title: Effect of a Combination of Omeprazole Plus Sustained Release Baclofen Versus Omeprazole Alone on Symptoms of Patients with Gastroesophageal Reflux Disease (GERD).
abstract: Previous studies have reported the efficacy of baclofen in the treatment of Gastroesophageal Reflux Diseases (GERD). The objective of present study is to evaluate the effect of co-administration of omeprazole 20 mg/d plus sustained Release baclofen (SR baclofen) vs. omeprazole 20 mg/d plus placebo on alleviation of symptoms in patients with a diagnosis of GERD. A prospective, double blind, placebo controlled trial included 60 patients with diagnosis of GERD have been done. Patients were randomly selected to receive either SR baclofen or a placebo in addition to omeprazole 20 mg/d for a period of 2 weeks. Patients were questioned regarding heartburn, regurgitation, chest pain and hoarseness at the base line and after 2 weeks. All patients tolerated the medications and no patients failed to complete the study due to adverse drug reactions. A total of 53 patients completed the study, 25 in SR baclofen and 28 in placebo group. After 2 weeks, 1 patient (4%) in SR baclofen group reported heartburn and regurgitation. However 13(46.4%) and 15 (53.6%) of patients in the placebo group had heartburn and regurgitation respectively. The analysis of the data shows that there is a significant difference between the two groups in heartburn and regurgitation (p < 0.0001, p < 0.0001 respectively). Statistical analysis revealed a significant difference in two groups regarding total GERD score (p <0.0001). The results of the present study suggest that a combination of SR baclofen and omeprazole may be a more effective treatment for heartburn and regurgitation than omeprazole alone.
authors.affiliation: Department of Clinical Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Abbasinazari
authors.affiliation: Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Tehran , Iran .
authors.forename: Yunes
authors.initials: Y
authors.lastname: Panahi
authors.affiliation: Department of Pharmaceutics, Shahid Beheshti University of Medical Sciences, Tehran, Iran .
authors.forename: Seyed Alireza
authors.initials: SA
authors.lastname: Mortazavi
authors.affiliation: Department of Clinical Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Fanak
authors.initials: F
authors.lastname: Fahimi
authors.affiliation: Baqiyatallah Research Center for Gastroentrology and Liver Diseases, Tehran, Iran .
authors.forename: Ghasem
authors.initials: G
authors.lastname: Valizadegan
authors.affiliation: Medicine Quran & Health Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran .
authors.forename: Reza
authors.initials: R
authors.lastname: Mohtashami
authors.affiliation: Research Center for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran .
authors.forename: Mohammad Amin
authors.initials: MA
authors.lastname: Pourhoseingholi
authors.affiliation: Department of Clinical Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Kambiz
authors.initials: K
authors.lastname: Shirvani Bakhtiari
keywords: Baclofen; GERD; Omeprazole; Sustained release