Effect of Herb Medicine Treatment for Functional Dyspepsia: A Randomized Placebo-Controlled and Compared Standard Treatment Trial

기능성 소화불량증 환자에 대한 한약복합제의 치료 효과: 무작위배정 표준치료제 위약 대조군 연구

  • Kim, Yeon-Mi (Dept. of Acupuncture and Moxibustion, College of Oriental Medicine, Daejeon University) ;
  • Park, Yang-Chun (Dept. of Internal Medicine, College of Oriental Medicine, Daejeon University) ;
  • Jo, Jeong-Hyo (Dept. of Internal Medicine, College of Oriental Medicine, Daejeon University) ;
  • Kang, Wee-Chang (Dept. of Applicative Statistics, College of Economics, Daejeon University) ;
  • Son, Mi-Won (Dong-A Pharm. co., LTD.) ;
  • Hong, Kwon-Eui (Dept. of Acupuncture and Moxibustion, College of Oriental Medicine, Daejeon University)
  • 김연미 (대전대학교 한의과대학 침구학교실) ;
  • 박양춘 (대전대학교 한의과대학 내과학교실) ;
  • 조정효 (대전대학교 한의과대학 내과학교실) ;
  • 강위창 (대전대학교 경영대학 응용통계학) ;
  • 손미원 (동아제약) ;
  • 홍권의 (대전대학교 한의과대학 침구학교실)
  • Received : 2009.01.07
  • Accepted : 2009.09.10
  • Published : 2010.01.30

Abstract

Objective: Functional dyspepsia is a prevalent disease. It impedes subjective quality of life. The purpose of this study was to examine the equivalent effect of herb medicine treatment (DA-9701) for functional dyspepsia. Methods: In this randomized, single-blinded, placebo-controlled study, we compared a herb medicine (DA-9701) with standard treatment (mosapride) and placebo for the treatment of functional dyspepsia. 42 volunteers who satisfied the requirements were enrolled in study. Severity of dyspepsia was measured by Nepean Dyspepsia Index (NDI) and Functional Dyspepsia Quality of Life (FD-QOL) before and after treatments. Results: 1. In the DA-9701 group, total key symptoms score was significantly lower and improve rate of key symptoms was higher than in the mosapride and placebo groups, but there were no statistically significant differences between three groups. 2. In the DA-9701 and mosapride groups, "nausea" and "bad breath" were significantly lower compared with the placebo group. 3. In the DA-9701 group, NDI Quality of Life scores were significantly higher, but there were no [other] statistically significant differences between the three groups. 4. In the DA-9701 and mosapride groups, FD-QOL scores were higher compared with the placebo group, but there were no statistically significant differences between the three groups. Conclusion: Herb medicine treatment (DA-9701) is effective to improve the symptoms and quality of life in patients with functional dyspepsia.

Keywords

References

  1. 박영태. 소화불량증의 정의 및 진단적 접근: 대한소화관운동학회. 기능성 소화불량증. 서울: 진기획. 2006:13-29.
  2. Talley NJ, Stanghellini V, Heading RC, KochKL, Malagelada JR, Tytgat GN. Functional gastroduodenal disorders. Gut. 1999;45(Suppl II):37-42.
  3. Huh C, Yang CH, Jang JG, Lee DH, Lee KL, Seol SY, et al. Functional Dyspepsia and Subgroups in Korea and Short Term Outcome of Therapeutic Trial of Cisapride ; Multicenter Study. Korean J Neurogastroenterol Motil. 1998; 4(1):1-12.
  4. 최명규. 기능성 소화불량증의 정의 및 역학. 대한 소화관운동학회 학술집담회. 2000;6:235-40.
  5. Rhie SY, Choi CH, Lee HW, Do MY, Lee SH, Han SP, et al. The Frequency of Functional Dyspepsia Subtypes and its Related Factors for Health Check up Subjects. Korean J Neurogastroenterol Motil. 2007;13:31-7.
  6. Jeon WH, Park JW, Kim JS, Hong JH, Hong SS, Park SK, et al. Oriental Medical Treatment Can Improve Quality of Life in Patients with Functional Dyspepsia. Korean J Orient Int Med. 2001;22(3):361-6.
  7. Lee KJ. Pathophysiology and Treatment of Functional Dyspepsia. Korean J Neurogastroenterol Motil. 2003;9:85-91.
  8. 전국한의과대학 비계내과학교수. 비계내과학. 서울: 도서출판동우. 2000:51-62, 65-74, 83-8,154-9.
  9. Paakkari I. Cardiotoxicity of new antihistamines and cisapride. Toxicol Lett. 2002;127:279-84. https://doi.org/10.1016/S0378-4274(01)00510-0
  10. Ji SW, Park HJ, Lee PR, Lee OY, Kim DK. Effects of Mosapride on Upper Gastrointestinal Symptoms and Gastric Emptying in Patients with Functional Dyspepsia. Korean J Neurogastroenterol Motil. 2004;10(1):27-34.
  11. Han YS, Chang YW, Chang R. A Randomized Study to Compare Domperidone Maleate with Itopride Hydrochloride in Dysmotility-type Functional Dyspepsia. Korean J Gastroenterol. 2003;41:284-9.
  12. Kim JY, Lee JY, Yoon SH. Effect of Naesowhajung- tang on Electrogastrography in children with functional dyspepsia. J Korean Orient Pediatrics. 2002;16(2):199-213.
  13. Yoon SH, Ryu BH, Ryu KW, Kim JS. Evaluation for Therapeutic Effectiveness of Banwhasashimtang in Functional Dyspepsia. Korean J Orient Int Med. 2003;24(2):329-36.
  14. 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). Korean J Orient Int Med. 2005;26(3):641-51.
  15. Won JM, Yoon SH, Kim JS, Ryu BH. Effect of Yukgunjatang Granule on Gastric Emptying in Rats. Korean J Orient Int Med. 2007;28(2):242-9.
  16. Kim JS, Yoon SH. Effect of Naeso-san on Gastric Motility between Normal Intact and Antral Dilatated Rats. Korean J Orient Int Med. 2008; 29(1):117-29.
  17. Nam HI, Kim HY, Son HS, Lim SW. Effect of Jungjungamiyjintang(JGT) on Gastric Emptying of Spregue-Dawley rat. Korean J Orient Int Med. 2007;28(2):209-16.
  18. Cho YK, Choi MG, Kim SH, Lee IS, Kim SW, Chung IS, et al. The Effect of Mosapride on Quality of Life in Functional Dyspepsia. Korean J Gastroenterol. 2004;43(3):160-7.
  19. Lee JH, Kim HY, Rho SH, Yoon DH, Kim KH, Choi JH, et al. Dyspepsia in Korean Population Who Needs Endoscopy? Korean J Gastrointest Endosc. 2001;22(1):1-7.
  20. Kim JS, Lee KJ, Kim JH, Hahm KB, Cho SW. Functional Gastrointestinal Disorders in Patients Referred to Specialist Gastroenterologists in a Tertiary Hospital. Korean J Neurogastroenterol Motil. 2004;10(2):111-7.
  21. Jones RH, Lydeard SE, Hobbs FD. Dyspepsia in England and Scotland. Gut. 1990;31:401-5. https://doi.org/10.1136/gut.31.4.401
  22. Agreus L, Svardsudd K, Nyren O, Tibblin G. Irritable bowel syndrome and dyspepsia in the general population: overlap and lack of stability over time. Gastroenterology. 1995;109:671-80. https://doi.org/10.1016/0016-5085(95)90373-9
  23. Kim DJ. Irregular, quick meal is associated with non-ulcer dyspepsia. J Korean Acad Fam Med. 1999;20(2):176-85.
  24. 이광재. 기능성 소화불량증의 치료 가이드라인. 대한소화관운동학회지. 2005;11(3):25-9.
  25. 고경봉. 기능성 소화불량증의 정신사회학적 측면. 대한소화관운동학회지. 2000;6(2):258-66.
  26. 전국한의과대학 본초학교수. 본초학. 서울: 영림사. 2000:252-4, 413-4, 453-4.
  27. 식품의약품안전청편집부. 대한약전 제8개정 의약품각조 제2부. 서울: 식품의약품안전청. 2002:1230-1, 1239, 1565.
  28. 지형준, 이상인. 대한약전 및 대한약전 외 한약규격 주해. 서울: 한국메디칼인덱스사. 1988:79-80, 664-5.
  29. Ruth M, Hamelin B, Rohss K, Lundell L. The effect of mosapride, a novel prokinetic, on acid reflux variables in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 1998; 12:35-40. https://doi.org/10.1046/j.1365-2036.1998.00268.x
  30. Taniyama K, Makimoto N, Furuichi A, Sakurai- Yamashita Y, Nagase Y, Kaibara M, et al. Functions of peripheral 5-hydroxytryptamine receptors, especially 5-hydroxytryptamine4 receptor, in gastrointestinal motility. J Gastroenterol. 2000; 35(8):575-82. https://doi.org/10.1007/s005350070056
  31. Bond EF, Heitkemper MM, Bailey SL. Estrogen suppresses gastric motility response to thyrotropinreleasing to hormone and stress in awake rats. Res Nurs Health. 1998;21(3):221-8. https://doi.org/10.1002/(SICI)1098-240X(199806)21:3<221::AID-NUR5>3.0.CO;2-J
  32. Heitkemper MM, Bond EF. Gastric motility in rats with varying ovarian hormone status. Res Nurs Health. 1995;17(1):9-19.
  33. 신현규. 한약제제등의 임상시험가이드라인 제정 연구(II). 서울: 식품의약품안정청연구결과보고서. 2005:135-44.
  34. Park YC, Jo JH, Son CG, Hong KE, Jeong IC, Kang WC, et al. Effect of Acupuncture Treatment for Functional Dyspepsia: A Randomized Controlled Trial. The Journal of Korean Acupuncture and Moxibustion Society. 2007;24(1):1-12.
  35. Talley NJ, Haque M, Wyeth JW, Stace NH, Tytgat GN, Stanghellini V, et al. Development of a new dyspepsia impact scale: the Nepean Dyspepsia Index. Aliment Pharmacol Ther. 1999;13(2):225-35. https://doi.org/10.1046/j.1365-2036.1999.00445.x
  36. Talley NJ, Verlinden M, Jones M. Validity of a new quality of life scale for functional dyspepsia: a United States multicenter trial of the Nepean Dyspepsia Index. Am J Gastroenterol. 1999;94(9):2390-7. https://doi.org/10.1111/j.1572-0241.1999.01363.x
  37. Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and development of a new 10-item short form. Aliment Pharmacol Ther. 2001;15(2):207-16. https://doi.org/10.1046/j.1365-2036.2001.00900.x
  38. Katz S. The science of quality of life. J Chronic Dis. 1987;40:459-63. https://doi.org/10.1016/0021-9681(87)90001-4
  39. 최명규. 기능성 위장질환에서 삶의 질. 대한소화기학회 춘계학술대회. 2002;spr:55-65.
  40. Lee EH, Hahm KB, Lee JH, Park JJ, Lee DH, Kim SK, et al. Development and validation of a functional dyspepsia-related quality of life (FD-QOL) scale in South Korea. J Gastroenterol Hepatol. 2006;21(1 Pt 2):268-74.