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Review
. 2019 Dec 12:98:152156.
doi: 10.1016/j.comppsych.2019.152156. Online ahead of print.

Vagus nerve stimulation (VNS) therapy in patients with treatment resistant depression: A systematic review and meta-analysis

Juliana M Bottomley  1 , Corinne LeReun  2 , Alex Diamantopoulos  3 , Stephen Mitchell  4 , Bradley N Gaynes  5
Affiliations
Free article
Review

Vagus nerve stimulation (VNS) therapy in patients with treatment resistant depression: A systematic review and meta-analysis

Juliana M Bottomley et al. Compr Psychiatry. .
Free article

Abstract

Background: Vagus nerve stimulation (VNS) therapy is approved for treatment-resistant depression (TRD). A recent 5-year comparative study prompted this review of its impact in this very severe population. Previous systematic literature reviews (SLR) cited concerns in terms of missing studies or patient duplication.

Methods: This SLR addressed these criticisms, assessed all outcomes of longer-term adjunctive VNS in all studies, irrespective of TRD severity, comparing where feasible with treatment-as-usual (TAU). We searched for adult VNS+TAU studies (January 1, 2000 to June 24, 2019). Comparative and single-arm studies were eligible. All reported efficacy, safety and quality of life (QOL) outcomes were assessed. Where possible, meta-analysis was used to calculate overall pooled effect estimates across studies at several time points.

Results: Of 22 identified studies, there were two randomized controlled (RCT), sixteen single-arm and four non-randomized comparative studies. Numerous depression-specific, safety and QOL measures were reported. Meta-analysis was possible for three efficacy [Montgomery-Asberg Depression Rating Scale, Clinician Global Impression-Improvement, Hamilton Rating Scale for Depression] and three safety [serious adverse events, study drop-outs and all-cause mortality] but no QOL measures. Data beyond 2 years was not poolable. Analyses demonstrated that antidepressant benefits improved to 24 months and safety issues were minimal. Heterogeneity was high and statistically significant.

Conclusions: Despite limitations in the evidence base, our comprehensive summary of VNS+TAU outcomes suggests that this treatment provides improving benefit and hope for this very hard-to-treat chronic population. More comparative TRD studies should describe safety and QOL.

Keywords: Long-term outcomes; Meta-analysis; Systematic review; Treatment resistant depression; Vagus nerve stimulation (VNS) therapy.

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Conflict of interest statement

Declaration of competing interest J Bottomley, C LeReun, A Diamantopoulos and S Mitchell have received consultancy payments from LivaNova. B Gaynes has received consultation payments from LivaNova addressing models of treatment resistant depression.

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