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