title: Clinical characteristics of elderly patients with proton pump inhibitor-refractory non-erosive reflux disease from the G-PRIDE study who responded to rikkunshito.
abstract: BACKGROUND
  The 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.
  
  
  METHODS
  Two 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.
  
  
  RESULTS
  There 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.
  
  
  CONCLUSIONS
  RKT 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).
  
  
  BACKGROUND
  (UMIN000005880).
authors.affiliation: Department of Internal Medicine and Gastroenterology, Saga Medical School, 5-1-1 Nabeshima, Saga 849-8501, Japan. sakatay@cc.saga-u.ac.jp.
authors.forename: Yasuhisa
authors.initials: Y
authors.lastname: Sakata
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: Toshihisa
authors.initials: T
authors.lastname: Takeuchi
authors.forename: Ryuichi
authors.initials: R
authors.lastname: Iwakiri
authors.forename: Kenji
authors.initials: K
authors.lastname: Furuta
authors.forename: Kouichi
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: Kazuma
authors.initials: K
authors.lastname: Fujimoto
authors.forename: Motoyasu
authors.initials: M
authors.lastname: Kusano
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Arakawa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D005746:Gastric Emptying; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D007564:Japan; D008297:Male; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D064750:Rabeprazole / Q000627:therapeutic use*; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; D054328:Proton Pump Inhibitors; C084136:liu-jun-zi-tang; D064750:Rabeprazole