Add-on baclofen eases reflux in certain PPI-refractory GERD patients
In patients with proton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD), add-on treatment with baclofen improves several reflux parameters, but only among those who are positive for symptom association probability, a study has found.
The study included 60 patients (median age 47.5 years, 68.3 percent female) with persisting GERD symptoms on twice-a-day PPI therapy. They were randomized to 4 weeks of treatment with either baclofen 10 mg (n=31) or placebo (n=29) three times a day as add-on therapy.
All patients underwent 24-hour impedance-pH monitoring on PPI prior to and after treatment. They also completed ReQuest diaries.
Of the patients, one withdrew consent, and five in the baclofen group discontinued treatment due to side effects. Results showed a trend towards a better response for general wellbeing in the baclofen group than in the placebo group (p=0.06).
When analysis was performed according to symptom association probability, the patients who tested positive (n=25) showed significant improvements with baclofen (p=0.02) and seemed to get worse with placebo (p=0.008).
The total number of reflux events dropped over time (p=0.01) mainly because of baclofen. Furthermore, the number of reflux events with a high proximal extent decreased significantly after baclofen (p=0.009) but not placebo.
The findings suggest that pH-impedance monitoring is necessary before initiating baclofen, as only symptom association probability-positive patients experience clinical benefit after 4 weeks of treatment.