1.Efficacy and Safety of Pulse Magnetic Therapy System in Insomnia Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Jiwu LIAO ; Sisi WANG ; Borong ZHOU ; Wei LIANG ; Ping MA ; Min LIN ; Weisen LIN ; Congrui LI ; Xiaotao ZHANG ; Hongyao LI ; Yin CUI ; Jiajia HU ; Yuanyi QIN ; Yanhua DENG ; Aibing FU ; Tianhua ZHU ; Shanlian ZHANG ; Yunhong QU ; Lu XING ; Wumei LI ; Fei FENG ; Xinping YAO ; Guimei ZHANG ; Jiyang PAN
Psychiatry Investigation 2023;20(6):559-566
Objective:
This study’s objective is to assess the efficacy and safety of Pulsed Magnetic Therapy System (PMTS) in improving insomnia disorder.
Methods:
Participants with insomnia disorder were randomly assigned to receive either PMTS or sham treatment for four weeks (n= 153; PMTS: 76, sham: 77). Primary outcomes are the Insomnia Severity Index (ISI) scores at week 0 (baseline), 1, 2, 3, 4 (treatment), and 5 (follow-up). Secondary outcomes are the Pittsburgh Sleep Quality Index at baseline and week 4, and weekly sleep diary-derived values for sleep latency, sleep efficiency, real sleep time, waking after sleep onset, and sleep duration.
Results:
The ISI scores of the PMTS group and the sham group were 7.13±0.50, 11.07±0.51 at week 4, respectively. There was a significant group×time interaction for ISI (F3.214, 485.271=24.25, p<0.001, ηp 2=0.138). Only the PMTS group experienced continuous improvement throughout the study; in contrast, the sham group only experienced a modest improvement after the first week of therapy. At the end of the treatment and one week after it, the response of the PMTS group were 69.7% (95% confidence interval [CI]: 58.6%–79.0%), 75.0% (95% CI: 64.1%–83.4%), respectively, which were higher than the response of the sham group (p<0.001). For each of the secondary outcomes, similar group×time interactions were discovered. The effects of the treatment persisted for at least a week.
Conclusion
PMTS is safe and effective in improving insomnia disorders.
Result Analysis
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