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

H. Suzuki, J. 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, T. Takebayashi, S. Miura, N. UemuraT. 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

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64 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 Jul

Keywords

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

ASJC Scopus subject areas

  • Physiology
  • Endocrine and Autonomic Systems
  • Gastroenterology

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    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., ... Tokita, K. (2014). Randomized clinical trial: Rikkunshito in the treatment of functional dyspepsia-a multicenter, double-blind, randomized, placebo-controlled study. Neurogastroenterology and Motility, 26(7), 950-961. https://doi.org/10.1111/nmo.12348