Evidence map›Paper›PMID 22081052›Full record

Trial reportJournal of gastroenterology2012

Rikkunshito improves symptoms in PPI-refractory GERD patients: a prospective, randomized, multicenter trial in Japan.

Kazunari Tominaga, Ryuichi Iwakiri, Kazuma Fujimoto, Yasuhiro Fujiwara, Mio Tanaka, Yasuyuki Shimoyama, Eiji Umegaki, Kazuhide Higuchi, Motoyasu Kusano, Tetsuo Arakawa and 1 more

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 4 pooled it
5.9field-weighted citation impact, top 4% 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

47 citing papers in PubMed, 4 syntheses or guidelines pooled it, 99 citations in OpenAlex.

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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

11 authors at 4 institutions in 1 country.

Kazunari TominagaDepartment of Gastroenterology, Osaka City University Graduate School of Medicine, 1-4-3, Asahimachi, Abeno-ku, Osaka, Japan. tomy@med.osaka-cu.ac.jp
Ryuichi Iwakiri
Kazuma Fujimoto
Yasuhiro Fujiwara
Mio Tanaka
Yasuyuki Shimoyama
Eiji Umegaki
Kazuhide Higuchi
Motoyasu Kusano
Tetsuo Arakawa
GERD 4 Study Group
Osaka City University · JPOsaka Medical and Pharmaceutical University · JPGunma University Hospital · JPSaga Medical School Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo seek a promising therapeutic regimen for proton pump inhibitor (PPI)-refractory patients with gastroesophageal reflux disease (GERD) after the standard PPI treatment, we compared the efficacies of rikkunshito (a Japanese traditional medication) combined with rabeprazole (RPZ) and a double dose of RPZ in a prospective randomized multicenter trial in Japanese PPI-refractory GERD patients.

methodsOne hundred and four patients with GERD symptoms remaining after 4-week treatment with RPZ (10 mg/day) were randomly assigned to 4 weeks of either combination therapy [rikkunshito (7.5 g/day) with a standard dose of RPZ (10 mg/day)] or a double dose of RPZ (20 mg/day). The primary endpoint was the improvement rate, calculated based on the frequency scale for the symptoms of GERD (FSSG) before and after treatment. Subgroup analysis was also performed with respect to each subject's background factors such as reflux esophagitis (RE)/non-erosive GERD (NERD), age, gender, and body mass index (BMI).

resultsFour-week treatment with rikkunshito combined with RPZ significantly decreased the FSSG score from 17.6 ± 6.5 to 12.0 ± 6.9, similar to the decrease seen on treatment with a double dose of RPZ. Regarding the therapeutic improvement rate, there were also significant effects in both groups. However, in the subgroup analysis based on RE/NERD, the improvement rate of male NERD patients in the rikkunshito group was significantly greater than that of such patients in the other group (P < 0.05). In the rikkunshito group, the treatment was more effective in NERD patients with a low BMI than in those with a high BMI (P < 0.05).

conclusionRikkunshito combined with standard-dose RPZ therapy may be a useful new strategy for PPI-refractory GERD patients.

Indexed as

2-PyridinylmethylsulfinylbenzimidazolesAdultAgedAged, 80 and overBody Mass IndexDose-Response Relationship, DrugDrugs, Chinese HerbalDrug Therapy, CombinationFemaleGastroesophageal RefluxHumansJapanMaleMiddle AgedProton Pump InhibitorsRabeprazole2-PyridinylmethylsulfinylbenzimidazolesDrugs, Chinese Herballiu-jun-zi-tangProton Pump InhibitorsRabeprazole

Identifiers

PMID22081052
OpenAlexW1977330961

What OpenQuestion holds

Textmetadata
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.