Comparative efficacy and safety of lactulose plus paraffin vs polyethylene glycol in functional constipation: a randomised clinical study.
Administration, Oral
Adult
Aged
Constipation
/ diagnosis
Drug Combinations
Female
Humans
Lactulose
/ administration & dosage
Laxatives
/ administration & dosage
Male
Middle Aged
Paraffin
/ administration & dosage
Polyethylene Glycols
/ administration & dosage
Quality of Life
Severity of Illness Index
Treatment Outcome
Constipation
Melaxose
Movicol
lactulose
laxative
paraffin
polyethylene glycol
quality of life
randomised study
Journal
United European gastroenterology journal
ISSN: 2050-6414
Titre abrégé: United European Gastroenterol J
Pays: England
ID NLM: 101606807
Informations de publication
Date de publication:
10 2020
10 2020
Historique:
pubmed:
1
7
2020
medline:
13
7
2021
entrez:
30
6
2020
Statut:
ppublish
Résumé
Few head-to-head comparisons of the different classes of laxatives have been conducted. The objective of this work is to compare the efficacy of lactulose plus paraffin vs polyethylene glycol in the treatment of functional constipation (non-inferiority study). This randomised, parallel-group, multicentre phase 4 study recruited patients with functional constipation diagnosed according to Rome III criteria. Patients received lactulose plus paraffin or polyethylene glycol for 28 days. The primary end point was the change from baseline in the Patient Assessment of Constipation-Symptoms (PAC-SYM) score. A total of 363 patients were randomised to lactulose plus paraffin ( Lactulose plus paraffin may be used interchangeably with polyethylene glycol for the pharmacological treatment of functional constipation.
Sections du résumé
BACKGROUND
Few head-to-head comparisons of the different classes of laxatives have been conducted.
OBJECTIVE
The objective of this work is to compare the efficacy of lactulose plus paraffin vs polyethylene glycol in the treatment of functional constipation (non-inferiority study).
METHODS
This randomised, parallel-group, multicentre phase 4 study recruited patients with functional constipation diagnosed according to Rome III criteria. Patients received lactulose plus paraffin or polyethylene glycol for 28 days. The primary end point was the change from baseline in the Patient Assessment of Constipation-Symptoms (PAC-SYM) score.
RESULTS
A total of 363 patients were randomised to lactulose plus paraffin (
CONCLUSION
Lactulose plus paraffin may be used interchangeably with polyethylene glycol for the pharmacological treatment of functional constipation.
Identifiants
pubmed: 32594884
doi: 10.1177/2050640620937913
pmc: PMC7707874
doi:
Substances chimiques
Drug Combinations
0
Laxatives
0
Polyethylene Glycols
3WJQ0SDW1A
Lactulose
4618-18-2
Paraffin
8002-74-2
Types de publication
Clinical Trial, Phase IV
Equivalence Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
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