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 < 0.001). The lower boundary of the 95% CI exceeded the pre-specified limit of −0.25, therefore establishing non-inferiority of lactulose plus paraffin vs polyethylene glycol. At least one adverse event occurred in 20 patients (11.2%) in the lactulose plus paraffin group and in 26 patients (14.2%) in the polyethylene glycol group, most of which were of mild or moderate severity and unrelated to study drugs. 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

Effect of Rosa damascene Mill. Hydroalcoholic Extract on the Treatment of Chronic Idiopathic Constipation in Adults

“…showed that lactulose 3350 could relieve chronic constipation in adults and had no side effects in patients [31] . Lee et al also showed that administration of lactulose 3350 in constipation treatment was able to relieve constipation in adults [32] .…”

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“…At least one adverse event occurred in 11.2% of patients in the lactulose plus paraffin group and in 14.2% of patients in the PEG group, most of which were of mild or moderate severity and unrelated to study drugs. This study, for the first time, established the non-inferiority of lactulose (in combination with paraffin) compared to PEG in the alleviation of symptoms of functional constipation in adults [37].…”

Oral Lactulose – A Safe and Effective Strategy for the Management of Constipation in Individuals with Impaired Glucose Tolerance and Diabetes

“…More recently, a multicenter RCT investigating escalating doses of lactulose in 250 patients with chronic constipation receiving 13, 26, or 39 g/day of crystal lactulose, respectively, for two weeks found that the 26 and 39 g doses induced significantly and dose-dependently greater increases in spontaneous bowel movements after 1 (primary endpoint) and 2 weeks, respectively, compared to placebo. With these doses, also significant improvements in stool consistency and • Increased frequency of defecation and number of bowel movements (9,10,(20)(21)(22)(23)(27)(28)(29)(30)(31)(32)(33)(34)36,37) • Relieved postpartum constipation (24)(25)(26) • Prebiotic properties (9,(44)(45)(46)(47)(48)(49) Tolerance and safety…”