1. Lansoprazole was not found to be efficacious in the treatment of persistent throat symptoms.
Evidence Rating Level: 1 (Excellent)
Persistent throat symptoms are frequently encountered in primary and secondary care settings. These symptoms may include voice hoarseness, the feeling of a lump in the throat, continuously clearing the throat, and general throat discomfort. As well, gastroesophageal reflux disease (GERD) affects 20% of the Western world, and is often linked to throat and voice symptoms. As a result, treatments for GERD such as proton pump inhibitors (PPIs) have become commonly prescribed for persistent throat symptoms, without sufficient evidence for their efficacy. In this double-blind, randomized controlled trial examining whether lansoprazole (a PPI) was superior to placebo in improving persistent throat symptoms. The study population consisted of 220 adults from eight otolaryngology clinics in the UK, who presented with at least 6 weeks of inexplicable throat symptoms, and sufficient severity determined by the reflux symptom index (RSI), a well-established self-report questionnaire scored out of 45 (higher scores indicate greater severity). Participant symptoms were classified as mild or severe based on the RSI score. The participants were randomized by blocks into the placebo or lansoprazole (30 mg twice daily) groups, stratified by the treatment clinic and symptom severity classification. The primary outcome measured was the RSI-score after 16 weeks, and secondary outcomes included treatment compliance, RSI-score after 12 months, quality of life, and appearance of the throat. From the results, no statistically significant difference was found in the primary outcome: At baseline, the mean RSI-scores were 22.0 (95% CI 20.4-23.6) and 21.7 (95% CI 20.5-23.0) for the lansoprazole and placebo groups respectively, and at 16 weeks, the scores were 17.4 (95% CI 15.5-19.4) and 15.6 (95% CI 13.8-17.3) respectively. The estimated difference was 1.9 points (95% CI -0.3 to 4.2, p = 0.096). Furthermore, there were no benefits for lansoprazole over placebo in the secondary outcome measures. Overall, the study did not show evidence for the advantage of treating persistent throat symptoms with PPIs, which has implication for informing clinical guidelines as well as current prescription practices by primary care doctors and otolaryngologists.
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