Clinical characteristics of elderly patients with proton pump inhibitor-refractory non-erosive reflux disease from the G-PRIDE study who responded to rikkunshito
- Equal contributors
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
BMC Gastroenterology 2014, 14:116 doi:10.1186/1471-230X-14-116Published: 2 July 2014
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.
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.
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.
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).