Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial
Open accessAbstract
BACKGROUND: The ReCharge Trial demonstrated that a vagal blocking device (vBloc) is a safe and effective treatment for moderate to severe obesity. This report summarizes 24-month outcomes. METHODS: with at least one comorbid condition were randomized to either vBloc therapy or sham intervention for 12 months. After 12 months, participants randomized to vBloc continued open-label vBloc therapy and are the focus of this report. Weight loss, adverse events, comorbid risk factors, and quality of life (QOL) will be assessed for 5 years. RESULTS: At 24 months, 123 (76 %) vBloc participants remained in the trial. Participants who presented at 24 months (n = 103) had a mean excess weight loss (EWL) of 21 % (8 % total weight loss [TWL]); 58 % of participants had ≥5 % TWL and 34 % had ≥10 % TWL. Among the subset of participants with abnormal preoperative values, significant improvements were observed in mean LDL (-16 mg/dL) and HDL cholesterol (+4 mg/dL), triglycerides (-46 mg/dL), HbA1c (-0.3 %), and systolic (-11 mmHg) and diastolic blood pressures (-10 mmHg). QOL measures were significantly improved. Heartburn/dyspepsia and implant site pain were the most frequently reported adverse events. The primary related serious adverse event rate was 4.3 %. CONCLUSIONS: vBloc therapy continues to result in medically meaningful weight loss with a favorable safety profile through 2 years. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01327976.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Two-year follow-up suggested sustained weight loss with vBloc®.
“Two-year follow-up suggested sustained weight loss [146, 147].”
From Clinical practice guidelines of the European Association for Endoscopic Surgery (EAES) on bariatric surgery: update 2020 endorsed by IFSO-EC, EASO and ESPCOP (2020) · cites this paper as [147]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Grundy, S. M., Brewer, H. B., Cleeman, J. I., Smith, S. C., & Lenfant, C. (2004) · Circulation · doi:10.1161/01.cir.0000111245.75752.c6 · Cited by 5,982 · see citing works
The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger
Stunkard, A. J., & Messick, S. (1985) · Journal of Psychosomatic Research · doi:10.1016/0022-3999(85)90010-8 · Cited by 4,687 · see citing works
Classification and Diagnosis of Diabetes
Fajans, S. S. (1990) · Medical Entomology and Zoology · Cited by 2,356 · see citing works
Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes
Schauer, P. R., Kashyap, S. R., Wolski, K., Brethauer, S. A., Kirwan, J. P., Pothier, C. E., Thomas, S., Abood, B., Nissen, S. E., & Bhatt, D. L. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1200225 · Cited by 2,164 · see citing works
(2) Classification and diagnosis of diabetes
American Diabetes Association (2015) · Diabetes Care · doi:10.2337/dc15-s005 · Cited by 1,841 · see citing works
Development of a brief measure to assess quality of life in obesity
Kolotkin, R. L., Crosby, R. D., Kosloski, K. D., & Williams, G. R. (2001) · Obesity Research · doi:10.1038/oby.2001.13 · Cited by 641 · see citing works
Ikramuddin, S., Blackstone, R. P., Brancatisano, A., Toouli, J., Shah, S. N., Wolfe, B. M., Fujioka, K., Maher, J. W., Swain, J., Que, F. G., et al. (2014) · JAMA · doi:10.1001/jama.2014.10540 · Cited by 214 · see citing works
Self-citationThe EMPOWER Study Group, Sarr, M. G., Billington, C. J., Brancatisano, R., Brancatisano, A., Toouli, J., Kow, L., Nguyen, N. T., Blackstone, R., Maher, J. W., et al. (2012) · Obesity Surgery · doi:10.1007/s11695-012-0751-8 · Cited by 162 · see citing works
Self-citationCamilleri, M., Toouli, J., Herrera, M. F., Kulseng, B. E., Kow, L., Pantoja, J. P., Mårvik, R., Johnsen, G., Billington, C. J., Moody, F. G., et al. (2008) · Surgery · doi:10.1016/j.surg.2008.03.015 · Cited by 159 · see citing works
Self-citationShikora, S. A., Toouli, J., Herrera, M. F., Kulseng, B. E., Zulewski, H., Brancatisano, R., Kow, L., Pantoja, J. P., Johnsen, G., Brancatisano, A., et al. (2013) · Journal of Obesity · doi:10.1155/2013/245683 · Cited by 99 · see citing works
Self-citationShikora, S. A., Wolfe, B. M., Apovian, C. M., Anvari, M., Sarwer, D. B., Gibbons, R. D., Ikramuddin, S., Miller, C. J., Knudson, M. B., Tweden, K. S., et al. (2015) · Journal of Obesity · doi:10.1155/2015/365604 · Cited by 83 · see citing works
Self-citationGastroplasty for obesity: Long‐term weight loss improved by vagotomy
Kral, J. G., Gortz, L., Hermansson, G., & Wallin, G. S. (1993) · World Journal of Surgery · doi:10.1007/bf01655710 · Cited by 68 · see citing works
TRUNCAL VAGOTOMY IN HYPOTHALAMIC OBESITY
Smith, D. S., Sarfeh, J., & Howard, L. R. (1983) · The Lancet · doi:10.1016/s0140-6736(83)92437-6 · Cited by 61 · see citing works
Gill, R. S., Majumdar, S. R., Rueda‐Clausen, C. F., Apte, S. S., Birch, D. W., Karmali, S., Sharma, A. M., Klarenbach, S. W., & Padwal, R. S. (2016) · Canadian Journal of Surgery · doi:10.1503/cjs.013315 · Cited by 21 · see citing works
Flagged first, then by citations
Research works printed but not linked: 1
- [13]Schauer PR Bhatt DL Kirwin JP Wolski K Brethauer SA Navaneethan SD Bariatric surgery versus intensive medical therapy in obese patients with diabetes—3-year outcomes NEJM 2014 PMC3372918 22449319
Cited by
Sorted by citations
Mechanick, J. I., Apovian, C., Brethauer, S., Garvey, W. T., Joffe, A. M., Kim, J., Kushner, R. F., Lindquist, R., Pessah-Pollack, R., Seger, J., et al. (2020) · Surgery for Obesity and Related Diseases · doi:10.1016/j.soard.2019.10.025 · Cited by 608 · see citing works
Self-citationMechanick, J. I., Apovian, C., Brethauer, S., Garvey, W. T., Joffe, A. M., Kim, J., Kushner, R. F., Lindquist, R., Pessah-Pollack, R., Seger, J., et al. (2019) · Endocrine Practice · doi:10.4158/gl-2019-0406 · Cited by 510 · see citing works
Self-citationDi Lorenzo, N., Antoniou, S. A., Batterham, R. L., Busetto, L., Godoroja, D., Iossa, A., Carrano, F. M., Agresta, F., Alarçon, I., Azran, C., et al. (2020) · Surgical Endoscopy · doi:10.1007/s00464-020-07555-y · Cited by 465 · see citing works
- Authors
- Apovian, C. M., Shah, S. N., Wolfe, B. M., Ikramuddin, S., Miller, C. J., Tweden, K. S., Billington, C. J., & Shikora, S. A.
- Affiliations
- Boston University (US)
- Tufts Medical Center (US)
- Oregon Health & Science University (US)
- University of Minnesota (US)
- ReShape Lifesciences (United States) (US)
- Brigham and Women's Hospital (US)
- Corresponding author
- Tweden, Katherine S.
- ORCID
- Venue
- Obesity Surgery
- Published
- 2016-08-10
- Volume
- 27
- Issue
- 1
- Pages
- 169-176
- ISSN
- 0960-8923 (ISSN-L)
- 1708-0428
- PMC
- PMC5187356
- OpenAlex
- W2513083063
- Cited by
- 145
- References
- 14
- Citations by year
- 2026: 8 · 2025: 14 · 2024: 12 · 2023: 13 · 2022: 12 · 2021: 20 · 2020: 20 · 2019: 20 · 2018: 17 · 2017: 6 · 2016: 2 · 2015: 1
- FWCI
- 16.62
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Obesity Surgery (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- MeSH terms
- Adult, Autonomic Nerve Block, Double-Blind Method, Electrodes, Implanted, Electric Stimulation Therapy, Female, Follow-Up Studies, Humans, Male, Middle Aged, Obesity, Morbid, Quality of Life, Risk Factors, Vagus Nerve, Weight Loss, Treatment Outcome, Cross-Over Studies, Vagus Nerve Stimulation
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
