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Comparative efficacy and safety of lactulose plus paraffin vs polyethylene glycol in functional constipation: a randomised clinical study.

ABSTRACT: 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 (n?=?179) or polyethylene glycol (n?=?184). On day 28, the mean PAC-SYM score decreased significantly vs baseline with both treatments (p?
Conclusion: Lactulose plus paraffin may be used interchangeably with polyethylene glycol for the pharmacological treatment of functional constipation.Trial registration: EudraCT number 2015-003021-34.

SUBMITTER: Piche T

PROVIDER: S-EPMC7707874 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Comparative efficacy and safety of lactulose plus paraffin vs polyethylene glycol in functional constipation: a randomised clinical study.

Piche T T Dapoigny M M

United European gastroenterology journal 20200628 8

<h4>Background</h4>Few head-to-head comparisons of the different classes of laxatives have been conducted.<h4>Objective</h4>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).<h4>Methods</h4>This randomised, parallel-group, multicentre phase 4 study recruited patients with functional constipation diagnosed according to Rome III criteria. Patients received lactulose plus paraff ...[more]

PMID: 32594884

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Project description:IMPORTANCE:Hepatic encephalopathy (HE) is a common cause of hospitalization in patients with cirrhosis. Pharmacologic treatment for acute (overt) HE has remained the same for decades. OBJECTIVE:To compare polyethylene glycol 3350-electrolyte solution (PEG) and lactulose treatments in patients with cirrhosis admitted to the hospital for HE. We hypothesized that rapid catharsis of the gut using PEG may resolve HE more effectively than lactulose. DESIGN, SETTING, AND PARTICIPANTS:The HELP (Hepatic Encephalopathy: Lactulose vs Polyethylene Glycol 3350-Electrolyte Solution) study is a randomized clinical trial in an academic tertiary hospital of 50 patients with cirrhosis (of 186 screened) admitted for HE. INTERVENTIONS:Participants were block randomized to receive treatment with PEG, 4-L dose (n?=?25), or standard-of-care lactulose (n?=?25) during hospitalization. MAIN OUTCOMES AND MEASURES:The primary end point was an improvement of 1 or more in HE grade at 24 hours, determined using the hepatic encephalopathy scoring algorithm (HESA), ranging from 0 (normal clinical and neuropsychological assessments) to 4 (coma). Secondary outcomes included time to HE resolution and overall length of stay. RESULTS:A total of 25 patients were randomized to each treatment arm. Baseline clinical features at admission were similar in the groups. Thirteen of 25 patients in the standard therapy arm (52%) had an improvement of 1 or more in HESA score, thus meeting the primary outcome measure, compared with 21 of 23 evaluated patients receiving PEG (91%) (P?<?.01); 1 patient was discharged before final analysis and 1 refused participation. The mean (SD) HESA score at 24 hours for patients receiving standard therapy changed from 2.3 (0.9) to 1.6 (0.9) compared with a change from 2.3 (0.9) to 0.9 (1.0) for the PEG-treated groups (P?=?.002). The median time for HE resolution was 2 days for standard therapy and 1 day for PEG (P?=?.01). Adverse events were uncommon, and none was definitely study related. CONCLUSIONS AND RELEVANCE:PEG led to more rapid HE resolution than standard therapy, suggesting that PEG may be superior to standard lactulose therapy in patients with cirrhosis hospitalized for acute HE. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01283152.

Project description:Background: Colonoscopy remains an optimal approach for early detection and treatment of gastrointestinal lesions, however adequate bowel preparation is the critical contributor to effective and safe colonoscopy. Polyethylene glycol (PEG)-based bowel cleansing regime has been the first recommendation before colonoscopy, however it remains unknown which regime is the optimal option. Aim: The aim of our study is to determine the comparative efficacy of 2 L PEG alone or plus ascorbic acid (Asc) vs. 4 L PEG alone for bowel cleansing prior to colonoscopy. Methods: We assigned two independent investigators to search and screen potential records, extract essential information, and appraise the risk of bias of individual study accordingly. Then, we adopted RevMan 5.3, Stata 14.0, and WinBUGS 1.4 software to perform all statistical analyses. We also calculated the surface under the cumulative ranking curve (SCURA) in order to rank all regimes. Results: Twelve studies involving 4,106 patients were analyzed finally. Pooled results indicated an improved bowel preparation efficacy in 2 L PEG plus ascorbic acid with split-dose regime rather than in 2 L PEG plus ascorbic acid (OR, 0.25; 95% CI, 0.18-0.36), 4 L PEG with split dose (OR, 3.18; 95% CI, 2.17-4.66), and 4 L PEG (OR, 4.53; 95% CI, 3.07-6.67) regimes, which was confirmed by network meta-analyses; a better compliance in 2 L PEG plus Asc with split dose (OR, 3.08; 95% CI, 1.51-6.30) and 4 L PEG with split dose (OR, 0.43; 95% CI, 0.22-0.82) regime rather than in 4 L PEG regime, but network meta-analyses generated inconsistency results; a higher preference in 2 L PEG plus Asc with split dose regime rather than in 4 L PEG split dose (OR, 2.24; 95% CI, 1.02-4.90), which were not supported by network meta-analyses; no statistically significant difference when all regimes compared with each other in terms of adverse events. Conclusions: As for bowel preparation before colonoscopy, 2 L PEG ascorbic acid with split dose should be optimally prescribed. Further studies investigating the comparative efficacy of 2 L PEG related to 4 L PEG, 4 L PEG with split dose, and 2 L PEG plus ascorbic acid with split dose, respectively are needed.

Dataset Information

Comparative efficacy and safety of lactulose plus paraffin vs polyethylene glycol in functional constipation: a randomised clinical study.

Publications

Comparative efficacy and safety of lactulose plus paraffin vs polyethylene glycol in functional constipation: a randomised clinical study.

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