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.
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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gastroenterology, Osaka City University Graduate School of Medicine, 1-4-3 Asahimachi, Abeno-ku, Osaka, Japan.
authors.forename: Kazunari
authors.initials: K
authors.lastname: Tominaga
authors.forename: Mototsugu
authors.initials: M
authors.lastname: Kato
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Takeda
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Shimoyama
authors.forename: Eiji
authors.initials: E
authors.lastname: Umegaki
authors.forename: Ryuichi
authors.initials: R
authors.lastname: Iwakiri
authors.forename: Kenji
authors.initials: K
authors.lastname: Furuta
authors.forename: Koichi
authors.initials: K
authors.lastname: Sakurai
authors.forename: Takeo
authors.initials: T
authors.lastname: Odaka
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Kusunoki
authors.forename: Akihito
authors.initials: A
authors.lastname: Nagahara
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Iwakiri
authors.forename: Takahisa
authors.initials: T
authors.lastname: Furuta
authors.forename: Kazunari
authors.initials: K
authors.lastname: Murakami
authors.forename: Hiroto
authors.initials: H
authors.lastname: Miwa
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kinoshita
authors.forename: Ken
authors.initials: K
authors.lastname: Haruma
authors.forename: Shin'ichi
authors.initials: S
authors.lastname: Takahashi
authors.forename: Sumio
authors.initials: S
authors.lastname: Watanabe
authors.forename: Kazuhide
authors.initials: K
authors.lastname: Higuchi
authors.forename: Motoyasu
authors.initials: M
authors.lastname: Kusano
authors.forename: Kazuma
authors.initials: K
authors.lastname: Fujimoto
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Arakawa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal; D054328:Proton Pump Inhibitors; C084136:liu-jun-zi-tang