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Rikkunshito improves symptoms in PPI-refractory GERD patients: a prospective, randomized, multicenter trial in Japan

  • Original Article—Alimentary Tract
  • Published:
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Abstract

Background

To seek a promising therapeutic regimen for proton pump inhibitor (PPI)-refractory patients with gastroesophageal reflux disease (GERD) after the standard PPI treatment, we compared the efficacies of rikkunshito (a Japanese traditional medication) combined with rabeprazole (RPZ) and a double dose of RPZ in a prospective randomized multicenter trial in Japanese PPI-refractory GERD patients.

Methods

One hundred and four patients with GERD symptoms remaining after 4-week treatment with RPZ (10 mg/day) were randomly assigned to 4 weeks of either combination therapy [rikkunshito (7.5 g/day) with a standard dose of RPZ (10 mg/day)] or a double dose of RPZ (20 mg/day). The primary endpoint was the improvement rate, calculated based on the frequency scale for the symptoms of GERD (FSSG) before and after treatment. Subgroup analysis was also performed with respect to each subject’s background factors such as reflux esophagitis (RE)/non-erosive GERD (NERD), age, gender, and body mass index (BMI).

Results

Four-week treatment with rikkunshito combined with RPZ significantly decreased the FSSG score from 17.6 ± 6.5 to 12.0 ± 6.9, similar to the decrease seen on treatment with a double dose of RPZ. Regarding the therapeutic improvement rate, there were also significant effects in both groups. However, in the subgroup analysis based on RE/NERD, the improvement rate of male NERD patients in the rikkunshito group was significantly greater than that of such patients in the other group (P < 0.05). In the rikkunshito group, the treatment was more effective in NERD patients with a low BMI than in those with a high BMI (P < 0.05).

Conclusion

Rikkunshito combined with standard-dose RPZ therapy may be a useful new strategy for PPI-refractory GERD patients.

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Acknowledgments

We are grateful to the GERD 4 Study Group, as listed below, for their contribution to this study. The GERD 4 Study Group: Shiroishi Kyoritsu Hospital, Kinoshita Clinic, Takashima Hospital, Nagae Pediatric Medicine Clinic, Arita Kyoritsu Hospital, Hiramatsu Hospital, Fujise Clinic, Imamura Clinic, Oda Regional Medical Center, Saga Prefectural Hospital Kouseikan, Jinnouchi Gastrointestinal and Internal Medicine, Kanzaki Clinic in Saga, Sousei Hospital, Taisyo Hospital, Osaka Saiseikai Nakatsu Hospital, Hoshigaoka Koseinenkin Hospital, Osaka City Juso Hospital, and Izumiotsu Municipal Hospital (all in Osaka, Japan).

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Authors and Affiliations

  1. Department of Gastroenterology, Osaka City University Graduate School of Medicine, 1-4-3, Asahimachi, Abeno-ku, Osaka, Japan

    Kazunari Tominaga, Yasuhiro Fujiwara & Tetsuo Arakawa

  2. Department of Internal Medicine, Saga Medical School, Saga, Japan

    Ryuichi Iwakiri, Kazuma Fujimoto & Mio Tanaka

  3. Department of Endoscopy and Endoscopic Surgery, Gunma University Hospital, Gunma, Japan

    Yasuyuki Shimoyama & Motoyasu Kusano

  4. Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan

    Eiji Umegaki & Kazuhide Higuchi

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  1. Kazunari Tominaga
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  2. Ryuichi Iwakiri
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  3. Kazuma Fujimoto
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  4. Yasuhiro Fujiwara
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Correspondence to Kazunari Tominaga.

Additional information

K. Tominaga and R. Iwakiri contributed equally to this work.

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Tominaga, K., Iwakiri, R., Fujimoto, K. et al. Rikkunshito improves symptoms in PPI-refractory GERD patients: a prospective, randomized, multicenter trial in Japan. J Gastroenterol 47, 284–292 (2012). https://doi.org/10.1007/s00535-011-0488-5

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  • DOI: https://doi.org/10.1007/s00535-011-0488-5

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