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Randomised clinical trial: the effect of baclofen in patients with gastro‐oesophageal reflux ‐ a randomised prospective study
Author(s) -
Cossentino M. J.,
Mann K.,
Armbruster S. P.,
Lake J. M.,
Maydonovitch C.,
Wong R. K. H.
Publication year - 2012
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2012.05068.x
Subject(s) - medicine , reflux , gerd , heartburn , baclofen , placebo , tolerability , gastroenterology , regurgitation (circulation) , esophageal ph monitoring , randomized controlled trial , anesthesia , agonist , adverse effect , disease , receptor , alternative medicine , pathology
Summary Background Baclofen, a GABA B 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.