Efficacy and Safety of Taeeumjowi-tang in Obese Korean Adults: A Double-Blind, Randomized, and Placebo-Controlled Pilot Trial

Sunju Park,Jeong-Su Park,Yun-Kyung Song,Chunhoo Cheon,Bo-Hyoung Jang,Hoyeon Go,Seong-Gyu Ko,Kyung-Soo Kim,Yongcheol Shin,Won Nahmkoong

doi:10.1155/2013/498935

Abstract

Objective. The purpose of this study was to assess the efficacy and safety of Taeeumjowi-tang (TJ001) as well as to estimate obesity-related factors. Methods. This was a 12-week trial with 5 visits. A total of 102 participants of both genders were randomized to either TJ001 (n = 57) group or the placebo group (n = 55). Subjects were administered 7 g of either TJ001 or placebo 3 times a day. The primary outcome was a rate of subjects who lost 5% or more of initial weight. Secondary outcomes included anthropometric parameters, lipid profiles, and body fat composition. Results. The subject response rate of ≥5% weight loss compared to baseline was similar in both groups, and no statistically significant difference was observed (P = 0.87). Changes in anthropometric parameters were greater during the first 4 weeks in the treatment group (P < 0.0001). There were no significant changes in both within groups and between groups for lipid profile and body fat composition. No adverse event was reported in either group. Conclusion. Although the difference between the groups regarding a rate of subjects who lost 5% or more of initial weight did not show statistical significance, TJ001 appears to be beneficial in safely controlling weight.

Highlights

Obesity is defined as abnormal or excessive fat accumulation that threatens health
The most recent Korean National Health and Nutrition Examination Survey (KNHANES) found that 35.2% of male adults, 28.6% of female adults, and 31.9% of adults aged over 19 were overweight according to Body mass index (BMI) calculations [2]
As one participant in the treatment group had allergic dermatitis after randomization, this subject was excluded from the ITT data set before receiving the intervention

Summary

Introduction

Obesity is defined as abnormal or excessive fat accumulation that threatens health. Obesity leads to physical and external complications and causes various diseases, such as cardiovascular disease, musculoskeletal disease, endocrinopathy, and psychological disease [1]. The World Health Organization (WHO) considers obesity to be lifestyle-related disease and calls for its management. A high prevalence of obesity has become a global problem. If the current trend continues, the obese population will be 700 million in 2015 and one-third of the world population in 2025. The most recent Korean National Health and Nutrition Examination Survey (KNHANES) found that 35.2% of male adults, 28.6% of female adults, and 31.9% of adults aged over 19 were overweight according to BMI calculations [2].

Methods

Results

Discussion

Conclusion