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一种草药制剂,六君子汤,对面部形状诊断分类的一种功能性消化不良更有效:一项安慰剂对照、双盲、随机试验。

An Herbal Medicine, Yukgunja-Tang is more Effective in a Type of Functional Dyspepsia Categorized by Facial Shape Diagnosis: A Placebo-Controlled, Double-Blind, Randomized Trial.

作者信息

Ko Seok-Jae, Park Jae-Woo, Lee Jae-Hyung, Lee Jung-Eun, Ha Na-Yeon, Nam Seong-Uk, Lee Jae-Hong, Jeon Soo-Hyung, Kim Jong-Won, Kang Changwan, Yeo Inkwon, Kim Jinsung

机构信息

Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Kyungheedae-ro 26, Dongdaemun-gu, Seoul 02447, Republic of Korea.

Department of Sasang Constitutional Medicine, College of Korean Medicine, Dong-Eui University, 62 Yangjeong-ro, Busanjin-gu, Busan 47227, Republic of Korea.

出版信息

Evid Based Complement Alternat Med. 2018 Oct 1;2018:8546357. doi: 10.1155/2018/8546357. eCollection 2018.

Abstract

INTRODUCTION

Functional dyspepsia (FD) is a functional gastrointestinal disorder characterized by persistent upper dyspeptic symptoms without organic lesions. There is no standard therapy for FD. Yukgunja-tang (YGJT) is an herbal medicine used for treating upper gastrointestinal symptoms in Asia. Studies on the effect of YGJT on FD have been conducted. However, the results were inconsistent. In medicine, traditional Korean medicine, FD patients are classified into bladder body (BB) or gallbladder body (GB) subtypes by the shape and angle of their faces. Each subtype may have different characteristics, physiology, and pathology of the same disease. YGJT is more effective for patients with BB subtype. The three-dimensional facial shape diagnostic system (3-FSDS) was shown to be effective in diagnosing BB or GB subtypes. This study aimed to investigate the effect of YGJT on FD patients classified using the 3-FSDS.

MATERIALS AND METHODS

The current study was a placebo-controlled, double-blinded, randomized, two-center trial. Eligible patients were diagnosed with either BB or GB FD subtype using the 3-FSDS. Ninety-six participants (48 BB and 48 GB subtypes) were randomly allocated to treatment or control groups in a 2:1 ratio. YGJT or placebo was administered for eight weeks. The primary outcome was assessed using the total dyspepsia symptom scale (TDS), while the secondary outcomes were assessed using the single dyspepsia symptom scale (SDS), proportion of responders, visual analog scale, Nepean dyspepsia index, functional dyspepsia-related quality of life, and spleen qi deficiency questionnaire.

RESULTS AND DISCUSSION

The result of TDS showed the superior effect of YGJT on BB over GB subtype. The subgroup analysis of TDS and SDS scores showed the superior effect of YGJT over placebo. Other outcome variables did not show any significant differences between groups.

CONCLUSION

YGJT may be considered for FD patients diagnosed with BB subtype using 3-FSDS.

摘要

引言

功能性消化不良(FD)是一种功能性胃肠疾病,其特征为持续存在上消化道消化不良症状且无器质性病变。FD尚无标准治疗方法。郁军加汤(YGJT)是一种在亚洲用于治疗上消化道症状的草药。已开展了关于YGJT对FD疗效的研究。然而,结果并不一致。在医学、传统韩医学中,FD患者根据面部形状和角度被分为胃脘型(BB)或胆腑型(GB)亚型。同一疾病的每个亚型可能具有不同的特征、生理和病理表现。YGJT对BB亚型患者更有效。三维面部形状诊断系统(3-FSDS)已被证明在诊断BB或GB亚型方面有效。本研究旨在探讨YGJT对使用3-FSDS分类的FD患者的疗效。

材料与方法

本研究为安慰剂对照、双盲、随机、双中心试验。符合条件的患者使用3-FSDS诊断为BB或GB FD亚型。96名参与者(48名BB亚型和48名GB亚型)以2:1的比例随机分配至治疗组或对照组。给予YGJT或安慰剂治疗8周。主要结局使用总消化不良症状量表(TDS)进行评估,次要结局使用单一消化不良症状量表(SDS)、缓解者比例、视觉模拟量表、内皮消化不良指数、功能性消化不良相关生活质量和脾气虚问卷进行评估。

结果与讨论

TDS结果显示YGJT对BB亚型的疗效优于GB亚型。TDS和SDS评分的亚组分析显示YGJT优于安慰剂。其他结局变量在组间未显示任何显著差异。

结论

对于使用3-FSDS诊断为BB亚型的FD患者,可考虑使用YGJT。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dce6/6188596/8e3983583f94/ECAM2018-8546357.001.jpg

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