51 DOI : 10.3831/KPI.2009.12.2.051 1) 2) Received : 09. 05. 25 Accepted : 09. 05. 31 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. 042-229-6816 E-mail : hkeacu@dju.ac.kr
52 12 2 2009 6 25% 2 13.4 25% 30 Herb drug medicine, H-D Over The Counter OTC Nepean Dyspepsia Index NDI-K II 1 2008 7 1 2007 11 30 30 8 22 2 1) 2) KGMP H-D 75 5% 3 (H-D) (OTC) 167 mg 8mg 230mg, 100mg 100 30 mg 12 mg 100mg 150 mg 6 mg 40 mg 167 mg 150 mg 3 mg 0.006 mg 180 mg 16 mg 250 mg 50 mg 20 75
53 H-D OTC 1 3 1 1 2 2 3) 4) 1 20 70 2 Rome Criteria Table 1 3 2 2 6 0 mild 1 moderate 2 severe 3 5) 1 2 3 2 4 5 6 6) H-D OTC NDI-K 2 1 3 NDI-K NDI-K CRF Case Report Form CRF dropout 7) NDI-K 1 NDI-K 15 2 5 6 5 25 5 1 5 8)
54 12 2 2009 6 1 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 2 2 5 NDI-K 15 1) NDI-K 15 NDI-K Table 7 2) NDI-K 15 H-D NDI-K
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%
56 12 2 2009 6 OTC 30 H-D OTC Nepean Dyspepsia Index NDI- K H-D OTC H-D 1 20 OTC 1 75 30 H-D OTC 15 Table 2 H-D 4:11 Table 3
57 H-D OTC 73.33, 86.67 % Table 4 H-D OTC 40,00, 40.00 % Table 4 Table 4 NDI-K Talley NDI-K 15 8 Table 5 NDI-K 8 p=0.002, p=<0.0001 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
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60 12 2 2009 6 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 15 15 Gender(n(%)) Male 4(26.7%) 4(26.7%) Female 11(73.3%) 11(73.3%) 1.0 Mean Age(y) 43.4 11.4 a) 34.7 10.7 0.040 Height( ) 162.8 8.4 163.3 6.90 0.869 Weight( ) 61.26 11.6 59.86 9.96 0.726 Severity of dyspepsia symptom 9.66 1.87 8.60 1.12 0.069 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 (0.07-0.73)
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) 0.791 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) 1.000 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 51.73 15.04 a) 43.87 17.00 0.190 After treatment 27.33 14.94 18.93 10.69 0.934 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 -24.40 18.73 a) 0.0002*** OTC -24.93 16.12 0.0001*** p-value b) 0.934 a): Mean standard deviation b): independent t-test (***: p 0.001)
62 12 2 2009 6 Table 7. Score of NDI-K Symptoms in the Two Group Before Treatment Symptom H-D OTC p-value b) Pain in upper abdomen 6.00 2.27 a) 4.33 3.85 0.162 Discomfort in upper abdomen 7.80 1.82 7.20 2.34 0.439 Burning in upper abdomen 5.93 2.63 3.67 3.04 0.038* Inability to finish a regular meal 7.33 2.55 6.47 3.02 0.403 Fullness after eating 7.67 2.60 8.47 2.85 0.429 Pressure in upper abdomen 6.00 3.72 4.60 4.04 0.333 Bloating in upper abdomen 6.13 2.88 6.33 2.94 0.852 Nausea 4.87 3.98 2.80 2.86 0.114 Heartburn 4.20 3.28 0.93 1.67 0.003* Cramps in upper abdomen 3.53 3.38 1.40 2.29 0.053 Chest pain 4.06 3.24 1.73 2.52 0.036* Bitter tasting fluid that comes to your mouth 4.47 3.58 3.87 3.29 0.637 Burping 6.53 3.44 6.40 2.85 0.909 Vomiting 2.80 3.47 1.20 2.57 0.162 Bad breath 3.27 3.37 1.33 2.02 0.069 Total symptom score 80.60 29.95 60.73 22.62 0.050* a): Mean standard deviation. b): independent t-test (*: p 0.05)
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 2.80 2.31 a) -3.20 3.17 0.002** Discomfort in upper abdomen 4.40 2.50-3.40 3.44 0.002** Burning in upper abdomen 3.47 3.00-2.47 3.16 0.009** Inability to finish a regular meal 3.00 3.12-4.33 4.20 0.001*** Fullness after eating 4.27 3.39-3.40 3.39 0.001*** Pressure in upper abdomen 3.20 2.65-2.80 3.69 0.011* Bloating in upper abdomen 3.47 3.36-2.67 3.13 0.005** Nausea 2.73 2.94-2.13 4.14 0.066 Heartburn 2.60 3.11-1.60 3.36 0.086* Cramps in upper abdomen 1.20 2.04-2.33 4.34 0.056 Chest pain 0.80 1.26-3.27 3.13 0.001*** Bitter tasting fluid that comes to your mouth 1.27 1.98-3.20 2.83 0.001*** Burping 4.60 4.10-1.93 4.89 0.148 Vomiting 0.73 1.58-2.07 3.15 0.023* Bad breath 0.66 1.18-2.60 3.11 0.006** Total symptom score 39.20 20.16-41.40 29.64 0.0001*** a): Mean standard deviation. (*: p 0.05, **: p 0.01, ***: p 0.001)
64 12 2 2009 6 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 1.60 1.88-2.73 3.49 a) 0.009** Discomfort in upper abdomen 2.60 2.13-4.60 2.92 0.0001*** Burning in upper abdomen 1.80 2.14-1.87 2.29 0.007** Inability to finish a regular meal 2.73 2.63-3.73 2.60 0.0001*** Fullness after eating 4.07 2.66-4.40 3.25 0.000*** Pressure in upper abdomen 1.73 2.07-2.87 4.27 0.021* Bloating in upper abdomen 2.47 2.45-3.87 3.81 0.002** Nausea 1.93 3.41-0.87 4.34 0.452 Heartburn 0.33 1.29-0.60 1.24 0.082 Cramps in upper abdomen 0.40 1.06-1.00 2.51 0.145 Chest pain 0 0-1.73 2.52 0.019* Bitter tasting fluid that comes to your mouth 2.07 2.02-1.80 2.86 0.029* Burping 2.53 2.03-3.87 3.68 0.001** Vomiting 0.53 1.46-0.67 3.18 0.430 Bad breath 0.40 1.12-0.93 1.83 0.068 Total symptom score 25.20 14.15-35.53 20.87 0.0001*** a): Mean standard deviation. (*: p 0.05, **: p 0.01, ***: p 0.001)
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 -3.20 3.17 a -2.73 3.49 a) 0.704 Discomfort in upper abdomen -3.40 3.44-4.60 2.92 0.312 Burning in upper abdomen -2.47 3.16-1.87 2.29 0.557 Inability to finish a regular meal -4.33 4.20-3.73 2.60 0.642 Fullness after eating -3.40 3.39-4.40 3.25 0.405 Pressure in upper abdomen -2.80 3.69-2.87 4.27 0.964 Bloating in upper abdomen -2.67 3.13-3.87 3.81 0.354 Nausea -2.13 4.14-0.87 4.34 0.420 Heartburn -1.60 3.36-0.60 1.24 0.288 Cramps in upper abdomen -2.33 4.34-1.00 2.51 0.311 Chest pain -3.27 3.13-1.73 2.52 0.150 Bitter tasting fluid that comes to your mouth -3.20 2.83-1.80 2.86 0.189 Burping -1.93 4.89-3.87 3.68 0.232 Vomiting -2.07 3.15-0.67 3.18 0.236 Bad breath -2.60 3.11-0.93 1.83 0.085 Total symptom score -41.40 29.64-35.53 20.87 0.536 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 73.97 9.28 a) 69.23 16.69 0.346 Knowledge/Control 57.14 12.37 61.90 24.21 0.505 Eat/drink 66.11 17.67 24.21 21.33 0.490 Sleep disturb 80.00 9.21 82.50 16.90 0.620 Total symptom score 69.31 7.29 71.19 16.99 0.698 a): Mean standard deviation. b): independent t-test
66 12 2 2009 6 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 89.36 10.17 a) 15.38 10.70 0.0001*** Knowledge/Contro l78.10 14.47 20.95 10.17 0.0001*** Eat/drink 76.67 17.67 10.56 20.76 0.0691 Sleep disturb 88.33 11.05 8.33 12.20 0.0192* Total symptom score 83.11 9.44 13.80 9.36 0.0001*** a): Mean standard deviation. *:p 0.05, ***: p 0.0001. 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 89.87 12.64 a) 20.64 20.86 0.002** Knowledge/Control 61.90 16.49 24.52 26.24 0.003** Eat/drink 86.42 18.69 26.24 20.04 0.061 Sleep disturb 95.83 7.72 13.33 16.00 0.006** Total symptom score 88.45 11.06 17.26 18.26 0.003** a): Mean standard deviation. *: p 0.01. 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 15.38 10.70 a) 20.64 20.86 a) 0.3951 Knowledge/Control 20.95 10.17 24.52 26.24 0.6290 Eat/drink 10.56 20.76 26.24 20.04 1.0000 Sleep disturb 8.33 12.20 13.33 16.00 0.3440 Total symptom score 13.80 9.36 17.26 18.26 0.5212 a): Mean standard deviation. b): independent t-test