• Hye Yeon Kim, Hae Sun Seo, Hee Ae Seo, Tae Yun Doh, Gyu Tae Chang, Jin Yong Lee, and Sun Haeng Lee.
• Department of Korean Pediatrics, Kyung Hee University Medical Center, Dongdaemun-gu, Seoul, Republic of Korea.
• Medicine (Baltimore). 2024 May 3; 103 (18): e37970e37970.

BackgroundDeer antlers have been used as strong tonifying medicine in Asian countries, especially for the growth and development of children in pediatrics of Korean medicine. The safety of deer antler in adults cannot be applied directly to children because of their physiological characteristics. To accumulate reliable data on the safety of deer antler in pediatric populations, well-designed clinical studies are required.MethodsThis research is a 12-week, randomized, double-blind, placebo-controlled clinical trial evaluating the safety of deer antler extract (DAE) in children. The DAE group received an intervention containing 1586 mg of DAE, whereas the control group received a placebo for 12 weeks. The safety was assessed by monitoring adverse drug reactions (ADRs) and laboratory test results.ResultsOne hundred participants were included in the safety analysis. Three and 2 participants in the DAE and control groups, respectively, reported ADRs. There was no significant difference in incidence between the 2 groups. ADRs are categorized into gastrointestinal and skin-related symptoms. No serious ADR was observed throughout the study. The laboratory test results were within or outside the normal range at clinically insignificant levels.ConclusionThe research discovered that the DAE is safe in terms of ADRs and laboratory parameters under the conditions studied. Further studies are required to accumulate safety data about DAE dosage adjustment and potential interactions with other medicines.Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.

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