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Randomized controlled trial of juzen-taiho-to in children with recurrent acute otitis media.
Auris Nasus Larynx 2017; 44(4):390-397AN

Abstract

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.

Authors+Show Affiliations

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: tomoy@med.kanazawa-u.ac.jp.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27810126

Citation

Ito, Makoto, et al. "Randomized Controlled Trial of Juzen-taiho-to in Children With Recurrent Acute Otitis Media." Auris, Nasus, Larynx, vol. 44, no. 4, 2017, pp. 390-397.
Ito M, Maruyama Y, Kitamura K, et al. Randomized controlled trial of juzen-taiho-to in children with recurrent acute otitis media. Auris Nasus Larynx. 2017;44(4):390-397.
Ito, M., Maruyama, Y., Kitamura, K., Kobayashi, T., Takahashi, H., Yamanaka, N., ... Yoshizaki, T. (2017). Randomized controlled trial of juzen-taiho-to in children with recurrent acute otitis media. Auris, Nasus, Larynx, 44(4), pp. 390-397. doi:10.1016/j.anl.2016.10.002.
Ito M, et al. Randomized Controlled Trial of Juzen-taiho-to in Children With Recurrent Acute Otitis Media. Auris Nasus Larynx. 2017;44(4):390-397. PubMed PMID: 27810126.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized controlled trial of juzen-taiho-to in children with recurrent acute otitis media. AU - Ito,Makoto, AU - Maruyama,Yumiko, AU - Kitamura,Ken, AU - Kobayashi,Toshimitsu, AU - Takahashi,Haruo, AU - Yamanaka,Noboru, AU - Harabuchi,Yasuaki, AU - Origasa,Hideki, AU - Yoshizaki,Tomokazu, Y1 - 2016/10/31/ PY - 2016/05/22/received PY - 2016/09/15/revised PY - 2016/10/06/accepted PY - 2016/11/5/pubmed PY - 2018/3/22/medline PY - 2016/11/5/entrez KW - Japanese herbal medicine (Kampo) KW - Juzen-taiho-to KW - Randomized controlled trial KW - Recurrent acute otitis media SP - 390 EP - 397 JF - Auris, nasus, larynx JO - Auris Nasus Larynx VL - 44 IS - 4 N2 - 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. SN - 1879-1476 UR - https://www.unboundmedicine.com/medline/citation/27810126/Randomized_controlled_trial_of_juzen_taiho_to_in_children_with_recurrent_acute_otitis_media_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0385-8146(16)30450-3 DB - PRIME DP - Unbound Medicine ER -