Evidence map›Paper›PMID 35697065›Full record

Trial reportZeitschrift fur Gastroenterologie2023

Menthacarin for long-term treatment of functional dyspepsia - Results from a clinical trial follow-up.

Martin Storr, Berenike Stracke

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Zeitschrift fur Gastroenterologie, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. 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

2 authors.

Martin StorrZentrum für Endoskopie, Starnberg, Germany und Medizinische Klinik und Poliklinik II, Klinikum Großhadern, München, Germany.
Berenike StrackeGlobal Medical Affairs, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMenthacarin was shown to be effective and safe in clinical trials in patients with functional dyspepsia (FD). Long-term treatment results have not been reported yet.

methodsAn open-label, 11-month follow-up (FU) was offered to FD patients who had undergone treatment with Menthacarin (1 gastro-resistant capsule b.i.d. vs. placebo (PL)) in a 4-week, double-blind, clinical trial. During FU, all patients (former verum and PL) were treated with 1 gastro-resistant capsule Menthacarin b.i.d. Main outcomes were the changes in pain intensity and severity of sensation of pressure, heaviness, and fullness from original baseline and global improvement.

results70 patients were included in the analyses (former Menthacarin group: 36, former PL group: 34). At the end of the PL-controlled study phase, all 3 main efficacy variables were statistically significantly improved in the Menthacarin group compared to PL. In the FU phase, former PL patients started to improve under Menthacarin treatment towards the outcomes seen in the former Menthacarin group (alignment at approximately 6 months), while former Menthacarin patients showed sustained or even continuously improved outcomes by month 12. At study end, more than 90% of patients were "much or very much improved" in both groups. Menthacarin treatment was well tolerated.

conclusionsThe favorable effects seen in the FU period suggest that Menthacarin is a valuable treatment option in FD patients who require symptomatic treatment also in the longer term for up to 12 months.

Indexed as

DyspepsiaDouble-Blind MethodFollow-Up StudiesHumansTreatment Outcome

Identifiers

PMID35697065
PMCPMC9998233

What Socratic holds

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Registered trials

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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.