OBJECTIVES:Reflux inhibitors, like the gamma-aminobutyric acid type B (GABA(B)) receptor agonist, baclofen, block transient lower esophageal sphincter relaxations (TLESRs) and are proposed as an add-on therapy in patients with proton pump inhibitor (PPI)-resistant gastroesophageal reflux. However, as other mechanisms of reflux become more important in the presence of a hiatal hernia (HH), the efficacy of reflux inhibitors to reduce acid and non-acid exposure may be hampered. Therefore, we compared the effect of baclofen in patients with no HH (-HH) and those with a large HH during PPI treatment. METHODS: A total of 27 gastroesophageal reflux disease (GERD) patients on PPI were included; 16 had -HH and 11 had a large (> or =3 cm) HH (+HH). During PPI treatment, the effect of baclofen (3 x 20 mg) on acid and non-acid reflux was evaluated in a randomized, double-blind, placebo-controlled cross-over study. Reflux was measured during 24 h using combined esophageal impedance and pH-metry. RESULTS: The majority of reflux events consisted of both gaseous and liquid reflux with a significant increase in non-acid, mixed reflux episodes in +HH patients compared with those in -HH patients. Acid exposure time was in the normal range in both patient groups during both placebo and baclofen. In this study, baclofen significantly reduced the total number of reflux episodes with 36% in -HH patients and 43% in +HH patients, but did not change the number of acid reflux episodes or total acid exposure time. CONCLUSIONS: This study shows that baclofen is also effective in patients with GERD with +HH, further underscoring the potential of reflux inhibitors as treatment of GERD.
RCT Entities:
OBJECTIVES: Reflux inhibitors, like the gamma-aminobutyric acid type B (GABA(B)) receptor agonist, baclofen, block transient lower esophageal sphincter relaxations (TLESRs) and are proposed as an add-on therapy in patients with proton pump inhibitor (PPI)-resistant gastroesophageal reflux. However, as other mechanisms of reflux become more important in the presence of a hiatal hernia (HH), the efficacy of reflux inhibitors to reduce acid and non-acid exposure may be hampered. Therefore, we compared the effect of baclofen in patients with no HH (-HH) and those with a large HH during PPI treatment. METHODS: A total of 27 gastroesophageal reflux disease (GERD) patients on PPI were included; 16 had -HH and 11 had a large (> or =3 cm) HH (+HH). During PPI treatment, the effect of baclofen (3 x 20 mg) on acid and non-acid reflux was evaluated in a randomized, double-blind, placebo-controlled cross-over study. Reflux was measured during 24 h using combined esophageal impedance and pH-metry. RESULTS: The majority of reflux events consisted of both gaseous and liquid reflux with a significant increase in non-acid, mixed reflux episodes in +HH patients compared with those in -HH patients. Acid exposure time was in the normal range in both patient groups during both placebo and baclofen. In this study, baclofen significantly reduced the total number of reflux episodes with 36% in -HH patients and 43% in +HH patients, but did not change the number of acid reflux episodes or total acid exposure time. CONCLUSIONS: This study shows that baclofen is also effective in patients with GERD with +HH, further underscoring the potential of reflux inhibitors as treatment of GERD.