Takeaway
- This study found no evidence of symptomatic benefit for patients with persistent throat symptoms who were treated empirically with a proton pump inhibitor (PPI) lansoprazole.
- Reflux symptom index (RSI) scores were similar between lansoprazole and placebo groups after 16 weeks of treatment and at the 12-month follow-up.
Why this matters
- PPIs are widely used in both primary and secondary care in the UK as empirical treatment for throat symptoms.
- No evidence supports the empirical use of PPIs to treat persistent throat and voice symptoms.
Study design
- A multicentre, double-blind, randomised, placebo-controlled trial of 346 patients with persistent throat symptoms (age, ≥18 years) who were randomly assigned (1:1) to receive 30 mg of lansoprazole or placebo twice daily for 16 weeks.
- Primary outcome: symptomatic response at 16 weeks measured using the total RSI score.
- Secondary outcome: symptom response at 12 months, quality of life and throat appearances.
- Funding: National Institute for Health Research Health Technology Assessment.
Key results
- At 16 weeks, improvements (reduction in RSI score) were seen in both groups: lansoprazole 17.4 (95% CI, 15.5 -19.4) and placebo 15.6 (95% CI, 13.8 -17.3).
- After adjustment for site and baseline symptom severity, no statistically significant difference was found in RSI score between the groups (estimated difference, 1.93 points; 95% CI, −0.35 to 4.20 points; P=.096).
- At 12 months, no significant difference was seen between the lansoprazole and placebo groups in (estimated difference; 95% CI):
- RSI score (2.4 points; −0.6 to 5.4 points);
- laryngopharyngeal RSI items without the heartburn score (2.8 points; 0.5 to 5.1 points);
- comprehensive reflux symptom score (4.8 points; −3.5 to 13.1 points); and
- laryngopharyngeal health-related quality of life (4.9 points; −1.3 to 11.1 points).
Limitations
- Lack of any objective measure of gastroesophageal reflux disease within the methodology.
This clinical summary originally appeared on Univadis, part of the Medscape Professional Network.
