Journal of Gastroenterology

, Volume 47, Issue 3, pp 284–292

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

  • Kazunari Tominaga
  • Ryuichi Iwakiri
  • Kazuma Fujimoto
  • Yasuhiro Fujiwara
  • Mio Tanaka
  • Yasuyuki Shimoyama
  • Eiji Umegaki
  • Kazuhide Higuchi
  • Motoyasu Kusano
  • Tetsuo Arakawa
  • and the GERD 4 Study Group
Original Article—Alimentary Tract

DOI: 10.1007/s00535-011-0488-5

Cite this article as:
Tominaga, K., Iwakiri, R., Fujimoto, K. et al. J Gastroenterol (2012) 47: 284. doi:10.1007/s00535-011-0488-5

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.

Keywords

HeartburnAbdominal discomfortRikkunshitoAcid-suppressive therapy

Copyright information

© Springer 2011

Authors and Affiliations

  • Kazunari Tominaga
    • 1
  • Ryuichi Iwakiri
    • 2
  • Kazuma Fujimoto
    • 2
  • Yasuhiro Fujiwara
    • 1
  • Mio Tanaka
    • 2
  • Yasuyuki Shimoyama
    • 3
  • Eiji Umegaki
    • 4
  • Kazuhide Higuchi
    • 4
  • Motoyasu Kusano
    • 3
  • Tetsuo Arakawa
    • 1
  • and the GERD 4 Study Group
  1. 1.Department of GastroenterologyOsaka City University Graduate School of MedicineOsakaJapan
  2. 2.Department of Internal MedicineSaga Medical SchoolSagaJapan
  3. 3.Department of Endoscopy and Endoscopic SurgeryGunma University HospitalGunmaJapan
  4. 4.Second Department of Internal MedicineOsaka Medical CollegeTakatsukiJapan