Evidence map›Paper›PMID 19902197›Full record

Trial reportEuropean journal of clinical pharmacology2010

Prospective randomized double-blind trial of racecadotril compared with loperamide in elderly people with gastroenteritis living in nursing homes.

Luca Gallelli, Manuela Colosimo, Grazia A Tolotta, Daniella Falcone, Laura Luberto, Lucia S Curto, Pierandrea Rende, Francesca Mazzei, Norma M Marigliano, Giovambattista De Sarro and 1 more

Open access · greenAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 17% 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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 58 citations in OpenAlex.

  1. 2017 Infectious Diseases Society of America Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017
    Guideline
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  8. Drug-Drug Interactions in Vestibular Diseases, Clinical Problems, and Medico-Legal Implications.International journal of environmental research and public health · 2021
    Review
  9. Article
  10. Article
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  12. Review
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  14. Review
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  16. Article
  17. Skin rash during treatment with generic itraconazole.Journal of pharmacology & pharmacotherapeutics · 2014
    Article
  18. Safety and efficacy of generic drugs with respect to brand formulation.Journal of pharmacology & pharmacotherapeutics · 2013
    Article
  19. Pharmacokinetic drug-drug interaction and their implication in clinical management.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2013
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Luca GallelliSchool of Medicine and Surgery, Department of Experimental and Clinical Medicine, University Magna Graecia of Catanzaro, Mater Domini University Hospital, Catanzaro, Italy. gallelli@unicz.it
Manuela Colosimo
Grazia A Tolotta
Daniella Falcone
Laura Luberto
Lucia S Curto
Pierandrea Rende
Francesca Mazzei
Norma M Marigliano
Giovambattista De Sarro
Salvatore Cucchiara
Magna Graecia University · ITAccademia di Belle Arti di Catanzaro · ITSapienza University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimOur aim was to compare the efficacy and tolerability of loperamide and racecadotril in elderly patients with acute diarrhea. RESEARCH DESIGN AND

methodsWe performed a randomized, prospective, double-blind, and parallel group design implemented in geriatric nursing homes in Catanzaro, Italy, from February 2008 to March 2009. Patients of both sexes were randomly allocated to receive either one tablet of racecadotril 100 mg every 8 h or two tablets of loperamide 2.0 mg followed by one tablet after each unformed stool, up to four tablets in any 24-h period. Patients were treated until recovery, defined as the production of two consecutive normal stools or no stool production for a period of 12 h.

resultsNormal stools were collected 36 +/- 4 h after the beginning of racecadotril and in 63 +/- 6 h from the beginning of loperamide administration (P < 0.01). The median time of abdominal pain in the intent-to-treat (ITT) population was 14 h for racecadotril and 28 h for loperamide. In the per-protocol (PP) population, the median time of abdominal pain was 14 h for racecadotril and 32 h for loperamide (P < 0.01). About the 50% of patients experienced at least one adverse event during the study: 12% in the racecadotril group and 60% in the loperamide group. The most frequently occurring adverse events were nausea and constipation. Genetic analysis did not report the presence of rapid or poor metabolizers. Pharmacoeconomic analysis performed at the end of our study documented an increase in costs in the loperamide group with respect to the racecadotril group (P < 0.01).

conclusionsRacecadotril is more effective than loperamide-probably due to drug interaction with loperamide-and it is not related to pharmacogenetic susceptibility. Racecadotril is also more cost effective than loperamide.

Indexed as

Abdominal PainAgedAged, 80 and overAgingAntidiarrhealsCytochrome P-450 Enzyme SystemDehydrationDiarrheaDouble-Blind MethodFemaleGastroenteritisHomes for the AgedHumansLoperamideMaleNursing HomesAntidiarrhealsCytochrome P-450 Enzyme SystemLoperamideracecadotrilThiorphan

Identifiers

PMID19902197
OpenAlexW2015247134

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.