Evidence map›Paper›PMID 22548767›Full record

Trial reportBMC gastroenterology2012

Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS).

Kouichi Sakurai, Akihito Nagahara, Kazuhiko Inoue, Junichi Akiyama, Katsuhiro Mabe, Junichi Suzuki, Yasuki Habu, Akihiro Araki, Tsuyoshi Suzuki, Katsuaki Satoh and 13 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC gastroenterology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 6 pooled it
3.8field-weighted citation impact, top 7% 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

20 citing papers in PubMed, 6 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Proton pump inhibitors for functional dyspepsia.The Cochrane database of systematic reviews · 2017
    Pooled it
  3. ACG and CAG Clinical Guideline: Management of Dyspepsia.The American journal of gastroenterology · 2017
    Guideline
  4. Proton pump inhibitors for functional dyspepsia.The Cochrane database of systematic reviews · 2017
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Famotidine, an Antiulcer Agent, Strongly InhibitsACS medicinal chemistry letters · 2018
    Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. Article
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

23 authors at 17 institutions in 1 country.

Kouichi SakuraiDepartment of Gastroenterology and Hepatology, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Kumamoto 860-8556, Japan. sakurai@s3.kcn-tv.ne.jp
Akihito Nagahara
Kazuhiko Inoue
Junichi Akiyama
Katsuhiro Mabe
Junichi Suzuki
Yasuki Habu
Akihiro Araki
Tsuyoshi Suzuki
Katsuaki Satoh
Haruhiko Nagami
Ryosaku Harada
Nobuo Tano
Masayasu Kusaka
Yasuhiko Fujioka
Toshikatsu Fujimura
Nobuyuki Shigeto
Tsuneyo Oumi
Jun Miwa
Hiroto Miwa
Kazuma Fujimoto
Yoshikazu Kinoshita
Ken Haruma
Kawasaki Medical School · JPHiroshima Kyoritsu Hospital · JPHyogo Medical University · JPJuntendo University · JPKumamoto University · JPKurosawa Hospital · JPNTT Medical Center · JPSaga Medical School Hospital · JPSaiseikai Ibaraki Hospital · JPSaitama International Medical Center · JPShimane University · JPTamano General Medical College · JPTokyo Medical and Dental University · JPTokyo Metropolitan Police Hospital · JPToshiba General Hospital · JPTsuyama Chuo Hospital · JPYamagata Prefectural Central Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn Japan, treatment guidelines are lacking for patients with upper gastrointestinal symptoms. We aimed to compare the efficacy of different drugs for the treatment of uninvestigated upper gastrointestinal symptoms.

methodsThis was a randomized, open-label, parallel-group multicenter study. Helicobacter pylori-negative, endoscopically uninvestigated patients ≥ 20 years of age with upper gastrointestinal symptoms of at least moderate severity (Global Overall Symptom score [GOS] ≥ 4 on a 7-point Likert scale) were randomized to treatment with omeprazole (10 mg once daily), famotidine (10 mg twice daily), mosapride (5 mg three times daily) or teprenone (50 mg three times daily). The primary endpoint was sufficient relief of upper gastrointestinal symptoms after 4 weeks of treatment (GOS ≤ 2). UMIN clinical trial registration number: UMIN000005399.

resultsOf 471 randomized patients, 454 were included in the full analysis set. After 4 weeks of treatment, sufficient symptom relief was achieved by 66.9% of patients in the omeprazole group, compared with 41.0%, 36.3% and 32.3% in the famotidine, mosapride and teprenone groups, respectively (all, p < 0.001 vs omeprazole). There were no treatment-related adverse events.

conclusionsThe favorable efficacy and safety profiles of omeprazole in relieving uninvestigated upper gastrointestinal symptoms support its use as first-line treatment in this patient group in Japan. Patients who show no improvement in symptoms despite PPI use, and those with alarm symptoms (such as vomiting, GI bleeding or acute weight loss) should receive further investigation, including prompt referral for endoscopy.

trial registrationUMIN000005399.

Indexed as

AlgorithmsBenzamidesDiterpenesDose-Response Relationship, DrugDyspepsiaFamotidineGastroesophageal RefluxGuideline AdherenceHumansJapanMorpholinesOmeprazoleProton Pump InhibitorsTreatment OutcomeUpper Gastrointestinal TractBenzamidesDiterpenesFamotidinegeranylgeranylacetoneMorpholinesmosaprideOmeprazoleProton Pump Inhibitors

Identifiers

PMID22548767
PMCPMC3419613
OpenAlexW2043968498

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.