Randomized clinical trial: rikkunshito in the treatment of functional dyspepsiaa multicenter, double-blind, randomized, placebo-controlled study

被引：115

作者：

Suzuki, H. ^{[1
]}

Matsuzaki, J. ^{[1
]}

Fukushima, Y. ^{[2
]}

Suzaki, F. ^{[3
]}

Kasugai, K. ^{[4
]}

Nishizawa, T. ^{[5
]}

Naito, Y. ^{[6
]}

Hayakawa, T. ^{[7
]}

Kamiya, T. ^{[8
]}

Andoh, T. ^{[9
]}

Yoshida, H. ^{[10
]}

Tokura, Y. ^{[11
]}

Nagata, H. ^{[12
]}

Kobayakawa, M. ^{[13
]}

Mori, M. ^{[14
]}

Kato, K. ^{[15
]}

Hosoda, H. ^{[16
]}

Takebayashi, T. ^{[17
]}

Miura, S. ^{[18
]}

Uemura, N. ^{[19
]}

Joh, T. ^{[8
]}

Hibi, T. ^{[1
]}

Tack, J. ^{[20
]}

机构：

[1] Keio Univ, Sch Med, Div Gastroenterol & Hepatol, Dept Internal Med, Tokyo 1608582, Japan

[2] Tokyo Eki Ctr Bldg Clin, Tokyo, Japan

[3] Yokohama Minami Kyosai Hosp, Div Gastroenterol, Yokohama, Kanagawa, Japan

[4] Aichi Med Univ, Dept Gastroenterol, Nagakute, Aichi 48011, Japan

[5] Natl Tokyo Med Ctr, Div Gastroenterol, Tokyo, Japan

[6] Kyoto Prefectural Univ Med, Dept Gastroenterol, Kyoto, Japan

[7] Hayakawa Clin, Tokai, Ibaraki, Japan

[8] Nagoya City Univ, Sch Med, Dept Gastroenterol, Nagoya, Aichi 467, Japan

[9] Social Insurance Kyoto Hosp, Div Gastroenterol, Kyoto, Japan

[10] Eiju Gen Hosp, Div Gastroenterol, Tokyo, Japan

[11] Tokura Yoshifumi Gastroenterol Clin, Kameoka, Japan

[12] Keiyu Hosp, Dept Internal Med, Yokohama, Kanagawa, Japan

[13] Natl Ctr Global Hlth & Med, Dept Clin Res, Tokyo, Japan

[14] Ogikubo GI Clin, Tokyo, Japan

[15] Meito Hosp, Nagoya, Aichi, Japan

[16] Natl Cerebral & Cardiovasc Ctr Res Inst, Dept Regenerat Med & Tissue Engn, Osaka, Japan

[17] Keio Univ, Sch Med, Dept Publ Hlth, Tokyo, Japan

[18] Natl Def Med Coll, Dept Gastroenterol, Tokorozawa, Saitama 359, Japan

[19] Kohnodai Hosp, Natl Ctr Global Hlth & Med, Div Gastroenterol, Ichikawa, Japan

[20] Katholieke Univ Leuven, Translat Res Ctr Gastrointestinal Disorders TARGI, Leuven, Belgium

来源：

NEUROGASTROENTEROLOGY AND MOTILITY | 2014年 / 26卷 / 07期

关键词：

epigastric pain; functional dyspepsia; Helicobacter pylori; postprandial fullness; rikkunshito; HELICOBACTER-PYLORI INFECTION; TRADITIONAL JAPANESE MEDICINE; CISPLATIN-INDUCED ANOREXIA; QUALITY-OF-LIFE; PLASMA GHRELIN; ACYLATED GHRELIN; HERBAL MEDICINE; CONSCIOUS DOGS; SYMPTOMS; IMPROVES;

D O I：

10.1111/nmo.12348

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

100201 [内科学];

摘要：

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 2.5g rikkunshito or placebo three times a day for 8weeks in this multicenter, randomized, placebo-controlled, parallel-group trial. The primary end point was the proportion of responders at 8weeks 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 8weeks reduced dyspepsia, particularly symptoms of epigastric pain and postprandial fullness. (UMIN Clinical Trials Registry, Number UMIN000003954).

引用

页码：950 / 961

页数：12

共 31 条

[1]

Rikkunshito Improves the Symptoms in Patients with Functional Dyspepsia, Accompanied by an Increase in the Level of Plasma Ghrelin [J].