Purpose of Review <p>Treatment-resistant depression (TRD) poses a significant clinical challenge, with standard therapies often failing to achieve remission. Vagus nerve stimulation (VNS), an approved neuromodulation therapy for TRD, shows variable efficacy and safety across studies. This systematic review evaluates the efficacy and safety of VNS and transcutaneous VNS (t-VNS) for adults with TRD compared to standard care, placebo, or no intervention, aiming to clarify its role in clinical practice.</p> Recent Findings <p>Following PRISMA guidelines, we searched PubMed, Embase, Cochrane Library, Scopus, and PsycINFO for studies on VNS in TRD until March 2025. Six studies (<i>n</i> = 1,523) were included: one randomized controlled trial (RCT), four observational studies, and one t-VNS feasibility study. Response rates ranged from 27 to 67.6%, with higher rates in long-term observational studies (e.g., 67.6% at 5 years). The RCT showed no significant primary outcome difference but significant secondary efficacy benefits (CGI-I, <i>p</i> = 0.004). t-VNS reduced depression severity but lacked clinical significance. VNS was well-tolerated, with mild to moderate adverse events (e.g., voice alteration, dyspnea).</p> Summary <p>VNS demonstrates moderate to high efficacy for TRD, particularly in long-term observational studies, with a favorable safety profile. Heterogeneity and methodological limitations necessitate further RCTs to confirm findings and explore t-VNS’s potential, guiding its integration into TRD management.</p>

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Efficacy and Safety of Vagus Nerve Stimulation for Treatment-Resistant Depression: a Systematic Review of Current Evidence

  • Oluwatobi Idowu,
  • Evelyn Omowunmi Fatoye,
  • Nicholas Aderinto,
  • Israel Charles Abraham,
  • Gbolahan Olatunji,
  • Emmanuel Kokori

摘要

Purpose of Review

Treatment-resistant depression (TRD) poses a significant clinical challenge, with standard therapies often failing to achieve remission. Vagus nerve stimulation (VNS), an approved neuromodulation therapy for TRD, shows variable efficacy and safety across studies. This systematic review evaluates the efficacy and safety of VNS and transcutaneous VNS (t-VNS) for adults with TRD compared to standard care, placebo, or no intervention, aiming to clarify its role in clinical practice.

Recent Findings

Following PRISMA guidelines, we searched PubMed, Embase, Cochrane Library, Scopus, and PsycINFO for studies on VNS in TRD until March 2025. Six studies (n = 1,523) were included: one randomized controlled trial (RCT), four observational studies, and one t-VNS feasibility study. Response rates ranged from 27 to 67.6%, with higher rates in long-term observational studies (e.g., 67.6% at 5 years). The RCT showed no significant primary outcome difference but significant secondary efficacy benefits (CGI-I, p = 0.004). t-VNS reduced depression severity but lacked clinical significance. VNS was well-tolerated, with mild to moderate adverse events (e.g., voice alteration, dyspnea).

Summary

VNS demonstrates moderate to high efficacy for TRD, particularly in long-term observational studies, with a favorable safety profile. Heterogeneity and methodological limitations necessitate further RCTs to confirm findings and explore t-VNS’s potential, guiding its integration into TRD management.