AUTHOR=Kim Sul-Ki , Joung Jin-Yong , Ahn Yo-Chan , Jung In-Chul , Son Chang-Gue 

TITLE=Beneficial Potential of Banha-Sasim-Tang for Stress-Sensitive Functional Dyspepsia via Modulation of Ghrelin: A Randomized Controlled Trial

JOURNAL=Frontiers in Pharmacology

VOLUME=12

YEAR=2021

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2021.636752

DOI=10.3389/fphar.2021.636752

ISSN=1663-9812

ABSTRACT=<p><bold>Background:</bold> 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. <italic>Banha-Sasim-Tang</italic> (BST) is an herbal prescription for treating a wide range of dyspepsia in traditional Korean medicine (TKM).</p><p><bold>Aim of the study:</bold> 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 <ext-link ext-link-type="uri" xlink:href="https://cris.nih.go.kr/" xmlns:xlink="http://www.w3.org/1999/xlink">https://cris.nih.go.kr/</ext-link>with the identification number KCT 0002811.</p><p><bold>Materials and methods:</bold> 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.</p><p><bold>Results:</bold> All participants completed the study (<italic>n</italic> = 15 for BST, <italic>n</italic> = 16 for placebo). BST decreased NDI-K scores compared with placebo, but the difference was not statistically significant (37.40 ± 27.40 <italic>vs</italic> 22.50 ± 23.85, <italic>p</italic> = 0.12). VAS scores and plasma total ghrelin levels were significantly improved in patients who were treated with BST (3.19 ± 1.60 <italic>vs</italic> 1.38 ± 2.85, <italic>p</italic> = 0.03 for VAS and 105.69 ± 287.89 <italic>vs</italic> -142.31 ± 314.32, <italic>p</italic> = 0.03 for total ghrelin). No BST-related adverse effects were observed during the trial.</p><p><bold>Conclusion:</bold> 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.</p><p><bold>Clinical Trial Registration:</bold><ext-link ext-link-type="uri" xlink:href="https://cris.nih.go.kr/" xmlns:xlink="http://www.w3.org/1999/xlink">https://cris.nih.go.kr/</ext-link>, identifier KCT 0002811.</p>