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- Title
Clinical characteristics of elderly patients with proton pump inhibitor-refractory non-erosive reflux disease from the G-PRIDE study who responded to rikkunshito.
- Authors
Sakata, Yasuhisa; Tominaga, Kazunari; Kato, Mototsugu; Takeda, Hiroshi; Shimoyama, Yasuyuki; Takeuchi, Toshihisa; Iwakiri, Ryuichi; Furuta, Kenji; Sakurai, Kouichi; Odaka, Takeo; Kusunoki, Hiroaki; Nagahara, Akihito; Iwakiri, Katsuhiko; Furuta, Takahisa; Murakami, Kazunari; Miwa, Hiroto; Kinoshita, Yoshikazu; Haruma, Ken; Takahashi, Shin'ichi; Watanabe, Sumio
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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).<bold>Trial Registration: </bold>(UMIN000005880).
- Subjects
JAPAN; GASTROINTESTINAL motility; HERBAL medicine; NON-erosive reflux disease; PROTON pump inhibitors; TREATMENT failure; TREATMENT effectiveness; BLIND experiment; CHINESE medicine; THERAPEUTICS
- Publication
BMC Gastroenterology, 2014, Vol 14, Issue 1, p116
- ISSN
1471-230X
- Publication type
journal article
- DOI
10.1186/1471-230X-14-116