Evidence map›Paper›PMID 26246907›Full record

Trial reportJournal of obesity2015

Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial.

Scott A Shikora, Bruce M Wolfe, Caroline M Apovian, Mehran Anvari, David B Sarwer, Robert D Gibbons, Sayeed Ikramuddin, Christopher J Miller, Mark B Knudson, Katherine S Tweden and 2 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of obesity, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed
–field-weighted citation impact
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

46 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Review
  10. Review
  11. Mechanism and Applications of Vagus Nerve Stimulation.Current issues in molecular biology · 2025
    Review
  12. Review
  13. Review
  14. Review
  15. Neuromodulation for functional upper gastrointestinal diseases.Gut microbiota and integrative wellness · 2023
    Article
  16. Clinical perspectives on vagus nerve stimulation: present and future.Clinical science (London, England : 1979) · 2022
    Review
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Scott A ShikoraDivision of General and Gastrointestinal Surgery, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA ; EnteroMedics Inc., 2800 Patton Road, St. Paul, MN 55113, USA.
Bruce M WolfeDepartment of Surgery, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.
Caroline M ApovianDepartment of Medicine, Section of Endocrinology, Diabetes and Nutrition, Boston University School of Medicine, 88 East Newton Street, Boston, MA 02118, USA.
Mehran AnvariDepartment of Surgery, McMaster University, 1280 Main Street West, Hamilton, ON, Canada L8S4L8.
David B SarwerDepartments of Psychiatry and Surgery, Perelman School of Medicine, Hospital of the University of Pennsylvania, 3535 Market Street, Philadelphia, PA 19104, USA.
Robert D GibbonsDepartments of Medicine and Public Health Sciences, University of Chicago, 5841 S. Maryland Avenue, Chicago, IL 60637, USA.
Sayeed IkramuddinDepartment of Surgery, University of Minnesota, University of Minnesota Medical Center, 420 Delaware Street SE, Minneapolis, MN 55455, USA.
Christopher J Miller3D Communications LLC, 8386 Six Forks Road, Raleigh, NC 27615, USA.
Mark B KnudsonEnteroMedics Inc., 2800 Patton Road, St. Paul, MN 55113, USA.
Katherine S TwedenEnteroMedics Inc., 2800 Patton Road, St. Paul, MN 55113, USA.
Michael G SarrDepartment of Gastroenterologic and General Surgery, Mayo Clinic Rochester, 200 First Street SW, Rochester, MN 55905, USA.
Charles J BillingtonDivision of Endocrinology and Diabetes, University of Minnesota, Minneapolis, Minnesota Veterans' Administration Medical Center, One Veterans Drive, Minneapolis, MN 55417, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectivesVagal block therapy (vBloc) is effective for moderate to severe obesity at one year. SUBJECTS/

methodsThe ReCharge trial is a double-blind, randomized controlled clinical trial of 239 participants with body mass index (BMI) of 40 to 45 kg/m or 35 to 40 kg/m with one or more obesity-related conditions. Interventions were implantation of either vBloc or Sham devices and weight management counseling. Mixed models assessed percent excess weight loss (%EWL) and total weight loss (%TWL) in intent-to-treat analyses. At 18 months, 142 (88%) vBloc and 64 (83%) Sham patients remained enrolled in the study.

results18-month weight loss was 23% EWL (8.8% TWL) for vBloc and 10% EWL (3.8% TWL) for Sham (P < 0.0001). vBloc patients largely maintained 12-month weight loss of 26% EWL (9.7% TWL). Sham regained over 40% of the 17% EWL (6.4% TWL) by 18 months. Most weight regain preceded unblinding. Common adverse events of vBloc through 18 months were heartburn/dyspepsia and abdominal pain; 98% of events were reported as mild or moderate and 79% had resolved.

conclusionsWeight loss with vBloc was sustained through 18 months, while Sham regained weight between 12 and 18 months. vBloc is effective with a low rate of serious complications.

Indexed as

Weight LossAbdominal PainBody Mass IndexDouble-Blind MethodDyspepsiaElectrodesFemaleFollow-Up StudiesHeartburnHumansMaleMiddle AgedNerve BlockObesity, MorbidRisk AssessmentTreatment Outcome

Identifiers

PMID26246907
PMCPMC4515300

What OpenQuestion holds

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Registered trials

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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.