Journal of Korean Medicine for Obesity Research (한방비만학회지)

The Society of Korean Medicine for obesity Research (한방비만학회)
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The Anti-obesity Effects of Bangpungtongseong-san and Daesiho-tang: A Study Protocol of Randomized, Double-blinded Clinical Trial

방풍통성산 및 대시호탕의 항비만효과 분석: 단일기관 무작위배정 이중맹검 임상시험 프로토콜

  • Oh, Jihong (Department of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Dongguk University) ;
  • Shim, Hyeyoon (Department of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Dongguk University) ;
  • Cha, Jiyun (Clinical Medicine Division, Korea Institute of Oriental Medicine) ;
  • Kim, Ho Seok (Clinical Medicine Division, Korea Institute of Oriental Medicine) ;
  • Kim, Min Ji (Clinical Medicine Division, Korea Institute of Oriental Medicine) ;
  • Ahn, Eun Kyung (Clinical Medicine Division, Korea Institute of Oriental Medicine) ;
  • Lee, Myeong-Jong (Department of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Dongguk University) ;
  • Lee, Jun-Hwan (Clinical Medicine Division, Korea Institute of Oriental Medicine) ;
  • Kim, Hojun (Department of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Dongguk University)
  • 오지홍 (동국대학교 한의과대학 한방재활의학교실) ;
  • 심혜윤 (동국대학교 한의과대학 한방재활의학교실) ;
  • 차지윤 (한국한의학연구원 임상의학부) ;
  • 김호석 (한국한의학연구원 임상의학부) ;
  • 김민지 (한국한의학연구원 임상의학부) ;
  • 안은경 (한국한의학연구원 임상의학부) ;
  • 이명종 (동국대학교 한의과대학 한방재활의학교실) ;
  • 이준환 (한국한의학연구원 임상의학부) ;
  • 김호준 (동국대학교 한의과대학 한방재활의학교실)
  • Received : 2020.11.04
  • Accepted : 2020.12.01
  • Published : 2020.12.30
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Abstract

Objectives: The aim of this study is to evaluate the effects of Bangpungtongseong-san (Fangfengtongsheng-san, BTS) and Daesiho-tang (Dachaihu-tang, DST) on weight loss and improvement in lipid metabolism and glucose metabolism. Furthermore, we intend to develop a prediction model for drug effects through the analysis of the single nucleotide polymorphism (SNP), gut-microbiota, and the expression of immune-related biomarkers. Methods: This study is a single-center, randomized, double-blind, parallel-design clinical trial. One hundred twenty-eight participants will be assigned to the BTS group (n=64) and DST group (n=64). Both groups will be administered 4 g medication three times a day for up to 2 weeks. The primary outcomes is weight loss. The secondary outcomes include bioelectrical impedance analysis, waist circumstance, body mass index, total cholesterol, high-density lipoprotein, triglyceride, insulin resistance. The exploratory outcomes include 3-day dietary recall, food frequency questionnaire, quality of life questionnaire, gut microbiota analysis, immune biomarkers analysis, and SNP analysis. Assessment will be made at baseline and at week 4, 8, and 12. Conclusions: This protocol will be implemented by approval of the Institutional Review Board of Dongguk University. The results of this trial will provide a systematic evidence for the treatment of obesity and enable more precise herbal medicine prescriptions.

Keywords

References

  1. Hruby A, Hu FB. The epidemiology of obesity: a big picture. Pharmacoeconomics. 2015 ; 33(7) : 673-89. https://doi.org/10.1007/s40273-014-0243-x
  2. Zhao L. The gut microbiota and obesity: from correlation to causality. Nat Rev Microbiol. 2013 ; 11(9) : 639-47. https://doi.org/10.1038/nrmicro3089
  3. Koeppen-Schomerus G, Wardle J, Plomin R. A genetic analysis of weight and overweight in 4-year-old twin pairs. Int J Obes Relat Metab Disord. 2001 ; 25(6) : 838-44. https://doi.org/10.1038/sj.ijo.0801589
  4. de Heredia FP, Gomez-Martinez S, Marcos A. Obesity, inflammation and the immune system. Proc Nutr Soc. 2012 ; 71(2) : 332- 8. https://doi.org/10.1017/S0029665112000092
  5. Organization for Economic Cooperation and Development (OECD). OECD health statistics 2020 [Internet]. Paris : OECD; 2020 [cited 2020 Oct 30]. Available from: https://www.oecd.org/health/health-data.htm.
  6. Kim SJ, Cho KW, Oh CS, Lee SM. Gender Differences in Obesity-related Socioeconomic Costs. J Health Info Stat. 2020 ; 45(2) : 181-190. https://doi.org/10.21032/jhis.2020.45.2.181
  7. Tanaka K, Nakanishi T. Obesity as a risk factor for various diseases: necessity of lifestyle changes for healthy aging. Appl Human Sci. 1996 ; 15(4) : 139-48. https://doi.org/10.2114/jpa.15.139
  8. Cowburn G, Hillsdon M, Hankey CR. Obesity management by life-style strategies. Br Med Bull. 1997 ; 53(2) : 389-408. https://doi.org/10.1093/oxfordjournals.bmb.a011619
  9. Kim MK, Lee WY, Kang JH, Kang JH, Kim BT, Kim SM, et al. 2014 clinical practice guidelines for overweight and obesity in Korea. Endocrinol Metab (Seoul). 2014 ; 29(4) : 405- 9. https://doi.org/10.3803/EnM.2014.29.4.405
  10. Seo MH, Lee WY, Kim SS, Kang JH, Kang JH, Kim KK, et al. 2018 Korean Society for the Study of Obesity Guideline for the management of obesity in Korea. J Obes Metab Syndr. 2019 ; 28(1) : 40-5. https://doi.org/10.7570/jomes.2019.28.1.40
  11. Nguyen NT, Varela JE. Bariatric surgery for obesity and metabolic disorders: state of the art. Nat Rev Gastroenterol Hepatol. 2017 ; 14(3) : 160-9. https://doi.org/10.1038/nrgastro.2016.170
  12. Kim MK, Kim CS. Recent advances in anti-obesity agents. The Korean Journal of Medicine. 2018 ; 93(6) : 501-8. https://doi.org/10.3904/kjm.2018.93.6.501
  13. Yanovski SZ, Yanovski JA. Long-term drug treatment for obesity: a systematic and clinical review. JAMA. 2014 ; 311(1) : 74-86. https://doi.org/10.1001/jama.2013.281361
  14. Severin R, Sabbahi A, Mahmoud AM, Arena R, Phillips SA. Precision medicine in weight loss and healthy living. Prog Cardiovasc Dis. 2019 ; 62(1) : 15- 20. https://doi.org/10.1016/j.pcad.2018.12.012
  15. Yanovski SZ, Yanovski JA. Toward precision approaches for the prevention and treatment of obesity. JAMA. 2018 ; 319(3) : 223-4. https://doi.org/10.1001/jama.2017.20051
  16. Kashyap PC, Chia N, Nelson H, Segal E, Elinav E. Microbiome at the frontier of personalized medicine. Mayo Clin Proc. 2017 ; 92(12) : 1855-64. https://doi.org/10.1016/j.mayocp.2017.10.004
  17. Xu L, Zhao W, Wang D, Ma X. Chinese medicine in the battle against obesity and metabolic diseases. Front Physiol. 2018 ; 9 : 850. https://doi.org/10.3389/fphys.2018.00850
  18. Sui Y, Zhao HL, Wong VC, Brown N, Li XL, Kwan AK, et al. A systematic review on use of Chinese medicine and acupuncture for treatment of obesity. Obes Rev. 2012 ; 13(5) : 409- 30. https://doi.org/10.1111/j.1467-789X.2011.00979.x
  19. Hasani-Ranjbar S, Nayebi N, Larijani B, Abdollahi M. 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. https://doi.org/10.3748/wjg.15.3073
  20. Han KS, Lee MJ, Kim H. Systematic review on herbal treatment for obesity in adults. Journal of Korean Medicine Rehabilitation. 2016 ; 26(4) : 23-35. https://doi.org/10.18325/jkmr.2016.26.4.23
  21. Park WH, Cha YY, Song YK, Park TY, Kim HJ, Chung WS, et al. The review on the study of oriental obesity pattern identification: focused on Korean research papers. Journal of Korean Medicine Rehabilitation. 2014 ; 24(2) : 83-93.
  22. KIOM. Obesity Korean medicine clinical practice guideline. Seoul : Elsevier Korea. 2016 : 57-170.
  23. Park SA, Bang KS, Chang YN, Lee JH, Lee JH, Jin JS. A review on pharmacological properties of Bangpungtongsung-san in obesity. The Korean Medicine Society for the Herbal Formula Study. 2014 ; 22(2) : 25-34. https://doi.org/10.14374/HFS.2014.22.2.025
  24. Choi EM, Ryu EK. Effects of Bang-Pung-Tong-Seoung-San on obese patients. Journal of Korean Medicine for Obesity Research. 2001 ; 1(1) : 69-77.
  25. Hioki C, Yoshimoto K, Yoshida T. Efficacy of bofu-tsusho-san, an oriental herbal medicine, in obese Japanese women with impaired glucose tolerance. Clin Exp Pharmacol Physiol. 2004 ; 31(9) : 614-9. https://doi.org/10.1111/j.1440-1681.2004.04056.x
  26. Song MY, Kim EK, Kong JC, Lee JH, Shin BC, Kwon KB. Inhibitory effect of Daesiho-tang(Dachaihu-tang) extracts on high-fat diet-induced obesity. Journal of Korean Medicine Rehabilitation. 2008 ; 18(3) : 41-9.
  27. Park JH, Lee MJ, Kim HJ, Hong SW, Lee DK, Yoo JW, et al. Efficacy and adverse events of Bangpungtongseong-san (Bofutsusho-san) and Bangkihwangki-tang (Boiogiot-tang) by oriental obesity pattern identification on obese subjects: randomized, double blind, placebo-controlled trial. Journal of Korean Medicine Rehabilitation. 2011 ; 21(2) : 265-78.
  28. Han K, Kwon O, Park HJ, Jung SY, Yang C, Son CG. Effect of Daesiho-tang on obesity with non-alcoholic fatty liver disease: a study protocol for a randomised, double-blind, placebo-controlled pilot trial. Trials. 2020 ; 21(1) : 128. https://doi.org/10.1186/s13063-020-4068-y
  29. World Health Organization. Waist circumference and waist-hip ratio: report of a WHO expert consultation. Geneva : World Health Organization. 2011.
  30. Yang W, Kelly T, He J. Genetic epidemiology of obesity. Epidemiol Rev. 2007 ; 29 : 49-61. https://doi.org/10.1093/epirev/mxm004
  31. Song HO, Kim SS. A literature review of single nucleotide polymorphisms in obesity genes. Journal of Korean Medicine for Obesity Research. 2004 ; 4(1) : 139-60.
  32. Llewellyn CH, Trzaskowski M, Plomin R, Wardle J. Finding the missing heritability in pediatric obesity: the contribution of genome-wide complex trait analysis. Int J Obes (Lond). 2013 ; 37(11) : 1506-9. https://doi.org/10.1038/ijo.2013.30
  33. Yang J, Bakshi A, Zhu Z, Hemani G, Vinkhuyzen AA, Lee SH, et al. Genetic variance estimation with imputed variants finds negligible missing heritability for human height and body mass index. Nat Genet. 2015 ; 47(10) : 1114-20. https://doi.org/10.1038/ng.3390
  34. Park JH, Shambhunath B, Lim CY, Kim H. Impact of GNB3, ADRB3, UCP2, and PPARγ-Pro12Ala polymorphisms on Boiogito response in obese subjects: a randomized, double-blind, placebo-controlled trial. Journal of Korean Medicine for Obesity Research. 2012 ; 12(2) : 28-43.
  35. Crovesy L, Masterson D, Rosado EL. Profile of the gut microbiota of adults with obesity: a systematic review. Eur J Clin Nutr. 2020 ; 74(9) : 1251-62. https://doi.org/10.1038/s41430-020-0607-6
  36. Ley RE, Backhed F, Turnbaugh P, Lozupone CA, Knight RD, Gordon JI. Obesity alters gut microbial ecology. Proc Natl Acad Sci U S A. 2005 ; 102(31) : 11070-5. https://doi.org/10.1073/pnas.0504978102
  37. Meijnikman AS, Gerdes VE, Nieuwdorp M, Herrema H. Evaluating causality of gut microbiota in obesity and diabetes in humans. Endocr Rev. 2018 ; 39(2) : 133-53. https://doi.org/10.1210/er.2017-00192
  38. Pigeyre M, Yazdi FT, Kaur Y, Meyre D. Recent progress in genetics, epigenetics and metagenomics unveils the pathophysiology of human obesity. Clin Sci (Lond). 2016 ; 130(12) : 943-86. https://doi.org/10.1042/CS20160136
  39. Lu YM, Xie JJ, Peng CG, Wang BH, Wang KC, Li LJ. Enhancing clinical efficacy through the gut microbiota: a new field of traditional Chinese medicine. Engineering. 2019 ; 5(1) : 40-9. https://doi.org/10.1016/j.eng.2018.11.013
  40. Liu J, Yue S, Yang Z, Feng W, Meng X, Wang A, et al. Oral hydroxysafflor yellow A reduces obesity in mice by modulating the gut microbiota and serum metabolism. Pharmacol Res. 2018 ; 134 : 40-50. https://doi.org/10.1016/j.phrs.2018.05.012
  41. Hussain A, Yadav MK, Bose S, Wang JH, Lim D, Song YK, et al. Daesiho-tang is an effective herbal formulation in attenuation of obesity in mice through alteration of gene expression and modulation of intestinal microbiota. PLoS One. 2016 ; 11(11) : e0165483. https://doi.org/10.1371/journal.pone.0165483
  42. Fujisaka S, Usui I, Nawaz A, Igarashi Y, Okabe K, Furusawa Y, et al. Bofutsushosan improves gut barrier function with a bloom of Akkermansia muciniphila and improves glucose metabolism in mice with diet-induced obesity. Scientific Reports. 2020 ; 10(1) : 5544. https://doi.org/10.1038/s41598-020-62506-w
  43. Kern PA, Ranganathan S, Li C, Wood L, Ranganathan G. Adipose tissue tumor necrosis factor and interleukin-6 expression in human obesity and insulin resistance. Am J Physiol Endocrinol Metab. 2001 ; 280(5) : E745-51. https://doi.org/10.1152/ajpendo.2001.280.5.E745
  44. Liu Y, Sun M, Yao H, Liu Y, Gao R. Herbal medicine for the treatment of obesity: an overview of scientific evidence from 2007 to 2017. Evid Based Complement Alternat Med. 2017 ; 2017 : 8943059.