Lipids & metabolic liver disease
Bariatric–metabolic surgery versus lifestyle intervention plus best medical care in non-alcoholic steatohepatitis (BRAVES): a multicentre, open-label, randomised trial
Authors' conclusion
Bariatric-metabolic surgery is more effective than lifestyle interventions and optimised medical therapy in the treatment of NASH.
Study context
- Population
- Adults aged 25–70 years with obesity (BMI 30–55 kg/m²), with or without T2D, with histologically confirmed non-alcoholic steatohepatitis (NASH); three hospitals in Rome, Italyrandomised 1:1:1
- Participants
- 288 adults
- Comparison
- RYGB or SG vs lifestyle modification plus best medical care
- Lifestyle modificationn = 96reference
- RYGBn = 96
- SGn = 96
- Primary endpoint
- Histological resolution of NASH without worsening of fibrosis
- Follow-up
- 1-year follow-up
Methodological detailsmulticentre, open-label, Biopsy screened 431; 103 (24%) without histological NASH, 40 (9%) declined
- Multicentre
- Open-label
- Biopsy screened 431; 103 (24%) without histological NASH, 40 (9%) declined
Primary result
As reported in the abstract
NASH resolution without worsening of fibrosis · 1 year
Probability of NASH resolution (times greater)
3.60
95% CI 2.19–5.92P < 0.0001
RYGB
Probability of NASH resolution (times greater)
3.67
95% CI 2.23–6.02P < 0.0001
SG
Further findings
Primary endpoint, per protocol analysis · 1 year — RYGB and SG vs Lifestyle modification
P < 0.0001
Denominator Lifestyle modification 80 · RYGB 77 · SG 79
- Primary endpoint, per protocol analysis: per protocol analysis: 236 (82%) completed the trial
Deaths and life-threatening complications
- Deaths or life-threatening complications
- 0
Safety
Severe adverse events after bariatric-metabolic surgery
- Severe AEs in participants who had surgery
- ten (6%)
- No re-operations required; resolved with medical or endoscopic management
Original publication
Bariatric–metabolic surgery versus lifestyle intervention plus best medical care in non-alcoholic steatohepatitis (BRAVES): a multicentre, open-label, randomised trial. Lancet. Published 21 April 2023. doi:10.
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