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.

• Authors: Makoto Ito, Yumiko Maruyama, Ken Kitamura, Toshimitsu Kobayashi, Haruo Takahashi, Noboru Yamanaka, Yasuaki Harabuchi, Hideki Origasa, Tomokazu Yoshizaki
• Journal: Auris, nasus, larynx (Auris Nasus Larynx) Vol. 44 Issue 4 Pg. 390-397 (Aug 2017) ISSN: 1879-1476 [Electronic] Netherlands
• PMID: 27810126 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2016. Published by Elsevier B.V.

Chemical References

• Anti-Bacterial Agents
• Drugs, Chinese Herbal
• Mitogens
• juzentaihoto

Topics

• Acute Disease
• Anti-Bacterial Agents (therapeutic use)
• Child, Preschool
• Drugs, Chinese Herbal (therapeutic use)
• Female
• Humans
• Infant
• Japan
• Male
• Middle Ear Ventilation
• Mitogens (therapeutic use)
• Otitis Media (prevention & control, therapy)
• Recurrence