Ko Seok-Jae, Park Jiseon, Kim Min-Ji, Kim Jinsung, Park Jae-Woo
Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
J Gastroenterol Hepatol. 2021 Jan;36(1):64-74. doi: 10.1111/jgh.15208. Epub 2020 Aug 17.
Functional dyspepsia (FD) is characterized by chronic and unexplained indigestion at upper abdomen. Because of unsatisfactory effect of conventional treatments, demand is growing for complementary and alternative medicine. Rikkunshito (RKT) is a herbal medicine, which has been widely used for FD in Asia; however, the evidence is lacking. We carried out systematic review and meta-analysis to evaluate the effect and safety of RKT in the treatment of FD.
Electronic databases were searched in April 2019, including PUBMED, EMBASE, and Cochrane Library. All eligible studies should be randomized controlled trials (RCTs) comparing RKT or combination therapy (RKT and western medicine) group to western medicine group. The primary outcome measure was the total clinical efficacy rate (TCE). The secondary outcomes were total dyspepsia symptom scale, gastric emptying rate, gastrin, motilin, recurrence 6 months after treatment, and Hamilton depression rating scale.
Fifty-two RCTs with 5475 patients were involved in this systematic review and meta-analysis. Compared with western medicine, RKT showed significant better result, with higher TCE (relative risk = 1.21, 95% confidence interval 1.17 to 1.25, P < 0.001). RKT presented higher reduction of total dyspepsia symptom scale, more improved gastric emptying rate, and lower recurrence 6 months after treatment compared with western medicine. However, there was no significant difference in Hamilton depression rating scale between RKT and western medicine group. Combination therapy brought significant symptom improvement with TCE compared with western medicine alone.
Rikkunshito and combination therapy might be considered an effective alternative treatment for FD. Further rigorously designed and high-quality RCTs are needed.
功能性消化不良（FD）的特征是上腹部慢性且原因不明的消化不良。由于传统治疗效果不尽人意，对补充和替代医学的需求日益增长。理气剂（RKT）是一种草药，在亚洲已广泛用于治疗FD；然而，相关证据尚缺。我们进行了系统评价和荟萃分析，以评估RKT治疗FD的疗效和安全性。
于2019年4月检索电子数据库，包括PUBMED、EMBASE和Cochrane图书馆。所有符合条件的研究均应为比较RKT或联合治疗组（RKT与西药）和西药组的随机对照试验（RCT）。主要结局指标为总临床有效率（TCE）。次要结局指标为总消化不良症状量表、胃排空率、胃泌素、胃动素、治疗后6个月复发率及汉密尔顿抑郁量表。
本系统评价和荟萃分析纳入了52项RCT，共5475例患者。与西药相比，RKT显示出显著更好的结果，TCE更高（相对危险度=1.21，95%置信区间1.17至1.25，P<0.001）。与西药相比，RKT在降低总消化不良症状量表方面效果更显著，胃排空率改善更明显，治疗后6个月复发率更低。然而，RKT组与西药组在汉密尔顿抑郁量表上无显著差异。与单纯西药相比，联合治疗在TCE方面带来了显著的症状改善。
理气剂和联合治疗可能被认为是FD的一种有效替代治疗方法。需要进一步进行设计严谨、高质量的RCT。
