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Randomized controlled trial of juzen-taiho-to in children with recurrent acute otitis media.

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.

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  • Publisher Full Text
  • 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.

    Source

    Auris, nasus, larynx 44:4 2017 Aug pg 390-397

    MeSH

    Acute Disease
    Anti-Bacterial Agents
    Child, Preschool
    Drugs, Chinese Herbal
    Female
    Humans
    Infant
    Japan
    Male
    Middle Ear Ventilation
    Mitogens
    Otitis Media
    Recurrence

    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 -