Efficacy and safety of Euiiyin-tang in Korean women with obesity: A randomized, double-blind, placebo-controlled, multicenter trial. (June 2020)

• Record Type: Journal Article
• Authors: Cheon, Chunhoo; Song, Yun-Kyung; Ko, Seong-Gyu
• Is Part Of: Complementary therapies in medicine. Volume 51(2020)
• Publication Date: 2020-06
• Subjects: BMI Body Mass Index -- SBP Systolic Blood Pressure -- DBP Diastolic Blood Pressure -- ALT Alanine Transaminase -- AST Aspartate Aminotransferase -- ALP Alkaline Phosphatase -- IUD intrauterine device -- KCRD Kyung Hee University Centre for Clinical Research and Drug Development -- CRO Contract Research Organisation -- IRBs Institutional Review Boards -- SD Standard Deviation -- CRP C-Reactive Protein -- BUN Blood Urea Nitrogen -- CRE Creatinine -- WC Waist Circumferences -- HC Hip Circumferences -- WHR Waist-to-Hip Ratio -- LDL Low Density Lipoprotein -- HDL High Density Lipoprotein -- TFA Total Fat Area -- VFA Visceral Fat Area -- SFA Subcutaneous Fat Area -- KOQOL Korean version of Obesity-related Quality of Life -- KEAT-26 Korean version of Eating Attitudes Test -- SRRS Social Readjustment Rating Scale -- SRI Stress Reaction Inventory -- ITT Intention-to Treat -- PP Per-protocol -- CT Computed Tomography -- QSCC Questionnaire for the Sasang Constitution Classification; Obesity -- Euiiyin-tang -- Herbal medicine -- Weight reduction -- Clinical trial; Alternative medicine -- Periodicals; Complementary Therapies -- Periodicals; Médecines parallèles -- Périodiques; Thérapeutique -- Périodiques; Alternative medicine; Electronic journals; Periodicals; 615.5
• DOI: 10.1016/j.ctim.2020.102423
• Languages: English
• ISSNs: 0965-2299

Abstract

Highlights: This study was the first clinical trial to evaluate the efficacy and safety of Euiiyin-tang for the treatment of obesity. Administration of Euiiyin-tang had potential weight loss effects in obese women. In a multivariate analysis, only Euiiyin-tang increased the success rate of weight loss. 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