优因汤治疗韩国肥胖女性的疗效和安全性：一项随机、双盲、安慰剂对照、多中心试验。

Efficacy and safety of Euiiyin-tang in Korean women with obesity: A randomized, double-blind, placebo-controlled, multicenter trial.

机构信息

Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Kyungheedae-ro 26, Dongdaemun-gu, Seoul 02447, Republic of Korea.

Department of Korean Medicine Rehabilitation, College of Korean Medicine, Gachon University, 1342 Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea.

出版信息

Complement Ther Med. 2020 Jun;51:102423. doi: 10.1016/j.ctim.2020.102423. Epub 2020 May 21.

DOI:10.1016/j.ctim.2020.102423

PMID:32507436

Abstract

BACKGROUND

Obesity is a global health problem and its incidence is on the rise. Euiiyin-tang is an herbal medicinal formula that is often used in the clinical treatment of obesity. The purpose of the present study was to evaluate the efficacy and safety of Euiiyin-tang in obesity treatment.

METHODS

A randomized, double-blind, placebo-controlled, multicenter trial was conducted. Participants with obesity were randomly assigned to receive Euiiyin-tang or placebo 3 times daily for 12-weeks. The primary outcome was weight reduction between the baseline and 12 weeks. The secondary outcomes included the rate of weight loss compared to baseline, and changes in body mass index, lipid profiles, and questionnaires related to the quality of life and diet. Safety factors, such as vital signs and laboratory parameters, were also measured.

RESULTS

A total of 149 participants were randomly distributed to either the Euiiyin-tang group (n = 76) or the placebo group (n = 73). Weight reduction in the Euiiyin-tang group was significantly greater than that in the placebo group (2.50 kg in the Euiiyin-tang group vs. 0.82 kg in the placebo group). The participant response rates of ≥3% weight loss compared to baseline was 36.8 % in the Euiiyin-tang group and 17.8 % in the placebo group. Body mass index, waist circumference, and hip circumference showed a greater change in the Euiiyin-tang group than in the placebo group (1.00, 3.23, and 2.00 in the Euiiyin-tang group vs. 0.33, 1.96, and 0.86 in the placebo group). Questionnaires, lipid profiles, and safety factors did not show significant differences between groups.

CONCLUSION

The results of this study suggest that Euiiyin-tang has beneficial effects on weight loss.

TRIAL REGISTRATION

Clinicaltrials.gov NCT01724099.

摘要

背景

肥胖是一个全球性的健康问题，其发病率呈上升趋势。惠阴汤是一种常用于临床肥胖治疗的草药配方。本研究旨在评估惠阴汤治疗肥胖的疗效和安全性。

方法

进行了一项随机、双盲、安慰剂对照、多中心试验。将肥胖参与者随机分为 3 次/d 接受惠阴汤或安慰剂治疗，疗程 12 周。主要结局为基线至 12 周时体重减轻量。次要结局包括与基线相比的体重减轻率，以及体重指数、血脂谱和与生活质量和饮食相关的问卷的变化。还测量了生命体征和实验室参数等安全因素。

结果

共有 149 名参与者被随机分配到惠阴汤组（n=76）或安慰剂组（n=73）。惠阴汤组的体重减轻量明显大于安慰剂组（惠阴汤组 2.50kg，安慰剂组 0.82kg）。惠阴汤组与基线相比≥3%体重减轻的参与者应答率为 36.8%，安慰剂组为 17.8%。惠阴汤组的体重指数、腰围和臀围变化大于安慰剂组（惠阴汤组 1.00、3.23 和 2.00，安慰剂组 0.33、1.96 和 0.86）。两组之间的问卷、血脂谱和安全因素没有显示出显著差异。