Randomized controlled trial of juzen-taiho-to in children with recurrent acute otitis media.
OBJECTIVE
Recurrent acute otitis media (AOM) in young children is rapidly increasing worldwide. Repeated antibiotic use leads to antibiotic-resistant pathogen development. Complementary and alternative medicine approaches have been suggested as a supplemental treatment option to conventional antimicrobial medicine. This randomized, parallel-group, open-label, non-herbal medicine controlled trial assessed the efficacy of a traditional Japanese herbal medicine, juzen-taiho-to (JTT) for AOM prevention in otitis-prone children.


METHODS
Children prone to recurrent AOM aged 6-48 months were recruited from 26 otolaryngology clinics in Japan and received conventional AOM treatment based on Japanese guidelines with or without 2 daily oral doses of JTT (0.10-0.25g/kg/day). The mean number of AOM episodes, coryza episodes, and duration of total antibiotic administration per month were compared during 3-month intervention.


RESULTS
At least one episode of AOM was diagnosed in 71% of JTT-group and 92% of control participants during follow-up. JTT administration reduced the frequency of AOM episodes by 57% compared with children who received conventional treatment alone (0.61±0.54 vs. 1.07±0.72 AOM instances/month; P=0.005) and also significantly decreased number of coryza episodes (P=0.015) and total antibiotic administration (P=0.024).


CONCLUSIONS
This is the first report of recurrent AOM prevention by herbal medication. JTT appears to effectively prevent recurrent AOM in children. Subsequent double-blind studies are needed to confirm the beneficial effects of JTT on recurrent AOM and upper respiratory tract infections.
Department of Pediatric Otolaryngology, Tochigi Children's Hospital, Jichi Medical University, Tochigi, Japan.
Makoto
M
Ito
Department of Otolaryngology, Kurobe Civic Hospital, Kurobe, Japan.
Yumiko
Y
Maruyama
Department of Otolaryngology-Head and Neck Surgery, Tokyo Medical & Dental University, Tokyo, Japan.
Ken
K
Kitamura
Department of Otolaryngology-Head and Neck Surgery, Tohoku University School of Medicine, Sendai, Japan.
Toshimitsu
T
Kobayashi
Department of Otolaryngology-Head and Neck Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Haruo
H
Takahashi
Department of Otolaryngology-Head and Neck Surgery, Wakayama Medical University, Wakayama, Japan.
Noboru
N
Yamanaka
Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical University, Asahikawa, Japan.
Yasuaki
Y
Harabuchi
Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences, Toyama, Japan.
Hideki
H
Origasa
Department of Otolaryngology-Head and Neck Surgery, Graduate School of Medical Science, Kanazawa University, Japan. Electronic address: tomoy@med.kanazawa-u.ac.jp.
Tomokazu
T
Yoshizaki
D000208:Acute Disease; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D002675:Child, Preschool; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007223:Infant; D007564:Japan; D008297:Male; D008876:Middle Ear Ventilation; D008934:Mitogens / Q000627:therapeutic use*; D010033:Otitis Media / Q000517:prevention & control* / Q000628:therapy; D012008:Recurrence
D000900:Anti-Bacterial Agents; D004365:Drugs, Chinese Herbal; D008934:Mitogens; C063587:juzentaihoto
Japanese herbal medicine (Kampo); Juzen-taiho-to; Randomized controlled trial; Recurrent acute otitis media