Randomised clinical trial: the effect of baclofen in patients with gastro-oesophageal reflux - a randomised prospective study

• Published in: Alimentary pharmacology & therapeutics Vol. 35; no. 9; pp. 1036 - 1044
• Main Authors: Cossentino, M. J., Mann, K., Armbruster, S. P., Lake, J. M., Maydonovitch, C., Wong, R. K. H.
• Format: Journal Article
• Language: English
• Published: Oxford Blackwell Publishing Ltd 01.05.2012; Blackwell
• Subjects: Adult; Baclofen - pharmacology; Baclofen - therapeutic use; Biological and medical sciences; Chest Pain - drug therapy; Chest Pain - etiology; Digestive system; Double-Blind Method; Eructation - drug therapy; Eructation - etiology; Esophageal pH Monitoring; Esophagus; Female; GABA-B Receptor Agonists - pharmacology; GABA-B Receptor Agonists - therapeutic use; Gastroenterology. Liver. Pancreas. Abdomen; Gastroesophageal Reflux - drug therapy; Gastroesophageal Reflux - physiopathology; Heartburn - drug therapy; Heartburn - etiology; Humans; Hydrogen-Ion Concentration; Male; Manometry; Medical sciences; Middle Aged; Other diseases. Semiology; Pharmacology. Drug treatments; Postprandial Period; Prospective Studies; Treatment Outcome; Human; Gastroesophageal reflux; Agonist; Muscle relaxant; Gabaergic agonist; Esophageal disease; Prospective; Randomization; Antispasmodic agent; Baclofen; Digestive diseases; Clinical trial; Gabaergic receptor B
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2012.05068.x

Summary Background Baclofen, a GABAB agonist, has been shown to reduce transient lower oesophageal sphincter relaxations (TLESRs), a major cause of gastro‐oesophageal reflux disease (GERD). Aim To examine the effect and tolerability of baclofen in GERD patients over a 2‐week period. Methods Forty‐three GERD patients with abnormal 24‐h pH tests were prospectively randomised to receive baclofen or placebo in a double‐blind fashion for 2 weeks. Oesophageal manometry, 24‐h pH monitoring, and a standard questionnaire was administered, before and after treatment. Results Thirty‐four patients completed the study. In the baclofen group there were significant decreases in 24‐h pH score (P = 0.020), percent of upright reflux episodes (P = 0.016), percent total time pH <4 (P = 0.003), number of reflux episodes (P = 0.018), number of reflux episodes longer than 5 min (P = 0.016), number of postprandial reflux episodes (P = 0.045), and percentage of time pH <4 (P = 0.003). No significant changes in reflux parameters were noted in the placebo group. Patients receiving baclofen had significantly less belching (P = 0.038), regurgitation (P = 0.036) and overall symptom score (P = 0.004) whereas placebo patients had less heartburn (P = 0.001), chest pain (P = 0.002), regurgitation (P = 0.017) and overall symptom score (P = 0.000). However, there were no significant differences in changes of reflux parameters or symptoms when comparing the two groups. Drowsiness did not limit baclofen use. Conclusions Baclofen was associated with a significant decrease in percent upright reflux by 24‐h pH monitoring and a significant improvement in belching, regurgitation and overall symptom score. Baclofen may be more effective in patients with predominantly upright reflux and belching.