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- Title
Electroacupuncture for treating cancer-related insomnia: a multicenter, assessor-blinded, randomized controlled, pilot clinical trial.
- Authors
Lee, Boram; Kim, Bo-Kyung; Kim, Mikyung; Kim, Ae-Ran; Park, Hyo-Ju; Kwon, O-Jin; Lee, Jun-Hwan; Kim, Joo-Hee
- 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),
- Subjects
INSOMNIA risk factors; INSOMNIA treatment; SALIVA analysis; RESEARCH; PILOT projects; STATISTICS; CONFIDENCE intervals; ACTIGRAPHY; HEALTH outcome assessment; FISHER exact test; TREATMENT effectiveness; RANDOMIZED controlled trials; SLEEP disorders; COMPARATIVE studies; T-test (Statistics); PEARSON correlation (Statistics); BLIND experiment; DESCRIPTIVE statistics; ANALYSIS of covariance; QUESTIONNAIRES; RESEARCH funding; TUMORS; STATISTICAL sampling; CLASSIFICATION of mental disorders; DATA analysis software; DATA analysis; ELECTROACUPUNCTURE; DISEASE complications
- Publication
BMC Complementary Medicine & Therapies, 2022, Vol 22, Issue 1, p1
- ISSN
2662-7671
- Publication type
Article
- DOI
10.1186/s12906-022-03561-w