Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2025
Latanoprost for Treatment of Ménière Disease: A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy of Intratympanic Management for Symptom Control.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Lindell Ellen, Tomanovic Tatjana, Dahlin Redfors Ylva, Engmér Berglin Cecilia, Karlberg Berglin Mikael
Аннотация
OBJECTIVE: A previous placebo-controlled crossover study of intratympanic latanoprost-a drug commonly used for glaucoma treatment-showed positive effects on hearing, tinnitus, and vertigo in patients with long-standing Ménière disease (MD). We aimed to test the safety and efficacy of intratympanic treatment with latanoprost 0.0005% versus placebo in patients with active MD concerning speech discrimination in noise, hearing, tinnitus, and vertigo.
STUDY DESIGN: A prospective, randomized, double-blind, placebo-controlled study over 3 months in patients with active stage II to III MD.
SETTING: Twelve otolaryngology referral centers across Sweden.
INTERVENTION: Patients were allocated to intratympanic injection of latanoprost 0.0005% administered as a single injection on day 1, or 3 injections over 3 consecutive days, or placebo administered as a single injection or 3 injections over 3 consecutive days.
MAIN OUTCOME MEASURES: The primary outcome was change in speech discrimination in noise, assessed using phonetically balanced monosyllabic Swedish words (PB S/N+4dB), from baseline (day 1) to day 14. Secondary outcomes were change in pure tone average measured at 0.25, 0.5, 1, 2, 3, 4, 6, and 8 kHz, tinnitus according to the Tinnitus Handicap Inventory (THI) score and vertigo measured at 2, 4, 6, and 8 weeks after the first injection. Hearing, tinnitus, and vertigo were also assessed according to a Likert scale scored from 0 to 10. Days with vertigo attacks lasting ≥20 minutes were registered twice a week by patients. LS means were compared for each outcome measure.
RESULTS: When comparing latanoprost (1 or 3 injections) with placebo (1 or 3 injections), no statistically significant difference was seen for the change in speech discrimination in noise from baseline to day 14, 0.4 (95% CI: -4.5; 5.3), P =0.88. None of the secondary efficacy measures showed a statistically significant difference between latanoprost and placebo. Latanoprost treatment was well tolerated.
CONCLUSIONS: In this placebo-controlled study, latanoprost was not more effective than placebo in the treatment of MD and did not improve speech discrimination in noise, hearing, and tinnitus or vertigo symptoms.
STUDY DESIGN: A prospective, randomized, double-blind, placebo-controlled study over 3 months in patients with active stage II to III MD.
SETTING: Twelve otolaryngology referral centers across Sweden.
INTERVENTION: Patients were allocated to intratympanic injection of latanoprost 0.0005% administered as a single injection on day 1, or 3 injections over 3 consecutive days, or placebo administered as a single injection or 3 injections over 3 consecutive days.
MAIN OUTCOME MEASURES: The primary outcome was change in speech discrimination in noise, assessed using phonetically balanced monosyllabic Swedish words (PB S/N+4dB), from baseline (day 1) to day 14. Secondary outcomes were change in pure tone average measured at 0.25, 0.5, 1, 2, 3, 4, 6, and 8 kHz, tinnitus according to the Tinnitus Handicap Inventory (THI) score and vertigo measured at 2, 4, 6, and 8 weeks after the first injection. Hearing, tinnitus, and vertigo were also assessed according to a Likert scale scored from 0 to 10. Days with vertigo attacks lasting ≥20 minutes were registered twice a week by patients. LS means were compared for each outcome measure.
RESULTS: When comparing latanoprost (1 or 3 injections) with placebo (1 or 3 injections), no statistically significant difference was seen for the change in speech discrimination in noise from baseline to day 14, 0.4 (95% CI: -4.5; 5.3), P =0.88. None of the secondary efficacy measures showed a statistically significant difference between latanoprost and placebo. Latanoprost treatment was well tolerated.
CONCLUSIONS: In this placebo-controlled study, latanoprost was not more effective than placebo in the treatment of MD and did not improve speech discrimination in noise, hearing, and tinnitus or vertigo symptoms.