Efficacy and safety of electroacupuncture on treating depression-related insomnia: a study protocol for a multicentre randomised controlled trial

Xuan Yin, Bo Dong, Tingting Liang, Ping Yin, Xia Li, Xiang Lin, Shuang Zhou, Xiaolu Qian, Lixing Lao, Shifen Xu, Xuan Yin, Bo Dong, Tingting Liang, Ping Yin, Xia Li, Xiang Lin, Shuang Zhou, Xiaolu Qian, Lixing Lao, Shifen Xu

Abstract

Introduction: Sleep disorders including insomnia occur frequently in depressive patients. Acupuncture is a widely recognised therapy to treat depression and sleep disorders in clinical practice. This multicentre randomised controlled trial (RCT) is aimed to investigate the efficacy and safety of electroacupuncture (EA) in the treatment of depression patients with insomnia.

Methods and analysis: We describe a protocol for a multicentre RCT. A total of 270 eligible patients in three different healthcare centres in Shanghai will be randomly assigned to one of these three groups: treatment group (EA + standard care), control A group (sham electroacupuncture + standard care) and control B group (standard care). Treatment will be given three times per week for 8 consecutive weeks. The primary outcome is the Pittsburgh Sleep Quality Index. The secondary outcomes are sleep parameters recorded in the actigraphy, Hamilton Rating Scale for Depression score and Self-rating Anxiety Scale score. Daily dose of patients' antidepressant and sedative-hypnotic medication will be recorded in the dairy. All adverse effects will be assessed by the Treatment Emergent Symptom Scale. Outcomes will be evaluated at baseline, 4 weeks post-treatment and 8 weeks post-treatment, as well as at 1-month, 3-month and 6-month follow-up.

Ethics and dissemination: The trial has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2017SHL-KY-04). Written informed consent will be obtained from all participants. The results of this study will be published in peer-reviewed journals or presented at academic conferences.

Trial registration number: NCT03122080; Pre-results.

Keywords: complementary medicine; electroacupuncture; insomnia; randomized controlled trial.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flowchart of the study. HAMD, Hamilton Rating Scale for Depression; PSQI, Pittsburgh Sleep Quality Index; SAS, Self-rating Anxiety Scale; TESS, Treatment Emergent Symptom Scale.
Figure 2
Figure 2
Streitberger Placebo needle (asia-med GmbH & Co. KG).

References

    1. Ferrari AJ, Somerville AJ, Baxter AJ, et al. . Global variation in the prevalence and incidence of major depressive disorder: a systematic review of the epidemiological literature. Psychol Med 2013;43:471–81. 10.1017/S0033291712001511
    1. Chin WY, Wan EY, Choi EP, et al. . The 12-month incidence and predictors of PHQ-9-screened depressive symptoms in chinese primary care patients. Ann Fam Med 2016;14:47–53. 10.1370/afm.1854
    1. Winokur A, Gary KA, Rodner S, et al. . Depression, sleep physiology, and antidepressant drugs. Depress Anxiety 2001;14:19–28. 10.1002/da.1043
    1. Nelson JC, Portera L, Leon AC. Residual symptoms in depressed patients after treatment with fluoxetine or reboxetine. J Clin Psychiatry 2005;66:1409–14. 10.4088/JCP.v66n1110
    1. Urrila AS, Karlsson L, Kiviruusu O, et al. . Sleep complaints in adolescent depression: one year naturalistic follow-up study. BMC Psychiatry 2014;14:283 10.1186/s12888-014-0283-y
    1. Medicine A. International classification of sleep disorders: diagnostic and coding manual. Chest 2000;41:160–60.
    1. Riemann D, Voderholzer U. Primary insomnia: a risk factor to develop depression? J Affect Disord 2003;76:255–9. 10.1016/S0165-0327(02)00072-1
    1. Ohayon MM, Roth T. Place of chronic insomnia in the course of depressive and anxiety disorders. J Psychiatr Res 2003;37:9–15. 10.1016/S0022-3956(02)00052-3
    1. Ohayon MM, Caulet M, Lemoine P. Comorbidity of mental and insomnia disorders in the general population. Compr Psychiatry 1998;39:185–97. 10.1016/S0010-440X(98)90059-1
    1. Gebara MA, Siripong N, DiNapoli EA, et al. . Effect of insomnia treatments on depression: a systematic review and meta-analysis. Depress Anxiety 2018;35:717–31. 10.1002/da.22776
    1. Trauer JM, Qian MY, Doyle JS, et al. . Cognitive behavioral therapy for chronic insomnia: a systematic review and meta-analysis. Annals of Internal Medicine 2013;47:191–204.
    1. Wilson K, Mottram P. A comparison of side effects of selective serotonin reuptake inhibitors and tricyclic antidepressants in older depressed patients: a meta-analysis. Int J Geriatr Psychiatry 2004;19:754–62. 10.1002/gps.1156
    1. Preskorn SH. The adverse effect profiles of the selective serotonin reuptake inhibitors: relationship to in vitro pharmacology. J Psychiatr Pract 2000;6:153–7. 10.1097/00131746-200005000-00006
    1. Chung KH, Li CY, Kuo SY, et al. . Risk of psychiatric disorders in patients with chronic insomnia and sedative-hypnotic prescription: a nationwide population-based follow-up study. J Clin Sleep Med 2015;11:543–51. 10.5664/jcsm.4700
    1. Santos Moraes WA, Burke PR, Coutinho PL, et al. . Sedative antidepressants and insomnia. Braz J Psychiatry 2011;33:91–5. 10.1590/S1516-44462011000100017
    1. Li CT, Bai YM, Lee YC, et al. . High dosage of hypnotics predicts subsequent sleep-related breathing disorders and is associated with worse outcomes for depression. Sleep 2014;37:803–9. 10.5665/sleep.3594
    1. 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. 10.1016/j.sleep.2017.02.012
    1. Yin X, Xu J, Dong B, et al. . Efficacy and safety of electroacupuncture on treating depression related sleep disorders: study protocol of a randomized controlled trial. Evid Based Complement Alternat Med 2016;2016:1–7. 10.1155/2016/1069597
    1. Chan YY, Lo WY, Yang SN, et al. . The benefit of combined acupuncture and antidepressant medication for depression: A systematic review and meta-analysis. J Affect Disord 2015;176:106–17. 10.1016/j.jad.2015.01.048
    1. Yeung WF, Chung KF, Tso KC, et al. . Electroacupuncture for residual insomnia associated with major depressive disorder: a randomized controlled trial. Sleep 2011;34:807–15. 10.5665/SLEEP.1056
    1. Chung KF, Yeung WF, Yu YM, et al. . Acupuncture for residual insomnia associated with major depressive disorder: a placebo- and sham-controlled, subject- and assessor-blind, randomized trial. J Clin Psychiatry 2015;76:e752 10.4088/JCP.14m09124
    1. MacPherson H, Altman DG, Hammerschlag R, et al. . Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med 2010;7:e1000261 10.1371/journal.pmed.1000261
    1. Uher R, Payne JL, Pavlova B, et al. . Major depressive disorder in DSM-5: implications for clinical practice and research of changes from DSM-IV. Depress Anxiety 2014;31:459–71. 10.1002/da.22217
    1. C. V. Credibility assessment in trials of acupuncture. Complementary Medical Research 1990;4:8–11.
    1. Taoying L, Yan L, Jiyang P, et al. . Study on minimal important difference of the pittsburgh sleep quality index based on clinical trial of traditional chinese medicine. Journal of Guangzhou University of Traditional Chinese Medicine 2013;30:574–8.
    1. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975;31:103 10.2307/2529712
    1. Cai H, Xia J, Xu D, et al. . A random allocation system using minimization method on Internet. Journal of The Fourth Military Medical University 2004;25:1278–80.
    1. Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet 1998;352:364–365. 10.1016/S0140-6736(97)10471-8
    1. Kleinhenz J, Streitberger K, Windeler J, et al. . Randomised clinical trial comparing the effects of acupuncture and a newly designed placebo needle in rotator cuff tendinitis. Pain 1999;83:235–41. 10.1016/S0304-3959(99)00107-4
    1. Freedland KE, Mohr DC, Davidson KW, et al. . Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions. Psychosom Med 2011;73 10.1097/PSY.0b013e318218e1fb
    1. Buysse DJ, Reynolds CF, Monk TH, et al. . The pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res 1989;28:193–213. 10.1016/0165-1781(89)90047-4
    1. Hamilton M. The hamilton rating scale for depression: Springer Berlin Heidelberg, 1986.
    1. Zung WW. A rating instrument for anxiety disorders. Psychosomatics 1971;12:371–9. 10.1016/S0033-3182(71)71479-0
    1. Institute of Mental Health N. TESS (Treatment Emergent Symptom Scale-Write-in). 1985.
    1. Buysse DJ, Angst J, Gamma A, et al. . Prevalence, course, and comorbidity of insomnia and depression in young adults. Sleep 2008;31:473–80. 10.1093/sleep/31.4.473
    1. Zhang G, Qu S, Zheng Y, et al. . Key regions of the cerebral network are altered after electroacupuncture at the Baihui (GV20) and Yintang acupuncture points in healthy volunteers: an analysis based on resting fcMRI. Acupunct Med 2013;31:383–8. 10.1136/acupmed-2012-010301
    1. Zhang ZJ, Wang XM, McAlonan GM. Neural acupuncture unit: a new concept for interpreting effects and mechanisms of acupuncture. Evid Based Complement Alternat Med 2012;2012:429412:1–23. 10.1155/2012/429412
    1. Zhang R, Lao L, Ren K, et al. . Mechanisms of acupuncture-electroacupuncture on persistent pain. Anesthesiology 2014;120:482–503. 10.1097/ALN.0000000000000101
    1. Kwon YB, Kang MS, Son SS, et al. . Different frequencies of electroacupuncture modified the cellular activity of serotonergic neurons in brainstem. Am J Chin Med 2000;28:435–41. 10.1142/S0192415X00000519
    1. Fang J. Acupuncture and Moxibustion Technique. Beijing: People’s Medical Publishing House, 2012.
    1. Burns T. End of the road for treatment-as-usual studies? Br J Psychiatry 2009;195:5–6. 10.1192/bjp.bp.108.062968
    1. Dawson L, Zarin DA, Emanuel EJ, et al. . Considering usual medical care in clinical trial design. PLoS Med 2009;6:e1000111 10.1371/journal.pmed.1000111
    1. Zhou X, Bi B, Zheng L, et al. . The prevalence and risk factors for depression symptoms in a rural Chinese sample population. PLoS One 2014;9:e99692 10.1371/journal.pone.0099692
    1. Dai J, Chiu HF, Xiang YT, et al. . The prevalence of insomnia and its socio-demographic and clinical correlates in older adults in rural China: a pilot study. Aging Ment Health 2013;17:761–5. 10.1080/13607863.2013.781117

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera