Efficacy and Safety of Electroacupuncture for Insomnia Disorder: A Multicenter, Randomized, Assessor-Blinded, Controlled Trial

References

• American Psychiatric Association. Sleep-wake disorders. 5th. In: Diagnostic and Statistical Manual of Mental Disorders. Arlington, VA: American Psychiatric Association; 2013.
   Google Scholar
• Nowicki Z, Grabowski K, Cubala WJ, et al. Prevalence of self-reported insomnia in general population of Poland. Psychiatr Pol. 2016;50(1):165–173. doi:10.12740/PP/58771
   Web of Science ®Google Scholar
• Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6(2):97–111. doi:10.1053/smrv.2002.0186
   PubMed Web of Science ®Google Scholar
• Bertisch SM, Pollock BD, Mittleman MA, et al. Insomnia with objective short sleep duration and risk of incident cardiovascular disease and all-cause mortality: Sleep Heart Health Study. Sleep. 2018;41(6). doi:10.1093/sleep/zsy047.
   PubMed Web of Science ®Google Scholar
• Katz DA, McHorney CA. The relationship between insomnia and health-related quality of life in patients with chronic illness. J Fam Pract. 2002;51(3):229–235.
   PubMed Web of Science ®Google Scholar
• Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Bixler EO. Insomnia with objective short sleep duration is associated with type 2 diabetes: a population-based study. Diabetes Care. 2009;32(11):1980–1985. doi:10.2337/dc09-0284
   PubMed Web of Science ®Google Scholar
• Woznica AA, Carney CE, Kuo JR, Moss TG. The insomnia and suicide link: toward an enhanced understanding of this relationship. Sleep Med Rev. 2015;22:37–46. doi:10.1016/j.smrv.2014.10.004
   PubMed Web of Science ®Google Scholar
• Sateia MJ, Buysse DJ, Krystal AD, Neubauer DN, Heald JL. Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017;13(2):307–349.
   PubMed Web of Science ®Google Scholar
• Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008;4(5):487–504.
   PubMed Web of Science ®Google Scholar
• Baron KG, Hooker S. Next steps for patients who fail to respond to cognitive behavioral therapy for insomnia (CBT-I): the perspective from behavioral sleep medicine psychologists. Curr Sleep Med Rep. 2017;3(4):327–332. doi:10.1007/s40675-017-0096-x
   Google Scholar
• Zachariae R, Lyby MS, Ritterband LM, O’Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia - A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016;30:1–10. doi:10.1016/j.smrv.2015.10.004
   PubMed Web of Science ®Google Scholar
• Buscemi N, Vandermeer B, Friesen C, et al. The efficacy and safety of drug treatments for chronic insomnia in adults: a meta-analysis of RCTs. J Gen Intern Med. 2007;22(9):1335–1350. doi:10.1007/s11606-007-0251-z
   PubMed Web of Science ®Google Scholar
• Vermeeren A. Residual effects of hypnotics: epidemiology and clinical implications. CNS Drugs. 2004;18(5):297–328. doi:10.2165/00023210-200418050-00003
   PubMed Web of Science ®Google Scholar
• National Institute of Health. National institutes of health state of the science conference statement on manifestations and management of chronic insomnia in adults, June 13–15, 2005. Sleep. 2005;28(9):1049–1057.
   Web of Science ®Google Scholar
• Bertisch SM, Wells RE, Smith MT, McCarthy EP. Use of relaxation techniques and complementary and alternative medicine by American adults with insomnia symptoms: results from a national survey. J Clin Sleep Med. 2012;8(6):681–691.
   PubMed Web of Science ®Google Scholar
• Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990–1997: results of a follow-up national survey. JAMA. 1998;280(18):1569–1575. doi:10.1001/jama.280.18.1569
   PubMed Web of Science ®Google Scholar
• Zhang Y, Lao L, Chen H, Ceballos R. Acupuncture use among american adults: what acupuncture practitioners can learn from national health interview survey 2007? Evid Based Complement Alternat Med. 2012;2012:710750. doi:10.1155/2012/710750
   Web of Science ®Google Scholar
• Lee HG, Jung DJ, Choi YM, et al. A systematic literature review on clinical research in human utilized electroacupuncture in Korea. J Acupunct Res. 2013;30(5):139–153. doi:10.13045/acupunct.2013053
   Google Scholar
• Xu H, Shi Y, Xiao Y, et al. Efficacy comparison of different acupuncture treatments for primary insomnia: a bayesian analysis. Evid Based Complement Alternat Med. 2019;2019:8961748. doi:10.1155/2019/8961748
   Web of Science ®Google Scholar
• Yeung WF, Chung KF, Tso KC, Zhang SP, Zhang ZJ, Ho LM. Electroacupuncture for residual insomnia associated with major depressive disorder: a randomized controlled trial. Sleep. 2011;34(6):807–815. doi:10.5665/SLEEP.1056
   PubMed Web of Science ®Google Scholar
• Yeung WF, Chung KF, Zhang SP, Yap TG, Law AC. Electroacupuncture for primary insomnia: a randomized controlled trial. Sleep. 2009;32(8):1039–1047.
   Web of Science ®Google Scholar
• Yin X, Gou M, Xu J, et al. Efficacy and safety of acupuncture treatment on primary insomnia: a randomized controlled trial. Sleep Med. 2017;37:193–200. doi:10.1016/j.sleep.2017.02.012
   PubMed Web of Science ®Google Scholar
• Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD. Management of chronic insomnia disorder in adults: a Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016;165(2):125–133. doi:10.7326/M15-2175
   PubMed Web of Science ®Google Scholar
• Kim SP, Kim JH, Kim BK, et al. Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial. Trials. 2017;18(1):177. doi:10.1186/s13063-017-1922-7
   Web of Science ®Google Scholar
• MacPherson H, Altman DG, Hammerschlag R, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. J Altern Complement Med. 2010;16(10):St1–14. doi:10.1089/acm.2010.1610
   Web of Science ®Google Scholar
• Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. doi:10.1136/bmj.c869
   PubMed Web of Science ®Google Scholar
• Zhao K. Acupuncture for the treatment of insomnia. Int Rev Neurobiol. 2013;111:217–234.
   Web of Science ®Google Scholar
• Yeung WF, Chung KF, Leung YK, Zhang SP, Law ACK. Traditional needle acupuncture treatment for insomnia: a systematic review of randomized controlled trials. Sleep Med. 2009;10(7):694–704. doi:10.1016/j.sleep.2008.08.012
   Web of Science ®Google Scholar
• Korean Acupuncture and Moxibustion Medicine Society Textbook Compilation Committee. The Acupuncture and Moxibustion Medicine. Paju: Jipmoondang; 2012.
   Google Scholar
• Gong X-I, Pan Z-H, Shen Y, Wang S. Blinding effect of non-penetrating sham needle in the randomized controlled trials of acupuncture: a systematic review. J Acupunct Tuina Sci. 2014;12(1):8–11. doi:10.1007/s11726-014-0738-1
   Google Scholar
• Park J, White A, Stevinson C, Ernst E, James M. Validating a new non-penetrating sham acupuncture device: two randomised controlled trials. Acupunct Med. 2002;20(4):168–174.
   Google Scholar
• Bastien CH, Vallieres A, Morin CM. Validation of the insomnia severity index as an outcome measure for insomnia research. Sleep Med. 2001;2(4):297–307. doi:10.1016/S1389-9457(00)00065-4
   PubMed Web of Science ®Google Scholar
• Cho YW, Song ML, Morin CM. Validation of a Korean version of the insomnia severity index. J Clin Neurol. 2014;10(3):210–215. doi:10.3988/jcn.2014.10.3.210
   PubMed Web of Science ®Google Scholar
• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193–213.
   PubMed Web of Science ®Google Scholar
• Sohn SI, Kim DH, Lee MY, Cho YW. The reliability and validity of the Korean version of the Pittsburgh sleep quality index. Sleep Breath. 2012;16(3):803–812. doi:10.1007/s11325-011-0579-9
   PubMed Web of Science ®Google Scholar
• Oh SM, Min KJ, Park DB. A study on the standardization of the hospital anxiety and depression scale for Koreans: a comparison of normal, depressed and anxious groups. J Korean Neuropsychiatr Assoc. 1999;38(2):289.
   Google Scholar
• Kim MH, Cho YS, Uhm WS, Kim S, Bae SC. Cross-cultural adaptation and validation of the Korean version of the EQ-5D in patients with rheumatic diseases. Qual Life Res. 2005;14(5):1401–1406. doi:10.1007/s11136-004-5681-z
   PubMed Web of Science ®Google Scholar
• Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):337–343. doi:10.3109/07853890109002087
   PubMed Web of Science ®Google Scholar
• Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004;27(1):26–35. doi:10.1016/j.jmpt.2003.11.003
   PubMed Web of Science ®Google Scholar
• Huang W, Kutner N, Bliwise DL. Autonomic activation in insomnia: the case for acupuncture. J Clin Sleep Med. 2011;7(1):95–102.
   Web of Science ®Google Scholar
• Park JH, Lee JH, Lee S, Shin JY, Kim TH. Adverse events related to electroacupuncture: a systematic review of single case studies and case series. Acupunct Med. 2020;964528420920287.
   Web of Science ®Google Scholar
• Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004;25(2):143–156. doi:10.1016/j.cct.2003.10.016
   PubMedGoogle Scholar
• Hughes CM, McCullough CA, Bradbury I, et al. Acupuncture and reflexology for insomnia: a feasibility study. Acupunct Med. 2009;27(4):163–168. doi:10.1136/aim.2009.000760
   Web of Science ®Google Scholar
• Yang M, Morin CM, Schaefer K, Wallenstein GV. Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference. Curr Med Res Opin. 2009;25(10):2487–2494. doi:10.1185/03007990903167415
   PubMed Web of Science ®Google Scholar
• Morin CM, Vallières A, Guay B, et al. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA. 2009;301(19):2005–2015. doi:10.1001/jama.2009.682
   PubMed Web of Science ®Google Scholar
• Guo J, Wang LP, Liu CZ, et al. Efficacy of acupuncture for primary insomnia: a randomized controlled clinical trial. Evid Based Complement Alternat Med. 2013;2013:163850. doi:10.1155/2013/163850
   Web of Science ®Google Scholar
• Wang Y-R, Zhao J-P, Hao D-F. Is sham acupuncture a real placebo: skeptical for sham acupuncture. World J Acupunct Moxibustion. 2017;27(2):1–5. doi:10.1016/S1003-5257(17)30110-1
   Web of Science ®Google Scholar
• Bernstein MH, Brown WA. The placebo effect in psychiatric practice. Curr Psychiatr. 2017;16(11):29–34.
   PubMedGoogle Scholar
• Polich G, Iaccarino MA, Kaptchuk TJ, Morales-Quezada L, Zafonte R. Placebo effects in traumatic brain injury. J Neurotrauma. 2018;35(11):1205–1212. doi:10.1089/neu.2017.5506
   PubMed Web of Science ®Google Scholar
• Liu Z, Chen X, Gao Y, et al. Involvement of GluR2 up-regulation in neuroprotection by electroacupuncture pretreatment via cannabinoid CB1 receptor in mice. Sci Rep. 2015;5:9490. doi:10.1038/srep09490
   PubMed Web of Science ®Google Scholar
• Spence DW, Kayumov L, Chen A, et al. Acupuncture increases nocturnal melatonin secretion and reduces insomnia and anxiety: a preliminary report. J Neuropsychiatry Clin Neurosci. 2004;16(1):19–28. doi:10.1176/jnp.16.1.19
   Web of Science ®Google Scholar
• Yang JL, Zhang R, Du L, Yang YS, Liu XC. Clinical observation on the neurotransmitters regulation in patients of insomnia differentiated as yang deficiency pattern treated with warm acupuncture and auricular point sticking therapy. Zhongguo Zhen Jiu. 2014;34(12):1165–1168.
   Google Scholar
• Zhou YL, Gao XY, Wang PY, Ren S. Effect of acupuncture at different acupoints on expression of hypothalamic GABA and GABA(A) receptor proteins in insomnia rats. Acupunct Res. 2012;37(4):302–307.
   Google Scholar
• Nordio M, Romanelli F. Efficacy of wrists overnight compression (HT 7 point) on insomniacs: possible role of melatonin? Minerva Med. 2008;99(6):539–547.
   PubMedGoogle Scholar
• Park HJ, Park HJ, Chae Y, Kim JW, Lee H, Chung JH. Effect of acupuncture on hypothalamic-pituitary-adrenal system in maternal separation rats. Cell Mol Neurobiol. 2011;31(8):1123–1127. doi:10.1007/s10571-011-9718-x
   Web of Science ®Google Scholar
• You W, Shi YJ, Han YJ, Jia BH, Tu Y. Effect of electroacupuncture of “Baihui” (GV 20)-”Yintang” (EX-HN 3) on the expression of glucocorticoid and glucocorticoid receptor mRNA of the chronic stress model rats. Acupunct Res. 2010;35(4):261–266.
   Google Scholar
• Huangfu YR, Peng W, Guo BJ, et al. Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: study protocol for a randomized controlled trial. J Integr Med. 2019;17(3):161–166. doi:10.1016/j.joim.2019.01.007
   Web of Science ®Google Scholar
• Wei XR, Wei GW, Zheng XN, et al. Effect of acupuncture stimulation of different acupoint combinations on sleep and expression of circadian clock and Bmal 1 genes in hypothalamus of insomnia rats. Acupunct Res. 2017;42(5):429–433.
   Google Scholar
• Zheng XN, Wu XF, Guo X, et al. Manual acupuncture stimulation of paired acupoints can relieve sleep disorder possibly by upregulating pineal melatonin protein and its receptor mRNA levels in the suprachiasmatic nucleus in insomnia rats. Acupunct Res. 2018;43(6):360–364.
   Google Scholar
• Lee H, Bang H, Kim Y, et al. Non-penetrating sham needle, is it an adequate sham control in acupuncture research? Complement Ther Med. 2011;19(Suppl 1):S41–48. doi:10.1016/j.ctim.2010.12.002
   Web of Science ®Google Scholar
• Mao JJ, Farrar JT, Armstrong K, Donahue A, Ngo J, Bowman MA. De qi: chinese acupuncture patients’ experiences and beliefs regarding acupuncture needling sensation–an exploratory survey. Acupunct Med. 2007;25(4):158–165. doi:10.1136/aim.25.4.158
   Google Scholar
• He W, Wang XY, Shi H, et al. Cutaneous neurogenic inflammation in the sensitized acupoints induced by gastric mucosal injury in rats. BMC Complement Altern Med. 2017;17(1):141.
   Web of Science ®Google Scholar
• Thompson BT, Schoenfeld D. Usual care as the control group in clinical trials of nonpharmacologic interventions. Proc Am Thorac Soc. 2007;4(7):577–582. doi:10.1513/pats.200706-072JK
   Google Scholar
• Elkins MR. Assessing baseline comparability in randomised trials. J Physiother. 2015;61(4):228–230. doi:10.1016/j.jphys.2015.07.005
   Google Scholar
• Drake CL, Pillai V, Roth T. Stress and sleep reactivity: a prospective investigation of the stress-diathesis model of insomnia. Sleep. 2014;37(8):1295–1304. doi:10.5665/sleep.3916
   PubMed Web of Science ®Google Scholar
• Zhang B, Wing YK. Sex differences in insomnia: a meta-analysis. Sleep. 2006;29(1):85–93. doi:10.1093/sleep/29.1.85
   PubMed Web of Science ®Google Scholar
• Sadeghniiat-Haghighi K, Yazdi Z, Firoozeh M. Comparison of two assessment tools that measure insomnia: the insomnia severity index and polysomnography. Indian J Psychol Med. 2014;36(1):54–57. doi:10.4103/0253-7176.127251
   Google Scholar