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Compr Psychiatry. 2019 Dec 12;98:152156. doi: 10.1016/j.comppsych.2019.152156. [Epub ahead of print]

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

Author information

1
Amygdala Limited, Letchworth Garden City SG6 2AA, UK. Electronic address: jmb@amygdala.uk.com.
2
Independent Statistician, Sainte-Anne, Guadeloupe, France. Electronic address: corinne.lereun@yahoo.fr.
3
Symmetron Limited, London, UK. Electronic address: alexd@symmetron.net.
4
Mtech Access Limited, Bicester, Oxfordshire OX26 4PP, UK. Electronic address: stephen.mitchell@mtechaccess.co.uk.
5
Department of Psychiatry, UNC School of Medicine, Chapel Hill, NC, USA. Electronic address: bradley_gaynes@med.unc.edu.

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

PMID:
31978785
DOI:
10.1016/j.comppsych.2019.152156
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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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