Evidence map›Paper›PMID 27048437›Full record

Trial reportObesity surgery2016

Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study.

John M Morton, Sajani N Shah, Bruce M Wolfe, Caroline M Apovian, Christopher J Miller, Katherine S Tweden, Charles J Billington, Scott A Shikora

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Obesity surgery, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
3.5field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 51 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Few-shot segmentation and fiber tractography of human vagus nerve using 3D-MUSE imaging.Proceedings of SPIE--the International Society for Optical Engineering · 2025
    Article
  6. Deep phenotyping obesity using EHR data: Promise, Challenges, and Future Directions.medRxiv : the preprint server for health sciences · 2024
    Article
  7. Vagus nerve stimulation (VNS): recent advances and future directions.Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2024
    Review
  8. Article
  9. Human microscopic vagus nerve anatomy using deep learning on 3D-MUSE images.Proceedings of SPIE--the International Society for Optical Engineering · 2024
    Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
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  19. Article
  20. The vagus neurometabolic interface and clinical disease.International journal of obesity (2005) · 2018
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 1 country.

John M MortonStanford School of Medicine, Stanford, CA, USA.
Sajani N ShahTufts Medical Center, Boston, MA, USA.
Bruce M WolfeOregon Health & Science University, Portland, OR, USA.
Caroline M ApovianBoston University, Boston, MA, USA.
Christopher J Miller3D Communications, LLC, Raleigh, NC, USA.
Katherine S TwedenEnteroMedics Inc, St Paul, MN, USA. ktweden@enteromedics.com.
Charles J BillingtonUniversity of Minnesota, Minneapolis, MN, USA.
Scott A ShikoraEnteroMedics Inc, St Paul, MN, USA.
Brigham and Women's Hospital · USOregon Health & Science University · USReShape Lifesciences (United States) · USStanford Medicine · USTufts Medical Center · USUniversity of Minnesota · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVagal nerve blockade (vBloc) therapy was shown to be a safe and effective treatment for moderate to severe obesity. This report summarizes the safety and efficacy of vBloc therapy in the prespecified subgroup of patients with moderate obesity.

methodsThe ReCharge Trial is a double-blind, randomized controlled clinical trial of participants with body mass index (BMI) of 40-45 or 35-40 kg/m(2) with at least one obesity-related comorbid condition. Participants were randomized 2:1 to implantation with either a vBloc or sham device with weight management counseling. Eighty-four subjects had moderate obesity (BMI 35-40 kg/m(2)) at randomization.

resultsFifty-three participants were randomized to vBloc and 31 to sham. Qualifying obesity-related comorbidities included dyslipidemia (73%), hypertension (58%), sleep apnea (33%), and type 2 diabetes (8%). The vBloc group achieved a percentage excess weight loss (%EWL) of 33% (11% total weight loss (%TWL)) compared to 19% EWL (6% TWL) with sham at 12 months (treatment difference 14 percentage points, 95% CI, 7-22; p < 0.0001). Common adverse events of vBloc through 12 months were heartburn/dyspepsia and implant site pain; the majority of events were reported as mild or moderate.

conclusionsvBloc therapy resulted in significantly greater weight loss than the sham control among participants with moderate obesity and comorbidities with a well-tolerated safety profile.

Indexed as

Vagus NerveAdultBody Mass IndexDiabetes Mellitus, Type 2Double-Blind MethodDyslipidemiasFemaleHumansHypertensionMaleMiddle AgedNerve BlockObesityTreatment OutcomeWeight LossActive implantable medical deviceBariatric surgeryLaparoscopic surgeryModerate obesityObesityRandomized controlled trialVagal nerve blocking

Identifiers

PMID27048437
PMCPMC4831996
OpenAlexW2330479957

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.