PMID- 24754318
OWN - NLM
STAT- MEDLINE
DCOM- 20140813
LR  - 20220410
IS  - 1528-1167 (Electronic)
IS  - 0013-9580 (Print)
IS  - 0013-9580 (Linking)
VI  - 55
IP  - 6
DP  - 2014 Jun
TI  - The long-term effect of vagus nerve stimulation on quality of life in patients 
      with pharmacoresistant focal epilepsy: the PuLsE (Open Prospective Randomized 
      Long-term Effectiveness) trial.
PG  - 893-900
LID - 10.1111/epi.12611 [doi]
AB  - OBJECTIVE: To evaluate whether vagus nerve stimulation (VNS) as adjunct to best 
      medical practice (VNS + BMP) is superior to BMP alone in improving long-term 
      health-related quality of life (HRQoL). METHODS: PuLsE (Open Prospective 
      Randomized Long-term Effectiveness) was a prospective, randomized, 
      parallel-group, open-label, and long-term effectiveness study (conducted at 28 
      sites in Europe and Canada). Adults with pharmacoresistant focal seizures (n = 
      112) received VNS + BMP or BMP (1:1 ratio). Medications and VNS parameters could 
      be adjusted as clinically indicated for optimal seizure control while minimizing 
      adverse effects. Primary endpoint was mean change from baseline HRQoL (using 
      Quality of Life in Epilepsy Inventory-89 total score; QOLIE-89). Secondary 
      endpoints included changes in seizure frequency, responder rate (>/=50% decrease in 
      seizure frequency), Centre for Epidemiologic Studies Depression scale (CES-D), 
      Neurological Disorders Depression Inventory-Epilepsy scale (NDDI-E), Clinical 
      Global Impression-Improvement scale (CGI-I), Adverse Event Profile (AEP), and 
      antiepileptic drug (AED) load. The study was prematurely terminated due to 
      recruitment difficulties prior to completing the planned enrollment of n = 362. 
      Results for n = 96 who had baseline and at least one follow-up QOLIE-89 
      assessment (from months 3-12) were included in this analysis. Mixed model 
      repeated measures (MMRM) analysis of variance was performed on change from 
      baseline for the primary and secondary endpoints. RESULTS: Significant 
      between-group differences in favor of VNS + BMP were observed regarding 
      improvement in HRQoL, seizure frequency, and CGI-I score (respective p-values < 
      0.05, 0.03, and 0.01). More patients in the VNS + BMP group (43%) reported 
      adverse events (AEs) versus BMP group (21%) (p = 0.01), a difference reflecting 
      primarily mostly transient AEs related to VNS implantation or stimulation. No 
      significant difference between treatment groups was observed for changes in 
      CES-D, NDDI-E, AEP, and AED load. SIGNIFICANCE: VNS therapy as a treatment 
      adjunct to BMP in patients with pharmacoresistant focal seizures was associated 
      with a significant improvement in HRQoL compared with BMP alone. A PowerPoint 
      slide summarizing this article is available for download in the Supporting 
      Information section here.
CI  - (c) 2014 The Authors Epilepsia published by Wiley Periodicals, Inc. on behalf of 
      International League Against Epilepsy.
FAU - Ryvlin, Philippe
AU  - Ryvlin P
AD  - TIGER, CRNL, INSERM U1028, CNRS 5292 and Hospices Civils de Lyon and Claude 
      Bernard Lyon-1 University, Lyon, France.
FAU - Gilliam, Frank G
AU  - Gilliam FG
FAU - Nguyen, Dang K
AU  - Nguyen DK
FAU - Colicchio, Gabriella
AU  - Colicchio G
FAU - Iudice, Alfonso
AU  - Iudice A
FAU - Tinuper, Paolo
AU  - Tinuper P
FAU - Zamponi, Nelia
AU  - Zamponi N
FAU - Aguglia, Umberto
AU  - Aguglia U
FAU - Wagner, Louis
AU  - Wagner L
FAU - Minotti, Lorella
AU  - Minotti L
FAU - Stefan, Hermann
AU  - Stefan H
FAU - Boon, Paul
AU  - Boon P
FAU - Sadler, Mark
AU  - Sadler M
FAU - Benna, Paolo
AU  - Benna P
FAU - Raman, Pradheep
AU  - Raman P
FAU - Perucca, Emilio
AU  - Perucca E
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20140422
PL  - United States
TA  - Epilepsia
JT  - Epilepsia
JID - 2983306R
RN  - 0 (Anticonvulsants)
SB  - IM
EIN - Epilepsia. 2014 Sep;55(9):1476
EIN - Epilepsia. 2015 Jun;56(6):983. PMID: 26047158
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anticonvulsants/therapeutic use
MH  - Drug Resistance
MH  - Epilepsies, Partial/drug therapy/psychology/*therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Quality of Life/*psychology
MH  - Treatment Outcome
MH  - *Vagus Nerve Stimulation/adverse effects
MH  - Young Adult
PMC - PMC4283995
OTO - NOTNLM
OT  - Epilepsy
OT  - Health-related quality of life
OT  - QOLIE-89
OT  - Seizures
OT  - Vagus nerve stimulation
EDAT- 2014/04/24 06:00
MHDA- 2014/08/15 06:00
CRDT- 2014/04/24 06:00
PHST- 2014/02/24 00:00 [accepted]
PHST- 2014/04/24 06:00 [entrez]
PHST- 2014/04/24 06:00 [pubmed]
PHST- 2014/08/15 06:00 [medline]
AID - 10.1111/epi.12611 [doi]
PST - ppublish
SO  - Epilepsia. 2014 Jun;55(6):893-900. doi: 10.1111/epi.12611. Epub 2014 Apr 22.