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

Abstract

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.

• Authors: M J Cossentino, K Mann, S P Armbruster, J M Lake, C Maydonovitch, R K H Wong
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 35 Issue 9 Pg. 1036-44 (May 2012) ISSN: 1365-2036 [Electronic] England
• PMID: 22428773 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: © 2012 Blackwell Publishing Ltd.

Chemical References

• GABA-B Receptor Agonists
• Baclofen

Topics

• Adult
• Baclofen (pharmacology, therapeutic use)
• Chest Pain (drug therapy, etiology)
• Double-Blind Method
• Eructation (drug therapy, etiology)
• Esophageal pH Monitoring
• Female
• GABA-B Receptor Agonists (pharmacology, therapeutic use)
• Gastroesophageal Reflux (drug therapy, physiopathology)
• Heartburn (drug therapy, etiology)
• Humans
• Hydrogen-Ion Concentration
• Male
• Manometry
• Middle Aged
• Postprandial Period
• Prospective Studies
• Treatment Outcome