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


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
Administration of rikkunshito for 8 weeks reduced dyspepsia, particularly symptoms of epigastric pain and postprandial fullness. (UMIN Clinical Trials Registry, Number UMIN000003954).
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
H
H
Suzuki
J
J
Matsuzaki
Y
Y
Fukushima
F
F
Suzaki
K
K
Kasugai
T
T
Nishizawa
Y
Y
Naito
T
T
Hayakawa
T
T
Kamiya
T
T
Andoh
H
H
Yoshida
Y
Y
Tokura
H
H
Nagata
M
M
Kobayakawa
M
M
Mori
K
K
Kato
H
H
Hosoda
T
T
Takebayashi
S
S
Miura
N
N
Uemura
T
T
Joh
T
T
Hibi
J
J
Tack
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D004415:Dyspepsia / Q000097:blood / Q000188:drug therapy*; D005260:Female; D054439:Ghrelin / Q000097:blood; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D016896:Treatment Outcome; D055815:Young Adult
D004365:Drugs, Chinese Herbal; D054439:Ghrelin; C084136:liu-jun-zi-tang
Helicobacter pylori; epigastric pain; functional dyspepsia; postprandial fullness; rikkunshito