Efficacy and safety of TJ001 on Korean obese adults, based on a double-blind, randomized, placebo-controlled and multicenter trial
Sunju Park Preventive Medicine, College of Oriental Medicine
Kyung Hee University
Seoul, Korea
Abstract:
Obesity, described as status of excessive fat, increases risk of metabolic syndromes. Its prevalence rate also increases rapidly in Korea despite of various therapeutic efforts. Therefore discovering new and alternative remedies for obesity becomes important. TJ001 (Taeeumjowitang), Ma Huang containing medicinal extract, is a widely used herbal agent treating obesity in Korea. However its efficacy and safety has not been fully investigated by clinical trial. Our study concerns about suggesting evidences of TJ001 through a double blind, randomized, and placebo-controlled (two arms) TJ001 clinical trial. For this study, we recruited Korean obese patients of both sexes, aged 18-65, from 4 hospitals. We treated patients with either TJ001 or placebo for 12 weeks, and measured outcomes every 4-week, with total 5 visits (screening, 0, 4, 8, and 12 weeks). Although it was non-significant when we set primary outcome as 'at least 5% or more weight loss rate', still, mean changes of weight, waist circumference (WC) and hip circumference (HC) between baseline and 4th week of TJ001 group were significant (p=0.005, 0.010, 0.022 respectively) in per protocol (pp) analysis. Mean changes of total cholesterol and LDL cholesterol during 12 week treatment were also significant compared with placebo group (p=0.026, 0.030 respectively). Our findings suggest that TJ001 can be more effective in controlling lipid profiles. In addition, we should adjust weight reduction rate in case of herbal formula, therefore we can present more plausible primary outcomes. As a results, this study confirms the efficacy and safety of TJ001, suggesting an alternative herbal remedy for obesity.
