Panminerva medica · 2025
Laryngopharyngeal reflux disease: a pilot study with a new multicomponent.
СтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Nacci Andrea, Galli Alberto, Bastiani Luca, Capobianco Silvia, Ciprandi Giorgio
Аннотация
BACKGROUND: This prospective observational study aimed to evaluate the efficacy and safety of a new multicomponent medical device containing Gingigel Pro®, sodium alginate, Tamarindus indica, hyaluronic acid, and vegetal extracts in patients with laryngopharyngeal reflux disease (LPRD).
METHODS: Twenty-two adult patients (13 females, 9 males; mean age: 49.9 years) with a clinical diagnosis of LPRD (R-RSI ≥18 and RSA >14) were enrolled. All patients were treated with the device (one stick twice daily for 2 months) and received standardized behavioral and dietary counseling. Assessments were performed at baseline and after treatment using the Revised Reflux Symptom Index (R-RSI), Voice Handicap Index-10 (VHI-10), and Reflux Sign Assessment (RSA). Patients were stratified into three subgroups based on symptom duration: 0-4 months, 5-8 months, and ≥9 months. Statistical analyses evaluated changes in total and item-specific scores across the overall population and subgroups. Tolerability and adverse events were also recorded.
RESULTS: All outcome scores improved significantly after treatment (P<0.0001 for R-RSI, VHI-10, and RSA). The proportion of patients with pathological R-RSI scores decreased from 100% to 9.1%, and with pathological RSA scores from 100% to 59.1%. Most R-RSI items improved significantly. Specific RSA signs related to acute inflammation (e.g., erythema and edema of the uvula, epiglottis, and vocal folds) also showed significant improvement. No adverse events were reported. Subgroup analysis showed that both symptoms and objective signs improved in all subgroups, with the greatest reductions observed in patients with symptom onset within 0-4 months.
CONCLUSIONS: This study provides the first clinical evidence that the tested multicomponent device is effective and safe in improving both subjective symptoms and objective signs of LPRD. The observed greater benefit in patients with recent symptom onset supports early intervention. These findings are consistent with current recommendations that prioritize non-acid-suppressive agents in LPRD management. Further randomized controlled trials are warranted.
METHODS: Twenty-two adult patients (13 females, 9 males; mean age: 49.9 years) with a clinical diagnosis of LPRD (R-RSI ≥18 and RSA >14) were enrolled. All patients were treated with the device (one stick twice daily for 2 months) and received standardized behavioral and dietary counseling. Assessments were performed at baseline and after treatment using the Revised Reflux Symptom Index (R-RSI), Voice Handicap Index-10 (VHI-10), and Reflux Sign Assessment (RSA). Patients were stratified into three subgroups based on symptom duration: 0-4 months, 5-8 months, and ≥9 months. Statistical analyses evaluated changes in total and item-specific scores across the overall population and subgroups. Tolerability and adverse events were also recorded.
RESULTS: All outcome scores improved significantly after treatment (P<0.0001 for R-RSI, VHI-10, and RSA). The proportion of patients with pathological R-RSI scores decreased from 100% to 9.1%, and with pathological RSA scores from 100% to 59.1%. Most R-RSI items improved significantly. Specific RSA signs related to acute inflammation (e.g., erythema and edema of the uvula, epiglottis, and vocal folds) also showed significant improvement. No adverse events were reported. Subgroup analysis showed that both symptoms and objective signs improved in all subgroups, with the greatest reductions observed in patients with symptom onset within 0-4 months.
CONCLUSIONS: This study provides the first clinical evidence that the tested multicomponent device is effective and safe in improving both subjective symptoms and objective signs of LPRD. The observed greater benefit in patients with recent symptom onset supports early intervention. These findings are consistent with current recommendations that prioritize non-acid-suppressive agents in LPRD management. Further randomized controlled trials are warranted.