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Randomized Controlled Trial
. 2014 Jul 2:14:116.
doi: 10.1186/1471-230X-14-116.

Clinical characteristics of elderly patients with proton pump inhibitor-refractory non-erosive reflux disease from the G-PRIDE study who responded to rikkunshito

Yasuhisa Sakata  1 , Kazunari Tominaga, Mototsugu Kato, Hiroshi Takeda, Yasuyuki Shimoyama, Toshihisa Takeuchi, Ryuichi Iwakiri, Kenji Furuta, Kouichi 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, Kazuma Fujimoto, Motoyasu Kusano, Tetsuo Arakawa; G-PRIDE study group
Collaborators, Affiliations
Randomized Controlled Trial

Clinical characteristics of elderly patients with proton pump inhibitor-refractory non-erosive reflux disease from the G-PRIDE study who responded to rikkunshito

Yasuhisa Sakata et al. BMC Gastroenterol. .

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).

Trial registration: (UMIN000005880).

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Figures

Figure 1
Figure 1
Patients enrolled in this study. Of 242 patients with a clinical diagnosis of PPI-refractory NERD, 95 were elderly patients (≥65 years) with ARD. ARD, acid-related dysmotility symptom; RKT group: rikkunshito (7.5 g/day 3 times) + rabeprazole (10 mg/day), PL group: placebo (7.5 g/day 3 times) + rabeprazole (10 mg/day).
Figure 2
Figure 2
Changes in FSSG scores after treatments of RKT or placebo. (A) Changes in total, ARD and RS scores of FSSG after the 4- and 8-week treatment. (B) Improvement degrees of total, ARD and RS scores of FSSG after the 4- and 8-week treatment. Values are expressed as mean ± SD. **P < 0.01 vs. before treatment (Wilcoxon’s signed rank test). #P < 0.05, ##P < 0.01 significant difference between each paired group (Wilcoxon’s signed rank test).
Figure 3
Figure 3
Improvement degrees of 12 subscale scores of FSSG after the 8-week treatment in the RKT and placebo 2 groups. (A) Improvement degrees in 5 subscale scores of ARD after the 8-week treatment. (B) Improvement degrees in 7 subscale scores of RS after the 8-week treatment. Values were expressed as mean ± SD. #P < 0.05, ##P < 0.01 significant difference between each paired group (Wilcoxon’s signed rank test).
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