Efficacy and Safety of Pulse Magnetic Therapy System in Insomnia Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

• 영문명: Efficacy and Safety of Pulse Magnetic Therapy System in Insomnia Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
• 발행기관: 대한신경정신의학회
• 저자명: Liao Jiwu Wang Sisi Zhou Borong Liang Wei Ma Ping Lin Min Lin Weisen Li Congrui Zhang Xiaotao
• 간행물 정보: 『Psychiatry Investigation』제20권 제6호, 559~566쪽, 전체 8쪽
• 주제분류: 의약학 > 정신과학
• 파일형태: PDF
• 발행일자: 2023.06.30

영문 초록

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.

목차

INTRODUCTION

METHODS

RESULTS

DISCUSSION

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키워드

Insomnia disorder Pulsed magnetic therapy system Non-pharmacological treatment ISI