Sweet 75 DOI : 10.3831/KPI.2010.13.4.075 Sweet Received : 10. 11. 12 Revised : 10. 11. 28 Accepted : 10. 12. 02 Key Words: Carpal tunnel sydrome, Sweet Bee Venom Pharmacopuncture, Scolopendrid Pharmacopuncture, Nerve Conduction Velocity Comparison of the Effects between Sweet Bee Venom Pharmacopuncture and Scolopendrid Pharmacopuncture on Carpal Tunnel Syndrome (Randomized, Controlled Clinical Trial) Ji-young Ku* Kyoung-hee Lee* Sung-Woo Cho** Sang-Chan Lee*** Hyoun-min Youn* Kyung-jeon Jang* Choon-ho Song* Chang-beohm Ahn* Cheol-hong Kim* *Department of Acupuncture & Moxibution College of Oriental Medicine, Dong-Eui University **Department of Oriental Rehabilitation Medicine, College of Oriental Medicine, Dong-Eui University ***Department of Neurology, Dong-Eui Hospital ABSTRACT Objectives : The purpose of this study is to compare the effects of Sweet Bee Venom Pharmacopuncture and Scolopendrid Pharmacopuncture on Carpal Tunnel Syndrome. Methods : From February to September 2010, the number of patients with Carpal Tunnel Syndrome who volunteered for this clinical study was 16 and 7 out of 16 patients complained both hands. Total 23 cases of hands were randomly divided by 2 groups. We injected Sweet Bee Venom Pharmacopuncture on PC7(Daereung) twice a week for 4weeks for experimental group(n=11), and Scolopendrid Pharmacopuncture with the same methods for control group(n=12). One case was dropped out due to itchiness of allergic response in the experimental group. Improvement of the symptoms was evaluated by Visual Analogue Scale, Pain Rating Scale, Tinel s sign, Phalen s sign and Nerve Conduction Velocity. Nerve Conduction Velocity was checked at baseline and the end of the trial and others were checked at baseline, after 2 and 4 weeks. Results : Both groups showed significant improvement in Visual Analogue Scale, Pain Rating Scale, but no significant difference between two groups. Only the control group showed significant reduction of the poitive response in the Tinel s sign and Phalen s sign. However, no groups improved in Nerve Conduction Velocity. Conclusions : These results showed that Sweet Bee Venom Pharmacopuncture and Scolopendrid Pharmacopuncture could decrease the symptoms of Carpal Tunnel Syndrome. Further studies will be required to examine more cases for the long period and use more various concentration and amount pharmacopuncture for the effect on Carpal Tunnel Syndrome. Correspondence : Cheol-hong Kim, Department of Acupuncture & Moxibution College of Oriental Medicine, Dong-Eui University, San 45-1, Yangjung 2-Dong, Busanjin-Gu, Busan, Korea, 614-710.. Tel. +82-51-850-8613 Fax. +82-51-867-5162 E-mail. kmdkch@deu.ac.kr This research was supported by KPI(Korea Pharmacopuncture Institute) in 2009.
76 Journal of Pharmacopuncture 13 4 2010 12 I II 9 1-3 5 30~60 70% 90% Sweet SBV SBV Visual Analog Scale VAS Pain Rating Scale PRS (Nerve Conduction Velocity, NCV) 1 IRB 2010 2 2010 9 16 7 23 1) 20 70 VAS 5 Tinel s sign Phalen s sign SBV 2) 1 3)
Sweet 77 8 0.1ml 0.5ml 2 1) screening VAS, PRS (SBV 1 2 4 8 VAS, PRS 2 5 3 2 (Fig.1) 2) SBV (LI11) 0.05ml 15-20 5mm 11mm 1ml 8mm 30guage (PC7) SBV 0.2ml 4 1) VAS 0 10 PRS PRS 2) Tinel s sign Phalen s sign 3) 8 (abductor pliicis brevis) (muscle belly) (tendon) (orthodromic)
78 Journal of Pharmacopuncture 13 4 2010 12 (Latency) (Amplitude) (Conduction Velocity) 4 SPSS version 18.0 for Win-dow (SPSS Co. USA) p-value 0.05 number(%) mean standard deviation paired t-test, Fisher s exact test t-test for independent sample McNemar PRS PRS PRS (Repeated ANCOVA) III 1 22 1 9 1 11 57.10 4.15 56.25 7.52 5 5 7 3.90 54.40 59.58 146.60 Tinel s sign Phlaen s sign 100% 92% VAS 7.00 1.05 6.25 1.06 PRS 92.70 21.78 70.17 21.25 PRS (Table 1) 2 VAS, PRS VAS 4 7.00 1.05 4.75 1.55(p=0.000) 4 2.70 1.16(p=0.001) (p=0.000) 2 follow up 3.20 2.35 (p=0.000) PRS 4 92.70 21.78 54.50 21.06(p=0.001) 4 25.70 21.84(p=0.003) (p=0.000) Tinel s sign Phalen s sign 10 (100%) 4 8 10 (100%) 7 (70%) (Table 2~5) 3 VAS, PRS VAS 4 6.25 1.06 4.21 1.50(p=0.000) 4 2.67 1.83(p=0.004) (p=0.000) 2 follow up 2.58 1.92 (p=0.000) PRS 4 70.17 21.25 39.08 22.37(p=0.003) 4 23.92 27.54(p=0.008) (p=0.000) Tinel s sign Phalen s sign 11 (92%) 4 8 10(83%) 4 (33%) (Table 2~5) 4 VAS, PRS 4.30 1.06, 67.00 22.84 3.58 1.98 46.25 31.44 p value 0.158 0.049 PRS PRS
Sweet 79 PRS PRS (Table 2~3) Tinel Phalen sign 100%-100%- 70% 92%-83%-33% (Table 4) 5 Motor nerve Amplitude Normal Limit Latency 5.66 1.99 5.51 1.76 Sensory nerve Finger to Wrist Conduction Velocity 32.97 4.63 34.02 5.00 (Table 6~7). IV Phalen s sign, Tinel s sign 80% 22% 12 1 6m/sec 70% 90% Sweet
80 Journal of Pharmacopuncture 13 4 2010 12 allergen 10,000 (phospholipase A2, hyaluronidase Bee Venom Sweet Bee Venom Sweet Bee Venom Bee Venom CT MRI 70 3000:1 1:1 SBV drop out 10,000:1 pilot test IRB SBV 1 (PC7) SBV 23 SBV 2 4 8 VAS, PRS, Tinel s sign, Phalen s sign 4 3 NCV 2 2 VAS 23 1 Drop out 22 2 20 57 61.5 VAS VAS 7.00 1.05 2.70 1.16 6.25 1.06 2.67 1.83 4.30 1.06 3.58 1.98 p value 0.158 2 3.20 2.35 2.58 1.92 22 2 20 2 10 1
Sweet 81 PRS 92.70 21.78 25.70 21.84 70.17 21.25 23.92 7.95 67.00 22.84 46.25 31.44 p value 0.049 p value 0.024 gain score PRS Tinel s sign Phalen s sign 100%-100%-70% 92%-83%-33% McNemar 0.016 Tinel s test Phalen s test Phalen s sign 88.9% Tinel, Phalen VAS, PRS Simpson Gilliat Sears 6 1 follow up 33 D. Rempel 8-22% 8-22% carpal tunnel release VAS, PRS, Tinel s sign, Phalen s sign SBV SBV SBV
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84 Journal of Pharmacopuncture 13 4 2010 12 stimulation of motor nerve. Electroencephalography and Clinical Neurophysio-logy(suppl). 1962;22:9-16 34. Padua L, Padua R, Aprile I, Pasqualetti, Tonali P. Multispective follow- up of untreated carpal tunnel syndrome. Neurology 2001;56(11):1459-66 35. Gerritsen AA, Uitdehaag BM, van Geldere D, Scholten RJ, de Vet HC, Bouter LM. Systemic review of randomized clinical trials of surgical treatment for carpal tunnel syndrome. Br J Surg 2001;88(10):1285-95 36. Han TR. Diagnosis and Treatment of Carpal Tinnel Sundrome. The Journal of Korean EMG, Electrodiagnositic Medicine. 2003;5(1):1-10 37. D Rempel, B Evanoff, P C Amadio, M de Krom, G Franklin, A Franzblau, R Gray, F Gerr, M Hagberg, T Hales, J N Katz, and G Pransky. Consensus criteria for the classification of carpal tunnel syndrome in epidemiologic studies. Am J Public Health, Oct 1998; 88: 1447-51. 38. Wren V. McCallister, MD, Thomas E. Trumble, MD. Decompressive Surgery Was Better Than Steroid Injection for Symptomatic and Neurophysiologic Outcomes in Carpal Tunnel Syndrome. The Journal of Bone and Joint Surgery (American). 2006;88:454.
Sweet 85 N= 23 randomized (After screening, Eligibility criteria) VAS, PRS, Tinel Øs sign, Phalen Øs sign NCV checked Group 1(SBV) N=11 Group 2(Scolopendrid) N=12 N=1 dropped out Because of pruritus During 2 weeks 4 injection N=10 completed During 2 weeks 4 injection N=12 completed VAS, PRS, Tinel s sign, Phalen s sign checked During 2 weeks 4 injection N=10 completed During 2 weeks 4 injection N=12 completed VAS, PRS, Tinel s sign, Phalen s sign NCV checked Fig. 1.
86 Journal of Pharmacopuncture 13 4 2010 12 Table 1. Baseline Characteristics of Patients. p value Sex(M/F) 1/9 1/11 1.000* Age 57.10 4.15 56.25 7.52 0.753* Distribution of hand (Right/Left) 5/5 7/5 1.000* The hand which uses mainly 10/0 11/1 1.000* (Right/Left) Distribution by Duration (Month) 63.90 54.40 59.58 46.60 0.843* Tinel s sign 10(100%) 11(92%) Phalen s sign 10(100%) 11(92%) VAS 7.00 1.05 6.25 1.06 0.112* PRS 92.70 21.78 70.17 21.25 0.024 Values are Number or MEAN SD *using paired t-test, Fisher s exact test, P 0.05 Table 2. Change of VAS in Each Group Pre 2weeks 4weeks 12weeks 7.00 1.05 4.75 1.55 2.70 1.16 3.20 2.35 6.25 1.06 4.21 1.50 2.67 1.83 2.58 1.92 Values are Number or MEAN SD Pre : primary report before 1st treatment 2weeks : report after 2weeks, 4th treatment 4weeks : report after 4weeks, 8th treatment 12weeks : report after 12weeks Table 3. Change of PRS in Each Group F P PRE 92.70 21.78 70.17 21.25 week 2.892 0.105 2weeks 54.50 21.06 39.08 22.37 Group 0.033 0.857 4weeks 25.70 21.87 23.92 27.54 week*group 2.665 0.119 Values are Number or MEAN SD Pre : primary report before 1st treatment 2weeks : report after 2weeks, 4th treatment 4weeks : report after 4weeks, 8th treatment using Repeated ANCOVA test, P 0.05
Sweet 87 Table 4. Positive Finding on the Physical Examination. Pre 2weeks 4weeks P tinel phalen 10(100%) 10(100%) 10(100%) 10(100%) 7(70%) 7(70%) 1.000 1.000 tinel phalen 11(92%) 11(92%) 10(83%) 10(83%) 4(33%) 4(33%) 0.016* 0.016* *using McNemar test, P 0.05 Values are Number(%) Pre : primary report before 1st treatment 2weeks : report after 2weeks, 4th treatment 4weeks : report after 4weeks, 8th treatment Table 5. Comparison on Pain between Groups. p-value (p-value) (p-value) between Group 2weeks-Pre -2.25 1.23(0.000*) -2.04 1.45(0.000*) 0.362 VAS 4weeks-2weeks 4weeks-Pre -2.05 1.34(0.001*) -4.30 1.06(0,000*) -1.54 1.50(0.004*) -3.58 1.98(0.000*) 0.209 0.158 12weeks-Pre -3.80 1.99(0.000*) -3.67 2.01(0.000*) 0.441 2weeks-Pre -38.20 23.37(0.001*) -31.08 28.79(0.003*) 0.268 PRS 4weeks-2weeks -28.80 22.24(0.003*) -15.17 16.24(0.008*) 0.056 4weeks-Pre -67.00 22.84(0.000*) Values are Number or MEAN SD *using paired t-test, Fisher s exact test, P 0.05 2weeks-Pre : the changes during 1st treatment-4th treatment 4weeks-2weeks : the changes during 8th treatment-4th treatment 4weeks-Pre : the changes during 8th treatment-1st treatment 12weeks-Pre : the changes during 1st treatment-after 12weeks -46.25 31.44(0.000*) 0.049* Table 6. Result of Motor Nerve Conduction Study Pre 4weeks Normal Limit Latency (msec) 5.66 1.99 4.83 1.86 5.51 1.76 4.86 1.90 3.60 Amplitude (mv) 6.42 3.42 8.51 3.61 6.68 3.57 8.46 3.50 5 Values are Number or MEAN SD Pre : primary report before 1st treatment 4weeks : final report after 4weeks, 8th treatment Normal Limit by Shin J. Oh Clinical electromyography using t-test for independent sample, P 0.05
88 Journal of Pharmacopuncture 13 4 2010 12 Table 7. Result of Sensory Nerve Conduction Study Pre 4weeks Normal Limit Amplitude Palm to Wrist 18.17 10.53 28.78 21.12 15.49 10.78 29.86 23.78 10 Finger to Wrist 9.00 4.67 12.66 7.73 8.90 4.68 13.94 9.81 10 Conduction Velocity Palm to Wrist 25.66 6.62 28.60 4.33 25.63 6.34 28.46 5.00 34.05 (msec) Finger to Wrist 29.60 6.89 32.97 4.63 29.59 5.28 34.02 5.00 41.26 Values are Number or MEAN SD Pre : primary report before 1st treatment 4weeks : final report after 4weeks, 8th treatment Normal Limit by Shin J. Oh Clinical electromyography using t-test for independent sample, P 0.05
Sweet 89 (Appendix 1). Visual Analog Scale (Appendix 2).