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

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),

The clinical efficacy and safety of acupuncture intervention on cancer-related insomnia: A systematic review and meta-analysis

“…The treatment group included 3 treatment: electroacupuncture (Frisk et al, 2012 ; Mao et al, 2014 ; Shen et al, 2016 ; Garland et al, 2017 ; Bao et al, 2021 ; Zhang et al, 2021 ; Lee et al, 2022 ) ( n = 7), manual acupuncture (Feng et al, 2011 ; Bokmand and Flyger, 2012 ; Song et al, 2015 ; Peng et al, 2016 ; Garland et al, 2019 ) ( n = 5) and auricular acupuncture (Höxtermann et al, 2021 ) ( n = 1). Of the 13 included articles, 11 (Feng et al, 2011 ; Mao et al, 2014 ; Song et al, 2015 ; Peng et al, 2016 ; Shen et al, 2016 ; Garland et al, 2017 , 2019 ; Bao et al, 2021 ; Höxtermann et al, 2021 ; Zhang et al, 2021 ; Lee et al, 2022 ) provided results for PSQI and ISI as continuous data measures, of which 7 (Feng et al, 2011 ; Mao et al, 2014 ; Song et al, 2015 ; Peng et al, 2016 ; Shen et al, 2016 ; Garland et al, 2017 ; Höxtermann et al, 2021 ) had PSQI as the primary outcome indicator and 3 (Garland et al, 2019 ; Zhang et al, 2021 ; Lee et al, 2022 ) had ISI as the primary outcome indicator; 3 (Garland et al, 2019 ; Zhang et al, 2021 ; Lee et al, 2022 ) had PSQI as the secondary outcome indicator and 1 paper (Bao et al, 2021 ) had ISI as the secondary outcome indicator. Another four (Bokmand and Flyger, 2012 ; Frisk et al, 2012 ; Song et al, 2015 ; Peng et al, 2016 ) provided results for efficacy analysis measures.…”

“…All included RCTs correctly used the randomization allocation method, with 9 items (Feng et al, 2011 ; Bokmand and Flyger, 2012 ; Mao et al, 2014 ; Song et al, 2015 ; Peng et al, 2016 ; Shen et al, 2016 ; Garland et al, 2017 ; Höxtermann et al, 2021 ; Zhang et al, 2021 ) using random number tables, 2 items (Frisk et al, 2012 ; Lee et al, 2022 ) using stratified randomization, and 2 items (Garland et al, 2019 ; Bao et al, 2021 ) using random squares. Seven items (Bokmand and Flyger, 2012 ; Mao et al, 2014 ; Garland et al, 2017 , 2019 ; Höxtermann et al, 2021 ; Zhang et al, 2021 ; Lee et al, 2022 ) mentioned allocation concealment (six Bokmand and Flyger, 2012 ; Mao et al, 2014 ; Garland et al, 2017 , 2019 ; Zhang et al, 2021 ; Lee et al, 2022 for opaque or closed envelope hiding and one Höxtermann et al, 2021 for central random hiding), and the rest were not mentioned. Three items (Bokmand and Flyger, 2012 ; Bao et al, 2021 ; Zhang et al, 2021 ) were blinded to subjects and researchers.…”

“…Three items (Bokmand and Flyger, 2012 ; Bao et al, 2021 ; Zhang et al, 2021 ) were blinded to subjects and researchers. Four items (Garland et al, 2019 ; Bao et al, 2021 ; Zhang et al, 2021 ; Lee et al, 2022 ) implemented blinding of outcome assessors. Five items (Frisk et al, 2012 ; Mao et al, 2014 ; Peng et al, 2016 ; Bao et al, 2021 ; Zhang et al, 2021 ) reported cases missing visits or active withdrawals, of which the number and reasons for missing visits or withdrawals were unbalanced, and the remaining eight (Feng et al, 2011 ; Bokmand and Flyger, 2012 ; Song et al, 2015 ; Shen et al, 2016 ; Garland et al, 2017 , 2019 ; Höxtermann et al, 2021 ; Lee et al, 2022 ) had no personnel withdrawal.…”

“…The results all showed that the combined therapy were more effective for CRI, but there were fewer studies on acupuncture alone, and no meta-analysis of acupuncture alone for CRI was found in recent years. Recently, some new randomized controlled trials were found to verify the efficacy of acupuncture for CRI (Lee et al, 2022 ) and meta-analysis was conducted for articles that met the study criteria to evaluate the efficacy and safety of acupuncture for CRI and to provide a medical reference for clinical treatment with acupuncture therapy.…”

Pharmacopuncture Effects on Insomnia Disorder: Protocol for a Multi-Site, Randomized, Acupuncture-Controlled, Clinical Trial

“…Nevertheless, based on previous studies on insomnia and consensus between Korean medicine specialists in neuropsychiatry [ 42 , 43 ], we primarily selected the acupoints GV20, EX-HN3, and bilateral HT7, PC6, BL63, and KI4, but we will allow the practitioners to modify the acupoints used according to their clinical decisions. All treatment-related parameters will be recorded for analysis.…”