Lansoprazole for persistent throat symptoms in secondary care: the TOPPITS RCT

Area of Science:

• Gastroenterology and Otolaryngology
• Clinical Trials and Evidence-Based Medicine

Background:

• Persistent throat symptoms are often attributed to laryngopharyngeal reflux (LPR).
• Proton pump inhibitors (PPIs) are increasingly prescribed for LPR despite limited evidence.
• This study investigates the efficacy of PPIs in managing these symptoms.

Purpose of the Study:

• To evaluate the effectiveness of lansoprazole compared to placebo in patients with persistent throat symptoms.
• To assess the symptomatic response using the Reflux Symptom Index (RSI) after 16 weeks of treatment.

Main Methods:

• A multicentre, double-blind, placebo-controlled, randomized Phase III trial involving 346 participants.
• Participants received either 30 mg of lansoprazole twice daily or a matching placebo for 16 weeks.
• The primary outcome measure was the change in the Reflux Symptom Index score.

Main Results:

• No significant difference in Reflux Symptom Index scores was observed between the lansoprazole and placebo groups at 16 weeks.
• Lansoprazole treatment resulted in slightly higher (worse) RSI scores compared to placebo (1.9 points higher).
• Similar outcomes were noted for secondary measures, including the Comprehensive Reflux Symptom Score and Laryngopharyngeal Reflux - Health Related Quality of Life scores.

Conclusions:

• Lansoprazole did not demonstrate a significant benefit over placebo for persistent throat symptoms.
• The findings suggest that PPIs may not be effective for treating LPR-attributed throat symptoms.
• This definitive trial provides robust evidence against the routine use of lansoprazole for this condition.