1. 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
- Author
-
Kazunari, Tominaga, Mototsugu, Kato, Hiroshi, Takeda, Yasuyuki, Shimoyama, Eiji, Umegaki, Ryuichi, Iwakiri, Kenji, Furuta, Koichi, Sakurai, Takeo, Odaka, Hiroaki, Kusunoki, Akihito, Nagahara, Katsuhiko, Iwakiri, Takahisa, Furuta, Kazunari, Murakami, Hiroto, Miwa, Yoshikazu, Kinoshita, Ken, Haruma, Shin'ichi, Takahashi, Sumio, Watanabe, Kazuhide, Higuchi, Motoyasu, Kusano, Kazuma, Fujimoto, Tetsuo, Arakawa, and Fuminao, Takeshima
- Subjects
Adult ,Male ,medicine.medical_specialty ,Nerd ,medicine.drug_class ,Rabeprazole ,Proton-pump inhibitor ,Placebo ,Severity of Illness Index ,Gastroenterology ,Medication Adherence ,Young Adult ,Double-Blind Method ,Quality of life ,Internal medicine ,medicine ,Humans ,Aged ,Aged, 80 and over ,business.industry ,Reflux ,Proton Pump Inhibitors ,Middle Aged ,medicine.disease ,Clinical trial ,Treatment Outcome ,Gastroesophageal Reflux ,Quality of Life ,GERD ,Drug Therapy, Combination ,Female ,business ,Drugs, Chinese Herbal ,medicine.drug - Abstract
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). 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). 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
- Published
- 2014
- Full Text
- View/download PDF