Randomized controlled trial of juzen-taiho-to in children with recurrent acute otitis media.
OBJECTIVERecurrent 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.
METHODSChildren 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.
RESULTSAt 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).
CONCLUSIONSThis 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.,
Department of Otolaryngology, Kurobe Civic Hospital, Kurobe, Japan.,
Department of Otolaryngology-Head and Neck Surgery, Tokyo Medical & Dental University, Tokyo, Japan.,
Department of Otolaryngology-Head and Neck Surgery, Tohoku University School of Medicine, Sendai, Japan.,
Department of Otolaryngology-Head and Neck Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.,
Department of Otolaryngology-Head and Neck Surgery, Wakayama Medical University, Wakayama, Japan.,
Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical University, Asahikawa, Japan.,
Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences, Toyama, Japan.
Department of Otolaryngology-Head and Neck Surgery, Graduate School of Medical Science, Kanazawa University, Japan. Electronic address: email@example.com.
Drugs, Chinese Herbal
Middle Ear Ventilation
Pub Type(s)Journal Article
Randomized Controlled Trial