Effect of baclofen on esophagogastric motility and gastroesophageal reflux in children with gastroesophageal reflux disease: A randomized controlled trial

Objective To evaluate the effect of baclofen, a gamma-amino-butyric-acid B receptor agonist that inhibits transient lower esophageal sphincter relaxation (TLESR), on the rates of TLESR, gastroesophageal reflux (GER), and gastric emptying (GE) in children with GER disease. Study design The efficacy of 0.5 mg/kg baclofen was evaluated in a randomized, double-blinded, placebo-controlled trial in 30 children. Patients were intubated with a manometric/pH assembly and given 250 mL of cow's milk. Esophageal motility and pH were then measured for 2 hours (control period). Baclofen or placebo was then administered, and 1 hour later 250 mL of milk was given again and measurements performed for another 2 hours (test period). The GE rate was measured by the C-13 octanoate breath test. Results Baclofen significantly reduced the incidence of TLESR (mean, 7.3 +/- 1.5 vs 3.6 +/- 1.2 TLESR/2 hours; P < .05) and acid GER (mean 4.2 +/- 0.7 vs 1.7 +/- 1.0 TLESR + GER/2 hours; P < .05) during the test period compared with the control period. Baclofen significantly accelerated the GE rate (median [interquartile range], GE(t1/2), 61 minutes [39, 81 minutes] vs 114 minutes [67, 170 minutes]; P < .05). Baclofen had no effect on the swallowing rate, pattern of esopageal peristalsis, or lower esophageal sphincter pressure. Conclusions Baclofen reduces GER in children by inhibiting the triggering of TLESR. Baclofen also accelerates GE.