Does the presence of a hiatal hernia affects the efficacy of the reflux inhibitor baclofen?

The presence of a hiatal hernia may hamper the efficacy of anti-TLESR therapy in the treatment of gastroesophageal reflux disease (GERD) as other mechanisms for reflux to occur become more important. Therefore, a randomized, placebo controlled double blind crossover studywill be performed, whereby the effect of baclofen on the rate of reflux episodes will be evaluated in GERD patient with (¡Ý 3cm) and without hiatal hernia. Patients will undergo twice a combined ambulatory 24 hours impedance pH metry measurement while on PPI¡¯s and 3x20mg baclofen or placebo. Acid and non-acid reflux rate, acid exposure time and acid clearance will be analysed for both studydays and compared between both patientgroups.

The efficacy of reflux inhibitors, which block transient lower esophageal sphincter relaxations (TLESRs), to reduce acid and non-acid exposure may be hampered in the presence of a hiatal hernia, as other mechanisms of reflux become more important.

The ambulatory impedance/ pH metry will be performed twice, at day 11 after the start of baclofen / placebo and with at least a 7 days wash out period between both study periods.

Twice a 24 hours ambulatory combined impedance measurement and pH metry (transnasally).

A dose of 3x20mg baclofen and a dose of 3xplacebo; the initial dose consisted of 3 x 5 mg baclofen. Every fourth day, the dose was increased by 5 mg three times daily until a dose of 20 mg three times daily was reached after 10 days.