DOI QR코드

DOI QR Code

Effects of a Herbal Medicine, Yukgunja-Tang Extract Granule, on Functional Dyspepsia Patients by Sasang Constitution: Placebo-Controlled, Double-Blind, Randomized Trial

기능성 소화불량에 대한 육군자탕 엑스과립의 사상체질별 치료효과: 위약 대조, 이중 맹검, 무작위 시험

  • Jeon, Su-Hyeong (Dept. of Sasang Constitutional Medicine, College of Korean Medicine, Dong-eui Univ.) ;
  • Kim, Jong-Won (Dept. of Sasang Constitutional Medicine, College of Korean Medicine, Dong-eui Univ.)
  • 전수형 (동의대학교 한의과대학 사상체질과) ;
  • 김종원 (동의대학교 한의과대학 사상체질과)
  • Received : 2018.05.28
  • Accepted : 2018.06.22
  • Published : 2018.06.30

Abstract

Objectives This study was aimed to compare effects of Yukgunja-tang (YGJT) extract granule on functional dyspepsia (FD) by sasang constitution. Methods A placebo-controlled, double-blind, randomized, two-center trial was performed. We obtained 3D face images of FD patients participating in this study using face-only scanner and classified them into two types as narrow face and wide face by 3D facial shape diagnosis system (3-FSDS). 96 subjects (48 subjects per type) were enrolled and were randomly allocated into treatment or control groups in a 2:1 ratio. YGJT extract granule or placebo were administered to each group during the 8 week treatment period. One of sasang constitutional specialist diagnosed their constitutions by referring to questionnaires and 3D face images. The primary outcome was total dyspepsia symptom scale (TDS scale), the secondary outcomes were single dyspepsia symptom scale (SDS scale), visual analog scale (VAS) and so on. This trial was registered with clinical research information service identifier: KCT0001920, 15 May, 2016. Results In the Taeeumin treatment group, the TDS scale was significantly decreased after 8 weeks compared to the control group (t=2.331, p=0.025) and the SDS scale also significantly decreased. (t=2.042, p=0.048). The specific effects of the YGJT extract granule without the placebo effect on the Taeeumin with functional dyspepsia were 30.61% in TDS scale and 28.33% in SDS scale. Conclusions The effects of Yukgunja-tang extract granule on functional dyspepsia was different according to Sasang constitution. So the constitution should be considered in randomized controlled trials using herbal extract granules.

Acknowledgement

Supported by : 한국보건산업진흥원

References

  1. Shin CM, Huh KC. Dagnosis and treatment of functional dyspepsia. J Korean Med Assoc. 2016;59(4):311-8.(Korean) https://doi.org/10.5124/jkma.2016.59.4.311
  2. Kim JR. Gastrointestinal disorders. Seoul: Ilchokak;2011.(Korean)
  3. Min BH, Huh KC, Jung HK, Yoon YH, Choi KD, Song KH, et al. Prevalence of uninvestigated dyspepsia and gastroesophageal reflux disease in Korea: a population-based study using the Rome III criteria. Dig Dis Sci. 2014;59(11):2721-9. https://doi.org/10.1007/s10620-014-3243-y
  4. Mahadeva S, Goh K. Epidemiology of functional dyspepsia. A global perspective. World J Gastroenterol. 2006;12(17):2661-6. https://doi.org/10.3748/wjg.v12.i17.2661
  5. Tack J, Talley NJ, Camilleri M, Holtmann G, Hu P, Malagelada JR, et al. Functional gastroduodenal disorders. Gastroenterology. 2006;130(5):1466-79. https://doi.org/10.1053/j.gastro.2005.11.059
  6. Park SK, Kim JS, Hong JH, Hong SS, Lim JH, Han SY, et al. An Evaluation & Clinical Report on Three cases of Functional Dyspepsia. J. Int. Korean Med. 2002;23(2):244-52.(Korean)
  7. Oh JH, Kim BS, Lim HY, Kim DW, Choi BH, Hur JI, et al. Three Cases Report of Functional Dyspepsia Patients Who were Administered by LJTG(Ljintang-Gamibang). J. Int. Korean Med. 2005;26(3):641-51. (Korean)
  8. Kang RY, Kim HJ, Han HJ, Park EY, Jang JA, Kim JW, et al. Two cases of the Gastric Dysmotility-like Dyspepsia in functional dyspepsia that were improved by Bojungiki-Tang. Herbal formula science. 2009;17(2):203-13.(Korean)
  9. Lee SY, Ban DJ, Bae HS, Park SS. A Case Study of Yul Gyuk Similarity in Soeumin Patient. J Sasang Constitut Med. 2009;21(1):263-9.(Korean)
  10. Kim SJ, Lee JH, Ko SJ, Pack JW. Clinical Case Report of Functional Dyspepsia with Gyejibanhasaenggangtang, Acupuncture, and Moxibustion. J. Int. Korean Med. 2016;37(2):406-11.(Korean)
  11. Yoon SH, Ryu BH, Ryu KW, Kim JS. Evaluation for Therapeutic Effectiveness of Banwhasashim-tang in Functional Dyspepsia. J. Int. Korean Med. 2003;24(2):329-36.(Korean)
  12. Park JW, Ko SJ, Han GJ,1 Yeo IK Ryu BH, Kim JS. The Effects of Banha-sasim-tang on Dyspeptic Symptoms and Gastric Motility in Cases of Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled, and Two-Center Trial. eCAM 2013, 265035.
  13. Xiao Y, Liu YY, Yu KQ, et al. Chinese herbal medicine liu jun zi tang and xiang sha liu jun zi tang for functional dyspepsia: meta-analysis of randomized controlled trials. eCAM 2012, 936459.
  14. Zhao L, Gan AP. Clinical and Psychological Assessment on Xinwei Decoction for Treating Functional Dyspepsia Accompanied with Depression and Anxiety. Am. J. Chin. Med. 2005;33(2),249-57. https://doi.org/10.1142/S0192415X05002801
  15. Zhang S, Zhao L, Wang H, Wang C, Huang S, Shen H, et al. Efficacy of modified LiuJunZi decoction on functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: a randomized controlled trial. BMC Complement Altern Med. 2013, 13:54. https://doi.org/10.1186/1472-6882-13-54
  16. Oikawa t, Ito G, Hoshino T, Koyama H, Hanawa T. Hangekobokuto (Banxia-huopo-tang), a Kampo Medicine that Treats Functional Dyspepsia. eCAM 2009;6(3):375-8.
  17. Kusunoki H, Haruma K, Hata J, Ishii M, Kamada T, Yamashita N, et al. Efficacy of Rikkunshito, a traditional Japanese medicine(Kampo), in treating functional dyspepsia. Intern Med. 2010;49(20):2195-202. https://doi.org/10.2169/internalmedicine.49.3803
  18. Shiratori M, Shoji T, Kanazawa M, Hongo M, Fukudo S. Effect of rikkunshito on gastric sensorimotor function under distention. Neurogastroenterol Motil. 2011;23(4):323-9. https://doi.org/10.1111/j.1365-2982.2010.01648.x
  19. Tatsuta M, Iishi H. Effect of treatment with Lui-Jun-Zi-Tang (TJ-43) on gastric emptying and gastrointestinal symptoms in dyspeptic patients. Aliment Pharmacol Ther. 1993;7:459-62.
  20. Kawahara H, Mitani Y, Nomura M, Nose K, Yoneda A, Hasegawa T, et al. Impact of rikkunshito, an herbal medicine, on delayed gastric emptying in profoundly handicapped patients. Pediatr Surg Int. 2009;25(11):987-90. https://doi.org/10.1007/s00383-009-2453-4
  21. Yagi M, Homma S, Kubota M, Iinuma Y, Kanada S, Kinoshita Y, et al. The herbal medicine Rikkunshi-to stimulates and coordinates the gastric myoelectric activity in post-operative dyspeptic children after gastrointestinal surgery. Pediatr Surg Int. 2004;19(12):760-5. https://doi.org/10.1007/s00383-003-1053-y
  22. Hayakawa T, Arakawa T, Kase Y, Akiyama S, Ishige A, Takeda S, et al. Liu-Jun-Zi-Tang, a kampo medicine, promotes adaptive relaxation in isolated guinea pig stomachs. Drugs Exp Clin Res. 1999;25:211-8.
  23. Kido T, Nakai Y, Kase Y, Sakakibara I, Nomura M, Takeda S, et al. Effects of rikkunshi-to, a traditional Japanese medicine, on the delay of gastric emptying induced by N(G)-nitro-L-arginine. J Pharmacol Sci. 2005;98:161-7. https://doi.org/10.1254/jphs.FPJ04056X
  24. Tominaga K, Kido T, Ochi M, Sadakane C, Mase A, Okazaki H, et al. The traditional Japanese medicine rikkunshito promotes gastric emptying via the antagonistic action of the 5-HT3 receptor pathway in rats. eCAM 2011, 248481.
  25. Kito Y, Suzuki H. Properties of Rikkunshi-to (TJ-43)-induced relaxation of rat gastric fundus smooth muscles. Am J Physiol Gastrointest Liver Physiol. 2010;298(5):755-63. https://doi.org/10.1152/ajpgi.00333.2009
  26. Saegusa Y, Hattori T, Nahata M et al. A New Strategy Using Rikkunshito to Treat Anorexia and Gastrointestinal Dysfunction. eCAM 2015, 364260.
  27. Togawa K, Matsuzaki J, Kobayakawa M, Fukushima Y, Suzaki F, Kasugai K, et al. Association of baseline plasma des-acyl ghrelin level with the response to rikkunshito in patients with functional dyspepsia. J Gastroenterol Hepatol. 2016;31(2):334-41. https://doi.org/10.1111/jgh.13074
  28. Suzuki H. Matsuzaki J, Fukushima Y, Suzaki F, Kasugai K, Nishizawa T, et al. Randomized clinical trial: rikkunshito in the treatment of functional dyspepsia-a multicenter, double-blind, randomized, placebo-controlled study. Neurogastroenterol Motil. 2014;26:950-961. https://doi.org/10.1111/nmo.12348
  29. Kim JY, Park JW, Ko SJ, Jeon SH, Kim JW, Yeo IK, et al. Effects of a Herbal Medicine, Yukgunja-Tang, on Functional Dyspepsia Patients Classified by 3-Dimensional Facial Measurement: A Study Protocol for Placebo-Controlled, Double-Blind, Randomized Trial. eCAM 2017, 2894507.
  30. Kim GC, Lee JW, Kim H, Shin SS, Lee HW, Lee YT et al. Basic Study on the Image Instrument of the Facial-form by the 3D-facial Scanner. Korean J Oriental Physiology & Pathology. 2008;22(2):497-501. (Korean)
  31. Na YJ, Kang SH, Kim JW, Jeon SH. A Study on the Response Differences to the Sasang Constitution Questionnaire by Sasang Constitutions in Adult Women with Menstrual Pain. J Sasang Constitut Med. 2016;28(4):330-337.(Korean) https://doi.org/10.7730/JSCM.2016.28.4.330
  32. Jeong JH, Jeon SH, Na, YJ, Kang SH, Dong SO, Lee SW, el al. A Study about a Short-form of the Sasang Constitution Questionnaire for Patient(SSCQ-P). J of Sasang Constitut Med, 2017;26(4):339-349. (Korean) https://doi.org/10.7730/JSCM.2014.26.4.339
  33. Jang ES, Beak YH, Park KH, Yoo JH, Jin HJ, Lee SW. Development and Validation of Brief KS-15 (Korea Sasang Constitutional Diagnostic Questionnaire) Based on Body Shape, Temperament and Symptoms. J of Sasang Constitut Med. 2015;27(2):211-221. (Korean) https://doi.org/10.7730/JSCM.2015.27.2.211
  34. Zhao L, Zhang S, Wang Z, Wang C, Huang S, Shen H, el al. Efficacy of Modified Ban Xia Xie Xin Decoction on Functional Dyspepsia of Cold and Heat in Complexity Syndrome: A Randomized Controlled Trial. eCAM 2013, 812143.
  35. Claudia M. Witt, Klaus Nilde. Clinical Research in Complementary and Integrative Medicine. 1st edition, Seoul: translated by Elsevier Korea LLC, 2013: 13-17.
  36. Huh Joon. Donguibogam. Hadong: Donguibogam Publisher. 2006: 72, 218.(Korean)