Open Access Research article

Clinical characteristics of elderly patients with proton pump inhibitor-refractory non-erosive reflux disease from the G-PRIDE study who responded to rikkunshito

Yasuhisa Sakata1*, Kazunari Tominaga2, Mototsugu Kato3, Hiroshi Takeda4, Yasuyuki Shimoyama5, Toshihisa Takeuchi6, Ryuichi Iwakiri7, Kenji Furuta8, Kouichi Sakurai9, Takeo Odaka10, Hiroaki Kusunoki11, Akihito Nagahara12, Katsuhiko Iwakiri13, Takahisa Furuta14, Kazunari Murakami15, Hiroto Miwa16, Yoshikazu Kinoshita8, Ken Haruma11, Shin’ichi Takahashi17, Sumio Watanabe12, Kazuhide Higuchi6, Kazuma Fujimoto1, Motoyasu Kusano5, Tetsuo Arakawa2 and and the G-PRIDE study group

Author Affiliations

1 Department of Internal Medicine and Gastroenterology, Saga Medical School, 5-1-1 Nabeshima, Saga 849-8501, Japan

2 Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka City, Japan

3 Division of Endoscopy, Hokkaido University Hospital, Hokkaido, Japan

4 Department of Pathophysiology and Therapeutics, Hokkaido University Faculty of Pharmaceutical Sciences, Hokkaido, Japan

5 Department of Endoscopy and Endoscopic Surgery, Gunma University Hospital, Gunma, Japan

6 Second Department of Internal Medicine, Osaka Medical College, Osaka, Japan

7 Department of Internal Medicine and Gastrointestinal Endoscopy, Saga Medical School, Saga, Japan

8 Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Shimane, Japan

9 Department of Gastroenterology, Kumamoto University Graduate School of Medicine, Kumamoto, Japan

10 Department of Gastroenterology, Chiba University Graduate School of Medicine, Chiba, Japan

11 Department of Gastroenterology, Kawasaki Medical School, Kawasaki, Japan

12 Department of Gastroenterology, Juntendo University School of Medicine, Juntendo, Japan

13 Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Nippon, Japan

14 Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan

15 Department of Gastroenterology, Faculty of Medicine, Oita University, Oita, Japan

16 Division of Upper Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan

17 Third Department of Internal Medicine, Kyorin Medical College, Kyorin, Japan

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BMC Gastroenterology 2014, 14:116  doi:10.1186/1471-230X-14-116

Published: 2 July 2014

Abstract

Background

The incidence and severity of gastroesophageal reflux disease (GERD) in Japan tends to increase in elderly women. Rikkunshito (RKT), a traditional Japanese medicine, acts as a prokinetic agent and improves gastric emptying and gastric accommodation. Our previous prospective randomized placebo-controlled study showed that RKT combined with a standard-dose of rabeprazole (RPZ) significantly improved the acid-related dysmotility symptoms (ARD) in elderly patients with proton pump inhibitor (PPI)-refractory non-erosive reflux disease (NERD). This study aimed to evaluate clinical characteristics of elderly PPI-refractory NERD patients with ARD symptoms who responded to RKT.

Methods

Two hundred forty-two patients with PPI-refractory NERD were randomly assigned to 8 weeks of either RPZ (10 mg/q.d.) + RKT (7.5 g/t.i.d.) (RKT group) or RPZ + placebo (PL group). Among them, 95 were elderly (≥65 years) with ARD (RKT group: n = 52; PL group: n = 43). We analyzed the changes using the 12 subscale score of frequency scale for the symptoms of GERD (FSSG) and 15 items of the Gastrointestinal Symptom Rating Scale at 4 and 8 weeks and compared the therapeutic efficacy between the 2 groups.

Results

There were no marked differences in baseline demographic or clinical characteristics in the 2 groups except for rate of current smoking. The FSSG score (mean ± SD at 0, 4, and 8 weeks) in both the RKT (16.0 ± 7.0; 9.9 ± 8.4; 7.0 ± 6.4) and PL (15.1 ± 6.4; 10.9 ± 6.7, 11.1 ± 8.5) groups significantly decreased after treatment. However, the degree of improvement of total and ARD scores of FSSG after the 8-week treatment was significantly greater in the RKT group than in the PL group. Combination therapy with RKT for 8 weeks showed significant improvement in 3 subscale scores (abdominal bloating, heavy feeling in stomach and sick feeling after meals) of the ARD domain and 1 subscale score (heartburn after meals) of the reflux symptom domain.

Conclusions

RKT may be useful for improving GERD symptoms in elderly PPI-refractory NERD patients with ARD. Thus, RKT was particularly effective for resolving postprandial GERD symptoms (heavy feeling in stomach, sick feeling, and heartburn after meals).

Trial registration

(UMIN000005880)

Keywords:
Gastroesophageal reflux; Acid-related dysmotility; Postprandial; Herbal medicine; Elderly patient