Steve Kisely1,2,3,4, Amy Li1, Nicola Warren1,2, Dan Siskind1,2. 1. The University of Queensland Southern Clinical School, Queensland, Australia. 2. Metro South Health Service, Woolloongabba, Australia. 3. Griffith Institute of Health, Griffith University, Queensland, Australia. 4. Departments of Psychiatry, Community Health and Epidemiology, Dalhousie University, Nova Scotia, Canada.
Abstract
BACKGROUND: Deep brain stimulation is increasingly being used for treatment-resistant depression. Blinded, randomized controlled trials of active versus sham treatment have been limited to small numbers. METHOD: We performed a systematic review and meta-analysis on the effectiveness of deep brain stimulation (DBS) in depression. Cochrane Central Register of Controlled Trials, PubMed/Medline, Embase and PsycINFO, Chinese Biomedical Literature Service System, and China Knowledge Resource Integrated Database were searched for single- or double placebo-controlled, crossover, and parallel-group trials in which DBS was compared with sham treatment using validated scales. RESULTS: Ten papers from nine studies met inclusion criteria, all but two of which were double-blinded RCTs. The main outcome was a reduction in depressive symptoms. It was possible to combine data for 190 participants. Patients on active, as opposed to sham, treatment had a significantly higher response (OR = 5.50; 95% CI = 2.79, 10.85; p < .0001) and reductions in mean depression score (SMD = -0.42; 95% CI = -0.72, -0.12; p = .006). However, the effect was attenuated on some of the subgroup and sensitivity analyses, and there were no differences for most other outcomes. In addition, 84 participants experienced a total of 131 serious adverse effects, although not all could be directly associated with the device or surgery. Finally, publication bias was possible. CONCLUSIONS: DBS may show promise for treatment-resistant depression but remains an experimental treatment until further data are available.
BACKGROUND: Deep brain stimulation is increasingly being used for treatment-resistant depression. Blinded, randomized controlled trials of active versus sham treatment have been limited to small numbers. METHOD: We performed a systematic review and meta-analysis on the effectiveness of deep brain stimulation (DBS) in depression. Cochrane Central Register of Controlled Trials, PubMed/Medline, Embase and PsycINFO, Chinese Biomedical Literature Service System, and China Knowledge Resource Integrated Database were searched for single- or double placebo-controlled, crossover, and parallel-group trials in which DBS was compared with sham treatment using validated scales. RESULTS: Ten papers from nine studies met inclusion criteria, all but two of which were double-blinded RCTs. The main outcome was a reduction in depressive symptoms. It was possible to combine data for 190 participants. Patients on active, as opposed to sham, treatment had a significantly higher response (OR = 5.50; 95% CI = 2.79, 10.85; p < .0001) and reductions in mean depression score (SMD = -0.42; 95% CI = -0.72, -0.12; p = .006). However, the effect was attenuated on some of the subgroup and sensitivity analyses, and there were no differences for most other outcomes. In addition, 84 participants experienced a total of 131 serious adverse effects, although not all could be directly associated with the device or surgery. Finally, publication bias was possible. CONCLUSIONS: DBS may show promise for treatment-resistant depression but remains an experimental treatment until further data are available.
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