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首页> 外文期刊>Neurogastroenterology and motility >Randomized clinical trial: Rikkunshito in the treatment of functional dyspepsia-a multicenter, double-blind, randomized, placebo-controlled study
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Randomized clinical trial: Rikkunshito in the treatment of functional dyspepsia-a multicenter, double-blind, randomized, placebo-controlled study

机译：随机临床试验：Rikkunshito治疗功能性消化不良-多中心，双盲，随机，安慰剂对照研究

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Background: Rikkunshito, a standardized Japanese herbal medicine, is thought to accelerate gastric emptying and relieve dyspepsia, although no large-scale, randomized, placebo-controlled trials of rikkunshito have been conducted. This study aimed to determine the efficacy and safety of rikkunshito for treating functional dyspepsia (FD). Methods: FD patients received 2.5 g rikkunshito or placebo three times a day for 8 weeks in this multicenter, randomized, placebo-controlled, parallel-group trial. The primary end point was the proportion of responders at 8 weeks after starting test drug, determined by global patient assessment (GPA). The improvement in four major dyspepsia symptoms severity scale was also evaluated. In addition, plasma ghrelin levels were investigated before and after treatment. Key Results: Two hundred forty-seven patients were randomly assigned. In the eighth week, the rikkunshito group had more GPA responders (33.6%) than the placebo (23.8%), although this did not reach statistical significance (p = 0.09). Epigastric pain was significantly improved (p = 0.04) and postprandial fullness tended to improve (p = 0.06) in the rikkunshito group at week 8. Rikkunshito was relatively more effective among Helicobacter pylori-infected participants (rikkunshito: 40.0% vs placebo: 20.5%, p = 0.07), and seemed less effective among H. pylori-uninfected participants (rikkunshito: 29.3% vs placebo: 25.6%, p = 0.72). Among H. pylori-positive individuals, acyl ghrelin levels were improved just in rikkunshito group. There were no severe adverse events in both groups. Conclusions & Inferences: Administration of rikkunshito for 8 weeks reduced dyspepsia, particularly symptoms of epigastric pain and postprandial fullness. (UMIN Clinical Trials Registry, Number UMIN000003954).
机译：背景：尽管尚未进行rikkunshito的大规模，随机，安慰剂对照试验，但标准化的日本草药Rikkunshito被认为可加速胃排空并缓解消化不良。这项研究旨在确定rikkunshito治疗功能性消化不良（FD）的功效和安全性。方法：在这项多中心，随机，安慰剂对照，平行组试验中，FD患者每天3次接受2.5 g rikkunshito或安慰剂治疗，持续8周。主要终点是通过全球患者评估（GPA）确定的开始测试药物后8周时应答者的比例。还评估了四种主要消化不良症状严重程度的改善。另外，在治疗之前和之后研究血浆生长素释放肽水平。关键结果：247名患者被随机分配。在第八周，rikkunshito组的GPA应答者（33.6％）比安慰剂（23.8％）多，尽管这没有统计学意义（p = 0.09）。在第8周时，rikkunshito组的上腹部疼痛明显改善（p = 0.04），餐后饱胀感有所改善（p = 0.06），在幽门螺杆菌感染的参与者中，Rikkunshito相对更有效（rikkunshito：40.0％，而安慰剂：20.5％）。 ，p = 0.07），并且在未感染幽门螺杆菌的参与者中似乎效果较差（rikkunshito：29.3％，而安慰剂：25.6％，p = 0.72）。在幽门螺杆菌阳性个体中，仅瑞克昆士多组的酰基生长素释放肽水平有所提高。两组均无严重不良事件。结论与推论：rikkunshito给药8周可减少消化不良，尤其是上腹部疼痛和餐后饱胀的症状。 （UMIN临床试验注册中心，编号UMIN000003954）。

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