Evidence map›Paper›PMID 22157329›Full record

Trial reportGut2012

A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia.

Kei Matsueda, Michio Hongo, Jan Tack, Youichi Saito, Hiroki Kato

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gut, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 90 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 9 pooled it
10.7field-weighted citation impact, top 1% 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.

NCT00761358 phase3completednot on this map

To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms

TypeinterventionalSponsorZeria PharmaceuticalRan2008 to 2010Enrolled820ConditionsFunctional DyspepsiaArmsZ-338, Placebo
NCT04957134 nacompletednot on this mapstarted 2021, after this paper: background citation

The Efficacy and Safety of Electro-acupuncture for Abdominal Obesity: Original Study for a Multicenter, Randomized, Sham-controlled Trial

TypeinterventionalSponsorHubei Hospital of Traditional Chinese MedicineRan2021 to 2023Enrolled66ConditionsObesity, AbdominalArmsElectro-acupuncture, Sham electro-acupuncture
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 9 syntheses or guidelines pooled it, 244 citations in OpenAlex.

  1. Pooled it
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  4. Guideline
  5. Prokinetics for functional dyspepsia.The Cochrane database of systematic reviews · 2018
    Pooled it
  6. ACG and CAG Clinical Guideline: Management of Dyspepsia.The American journal of gastroenterology · 2017
    Guideline
  7. Pooled it
  8. Guideline
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  10. Trial
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  12. Double-Blind, Randomized, Placebo-Controlled Trial of DA-9701 in Parkinson's Disease: PASS-GI Study.Movement disorders : official journal of the Movement Disorder Society · 2020
    Trial
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30 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 2 countries.

Kei MatsuedaSakura Life Clinic, 1-14-7-2F, Kinshi, Sumida, Tokyo 130-0013 Japan. matsueda@slclinic.com
Michio Hongo
Jan Tack
Youichi Saito
Hiroki Kato
Zeria Pharmaceutical (Japan) · JPKU Leuven · BESumitomo Mitsui Banking Corporation · JPTohoku University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine the efficacy of acotiamide, an acetylcholinesterase inhibitor, in patients with functional dyspepsia (FD) in a 4-week trial.

methodsA multicentre, randomised, placebo-controlled, parallel-group, phase III trial was carried out, in which patients with FD received 100 mg of acotiamide or placebo three times a day for 4 weeks, with 4 weeks post-treatment follow-up. The primary efficacy end points were global assessment of overall treatment efficacy (OTE) and elimination rate of all three meal-related symptoms (postprandial fullness, upper abdominal bloating and early satiation), as derived from daily diaries. Secondary efficacy end points were individual symptom scores and quality of life. Adverse events were monitored.

results52.2% of those receiving acotiamide and 34.8% in the placebo group (p<0.001) were classified as responders according to a global assessment of OTE. Over 4 weeks, the elimination rate for all three meal-related symptoms was 15.3% among patients receiving acotiamide compared with 9.0% in the placebo group (p=0.004). The significant benefit of acotiamide over placebo in OTE and elimination rate was maintained during the 4 week post-treatment follow-up. All other secondary efficacy end points, including quality of life, were significantly improved with 100 mg of acotiamide as compared with placebo. The number needed to treat was 6 for OTE and 16 for symptom elimination rate. The incidence of adverse events was similar between the acotiamide group and placebo group and no significant cardiovascular effects due to treatment were seen.

conclusionsOver 4 weeks, acotiamide significantly improved symptom severity and eliminated meal-related symptoms in patients with FD. TRIAL REGISTRATION NUMBER: http://ClinicalTrials.gov number, NCT00761358.

Indexed as

AdultBenzamidesCholinesterase InhibitorsDouble-Blind MethodDyspepsiaEatingFemaleHumansMalePostprandial PeriodThiazolesTime FactorsTreatment OutcomeBenzamidesCholinesterase InhibitorsThiazolesZ 338

Identifiers

PMID22157329
PMCPMC3345932
OpenAlexW2106015028

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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 Socratic graph.