What is the clinical evidence from this study?

Study design: RCT. Population: moderate to severe obesity (n=239). Intervention: Vagal block therapy (vBloc) vs. Sham devices. Primary outcome: percent excess weight loss (%EWL) (p=< 0.0001).

What question did this study set out to answer?

The aim is to evaluate the long-term effectiveness of vagal block therapy for weight management in obese patients.

January 1, 2015Journal of ObesityOpen Access

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

Q: What are the key findings of this study?

Vagal block therapy (vBloc) resulted in greater sustained weight loss at 18 months compared to sham (23% vs 10% excess weight loss; P < 0.0001).

Q: What question did this study set out to answer?

The aim is to evaluate the long-term effectiveness of vagal block therapy for weight management in obese patients.

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Key result

Vagal block therapy (vBloc) resulted in greater sustained weight loss at 18 months compared to sham (23% vs 10% excess weight loss; P < 0.0001).

Why the study?

Does vagal block therapy (vBloc) improve weight loss compared to sham in participants with moderate to severe obesity?

Population

239 participants with body mass index of 40 to 45 kg/m² or 35 to 40 kg/m² with one or more obesity-related…

Comparison

Implantation of vagal block therapy device and… vs Implantation of Sham device and weight…

Design

RCT, randomized, double-blind

Follow-up

18 months

Authors

SSScott A. ShikoraBrigham and Women's Hospital BWBruce M. WolfeOregon Health & Science University CACaroline M. ApovianBrigham and Women's Hospital

Discussion

Member takes

Implication

Supports vBloc as an option for obesity management; extends RCT evidence for neuromodulation to 18 months.

Key Points

The aim is to evaluate the long-term effectiveness of vagal block therapy for weight management in obese patients.
Randomized controlled trial involving 239 participants with varying obesity levels.
Participants received either vagal block or Sham devices combined with weight management counseling.
Intent-to-treat analyses using mixed models to assess weight loss outcomes at 18 months.
Vagal block resulted in 23% excess weight loss (8.8% total weight loss) compared to 10% excess weight loss (3.8% total weight loss) for Sham (P < 0.0001).
Most participants using vBloc maintained their previous weight loss, while Sham participants regained over 40% of their weight.
Common mild to moderate adverse events included heartburn/dyspepsia and abdominal pain, with a high resolution rate.

Study Design

Type

RCT (n=239)

Blinding

Double-blind

Randomization

randomized

Structured PICO

Does vagal block therapy (vBloc) improve weight loss compared to sham in participants with moderate to severe obesity?

Population

239 participants with moderate to severe obesity (BMI 40-45, or 35-40 with comorbidities) followed for 18 months.

Intervention

Implantation of vagal block therapy (vBloc) device and weight management counseling

Comparator

Implantation of Sham device and weight management counseling

Outcome

Percent excess weight loss (%EWL) and total weight loss (%TWL) at 18 monthssurrogate

Main Result

Absolute Event Rate: 23% vs 10%

p-value: p=< 0.0001

Vagal block therapy provides sustained and superior weight loss compared to sham at 18 months in patients with moderate to severe obesity.

Cite This Study

Shikora et al. (2015) conducted an RCT in moderate to severe obesity (n=239). Vagal block therapy (vBloc) vs. Sham devices was evaluated on percent excess weight loss (%EWL) (p=< 0.0001). Vagal block therapy (vBloc) resulted in greater sustained weight loss at 18 months compared to sham (23% vs 10% excess weight loss; P < 0.0001).

synapsesocial.com/papers/6a337657cce949c3f40e588d https://doi.org/10.1155/2015/365604

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

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

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

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

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