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1 51 DOI : /KPI ) 2) Received : Accepted : Effect of herb drug medicine Treatment for Functional Dyspepsia: Controlled Trial Lee Jae-Jin 1), Son mi-won 2), Hong Kwon-eui 1) Key Words: Herb drug medicine treatment, Functional Dyspepsia, Nepean Dyspepsia Index 1) Dept. of Acupunture & Moxibustation, College of Oriental Medicine, Daejeon University, 2) Dong-A Phamaceutical Co. ABSTRACT Obejective : Functional dyspepsia is a prevalent disease. It impedes subjective quality of life. The purpose of this research is to examine the equivalent effect of herb drug medicine treatment(h-d)and Over the Counter(OTC) for functional dyspepsia. Method : In this controlled study, we compared herb drug medicine(h-d) with Over the Counter(OTC) of functional dyspepsia. 30 volunteers who satisfied the requirements were enrolled in study. Severity of dyspepsia was measured by Nepean Dyspepsia Index(NDI-K) before and after treatments. Result : The results are summarized as follows. 1. In Herb drug medicine and Over the Counter groups, total key symptoms score of after treatment were significantly decreased and improve rate of key symptoms was higher than before treatment, but there were no statistical significance between two groups. 2. In Herb drug medicine and Over the Counter groups, each symptoms score of after treatment were significantly decreased and improve rate of key symptoms was higher than before treatment, but there were no statistical significance between two groups. 3. In Herb drug medicine and Over the Counter groups, quality of life score of after treatment were significantly decreased and improve rate of key symptoms was higher than before treatment, but there were no statistical significance between two groups. Conclusion : Herb drug medicine treatment(h-d) is effective to improve the symptoms and quality of life in patients with functional dyspepsia. I dyspepsia functional dyspepsia Corresponding author : Hong Kwon-eui, Dept. of Acupunture and Moxibustion, College of Oriental Medicine, Daejeon University Tel hkeacu@dju.ac.kr

2 % % 30 Herb drug medicine, H-D Over The Counter OTC Nepean Dyspepsia Index NDI-K II ) 2) KGMP H-D 75 5% 3 (H-D) (OTC) 167 mg 8mg 230mg, 100mg mg 12 mg 100mg 150 mg 6 mg 40 mg 167 mg 150 mg 3 mg mg 180 mg 16 mg 250 mg 50 mg 20 75

3 53 H-D OTC ) 4) Rome Criteria Table mild 1 moderate 2 severe 3 5) ) H-D OTC NDI-K NDI-K NDI-K CRF Case Report Form CRF dropout 7) NDI-K 1 NDI-K )

4 NDI-K 8 2 NDI-K 15 NDI-K NDI-K NDI-K Fig 1 9) t paired t-test t independent t-test Fisher s exact test Kappa Windows SAS 9.1 p p-value 0.05 Table 3 3 Table 4 4 NDI-K NDI-K 15 8 Table 5 1) NDI-K NDI-K 8 p=0.002 p=<0.0001) Table 6 III 1 30 H-D OTC 15 Table NDI-K 15 1) NDI-K 15 NDI-K Table 7 2) NDI-K 15 H-D NDI-K

5 55 12 Table 8 7 3) OTC NDI-K 15 OTC NDI-K 10 Table 9 4) NDI-K 15 NDI-K Table 10 6 NDI-K 1) NDI-K NDI-K Table 11 2) H-D NDI-K H-D NDI-K Table 12 3) OTC NDI-K OTC NDI-K Table 13 4) NDI-K 15 NDI-K Table 14 IV 25% 38-41% 32% 13.4% 15.4% 15.5% 25% dyspepsia 3 81%

6 OTC 30 H-D OTC Nepean Dyspepsia Index NDI- K H-D OTC H-D 1 20 OTC H-D OTC 15 Table 2 H-D 4:11 Table 3

7 57 H-D OTC 73.33, % Table 4 H-D OTC 40,00, % Table 4 Table 4 NDI-K Talley NDI-K 15 8 Table 5 NDI-K 8 p=0.002, p=< Table 6 H-D OTC NDI-K 15 NDI-K Table 7 H-D NDI-K H-D 12 Table 8 OTC 10 Table 9 H-D NDI-K NDI-K Table 11 NDI- K H-D Table 12 OTC Table 13 Table 14

8 H-D OTC H-D V 30 H-D OTC NDI-K 1 NDI-K 2 NDI-K 3 NDI-K VI 1. Choi MG. Definition and Epidemilogy of Functional Dyspepsia. The Korean Society of Gastrointestinal Motility. 2000;6: Lee JH, Kim HY, Rho SH, Yoon DH, Kim KH, Choi JH. Which Patients do examinate Endoscopy Test on Functional Dyspepsia in Korea. The Korean Society of Gastrointestinal Motility. 2001;22: Park YT. Approch Definition and Diagnosis of Dyspepsia, Seoul, Jin publishing. 2006: Talley NJ, Stanghellini V, Heading RC, Koch KL, Malagelada JR, Tytgat GN. Functional gastroduodenal disorders. Gut. 1999;45(Suppl ): Huh C, Yang CH, Jang JG, Lee DH, Lee GL, Seol SY, Lee YJ, Han YS, Rim KS, Rhee PL, Shin WC, Lee KJ, Chung MK, Na YH. Functional Dyspepsia and Subgroups in Korea and Short Term Outcome of Therapeutic Trial of Cisapride ; Multicenter Study. The Korean Society of Gastrointestinal Motility. 1998;4(1): Lee SY, Choi CH, Lee HY, Do MY, Lee SH, Han SP, Huh C, Kin HJ, Kim JY, Kim JG, Jang SK, Park SM. Original Articles : The Frequency of Functional Dyspepsia Subtypes and its Related Factors for Health Check up Subjects. The Korean Society of Gastrointestinal Motility. 2007;13: Seoul: Dong-Woo Publishing co. 2000:51-62, 65-74, 83-8, Effects of Mosapride on Upper Gastrointestinal Symptoms and Gastric Emptying in Patients with Functional Dyspepsia. The Korean Society of Gastrointestinal Motility. 2004;10(1): A Randomized Study to Compare Domperidone Maleate with Itopride Hydrochloride in Dysmotility-type Functional Dyspepsia. The Korean Society of Gastrointestinal Motility. 2003;41: ;16(2): ;24(2): ;26(3):

9 ;28(2): : ;28(2): Jones RH, Lydeard SE, Hobbs FD. Dyspepsia in England and Scotland. Gut. 1990;31: 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: ;20(2): Kim HS, Lee GJ, Kim JH, Ham KB, Cho SW. Functional Gastrointestinal Disorders in Patients Referred to Specialist Gastroenterologists in a Tertiary Hospital. The Korean Society of Gastrointestinal Motility. 2004;10(2): Lee GJ. Pathophysiology and Treatment of Functional Dyspepsia. The Korean Society of Gastrointestinal Motility 2003;9: Lee GJ. Guidline of Treatment on Functional Dyspepsia. The Korean Society of Gastrointestinal Motility. 2005;11(3): Ko KB. Aspect of Spycosociology for functional dyspepsia. The Korean Society of Gastrointestinal Motility. 2000;6: ;289-90, 291-2, 334-5, 336-7, 342-3, 344-5, 348-9, 413-4, ; Bond EF, Heitkemper MM, Bailey SL. Estrogen suppresses gastric motility response to thyrotropin-releasing to hormone and stress in awake rats. Res Nurs Health. 1998;21(3): Heitkemper MM, Bond EF. Gastric motility in rats with varying ovarian hormone status. Res Nurs Health. 1995;17(1): : Park YC, Jo JH, Hong KE, Jung YC, Kang WC, Choi SM. Effect of Acupuncture Treatment for Functional Dyspepsia: A Randomized Controlled Trial. The Journal of Korean Acupuncture and Moxibustion Society. 2007;24(1): Talley NJ, Haque M, Wyeth JW, Stace NH, Tytgat GN, Stanghellini V, Holtmann G, Verlinden M, Jones M. Development of a new dyspepsia impact scale: the Nepean Dyspepsia Index. Aliment Pharmacol Ther. 1999;13(2): 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): 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): Katz S. The science of quality of life. J Chronic Dis. 1987;40: Choi MG. Quality of Life in Functional Dyspepsia. The Korean of Gastroenterology. 2002;spr: Jo YK, Choi MG, Kim SH, Lee YS, Kim SY, Jeong YS, Lee SL, Choi SC, Seol SY. The Effect of Mosapride on Quality of Life in Functional Dyspepsia. The Korean of Gastroenterology. 2004;43(3):160-7.

10 Research Doctor statistician Research Doctor Pharmacist Research Doctor H-D& OTC screening assignment NDI-K during 2wk NDI-K Fig. 1. Design of study. NDI-K: Nepean dyspepsia index H-D: Herb drug medicine treatment OTC: Over The Counter Table 1. Definition of Functional Dyspepsia in Rome Criteria 2) At least 12 weeks, which need not be consecutive, in the preceding 12 months of: 1. Persistent or recurrent symptoms (pain or discomfort centered in the upper abdomen); 2. No evidence of organic disease that is likely to explain the symptoms; and 3. No evidence that dyspepsia is exclusively relieved by defecation or associated with the onset of a change in stool frequency or stool form (i.e., not irritable bowel). Table 2. Clinical Characteristics of Two Patients Groups Treated with H-D and OTC H-D OTC Fisher s exact test p-values T-test Total number Gender(n(%)) Male 4(26.7%) 4(26.7%) Female 11(73.3%) 11(73.3%) 1.0 Mean Age(y) a) Height( ) Weight( ) Severity of dyspepsia symptom a) : Mean standard deviation Table 3. Surmise about Treatment in Two Patients Groups Treated with H-D and OTC H-D OTC Kappa(95% CI) Surmise about treatment(%) H-D OTC 11(73.3) 4(33.3) 5(26.7) 10(66.7) 0.40 ( )

11 61 Table 4. Subtype and Byeonjeung Type of Functional Dyspepsia in Treated with H-D and OTC H-D OTC Fisher s exact test Ulcer-like Dyspepsia 1(6.67) 1(6.67) Subtype Dysmotility-like Dyspepsia 11(73.33) 13(86.67) Unspecified Dyspepsia 3(20.00) 1(6.67) Disharmony between liver and stomach syndrome 6(40.00) 6(40.00) Stagnated meal syndrome 2(13.33) 2(13.33) Byeonjeung Type Spleen-stomach dampness-heat syndrome 0(0.00) 1(6.67) Simultaneous occurrence of cold and heat syndrome 3(20.00) 2(13.33) Hypofunction of spleen and stomach syndrome 4(26.67) 4(26.67) Table 5. Mean Changes of Dyspepsia Key Symptoms between before and after Treatment NDI-K score H-D OTC p-value b) Before treatment a) After treatment a): Mean standard deviation b): independent t-test Table 6. Mean changes of dyspepsia key symptoms between before and after treatment with H-D and OTC NDI-K score Mean change Paird t-test H-D a) *** OTC *** p-value b) a): Mean standard deviation b): independent t-test (***: p 0.001)

12 Table 7. Score of NDI-K Symptoms in the Two Group Before Treatment Symptom H-D OTC p-value b) Pain in upper abdomen a) Discomfort in upper abdomen Burning in upper abdomen * Inability to finish a regular meal Fullness after eating Pressure in upper abdomen Bloating in upper abdomen Nausea Heartburn * Cramps in upper abdomen Chest pain * Bitter tasting fluid that comes to your mouth Burping Vomiting Bad breath Total symptom score * a): Mean standard deviation. b): independent t-test (*: p 0.05)

13 63 Table 8. Mean Changes of NDI-K Symptoms in the Group Treated with H-D Symptom After score Mean change Parid t-test Pain in upper abdomen a) ** Discomfort in upper abdomen ** Burning in upper abdomen ** Inability to finish a regular meal *** Fullness after eating *** Pressure in upper abdomen * Bloating in upper abdomen ** Nausea Heartburn * Cramps in upper abdomen Chest pain *** Bitter tasting fluid that comes to your mouth *** Burping Vomiting * Bad breath ** Total symptom score *** a): Mean standard deviation. (*: p 0.05, **: p 0.01, ***: p 0.001)

14 Table 9. Mean Changes of NDI-K Symptoms in the Group Treated with OTC Symptom After score Mean change Parid t-test Pain in upper abdomen a) 0.009** Discomfort in upper abdomen *** Burning in upper abdomen ** Inability to finish a regular meal *** Fullness after eating *** Pressure in upper abdomen * Bloating in upper abdomen ** Nausea Heartburn Cramps in upper abdomen Chest pain * Bitter tasting fluid that comes to your mouth * Burping ** Vomiting Bad breath Total symptom score *** a): Mean standard deviation. (*: p 0.05, **: p 0.01, ***: p 0.001)

15 65 Table 10. Mean Changes of NDI-K Symptoms in Two Patients Groups Treated with H-D and OTC Symptom H-D OTC p-value b) Pain in upper abdomen a a) Discomfort in upper abdomen Burning in upper abdomen Inability to finish a regular meal Fullness after eating Pressure in upper abdomen Bloating in upper abdomen Nausea Heartburn Cramps in upper abdomen Chest pain Bitter tasting fluid that comes to your mouth Burping Vomiting Bad breath Total symptom score a): Mean standard deviation. b): independent t-test Table 11. Quality of Life Score of NDI-K Symptoms in the Two Group Before Treatment Quality of Life H-D OTC p-value b) Interference a) Knowledge/Control Eat/drink Sleep disturb Total symptom score a): Mean standard deviation. b): independent t-test

16 Table 12. Mean Changes of NDI-K Quality of Life Score in the Group Treated with H-D Quality of Life After score Mean change Paird t-test Interference a) *** Knowledge/Contro l *** Eat/drink Sleep disturb * Total symptom score *** a): Mean standard deviation. *:p 0.05, ***: p Table 13. Mean Changes of NDI-K Quality of Life Score in the Group Treated with H-D Quality of Life After score OTC Paird t-test Interference a) ** Knowledge/Control ** Eat/drink Sleep disturb ** Total symptom score ** a): Mean standard deviation. *: p Table 14. Mean Changes of NDI-K Symptoms in Two Patients Groups Treated with H-D and OTC Quality of Life H-D OTC p-value b) Interference a) a) Knowledge/Control Eat/drink Sleep disturb Total symptom score a): Mean standard deviation. b): independent t-test

Lumbar spine

Lumbar spine CT 32 111 DOI : 10.3831/KPI.2010.13.2.111 Lumbar Spine CT 32 Received : 10. 05. 23 Revised : 10. 06. 04 Accepted : 10. 06. 11 Key Words: Disc herniation, CT scan, Clinical analysis The Clinical