Effects of Astragalus Extract Mixture HT042 on Height Growth in Children with Mild Short Stature: A Multicenter Randomized Controlled Trial.

Phytother Res. 2018 Jan;32(1):49-57. doi: 10.1002/ptr.5886. Epub 2017 Nov 12. Lee D1, Lee SH2, Song J1, Jee HJ3, Cha SH4, Chang GT5. Author information 1 Department of Herbal Pharmacology, Kyung Hee University College of Korean Medicine, Seoul, South Korea. 2 Department of Pediatrics, Kyung Hee University College of Korean Medicine, Seoul, South Korea. 3 Department of Biostatistics, Korea University College of Medicine, Seoul, South Korea. 4 Department of Pediatrics, Kyung Hee University College of Medicine, Seoul, South Korea. 5 Pediatrics of Korean Medicine, Kyung Hee University Hospital at Gangdong, Seoul, South Korea. Abstract HT042 is a standardized functional food ingredient approved by Korean Food and Drug Administration with a claim 'HT042 can help height growth of children'. We aimed to evaluate the safety and efficacy of HT042 on height growth in children with mild short stature. A multicenter, randomized, double-blind, placebo-controlled parallel study was performed on children aged 6-8 years with height ranked below the 25th percentile. In 129 children, height gain was significantly higher in HT042 group than placebo group after 24 weeks (mean difference, 0.29 cm; 95% CI, 0.01 to 0.57 cm; p = 0.027). The difference was elevated when the efficacy analysis was restricted to children below the 10th percentile (mean difference, 0.45 cm; 95% CI, 0.04 to 0.87 cm; p = 0.031). Because bone age advancement was lower in HT042 group, height standard deviation score gain for bone age was higher in HT042 group and the difference was significant in children below the 10th percentile (mean difference, 0.20 score; 95% CI, 0.00 to 0.39 points; p = 0.045). Serum IGF-1 and IGFBP-3 levels were significantly increased compared with baseline within HT042 group, but group difference was not significant. HT042 supplementation helped to increase height growth in children without skeletal maturation and was more effective in much shorter children. The effects might be mediated by increases in serum IGF-1 and IGFBP-3 levels. Copyright © 2017 John Wiley & Sons, Ltd. KEYWORDS: Astragalus extract mixture; children; clinical trial; mild short stature PMID: 29130588 DOI: 10.1002/ptr.5886 [Indexed for MEDLINE]