Euiiyin-tang in the treatment of obesity: study protocol for a randomised controlled trial

Chunhoo Cheon, Soobin Jang, Jeong-Su Park, Youme Ko, Doh Sun Kim, Byung Hoon Lee, Hyun Jong Song, Yun-Kyung Song, Bo-Hyoung Jang, Yong-Cheol Shin, Seong-Gyu Ko, Chunhoo Cheon, Soobin Jang, Jeong-Su Park, Youme Ko, Doh Sun Kim, Byung Hoon Lee, Hyun Jong Song, Yun-Kyung Song, Bo-Hyoung Jang, Yong-Cheol Shin, Seong-Gyu Ko

Abstract

Background: Obesity is a public health concern in many countries due to its increasing prevalence. Euiiyin-tang is an herbal medicine formula often used as a clinical treatment for obesity. It acts to eliminate humidity and purify the blood, the causes of obesity identified by the theoretical framework of Korean medicine. The purpose of this study is to evaluate the efficacy and safety of Euiiyin-tang in treating obesity.

Methods/design: This study is a randomised, double-blinded and placebo-controlled, multicentre trial. It has two parallel arms: the Euiiyin-tang group and the placebo group. A total of 160 obese adult women will be enrolled in the trial. The participants will be randomly divided at a 1:1 ratio at visit 2 (baseline). The participants will be administered Euiiyin-tang or placebo for 12 weeks. The primary endpoint is the change in weight occurring between baseline and post-treatment. The secondary outcomes include average weight reduction, changes in body fat, waist and hip circumferences, body mass index, and lipid profile, and the results of questionnaires such as the Korean version of Obesity-related Quality of Life, the Korean version of Eating Attitudes Test, the Social Readjustment Rating Scale, and the Stress Reaction Inventory.

Discussion: The present study will provide research methodologies for evaluating the efficacy and safety of Euiiyin-tang in patients with obesity. In addition, it will provide evidence of correlation between obesity and Sasang constitutional medicine.

Trial registration: ClinicalTrials.gov, NCT01724099 . Registered on 2 November 2012.

Keywords: Euiiyin-tang; Herbal medicines; Obesity; Randomised controlled trial; Sasang constitution.

Figures

Fig. 1
Fig. 1
Flow chart of the Euiiyin-tang clinical trial
Fig. 2
Fig. 2
SPIRIT schedule for the trial

References

    1. Asia Pacific Cohort Studies Collaboration The burden of overweight and obesity in the Asia-Pacific region. Obes Rev. 2007;8(3):191–6. doi: 10.1111/j.1467-789X.2006.00292.x.
    1. Kim DM, Ahn CW, Nam SY. Prevalence of obesity in Korea. Obes Rev. 2005;6:117–21. doi: 10.1111/j.1467-789X.2005.00173.x.
    1. Oh SW. Obesity and metabolic syndrome in Korea. Diabetes Metab J. 2011;35(6):561–6. doi: 10.4093/dmj.2011.35.6.561.
    1. Bray GA. Obesity: the disease. J Med Chem. 2006;49(14):4001–07. doi: 10.1021/jm0680124.
    1. Kang JH, Jeong BG, Cho YG, Song HR, Kim KA. Socioeconomic costs of overweight and obesity in Korean adults. J Korean Med Sci. 2011;26(12):1533–40. doi: 10.3346/jkms.2011.26.12.1533.
    1. Rodgers RJ, Tschop MH, Wilding JP. Anti-obesity drugs: past, present and future. Dis Model Mech. 2012;5(5):621–6. doi: 10.1242/dmm.009621.
    1. Hong S-Y, Lim H-H, Lee T-H. Effect of Coicis Semen on starvation stress in mice. J Korean Med. 2003;24(3):23–34.
    1. Lee Y-JS, Young-Jong, Lee E-S, Park J-S, Kim S-K. Effects of Coicis Semen on the hyperlipidemia in rat. Korea J Herbology. 2004;19(3):129–36.
    1. Lee Y-J, Sohn Y-J, Lim D-B, Lee E-S, Park J-S, Kim S-K. Original articles: effects of coicis semen on the hyperlipidemia induced by fructose-rich chow in rat. Korea J Herbology. 2005;20(1):85–92.
    1. Lee Y-J, Lee M-J. The efficiency of Ephedrae Herba on the obese Zucker rat's lipid of blood serum and fatty acid metabolism of skeletal muscles. J Oriental Rehabilitation Med. 2005;15(3):99–111.
    1. Park J-M, Kim H-J, Kim J-A, Kim S-J, Ko B-P. The effects of evodia rutaecarpa and ephedra sinica on the resting metabolic rate and body composition of obese women on a low-calorie diet: a double-blinded randomized controlled clinical trial. J Korean Med. 2005;26(3):249–62.
    1. Park J-C, Song Y-K, Lim H-H. Effect of atractylodis macrocephalae rhizoma on starvation stress in mice. J Korean Med. 2004;25(3):55–66.
    1. Korean Pharmaceutical Association . Explanation on Herbal Medicine and Medication Counselling. Seoul: Korean Pharmaceutical Association; 2006.
    1. Fǔzhòng H. Displays of Enlightened Physicians (Míng Yī Zhǐ Zhǎng). China: People's Medical Publishing House; 1982.
    1. Heo J. Treasured Mirror of Eastern Medicine (Dongeuibogam). Korea: Bubin Publishers Co; 2007.
    1. Baek Y, Park K, Lee S, Jang E. The prevalence of general and abdominal obesity according to sasang constitution in Korea. BMC Complement Altern Med. 2014;14:298. doi: 10.1186/1472-6882-14-298.
    1. Kim JY, Pham DD. Sasang constitutional medicine as a holistic tailored medicine. Evid Based Complement Alternat Med. 2009;6(Suppl 1):11–9. doi: 10.1093/ecam/nep100.
    1. Lee J-M. The manuscripts left by Dong-Mu. Seoul: Cheonggye; 1999.
    1. Kim SH, Ko B-H, Song I-B. A study on the standardization of QSCCII (Questionnaire for the Sasang Constitution Classification II) J Korean Med. 1996;17(2):337–93.
    1. Kim S-H, Lee Y, Koh B-H, Jang E. Assessing the diagnostic accuracy of the Questionnaire for Sasang Constitutional Classification II (QSCC II): a systematic review. Eur J Integrative Med. 2013;5(5):393–98. doi: 10.1016/j.eujim.2013.05.003.
    1. Shirin H-R, Neda N, Bagher L, Mohammad A. A systematic review of the efficacy and safety of herbal medicines used in the treatment of obesity. World J Gastroenterol. 2009;15(25):3073–85. doi: 10.3748/wjg.15.3073.
    1. Park K-M, Lim H-H, Song Y-K. Anti-inflammation and anti-obesity effects of Euiiin-tang granules on high fat diet-induced obese C57BL/6 J mice. J Oriental Rehabilitation Med. 2012;22(2):47–66.
    1. Heymsfield SB, Allison DB, Vasselli JR, Pietrobelli A, Greenfield D, Nunez C. Garcinia cambogia (hydroxycitric acid) as a potential antiobesity agent: a randomized controlled trial. JAMA. 1998;280(18):1596–600. doi: 10.1001/jama.280.18.1596.
    1. David M, Campbell MJ, Say Beng T, Tan SH. Sample size tables for clinical studies. Chichester: John Wiley & Sons; 2011.
    1. Chae KH, Won CW, Choi H, Kim BS. Obesity indices and obesity-related quality of life in adults 65 years and older. Korean J Family Med. 2010;31(7):540–46. doi: 10.4082/kjfm.2010.31.7.540.
    1. Rhee M-K, Lee Y-H, Park S-H, et al. A standardization study of the Korean Version of Eating Attitudes Test-26 I: reliability and factor analysis. Korean J Psychosomatic Med. 1998;6(2):155–75.
    1. Holmes T, Rahe R. The Social Readjustment Rating Scale. J Psychosomatic Research. 1967;11:213–21. doi: 10.1016/0022-3999(67)90010-4.
    1. Koh KB, Park J-K, Kim CH. Development of the Stress Response Inventory. J Korean Neuropsychiatr Assoc. 2000;39(4):707–19.
    1. Backholer K, Walls HL, Magliano DJ, Peeters A. Setting population targets for measuring successful obesity prevention. Am J Public Health. 2010;100(11):2033–7. doi: 10.2105/AJPH.2010.200337.
    1. Wang SS, Brownell KD. Public policy and obesity: the need to marry science with advocacy. Psychiatric Clinics of North America. 2005;28(1):235–52. doi: 10.1016/j.psc.2004.09.001.
    1. Park S, Nahmkoong W, Cheon C, et al. Efficacy and safety of Taeeumjowi-tang in obese Korean adults: a double-blind, randomized, and placebo-controlled pilot trial. Evid Based Complement Alternat Med. 2013;2013:498935.
    1. Auvichayapat P, Prapochanung M, Tunkamnerdthai O, et al. Effectiveness of green tea on weight reduction in obese Thais: a randomized, controlled trial. Physiol Behav. 2008;93(3):486–91. doi: 10.1016/j.physbeh.2007.10.009.
    1. Ryu S-M, Song M-Y, Chung S-H. The effect of very low calorie diet with Chegamuiyiin-tang (Tljianylylren-tang) on body composition and size in obese women. J Oriental Rehabilitation Med. 2006;16(4):1–14.
    1. Park S, Park JS, Cheon C, et al. A pilot study to evaluate the effect of Taeumjowi-tang on obesity in Korean adults: study protocol for a randomised, double-blind, placebo-controlled, multicentre trial. Trials. 2012;13:33. doi: 10.1186/1745-6215-13-33.

Source: PubMed

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