Guidance
4 Efficacy
4 Efficacy
This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.
4.1 A randomised controlled trial (RCT) of 56 patients with obesity comparing duodenal–jejunal bypass sleeve (DJBS) (n=27) against sham endoscopy (n=29) reported a significantly higher percentage of excess weight loss at 12-week follow-up for the DJBS group (n=13) than for the sham endoscopy group (n=24): 11.9±1.4% and 2.7±2.0% respectively (p=0.001). A case series of 42 patients with obesity treated by DJBS reported 47.0±4.4% (p<0.0001) excess weight loss at 52-week follow-up.
4.2 An RCT of 18 patients with obesity and type 2 diabetes comparing DJBS (n=12) against sham endoscopy (n=6) reported that glycosylated haemoglobin (HbA1c) values decreased by 1.3±0.9% for the DJBS group and by 0.8±0.3% in the sham endoscopy group (p>0.05) at 12-week follow-up. At 24-week follow-up, the HbA1c had decreased by 2.4±0.7% in the DJBS group and by 0.8±0.4% in the sham endoscopy group (p>0.05). These differences were not statistically significant.
4.3 The case series of 42 patients with obesity treated by DJBS reported significant reductions from baseline in total cholesterol (from 197±7 mg/dL to 161±8 mg/dL; p<0.0001), triglycerides (from 160±16 mg/dL to 115±11 mg/dL; p=0.002) and blood pressure (systolic from 134±3 mmHg to 125±2 mmHg [p=0.01] and diastolic from 85±1 mmHg to 71±2 mmHg [p<0.0001]) at 52-week follow-up.
4.4 Implantation failure was reported in 20% (4/25) of patients because of a short duodenal bulb (n=3) or a combination of patient anatomy and investigator inexperience (n=1) in the RCT of 56 patients.
4.5 The case series of 42 patients with obesity reported that, without any kind of maintenance programme, patients who completed 52 weeks of follow-up regained a mean of 4.4 kg 6 months after removal of the DJBS.
4.6 A case series of 22 patients with obesity and type 2 diabetes reported that improvement in HbA1c levels continued for up to 6 months after device removal in 11 patients (mean percentage decrease 1.7±0.7%).
4.7 The specialist advisers listed an additional key efficacy outcome measure as patient-reported quality of life.