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- Title
A randomized, placebo-controlled, double-blind clinical trial of rikkunshito for patients with non-erosive reflux disease refractory to proton-pump inhibitor: the G-PRIDE study.
- Authors
Tominaga, Kazunari; Kato, Mototsugu; Takeda, Hiroshi; Shimoyama, Yasuyuki; Umegaki, Eiji; Iwakiri, Ryuichi; Furuta, Kenji; Sakurai, Koichi; Odaka, Takeo; Kusunoki, Hiroaki; Nagahara, Akihito; Iwakiri, Katsuhiko; Furuta, Takahisa; Murakami, Kazunari; Miwa, Hiroto; Kinoshita, Yoshikazu; Haruma, Ken; Takahashi, Shin'ichi; Watanabe, Sumio; Higuchi, Kazuhide
- Abstract
Background: The aim of this study was to investigate the efficacy of rikkunshito (RKT), a traditional Japanese medicine, combined with proton pump inhibitor (PPI) in patients with PPI-refractory non-erosive reflux disease (NERD). Methods: Patients with PPI-refractory NERD ( n = 242) were randomly assigned to the RKT group [rabeprazole (10 mg/day) + RKT (7.5 g/t.i.d.) for 8 weeks] or the placebo group (rabeprazole + placebo). After the 4- and 8-week treatments, we assessed symptoms and quality of life (QOL) using the Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (FSSG), Gastrointestinal Symptom Rating Scale (GSRS), and Short-Form Health Survey-8 (SF-8). Results: There were no significant differences in FSSG and GSRS score improvement between these groups after the 4- and 8-week treatments. The mental component summary (MCS) scores of the SF-8 improved more in the RKT group (from 45.8 ± 8.1 to 48.5 ± 7.4) than in the placebo group (from 47.7 ± 7.1 to 48.4 ± 7.5) after the 4-week treatment ( P < 0.05). The 8-week treatment with RKT was more effective for improvement of the degree of MCS score in patients with a low body mass index (<22) ( P < 0.05) and significantly improved the acid-related dysmotility symptoms of FSSG in female and elderly patients (≥65 years). Conclusion: There were no significant differences in improvement of GERD symptoms in patients with PPI-refractory NERD between these groups. However, RKT may be useful for improving mental QOL in non-obese patients and acid-related dyspeptic symptoms, especially in women and the elderly.
- Subjects
RANDOMIZED controlled trials; BLIND experiment; PROTON pump inhibitors; QUALITY of life; GASTROESOPHAGEAL reflux; GASTROINTESTINAL diseases
- Publication
Journal of Gastroenterology, 2014, Vol 49, Issue 10, p1392
- ISSN
0944-1174
- Publication type
Article
- DOI
10.1007/s00535-013-0896-9