Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Complementary Medicine and Therapies
Published in: BMC Complementary Medicine and Therapies 1/2022

Open Access 01-12-2022 | Insomnia | Research article

Electroacupuncture for treating cancer-related insomnia: a multicenter, assessor-blinded, randomized controlled, pilot clinical trial

Authors: Boram Lee, Bo-Kyung Kim, Mikyung Kim, Ae-Ran Kim, Hyo-Ju Park, O-Jin Kwon, Jun-Hwan Lee, Joo-Hee Kim

Published in: BMC Complementary Medicine and Therapies | Issue 1/2022

Login to get access

Abstract

Background

Insomnia is one of the most frequent symptoms in people with cancer. Electroacupuncture has been widely used in people with cancer or insomnia. We explored the feasibility and preliminary effectiveness of electroacupuncture for cancer-related insomnia.

Methods

People with cancer and insomnia disorder were randomly allocated to electroacupuncture, sham-electroacupuncture, or usual care groups. Participants received either 10 sessions of electroacupuncture at real acupoints, sham-electroacupuncture at non-acupoints, or usual care in each group for 4 weeks. We calculated the recruitment, adherence, and completion rates of participants. The Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep diary and actigraphy-derived sleep parameters, Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Montreal Cognitive Assessment (MoCA), and salivary levels of cortisol and melatonin were evaluated as outcome measures.

Results

Twenty-two participants were enrolled (8, 6, and 8 respectively in the electroacupuncture, sham-electroacupuncture, and usual care groups) and 20 participants completed the trials (8, 4, and 8 respectively). The recruitment, adherence, and completion rates were 78.57% (22/28), 95.45% (21/22), and 90.91% (20/22), respectively. Most of the participants had previously received conventional treatment for insomnia, but few had received Korean medicine treatment, without any demographic or clinical differences between groups. In the electroacupuncture group, there was a statistically significant reduction of 10.13 (mean) ± 8.15 (standard deviation) and 5 ± 3.70 points in mean ISI and PSQI scores at 4 weeks post-treatment (P = .0098 and .0066), compared with sham-electroacupuncture (2.06 ± 7.15 and 1.61 ± 4.34; P = .4796 and .3632) and usual care (3.25 ± 2.60 and 1.38 ± 2.13; P = .0096 and .1112). Although there was no significant difference in ISI score between groups at 4 weeks post-treatment, the electroacupuncture group continued to improve significantly at 4 weeks’ follow-up, showing borderline and significant differences compared to the sham-electroacupuncture and usual care (P = .0614 and .0015). The FACT-F scores in electroacupuncture group showed a significant improvement compared with the sham-electroacupuncture group (P = .0305). No electroacupuncture-related adverse events were reported.

Conclusions

Electroacupuncture might be feasible for cancer-related insomnia, despite slow participant recruitment. Additional trials with adequately powered sample sizes and a substantial change to the recruitment procedure are needed.

Trial registration

Clinical Research Information Service, KCT0002162. Submitted 27 October 2016, Registered 2 December 2016 - Retrospectively registered (The first participant enrolment: 28 November 2016),
Appendix
Available only for authorised users
Literature
1.
Mercadante S, Aielli F, Adile C, Ferrera P, Valle A, Cartoni C, et al. Sleep disturbances in patients with advanced cancer in different palliative care settings. J Pain Symptom Manag. 2015;50(6):786–92.CrossRef
2.
Yennurajalingam S, Balachandran D, Pedraza Cardozo SL, Berg EA, Chisholm GB, Reddy A, et al. Patient-reported sleep disturbance in advanced cancer: frequency, predictors and screening performance of the Edmonton symptom assessment system sleep item. BMJ Support Palliat Care. 2017;7(3):274–80.PubMed
3.
Savard J, Savard MH. Insomnia and cancer: prevalence, nature, and nonpharmacologic treatment. Sleep Med Clin. 2013;8(3):373–87.CrossRef
4.
Savard J, Liu L, Natarajan L, Rissling MB, Neikrug AB, He F, et al. Breast cancer patients have progressively impaired sleep-wake activity rhythms during chemotherapy. Sleep. 2009;32(9):1155–60.PubMedPubMedCentralCrossRef
5.
Schieber K, Niecke A, Geiser F, Erim Y, Bergelt C, Buttner-Teleaga A, et al. The course of cancer-related insomnia: don't expect it to disappear after cancer treatment. Sleep Med. 2019;58:107–13.PubMedCrossRef
6.
Cheng KK, Lee DT. Effects of pain, fatigue, insomnia, and mood disturbance on functional status and quality of life of elderly patients with cancer. Crit Rev Oncol Hematol. 2011;78(2):127–37.PubMedCrossRef
7.
Savard J, Morin CM. Insomnia in the context of cancer: a review of a neglected problem. J Clin Oncol. 2001;19(3):895–908.PubMedCrossRef
8.
9.
Johnson JA, Rash JA, Campbell TS, Savard J, Gehrman PR, Perlis M, et al. A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for insomnia (CBT-I) in cancer survivors. Sleep Med Rev. 2016;27:20–8.PubMedCrossRef
10.
Matthews EE, Schmiege SJ, Cook PF, Berger AM, Aloia MS. Adherence to cognitive behavioral therapy for insomnia (CBTI) among women following primary breast cancer treatment: a pilot study. Behav Sleep Med. 2012;10(3):217–29.PubMedCrossRef
11.
Morin CM, Vallieres A, Guay B, Ivers H, Savard J, Merette C, et al. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. Jama. 2009;301(19):2005–15.PubMedPubMedCentralCrossRef
12.
13.
Lee HG, Jung DJ, Choi YM, Yook TH, Song BY, Jeong SG, et al. A systematic literature review on clinical research in human utilized Electroacupuncture in Korea. J Acupunct Res. 2013;30(5):139–53.CrossRef
14.
Rossi E, Vita A, Baccetti S, Di Stefano M, Voller F, Zanobini A. Complementary and alternative medicine for cancer patients: results of the EPAAC survey on integrative oncology centres in Europe. Support Care Cancer. 2015;23(6):1795–806.PubMedCrossRef
15.
Mao JJ, Palmer CS, Healy KE, Desai K, Amsterdam J. Complementary and alternative medicine use among cancer survivors: a population-based study. J Cancer Surviv. 2011;5(1):8–17.PubMedCrossRef
16.
Molassiotis A, Fernandez-Ortega P, Pud D, Ozden G, Scott JA, Panteli V, et al. Use of complementary and alternative medicine in cancer patients: a European survey. Ann Oncol. 2005;16(4):655–63.PubMedCrossRef
17.
Brauer JA, El Sehamy A, Metz JM, Mao JJ. Complementary and alternative medicine and supportive care at leading cancer centers: a systematic analysis of websites. J Altern Complement Med (New York, NY). 2010;16(2):183–6.CrossRef
18.
Choi TY, Kim JI, Lim HJ, Lee MS. Acupuncture for managing cancer-related insomnia: a systematic review of randomized clinical trials. Integr Cancer Therapies. 2017;16(2):135–46.CrossRef
19.
Dan ZJ. A randomized controlled clinical study of acupuncture intervention for cancer patients with insomnia. Master's thesis of Chengdu University of Traditional Chinese Medicine 2013. 2013.
20.
Song JR, Zhao YL, Peng XH, Hu YP. Clinical randomized controlled study of using acupuncture to treat tumor patients with insomnia. J Sichuan Tradit Chin Med. 2015;33:163–4.
21.
Kim M, Kim JE, Lee HY, Kim AR, Park HJ, Kwon OJ, et al. Electroacupuncture for treating insomnia in patients with cancer: a study protocol for a randomised pilot clinical trial. BMJ Open. 2017;7(8):e016269.PubMedPubMedCentralCrossRef
22.
Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat J Appl Stat Pharm Ind. 2005;4(4):287–91.
23.
24.
Zhao K. Acupuncture for the treatment of insomnia. Int Rev Neurobiol. 2013;111:217–34.
25.
Gong XL, Pan ZH, Shen Y, Wang S. Blinding effect of non-penetrating sham needle in the randomized controlled trials of acupuncture: a systematic review. J Acupunct Tuina Sc. 2014;12(1):8–11.CrossRef
26.
Xie CC, Wen XY, Jiang L, Xie MJ, Fu WB. Validity of the "streitberger" needle in a chinese population with acupuncture: a randomized, single-blinded, and crossover pilot study. Evid Based Complement Alternat Med. 2013;2013:251603.PubMedPubMedCentralCrossRef
27.
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.PubMedCrossRef
28.
Savard MH, Savard J, Simard S, Ivers H. Empirical validation of the insomnia severity index in cancer patients. Psychooncology. 2005;14(6):429–41.PubMedCrossRef
29.
Cho YW, Song ML, Morin CM. Validation of a Korean version of the insomnia severity index. J Clin Neurol (Seoul, Korea). 2014;10(3):210–5.CrossRef
30.
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.PubMedCrossRef
31.
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):803–12.PubMedCrossRef
32.
Lee EH, Chun M, Kang S, Lee HJ. Validation of the functional assessment of Cancer therapy-general (FACT-G) scale for measuring the health-related quality of life in Korean women with breast cancer. Jpn J Clin Oncol. 2004;34(7):393–9.PubMedCrossRef
33.
Minton O, Stone P. A systematic review of the scales used for the measurement of cancer-related fatigue (CRF). Ann Oncol. 2009;20(1):17–25.PubMedCrossRef
34.
Lee JY, Lee DW, Cho SJ, Na DL, Jeon HJ, Kim SK, et al. Brief screening for mild cognitive impairment in elderly outpatient clinic: validation of the Korean version of the Montreal cognitive assessment. J Geriatr Psychiatry Neurol. 2008;21(2):104–10.PubMedCrossRef
35.
Arcuri GG, Palladini L, Dumas G, Lemoignan J, Gagnon B. Exploring the measurement properties of the Montreal cognitive assessment in a population of people with cancer. Support Care Cancer. 2015;23(9):2779–87.PubMedCrossRef
36.
37.
Akimoto T, Nakahori C, Aizawa K, Kimura F, Fukubayashi T, Kono I. Acupuncture and responses of immunologic and endocrine markers during competition. Med Sci Sports Exerc. 2003;35:1296–302.PubMedCrossRef
38.
Liu S, Zhou W, Ruan X, Li R, Lee T, Weng X, et al. Activation of the hypothalamus characterizes the response to acupuncture stimulation in heroin addicts. Neurosci Lett. 2007;421:203–8.PubMedCrossRef
39.
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 Neuropsychiatr Clin Neurosci. 2004;16:19–28.CrossRef
40.
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;38(6):407–16.PubMedCrossRef
41.
Bang HJ, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004;25(2):143–56.PubMedCrossRef
42.
Carson N, Leach L, Murphy KJ. A re-examination of Montreal cognitive assessment (MoCA) cutoff scores. Int J Geriatr Psychiatry. 2018;33(2):379–88.PubMedCrossRef
43.
Hughes CM, McCullough CA, Bradbury I, Boyde C, Hume D, Yuan J, et al. Acupuncture and reflexology for insomnia: a feasibility study. Acupunct Med. 2009;27(4):163–8.PubMedCrossRef
44.
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):2487–94.PubMedCrossRef
45.
46.
Zhang CS, Tan HY, Zhang GS, Zhang AL, Xue CC, Xie YM. Placebo devices as effective control methods in acupuncture clinical trials: a systematic review. PLoS One. 2015;10(11):e0140825.PubMedPubMedCentralCrossRef
47.
Jung CY, Jang MG, Cho JY, Kim EJ, Park IS, Kim KS. The study of the sham acupuncture for acupuncture clinical trials. J Acupunct Res. 2008;25(6):77–93.
48.
Smith CA, de Lacey S, Chapman M, Ratcliffe J, Norman RJ, Johnson NP, et al. Effect of acupuncture vs sham acupuncture on live births among women undergoing in vitro fertilization: a randomized clinical trial. Jama. 2018;319(19):1990–8.PubMedPubMedCentralCrossRef
49.
Mao JJ, Farrar JT, Bruner D, Zee J, Bowman M, Seluzicki C, et al. Electroacupuncture for fatigue, sleep, and psychological distress in breast cancer patients with aromatase inhibitor-related arthralgia: a randomized trial. Cancer. 2014;120(23):3744–51.PubMedCrossRef
50.
Feng Y, Wang XY, Li SD, Zhang Y, Wang HM, Li M, et al. Clinical research of acupuncture on malignant tumor patients for improving depression and sleep quality. J Tradit Chin Med. 2011;31(3):199–202.PubMedCrossRef
51.
Yin X, Gou M, Xu J, Dong B, Yin P, Masquelin F, et al. Efficacy and safety of acupuncture treatment on primary insomnia: a randomized controlled trial. Sleep Med. 2017;37:193–200.PubMedCrossRef
52.
Ding SS, Hong SH, Wang C, Guo Y, Wang ZK, Xu Y. Acupuncture modulates the neuro-endocrine-immune network. QJM. 2014;107(5):341–5.PubMedCrossRef
53.
54.
55.
Garland SN, Xie SX, DuHamel K, Bao T, Li Q, Barg FK, et al. Acupuncture versus cognitive behavioral therapy for insomnia in cancer survivors: a randomized clinical trial. J Natl Cancer Inst. 2019;111(12):1323–31.PubMedPubMedCentralCrossRef
56.
Lee B, Kim BK, Kim HJ, Jung IC, Kim AR, Park HJ, et al. Efficacy and safety of electroacupuncture for insomnia disorder: a multicenter, randomized, assessor-blinded, controlled trial. Nat Sci Sleep. 2020;12:1145–59.PubMedPubMedCentralCrossRef
57.
Nelson J, Harvey AG. The differential functions of imagery and verbal thought in insomnia. J Abnorm Psychol. 2002;111(4):665–9.PubMedCrossRef
Metadata
Title
Electroacupuncture for treating cancer-related insomnia: a multicenter, assessor-blinded, randomized controlled, pilot clinical trial
Authors
Boram Lee
Bo-Kyung Kim
Mikyung Kim
Ae-Ran Kim
Hyo-Ju Park
O-Jin Kwon
Jun-Hwan Lee
Joo-Hee Kim
Publication date
01-12-2022
Publisher
BioMed Central
Published in
BMC Complementary Medicine and Therapies / Issue 1/2022
Electronic ISSN: 2662-7671
DOI
https://doi.org/10.1186/s12906-022-03561-w

Other articles of this Issue 1/2022

BMC Complementary Medicine and Therapies 1/2022 Go to the issue

Research

Discovery and identification of potential anti-melanogenic active constituents of Bletilla striata by zebrafish model and molecular docking

Research

Complementary medicine in psychology practice: an analysis of Australian psychology guidelines and a comparison with other psychology associations from English speaking countries

Research

Ninjinyoeito ameliorated cigarette smoke extract-induced apoptosis and inflammation through JNK signaling inhibition in human lung fibroblasts

Case report

Paravertebral abscess and bloodstream infection caused by Burkholderia pseudomallei after acupuncture: a case report

Research

Bacterial diversity in the intestinal mucosa of heart failure rats treated with Sini Decoction

Research

Lifestyle and health behaviour change support in traditional acupuncture: a mixed method survey study of reported practice (UK)