Welcome to our weekly round-up of the latest bariatric and obesity-related papers published in the medical literature. As ever, we have looked far and wide to give you an overview of papers including outcomes from the BRAVES RCT, ursodeoxycholic acid (UDCA) has no effects after bariatric surgery, two studies examining postoperative nausea and vomiting (PNOV) and visceral adipose tissue (VAT) reduction in adolescents undergoing RYGB, and more (please note, log-in maybe required to access the full paper).
Bariatric–metabolic surgery versus lifestyle intervention plus best medical care in non-alcoholic steatohepatitis (BRAVES): a multicentre, open-label, randomised trial
UK and Italian researchers, reporting The Lancet, have reported bariatric-metabolic surgery is more effective than lifestyle interventions and optimised medical therapy in the treatment of non-alcoholic steatohepatitis (NASH).
These are the outcomes from a multicentre, open-label, randomised trial at three major hospitals in Rome, Italy. They 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%]). Participants aged 25–70 years with obesity (BMI 30–55 kg/m2) with or without type 2 diabetes, with histologically confirmed NASH. The primary endpoint of the study was histological resolution of NASH without worsening of fibrosis at one-year follow-up.
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 vs. 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 vs. 15 (19%) of 80 in the lifestyle modification group (p<0.0001).
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Ursodeoxycholic Acid Use After Bariatric Surgery: Effects on Metabolic and Inflammatory Blood Markers
UDCA treatment leads to a higher, but clinically irrelevant increase in ALP level in patients six months after bariatric surgery, and except for the reduction of gallstone formation, UDCA has no effects after bariatric surgery, according to researchers from The Netherlands.
Reporting in Obesity Surgery, they examined the impact of UDCA on liver enzymes, haemoglobin A1c (HbA1c), lipids and inflammation markers. In total, 513 patients in the UPGRADE trial (placebo-controlled, double-blind) were randomised between UDCA 900mg daily or placebo pills for 6 months after bariatric surgery. Patients without blood measurements pre- or six months postoperatively were excluded. The change in liver enzymes, Hba1c, lipids and inflammation markers after surgery were compared between the UDCA and placebo group, followed by a postoperative cross-sectional comparison.
Preoperative blood values did not differ between UDCA (n=266) and placebo (n=247) groups. Increase of alkaline phosphatase (ALP) was greater in the UDCA group (mean difference 3.81 U/l [95%CI 0.50 7.12]). Change in other liver enzymes, HbA1c, lipids, and CRP levels did not differ.
Postoperative cross-sectional comparison in 316 adherent patients also revealed a higher total cholesterol (mean difference 0.25 mg/dl [95%CI 0.07–0.42]), lower aspartate aminotransferase (mean difference −3.12 U/l [−5.16 – −1.08]) and lower alanine aminotransferase level (mean difference −5.89 U/l [−9.41 – −2.37]) in the UDCA group.
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Penehyclidine hydrochloride for treating postoperative nausea and vomiting after laparoscopic bariatric surgery: a double-blinded randomized controlled trial
Penehyclidine did not decrease incidence and severity of PONV in patients undergoing laparoscopic bariatric surgery (LBS), investigators from the 1st Affiliated Hospital with Nanjing Medical University, Nanjing, China, report in the journal BMC Anesthesiology.
They noted that penehyclidine hydrochloride has been reported to be effective in preventing PONV. Considering the potential preventive effects of penehyclidine against PONV, they hypothesised that intravenous infusion of penehyclidine may alleviate PONV within the first 48 h in patients scheduled for LBS.
Patients who underwent LBS were randomly assigned (1:2) to receive saline (Control group, n=113) or a single intravenous dose of penehyclidine 0.5 mg (PHC group, n=221). The primary outcome was incidence of PONV within the first 48h postoperatively. Secondary endpoints included severity of PONV, need for rescue antiemetic therapy, volume of water intake, and time to first flatus.
PONV occurred in 159 (48%) patients within the first 48h postoperatively, including 51% in the control group and 46% in the PHC group. There was no significant difference in the incidence or severity of PONV between the two groups (p>0.05). Within the first 24h and 24–48h, no significant difference was found in incidence or severity of PONV, postoperative nausea, postoperative vomiting, need for rescue antiemetic therapy, or volume of water intake (p>0.05). Kaplan–Meier curves showed that penehyclidine was significantly associated with a prolonged time to first flatus (median onset time: 22h vs. 21h, p=0.036).
They researchers noted that a single intravenous dose of penehyclidine (0.5mg) was associated with a slightly prolonged time to first flatus.
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Changes in Adipose Tissue Distribution and Relation to Cardiometabolic Risk Factors Following Roux-en-Y Gastric Bypass in Adolescents
Adiposity measures all decreased after RYGB, but poorly predicted change in cardiometabolic risk, according to researchers from Sweden, the UK and US.
Writing in SOARD, the researchers hypothesised that visceral adipose tissue (VAT) reduction in adolescents undergoing RYGB would be greater than other depots and associated with improvement in cardiometabolic risk factors.
Fifty-nine adolescents underwent dual X-ray absorptiometry (DXA) pre-operatively and at 1-, 2-, and 5-years after RYGB. Changes in body composition in multiple depots (total fat, lean body, gynoid fat, android fat, subcutaneous adipose tissue [SAT], and VAT) and cardiometabolic risk factors were assessed using multiple linear regression analysis and generalized estimating equations adjusting for age, sex, and baseline risk factor levels.
At 1 year post-RYGB a significant reduction was observed across all body composition measures (p<0.001) with the greatest reduction observed in VAT (-65.1%[-68.7, -61.8]). From year 1 to 5 years post-RYGB a regain was observed in all depots except lean body mass (p=0.105). Change in VAT at 1 year correlated with change in triglycerides (slope: 0.21mg/dL/kg, p=0.034) and fasting plasma insulin (slope: 44pmol/L/kg, p=0.027).
However, despite significant reductions at one year, a steady regain was observed out to five years, with values still well below baseline. They added that further research should consider control group comparison and extended follow-up.
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ST36 acupoint injection with anisodamine for postoperative nausea and vomiting in female patients after bariatric surgery: a prospective, randomized controlled trial
The addition of ST36 acupoint injection with anisodamine significantly reduced postoperative vomiting without affecting nausea in female patients with obesity undergoing laparoscopic sleeve gastrectomy, according to Chinese researchers writing Surgical Endoscopy.
Their study evaluated the efficacy of ST36 acupoint injection with anisodamine in prevention of PONV among female patients after bariatric surgery.
Ninety patients undergoing laparoscopic sleeve gastrectomy were randomly allocated to anisodamine or control group at the ratio of 2:1. The incidence and severity of PONV were assessed during the first 3 postoperative days and at 3 months. The quality of early recovery of anesthesia, gastrointestinal function, sleep quality, anxiety, depression and complications were also evaluated.
In the anisodamine group, 25 patients (42.4%) experienced vomiting within postoperative 24h compared with 21 (72.4%) in the control. Time to first rescue antiemetic was 6.5 h in anisodamine group, and 1.7 h in the control group (p=0.011). Less rescue antiemetic was required during the first 24 h in the anisodamine group (p=0.024). There were no differences in either postoperative nausea or other recovery characteristics.
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