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

作者：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; Kusano Motoyasu; Fujimoto Kazuma; Arakawa Tetsuo^*

来源：Journal of Gastroenterology, 2014, 49(10): 1392-1405.

DOI：10.1007/s00535-013-0896-9

• Gastroesophageal reflux
• Quality of life
• Non-erosive reflux disease
• Herbal medicine
• Alternative medicine

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). %26lt;br%26gt;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). %26lt;br%26gt;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%26lt;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 (%26lt; 22) (P%26lt;0.05) and significantly improved the acid-related dysmotility symptoms of FSSG in female and elderly patients (C65 years). %26lt;br%26gt;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.

• 出版日期2014-10