DOI QR코드

DOI QR Code

산조인탕치료가 여성갱년기 수면장애에 미치는 효과 : 체계적 문헌고찰 및 메타분석

Sanjoin-tang (Suanzaoren decoction) for Insomnia in Menopausal Syndromes: A Systematic Review and Meta-analysis

  • 전지희 (대전대학교 한의과대학 예방의학교실 대학원) ;
  • 최태영 (한국한의학연구원 임상의학부) ;
  • 이명수 (한국한의학연구원 임상의학부) ;
  • 송은혜 (대전대학교 한의과대학 예방의학교실 대학원) ;
  • ;
  • 박선주 (대전대학교 한의과대학 예방의학교실)
  • Jun, Ji Hee (Department of Preventive Medicine, College of Korean Medicine, Daejeon University) ;
  • Choi, Tae-Young (Clinical Medicine Division, Korea Institute of Oriental Medicine) ;
  • Lee, Myeong Soo (Clinical Medicine Division, Korea Institute of Oriental Medicine) ;
  • Song, Eunhye (Department of Preventive Medicine, College of Korean Medicine, Daejeon University) ;
  • Ang, Lin (Korea University of Science and Technology, Korean Convergence Medicine) ;
  • Park, Sunju (Department of Preventive Medicine, College of Korean Medicine, Daejeon University)
  • 투고 : 2020.03.04
  • 심사 : 2020.03.20
  • 발행 : 2020.04.30

초록

Objectives : The purpose of this systematic review was to investigate the efficacy and safety of Sanjoin-tang (Suanzaoren decoction, SZRD) for insomnia in menopausal syndromes. Method : We searched the following databases: PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Science and Technique Journals Database (VIP), Wanfang, Research Information Service System (RISS), OASIS, Korean studies Information Service System (KISS), and National Digital Science Library (NDSL) databases. Randomized controlled trials (RCTs) or quasi-RCTs that used SZRD for women in menopause were included. The methodological quality of each RCT was assessed using the risk of bias tool. Results : In total, nine RCTs were finally included. The included RCTs had a high risk of bias across their domains. Three RCTs examined the effects of SZRD compared with western medicine (WM) in insomnia. Three RCTs showed favorable effects of SZRD with insomnia. Infrastructure also showed that SZRD resulted in better clinical WM (RR 1.19, 95% CI 1.07 to 1.32, P=0.001, I2=0%). Four RCTs showed favorable effects of Modified SZRD with insomnia. Infrastructure also showed that Modified SZRD resulted in better clinical WM (RR 1.13, 95% CI 1.04 to 1.23, P=0.004, I2=0%). Among the 4 RCTs, three RCTs showed an equivalent effect on the total Pittsburh Sleep Quality Index (PSQI). The meta-analysis also showed that Modified SZRD had a superior effect on the total of PSQI (total of PSQI : MD -2.55, 95% CI -3.72 to -1.37, P<0.0001, I2=85%). Only 2 trials reported adverse events and none reported severe adverse events. Conclusion : SZRD appears to be safe, but there is insufficient evidence to make a definitive conclusion because only a few studies reported adverse events. Due to the poor methodological quality of the included studies and the small number of trials included, the evidence cannot be reproduced and assessed. Well-designed RCTs with a larger sample size are needed in the future.

키워드

참고문헌

  1. Takahashi TA, Johnson KM. Menopause. Med Clin North Am. 2015;99(3):521-34. https://doi.org/10.1016/j.mcna.2015.01.006
  2. Kim YH, Ha EH, Shin SJ. A study on the menopausal symptomes and quality of life in middle aged women. J Korean Acad Nurs. 2003;33(5):601-8. https://doi.org/10.4040/jkan.2003.33.5.601
  3. Shin C, Lee S, Lee T, Shin K, Yi H, Kim K, et al. Prevalence of insomnia and its relationship to menopausal status in middleaged Korean women. Psychiatry Clin Neurosci. 2005;59(4):395-402. https://doi.org/10.1111/j.1440-1819.2005.01391.x
  4. Holmberg L, Iversen OE, Rudenstam CM, Hammar M, Kumpulainen E, Jaskiewicz J, et al. Increased risk of recurrence after hormone replacement therapy in breast cancer survivors. J Natl Canc Inst. 2008;100(7):475-82. https://doi.org/10.1093/jnci/djn058
  5. Nelson HD. Commonly used types of postmenopausal estrogen for treatment of hot flashes scientific review. JAMA. 2004;291(13): 1610-20. https://doi.org/10.1001/jama.291.13.1610
  6. Cheng B, Liu Y, Tian J, Gao R, Liu Y. Complementary and alternative medicine for the treatment of insomnia: an overview of scientific evidence from 2008 to 2018. Curr Vasc Pharmacol. 2019.
  7. Singh A, Zhao K. Treatment of insomnia with traditional chinese herbal medicine. Int Rev Neurobiol 2017;135:97-115. https://doi.org/10.1016/bs.irn.2017.02.006
  8. Zhu XS, Liew YL, Liu ZL. Chinese herbal medicine for menopausal symptoms. Cochrane Database Syst Rev. 2016;3:CD009023.
  9. Yeh CH, Arnold CK, Chen YH, Lai JN. Suan zao ren tang as an original treatment for sleep difficulty in climacteric women: a prospective clinical observation. Evid Based Complement Alternat Med. 2011;2011:673813.
  10. Jiang JG, Huang XJ, Chen J. Separation and purification of saponins from semen ziziphus jujuba and their sedative and hypnotic effects. J Pharm Pharmacol. 2007;59(8):1175-80. https://doi.org/10.1211/jpp.59.8.0017
  11. Zhou QH, Zhou XL, Xu MB, Jin TY, Rong PQ, Zheng GQ, et al. Suanzaoren formulae for insomnia: updated clinical evidence and possible mechanisms. Front Pharmacol. 2018;9:76. https://doi.org/10.3389/fphar.2018.00076
  12. Xie CL, Gu Y, Wang WW, Lu L, Fu DL, Liu AJ, et al. Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials. BMC Complement Altern Med. 2013;13:18. https://doi.org/10.1186/1472-6882-13-18
  13. Nie HY, Huang XT, Chen XF, Hu JJ. Systematic evaluation of the therapeutic effect of modified suanzaoren decoction and western medicine on menopausal insomnia. Pract Clin J Integr Tradit Chin Western Med. 2015;15(12):22-4, 34.
  14. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions. Version 5.1.0 (updated March 2011): The Cochrane Collaboration. 2011.
  15. Yang GH. Observation on the therapeutic effect of suanzaoren decoction on insomnia of female menopause Yixue Meixue Meirong. 2015;24(4):313-4.
  16. Li K. Modified suanzaorentang 56 cases improve the quality of sleep in patients with insomnia menopause effectiveness analysis. Systems Med. 2016;1(2):31-3.
  17. Zhang Y. Analysis of the effect of suanzaoren decoction on insomnia of female menopause Med Diet Health. 2018(6):148, 51.
  18. Hou JX. Study on the clinical experience of the treatment of internal emergency with the combination of chinese and western medicine Special Health. 2018(19):252-3.
  19. Li QA, Dai DC, Qiao Y. Observation on the therapeutic effect of suanzaoren decoction on insomnia in menopause China Prac Med. 2013;8(7):154-5.
  20. Yao LN, Tang W. Clinical effect of suanzaoren decoction on insomnia in menopause Family Therapist 2015;12(1):344-5.
  21. Zhao GP, Zhang HL, Xue C, Feng WJ. Efficacy observation of semen ziziphi spinosae decoction on climacteric insomnia. Shanxi TCM. 2017;33(2):20-2.
  22. Zhou Q, Huang XC. Curative Effect Observation of Modified Suanzaoren Decoction on Menopausal Insomnia. Liaoning TCM. 2013;40(6):1165-6.
  23. Zheng J. Clinical efficacy of suanzaorentang (a traditional chinese medicine patent prescription) in treatment of 60 patients with menopause insomnia. Chin J School Doctor 2017;31(7):522-3.
  24. Jang IS, Yang CS, Lee SD, Han CH. A review on herbal medical products associated with toxic events in Korea : mistake and true. J Korean Med. 2007;28(1):1-10.
  25. Schulz KF, Altman DG, Moher D, Consort Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. https://doi.org/10.1136/bmj.c332
  26. Cheng CW, Wu TX, Shang HC, Li YP, Altman DG, Moher D, et al. CONSORT extension for chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration. Ann Intern Med. 2017;167(2):112-21. https://doi.org/10.7326/m16-2977