불면 장애에 대한 약침술 치료법 제안을 위한 체계적 문헌 고찰과 메타 분석 연구 = A Systematic Review and Meta-Analysis of Pharmacopuncture Treatment for Insomnia Disorder

다국어 초록 (Multilingual Abstract)

Objectives: The objective of this study was to perform a systematic review and meta-analysis of pharmacopuncture treatment for insomnia disorder to derive clinical evidence and recommendation grades. Methods: Studies that verified effects of pharmacopuncture on primary insomnia were included. Characteristics and quality of included studies were assessed using Risk of Bias (RoB). Results: A total of 25 studies were selected. Pittsburgh Sleep Quality Index (PSQI) and effective rate were primarily used for outcome measurement. Vitamin B12 was the most used pharmacopuncture material. The most frequently used acupuncture point was Anmian (Ex-HN). The volume of the acupuncture solution ranged from 0.25 mL to 2 mL. Acupuncture treatment depth was 0.5 cm to 2 cm. In three studies, the procedure was performed at 16:00. Meta-analysis of studies revealed that the effective rate of the pharmacopuncture group was significantly higher than the group using sleeping pills group (RR: 1.21, 95% CI: 1.01 to 1.45, p=0.04, I²=69%). PSQI was decreased in the intervention group (MD=-2.19, 95% CI: -2.90 to -1.48, p<0.00001, I²=0%). Effective rates of pharmacopuncture and acupuncture groups were higher than that of the acupuncture group (RR: 1.11, 95% CI: 1.05 to 1.17, p=0.0002, I²=0%). PSQI was decreased in the intervention group (MD=-1.87, 95% CI: -2.36 to -1.38, p<0.00001, I²=0%). Although the effectiveness rate of the pharmacopuncture group was not significantly higher than that of the acupuncture group (RR: 1.12, 95% CI: 0.98 to 1.27, p=0.1, I²=9%), the PSQI was decreased in the pharmacopuncture group (MD=-2.10, 05% CI: -3.29 to -0.91, p=0.0005, I²=34%). The quality of clinical studies was poor. Conclusions: Based on results of this study, it is proper to use 0.5 to 2 mL of pharmacopuncture solution such as Danshen and Ciwujia with a depth of 0.5 to 2 cm at around 4 p.m. to treat insomnia disorder, focusing on Anmian (Ex-HN) and Sameumgyo (SP6).

참고문헌 (Reference)

1 한선정, "일주기 리듬 수면장애" 대한수면연구학회 5 (5): 74-81, 2008

2 이유환, "삼기활력약침이 불면, 피로에 미치는 효과" 대한침구의학회 29 (29): 101-113, 2012

3 김유진, "불면증 환자의 스트레스, 심리적 강인성, 사회적 지지 및 삶의 질 간의 관계" 대한스트레스학회 24 (24): 137-150, 2016

4 임영찬, "불면증 환자에서 스트레스 및 수면 관련 변인이 삶의 질에 미치는 영향" 대한신경정신의학회 55 (55): 277-285, 2016

5 김동희, "불면장애에 대한 혈부축어탕의 체계적 문헌 고찰 및 메타분석 연구" 대한한방신경정신과학회 28 (28): 319-332, 2017

6 서동균, "蟾酥약침이 수면장애 환자의 불면 및 우울 증상에 미치는 영향에 대한 임상적 고찰" 대한침구의학회 32 (32): 175-183, 2015

7 김원일, "完骨 神門 三陰交 自家指壓이 睡眠障碍와 疲勞에 미치는 效果" 경락경혈학회 21 (21): 81-94, 2004

8 윤형선, "不眠환자에 대한 紫河車 藥針 효능의 관한 연구" 대한침구의학회 21 (21): 99-106, 2004

9 Wang W, "Treatment of senile functional insomnia with Ciwujia acupoint injection" 33 (33): 1836-1837, 2012

10 T. Ohta, "Treatment of Persistent Sleep-Wake Schedule Disorders in Adolescents with Methylcobalalmin(Vitamin B12)" 14 (14): 414-419, 1991

11 Zhang H, "The clinical study for insomnia by acupuncture adding acupoint injection" Guangzhou University of Chinese Medicine 2009

12 Bao J, "The clinical curative effect observation of Acupoint injection combined with acupuncture Treated the insomnia of Kidney/Heart Disharmony" Guangxi University of Traditional Chinese Medicine 2017

13 Lim JH, "The Pilot Survey of the Perception on the Practice Pattern, Diagnosis, and Treatment on Korean Medicine Insomnia: Focusing on the Difference between Korean Medical Neuropsychiatry Specialists and Korean Medical General Practitioners" 1-11, 2018

14 Kim KK, "The Effects of CJS03 on 5-HT2c Receptor and Sleep Structure" Neuropsychiatry Graduate School, Daejeon University 2015

15 Xi YB, "Sleep Points Inject Treating 56 Cases of Intractable insomnia with Danshen Injection" 25 (25): 62-63, 2011

16 Song GE, "Research trend of clinical papers for insomnia treatment using Pharmacopuncture in China" 30 (30): 265-274, 2019

17 Mundey K, "Phase-dependent treatment of delayed sleep phase syndrome with melatonin" 28 (28): 1271-1278, 2005

18 Korean Pharmacopuncture Institute, "Pharmacopuncturology" Elsevier Korea 3-5, 2011

19 Kong X, "Observations on the Curative Effect of Acupoint Injection and Acupuncture on Intractable Insomnia" 25 (25): 25-, 2017

20 Xu W, "Observation on Therapeutic Effect of Wrist Ankle Acupuncture Combined with Point Injection on Insomnia" 23 (23): 27-28, 2015

21 Zou X, "Observation on Therapeutic Effect of Acupoint Injection on Insomnia" 10 (10): 52-, 2010

22 Bai X, "Observation on Therapeutic Effect of 50 Cases of Insomnia Treated by Acupoint Injection" 21 (21): 39-, 2006

23 Chai Y, "Observation on Curative Effect of Acupoint Injection and Ear Point Pressing on Insomnia" 37 (37): 2231-2233, 2010

24 Lei R, "Observation of curative effect of acupoint injection of Methycobal injection on insomnia" 34 (34): 38-39, 2016

25 Kim SY, "NECA’s guidance for undertaking systematic reviews and meta-analysis for intervention" National Evidence-based Healthcare Collaborating Agency 64-, 2011

26 National Evidence-based Healthcare Collaborating Agency, "NECA’s guidance for undertaking systematic reviews and meta-analyses for intervention"

27 Liu LS, "Mechanism of acupuncture at Sanyinjiao, Shenmen and Neiguan on hypothalamic 5-HT content and imbalance of Glu/GABA Gln metabolic pathway in insomnia rats"

28 National College of Korean Medicine’s Neuropsychiatry textbook compilation committee, "Korean Neuropsychiatry" Jipmoondang 252-255, 2011

29 Health Insurance Review & Assessment Service, "Healthcare Bigdata Hub. National Interest Disease Statistics"

30 Schunemann H, "GRADE Handbook : handbook for grading the quality of evidence and the strength of recommendations using the GRADE approach. 2013" 2018

31 Xiao J, "Experimental study on the effects of Ciwujia Injection on sleep in rats" 31 (31): 1031-1032, 2009

32 Huang Y, "Evaluation of the curative effect of Danhong injection on senile insomnia" 23 (23): 309-313, 2011

33 Yi PL, "Effects of Electroacupuncture at"Anmian(Extra)"Acupoints on Sleep Activities in Rats : The Implication of the Caudal Nucleus tractus solitarius" 11 : 579-590, 2004

34 American Psychiatric Association, "Diagnostic and statistical manual of mental disorders" Hakjisa 392-393, 2013

35 Choi HY, "Current Clinical Practice of Insomnia" 36 (36): 84-92, 2013

36 Shi R, "Clinical Ｒesearch of Acupuncture Combined with Auricular Point Sticking in Treating Insomnia" 29 (29): 143-144, 2014

37 Quan X., "Clinical study on acupoint injection combined with acupuncture in treating insomnia of heart-kidney noninteraction pattern" Heilongjiang University of Traditional Chinese Medicine 2017

38 Shi L, "Clinical study of acupoint injection of gastrodin in the treatment of insomnia" 9 (9): 41-43, 2011

39 Fu B, "Clinical research of treatment of heart and spleen deficiency type insomnia by acupuncture combined with acupoints injection" 7 (7): 21-23, 2015

40 Zhang X., "Clinical observation of Danshen Ningshen in treating insomnia (blood stasis type)" Changchun University of Chinese Medicine 2020

41 Fei Y, "Clinical observation of 20 cases of insomnia treated with acupoint injection combined with massage technique" 34 (34): 558-559, 2012

42 Du Y, "Clinical Study on Vitamin B12 Combined with Sanzaoren Decoction in Treating Insomnia" 34 (34): 787-788, 2018

43 Zhang P., "Clinical Study on Treatment of Insomnia of Deficiency of Heart and Spleen by Point Injection at Sahwa Point" Guangzhou University of Chinese Medicine 2016

44 Li P., "Clinical Study on Acupoint Injection of Shenmai cooperating with Acupuncture for Treatment of Liver and Kidney Yin Deficiency type of Insomnia" Guangzhou University of Chinese Medicine 2014

45 Huang Y, "Clinical Observation on 50 Cases of Insomnia Treated by Acupoint Injection and Chinese Medicine" 28 (28): 150-151, 2008

46 Gong Y, "Clinical Observation on 29 Cases of Anxiety Insomnia Treated by Injecting Normal Saline at Fengchi Point" 10 (10): 16-17, 2010

47 Zhang C, "Clinical Observation of Qingkailing Acupoint Injection in Treating Insomnia with Internal Disturbance of Phlegm and Heat" 26 (26): 30-31, 2018

48 Leger D, "Chronic insomnia, quality-of-life, and utility scores : comparison with good sleepers in a cross-sectional international survey" 13 (13): 43-51, 2012

49 NCMIK, "CRIS research"

50 Higgins J, "Analysing and presenting results. Cochrane handbook for systematic reviews of interventions 4.2.6" John Wiley & Sons Inc 79-165, 2008

51 Ming X., "Acupoint injection combined with Acupuncture for insomnia with Cardiasplenic Asthenia : a Research Protocol for Clinical trial" Guangzhou University of Chinese Medicine 2014

52 Su J, "Acupoint Injection Combined with Chiropractic Therapy in the Treatment of Insomnia with Yang Deficiency Type" 31 (31): 90-93, 2014

53 Lee JH, "A clinical study on the insomnia treatment of Sanjoincho Pharmacopuncture" 11 (11): 79-86, 2000

54 Bao Z, "60 Cases of Intractable Insomnia Treated by Acupoint Injection and Massage" 34 (34): 945-946, 2014