Auris, nasus, larynx · 2023
Efficacy of tokishakuyakusan and mecobalamin on post-infectious olfactory dysfunction: A prospective multicenter study.
Рандомизированное исследованиеМногоцентровое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Kobayashi Masayoshi, Miwa Takaki, Mori Eri, Shiga Hideaki, Tsuzuki Kenzo, Okutani Fumino, Hayama Masaki, Akazawa Hitoshi, Nakamura Yosuke, Suzuki Motohiko, Matsuwaki Yoshinori, Ogino Eriko, Shikina Takashi, Ikeda Katsuhisa, Hyo Yukiyoshi, Kashiwagi Takashi, Kondo Kenji, Shibata Minori, Ueno Takayoshi
Аннотация
OBJECTIVE: To determine if tokishakuyakusan (TSS) is effective for treating post-infectious olfactory dysfunction (PIOD) compared with vitamin B12 (mecobalamin).
METHODS: We conducted a randomized, nonblinded clinical trial. Patients with PIOD enrolled in 17 hospitals and clinics from 2016 to 2020 were randomly divided into two groups, and we administered TSS or mecobalamin for 24 weeks. Their olfactory function was examined using interviews and T&T olfactometry. The improvement of olfactory dysfunction was assessed following the criteria of the Japanese Rhinologic Society.
RESULTS: Overall, 82 patients with PIOD were enrolled in this study. In the TSS and mecobalamin groups, 39 patients completed the medication regimen. In the TSS and mecobalamin groups, olfactory dysfunction was significantly improved based on self-reports and olfactory test results. The improvement rate of olfactory dysfunction was 56% in the TSS group and 59% in the mecobalamin group. Early intervention within 3 months produced a better prognosis than the treatment initiated after 4 months. Furthermore, age and sex differences were not observed. Both medications produced no severe adverse events.
CONCLUSION: The present study showed that TSS and mecobalamin might be useful for treating PIOD.
METHODS: We conducted a randomized, nonblinded clinical trial. Patients with PIOD enrolled in 17 hospitals and clinics from 2016 to 2020 were randomly divided into two groups, and we administered TSS or mecobalamin for 24 weeks. Their olfactory function was examined using interviews and T&T olfactometry. The improvement of olfactory dysfunction was assessed following the criteria of the Japanese Rhinologic Society.
RESULTS: Overall, 82 patients with PIOD were enrolled in this study. In the TSS and mecobalamin groups, 39 patients completed the medication regimen. In the TSS and mecobalamin groups, olfactory dysfunction was significantly improved based on self-reports and olfactory test results. The improvement rate of olfactory dysfunction was 56% in the TSS group and 59% in the mecobalamin group. Early intervention within 3 months produced a better prognosis than the treatment initiated after 4 months. Furthermore, age and sex differences were not observed. Both medications produced no severe adverse events.
CONCLUSION: The present study showed that TSS and mecobalamin might be useful for treating PIOD.