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
ABSTRACT
In the present study, we aimed to investigate patients with a documented diagnosis of functional dyspepsia [FD] who had been admitted to our outpatient Gastroenterology Clinic and provided consent to participate in this randomized, double-blind, placebo-controlled trial of the therapeutic impact off amotidine on the symptoms and quality ofl ife of FD patients. A total of 160 patients attending our outpatient clinic with a diagnosis of FD according to Rome III criteria were enrolled in this double-blind study. They were randomized into case [famotidine treatment] and placebo groups; patients were asked to refill the Honk Kong dyspepsia index [a self global assessment tool] before the start of the study as well as after 3 months of treatment. Both famotidine and placebo led to significant improvements in dyspepsia symptoms, except for vomiting in both groups and loss of appetite in the placebo control group. However, the extent of these improvements was not different between the two study groups for most of the study parameters, whereas belching, feeling of acid regurgitation, heartburn, and the total score for the Hong Kong dyspepsia index were significantly more responsive to famotidine than placebo. No significant effectiveness off amotidine therapy was found regarding quality of life. This study showed a significant improvement in the total dyspepsia scores of FD, with a marked effect on belching, heartburn, and the feeling of acid regurgitation. These findings suggest that famotidine may be administered in certain FD patients who have significantly more symptoms of belching, heartburn, and acid regurgitation