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

BMC Gastroenterology

Research Article

Takahisa Furuta¹  Motoyasu Kusano²  Yasuyuki Shimoyama²  Kenji Furuta³  Yoshikazu Kinoshita³  Takeo Odaka⁴  Kazunari Murakami⁵  Sumio Watanabe⁶  Akihito Nagahara⁶  Hiroaki Kusunoki⁷  Ken Haruma⁷  Kouichi Sakurai⁸  Tetsuo Arakawa⁹  Kazunari Tominaga⁹  Yasuhisa Sakata^1,10  Kazuma Fujimoto^1,10  Ryuichi Iwakiri^1,11  Katsuhiko Iwakiri^1,12  Hiroshi Takeda^1,13  Mototsugu Kato^1,14  Hiroto Miwa^1,15  Toshihisa Takeuchi^1,16  Kazuhide Higuchi^1,16  Shin’ichi Takahashi^1,17 

[1] Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan;Department of Endoscopy and Endoscopic Surgery, Gunma University Hospital, Gunma, Japan;Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Shimane, Japan;Department of Gastroenterology, Chiba University Graduate School of Medicine, Chiba, Japan;Department of Gastroenterology, Faculty of Medicine, Oita University, Oita, Japan;Department of Gastroenterology, Juntendo University School of Medicine, Juntendo, Japan;Department of Gastroenterology, Kawasaki Medical School, Kawasaki, Japan;Department of Gastroenterology, Kumamoto University Graduate School of Medicine, Kumamoto, Japan;Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka City, Japan;Department of Internal Medicine and Gastroenterology, Saga Medical School, 5-1-1 Nabeshima, 849-8501, Saga, Japan;Department of Internal Medicine and Gastrointestinal Endoscopy, Saga Medical School, Saga, Japan;Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Nippon, Japan;Department of Pathophysiology and Therapeutics, Hokkaido University Faculty of Pharmaceutical Sciences, Hokkaido, Japan;Division of Endoscopy, Hokkaido University Hospital, Hokkaido, Japan;Division of Upper Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan;Second Department of Internal Medicine, Osaka Medical College, Osaka, Japan;Third Department of Internal Medicine, Kyorin Medical College, Kyorin, Japan;

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

DOI  :  10.1186/1471-230X-14-116

 received in 2014-04-03, accepted in 2014-06-26,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsTwo 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.ResultsThere 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.ConclusionsRKT 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)

【 授权许可】

CC BY   
© Sakata et al.; licensee BioMed Central Ltd. 2014