT 0002811.
功能性消化不良（FD）是一种高度复杂的病理生理疾病，其治愈率低且复发率高。因此，越来越多的临床医生和患者在寻找替代草药。（BST）是韩国传统医学（TKM）中用于治疗多种消化不良的草药配方。本研究旨在评估BST对伴有心理应激相关症状的FD患者的疗效，并研究胃饥饿素的作用。本研究已在https://cris.nih.go.kr/注册，识别号为KCT 0002811。共有31名符合罗马IV标准和心理应激相关模式的FD参与者被纳入一项双盲、随机、对照研究。参与者被随机分配到BST组（每日两次，每次10克，共4周）或安慰剂组。主要终点是纽卡斯尔消化不良指数 - 韩语版（NDI - K）评分的变化。次要终点是视觉模拟量表（VAS）评分和血浆胃饥饿素水平的变化。所有参与者均完成了研究（BST组 = 15人，安慰剂组 = 16人）。与安慰剂相比，BST降低了NDI - K评分，但差异无统计学意义（37.40 ± 27.40对22.50 ± 23.85，P = 0.12）。接受BST治疗的患者VAS评分和血浆总胃饥饿素水平显著改善（VAS：3.19 ± 1.60对1.38 ± 2.85，P = 0.03；总胃饥饿素：105.69 ± 287.89对 - 142.31 ± 314.32，P = 0.03）。试验期间未观察到与BST相关的不良反应。我们的结果表明BST对FD患者具有临床潜力，并且是第一项表明调节血浆胃饥饿素是其相应机制之一的研究。https://cris.nih.go.kr/，识别号KCT 0002811。
