Efficacy of Maoto, a Traditional Japanese Medicine, in the Treatment of Common Cold in Children: A Retrospective Cohort Study

ABSTRACT Background Colds in children vary from mild self‐limiting illness to severe cases that may progress to pneumonia or encephalitis. No effective therapy currently exists for viral colds in children. Promoting early recovery may reduce the burdens on families, schools, and healthcare systems. To the best of our knowledge, this is the first observational study to evaluate the effectiveness of maoto in pediatric colds. Methods A multicenter retrospective cohort study was conducted across nine pediatric clinics in Japan. A total of 102 children aged ≤ 5 years were enrolled, of whom 61 received maoto (mean age 1.19 ± 1.1 years) and 41 received usual treatment (mean age 1.6 ± 1.4 years). Body temperature was assessed as the primary outcome, whereas symptom scores documented in a structured “cold diary” were analyzed as exploratory outcomes. Results No baseline differences were found between the groups. In the maoto group, body temperature decreased significantly in the afternoon of Day 1 and in the morning and afternoon of Day 3. Additionally, in exploratory analyses, symptom scores were lower for fatigue (days 1–4), decreased food and milk intake (days 2–3), phlegm (Day 6), and asthma symptoms (days 1–4), whereas scores were higher for nasal symptoms (days 1–2) and cough (Day 1). Antipyretic use was significantly lower in the maoto group. No difficulties in administration were reported, suggesting good tolerability in children aged < 5 years. Conclusion Maoto was associated with earlier improvement of fever and reduced antipyretic use in children aged < 5 years with common colds.