التفاصيل البيبلوغرافية
| العنوان: |
Bariatric–metabolic surgery versus lifestyle intervention plus best medical care in non-alcoholic steatohepatitis (BRAVES): a multicentre, open-label, randomised trial. |
| المؤلفون: |
Verrastro, Ornella1 (AUTHOR), Panunzi, Simona1,2 (AUTHOR), Castagneto-Gissey, Lidia3 (AUTHOR), De Gaetano, Andrea2 (AUTHOR), Lembo, Erminia1 (AUTHOR), Capristo, Esmeralda1,4 (AUTHOR), Guidone, Caterina4 (AUTHOR), Angelini, Giulia1 (AUTHOR), Pennestrì, Francesco4 (AUTHOR), Sessa, Luca4 (AUTHOR), Vecchio, Fabio Maria5 (AUTHOR), Riccardi, Laura1,4 (AUTHOR), Zocco, Maria Assunta1,4 (AUTHOR), Boskoski, Ivo1,4 (AUTHOR), Casella-Mariolo, James R6 (AUTHOR), Marini, Pierluigi6 (AUTHOR), Pompili, Maurizio1,4 (AUTHOR), Casella, Giovanni4 (AUTHOR), Fiori, Enrico3 (AUTHOR), Rubino, Francesco7 (AUTHOR) |
| المصدر: |
Lancet. May/Jun2023, Vol. 401 Issue 10390, p1786-1797. 12p. |
| مصطلحات موضوعية: |
*GASTRIC bypass, *NON-alcoholic fatty liver disease, *MEDICAL care, *SLEEVE gastrectomy, *ENDOSCOPIC surgery, *TYPE 2 diabetes |
| مصطلحات جغرافية: |
ROME |
| مستخلص: |
Observational studies suggest that bariatric–metabolic surgery might greatly improve non-alcoholic steatohepatitis (NASH). However, the efficacy of surgery on NASH has not yet been compared with the effects of lifestyle interventions and medical therapy in a randomised trial. We did a multicentre, open-label, randomised trial at three major hospitals in Rome, Italy. We included participants aged 25–70 years with obesity (BMI 30–55 kg/m2), with or without type 2 diabetes, with histologically confirmed NASH. We randomly assigned (1:1:1) participants to lifestyle modification plus best medical care, Roux-en-Y gastric bypass, or sleeve gastrectomy. The primary endpoint of the study was histological resolution of NASH without worsening of fibrosis at 1-year follow-up. This study is registered at ClinicalTrials.gov , NCT03524365. Between April 15, 2019, and June 21, 2021, we biopsy screened 431 participants; of these, 103 (24%) did not have histological NASH and 40 (9%) declined to participate. We randomly assigned 288 (67%) participants with biopsy-proven NASH to lifestyle modification plus best medical care (n=96 [33%]), Roux-en-Y gastric bypass (n=96 [33%]), or sleeve gastrectomy (n=96 [33%]). In the intention-to-treat analysis, the percentage of participants who met the primary endpoint was significantly higher in the Roux-en-Y gastric bypass group (54 [56%]) and sleeve gastrectomy group (55 [57%]) compared with lifestyle modification (15 [16%]; p<0·0001). The calculated probability of NASH resolution was 3·60 times greater (95% CI 2·19–5·92; p<0·0001) in the Roux-en-Y gastric bypass group and 3·67 times greater (2·23–6·02; p<0·0001) in the sleeve gastrectomy group compared with in the lifestyle modification group. In the per protocol analysis (236 [82%] participants who completed the trial), the primary endpoint was met in 54 (70%) of 77 participants in the Roux-en-Y gastric bypass group and 55 (70%) of 79 participants in the sleeve gastrectomy group, compared with 15 (19%) of 80 in the lifestyle modification group (p<0·0001). No deaths or life-threatening complications were reported in this study. Severe adverse events occurred in ten (6%) participants who had bariatric-metabolic surgery, but these participants did not require re-operations and severe adverse events were resolved with medical or endoscopic management. Bariatric-metabolic surgery is more effective than lifestyle interventions and optimised medical therapy in the treatment of NASH. Fondazione Policlinico Universitario A Gemelli, Policlinico Universitario Umberto I and S Camillo Hospital, Rome, Italy. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
Academic Search Index |
