Kim Yun Hee, Kim Jun Young, Kwon O-Jin, Jung So Young, Joung Jin-Yong, Yang Chang Sop, Lee Jun-Hwan, Cho Jung-Hyo, Son Chang-Gue
Korean Medicine Convergence Research Division, Korea Institute of Oriental Medicine (KIOM), Daejeon, Korea.
Liver and Immunology Research Center, Daejeon Oriental Hospital of Daejeon University, Daejeon, Korea.
Front Pharmacol. 2021 Aug 27;12:698887. doi: 10.3389/fphar.2021.698887. eCollection 2021.
This study evaluated the efficacy and safety of (BST) in patients with functional dyspepsia (FD). BST ( in traditional Chinese medicine and in Kampo medicine) is traditionally prescribed for the treatment of dyspepsia with epigastric stiffness and gastric fullness in China, Japan, and Korea. Patients with FD were randomly administered an oral dose (10 g) of BST syrup or placebo, twice a day for 4 weeks. The primary outcome was the symptom checklist part of the Nepean dyspepsia index (NDI). The secondary outcomes were the quality of life (QoL) part of the NDI, functional dyspepsia-related QoL (FD-QoL), and visual analog scale (VAS). A total of 60 patients with FD were screened, and 50 were randomized into BST group (n = 25) and placebo group (n = 25). Two patients in the placebo group withdrew before the start of the treatment. Administration of BST syrup resulted in improvement in the symptom-related NDI score in the BST group compared with that in the control group; however, the difference was not significant. BST syrup significantly improved "fullness after eating" index of NDI at follow-up time point (2.88 ± 2.65 vs 4.78 ± 2.69, = 0.0081). In the total score of the QoL section of the NDI and FD-QoL scales, there was no significant improvement in the BST group compared to that in the placebo group. With regard to improvement in overall FD symptoms, the VAS scale showed improvement in both groups, but the difference was not significant. Interestingly, follow-up investigation showed a significantly beneficial effect of BST on FD symptoms, when compared to placebo. Significant improvement observed in VAS score (39.60 ± 22.29 vs 52.17 ± 20.55, = 0.048). This indicated that the effect of BST lasted even after the completion of the medication regimen. Overall, our data suggest that while BST showed no significant improvement in the symptom-related NDI score and the QoL related scores in NDI and FD-QoL after 4 weeks of treatment, it effectively improved the VAS score and fullness after eating-related symptoms in the follow-up visit. https://cris.nih.go.kr; Identifier KCT 0002013.
本研究评估了（某种中药复方）（BST）治疗功能性消化不良（FD）患者的疗效和安全性。BST（中药名为[具体中文名]，汉方名为[具体汉方名]）在中国、日本和韩国传统上用于治疗伴有上腹部胀满和胃部饱胀感的消化不良。FD患者被随机口服一剂（10克）BST糖浆或安慰剂，每日两次，共4周。主要结局指标是内皮恩消化不良指数（NDI）的症状清单部分。次要结局指标是NDI的生活质量（QoL）部分、功能性消化不良相关生活质量（FD-QoL）和视觉模拟量表（VAS）。共筛选了60例FD患者，50例被随机分为BST组（n = 25）和安慰剂组（n = 25）。安慰剂组有2例患者在治疗开始前退出。与对照组相比，BST糖浆使BST组中与症状相关的NDI评分有所改善；然而，差异不显著。在随访时间点，BST糖浆显著改善了NDI的“进食后饱胀感”指数（2.88±2.65 vs 4.78±2.69，P = 0.0081）。在NDI和FD-QoL量表的QoL部分总分方面，BST组与安慰剂组相比无显著改善。关于FD总体症状的改善，VAS量表显示两组均有改善，但差异不显著。有趣的是，随访调查显示，与安慰剂相比，BST对FD症状有显著有益影响。VAS评分有显著改善（39.60±22.29 vs 52.17±20.55，P = 0.048）。这表明即使在药物治疗方案结束后，BST的效果仍然持续存在。总体而言，我们的数据表明，虽然治疗4周后BST在与症状相关的NDI评分以及NDI和FD-QoL中与QoL相关的评分方面没有显著改善，但它在随访中有效改善了VAS评分和进食后饱胀感相关症状。https://cris.nih.go.kr；标识符KCT 0002013 。
Front Pharmacol. 2021-8-27
J Ethnopharmacol. 2019-3-30
Medicine (Baltimore). 2023-9-1
J Tradit Chin Med. 2019-12
J Ethnopharmacol. 2019-3-30
Pak J Med Sci. 2018
Nat Rev Dis Primers. 2017-11-3
Zotero 插件
