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

SOURCE: Psychiatry Investigation. 20(6) (pp 559-566), 2023.

DATE OF PUBLICATION: June 2023.

AUTHORS: Liao J.; Wang S.; Zhou B.; Liang W.; Ma P.; Lin M.; Lin W.; Li C.; Zhang X.; Li H.; Cui Y.; Hu J.; Qin Y.; Deng Y.; Fu A.; Zhu T.; Zhang S.; Qu Y.; Xing L.; Li W.; Feng F.; Yao X.; Zhang G.; Pan J.

ABSTRACT
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 groupxtime interaction for ISI (F<inf>3.214</inf>,<inf>485.271</inf>=24.25, p<0.001, eta<inf>p2</inf>=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 groupxtime interactions were discovered. The effects of the treatment persisted for at least a week.

CONCLUSION: PMTS is safe and effective in improving insomnia disorders.

LINK TO FULL ARTICLE: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10307909/