Adding baclofen may improve GERD symptoms, but long-term use may increase side effects

Add-on therapy with baclofen reduced reflux symptoms among patients with refractory gastroesophageal reflux disease (GERD) but prolonged use led to an increased incidence of side effects and failed to effectively reduce acid reflux occurrence, a review found.

Baclofen as an add-on treatment can improve the symptoms of patients with refractory gastroesophageal reflux disease (GERD), reduce the incidence of nonacidic reflux, and improve DeMeester scores, but long-term use leads to increased side effects and is not effective in reducing the occurrence of acid reflux, according to a new study.

Researchers reviewed the peer-reviewed literature for studies published through October 2023, finding four randomized controlled trials (RCTs) and six single-arm prospective studies. Results of their meta-analysis were published June 13 by the Journal of Clinical Gastroenterology.

Compared with the use of proton pump inhibitors (PPI) alone, supplementary baclofen improved symptoms (as measured by the GERD Q score) in refractory GERD (standardized mean difference, −0.78 [95% CI, −1.06 to −0.51]; I2=0%), decreased frequency of nonacidic reflux episodes (standardized mean difference, −0.93 [95% CI, −1.49 to −0.37]; I2=63%), and improved DeMeester scores (standardized mean difference, −0.82 [95% CI, −1.61 to −0.04]; I2=81%). But there was no significant difference between groups in acid reflux episodes (standardized mean difference, −0.12 [95% CI, −0.49 to 0.19]; I2=0%) or proximal reflux (standardized mean difference, −0.47 [95% CI, −1.08 to 0.14]; I2=60%).

Due to variations in dosing schedules across the studies, the review authors were not able to conduct a pooled analysis of adverse effects. However, looking at the studies that used the same dose and schedule (20 mg, t.i.d.), they found that the three most common adverse effects (somnolence, dizziness, and fatigue) increased with the duration of baclofen treatment.

The study authors concluded that baclofen effectively alleviated symptoms associated with reflux and significantly reduced the incidence of nonacidic reflux, but did not cause a statistically significant difference in acid reflux or proximal reflux. Baclofen may also be effective for GERD-related cough and laryngopharyngeal reflux, they noted.

"Nevertheless, it is important to note that our study observed a high incidence of adverse events associated with baclofen usage, emphasizing the need for strict control over its administration within appropriate populations to optimize treatment benefits," the researchers wrote.