A Randomized, Multicenter, Placebo-Controlled Trial of Polyethylene Glycol Laxative for Chronic Treatment of Chronic Constipation
| Autor: | Jorge L. Herrera, John McGowan, Mark Vb Cleveland, Jack A. DiPalma |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Constipation Nausea medicine.medical_treatment Laxative Placebo-controlled study Administration Oral Polyethylene glycol Gastroenterology Drug Administration Schedule Polyethylene Glycols law.invention chemistry.chemical_compound Double-Blind Method Randomized controlled trial law Internal medicine medicine Humans Aged Aged 80 and over Chronic constipation Hepatology business.industry Follow up studies Middle Aged Surgery Treatment Outcome chemistry Patient Satisfaction Chronic Disease Female medicine.symptom business Follow-Up Studies |
| Zdroj: | The American Journal of Gastroenterology. 102:1436-1441 |
| ISSN: | 1572-0241 0002-9270 |
| DOI: | 10.1111/j.1572-0241.2007.01199.x |
| Popis: | Polyethylene glycol (PEG) 3350 (MiraLAX) is currently approved for the short-term treatment of occasional constipation. This study was designed to compare the safety and efficacy of PEG laxative versus placebo over a 6-month treatment period in patients with chronic constipation.Study subjects who met defined criteria for chronic constipation were randomized in this double-blind, placebo-controlled, parallel, multicenter study to receive PEG laxative as a single daily dose of 17 g or placebo for 6 months. Baseline constipation status was confirmed during a 14-day observation period. As a primary efficacy variable, treatment success was defined as relief of modified ROME criteria for constipation for 50% or more of their treatment weeks. Various secondary measures were assessed. An Interactive Voice Response System (IVRS) recorded daily bowel movement experience and study efficacy and safety information. Laboratory testing at baseline and monthly for the study duration was analyzed for hematology, blood chemistry including amylase, GGT, uric acid, lipids, and urinalysis.A total of 304 patients were enrolled and received treatment at one of 50 centers. Successful treatment according to the primary efficacy variable was seen in 52.0% of PEG and 11% of placebo subjects (P0.001). Similar efficacy was seen in a subgroup of 75 elderly subjects. According to the primary efficacy definition (based on individual treatment weeks), 61% of PEG treatment weeks versus 22% of the placebo weeks were successful (P0.001). There were no significant differences in laboratory findings or adverse events except for the gastrointestinal category where diarrhea, flatulence, and nausea were the most frequent with PEG although they were not individually statistically significant compared with placebo. Similar results were observed when analyzed for differences due to gender, race, or age.PEG laxative is safe and effective for use in patients with chronic constipation for 6 months. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|