Magnesium alginate versus proton pump inhibitors for the treatment of laryngopharyngeal reflux: a non-inferiority randomized controlled trial

Abstract

Purpose Proton pump inhibitors (PPIs) are commonly prescribed for laryngopharyngeal reflux (LPR), but their efficacy remains debated. Alginates is an option for the treatment of LPR with few adverse effects. The study aimed to investigate the non-inferiority of an alginate suspension (Gastrotuss®) compared to PPIs (Omeprazole) in reducing LPR symptoms and signs. Methods A non-inferiority randomized controlled trial was conducted. Fifty patients with laryngopharyngeal symptoms (Reflux Symptom Index -RSI- ≥ 13) and signs (Reflux Finding Score -RFS- ≥ 7) were randomized in two treatment groups: (A) Gastrotuss® (20 ml, three daily doses) and, (B) Omeprazole (20 mg, once daily). The RSI and the RFS were assessed at baseline and after 2 months of treatment. Results Groups had similar RSI and RFS scores at baseline. From pre- to 2-month posttreatment, the mean RSI significantly decreased (p = 0.001) in alginate and PPI group (p = 0.003). The difference between groups in the RSI change was not significant (95%CI: − 4.2–6.7, p = 0.639). The mean RFS significantly decreased in alginate (p = 0.006) and PPI groups (p = 0.006). The difference between groups in the mean change RFS was not significant (95%CI: − 0.8; 1.4, p = 0.608). Conclusion After 2 months of treatment, LPR symptoms and signs are significantly reduced irrespective of the treatment. Alginate was non-inferior to PPIs and may represent an alternative treatment to PPIs for the treatment of LPR.

Review article: Diagnosis and management of laryngopharyngeal reflux

“…Notably, all patients received lifestyle modifications, which could account for the lack of a difference between groups. In a non‐inferiority randomised controlled trial of 50 patients with RSI ≥ 13 and RFS ≥ 7, Pizzorni et al 116 demonstrated that patients treated with alginates (Gastrotuss 20 mL, three times per day) or omeprazole 20 mg daily had significant improvement in mean RSI, and alginates were non‐inferior to PPIs.…”

The Differences between Gastroesophageal and Laryngopharyngeal Reflux

“…Alginate forms a gelatinous layer on top of the gastric contents and makes a mechanical barrier, thereby reducing contact between the reflux contents and esophageal mucosa. Alginate also has a significant inhibitory effect on pepsin, and is, according to some research, non-inferior to PPI [13,29]. Other noninvasive treatment options include using external upper esophageal sphincter compression device.…”

Is there a role for voice therapy in the treatment of laryngopharyngeal reflux? A pilot study

“…Laryngopharyngeal reflux (LPR) is an inflammatory condition where stomach contents move in a retrograde fashion, enter and affect the upper aero-digestive tract 1 causing a variable presentation of symptoms that can include dysphonia (chronic or intermittent), excessive throat clearing, globus sensation, chronic cough, vocal fatigue or vocal effort, sore throat and dysphagia among others 2 , 3 . The prevalence of LPR-related symptoms ranges from 10% to 30% in otolaryngology department consultations, reaching up to 50% in clinical laryngology practices 4 .…”

“…The prevalence may be increasing given the ever-worsening lifestyle and dietary habits of most Western cultures 4 . Treatment options for LPR include diet and lifestyle modifications, proton pump inhibitors (PPIs), H2 blockers and/or alginate or magaldrate 3 .…”