A randomized, double-blind, placebo-controlled study depicted that 10 mg baclofen three times a day is an effective adjuvant therapy in patients diagnosed with proton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD) symptoms. This study was designed to compare baclofen with placebo as add-on therapy for persistent troublesome GERD symptoms despite optimized PPI therapy.

A total of 60 patients were involved (age 47.5 years [range 19-73], 41 females/19 males), and 31 were randomly assigned to baclofen. People with persisting typical GERD symptoms on twice a day PPI therapy were randomly allocated to either baclofen 10 mg or placebo three times daily for four weeks. Participants underwent 24 hours impedance-pH monitoring on-PPI before and after therapy. Participants filled out ReQuest diaries throughout the trial. With the aid of mixed models, an analysis of data was done.

Notably, 1 patient revoked consent, and five patients in the baclofen group discontinued therapy owing to negative effects. When compared to the placebo group, the baclofen-treated group showed a trend towards a greater response for general wellbeing. When patients were subdivided according to symptom association probability (SAP), only the SAP+ (n = 25) group benefited substantially with baclofen and deteriorated with placebo. Because of the baclofen condition, the overall number of reflux incidents reduced with time.

The number of high proximal extent reflux incidents decreased considerably after baclofen but not after placebo. The γ-aminobutyric acid agonist baclofen reduces various reflux parameters in PPI-resistant GERD symptoms. However, pH-impedance monitoring is required prior to treatment since only SAP+ patients have clinical improvement after 4 weeks.