A patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression

Scott M Berry,1 Kristine Broglio,1 Mark Bunker,2 Amara Jayewardene,2 Bryan Olin,2 A John Rush31Berry Consultants, Austin, TX, USA; 2Cyberonics, Inc, Houston, TX, USA; 3Duke-NUS, Office of Clinical Sciences, SingaporeObjective: To compare response and remission rates in depressed patients with chroni...

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Autores principales:	Berry SM, Broglio K, Bunker M, Jayewardene A, Olin B, Rush AJ
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2013
Materias:	Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/ec22294298ec43e0ae47746c557a73c5
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spelling	oai:doaj.org-article:ec22294298ec43e0ae47746c557a73c52021-12-02T03:16:31ZA patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression1179-1470https://doaj.org/article/ec22294298ec43e0ae47746c557a73c52013-03-01T00:00:00Zhttp://www.dovepress.com/a-patient-level-meta-analysis-of-studies-evaluating-vagus-nerve-stimul-a12338https://doaj.org/toc/1179-1470Scott M Berry,1 Kristine Broglio,1 Mark Bunker,2 Amara Jayewardene,2 Bryan Olin,2 A John Rush31Berry Consultants, Austin, TX, USA; 2Cyberonics, Inc, Houston, TX, USA; 3Duke-NUS, Office of Clinical Sciences, SingaporeObjective: To compare response and remission rates in depressed patients with chronic treatment-resistant depression (TRD) treated with vagus nerve stimulation (VNS) Therapy&reg; plus treatment as usual (VNS + TAU) or TAU alone in a meta-analysis using Bayesian hierarchical models.Data sources and study selection: Six outpatient, multicenter, clinical trials that have evaluated VNS + TAU or TAU in TRD, including two single-arm studies of VNS + TAU (n = 60 and n = 74), a randomized study of VNS + TAU versus TAU (n = 235), a randomized study of VNS + TAU comparing different VNS stimulation intensities (n = 331), a nonrandomized registry of VNS + TAU versus TAU (n = 636), and a single-arm study of TAU (n = 124) to provide longer-term, control data for comparison with VNS-treated patients.Data extraction: A systematic review of individual patient-level data based on the intent-to-treat principle, including all patients who contributed more than one post-baseline visit. Response was based on the Montgomery&ndash;&Aring;sberg Depression Rating Scale (MADRS) and the Clinical Global Impressions scale&#39;s Improvement subscale (CGI-I), as these were the two clinician-rated measures common across all or most studies. Remission was based on the MADRS.Results: Outcomes were compared from baseline up to 96 weeks of treatment with VNS + TAU (n = 1035) versus TAU (n = 425). The MADRS response rate for VNS + TAU at 12, 24, 48, and 96 weeks were 12%, 18%, 28%, and 32% versus 4%, 7%, 12%, and 14% for TAU. The MADRS remission rate for VNS + TAU at 12, 24, 48, and 96 weeks were 3%, 5%, 10%, and 14% versus 1%, 1%, 2%, and 4%, for TAU. Adjunctive VNS Therapy was associated with a greater likelihood of response (odds ratio [OR] = 3.19, 95% confidence interval [CI]: 2.12, 4.66) and remission (OR = 4.99, CI: 2.93, 7.76), compared with TAU. For patients who had responded to VNS + TAU at 24 weeks, sustained response was more likely at 48 weeks (OR = 1.98, CI: 1.34, 3.01) and at 96 weeks (OR = 3.42, CI: 1.78, 7.31). Similar results were observed for CGI-I response.Conclusion: For patients with chronic TRD, VNS + TAU has greater response and remission rates that are more likely to persist than TAU.Keywords: Bayesian meta-analysis, remission rate, response rate, treatment-resistant depression, vagus nerve stimulation, VNS TherapyBerry SMBroglio KBunker MJayewardene AOlin BRush AJDove Medical PressarticleMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2013, Iss default, Pp 17-35 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medical technology R855-855.5
spellingShingle	Medical technology R855-855.5 Berry SM Broglio K Bunker M Jayewardene A Olin B Rush AJ A patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression
description	Scott M Berry,1 Kristine Broglio,1 Mark Bunker,2 Amara Jayewardene,2 Bryan Olin,2 A John Rush31Berry Consultants, Austin, TX, USA; 2Cyberonics, Inc, Houston, TX, USA; 3Duke-NUS, Office of Clinical Sciences, SingaporeObjective: To compare response and remission rates in depressed patients with chronic treatment-resistant depression (TRD) treated with vagus nerve stimulation (VNS) Therapy&reg; plus treatment as usual (VNS + TAU) or TAU alone in a meta-analysis using Bayesian hierarchical models.Data sources and study selection: Six outpatient, multicenter, clinical trials that have evaluated VNS + TAU or TAU in TRD, including two single-arm studies of VNS + TAU (n = 60 and n = 74), a randomized study of VNS + TAU versus TAU (n = 235), a randomized study of VNS + TAU comparing different VNS stimulation intensities (n = 331), a nonrandomized registry of VNS + TAU versus TAU (n = 636), and a single-arm study of TAU (n = 124) to provide longer-term, control data for comparison with VNS-treated patients.Data extraction: A systematic review of individual patient-level data based on the intent-to-treat principle, including all patients who contributed more than one post-baseline visit. Response was based on the Montgomery&ndash;&Aring;sberg Depression Rating Scale (MADRS) and the Clinical Global Impressions scale&#39;s Improvement subscale (CGI-I), as these were the two clinician-rated measures common across all or most studies. Remission was based on the MADRS.Results: Outcomes were compared from baseline up to 96 weeks of treatment with VNS + TAU (n = 1035) versus TAU (n = 425). The MADRS response rate for VNS + TAU at 12, 24, 48, and 96 weeks were 12%, 18%, 28%, and 32% versus 4%, 7%, 12%, and 14% for TAU. The MADRS remission rate for VNS + TAU at 12, 24, 48, and 96 weeks were 3%, 5%, 10%, and 14% versus 1%, 1%, 2%, and 4%, for TAU. Adjunctive VNS Therapy was associated with a greater likelihood of response (odds ratio [OR] = 3.19, 95% confidence interval [CI]: 2.12, 4.66) and remission (OR = 4.99, CI: 2.93, 7.76), compared with TAU. For patients who had responded to VNS + TAU at 24 weeks, sustained response was more likely at 48 weeks (OR = 1.98, CI: 1.34, 3.01) and at 96 weeks (OR = 3.42, CI: 1.78, 7.31). Similar results were observed for CGI-I response.Conclusion: For patients with chronic TRD, VNS + TAU has greater response and remission rates that are more likely to persist than TAU.Keywords: Bayesian meta-analysis, remission rate, response rate, treatment-resistant depression, vagus nerve stimulation, VNS Therapy
format	article
author	Berry SM Broglio K Bunker M Jayewardene A Olin B Rush AJ
author_facet	Berry SM Broglio K Bunker M Jayewardene A Olin B Rush AJ
author_sort	Berry SM
title	A patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression
title_short	A patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression
title_full	A patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression
title_fullStr	A patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression
title_full_unstemmed	A patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression
title_sort	patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression
publisher	Dove Medical Press
publishDate	2013
url	https://doaj.org/article/ec22294298ec43e0ae47746c557a73c5
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A patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression

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