Ha Na-Yeon, Jeong Hae-In, Lee Ha-Nul, Ko Seok-Jae, Park Jae-Woo, Kim Jinsung
Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
Medicine (Baltimore). 2020 Sep 25;99(39):e22358. doi: 10.1097/MD.0000000000022358.
Functional dyspepsia (FD) is characterized by persistent and recurrent dyspeptic symptoms, such as postprandial fullness and epigastric pain. Although it is rarely severe or life-threatening, it can degrade the quality of life and cause social and economic issues. As symptoms often persist despite the treatment with conventional Western medicine, herbal medicine can be considered as an alternative for treating FD. Siho-sogan-san (SHS) is a traditional herbal formula prescribed for dyspepsia for hundreds of years. This protocol for a systematic review was designed to evaluate the safety and efficacy of SHS for the treatment of FD through a meta-analysis.
Studies will be searched from the following electronic databases up to March 2020: Embase, MEDLINE (via PubMED), Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine Database, Korean Medical Database, KoreaMed, Korean Studies Information Service System, National Digital Science Library, Oriental Medicine Advanced Searching Integrated System, China National Knowledge Infrastructure Database, and Citation Information by Nii. Randomized controlled trials of SHS and herb-added SHS for treating FD will be selected in this review. The control groups of no-treatment, placebo, and conventional Western medicine will be compared with SHS for its efficacy. The synergetic effect of SHS with Western medicine will also be analyzed in comparison with conventional Western medicine alone. Two independent reviewers will collect the data and assess the risk of bias in individual studies. The total clinical effectiveness rate will be synthesized and evaluated as primary outcome.
This systematic review will present an adequate clinical evidence of SHS for the treatment of FD based on specific parameters, including dyspepsia-related symptoms, gastric emptying, and adverse events.
This study will provide evidence for the safety and efficacy of SHS for the treatment of patients with FD. REVIEW REGISTRY UNIQUE IDENTIFYING NUMBER:: reviewregistry952.
功能性消化不良（FD）的特征是持续和反复出现消化不良症状，如餐后饱胀感和上腹部疼痛。尽管它很少严重或危及生命，但会降低生活质量并引发社会和经济问题。由于尽管使用传统西药治疗，症状仍常常持续，草药可被视为治疗FD的一种替代方法。四和苏肝散（SHS）是一种用于消化不良的传统草药配方，已沿用数百年。本系统评价方案旨在通过荟萃分析评估SHS治疗FD的安全性和有效性。
截至2020年3月，将从以下电子数据库进行检索：Embase、MEDLINE（通过PubMed）、Cochrane对照试验中心注册库、联合与补充医学数据库、韩国医学数据库、KoreaMed、韩国研究信息服务系统、国家数字科学图书馆、东方医学高级检索集成系统、中国国家知识基础设施数据库和Nii的引文信息。本评价将选择SHS及加用草药的SHS治疗FD的随机对照试验。将未治疗、安慰剂和传统西药对照组与SHS进行疗效比较。还将与单独使用传统西药相比，分析SHS与西药的协同作用。两名独立评价者将收集数据并评估个体研究中的偏倚风险。将综合并评估总临床有效率作为主要结局。
本系统评价将基于特定参数，包括与消化不良相关的症状、胃排空和不良事件，提供SHS治疗FD的充分临床证据。
本研究将为SHS治疗FD患者的安全性和有效性提供证据。评价注册唯一识别号：reviewregistry952。
