PMID- 24990161 OWN - NLM STAT- MEDLINE DCOM- 20150413 LR - 20211021 IS - 1471-230X (Electronic) IS - 1471-230X (Linking) VI - 14 DP - 2014 Jul 2 TI - Clinical characteristics of elderly patients with proton pump inhibitor-refractory non-erosive reflux disease from the G-PRIDE study who responded to rikkunshito. PG - 116 LID - 10.1186/1471-230X-14-116 [doi] AB - 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). FAU - Sakata, Yasuhisa AU - Sakata Y AD - Department of Internal Medicine and Gastroenterology, Saga Medical School, 5-1-1 Nabeshima, Saga 849-8501, Japan. sakatay@cc.saga-u.ac.jp. FAU - Tominaga, Kazunari AU - Tominaga K FAU - Kato, Mototsugu AU - Kato M FAU - Takeda, Hiroshi AU - Takeda H FAU - Shimoyama, Yasuyuki AU - Shimoyama Y FAU - Takeuchi, Toshihisa AU - Takeuchi T FAU - Iwakiri, Ryuichi AU - Iwakiri R FAU - Furuta, Kenji AU - Furuta K FAU - Sakurai, Kouichi AU - Sakurai K FAU - Odaka, Takeo AU - Odaka T FAU - Kusunoki, Hiroaki AU - Kusunoki H FAU - Nagahara, Akihito AU - Nagahara A FAU - Iwakiri, Katsuhiko AU - Iwakiri K FAU - Furuta, Takahisa AU - Furuta T FAU - Murakami, Kazunari AU - Murakami K FAU - Miwa, Hiroto AU - Miwa H FAU - Kinoshita, Yoshikazu AU - Kinoshita Y FAU - Haruma, Ken AU - Haruma K FAU - Takahashi, Shin'ichi AU - Takahashi S FAU - Watanabe, Sumio AU - Watanabe S FAU - Higuchi, Kazuhide AU - Higuchi K FAU - Fujimoto, Kazuma AU - Fujimoto K FAU - Kusano, Motoyasu AU - Kusano M FAU - Arakawa, Tetsuo AU - Arakawa T CN - G-PRIDE study group LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20140702 PL - England TA - BMC Gastroenterol JT - BMC gastroenterology JID - 100968547 RN - 0 (Drugs, Chinese Herbal) RN - 0 (Proton Pump Inhibitors) RN - 0 (liu-jun-zi-tang) RN - 32828355LL (Rabeprazole) SB - IM MH - Aged MH - Aged, 80 and over MH - Double-Blind Method MH - Drugs, Chinese Herbal/*therapeutic use MH - Female MH - *Gastric Emptying MH - Gastroesophageal Reflux/*drug therapy MH - Humans MH - Japan MH - Male MH - Proton Pump Inhibitors/*therapeutic use MH - Rabeprazole/*therapeutic use MH - Treatment Failure MH - Treatment Outcome PMC - PMC4090183 FIR - Mabe, Katsuhiro IR - Mabe K FIR - Kudo, Mineo IR - Kudo M FIR - Oizumi, Hiroko IR - Oizumi H FIR - Eto, Kazunori IR - Eto K FIR - Muto, Shuichi IR - Muto S FIR - Serikawa, Shinya IR - Serikawa S FIR - Sakamoto, Jyun IR - Sakamoto J FIR - Hokari, Kaku IR - Hokari K FIR - Nema, Hiroaki IR - Nema H FIR - Kakizaki, Satoru IR - Kakizaki S FIR - Kudo, Tomohiro IR - Kudo T FIR - Suzuki, Hideyuki IR - Suzuki H FIR - Takahashi, Kazuhiro IR - Takahashi K FIR - Asaoka, Daisuke IR - Asaoka D FIR - Hojyo, Mariko IR - Hojyo M FIR - Nakamura, Kenji IR - Nakamura K FIR - Tokunaga, Kengo IR - Tokunaga K FIR - Matsumura, Tomoaki IR - Matsumura T FIR - Nakajima, Kenichi IR - Nakajima K FIR - Sugimoto, Mitsushige IR - Sugimoto M FIR - Yamada, Takanori IR - Yamada T FIR - Maruyama, Yasuhiko IR - Maruyama Y FIR - Kageoka, Masanobu IR - Kageoka M FIR - Shirai, Naohito IR - Shirai N FIR - Kodaira, Makoto IR - Kodaira M FIR - Tanigawa, Testuya IR - Tanigawa T FIR - Kameda, Natsuhiko IR - Kameda N FIR - Uno, Hironori IR - Uno H FIR - Nakagawa, Koichiro IR - Nakagawa K FIR - Ochi, Masahiro IR - Ochi M FIR - Otani, Kenjiro IR - Otani K FIR - Oiso, Ryuta IR - Oiso R FIR - Ashida, Kiyoshi IR - Ashida K FIR - Yamashita, Hirosi IR - Yamashita H FIR - Sakaguchi, Masahiro IR - Sakaguchi M FIR - Makoto, Sanomura IR - Makoto S FIR - Kaseda, Shinya IR - Kaseda S FIR - Shiraki, Masahiro IR - Shiraki M FIR - Saito, Osamu IR - Saito O FIR - Kondo, Takashi IR - Kondo T FIR - Tomita, Toshihiko IR - Tomita T FIR - Watari, Jiro IR - Watari J FIR - Fukui, Hirokazu IR - Fukui H FIR - Abe, Takashi IR - Abe T FIR - Oku, Jyunsuke IR - Oku J FIR - Kawaguchi, Mitsuhiko IR - Kawaguchi M FIR - Adachi, Kyoichi IR - Adachi K FIR - Komazawa, Yoshinori IR - Komazawa Y FIR - Yuki, Mika IR - Yuki M FIR - Fujisawa, Tomoo IR - Fujisawa T FIR - Kushiyama, Yoshinori IR - Kushiyama Y FIR - Kakuta, Erina IR - Kakuta E FIR - Miyaoka, Youichi IR - Miyaoka Y FIR - Morito, Yoshiya IR - Morito Y FIR - Furuta, Koichiro IR - Furuta K FIR - Eguchi, Yuichiro IR - Eguchi Y FIR - Kuroki, Shigetaka IR - Kuroki S FIR - Tsunada, Seiji IR - Tsunada S FIR - Ogata, Shinichi IR - Ogata S FIR - Yamanouchi, Kohei IR - Yamanouchi K FIR - Noda, Takahiro IR - Noda T FIR - Tsuruoka, Nanae IR - Tsuruoka N FIR - Hasuda, Kiwamu IR - Hasuda K FIR - Oda, Yasushi IR - Oda Y FIR - Murao, Testuya IR - Murao T FIR - Shiota, Seiji IR - Shiota S FIR - Abe, Hisanori IR - Abe H FIR - Yasaka, Shigeaki IR - Yasaka S FIR - Takeshima, Fuminao IR - Takeshima F EDAT- 2014/07/06 06:00 MHDA- 2015/04/14 06:00 PMCR- 2014/07/02 CRDT- 2014/07/04 06:00 PHST- 2014/04/03 00:00 [received] PHST- 2014/06/26 00:00 [accepted] PHST- 2014/07/04 06:00 [entrez] PHST- 2014/07/06 06:00 [pubmed] PHST- 2015/04/14 06:00 [medline] PHST- 2014/07/02 00:00 [pmc-release] AID - 1471-230X-14-116 [pii] AID - 10.1186/1471-230X-14-116 [doi] PST - epublish SO - BMC Gastroenterol. 2014 Jul 2;14:116. doi: 10.1186/1471-230X-14-116.