Wei-Li Wang1, Shen-Yi Wang2, Hao-Yuan Hung3, Mu-Hong Chen4, Chi-Hung Juan5, Cheng-Ta Li6. 1. Department of Psychiatry, Taoyuan Armed Forces General Hospital, Taoyuan, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Master of Public Health Degree Program, College of Public Health, National Taiwan University, Taipei, Taiwan. 2. Department of Psychiatry, Taoyuan Armed Forces General Hospital, Taoyuan, Taiwan. 3. Department of Pharmacology, National Defense Medical Center, Taipei, Taiwan; Department of Pharmacy Practice, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Graduate Institute of Medical Sciences, National Defense Medical Center, Taipei, Taiwan. 4. Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming Chiao-Tung University, Taipei, Taiwan. 5. Institute of Cognitive Neuroscience, National Central University, Jhongli, Taiwan. 6. Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Department of Pharmacy Practice, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming Chiao-Tung University, Taipei, Taiwan; Institute of Cognitive Neuroscience, National Central University, Jhongli, Taiwan; Institute of Brain Science, National Yang-Ming Chiao-Tung University, Taipei, Taiwan; Institute of Brain Science and Brain Research Center, School of Medicine, National Yang-Ming Chiao-Tung University, Taipei, Taiwan. Electronic address: ctli2@vghtpe.gov.tw.
Abstract
BACKGROUND: To study the safety and patients' tolerance of transcranial magnetic stimulation (TMS), we conducted a systematic review and meta-analysis of the major depressive disorder population. METHODS: Our study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We searched the literature published before April 30th, 2021 and performed a random-effects meta-analyses which included drop-out due to adverse events, serious adverse events and other non-serious adverse events as primary and secondary outcomes. RESULTS: A total of 53 randomized sham-controlled trials with 3,273 participants were included. There was no increased risk of drop-out due to an adverse event (active TMS intervention group=3.3%, sham TMS intervention group=2.3%, odds ratio = 1.30, 95% CI= 0.78-2.16, P = 0.31) or a serious adverse event (active TMS intervention group=0.9%, sham TMS intervention group=1.5%, odds ratio = 0.67, 95% CI= 0.29-1.55, P = 0.35). Our findings suggest that TMS intervention may significantly increase the risk of non-serious adverse events including: headaches (active TMS intervention group=22.6%, sham TMS intervention group=16.2%, odds ratio = 1.48, 95% CI= 1.15-1.91, P = 0.002), discomfort (active TMS intervention group=10.9%, sham TMS intervention group=5.0%, odds ratio 1.98, 95% CI= 1.22-3.21, P = 0.006) and pain (active TMS intervention group=23.8%, sham TMS intervention group=5.2%, odds ratio= 8.09, 95% CI= 4.71-13.90, P < 0.001) at the stimulation site, but these non-serious events were mostly mild and transient after TMS treatment. CONCLUSIONS: These findings provide evidence for the safety and patients' tolerance of transcranial magnetic stimulation technique as an alternative monotherapy or as an add-on treatment for major depressive disorder.
BACKGROUND: To study the safety and patients' tolerance of transcranial magnetic stimulation (TMS), we conducted a systematic review and meta-analysis of the major depressive disorder population. METHODS: Our study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We searched the literature published before April 30th, 2021 and performed a random-effects meta-analyses which included drop-out due to adverse events, serious adverse events and other non-serious adverse events as primary and secondary outcomes. RESULTS: A total of 53 randomized sham-controlled trials with 3,273 participants were included. There was no increased risk of drop-out due to an adverse event (active TMS intervention group=3.3%, sham TMS intervention group=2.3%, odds ratio = 1.30, 95% CI= 0.78-2.16, P = 0.31) or a serious adverse event (active TMS intervention group=0.9%, sham TMS intervention group=1.5%, odds ratio = 0.67, 95% CI= 0.29-1.55, P = 0.35). Our findings suggest that TMS intervention may significantly increase the risk of non-serious adverse events including: headaches (active TMS intervention group=22.6%, sham TMS intervention group=16.2%, odds ratio = 1.48, 95% CI= 1.15-1.91, P = 0.002), discomfort (active TMS intervention group=10.9%, sham TMS intervention group=5.0%, odds ratio 1.98, 95% CI= 1.22-3.21, P = 0.006) and pain (active TMS intervention group=23.8%, sham TMS intervention group=5.2%, odds ratio= 8.09, 95% CI= 4.71-13.90, P < 0.001) at the stimulation site, but these non-serious events were mostly mild and transient after TMS treatment. CONCLUSIONS: These findings provide evidence for the safety and patients' tolerance of transcranial magnetic stimulation technique as an alternative monotherapy or as an add-on treatment for major depressive disorder.