Journal of Korean Medicine Rehabilitation Vol. 29 No. 2, April 2019 pissn eissn Review

Journal of Korean Medicine Rehabilitation Vol. 29 No. 2, April 2019 pissn 1229-1854 eissn 2288-4114 https://doi.org/10.18325/jkmr.2019.29.2.171 Review Article 황련해독탕약침치료에대한임상논문고찰 : 국내학술지의증례보고와대조군연구중심으로 이수환 김순중세명대학교부속제천한방병원한방재활의학과 An Intensive Review On Clinical Thesis about Hwangryunhaedok-tang Pharmacopuncture Treatment: Focused on Case Reports and Controlled Studies in Korean Academic Journals Soo-Hwan Lee, K.M.D., Soon-Joong Kim, K.M.D. Department of Rehabilitation Medicine of Korean Medicine, Semyung University Jecheon Korean Medicine Hospital 이논문은 2018 학년도세명대학교교내학술연구비지원에의해수행된연구임. RECEIVED March, 13, 2019 REVISED April, 1, 2019 ACCEPTED April, 2, 2019 CORRESPONDING TO Soon-Joong Kim, Department of Rehabilitation Medicine of Korean Medicine, Semyung University Jecheon Korean Medicine Hospital, 66 Semyeong-ro, Jecheon 27136, Korea TEL (043) 649 1920 FAX (043) 645-1382 E-mail kimsj@semyung.ac.kr Copyright 2019 The Society of Korean Medicine Rehabilitation Objectives The purpose of this thesis is to compare and analyze outcomes of case studies and controlled studies about Hwangryunhaedok-tang (HHT) pharmacopuncture in clinical studies. Based on these studies reporting clinical effects by using HHT pharmacopuncture, we object to deduct the comparative review in applying clinical disorders limitedly. And conclusionally, by using this comparative review, we aim to make the fine evidence in treating clinical specific diseases. Methods We searched 106 studies about HHT pharmacopuncture from 6 Korean web databases by using in Korean word 'Hwangryunhaedok-tang pharmacopuncture'. This search had been progressed throughout 1 month (January, 2019). There was 106 thesis and we excluded studies that are not related to HHT pharmacopuncture, experimental research, not the case report or randomized controlled trials, non-randomized controlled trials, not using HHT pharmacopuncture, not using only one pharmacopuncture, and not using HHT pharmacopuncture for major treating method. As a result, 39 thesis are selected as a population. Results We analyzed 34 case reports and 5 controlled studies. As the final outcome, HHT pharmacopuncture was used in musculoskeletal diseases, dermatopathy, and 32 specific diseases. Conclusions After analyzing 39 studies, effective symptom changes clinically and statistically by using HHT pharmacopuncture herbal acupuncture were identified. However, these thesis designs were reported deficiently in many parts such as not excluding other confounding variables. After modifying defects of thesis design and conduct study, it can play a role as the evidence using HHT pharmacopuncture more precisely. (J Korean Med Rehabil 2019;29(2):171-188) Key words Hwangryunhaedok-tang, HHT, Pharmacopuncture, Acupuncture, Case study, Randomized controlled trial www.e-jkmr.org 171

이수환 김순중 서론»»» 藥鍼療法은한국한의학적원리에기원한독특한치료기술로서, 침구요법과약물요법을결합한한방의료행위이다. 현재제조되어임상에활용하고있는약침종류로는경락장약침, 팔강약침, 동물성약침, 산삼약침등이있다. 그중황련해독탕약침은음양, 표리, 한열, 허실의팔강에준해서약침을이용하는팔강약침에속하며, 증례보고, 대조군연구, 실험연구등에서다용되고있다 1). 黃連解毒湯은황련, 황금, 황백, 치자로구성된처방으로, 東醫寶鑑 2) 에 治傷寒大熱煩燥不得眠差後飮酒乃一切熱毒 이라고기재되어있으며, 이를토대로추출한약침이황련해독탕약침이다. 최근문헌적으로는경추추간판탈출증과같은근골격계질환뿐만아니라, 감모, 천식, 기관지확장증등의호흡기질환, 대상포진과한포진등의피부과질환에사용한다고기록되어있다 1). 추가적으로, 실험연구에서는알레르기성비염 3), 아토피피부염 4), 대장염 5), 외열스트레스 6) 등의질환에서황련해독탕약침의개선효과에대해보고하였으며, 임상연구에서는 Behcet s syndrome 7), Lumbar spondylolisthesis 8), 요추추간판탈출증 9,10), 구안와사 11) 등에황련해독탕약침사용후호전된사례들이보고되고있다. 자하거약침 12), 오공약침 13), 홍화약침 14) 그리고중성어혈약침 15) 등현재임상에서다용되고있는약침의경우, 임상논문을종합한고찰논문이보고되었다. 황련해독탕약침의효능에기반을두어다수의연구들이보고되고있으나, 임상논문을종합한고찰논문은보고되지않았다. 이에본고에서는황련해독탕약침을사용하여임상적효과에대해보고한논문들을고찰한후, 보다정확한정보를포함한임상논문연구설계에대한방향성을제시하고, 올바른적응증을확립하여임상한의사가질높은근거를바탕으로환자를진료할수있도록보탬이되고자본연구를진행하게되었다. 대상및방법»»» 1. 자료수집본논문의자료수집은국내에발표된논문으로국한 Table I. Searched Database to Investigate Korean Traditional Medicine Issues Database Domain Korean Traditional Knowledge http://www.koreantk.com Portal Research Information Sharing http://www.riss.kr Service Oriental Medicine Advanced http://oasis.riom.kr Searching Integrated System National Digital Science Library http://www.ndsl.kr National Assembly Library http://www.nanet.go.kr Korean Medical Database http://kmbase.medric.or.kr Total 6 하였으며, 국내전자데이터베이스검색을기반으로실시하였다. 논문검색은 2019년 1월이전출간된논문으로한정하였으며, 한국전통지식포탈, 학술연구정보서비스 (Research Information Sharing Service, RISS), 전통의학지식포털 (Oriental Medicine Advanced Searching Integrated System, OASIS), 과학기술정보통합서비스 (National Digital Science Library, NDSL), 국회도서관, 한국의학논문데이터베이스 등을통해검색하였다. 검색어는한글로표기된 황련해독탕약침 과 황련해독탕 and 약침 으로한정하였다 (Table I). 2. 대상논문선정기준 상기 6개의 Database 를통하여검색한논문중, 황련해독탕약침을주된치료방법중하나로사용하여임상적으로환자를치료한증례보고 (Case report), 무작위대조군연구 (randomized controlled trial, RCT), 비무작위대조군연구 (non-randomized controlled trial, NRCT) 논문을선정하였다. 실험연구, 황련해독탕약침사용과관련성이없는논문, 단일약침을사용하지않은논문, 황련해독탕약침을사용하지않은논문, 황련해독탕약침을주된치료방법으로사용하지않은논문, 증례보고나대조군연구가아닌논문은선정대상에서제외하였다. 3. 대상논문선정결과 상기데이터베이스에서상기검색어로검색한결과, 총 213개의논문이검색되었으며, 중복되는논문 107개를제 172 J Korean Med Rehabil 2019;29(2):171-188.

황련해독탕약침치료에대한임상논문고찰 : 국내학술지의증례보고와대조군연구중심으로 외하여, 106개의논문이분석대상으로요약되었다. 이중추가적으로실험연구 15개, 관련성이없는논문 7개, 황련해독탕약침을단일수단으로사용하지않은논문 10 개, 황련해독탕약침을사용하지않은논문 28개, 황련해독탕약침이주치료방법이아닌논문 2개, 증례보고나대조군연구가아닌논문 5개를제외하였다. 결과적으로총 39개의논문이분석대상으로선정되었다 (Fig. 1). 결과»»» 1. 대상논문분석본임상논문고찰의모집단논문 39편중, 증례보고가 34편 7-11,16-44), 대조군연구 5편 45-49) 이었으며, 각논문의저자, 연구형태, 적용된질환, 각증례와대조군연구의모 Fig. 1. A flow chart of the trial selection process. Studies Included in Analysis are 39 thesis. OASIS: Oriental Medicine Advanced Searching Integrated System, RCT: randomized controlled trial, NRCT: non-randomized controlled trial. www.e-jkmr.org 173

이수환 김순중 Table II. Information of Case Studies Author (year) Study design Applied disease Number of patient Acupoint/Dosage Ahn (2002) 7) Case report Behcet s Syndrome 1 GB21/0.3 ml, Site of region (Anus)/ 0.1 ml Park (2014) 8) Case report Grade II Lumbar spondylolisthesis Kim (2015) 9) Case report L-spine disk herniation Kim (2014) 10) Case report Herniated intervertebral lumbar disc patients 4 Ligaments between L4, L5, S1 Spinous process, UB (23, 24, 25, 26, 51, 52)/ 0.1 ml 10 Ligaments between L4, L5, S1 spinous process, BL (23, 24, 25, 26)/0.1 ml 46 L4, L5, S1 Intervertebral ligament, BL (23, 24, 25, 26)/0.1 ml Yang Case report Facial paralysis 25 ST7, ST3/0.2 ml, (2014) 11) ST4/0.1 ml Kim (2016) 16) Case report Chronic urticaria 1 Site of lesion/1.0 ml, LI11, SP10/0.5 ml Frequency of treatment 1 time/2 days 1. Body detoxication method 7 times/week 1. Chuna therapy 2. Herbal medicine 3. Acupuncture 4. Physical therapy 7 times/week 1. Acupuncture 3. Chuna therapy 4. Physical therapy 7 times/week 1. Acupuncture 3. Chuna therapy 4. Physical therapy 1 time/day 1. Acupuncture 2. Electroacupuncture 3. Herbal medication 1 time/day 1. Acupuncture 2. Wet cupping therapy 3. Herbal medication 4. Physical therapy Lee (2017) 17) Case report Cholinergic urticaria 1 BL (13, 15)/0.2 ml Unspecified 1. Acupuncture 3. Melonis Calyx vomiting therapy Kim (2016) 18) Case report Alopecia areata 1 Scalp (site of legion)/0.1 ml Yoon Case report Androgenic (2014) 19) alopecia 1 Scalp (site of legion)/0.1 ml 1 time/day 1. Herbal medication 2. Acupuncture 3. Needle-embedding therapy 4. External therapy Unspecified 1. Herbal medication 2. Acupuncture 3. Needle-embedding therapy Other treatment Outcome 1. Feeling of patients 2. Changes in pictures until admission to discharge 1. NRS 2. Walking distance 1. VAS 2. ODI 1. Grade of disc herniation 2. NRS 3. SF-36 1. House-Brackmann Grade 2. NRS 1. CU-Q20L 2. Urticaria Activity Score 3. Picture evaluation 4. DITI 1. UAS 2. Severity Scoring of Redness (0-3) 3. CU-Q20L 4. Insomia Score 5. Picture of skin legion 1. Visual evaluation 2. VAS 1. Visual evaluation 2. VAS 174 J Korean Med Rehabil 2019;29(2):171-188.

황련해독탕약침치료에대한임상논문고찰 : 국내학술지의증례보고와대조군연구중심으로 Table II. Continued Author (year) Study design Applied disease Kim (2015) 20) Case report Allergic contact dermatitis Eom (2014) 21) Case report Allergic contact dermatitis Lim (2015) 22) Case report Nummular dermatitis with allergic dermatitis Lim (2015) 23) Case report Contact dermatitis by pain relieving patch deteriorated after taking lotus root Number of patient Acupoint/Dosage 1 LI11/0.25 ml, Site of pain/0.1 ml Frequency of treatment 1 time/day 1. Herbal medication 2. Acupuncture 3. Carbon phototherapy 4. External therapy 1 Ashi-point/0.8 ml 2 times/day 1. Herbal medication 2. External therapy 3. Acupuncture 1 Acupoints near site of lesion/2.0 ml 1 Acupoints near site of lesion/1.0 ml Unspecified 1. Herbal medication 2. Acupuncture 3. External therapy 5 times/week 1. Acupuncture 3. External therapy Other treatment Outcome Jeong Case report Essential tremor 3 CV (23, 17)/0.2 ml Unspecified Acupuncture NRS (2013) 24) 1. SCORAD Index 2. VAS 1. NRS 2. DLQI 1. VAS 2. Visual evaluiation VAS Shin (2014) 25) Case report Steroid rebound phenomenon after steroids treatment for pompholyx Hwang Case report Stroke patient with (2016) 26) hot flushes Kim (2016) 27) Case report Allergic purpura 2 ST36/0.25 ml, Site of lesion/0.1 ml Kang Case report Hypogeusia induced (2015) 28) by onion juice 1 Site of lesion/1~2 ml Unspecified 1. Acupuncture 1 ST07/0.4 ml 1 time/day 1. Herbal medication 2. Acupuncture 3. Westmed medication 1 time/day 1. Herbal medication 2. Acupuncture 3. External treatment 1 Unspecified Unspecified 1. Herbal medication 2. Acupuncture 3. Electroacupuncture 4. Infrared ray 5. Moxibustion Jung Case report Pityriasis rosea 1 Site of pruritus/0.5 ml 1 time/day 1. Acupuncture (2007) 29) The change of symptoms (Severe, Moderate, Mild, Normal) 1. The frequency of hot flushes 2. The degree of hot flushes 3. PSQI 4. DITI 1. The progress of symptom 2. VAS 1. Self reports 2. VAS 1. Kunz Evaluation Scale 2. VAS www.e-jkmr.org 175

이수환 김순중 Table II. Continued Author (year) Study design Applied disease Lee (2016) 30) Case report Pemphigus vulgaris with generalized pruritus Seo (2015) 31) Case report Failed back surgery syndrome Seo (2016) 32) Case report Failed back surgery syndrome Number of patient Acupoint/Dosage Frequency of treatment 1 BL (18, 13)/0.1 ml 1 time/day 1. Herbal medication 2. Acupuncture 3. Westmed treatment 4. Extrernal therapy 5. Carbon phototherapy 10 Lumbosacral spinous process, Intraspinous process, BL (23, 24, 25, 26)/0.1 ml 4 GV (3, 30), BL (23, 24), Other acupoint Kim (2015) 33) Case report Acne 22 Acne concentreated site/0.1 ml 7 times/week 1. Chuna therapy 3. Acupuncture 4. Physical therapy Unspecified 1. Acupuncture 3. Relaxative Chuna 4. Physical therapy 1 time/week 1. Herbal medication 2. Extrusion treatment Jo (2017) 34) Case report Eczema with oozing 23 LI4, ST36/0.5 ml Unspecified 1. Herbal medication 2. Acupuncture Hong Case report Seborrheic dermatitis 2 LI20, SI18, (2012) 35) ST7/Unspecified Other treatment Outcome Skin observation 1. NRS 2. PFWD 3. ODI 1. VAS 2. PFWD 3. ODI 1. KAGS 2. Evaluation of patient satisfaction VAS Unspecified Acupuncture VAS Heo (2015) 36) Case report Pressure ulcer 3 Site of lesion/0.1 ml 1 time/day 1. Herbal medication 2. External treatment Lee (2003) 37) Case report Chronic conjunctivitis or xerophthalmia 1 B15, B18/0.05 ml 1~2 times/week AHCPR stages of pressure ulcer External treatment Visual evaluation Cho (2003) 38) Case report Chest heating sensation Hong Case report Piriformis muscle (2014) 39) syndrome Park (2014) 40) Case report Osgood-Schlatter disease 2 BL (13, 14, 15)/0.3 ml 1 time/day Herbal medication DITI 1 Trigger points/1.5 ml 1 time/day 1. Acupuncture 2. Electroacupuncture 3. Herbal medication 4. Cupping therapy 5. Physical therapy 6. Rehabilitation treatment 2 Tibial tuberosity tender point/0.4 ml 1. NRS 2. Physical examination 3. DITI 1 time/week Acupuncture Subjective pain evaluation Lee (2018) 41) Case report Psoriasis 1 Site of lesion/0.2 ml 6 times/week 1. Acupuncture 3. Ointment treatment 1. PASI Score 2. Subjective pruritus 176 J Korean Med Rehabil 2019;29(2):171-188.

황련해독탕약침치료에대한임상논문고찰 : 국내학술지의증례보고와대조군연구중심으로 Table II. Continued Author (year) Study design Applied disease Number of patient Acupoint/Dosage Frequency of treatment Huh (2007) 42) Case report Herpes zoster 2 Ashi-point/0.05 ml 1 time/day 1. Acupuncture Je (2010) 43) Case report Post-stroke depression Other treatment Outcome 15 GB21, LI11/0.5 ml 5 times/week Acupuncture 1. BDI 2. HAM-D 3. MMT 4. LFT 5. RFT Jang (2003) 44) Case report Headache 82 GB20/1 ml Unspecified None 1. Period of Headache 2. Region of Headache 3. Headache Score (0-4) NRS: Numeric Rating Scale, VAS: Visual Analogue Scale, ODI: Oswestry Disability Index, SF-36: short-form 3, CU-Q20L: Chronic urticaria Quality of Life Questionaire, DITI: digital infrared thermal imaging, UAS: Urticaria Activity Score, SCORAD Index: the SCORAD Index for Severity Scoring of Atopic Dermatitis, DLQI: Dermatology Life Quality Index, PSQI: Pittsburgh sleep quality index, PFWD: pain-free walking distance, KAGS: Clinical pictures and Korean Acne Grading System, AHCPR: Agency for Health Care Policy and Research, PASI: Pruritus Score According to Sleep Disturbance, BDI: beck depression inventory, HAM-D: Hamilton Rating Scale for Depression, MMT: Manual Muscle Test, LFT: Liver Functional Test, RFT: Renal Functional Test. VAS Table III. Information of Controlled Studies Author (year) Study design Lee (2012) 45) RCT Neck pain caused by traffic accidents Kim (2006) 46) RCT Functional headache Lee (2014) 47) RCT Cervical pain caused by traffic accidents Kim (2018) 48) NRCT Cervical pain caused by traffic accidents Lee (2015) 49) NRCT Peripheral facial paralysis Applied disease Intervention Control Acupoint/Dosage HHT pharmacopuncture +OT (n=24) HHT pharmacopuncture (n=13) HHT pharmacopuncture +OT (n=20) HHT pharmacopuncture +OT (n=22) HHT pharmacopuncture +OT (n=17) 1. CT+OT (n=29) 2. HHT pharmacopuncture +CT+OT (n=34) Ashi-point/ 1.0 ml N/S (n=13) GB (20, 21), LI4/0.1 ml BV+OT (n=20) GB (20, 21), SI15/ 0.1~0.2 ml 1. BV+OT (n=18) 2. JSEH+OT (n=12) Tender point/ 0.1 ml JH+OT (n=17) ST (3, 4, 7)/ 0.5 ml, TE17/ unspecified Frequency of treatment 2 times/week 1. Acupuncture Other treatment Outcome 1. VAS 2. NDI 1 time/2 days None 1. VAS 2. BPI 1 time/2 days 1. Acupuncture 3. Physical therapy 1 time/day 1. Acupuncture 3. Physical therapy 5 times/week 1. Acupuncture 2. Electroacupuncture 3. Herbal medication 4. Westmed treatment 5. Infrared therapy 6. Moxibustion 1. VAS 2. Pain threshold 3. NDI 1. NDI 2. PGA 1. House-Brackmann Grading System 2. Y-System 3. Sunnybrook Scale RCT: randomized controlled trial, HHT: Hwangryunhaedok-tang, OT: other treatment, CT: Chuna therapy, VAS: Visual Analogue Scale, NDI: Neck Disability Index, N/S: normal saline, BPI: brief pain inventory, BV: bee venom pharmacopuncture, NRCT: non-randomized controlled trial, JSEH: Jungsungeouhyul pharmacopuncture, PGA: patient's global assessment, JH: Jahague Pharmacopuncture, Y-System: Yanagihara s Unweighted Grading System. www.e-jkmr.org 177

이수환 김순중 집단규모, 시술부위및시술양, 시술빈도, 타병행치료, 결과도출방법등에대해분석하였으며, 결과내용은다음의표와같다 (Table II, III). 2. 황련해독탕약침적용질환분류 39편의모집단논문중, 임상적으로적용되어효과가있는질환은근골격계및피부외과계질환이대다수를차지하였다. 단일질환으로는알레르기성피부염 20-22), 교통사고로인한경추통 45,47,48) 이각 3편, 요추추간판탈출증 9,10), 안면마비 11,49), 두드러기 16,17), 탈모 18,19), 척추수술후실패증후군 31,32), 두통 44,46) 이각 2편, 베체트병 7), 척추전방전위증 8), 접촉성피부염 23), 본태성진전 24), 한포진 25), 안면홍 조 26), 알레르기성자반증 27), 미각장애 28), 장미색비강진 29), 심상성천포창 30), 여드름 33), 삼출을주소증으로한습진 34), 지루성피부염 35), 욕창 36), 만성결막염또는안구건조증 37), 흉부상열감 38), 이상근증후군 39), 오스굿- 슐라터병 40), 건선 41), 대상포진 42), 뇌졸중후우울증 43) 이각 1편씩보고되었다. 3. 황련해독탕약침증례보고모집단분석증례보고 34편의논문중 1예논문이 17편 7,16-23,25,26,28-30, 37,39,41) (50%), 2예논문이 5편 27,35,38,40,42) (15%), 3예논문이 2편 24,36) (6%), 4예논문이 2편 8,32) (6%), 10예논문 2편 9,31) (6%), 15예논문 1편 43) (3%), 22예논문 1편 33) (3%), 23예논문 1편 34) (3%), 25예논문이 1편 11) (3%), 46예논문 1편 10) Fig. 2. The analysis of case report. Fifty percent of thesis are 1 case thesis. Fig. 3. The analysis of treating site of case report. Acupoint is the largest portion of treating site. AP: acupoint, AS: anatomical site, NAP: not acupoint. 178 J Korean Med Rehabil 2019;29(2):171-188.

황련해독탕약침치료에대한임상논문고찰 : 국내학술지의증례보고와대조군연구중심으로 (3%), 82예논문 1편 44) (3%) 이었다 (Fig. 2). 무작위대조군연구및비무작위대조군연구 5편의논문중, 피험자평균인원수는약 48명이었으며, 가장적은피험자수는 26명 46), 가장많은피험자수는 87명 45) 으로조사되었다. 4. 황련해독탕약침시술분석 1) 시술부위황련해독탕약침증례보고 34편의논문중, 시침한경혈의명칭을정확히나타낸논문은 11편 11,17,24,26,30,34,35,37,38,43,44), 아시혈 환처등해부학적부위를사용한논문 10편 18,19,21, 25,29,33,36,39-41), 경혈과해부학적부위를모두활용한논문 9편 7,8,9,16,20,23,27,31,42), 경혈을사용하였으나, 정확한혈위명을명시하지않은논문 1편 22), 경혈은명시되었으나, 해부 학적부위가명시되지않은논문 1편 32), 혈위나부위에대한명시가없는논문 1편 28) 으로조사되었다 (Fig. 3). RCT 및 NRCT 논문 5편중, 단독경혈을사용한논문 3편 46,47,49), 아시혈등해부학적부위또는환처를사용한논문 1편 48), 경혈과해부학적부위를모두활용한논문 1편 45) 으로조사되었다 (Fig. 4). 2) 시술방법증례보고 34편의논문중, 황련해독탕약침의주입기방향을언급한논문은 3편 24,36,41), 자침깊이를명시한논문 2 편 9,24), 시술자의숙련도를명시한논문은없었다. 총주입량은 0.2~3 ml의범위를나타내었으며, 총주입량이불분명한논문 4편 25,28,31,35), 혈위별주입량이동일한논문 18편 8,9,10,17-19,24,26,30,31,33,36,38,39,41-44), 혈위별주입량이동일하지않 Fig. 4. The analysis of treating site of randomized controlled trials and non-randomized controlled trials. More than 50% of the treating site is acupoint only. AP: acupoint, AS: anatomical site. Fig. 5. The analysis about injected point of case report. Same amount per point is the largest group. SAPP: same amount per point, NSAPP: not same amount per point. www.e-jkmr.org 179

이수환 김순중 은논문 6편 7,11,16,21,27,37), 주입량이동일한지확인불가능한논문 10편 21-23,25,28,29,32,34,35,40) 으로조사되었다 (Fig. 5). RCT 및 NRCT 5편의논문중, 황련해독탕약침주입기방향을언급한논문은 1편 47) 이었으며, 자침깊이를언급한논문은없었다. 시술자의숙련도를언급한논문은 1편 45) 이었다. 주입량의범위는 0.6~1 ml였으며, 주입량이불분명한논문은없었다. 혈위별주입량이동일한논문은 2 편 46,48) 이었으며, 주입량이동일하지않은논문 1편 47), 주입량이동일한지확인불가능한논문 2편 45,49) 으로조사되었다 (Fig. 6). 3) 시술횟수및기간증례보고논문 34편에서시술횟수가명시된논문은 23편 7-11,16,18,20,21,23,26,27,29-31,33,37-43), 시술횟수가명시되지않은논문 11편 17,19,22.24,25,28,32,34-36,44), 시술횟수가매일인논문 16편 11,16,18,20,21,26,27,29-31,33,36,38-40,42), 시술횟수가주 2~3회인논문 2편 7,37), 시술횟수가주 4~6회인논문 6편 8-10,23,1,43) 으로조사되었다 (Fig. 7). RCT 및 NRCT 5편의논문중, 5편모두시술횟수가명시되어있었으며, 시술횟수가매일인논문은 1편 48), 시술횟수가주 2~3회인논문은 3편 45-47), 시술횟수가 4~6회인논문은 1편 49) 으로조사되었다 (Fig. 8). Fig. 6. The analysis about injected point of randomized controlled trials and non-randomized controlled trials. Three theses show the injected amount. SAPP: same amount per point, NSAPP: not same amount per point. Fig. 7. The frequency of Hwangryunhaedok-tang (HHT) pharmacopuncture treatment of case report. Everyday is the largest portion of HHT pharmacopuncture treatment frequency. 180 J Korean Med Rehabil 2019;29(2):171-188.

황련해독탕약침치료에대한임상논문고찰 : 국내학술지의증례보고와대조군연구중심으로 5. 대상질환의한방변증및병인 황련해독탕약침임상논문 39편에서각각의질환에대해명시된한방변증을조사한결과, 蟲證 7), 陽虛 8,10), 陰虛 26), 痰飮 8), 風寒濕 8,11,17,37), 外傷 10), 勞傷 10), 瘀血 10,18,36,41,45,48,49), 肝氣鬱結 11), 氣血兩虛 11,18,19), 風熱證 16,17,20,21,27,29,35), 傷寒熱毒 17,23), 血熱 17,18,26,29,38,41), 食毒 17), 濕熱 18,20-23,25,27,41), 實熱證 33), 肝腎不足 18,25), 七情 19,37,46), 血虛風燥 22,29), 傷心脾 28), 心火脾濕 30,41), 濕症 34), 乾症 34), 陽明胃熱 35), 肝熱 37), 挫閃腰痛 39) 39), 風腰痛등으로조사되었다. 6. 황련해독탕약침의효과분석및평가도구증례보고논문 34편및 RCT NRCT 논문 5편모두임상적또는통계적으로유의한증상개선이있다고보고되었다. 부작용이보고된논문은없었다. 대상질환치료결과에대한평가도구로는 Numerical Rating Scale (NRS) 8 편 8,10,11,21,24,26,31,39), Walking Distance 1편 8), Visual Analogue Scale 12편 9,18-20,22,23,27,28,32,34,35,42), Oswestry Disability Index 3편 9,31,32), 추간판탈출정도 1편 10), Short-form 36 1편 10), House-Brackmann Grade 1편 11), Urticaria Activity Score 2편 20,21), digital infrared thermal imaging 4편 16,26,38,39), 불면증시간 17), the SCORAD Index for Severity Scoring of Fig. 8. The frequency of Hwangryunhaedok-tang (HHT) pharmacopuncture treatment of randomized controlled trials and nonrandomized controlled trials. The largest part of HHT pharmacopuncture treatment frequency is 2-3 times/week. Fig. 9. The Evaluating Scale of more than 1 case. Visual Analogue Scale (VAS) is the largest part of evaluating scale. NRS: Numerical Rating Scale, ODI: Oswestry Disability Index, UAS: Urticaria Activity Score, DITI: digital infrared thermal imaging, PFWD: pain-free walking distance. www.e-jkmr.org 181

이수환 김순중 Atopic Dermatitis (SCORAD Index) 1편 20), Dermatology Life Quality Index 1편 21), Pittsburgh sleep quality index 1편 26), Kunz Evaluation Scale 1편 29), Pain-free Walking Distance 2편 31,32), Clinical pictures and Korean Acne Grading System 1편 33), Agency for Health Care Policy and Research 1편 36), 이학적검사 1편 39), Pruritus Score According to Sleep Disturbance 1편 41), beck depression inventory/hamilton Rating Scale for Depression/Manual Muscle Test/Liver Functional Test/ Renal Functional Test 각 1편 43) 으로조사되었다. 증례보고논문에있어추적관찰한논문은총 3편이었으며, 치료종결후 2주및 2개월 1편 16), 종결후 1개월 1편 27), 종결후 1년 1편 35) 으로조사되었다 (Fig. 9). RCT NRCT 논문 5편중치료종결후추적관찰한논문은없었다. 39편의논문모두결과도출후한계점과개선점을결론부에간단히명시하였다. 7. 병행치료에대한분석증례보고논문 34편중황련해독탕약침을단독으로사용한논문은 1편 44) 에그쳤다. 호침치료를병행한논문은 26편 8-11,16-28,32,34-36,39-43), 전침치료를병행한논문 6편 11,23, 29-31,39), 부항치료를병행한논문 2편 16,39), 한약물치료를병행한논문 27편 7-11,16-23,25-34,38,39,41,42), 물리치료를병행한논문 7편 8-10,16,31,32,39), 추나요법을병행한논문 5편 8-10,31,32), 외치요법을병행한논문 10편 18,20-23,27,30,36,37,41), 양약치료를병행한논문 2편 26,30) 이었으며, 기타병행된요법으로는인체해독요법 7), 과체토법 17), 매선요법 18,19), Carbon 광선치료 20,22), Infrared 23), 뜸요법 23), 압출치료 33) 그리고재활치료 39) 로조사되었다. RCT 및 NRCT 5편에서황련해독탕약침을단독으로사용한논문 1편 46), 호침치료를병행한논문 4편 45,47-49), 전침치료를병행한논문 1편 49), 한약물치료를병행한논문 4편 45,47-49), 물리치료를병행한논문 2편 47,48), 추나요법을병행한논문 1편 45), 양약치료를병행한논문 49), 기타병행된요법은 Infrared 49) 로조사되었다. 8. Controlled Study 연구설계 5편의 RCT 및 NRCT 논문중 1편 46) 만이대조군집단에생리식염수를위약으로사용하였다. 나머지 4편의경우는 Table IV. Type of Group in Controlled Trials Experimental group Control group Number HHT pharmacopuncture N/S 1 HHT pharmacopuncture+ot OT 4 Total - 5 HHT: Hwangryunhaedok-tang, OT: other treatment, N/S: normal saline. 각각추나치료 추나와황련해독탕약침동시시술군 45), 분리정제봉약침군 47,48), 중성어혈약침군 48), 자하거약침군 49) 으로대조군을구성하였다 (Table IV). 9. 대조군연구논문의질및오류평가 대조군연구논문의질및오류를평가함에있어, 2명의연구자 (SHL, SJK) 가독립적으로비뚤림평가를시행하였으며, 의견이서로다를경우충분한토의롤통해결론을도출하였다. 본임상논문고찰에서질평가를하기위해 3편의 RCT 45-47) 에는 Risk of Bias (RoB) 를적용하였으며, 2편의 NRCT 48,49) 에는 Risk of Bias for Nonrandomized Studies (RoBANS) 를적용하여평가하였다. 무작위대조군연구 3편의경우, 무작위배정순서생성항목에있어, 1 편 45) 은블록무작위배정방법을사용하여 낮음 으로평가되었으며, 잔여 2편 46,47) 은명시된무작위배정법이없어 불확실 로평가되었다. 배정순서은폐항목에있어, 3편모두 불확실 로평가되었다. 연구참여자 연구자에대한맹검항목에있어, 2편의논문 45,47) 은연구자의의지가개입되지못하게함을명시함으로써 낮음 으로평가되었고, 잔여 1편은맹검에대한명시가없어 불확실 로평가되었다. 결과평가에대한맹검에있어 3편모두 불확실 로평가되었다. 완전하지않은결과보고및선택적보고항목에있어, 모두결측치가없으며측정수치를빠짐없이기재하였기에 낮음 으로평가되었다. 기타교란변수제거항목에있어, 1편은타치료를배제함으로써 낮음 으로평가되었고, 잔여 2편의경우타치료를병행하여 높음 으로평가되었다 (Table V). 비무작위대조군연구들은 2편 48,49) 이었으며, 대상군비교가능성, 대상군선정항목에있어, 2편의논문 48,49) 모두 불확실 로평가되었다. 교란변수항목에있어, 2편의논문 48,49) 모두황련해독탕약침외타치료를병행하여 높음 으로평가되었다. 연구자 연구참여 182 J Korean Med Rehabil 2019;29(2):171-188.

황련해독탕약침치료에대한임상논문고찰 : 국내학술지의증례보고와대조군연구중심으로 Table V. Quality Assessment of Each Included Randomized Controlled Trials Risk of bias First author Adequate Blinding of Blinding of Incomplete Free of (year) Allocation Free of sequence participants outcome outcome data selective concealment other bias generation and personnel assessment addressed reporting Lee (2002) 45) L U L U L L H Kim (2006) 46) U U U U L L L Lee (2014) 47) U U L U L L H Risk of bias: Low risk of bias (L), High risk of bias (H), and Unclear (U). Table VI. Quality Assessment of Each Included Non-Randomized Controlled Trials First author (year) Conefounding variables Selection of participants Risk of bias for non-randomized studies Measurement of intervention Blinding of participants and personnel Blinding for outcome assessment Incomplete outcome data Kim (2018) 48) U U H U U L L Lee (2015) 49) U L H U U L L Risk of bias for non-randomized studies: Low risk of bias (L), Hgh risk of bias (H), and Unclear (U). Selective outcome reporting 자맹검항목과결과평가에대한맹검항목에있어 2편의논문 48,49) 모두명시된바가없어 불확실 로평가되었다. 불충분하거나선택적결과보고항목에있어, 2편 48,49) 모두결측치가없으며측정수치를빠짐없이기재하였기에 낮음 으로평가되었다 (Table VI). 고찰»»» 藥鍼療法은한의학적인변증, 진단에의거하여한약재에서추출, 정제, 희석, 혼합, 분리, 증식또는융합한다양한약침약물을약침주입기를이용하여經穴, 아시혈, 경근, 관절강내등에주입시키는한방의료행위이다. 현재임상에서는주로경락장에위치한민감한부위인경락에약침을주입하여각해당질환을치료하고있다 50). 黃連解毒湯은 方藥合編 51) 에 瀉火解毒의효능이있고, 三焦의熱毒으로인해발생한증상과, 外科의癰腫疔毒을치료한다 고기재되어있다. 황련해독탕약침은위와같은방제를기반으로하여개발된팔강약침중하나이다 1). 2018년 11월까지보고된실험연구에의거하면, 황련해독탕약침시술이 i-nitric oxide synthases 생성을억제하여알레르기성비염의발생률을낮추는등이비인후과질환에사용될수있음을확인하였으며 3), 발목염좌에서 Weight Bearing Ratio를측정한결과대조군에비해유의한효과를보인것을통해근골격계질환에사용될수있음을보였다 52). 또한대장염유발백서에서 tumor-necrosis factor-a, interleukin-6를측정전후비교한결과, 유의한감소가나타나는것을통해내과적질환에도응용가능하다는것을보여주고있다 5). 위와같이기존한의학적문헌근거와, 이를근거로한다양한목적의실험논문이있으며, 추가적으로다양한질환의증례보고와대조군연구가보고되고있다. 현재까지자하거약침 12), 오공약침 13), 홍화약침 14) 그리고중성어혈약침 15) 등다른종류의약침의경우, 국내데이터베이스검색을통해임상논문고찰논문이보고되었으며, 내용역시약침주입부위, 주입량, 효과, 병행치료등구체적이고세분화된내용까지비교분석되어있다. 따라서임상한의사들이상기한약침을임상에적용함에있어, 논문적근거를토대로보다객관적인진료를가능하게한다. 하지만황련해독탕약침의임상적증례보고와대조군연구는다수발표되고있으나, 임상논문을종합한고찰논문은보고되지않았다. 이에본저자는국내학술정보검색데이터베이스를이용하여인체대상황련해독탕약침시술결과논문들을수집하였으며, 이에대한다양한항목의고찰을진행하였고, 다음과같은결과를얻게되었다. 6개의국내전자데이터베이스검색을통해최종적으로 www.e-jkmr.org 183

이수환 김순중 39편의논문을설정하였으며, 그중증례보고가 34편 7-11,16-44), 대조군연구가 5편 45-49) 였으며, 질환 시술내용 효과분석 병행치료등의상세한내용들이기재되어있었다. 황련해독탕약침을시술하여효과가있다고보고된질환은근골격계, 피부외과계및신경계질환이대부분을차지하였다. 기타질환으로만성결막염또는안구건조증 37), 흉부상열감 38), 뇌졸중후우울증 43) 을치료했을시임상적으로의의가있었다고보고되었다. 황련해독탕탕제의본연의효능인消炎의효능을활용하여근육및골격에발생한염증을억제하고, 上焦와中焦의열을내려주는淸熱의효능을적용하여피부외과계염증질환에적용한것으로보인다. 다양한질환이보고되었음에도불구하고, 연구설계자체및연구수행과정에서미비한점을확인할수있었다. 증례보고 34편의논문중, 80% 이상에해당하는논문이 10예이하의 Case report 논문으로조사되었다. 증례수가충분하지않아각적용질환에보편적으로적용가능한지의여부를명확히판단하기곤란하다. Case 수가적을경우, 치료결과보고에대한신빙성이저하될수있다. 이에따라, 향후증례연구시단일질환에있어 10예이상의충분한증례가확보되어논문이보고된다면임상한의사들이실제진료함에있어황련해독탕약침시술시보다객관적인근거자료가될수있다. 또한시술부위에있어, 증례보고 1편 28) 을제외하고는대부분경혈의명칭이나아시혈 환처등명확한부위를명시하였다. 하지만해당경혈및시술부위선택에대한근거가명시된논문은없었다. 시술부위선택근거가명시되지않아치료자가어떤치료의도로시술부위를설정하였는지파악하기곤란하다. 향후연구시해당시술부위선택근거에대한명시가있을경우, 임상에활용함에있어보다근거중심적인진료가가능하리라사료된다. 시술방법의경우, 주입기방향및시술자의숙련도를언급한논문은소수에불과하였다. 아직까지임상한의사가진료함에있어, 주입기방향과시술자의숙련도의중요성에대한인지가부족한것으로사료된다. 주입기방향과깊이가명시된논문이소수에불과하여, 질환별약침치료를적용함에있어, 동일한치료효과를보장할수없으며, 더욱이시술자의숙련도에따라약침시술의결과가달라질수있기에치료효과의재현성을보장하기가곤란하다. 따라서이후연구설계시연구의재현성을위 해주입기방향, 자침깊이그리고시술자의숙련도를명시하게된다면, 보다정확한근거를바탕으로임상에적용할수있으리라사료된다. 주입량이동일한지확인불가능한논문이전체증례보고의 30% 정도로조사되었다. Acupoint별주입량에대한정확한명시가있어야이후동일질환에대해황련해독탕약침을시술함에있어해당논문에서제시한치료효과와유사한효과를낼수있으리라사료된다. 약침시술에서 point 별규격화된주입량이명시된점이없고, 추가적으로 point 별주입량을규격화한다면타연구를수행함에있어보다더객관적인지표로작용할수있을것이다. 또한시술횟수및기간에있어, 약 30% 에해당하는논문이시술횟수가명시되지않았으며, 상기했던질환들에황련해독탕약침을적용시동일한치료효과를내기위한근거가불충분하다. 차후발표되는논문에는보다객관적인근거확립을위해시술횟수와기간이정확히명시될필요가있다. 황련해독탕약침모집단논문 39편에있어, 각논문에명시된질환별한방변증을조사한결과, 瘀血이나熱證이다수를차지하는것으로나타났다. 한의과대학공통교육과정인한방병리학에서명시된변증명이사용된다면, 황련해독탕약침을적용함에있어보다더규격화한자료를만들수있으리라사료된다. 황련해독탕약침시술후 39편논문모두임상적또는통계적으로유의한증상호전이있다고보고되었으며, 부작용을보고한논문은전무하였다. 대상질환치료결과평가도구로는 VAS 와 NRS가각각 12편 9,18-20,22,23,27,28,32,34,35,42) 과 8편 8,10,11,21,24,26,31,39) 으로, 전체논문의 50% 이상을차지하였다. 추적관찰항목에있어, 추적관찰을시행한논문은전체논문중약 8% 에불과하였다. 추적관찰이시행되지않을경우, 실제환자를대상으로한예후상담과향후치료계획을설정하기곤란하다. 향후연구를설계함에있어, 황련해독탕약침의효과지속성을파악하기위해추적관찰을진행하게된다면, 질병치료계획을세움에있어보다수월하게할수있으리라사료된다. 황련해독탕약침을질환에적용함에있어, 효과를정확하게증명하기위해서는단독으로황련해독탕약침을사용해야하고, 타치료방법을배제해야한다. 그러나황련해독탕약침을단독으로사용한논문은증례보고와 RCT 각 1편에그쳤다. 타치료방법을병행할경우, 교란변수가 184 J Korean Med Rehabil 2019;29(2):171-188.

황련해독탕약침치료에대한임상논문고찰 : 국내학술지의증례보고와대조군연구중심으로 삽입되어논문에명시된결과가황련해독탕약침단독효능인지타요법에의한효능인지를증명하기어렵다. 따라서차후증례및대조군연구설계시황련해독탕약침의단독효능을증명하기위해교란변수인병행요법을제외시키는방향으로개선해야할것이다. 대조군연구의연구설계에서단 1편만이대조군집단에생리식염수를위약으로사용하였으며, 나머지논문의경우, 치료효과를증명함에있어변수가될수있는타약침치료혹은추나치료등을병행하였다. 향후연구설계시에는대조군집단에실험군에주입하는황련해독탕약침과외견상동일하며, 다른교란변수성분이개입되지않도록생리식염수등으로대체하여교란변수를최소화시킨다면보다더황련해독탕약침의단독효능을알수있을것이다. 마지막으로, 대조군연구모집단논문 5편의오류및질평가를하였으며, 3편의 RCT 45-47) 에는 RoB를, 2편의 NRCT 48-49) 에는 RoBANS 를적용하여평가하였다. 평가결과, 상당수항목에서 불확실 과 높음 으로평가되었다. 불확실 과 높음 으로평가된항목이다수있어, 연구의오류가있을수있다는가능성이다분하다. 상기한연구평가내용을통해, 추후연구에서 불확실 과 높음 으로평가된항목을개선한다면, 논문작성에있어오류를줄이고다양한항목에서질적수준이높은논문을작성할수있을것이다. 본고에서는본논문을통해국내학술지에보고된황련해독탕약침의증례보고논문및대조군연구논문 39편을통해, 시술후증상이임상적및통계적으로호전된결과를확인하였다. 하지만이를시행한연구설계에있어, 상기한여러항목에서미진한부분들이발견되었다. 이와같이부족한점을보완한후결과를정리한다면임상에응용시많은한의사가공통적으로해당질환에해당약침을적용할수있도록더욱근거중심적인척도로써의역할을할수있을것이다. 본고는황련해독탕약침이국내 Database 를기초로, 학술적문헌이아닌실제임상에응용되었을때어떤결과를나타내고보고되었는지종합한논문이며, 지금까지진행되었던연구들을종합하여다양한항목에서비교분석을시도한첫논문이라는점에의의가있으나, 단지경향성만을분석한한계가있다. 따라서임상논문을단순비교연구한점에그쳐향후체계적문헌고찰이추가로이루어진다면임상에서황련해독 탕약침을사용함에있어더정확한근거자료를바탕으로진료할수있으리라사료된다. 결론»»» 2019년 1월이전출간된논문에서, 실제환자를대상으로황련해독탕약침을시술한결과를보고한논문 39편을비교분석하여다음과같은결과를얻었다. 1. 39편의논문중증례보고가 34편, 대조군연구가 5편이었다. 2. 39편의논문중황련해독탕약침은임상에서근골격계및피부외과계질환에적용되었다. 단일질환으로는, 알레르기성피부염, 교통사고로인한경추통이각 3편씩으로최다수로보고되었다. 3. 증례보고 34편의논문중 1예논문이 50% 로반수에해당하였고, 대다수의논문에서시술부위가명시되어있었다. 4. 시술방법의경우, 증례보고 13편의논문중, 주입기방향, 시술자의숙련도, 자침깊이를명시한논문은소수에그쳤다. 혈위별주입량을정확히명시하지않은논문이 10편으로보고되어전체의약 30% 에이르렀다. RCT, NRCT 논문의경우, 주입량명시논문은 3편에불과했다. 5. 39편의대상논문중, 황련해독탕약침의한방변증과병인에있어, 주로瘀血이나熱證이다수를차지하는것으로나타났다. 6. 병행치료에있어, 황련해독탕약침을단독으로사용한논문은 Case report 1편, 대조군연구 1편에그쳤다. 7. 대조군연구에있어, RoB와 RoBANS를통해논문의오류와질을평가한결과, 5편의대부분의항목에서 불확실 (Unclear) 로판정되었다. 8. 본논문은황련해독탕약침의임상질환적용례논문을비교분석한논문으로, 향후추가적인체계적문헌고찰 (Systemic Review) 이요구된다. References»»» 1. Korean Pharmacopuncture Institute Science Committee. www.e-jkmr.org 185

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