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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial

Authors: Sung-Phil Kim, Joo-Hee Kim, Bo-Kyung Kim, Hyeong-Jun Kim, In Chul Jung, Jung Hyo Cho, Jung-Eun Kim, Mi-Kyung Kim, O-Jin Kwon, Ae-Ran Kim, Hyo-Ju Park, Bok-Nam Seo

Published in: Trials | Issue 1/2017

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Abstract

Background

Insomnia is a common sleep disorder that affects many adults either transiently or chronically. The societal cost of insomnia is on the rise, while long-term use of current drug treatments can involve adverse effects. Recently, electroacupuncture (EA) has been used to treat various conditions including insomnia. The objective of this study is to provide scientific evidence for the effect and safety of using EA to treat insomnia.

Methods/design

In this multicentre, assessor-blind, three-arm, parallel-design, randomised controlled trial, 150 participants will be assigned to the EA group, the sham EA (SEA) group, or the usual care group. The EA and SEA groups will receive the specific treatments 2–3 times a week for 4 weeks, for a total of 10 sessions, whereas the usual care group will not receive EA and will continue with usual care during the same time period. The primary outcome measure will be changes in the Insomnia Severity Index 5 weeks after randomisation. The secondary outcomes will include the Pittsburgh Sleep Quality Index, the Hospital Anxiety and Depression Scale, a sleep diary, the EuroQoL-5 dimension questionnaire, the levels of melatonin and cortisol, and the Patient Global Impression of Change. Safety will be assessed at each visit.

Discussion

The results of this multicentre randomised controlled trial will contribute to provide rigorous clinical evidence for the effects and safety of EA for insomnia disorder.

Trial registration

Korean Clinical Trial Registry, CRIS, KCT0001685. Registered on 2 November 2015 (retrospectively registered). Date of enrolment of the first participant to the trial 13 October 2015.
Appendix
Available only for authorised users
Literature
1.
NIH State-of-the-Science Conference Statement on Manifestations and Management of ChronicInsomnia in Adults. NIH Consens Sci Statements. 2005;22(2):1–30. PMID: 17308547.
2.
Doghramji K. The epidemiology and diagnosis of insomnia. Am J Manag Care. 2006;12(8 Suppl):S214–20.PubMed
3.
AP Association. Diagnostic and Statistical Manual of Mental Disorders Fifth Edition in Korean. Arlington: American Psychiatric Association; 2015.
4.
Cao H, Pan X, Li H, Liu J. Acupuncture for treatment of insomnia: a systematic review of randomized controlled trials. J Altern Complement Med (New York, NY). 2009;15(11):1171–86.CrossRef
5.
Ozminkowski RJ, Wang S, Walsh JK. The direct and indirect costs of untreated insomnia in adults in the United States. Sleep. 2007;30(3):263–73.PubMed
6.
Taylor DJ, Mallory LJ, Lichstein KL, Durrence HH, Riedel BW, Bush AJ. Comorbidity of chronic insomnia with medical problems. Sleep. 2007;30(2):213–8.PubMed
7.
Buscemi N, Vandermeer B, Friesen C, Bialy L, Tubman M, Ospina M, 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):1335–50.CrossRefPubMedPubMedCentral
8.
Soldatos CR, Dikeos DG, Whitehead A. Tolerance and rebound insomnia with rapidly eliminated hypnotics: a meta-analysis of sleep laboratory studies. Int Clin Psychopharmacol. 1999;14(5):287–303.CrossRefPubMed
9.
Ernst E, Lee MS, Choi TY. Acupuncture for insomnia? An overview of systematic reviews. Eur J Gen Pract. 2011;17(2):116–23.CrossRefPubMed
10.
Yeung WF, Chung KF, Leung YK, Zhang SP, Law AC. Traditional needle acupuncture treatment for insomnia: a systematic review of randomized controlled trials. Sleep Med. 2009;10(7):694–704.CrossRefPubMed
11.
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):807–15.PubMedPubMedCentral
12.
Yeung WF, Chung KF, Zhang SP, Yap TG, Law AC. Electroacupuncture for primary insomnia: a randomized controlled trial. Sleep. 2009;32(8):1039–47.PubMedPubMedCentral
13.
14.
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):168–74.CrossRefPubMed
15.
Xl G, Pan Z, 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.CrossRef
16.
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.CrossRefPubMed
17.
18.
Buysse DJ, Reynolds CF, 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.CrossRefPubMed
19.
Sohn SI, Kim do H, Lee MY, Cho YW. The reliability and validity of the Korean version of the Pittsburgh Sleep Quality Index. Sleep Breath. 2012;16(3):803–12.CrossRefPubMed
20.
Cho YW. Sleep scale and sleep hygiene. J Korean Sleep Res Soc. 2004;1(1):12–23.CrossRef
21.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.CrossRefPubMed
22.
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):289–96.
23.
Lemoine P, Garfinkel D, Laudon M, Nir T, Zisapel N. Prolonged-release melatonin for insomnia—an open-label long-term study of efficacy, safety, and withdrawal. Ther Clin Risk Manag. 2011;7:301–11.PubMedPubMedCentral
24.
25.
Terzieva DD, Mateva ND, Vladimirova-Kitova LG. Melatonin reference limits at 3:00 AM and 8:00 AM in healthy adults. Clin Lab. 2009;55(9–10):359–61.PubMed
26.
Cho YS, Kim MH, Uhm WS, Kim S, Oh SI, Bae SC. Cross-cultural adaptation and validation of the Korean version of the EQ-5D in patients with rheumatic diseases. J Korean Rheum Assoc. 2005;12(3):173–88.
27.
28.
Morin CM. Measuring outcomes in randomized clinical trials of insomnia treatments. Sleep Med Rev. 2003;7(3):263–79.CrossRefPubMed
29.
Kapur VK, Redline S, Nieto FJ, Young TB, Newman AB, Henderson JA. The relationship between chronically disrupted sleep and healthcare use. Sleep. 2002;25(3):289–96.PubMed
30.
Sivertsen B, Krokstad S, Mykletun A, Overland S. Insomnia symptoms and use of health care services and medications: the HUNT-2 study. Behav Sleep Med. 2009;7(4):210–22.CrossRefPubMed
31.
Tang L, Ma C, You F, Ding L. Impacts of the low-frequency electric stimulation at the acupoints on the content of plasma 5-HT and NE in the patients with post-stroke insomnia. Zhongguo Zhen Jiu. 2015;35(8):763–7.PubMed
32.
Hardeland R. New approaches in the management of insomnia: weighing the advantages of prolonged-release melatonin and synthetic melatoninergic agonists. Neuropsychiatr Dis Treat. 2009;5:341–54.CrossRefPubMedPubMedCentral
33.
Cummings C. Melatonin for the management of sleep disorders in children and adolescents. Paediatr Child Health. 2012;17(6):331–6.PubMedPubMedCentral
34.
Roth T, Seiden D, Sainati S, Wang-Weigand S, Zhang J, Zee P. Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia. Sleep Med. 2006;7(4):312–8.CrossRefPubMed
35.
Nordio M, Romanelli F. Efficacy of wrists overnight compression (HT 7 point) on insomniacs: possible role of melatonin? Minerva Med. 2008;99(6):539–47.PubMed
36.
Spence DW, Kayumov L, Chen A, Lowe A, Jain U, Katzman MA, et al. Acupuncture increases nocturnal melatonin secretion and reduces insomnia and anxiety: a preliminary report. J Neuropsychiatry Clin Neurosci. 2004;16(1):19–28.CrossRefPubMed
37.
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):1123–7.CrossRefPubMed
38.
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. Zhen Ci Yan Jiu. 2010;35(4):261–6.PubMed
39.
Linde K, Niemann K, Meissner K. Are sham acupuncture interventions more effective than (other) placebos? A re-analysis of data from the Cochrane review on placebo effects. Forsch Komplementmed. 2010;17(5):259–64.CrossRefPubMed
40.
Carneiro M, Kawakita K. Re-analysis of acupuncture trials with sham interventions based on data from the Cochrane Review. Japanese Acupunct Moxibustion. 2015;11(1):1–11.
41.
Stephen B. Sham acupuncture is not a placebo treatment—implications and problems in research. Japanese Acupunct Moxibustion. 2012;8(1):4–8.
42.
Perlis ML, McCall WV, Jungquist CR, Pigeon WR, Matteson SE. Placebo effects in primary insomnia. Sleep Med Rev. 2005;9(5):381–9.CrossRefPubMed
43.
Korean Acupuncture and Moxibustion Medicine Society Textbook Compilation Committee. The Acupuncture and Moxibustion Medicine. Paju: Jipmoondang; 2012.
Metadata
Title
Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial
Authors
Sung-Phil Kim
Joo-Hee Kim
Bo-Kyung Kim
Hyeong-Jun Kim
In Chul Jung
Jung Hyo Cho
Jung-Eun Kim
Mi-Kyung Kim
O-Jin Kwon
Ae-Ran Kim
Hyo-Ju Park
Bok-Nam Seo
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1922-7

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