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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). TRIAL REGISTRATION: (UMIN000005880).

SUBMITTER: Sakata Y

PROVIDER: S-EPMC4090183 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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

Sakata Yasuhisa Y Tominaga Kazunari K Kato Mototsugu M Takeda Hiroshi H Shimoyama Yasuyuki Y Takeuchi Toshihisa T Iwakiri Ryuichi R Furuta Kenji K Sakurai Kouichi K Odaka Takeo T Kusunoki Hiroaki H Nagahara Akihito A Iwakiri Katsuhiko K Furuta Takahisa T Murakami Kazunari K Miwa Hiroto H Kinoshita Yoshikazu Y Haruma Ken K Takahashi Shin'ichi S Watanabe Sumio S Higuchi Kazuhide K Fujimoto Kazuma K Kusano Motoyasu M Arakawa Tetsuo T

BMC gastroenterology 20140702

<h4>Background</h4>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 ...[more]

PMID: 24990161

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Project description:Objective: To assess the correlation between the incidence of non-erosive reflux disease (NERD) and psychological factors, especially somatoform disorders. To investigate the characteristics of gut microbiome in NERD patients. Methods: We enrolled 24 NERD patients and 24 healthy controls. All patients were evaluated via GerdQ, SOMS-7, SAS, HAMA, and HAMD. Fecal samples were collected and 16S rRNA sequencing was performed to evaluate the gut microbiome composition. Results: The main symptoms of the NERD patients were regurgitation (87.5%), belching (66.7%), pharyngeal discomfort (50%), and heartburn (37.5%). The average score of GerdQ was 13.42 ± 3.41. In 15 patients (62.5%), the total score of the last two items was <3 points, while the average score of 24 patients was 3.63 ± 2.32. NERD patients with somatoform disorders accounted for 50%. There were 17 patients without anxiety, 6 patients with mild anxiety (25%), 1 patient with moderate anxiety (4.2%), and no patient with severe anxiety. There were 22 patients (91.7%) without depression, 2 patients (8.3%) with mild depression, and no patient with moderate or severe depression. The alpha diversity of NERD group was higher than HC, which showed significant difference (P < 0.05). The beta-diversity was significantly different between HC and NERD patients (P = 0.026), male and female patients (P = 0.009). The beta-diversity was also significantly different between male and female patients (P = 0.009). There were several bacteria with significant differences between HC and NERD group, and NERD patients with or without somatoform disorders, such as Firmicutes, TM7 were enriched in the NERD group compared with the healthy control group, while Bacteroidetes were enriched in the healthy controls. Conclusions: NERD symptoms overlap with somatoform disorders. NERD symptoms have an impact on the daily life quality of patients. Some of them are accompanied by anxiety and depression of different degrees, and the two are significantly correlated. The diversity of gut microbiome in patients with NERD is significantly higher than healthy controls, which has its characteristics. The predominant bacteria in gut microbiome of patients with NERD are similar to the healthy population, with Firmicutes and Bacteroidetes as the main ones. The composition of gut microbiome in NERD patients with or without somatoform disorder is significantly different, which may be related to the interaction of microbiome-brain-gut axis.

Dataset Information

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

Publications

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

Similar Datasets

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