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Auricular Acupressure for Hemodialysis Patients with Insomnia: A Multicenter Double-Blind Randomized Sham-Controlled Trial.

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机构: [1]Hemodialysis Department, Second Affiliated Hospital of Guangzhou University of Chinese Medicine/Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. [2]Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, China. [3]Evidence-based Chinese Medicine and Clinical Research Service Group, Guangdong Provincial Academy of Chinese Medical Sciences/Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. [4]Hemodialysis Department, Guangzhou Charity Hospital, Guangzhou, China. [5]Hemodialysis Department, Guangzhou HEMC (Higher Education Mega Center) Hospital, Guangzhou, China. [6]Hemodialysis Department, Guangzhou Hospital of Traditional Chinese Medicine, Guangzhou, China. [7]Hemodialysis Department, Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen, China. [8]Hemodialysis Department, Wuyi Hospital of Traditional Chinese Medicine, Jiangmen, China.
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Background and objectives: The effect of auricular acupressure (AA) for maintenance hemodialysis (MHD) patients with insomnia has been controversial. This study assessed the efficacy and safety of AA for MHD patients with chronic insomnia. Design, setting, participants, and measurements: This was a multicenter, double-blind (participant and assessor), randomized sham-controlled trial. A total of 133 subjects were randomized to receive AA on active points (AA group, n = 64) or on sham auricular acupressure (SAA) points (SAA group, n = 69) for 8 weeks and followed up for 12 weeks. AA was provided by assigned qualified nurses who were not involved in assessment. The primary outcome was the clinical response rate, which was defined as the percentage of participants who reached a reduction of Pittsburgh Sleep Quality Index (PSQI) global score ≥3 in each group. Secondary outcomes included changes in PSQI scores over time, PSQI scores and hypnotics use at each visit, and changes in the weekly dose of hypnotics for drug-dependent subjects. Results: At week 8, the AA group yielded a higher clinical response rate than the SAA group (AA: 55% vs. SAA: 36%, odds ratio: 1.5, 95% confidence interval: 1.0-2.2, p = 0.033). Both groups showed a reduction in PSQI global scores during treatment and follow-up, compared with the baseline, respectively. A significant change of PSQI global score was observed over time (F = 28.387, p < 0.001). PSQI global score of the AA group was relatively lower than that of the SAA group at each visit (p < 0.05 at week 16 and 20). For those depending on hypnotics, AA reduced their consumption of hypnotics. The intervention was safe, and its adherence was satisfactory. Conclusion: AA could serve as a complementary or alternative therapy for MHD patients with insomnia by improving their sleep quality and reducing their use of hypnotics. Clinical trial registration: Clinicaltrials.gov, Identifier: NCT03015766.

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大类 | 4 区 医学
小类 | 4 区 全科医学与补充医学
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Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE

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第一作者机构: [1]Hemodialysis Department, Second Affiliated Hospital of Guangzhou University of Chinese Medicine/Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. [2]Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, China.
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