Randomized clinical trial

Rikkunshito in the treatment of functional dyspepsia-a multicenter, double-blind, randomized, placebo-controlled study

Hidekazu Suzuki, Juntaro Matsuzaki, Y. Fukushima, F. Suzaki, K. Kasugai, T. Nishizawa, Y. Naito, T. Hayakawa, T. Kamiya, T. Andoh, H. Yoshida, Y. Tokura, H. Nagata, M. Kobayakawa, M. Mori, K. Kato, H. Hosoda, Toru Takebayashi, S. Miura, N. Uemura & 33 others T. Joh, T. Hibi, J. Tack, Kunio Kasugai, Toshihiro Nishizawa, Yuji Naito, Takashi Joh, Soichiro Miura, Naomi Uemura, Yasushi Fukushima, Fumio Suzaki, Toshihiko Hayakawa, Takashi Ando, Hideo Yoshida, Yoshifumi Tokura, Hiroshi Nagata, Masao Kobayakawa, Mikiji Mori, Kimihiko Kato, Yoshikazu Tsuzuki, Akihiro Iwata, Kunio Kobayashi, Hiroyuki Imaeda, Yasuharu Yamaguchi, Eisuke Iwasaki, Hirokazu Komatsu, Hiroshi Serizawa, Yuichi Oyamada, Yuzo Yagou, Takeshi Yoshida, Jiro Nishida, Sayuri Yamamoto, Kazuhiko Tokita

Research output: Contribution to journalArticle

55 Citations (Scopus)

Abstract

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).

Original languageEnglish
Pages (from-to)950-961
Number of pages12
JournalNeurogastroenterology and Motility
Volume26
Issue number7
DOIs
Publication statusPublished - 2014

Fingerprint

Dyspepsia
Randomized Controlled Trials
Placebos
Helicobacter pylori
Therapeutics
Ghrelin
liu-jun-zi-tang
Pain
Herbal Medicine
Gastric Emptying
Registries
Clinical Trials
Safety

Keywords

  • Epigastric pain
  • Functional dyspepsia
  • Helicobacter pylori
  • Postprandial fullness
  • Rikkunshito

ASJC Scopus subject areas

  • Endocrine and Autonomic Systems
  • Gastroenterology
  • Physiology
  • Medicine(all)

Cite this

Randomized clinical trial : Rikkunshito in the treatment of functional dyspepsia-a multicenter, double-blind, randomized, placebo-controlled study. / Suzuki, Hidekazu; Matsuzaki, Juntaro; Fukushima, Y.; Suzaki, F.; Kasugai, K.; Nishizawa, T.; Naito, Y.; Hayakawa, T.; Kamiya, T.; Andoh, T.; Yoshida, H.; Tokura, Y.; Nagata, H.; Kobayakawa, M.; Mori, M.; Kato, K.; Hosoda, H.; Takebayashi, Toru; Miura, S.; Uemura, N.; Joh, T.; Hibi, T.; Tack, J.; Kasugai, Kunio; Nishizawa, Toshihiro; Naito, Yuji; Joh, Takashi; Miura, Soichiro; Uemura, Naomi; Fukushima, Yasushi; Suzaki, Fumio; Hayakawa, Toshihiko; Ando, Takashi; Yoshida, Hideo; Tokura, Yoshifumi; Nagata, Hiroshi; Kobayakawa, Masao; Mori, Mikiji; Kato, Kimihiko; Tsuzuki, Yoshikazu; Iwata, Akihiro; Kobayashi, Kunio; Imaeda, Hiroyuki; Yamaguchi, Yasuharu; Iwasaki, Eisuke; Komatsu, Hirokazu; Serizawa, Hiroshi; Oyamada, Yuichi; Yagou, Yuzo; Yoshida, Takeshi; Nishida, Jiro; Yamamoto, Sayuri; Tokita, Kazuhiko.

In: Neurogastroenterology and Motility, Vol. 26, No. 7, 2014, p. 950-961.

Research output: Contribution to journalArticle

Suzuki, H, Matsuzaki, J, Fukushima, Y, Suzaki, F, Kasugai, K, Nishizawa, T, Naito, Y, Hayakawa, T, Kamiya, T, Andoh, T, Yoshida, H, Tokura, Y, Nagata, H, Kobayakawa, M, Mori, M, Kato, K, Hosoda, H, Takebayashi, T, Miura, S, Uemura, N, Joh, T, Hibi, T, Tack, J, Kasugai, K, Nishizawa, T, Naito, Y, Joh, T, Miura, S, Uemura, N, Fukushima, Y, Suzaki, F, Hayakawa, T, Ando, T, Yoshida, H, Tokura, Y, Nagata, H, Kobayakawa, M, Mori, M, Kato, K, Tsuzuki, Y, Iwata, A, Kobayashi, K, Imaeda, H, Yamaguchi, Y, Iwasaki, E, Komatsu, H, Serizawa, H, Oyamada, Y, Yagou, Y, Yoshida, T, Nishida, J, Yamamoto, S & Tokita, K 2014, 'Randomized clinical trial: Rikkunshito in the treatment of functional dyspepsia-a multicenter, double-blind, randomized, placebo-controlled study', Neurogastroenterology and Motility, vol. 26, no. 7, pp. 950-961. https://doi.org/10.1111/nmo.12348
Suzuki, Hidekazu ; Matsuzaki, Juntaro ; Fukushima, Y. ; Suzaki, F. ; Kasugai, K. ; Nishizawa, T. ; Naito, Y. ; Hayakawa, T. ; Kamiya, T. ; Andoh, T. ; Yoshida, H. ; Tokura, Y. ; Nagata, H. ; Kobayakawa, M. ; Mori, M. ; Kato, K. ; Hosoda, H. ; Takebayashi, Toru ; Miura, S. ; Uemura, N. ; Joh, T. ; Hibi, T. ; Tack, J. ; Kasugai, Kunio ; Nishizawa, Toshihiro ; Naito, Yuji ; Joh, Takashi ; Miura, Soichiro ; Uemura, Naomi ; Fukushima, Yasushi ; Suzaki, Fumio ; Hayakawa, Toshihiko ; Ando, Takashi ; Yoshida, Hideo ; Tokura, Yoshifumi ; Nagata, Hiroshi ; Kobayakawa, Masao ; Mori, Mikiji ; Kato, Kimihiko ; Tsuzuki, Yoshikazu ; Iwata, Akihiro ; Kobayashi, Kunio ; Imaeda, Hiroyuki ; Yamaguchi, Yasuharu ; Iwasaki, Eisuke ; Komatsu, Hirokazu ; Serizawa, Hiroshi ; Oyamada, Yuichi ; Yagou, Yuzo ; Yoshida, Takeshi ; Nishida, Jiro ; Yamamoto, Sayuri ; Tokita, Kazuhiko. / Randomized clinical trial : Rikkunshito in the treatment of functional dyspepsia-a multicenter, double-blind, randomized, placebo-controlled study. In: Neurogastroenterology and Motility. 2014 ; Vol. 26, No. 7. pp. 950-961.
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abstract = "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).",
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TY - JOUR

T1 - Randomized clinical trial

T2 - Rikkunshito in the treatment of functional dyspepsia-a multicenter, double-blind, randomized, placebo-controlled study

AU - Suzuki, Hidekazu

AU - Matsuzaki, Juntaro

AU - Fukushima, Y.

AU - Suzaki, F.

AU - Kasugai, K.

AU - Nishizawa, T.

AU - Naito, Y.

AU - Hayakawa, T.

AU - Kamiya, T.

AU - Andoh, T.

AU - Yoshida, H.

AU - Tokura, Y.

AU - Nagata, H.

AU - Kobayakawa, M.

AU - Mori, M.

AU - Kato, K.

AU - Hosoda, H.

AU - Takebayashi, Toru

AU - Miura, S.

AU - Uemura, N.

AU - Joh, T.

AU - Hibi, T.

AU - Tack, J.

AU - Kasugai, Kunio

AU - Nishizawa, Toshihiro

AU - Naito, Yuji

AU - Joh, Takashi

AU - Miura, Soichiro

AU - Uemura, Naomi

AU - Fukushima, Yasushi

AU - Suzaki, Fumio

AU - Hayakawa, Toshihiko

AU - Ando, Takashi

AU - Yoshida, Hideo

AU - Tokura, Yoshifumi

AU - Nagata, Hiroshi

AU - Kobayakawa, Masao

AU - Mori, Mikiji

AU - Kato, Kimihiko

AU - Tsuzuki, Yoshikazu

AU - Iwata, Akihiro

AU - Kobayashi, Kunio

AU - Imaeda, Hiroyuki

AU - Yamaguchi, Yasuharu

AU - Iwasaki, Eisuke

AU - Komatsu, Hirokazu

AU - Serizawa, Hiroshi

AU - Oyamada, Yuichi

AU - Yagou, Yuzo

AU - Yoshida, Takeshi

AU - Nishida, Jiro

AU - Yamamoto, Sayuri

AU - Tokita, Kazuhiko

PY - 2014

Y1 - 2014

N2 - 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).

AB - 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).

KW - Epigastric pain

KW - Functional dyspepsia

KW - Helicobacter pylori

KW - Postprandial fullness

KW - Rikkunshito

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