Evidence map›Paper›PMID 24535455›Full record

Trial reportJournal of gastroenterology2014

A randomized, placebo-controlled, double-blind clinical trial of rikkunshito for patients with non-erosive reflux disease refractory to proton-pump inhibitor: the G-PRIDE study.

Kazunari Tominaga, Mototsugu Kato, Hiroshi Takeda, Yasuyuki Shimoyama, Eiji Umegaki, Ryuichi Iwakiri, Kenji Furuta, Koichi Sakurai, Takeo Odaka, Hiroaki Kusunoki and 14 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 pooled it
5.2field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 2 syntheses or guidelines pooled it, 61 citations in OpenAlex.

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  14. Recent Advances inMetabolites · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 12 institutions in 1 country.

Kazunari TominagaDepartment of Gastroenterology, Osaka City University Graduate School of Medicine, 1-4-3 Asahimachi, Abeno-ku, Osaka, Japan.
Mototsugu Kato
Hiroshi Takeda
Yasuyuki Shimoyama
Eiji Umegaki
Ryuichi Iwakiri
Kenji Furuta
Koichi 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
Motoyasu Kusano
Kazuma Fujimoto
Tetsuo Arakawa
G-PRIDE Study Group
Osaka City University · JPOsaka Medical and Pharmaceutical University · JPShimane University · JPChiba University · JPHokkaido University · JPHyogo Medical University · JPKawasaki Medical School · JPHamamatsu University · JPJuntendo University · JPKyorin University · JPOita University · JPSaga Medical School Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of this study was to investigate the efficacy of rikkunshito (RKT), a traditional Japanese medicine, combined with proton pump inhibitor (PPI) in patients with PPI-refractory non-erosive reflux disease (NERD).

methodsPatients with PPI-refractory NERD (n = 242) were randomly assigned to the RKT group [rabeprazole (10 mg/day) + RKT (7.5 g/t.i.d.) for 8 weeks] or the placebo group (rabeprazole + placebo). After the 4- and 8-week treatments, we assessed symptoms and quality of life (QOL) using the Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (FSSG), Gastrointestinal Symptom Rating Scale (GSRS), and Short-Form Health Survey-8 (SF-8).

resultsThere were no significant differences in FSSG and GSRS score improvement between these groups after the 4- and 8-week treatments. The mental component summary (MCS) scores of the SF-8 improved more in the RKT group (from 45.8 ± 8.1 to 48.5 ± 7.4) than in the placebo group (from 47.7 ± 7.1 to 48.4 ± 7.5) after the 4-week treatment (P < 0.05). The 8-week treatment with RKT was more effective for improvement of the degree of MCS score in patients with a low body mass index (<22) (P < 0.05) and significantly improved the acid-related dysmotility symptoms of FSSG in female and elderly patients (≥ 65 years).

conclusionThere were no significant differences in improvement of GERD symptoms in patients with PPI-refractory NERD between these groups. However, RKT may be useful for improving mental QOL in non-obese patients and acid-related dyspeptic symptoms, especially in women and the elderly.

Indexed as

AdultAgedAged, 80 and overDouble-Blind MethodDrugs, Chinese HerbalDrug Therapy, CombinationFemaleGastroesophageal RefluxHumansMaleMedication AdherenceMiddle AgedProton Pump InhibitorsQuality of LifeSeverity of Illness IndexTreatment OutcomeDrugs, Chinese Herballiu-jun-zi-tangProton Pump Inhibitors

Identifiers

PMID24535455
OpenAlexW1992844831

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.