KOREAN JOURNAL OF ACUPUNCTURE pissn / eissn REVIEW ARTICLE Korean Journal of Acupuncture Vol.36, No.2, pp ,

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1 pissn / eissn REVIEW ARTICLE Korean Journal of Acupuncture Vol.36, No.2, pp , 퇴행성슬관절염의화침치료에대한체계적문헌고찰및메타분석 : 최근 5 년간의호침치료비교연구를중심으로 동신대학교목포한방병원침구과 A Systematic Review and Meta-Analysis of Fire Needling Treatment for Knee Osteoarthritis: Focused on Comparative Studies with Manual Acupuncture Treatment during Recent Five Years Hong-Je Ko, Jae-Hee Yoo, Jeong-Cheol Shin Department of Acupuncture and Moxibustion, Dongshin University Mokpo Hospital of Korean Medicine Objectives : The purpose of this study is to review the effectiveness of fire needling treatment for knee osteoarthritis in comparison with manual acupuncture treatment. Methods : Through four foreign online databases (PubMed, Cochrane library, EMBASE, and CNKI) and five domestic online databases (NDSL, RISS, KISS, OASIS, and KTKP), we searched for clinical studies that performed fire needling treatment for knee osteoarthritis until May 10, Only randomized controlled trials were selected and we assessed the risk of bias according to the Cochrane RoB criteria. This review examined the selected studies into first author, publication year, sample size, outcome measurements, results, acupoints, treatment time & period and so on. Results : A total of 7 RCTs were selected in this review and all were conducted in China. Treatment period of more than 4 weeks and treatment visits of 10 to 20 times were the most common. EX-LE4 and ST35 (=EX-LE5) acupoints were most frequently selected in treatment. Among the evaluation indexes, a total efficacy rate was used the most. Most of fire needling groups showed more significant results compared with the manual acupuncture groups statistically. Conclusions : All studies showed that fire needling treatments for knee osteoarthritis were more effective than manual acupuncture treatments statistically. Therefore, the results of this study could be utilized as a preliminary data for another clinical research on fire needling treatment for knee osteoarthritis. However, further well-designed randomized controlled trials will be needed to develop sufficient evidence about the effectiveness and safety of fire needling treatment for knee osteoarthritis in the future. Key words : knee osteoarthritis, fire needling, randomized controlled trials, systematic review, meta-analysis 서 론 슬관절은인체에서가장큰윤활관절 (Synovial joint) 로가동성 은높지만상대적으로불안정하고체중의부하를직접적으로받는관절이다 1). 이에따라직접적이고지속적인상하의압력에노출되기쉬워퇴행성변화가쉽게나타나는관절이기도하다 2). 특히, 퇴 Received May 16, 2019, Revised June 9, 2019, Accepted June 10, 2019 Corresponding author: Jeong-Cheol Shin Department of Acupuncture and Moxibustion, Dongshin University Mokpo Hospital of Korean Medicine, 313 Baeknyeondae-ro, Mokpo 58665, Korea Tel: , Fax: , fire-sjc@hanmail.net This research was supported by the Dongshin University research grants. CC This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. 104 Copyright 2019, SOCIETY FOR MERIDIAN AND ACUPOINT

2 A Systematic Review and Meta-Analysis of Fire Needling Treatment for Knee Osteoarthritis 행성슬관절염은무릎관절연골의변성, 마모와관절주위의골극형성, 골경화와같은변화가동반되는관절질환으로, 발생빈도는 55 세이상의약 80%, 75세이상에서는거의전인구에서나타난다 1). 일반적으로, 경도의동통, 피로감, 운동장애, 종창및관절주위압통, 마찰음등의임상증상을보이며 1), 1차적으로보존치료로운동및체중감량, 온열요법등을시행하며통증의정도와환자의상태에따라비스테로이드성항염증제 (Non-steroidal anti-inflammatory drugs, NSAIDs) 와히알루론산관절강내주사를시행한다. 만약퇴행성변화가심하고통증이극심한경우에는수술요법등을고려한다 2). 최근, 국내에서도퇴행성슬관절염의한의학적침치료로호침, 약침, 도침, 온침, 매선등을활용하는연구 3-8) 가활발히진행되고있고, 연구방법에있어서도증례보고 (Case report & series), 무작위배정비교임상시험연구 (RCT), 체계적문헌고찰 (Systematic Review) 등다양한형태로연구가이루어지고있다. 특히나, 온침치료와화침치료와같은가열식침치료는다양한근골격계질환의치료에응용되며국내외에서연구가활발히진행되고있다. 그중에서도화침은침을불에달군후통처를자극함으로써세포재생을촉진시키는방법으로침치료에프롤로테라피 (Prolotherapy) 개념을접목시켜관절및인대질환에다양하게응용되고있지만 9,10), 현재국내에서화침치료를퇴행성슬관절염에적용한연구는전무하며해외에서대다수의연구가이루어지고있는실정이다. 이에본저자는퇴행성슬관절염에대한화침치료의유의성을알아보고자국내 외데이터베이스를바탕으로무작위배정비교임상시험연구 (RCT) 만을선별한후연구동향을분석하고고찰하여그결과를보고하고자한다. 연구방법 1. 연구대상선정및제외기준본연구는화침치료가일반호침치료와비교하였을때퇴행성슬관절염에효과가있는지를확인하기위해수행되었으며, 2019년 5월 10일까지발표된최근 5년간의국 내외논문중퇴행성슬관절염에화침치료를적용한무작위배정비교임상시험 (RCT) 논문을대상으로하였다 년중국에서퇴행성슬관절염의화침치료가일반호침및온침치료보다유의한효과가있다는결과를제시한메타분석연구 11) 가발표된연유로연구선정에있어 최근 5년간 이라고발표연도에제한을두었다. 퇴행성슬관절염에화침치료를중재로설정한 RCT 만을본체 계적문헌고찰및메타분석에포함시켰으며, 비무작위배정비교임상시험 (non-randomized controlled trial, nrct), 환자대조군연구 (case-control study, CCS), 연속증례군보고 (case series), 단일증례보고 (case report), 인간이대상이아닌실험실연구 (in vivo or in vitro), 문헌고찰, 프로토콜논문등은제외하였다. 논문선정에있어기술된언어에대한제한을두지않았고출판형태에따른제한도없었다. 다만, 화침치료와그외치료들이시험군과대조군에단독혹은복합적으로다양하게적용되어화침치료의유효성을판단하는데기준이일관되지않고불명확한부분이존재하였다. 이에일반호침치료대비화침치료의유효성을판단하기위해대조군을일반호침치료로명확히선정한연구만을설계에포함시켰으며치료결과에일부나마영향을미칠수있는여타치료를시험군과대조군에포함시킨경우본연구에서제외시켰다. 2. 문헌검색논문검색은총 9개의국 내외검색엔진을이용하였으며, Pubmed, Cochrane library, EMBASE, CNKI (China National Knowledge Infrastructure) 등총 4개의국외데이터베이스와한국학술정보 (Korean Studies Information Service System, KISS), 국가과학기술정보센터 (National Digital Science Library, NDSL), 학술연구정보서비스 (Research Information Sharing Service, RISS), 전통의학정보포털 (Oriental Medicine Advanced Searching Integrated System, OASIS), 한국전통지식포탈 (Korean Traditional Knowledge Portal, KTKP) 등총 5개의국내데이터베이스를사용하였다. 대상자검색어설정은영어로는 osteoarthritis, knee osteoarthritis, osteoarthrosis, degenerative arthritis, degenerative joint disease, knee joint, knee pain, knee 등을각데이터베이스실정에맞게조정하였으며, 민감도를높이기위해복수형표현도고려하였다. 중국어로는 膝关节炎, 退行性膝关节炎, 退行性关节炎, 骨关节炎, 关节炎, 膝关节, 膝盖, 退行性, 膝关节骨炎, 变性关节疾病, 膝痛 등을사용하였으며, 한글표현으로는 퇴행성슬관절염, 퇴행성관절염, 슬관절염, 골관절염, 관절염, 슬관절, 무릎, 퇴행성 등을조합하여검색하였다. 중재치료검색어설정은 fire needle, fire needling, fire acupuncture, burning acupuncture, hwachim, 火针, 毫火针, 燔针, 淬针, 화침 등으로하였다. 실제검색은각검색데이터베이스의환경에맞게수정및변화 105

3 시켜사용하였다. 검색시이용한각데이터베이스별검색식은 Appendix 1에첨부하였다. 3. 자료선별및추출자료의검색및선별은두명의연구자가독립적으로수행하였다. 초기검색후제목및초록을통해논문선정기준에적합성여부를판단하여 1차적으로논문을선정하고두명의연구자가원문을검토한후결과도출을위해의견을조율하여최종적으로논문을선정하였다. 의견이일치하지않은경우에는제 3연구자가개입하여적합성여부를판단한후결정하였다. 4. 자료분석및관리서지관리프로그램인 EndNote X8.2 를통해검색한문헌을정리하였고내용및결과를 Excel 프로그램을이용하여추출및분석하였다. EndNote 와 Excel 을이용해정리한자료를바탕으로각논문들에대한문헌고찰을시행하였다. 5. 비뚤림위험평가두명의연구자가최종선정논문에대해코크란비뚤림위험평가도구 ( Risk of bias (RoB) by Cochrane collaboration) 12) 를이용하여독립적으로평가하였다. 독립된두연구자사이의평가가불일치할경우제 3연구자가개입하여합의를통해결정하였다. 6. 통계분석분석은 R-studio version 의메타패키지를활용하였다. 치료효과여부를통해도출한총유효율 (Total efficacy rate) 을이분형변수로간주하였고이분형변수결과는비교위험도 (Relative Risk, RR) 를활용하였다. 이질성평가 (Heterogeneity test) 를수행하여연구결과에의미있는차이의여부를평가하였다. I 2 과 Cochrane Q-검정을활용하여이질성을평가하였으며, I 2 이 50% 이상이거나 Cochrane Q-검정결과 p<0.1 인경우이질성이있다고판단하였다. 통계적으로유의미한이질성이발견되지않아고정효과모형 (Fixed effect model) 을활용하였고결과는숲그림 (forest flot) 과 RR의점추정치와그신뢰구간으로제시하였다. RR의경우 p<0.05 인경우통계적으로유의미하다고간주하였다. 결과 1. 문헌선정결과문헌검색결과, PubMed 5편, Cochrane library 3편, EMBASE 3편, CNKI 147편, KISS 0편, NDSL 0편, RISS 0편, OASIS 0편, KTKP 0편으로총 158 편의논문이검색되었다. 이중중복된논문 6편을제거하고제목과초록을확인하여퇴행성슬관절염과관련이없는논문과연구디자인방법상인간을대상으로한임상연구가아닌문헌들을배제하는 1차스크리닝을진행하였다. 남은 83개문헌의원문을확인하여 RCT 가아닌논문 13편, 시험군과대조군선정및배제기준에부합하지않은논문 63편등총 76편의연구문헌이배제되었다. 최종적으로총 7편의논문이선정되었고이를토대로체계적문헌고찰및메타분석을진행하였다. 문헌선택에관한내용은 PRIS (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 의 flow chart를이용하여 Fig. 1에도식화하였다. 2. 선정문헌특성및결과분석선정된논문들에대한세부사항은아래 Table 1과 Table 2에정리하였다. 1) 논문개요 : 7편의연구모두중국에서발표되었으며, 2014, 2016, 2017, 2018년고루연구가수행되었다. 2) 연구대상자수 : 각연구에서시험군과대조군을합한총피험자수는최소 55명에서최고 81명이었고 50명이상 75명미만인연구가 4편, 75명이상 100명미만인연구가 3편이었다. ( 단, 한편의연구는화침조, 일반호침조, 취합조세군을비교연구한논문으로본고찰에서는화침조와일반호침조의비교만을적용하여분석하였다.) 3) 진단기준 : 각연구에서서로다른슬관절염진단및피시험자선정기준이활용되었는데, 그중중국의학회류머티스학분회에서제시한슬관절염진단기준이가장많이사용되었다. 상기진단기준에따르면다음조건 (1 근 1개월간슬관절통반복적호소 2 X선촬영상관절간극축소, 연골하경화또는낭성변화, 뼈마디형성관찰 3 관절액검사상성상투명및점조, 백혈구수치 2000 개 / ml 미만 4 연령 40 세이상 5 조조강직시간 30 분미만 6 활동시골마찰음 ) 중 1,2 또는 1,3,5,6 또는 1,4,5,6 을각각동시충족하는경우에슬관절염으로진단내릴수있다고명시하였다. 4) 시험군치료기간및횟수 : 치료기간의경우, 4주미만인연구 106

4 A Systematic Review and Meta-Analysis of Fire Needling Treatment for Knee Osteoarthritis Fig. 1. Flow Diagram according to the Diagram of PRIS. Table 1. Data of Included Studies First Author (year) Sample size Intervention group Control group 1. Cheng (2018)13) 78 (38:40) FNA (n=38) (n=40) 2. Hu 14) (2017) 81 (42:39) FNA (n=42) (n=39) 3. Gan 15) (2017) 69 (35:34) FNA BC (n=35) (n=34) 4. Chen (2016)16) 5. Zheng 17) (2016) 55 (28:27) 70 (35:35) FNA BC (n=28) FNA (n=35) (n=27) (n=35) 6. He 18) (2014) 70 (35:35) FNA (n=35) 7. Tang 19) (2014) 76 (38:38) FNA (n=38) Outcome measurements Main result Adverse Events 1. HSS knee score 2. Chinese symptomatic grading and quantifying score 3. Total efficacy rate 1. Lysholm knee score 2. AIMS2-SF score 3. Total efficacy rate 1. WOC score 2. JOA score 3. Total efficacy rate 1. Total efficacy rate 1. (p 0.05) 2. (p 0.05) 3. (p 0.05) (p 0.01) (p 0.01) (p 0.05) (p 0.05) (p 0.05) (p 0.05) (p 0.05) (n=35) (n=38) 1. Total efficacy rate 2. ISOA score 1. (p 0.05, 0.01) 2. (p 0.05) 3. NSD 1. NSD 2. NSD (only social functioning) (p 0.05) *excluding combination group 1. (p 0.05) 2. (p 0.05) WOC score VAS score Total efficacy rate Total efficacy rate SF-36 score I : Intervention group, C : Control group, : Not reported, FNA : Fire needle acupuncture, : Manual acupuncture, VAS : Visual Analog Scale, WOC : Western Ontario and McMaster Universities Arthritis Index, HSS : Hospital for Special Surgery Knee Score, AIMS2-SF : Arthritis Impact Measurement Scales version 2 - Short Form, JOA : Japanese Orthopedic Association Scores, SF-36 : 36-item Short Form Health Survey, ISOA : Index of Severity for Osteoarthritis of the knee, BC : Blood letting cupping, NSD : Not significantly differences

5 Table 2. Characteristics of Intervention First Author (year) Needle type / Depths of insertion Acupoints Retention time Treatment session & period 1. Cheng (2018) 13) Unclear / 寸 SP10, ST34, EX-LE4, ST35 (=EX-LE5), ST36 2. Hu Unclear / mm ST32, EX-LE4, ST35 (2017) 14) (=EX-LE5), GB34, SP9, ST34, SP10, GB33, ST36 3. Gan 0.8 mm 50 mm / 1.5 cm Ashi point, EX-LE4, ST35 (2017) 15) (=EX-LE5) 4. Chen Unclear / 0.1 cm GB33, ST34, Ashi point, SP10, (2016) 16) EX-LE4, ST35 (=EX-LE5) 5. Zheng 0.35 mm 25 mm / 5 10 mm Ashi point, EX-LE4, ST35 (2016) 17) (GB34, ST36, etc.) & 3 5 mm (=EX-LE5), GB34, SP10, (EX-LE4, ST35 (=EX-LE5), etc.) ST34, EX-LE2, ST36+α 6. He 0.4 mm 35 mm / cm ST34, SP10, EX-LE2, (2014) 18) ST35(=EX-LE5), EX-LE4, GB34, ST36, Ashi point 7. Tang 0.5 mm (25 30 mm) / 0.5 cm Ashi point, GB34, ST34, SP10, (2014) 19) EX-LE4, ST35 (=EX-LE5)+α No retention 3 times per a week / 4 weeks continued 30 min. Once per 2 days / 15 times for a session / 1 session No retention (BC 10 min.) No retention (BC 5 10 min.) No retention No retention Once a day & a day rest after 6 days for a session / 4 sessions Once per 2 days & 3 times per a week / 14 days for a session / 1 session Once per 2 days & 10 days for a session (2 days rest after a session) / 2 sessions Once per 2 days & 3 times per a week / 4 weeks continued No retention Twice per a week / 8 weeks continued 가 2편이고 4주이상인연구가 5편이었다. 4주간치료한연구가가장많았으며 8주간치료한연구도 1편존재하였다. 치료횟수의경우, 일정정도치료기간에비례하였으며 10회미만인연구가 1편, 10회이상 20회미만인연구가 5편, 20회이상인연구가 1편이었다. 5) 치료혈위및치료방법 : 7편의연구에서시험군치료시행시선택된혈위를분석해본결과, 內膝眼 ( 經外奇穴 ) (EX-LE4) 과犊鼻 (ST35) (= 外膝眼, EX-LE5) 가 7회로가장많이선택되었다. 선택된치료혈위에대한내용은아래 Table 3에정리하였다. 화침치료시사용된침의두께및깊이는연구별로굉장히다양했으며, 한편의연구 14) 를제외하고유침은하지않았다. 6) 평가지표 : 7편의선정연구에서다양한평가지표가사용되었으며, 그중유효한치료결과의비율을보여주는총유효율 (Total efficacy rate) 은모든연구에서공통적으로사용되었다. 그리고임상에서관절질환환자의동통과기능상태를평가하기위해이용되는설문도구인 WOC (Western Ontario and McMaster Universities Arthritis Index) 가 2편의연구에서이용되었다. 그외다른지표들이다양하게평가지표로이용되었으며, 그에대한결과는상기 Table 1에정리하였다. 7) 치료효과 : 대부분의연구에서시험군이대조군보다치료후각각의평가결과에서호전을보였다. 다만, Zheng (2016) 의연구 17) 에서는화침군이호침군에비해痊愈, 显效비율에서는통계적으로유의한차이를보였으나 (p<0.01), 痊愈, 显效, 有效비율인총유효율 (Total efficacy rate) 에서는결과수치는높았으나통계적으로유의한차이는없었다 (p>0.05). 또한, He (2014) 의연구 18) 에서는 Table 3. Frequency of Acupoints Frequency Name of acupoints 7 EX-LE4 7 ST35(=EX-LE5) 6 ST34 6 SP10 5 Ashi point 4 ST36 4 GB34 2 GB33 2 EX-LE2 1 ST32 1 SP9 45 Total 11 acupoints+α 화침군이호침군에비해총유효율은높았지만 p value 값에대한언급이없어통계적유의성을판단하기어려웠고 SF-36 지표에서도 social role functioning 항목에서만화침군이호침군에비해통계적으로유의한차이를보이고 (p<0.05) 나머지항목에서는 p value 값에대한언급이없어총유효율항목과마찬가지로통계적유의성을판단하기어려웠다. 최종선정된 7편의연구에서상기언급된부분을제외한다른지표에대해시험군이대조군보다통계적으로유의하게호전되었다는결과를보였다. 8) 이상반응보고 : 7편의연구모두에서이상반응보고는없었다. 3. 비뚤림위험평가선정된 7편의무작위배정비교임상시험에대해서코크란비뚤 108

6 A Systematic Review and Meta-Analysis of Fire Needling Treatment for Knee Osteoarthritis 림위험평가도구 ( Risk of bias (RoB) by Cochrane collaboration) 를적용하여각항목에대한비뚤림위험을평가하였다. 비뚤림위험평가에대한결과는 Revman 프로그램을이용하여도식화하였다 (Fig. 2, 3). 1) 무작위배정순서생성 (Random Sequence Generation): Low Risk 연구는 5편으로무작위숫자표, 추첨표를이용하여무작위배정을하였다는언급이있었고, 나머지 2편의연구는 무작위배정 이라는표현만존재할뿐, 무작위배정방법에대한내용이언급되지않아 Unclear Risk로분류하였다. 2) 배정순서은폐 (Allocation Concealment): 모든연구에서배정순서은폐에대한내용이언급되지않아 Unclear Risk 로분류하였다. 3) 연구참여자, 연구자에대한눈가림 (Blinding of Participants and Personnel): 화침이라는중재의특성상치료의눈가림이불가능하므로 7편의연구모두 High Risk 로분류하였다. 4) 결과평가에대한눈가림 (Blinding of Outcome Assessment): 치료의눈가림이되지않은게분명한환자가결과평가에참여하고평가지표의특성상치료자외에도참여자의주관적인평가가들어갈것으로판단되어 7편의연구모두 High Risk 로분류하였다. 5) 불충분한결과자료 (Incomplete Outcome Data): Low Risk 연구는 4편으로시험군과대조군의총피험자수가연구시작전과후일치하여결측치가없는것으로판단되어 Low Risk 로분류하였다. 3편의연구에서는결측치의수가시험군과대조군에서불균등하게나타나 High Risk 로분류하였다. 6) 선택적보고 (Selective Reporting): 프로토콜및사전계획에대한언급이없어 7편의연구모두 Unclear Risk 로분류하였다. 7) 그외비뚤림 (Other Bias): 추가비뚤림위험을확인하기어려워 7편의연구모두 Unclear Risk 로분류하였다. 4. 메타분석결과화침과일반호침치료의총유효율 (Total efficacy rate) 을메타분석으로비교하였다. I 2 값은 0% 로이질성은낮았으며 Cochrane Q-검정결과 p=0.7485로유의미한이질성을발견할수없어고정효과모형 (Fixed effect model) 을활용하였다. 시험군의총유효율 Fig. 3. Risk of bias summary (RCT). (+) : Low risk of bias, ( ) : High risk of bias, (?) : Unclear risk of bias. Fig. 2. Risk of bias graph (RCT)

7 Fig. 4. Meta Results of Total Efficacy Rate. 은대조군의총유효율보다 1.11 배 (95% CI: 1.04, 1.19) 높았으며이는통계적으로유의미했다 (p=0.0013) (Fig. 4). 고찰 슬관절은퇴행성관절염이나타나면서관절염과관련한증상이가장흔히발생되는부분으로, 통증은서서히나타나며초기에는활동시에나타나지만진행하면서휴식시에도통증이발생한다 20). 퇴행성관절염의자연경과는매우다양하여일부는호전을보이고다른일부는상태가안정적으로유지되나대부분의경우연령의증가에따른퇴행성변화로증상이악화되고보행장애까지동반되기도한다 21). 퇴행성슬관절염의치료는기능과삶의질개선그리고통증조절을목표로하며 22), 대부분의경우보존치료를먼저시행하며심한통증이지속되거나관절의불안정성, 변형, 강직으로인한운동제한등이진행하면수술치료를적용한다 2). 한의학에서퇴행성슬관절염은鶴膝風, 膝部痺症으로볼수있으며, 膝蓋가隱隱히疼痛하고腫瘍은솜처럼말랑말랑하고皮膚色은변하지않으며, 관절의변형으로鶴의다리처럼무릎부분이불거져튀어나오는것이특징이다. 원인은風寒濕등의外邪로인해氣血運行이閉阻된것과노화에따라肝腎衰弱하여筋骨이傷한것으로분류하여經脈을소통시키고氣血을조화시키는치료법을사용하였다 1). 화침은자침전에침끝을燒熱한후에신체특정부위나경혈에刺入함으로써각종질병을치료하고예방하는침법으로 黃帝內經 에서는불로鍼을불에달궈痺症을치료하는방법이라기록하였다. 이러한화침요법은鍼과灸의작용을동시에이용하는데溫熱을치료원리로삼았다고할수있다 1). 현재는溫熱자극을통해관절내부및인대에염증반응을일으켜주변조직을강화하고, 陽 氣를助陽시키고, 經穴및經絡을열어祛邪시키는의미등으로사용하고있다 23). 현재임상에서는퇴행성슬관절염에다양한한의학적치료를이용하나화침치료에대한연구가아직전무한상황으로, 추후임상에서의보다나은화침치료적용을위해화침의안전성및유효성에대한다양한연구가꾸준히진행되어야할것으로사료된다. 퇴행성슬관절염에대한화침치료의유의성을알아보고자국내 외 9개의온라인데이터베이스를이용하여미리설정한선정및배제기준에따라 7편의 RCT 연구를선정하였다. 7편의연구는모두중국에서시행되었으며중국내에서는퇴행성슬관절염에화침치료를응용한연구가매해꾸준히진행되고있는것을확인할수있었다. 모든연구의시험군과대조군을화침과일반호침치료로만제한하였으나 2편의연구 15,16) 에서는시험군치료에발관법 ( 拔罐法 ) 이결합되어있는데, 이는화침치료후혈위주변으로유출되는삼출물을제거하기위한용도로사용되어이를화침과발관법의개별치료로보기에는무리가있을것으로사료되어선정논문에포함시켰다. 다만, 시간차이를두고개별적으로화침과유관법을시행한연구들은모두배제하였다. 치료기간과횟수는각각 4주이상, 10 회이상 20 회미만의장기치료가가장많았으며, 이는퇴행성슬관절염이질환특성상급성질환이아닌만성질환이기에꾸준한치료를목표로연구가진행된것으로사료된다. 선택된치료혈위는內膝眼 ( 經外奇穴 ) (EX-LE4), 犊鼻 (ST35) (= 外膝眼, EX-LE5) 이가장많이선택되었는데, 이혈위들은슬개골과가장가까운혈위들로슬관절을직접자극하기에가장적합한위치로서다양한연구에서선택되었을것으로사료된다. 또한, 화침치료시사용된침의두께및치료깊이는각연구별로매우다양하여경향성을보이지않았고, 30분간유침을시행한한편의연구 14) 를제외하고는모든연구가유침을하지않았다. 이는 110

8 A Systematic Review and Meta-Analysis of Fire Needling Treatment for Knee Osteoarthritis 화침의치료특성상자극이강하고여타치료보다더침습적인치료이기때문으로사료된다. 각논문에서는다양한평가지표들이사용되었는데, 총유효율 (Total efficacy rate) 은모든연구에서공통적으로이용되었고, 2 편의연구에서 WOC 가이용되었다. 그외에도각각의의미를지닌다양한평가지표들이이용되었지만대부분이주관적인증상개선및개인평가를기반으로설문에의존하는지표들로추후임상연구에서는조금더타당성과신뢰성이높은객관적인지표들이개발될필요가있을것으로사료된다. 또한, 퇴행성슬관절염의평가지표가다양하다는것은결과평가에있어국제적으로명확한기준이존재하지않다는것을반증하는것으로생각해볼수있으며보다구체적이고정확한기준을가지고평가도구를통일하는것도필요하리라사료된다. 대부분의연구에서시험군이대조군보다치료후각각의평가결과에서통계적으로유의미한결과를보였다. Zheng (2016) 의연구 17) 에서痊愈, 显效비율은화침군이 90.9%, 호침군이 9.4% 로결과수치상으로큰차이를보이면서도통계적으로유의미하였으나 (p<0.01) 痊愈, 显效, 有效비율인총유효율은화침군이 96.9%, 호침군이 93.75% 로화침군의결과수치가높았지만통계적으로유의한의미는없었다 (p>0.05). 또한, He (2014) 의연구 18) 에서총유효율이화침군은 90.6%, 호침군은 88.2% 로화침군이높은수치를보였지만 p value 값에대한언급이없어통계적유의성을확인하기어려웠고, SF-36 중에서도 social role functioning 항목만화침군이 68.09±5.67, 호침군이 64.65±7.60 으로통계적으로유의한차이를보였지만 (p<0.05) 그외지표항목에대해서는 p value 값에대한언급이없어마찬가지로통계적유의성을확인하는데어려움이있었다. He (2014) 의연구 18) 가화침조, 일반호침조, 취합조세군을비교연구한논문으로화침조와일반호침조를단독으로비교하여화침만의치료효능을입증하기에는약간의제한점이있었다. 7편의연구모두화침치료후의이상반응에대한보고는없었지만화침치료의특성상자극이강하고침습적인치료이므로상기연구들에서이상반응이보고가없었을지라도그안전성에대해서는명확히확인할수없어추후이상반응에대한지속적인관찰이필요할것으로보인다. 코크란비뚤림위험평가도구 ( Risk of bias (RoB) by Cochrane collaboration) 를이용해비뚤림위험을분석한결과, 대다수의연구에서무작위숫자표나추첨표를이용하여배정순서를정해비뚤림위험이낮았지만모든연구에서배정순서은폐, 선택적보고, 그외비뚤림에대한언급이부족하였고, 일부연구에서 는연구도중피시험자탈락이발생하여불충분한결과자료항목에서비뚤림위험이높았다. 화침이라는중재치료특성상눈가림을시행하는데한계가있고결과평가에있어서도주관적인평가를배제할수없어추후연구및평가방법설정에있어지속적인연구가필요할것으로사료된다. 최종선정된 7편의연구에서모두치료결과를통해도출한총유효율 (Total efficacy rate) 이기재되어있었고, 이를이분형자료로잡아메타분석을진행하였다. 그외의평가지표들은매우다양하여평가상공통점을찾기어려워메타분석에서제외하였다. 메타분석결과, 시험군의총유효율은대조군에비해 1.11 배높고통계적유의성이있었으며, Cochrane Q-검정결과유의미한이질성은발견되지않았다. 상기결과를살펴보았을때, 퇴행성슬관절염환자에화침치료를시행한경우가일반호침치료를시행한경우보다총유효율증가등유의미한효과가있었음을확인할수있었다 년중국에서발표된퇴행성슬관절염의화침치료에대한메타분석연구는대조군에일반호침뿐만아니라온침까지포함시킨부분이본연구와달랐으며, 메타분석결과두연구모두총유효율에서시험군이대조군보다통계적으로유의미한결과를보인것을제외하고는연구결과를두고비교하기에일부어려움이있었다. 본연구를통해결론적으로화침치료가호침치료에비해퇴행성슬관절염에통계적으로효과가있는것으로확인되었으나, 검색에사용된 9개의데이터베이스외의데이터베이스에존재하는연구나타국가의연구및현재진행중인연구는포함되지못해누락된논문들이존재하리라사료된다. 국내에서시행된연구는없었고주관적인평가지표를사용한연구가많고공통적인평가지표가부족하여결과의비교 해석이제한적일수있다는점, 연구의질평가에서도비뚤림평가관련내용의언급이부족했다는점이한계점으로남았다. 본연구결과를바탕으로퇴행성슬관절염에화침치료를적용한연구들이지속적으로이루어져이를통해향후에화침을이용한다양한근골격계질환치료가활발히이루어지길기대해본다. 결론 1. 본연구의결과로보아화침치료는호침치료보다퇴행성슬관절염치료에있어임상적으로유의미한결과를나타내었다

9 2. 치료기간은 4주이상, 치료횟수는 10회이상 20회미만, 치료혈위는內膝眼 ( 經外奇穴 ) (EX-LE4), 犊鼻 (ST35) (= 外膝眼, EX-LE5) 가가장많았다. 3. 평가지표고찰결과, 화침치료를퇴행성슬관절염에적용하고치료효과를객관적으로파악하기위해객관적인평가기준이마련되고비뚤림위험이낮은질높은임상연구설계가시행되어야할것으로사료된다. 4. 본연구가퇴행성슬관절염에화침치료를적용한임상연구를진행함에있어기초자료로활용될수있기를바란다. 감사의글 This research was supported by the Dongshin University research grants. References 1. Korean Acupuncture & Moxibustion Medicine Society. The acupuncture and moxibustion medicine. 4th ed. Seoul : Hanmi Medical Publishing Company : 130-2, Korean Orthopedic Association. Orthopedics. 7th ed. Seoul : Newest Medicine Company : Park IS, Jung CY, Jang MK, Kang MS, Lee SW, Kim EJ, et al. A randomized clinical trial of local acupoints compared with distal acupoints in degenerative osteoarthritis on knee. Journal of Acupuncture Research ; 25(2) : Shin SY, Seo DK, Kim SY, Seo JC, Seo YJ, Lee YJ, et al. The effect of chinemys reevesii gray pharmacopuncture for women with knee osteoarthritis. Journal of Acupuncture Research ; 32(3) : Lee JH, Yang TJ, Lee DG, Lee OJ, Wei TS. The effect of needle-embedding therapy on osteoarthritis of the knee combined with korean medical treatment : report of five cases. Journal of Acupuncture Research ; 31(4) : Park MS, Oh SJ, Lee JH, Jun SA, Gong HM, Choi SH, et al. Miniscalpel acupuncture treatment on a knee degenerative osteoarthritis patient, who does not responded to acupuncture treatment. Journal of Acupuncture Research ; 33(3) : Min WK, Yeo SJ, Kim EW, Song HS, Koo ST, Lee JD, et al. Comparison of warm-needling and acupuncture for knee osteoarthritis: A randomized controlled trial. Korean Journal of Acupuncture ; 30(1) : acu Kim HB, Lee RM, Lee MH, Choi YS, Kim JI, Lee YH, et al. Comparative study of effects of Intramuscular bee venom herbal acupuncture and Intracutaneous bee venom herbal acupuncture in knee osteoarthritis patients. Journal of Acupuncture Research ; 25(2) : Han SH, Lee JS. A case report on burning acupuncture treatments for stable compression fracture. The Journal of Korea CHUNA Manual Medicine for Spine & Nerves ; 3(1) : Kim BG, Shin JY, Seo KM. The effect of prolotherapy for the chronic pain of musculoskeletal system. Annals of Rehabilitation Medicine ; 25(1) : Wu HW, Shi PP, Wang JM. Effects of fire needle therapy on knee osteoarthritis : meta analysis. Chinese Journal of Information on Traditional Chinese Medicine ; 21(5) : Higgins JPT AD, Sterne JAC. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0(updated March 2011). The Cochrane Collaboration; Cheng G, Wu H. Clinical observation on 38 cases of knee osteoarthritis treated with fire needle 5 acupoints of knee. Shenzhen Journal of Integrated Traditional Chinese and Western Medicine ; 28(15) : Hu QS. Efficacy observation of fire filiform-needle therapy in treating elderly knee osteoarthritis. Shanghai Journal of Acupuncture and Moxibustion ; 36(9) : Gan YH. Clinical observation on the wind-cold-dampness type of knee osteoarthritis with the treatment of fire-needle and cupping. Master s thesis in Changchun University of Traditional Chinese Medicine

10 A Systematic Review and Meta-Analysis of Fire Needling Treatment for Knee Osteoarthritis 16. Chen Q, Shao BB. Clinical observation on the treatment of knee osteoarthritis with fire needle combined with cupping. Health for Everyone ; 10 : Zheng M, Hong KD, Chen SJ, Gong DG, Lin ZG. Observations on the effect of filiform fire needling in treating knee osteoarthritis. Chinese Medicine Modern Distance Education of China ; 14(5) : He TF, Song YH, Ding JL, Zhu XY, Duan XD, Zhou LY, et al. Effect of fire needling plus filiform needles on the quality of life in knee osteoarthritis patients. Shanghai Journal of Acupuncture and Moxibustion ; 33(12) : j.issn Tang ZG. Clinical efficacy of fire acupuncture in the treatment of knee arthritis. Guide of China Medicine ; 12(34) : American Academy of Orthopaedic Surgeons. Essentials of musculoskeletal care. 4th ed. Seoul : Hanwoori : David T.F. Osteoarthritis of the knee. N Engl J Med ; 354(8) : Bellamy N. Outcome measurement in osteoarthritis clinical trials. J Rheumatol Suppl ; 43 : Park SJ, Ahn SG. A literature review and a clinical examination of burning acupuncture therapy of using D.I.T.I.. Journal of Acupuncture Research ; 15(2) :

11 Appendix 1. Search Strategy of PubMed, Cochrane library, EMBASE, and CNKI 1. PubMed #1 : Search (Osteoarthritis [TW] OR Osteoarthritides [TW] OR Osteoarthrosis [TW] OR Osteoarthroses [TW] OR Arthritis, Degenerative [TW] OR Arthritides, Degenerative [TW] OR Degenerative Arthritides [TW] OR Degenerative Arthritis [TW] OR Osteoarthrosis Deformans [TW] OR Knee Osteoarthritides [TW] OR Knee Osteoarthritis [TW] OR Osteoarthritides, Knee [TW] OR Osteoarthritis Of Knee [TW] OR Knee, Osteoarthritis Of [TW] OR Knees, Osteoarthritis Of [TW] OR Osteoarthritis Of Knees [TW] OR Degenerative joint disease [TW] OR Knee joint [TW] OR Knee pain [TW] OR Knee [TW] OR Osteoarthritis [MeSH] OR Osteoarthritis, Knee [MeSH]) #2 : Search (Hwachim [TW] OR Fire needle [TW] OR Fire needling [TW] OR Fire acupuncture [TW] OR Burning acupuncture [TW] OR Burning acupuncture therapy [TW] OR Fire needling therapy [TW]) #3 : #1 AND #2 2. Cochrane library #1 : [mh osteoarthritis, knee ] #2 : [mh oseoarthritis ] #3 : Osteoarthritis :ti,ab,kw or Osteoarthritides :ti,ab,kw or Osteoarthrosis :ti,ab,kw or Osteoarthroses :ti,ab,kw or Arthritis, Degenerative :ti,ab,kw or Arthritides, Degenerative :ti,ab,kw or Degenerative Arthritides :ti,ab,kw or Degenerative Arthritis :ti,ab,kw or Osteoarthrosis Deformans :ti,ab,kw or Knee Osteoarthritides :ti,ab,kw or Knee Osteoarthritis :ti,ab,kw or Osteoarthritides, Knee :ti,ab,kw or Osteoarthritis Of Knee :ti,ab,kw or Knee, Osteoarthritis Of :ti,ab,kw or Knees, Osteoarthritis Of :ti,ab,kw or Osteoarthritis Of Knees :ti,ab,kw or Degenerative joint disease :ti,ab,kw or Knee joint :ti,ab,kw or Knee pain :ti,ab,kw or Knee :ti,ab,kw #4 : #1 OR #2 OR #3 #5 : Hwachim :ti,ab,kw or Hwa-acupuncture :ti,ab,kw or Fire needle :ti,ab,kw or Fire needling :ti,ab,kw or Fire acupuncture :ti,ab,kw or Burning acupuncture :ti,ab,kw or Burning acupuncture therapy :ti,ab,kw or Fire needling therapy :ti,ab,kw #6 : #4 AND #5 3. EMBASE #1 : knee osteoarthritis /exp OR knee osteoarthritis #2 : osteoarthritis /exp OR osteoarthritis OR arthrosis, knee OR gonarthrosis OR knee osteoarthritis OR knee joint arthrosis OR knee joint osteoarthritis OR knee osteo-arthritis OR knee osteo-arthrosis OR knee osteoarthrosis OR osteoarthritis, knee OR osteoarthrosis, knee OR degenerative arthritis /exp OR degenerative arthritis OR degenerative joint disease OR knee joint /exp OR knee joint OR knee OR knee pain /exp OR knee pain #3 : #1 OR #2 #4 : hwachim OR hwa-acupuncture OR fire needle OR fire needling OR fire acupuncture OR burning acupuncture OR burning acupuncture therapy OR fire needling therapy #5 : #3 AND #4 4. CNKI TI=( 膝关节炎 + 退行性膝关节炎 + 退行性关节炎 + 骨关节炎 + 关节炎 + 膝关节 + 膝盖 + 退行性 + 膝关节骨炎 + 变性关节疾病 + 膝痛 + OA + KOA + Osteoarthritis + Osteoarthrosis + Degenerative Arthritis + Knee Osteoarthritis + Degenerative joint disease + Knee joint + Knee pain ) AND TI=( Hwa-acupuncture + fire + fire needling + fire needle + fire acupuncture + burning acupuncture + 火针 + 毫火针 + 燔针 + 淬针 ) 114