Evidence map›Paper›PMID 31953634›Full record

Trial reportEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2020

Influence of proton pump inhibitor therapy on occurrence of voice prosthesis complications.

Ana Danic Hadzibegovic, Ana Kozmar, Irzal Hadzibegovic, Drago Prgomet, Davorin Danic

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.8field-weighted citation impact, top 10% 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

3 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Inverse correlation between acid reflux and dwell time of voice protheses (ProvoxEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
    Article
  3. 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

5 authors at 3 institutions in 1 country.

Ana Danic HadzibegovicClinical Department for Otorhinolaryngology and Head and Neck Surgery, University Hospital Centre Zagreb, Kišpatićeva 12, 10000, Zagreb, Croatia. ana_djanic@yahoo.com.ORCID http://orcid.org/0000-0001-8513-5032
Ana KozmarDepartment of Laboratory Diagnostics, University Hospital Center Zagreb, Zagreb, Croatia.
Irzal HadzibegovicFaculty of Medicine, Josip Juraj Strossmayer University of Osijek, Osijek, Croatia.
Drago PrgometClinical Department for Otorhinolaryngology and Head and Neck Surgery, University Hospital Centre Zagreb, Kišpatićeva 12, 10000, Zagreb, Croatia.
Davorin DanicFaculty of Dental Medicine and Health Care, Josip Juraj Strossmayer University of Osijek, Osijek, Croatia.
University Hospital Centre Zagreb · HRUniversity Hospital Dubrava · HRUniversity of Osijek · HR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIt has been shown that the reflux of the gastric content to the proximal oesophagus influences incidence of voice prosthesis (VP) complications in laryngectomized patients. We conducted prospective randomised study to investigate the relationship between pepsin concentration in saliva and occurrence of VP complications before and after 3 months of proton pump inhibitor (PPI) therapy.

methods60 laryngectomized patients with VP and 30 controls were included in the study. Saliva samples were collected in the morning and concentration of pepsin were measured by Human Pepsin (PG) ELISA kit. Thirty-Four (57%) patients reported one or more VP complication and were randomised in two groups, with and without PPI therapy, 40 mg pantoprazole per day for 3 months.

resultsPatients who had longer time since last VP change had higher incidence of periprosthetic and transprosthetic leakage and Candida colonisation. Pepsin was found in all saliva samples. Median saliva pepsin concentration level did not significantly differ between laryngectomized patients and control subjects, or between patients with and without VP complications, and there was no correlation between saliva pepsin concentration levels and type of VP complication. After 3 months therapy, there was no difference in median saliva pepsin level or incidence of VP complication between patients with and without PPI therapy.

conclusionAlthough reflux was proposed to be associated with VP complications and pepsin was proven as a most sensitive and specific marker of EER, we did not find any statistically significant correlation between pepsin levels and occurrence of VP complications. A 3 months 40 mg pantoprazole therapy was ineffective in reduction of VP complications in our study group.

Indexed as

Larynx, ArtificialProton Pump InhibitorsHumansPepsin AProspective StudiesSalivaPepsin AProton Pump InhibitorsGastroesophageal refluxPepsinProton pump inhibitorsVoice prosthesis

Identifiers

PMID31953634
OpenAlexW2999813350

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.