Ha Na-Yeon, Lee Ha-Nul, Jeong Hae-In, 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):e22359. doi: 10.1097/MD.0000000000022359.
Functional dyspepsia (FD) is a common condition characterized by gastrointestinal symptoms, such as abdominal fullness and epigastric pain. With the limitations of conventional Western medical treatments, symptoms often recur and lead to poor quality of life. Soyo-san (SYS) is a traditional herbal medicine that has been frequently used to treat indigestion. This protocol was designed to investigate the safety and efficacy of SYS for treating FD through a systematic review and meta-analysis.
Trials will be searched from the following 11 electronic databases, up to March 2020: EMBASE, Medline (via PubMED), the Cochrane Central Register of Controlled Trials (CENTRAL), Allied and Complementary Medicine Database (AMED), Korean Medical Database (KMbase), KoreaMed, Korean Studies Information Service System (KISS), National Digital Science Library (NDSL), Oriental Medicine Advanced Searching Integrated System (OASIS), China National Knowledge Infrastructure Database (CNKI), and Citation Information by Nii (CiNii). Randomized controlled trials (RCTs) of SYS or modified SYS for FD will be included in this systematic review. The effects of control interventions such as placebo, no-treatment, and conventional Western medicine will be compared with those of SYS. RCTs investigating the synergetic effect of SYS and Western medicine compared with conventional Western medicine alone will also be evaluated. Two investigators will independently extract the data and assess the risk of bias in the included studies. The total clinical effective rate will be measured as the main outcome.
This systematic review will provide data on the use of SYS in the treatment of FD, based on indicators such as dyspepsia-related symptom score, recurrence rate, and adverse events.
This study will determine the safety and efficacy of SYS for the treatment of FD. REVIEW REGISTRY UNIQUE IDENTIFYING NUMBER:: reviewregistry969.
功能性消化不良（FD）是一种常见病症，其特征为胃肠道症状，如腹胀和上腹部疼痛。由于传统西医治疗存在局限性，症状常反复出现并导致生活质量下降。柴朴汤（SYS）是一种常用于治疗消化不良的传统草药。本方案旨在通过系统评价和荟萃分析研究柴朴汤治疗功能性消化不良的安全性和有效性。
将检索以下11个电子数据库截至2020年3月的试验：EMBASE、Medline（通过PubMED）、Cochrane对照试验中心注册库（CENTRAL）、补充与替代医学数据库（AMED）、韩国医学数据库（KMbase）、KoreaMed、韩国研究信息服务系统（KISS）、国家数字科学图书馆（NDSL）、东方医学高级检索集成系统（OASIS）、中国知网数据库（CNKI）和日本国立情报学研究所引文信息数据库（CiNii）。本系统评价将纳入柴朴汤或改良柴朴汤治疗功能性消化不良的随机对照试验（RCT）。将安慰剂、无治疗和传统西医等对照干预措施的效果与柴朴汤的效果进行比较。还将评估研究柴朴汤与西医联合使用相对于单纯传统西医的协同作用的随机对照试验。两名研究人员将独立提取数据并评估纳入研究的偏倚风险。将总临床有效率作为主要结局指标进行测量。
本系统评价将基于消化不良相关症状评分、复发率和不良事件等指标，提供柴朴汤治疗功能性消化不良的相关数据。
本研究将确定柴朴汤治疗功能性消化不良的安全性和有效性。综述注册唯一识别号：reviewregistry969。
