title: 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).
  
  
  OBJECTIVE
  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.affiliation: Walter Reed National Military Medical Center, Department of Gastroenterology, Bethesda, MD, USA.
authors.forename: M J
authors.initials: MJ
authors.lastname: Cossentino
authors.forename: K
authors.initials: K
authors.lastname: Mann
authors.forename: S P
authors.initials: SP
authors.lastname: Armbruster
authors.forename: J M
authors.initials: JM
authors.lastname: Lake
authors.forename: C
authors.initials: C
authors.lastname: Maydonovitch
authors.forename: R K H
authors.initials: RK
authors.lastname: Wong
mesh_terms: D000328:Adult; D001418:Baclofen / Q000494:pharmacology / Q000627:therapeutic use*; D002637:Chest Pain / Q000188:drug therapy / Q000209:etiology; D004311:Double-Blind Method; D004884:Eructation / Q000188:drug therapy / Q000209:etiology; D050782:Esophageal pH Monitoring; D005260:Female; D058786:GABA-B Receptor Agonists / Q000494:pharmacology / Q000627:therapeutic use*; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000503:physiopathology; D006356:Heartburn / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008365:Manometry; D008875:Middle Aged; D019518:Postprandial Period; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D058786:GABA-B Receptor Agonists; D001418:Baclofen