Intragastric botulinum toxin injection for weight loss: current trends, shortcomings and future ...

Albani et al.29 2005 Italy Open-label 38.2≤BMI≤56.7 8 (8/NA) 16 wk 500 10/antrum No NR IBI is effective for weight loss independent of changes in hunger or satiety Nausea in one (12.5%) patient García-Compean et al.32 2005 Mexico Clinical trial BMI over 30 12 (12/NA) 12 wk 100 8/antropyloric No NR IBI does not seem to reduce body weight or induce changes in GE in patients with obesity NR Gui et al.33 2006 Italy RCT BMI≥30 14 (10/4) 5 wk 133, 200 8/antrum No NR IBI is an effective method for weight loss, and BTA has potential activity as a clinical tool for gastric motility and possibly for manipulation of appetite NR Júnior et al.28 2006 Brazil Pilot study BMI ≥40 12 (12/NA) 12 wk 200, 300 8, 16, 24/antropyloric No NR No significant change in weight before and after the IBI NR Foschi et al.22 2007 Italy RCT BMI ≥35 with 2 complications of obesity or BMI≥40 without complications 24 (12/12) 8 wk 200 12/antrum, fundus No 1200 kcal diet Greater weight loss, BMI reduction, early satiety and delayed GE in IBI group NR Mittermair et al.23 2007 USA RCT 30≤BMI≤35 10 (5/5) 6 mo 200 16/antrum, body No NR IBI does not appear to reduce body weight NR Topazian et al.35 2008 USA Pilot study BMI≥30 10 (10/NA) 16 wk 100, 300 5/antrum Yes NR Beneficial effects of 300 U BTA (not 100 U) on weight loss and satiation was observed Diarrhea in two (20%) patients Foschi et al.25 2008 Italy RCT 35≤BMI<40 with two complications of obesity or BMI >40 30 (18/12) 8 wk 200 20/antrum, fundus No 1,200 kcal liquid diet IBI makes weight loss easier and decreases GE and capacity NR Li et al.27 2012 China RCT BMI>28 19 (9/10) 12 wk 200, 300 20/antrum, body, fundus No NR Endoscopic multiple punctures of BTA with fundic injections could potentially lead to weight loss and a decrease in BMI by slowing down GE. The impact of BTA on ghrelin levels might also play a role in suppressing appetite NR Topazian et al.30 2013 USA RCT BMI ≥30 and body weight ≥85 kg 60 (45/15) 24 wk 100, 300, 500 15/antrum Yes NR Injections of 300 U of BTA into gastric antral muscularis propria under EUS guidance may induce delays in GE, but they do not cause body weight loss NR Chen et al.31 2016 Norway RCT 35≤BMI≤44 20 (10/10) 6 mo NR NR/antrum No NR Reduced body weight is associated with increased satiety in IBI group Dumping syndrome in one (10%) patient after 12 mo de Moura et al.36 2019 Brazil RCT BMI>50 32 (16/16) 24 wk 200 40/antrum, body Yes In the first 14 days, a restricted liquid diet of up to 700 kcal/day; days 15-25, up to 800 kcal/day; day 26 through the end of the 6-month, up to 1000 kcal/day IBI is not an effective way for weight loss NR Durmus et al.44 2019 Turkey Clinical trial Patients with obesity 52 (26/26) 3 mo 100 NR/NR No Healthy eating habit The intragastric balloon is a more efficient treatment than IBI, although it has more complications NR Gameel et al.34 2020 Egypt Open-label BMI≥30 25 (25/NA) 16 wk 100 5/antrum, pyloric ring Yes NR IBI seems to be effective for weight loss NR Ferhatoglu et al.26 2020 Turkey Observational study BMI≥30 87 (44/43) 6 mo 100 20/pyloric ring, fundus, cardia No 1,000 kcal restricted diet The pairing of a calorie-restricting diet with IBI would become a popular bariatric therapy for patients with obesity NR Kanlioz et al.24 2020 Turkey Observational study BMI≥25 178 (178/ NA) 6 mo 200 20/antrum No Hypocaloric diet No significant decrease in BMI was observed NR Kaya et al.38 2020 Turkey Pilot study BMI≥25 56 (56/ NA) 6–9 mo 250 10/antrum No 1,200 kcal diet IBI can be beneficial in weight loss Abdominal pain and vomiting in one (1.8%) patient Liu et al.17 2020 Taiwan Observational study 27≤BMI≤30 126 (126/ NA) 6 mo 300, 400 NR/fundus, body, antrum No 300 kcal less than their daily requirement IBI, especially on fundus, is an effective method for weight loss. Alterations in ghrelin and other incretins, along with delayed GE, are the keys to decreasing eating amount and reaching early satiety NR 30≤BMI≤35 Sánchez-Torralvo et al.45 2022 Spain RCT BMI>40 or BMI >35 with comorbidities 52 (28/24) 24 wk 200 16/antrum, fundus No 1,500 kcal Mediterranean diet IBI is an effective and safe procedure to achieve moderate weight loss and improve quality of life NR Şen et al.39 2021 Turkey Observational study 26≤BMI≤31.6 13 (13/NA) 6 mo 300 24/antrum, body, fundus No 1,200-calorie low-carbohydrates diet IBI as a weight loss therapy does not provide significant results Total gastric necrosis in one patient (7.6%) Abesadze et al.40 2021 Georgia Open-label Women of reproductive age with 25<BMI<40 32 (32/NA) 12 wk 1000 NR No NR IBI is an effective and safe method in young overweight, class I-II obese women. Endocrine disorders are not contraindications for the procedure NR Hsu et al.37 2022 Taiwan Clinical trial BMI>25 71 (49/22) 12 wk 300 30/antrum, body, fundus No Low-calorie high-protein diet IBI is more effective than diet control alone Nausea (4%), diarrhea (2%), constipation (24.4%), urinary disorder (2%), and abdominal pain (2%) Özdil et al.41 2022 Turkey Pilot study BMI>30 72 (24/48) 6 mo 200 NR/antrum, fundus No Calorie-restricted (15–20 kcal/kg) diet IBI is a minimally invasive and temporary effective method to be used in the treatment of obesity NR Tayyem et al.42 2022 Jordan Prospective cohort BMI>25 176 (88/88) 6 mo 100 6/antrum, cardia, fundus No 1,200–1,300 kcal/day IBI is a minimally invasive, effective, and safe procedure capable of suppressing appetite and promoting weight loss Nausea, vomiting, and abdominal pain (9%) Altunal et al.46 2023 Turkey Retrospective cohort BMI>30 701 (160/541) 3 mo 500 25/fundus No NR IBI combined with liraglutide is a safe method that provides a more effective weight loss than IBI alone Nausea (9.4%), vomiting (7%), abdominal pain (1.7%), flatulence (7.8%), diarrhea (1%), and constipation (9.4%) Köseoğlu et al.43 2024 Turkey Clinical trial BMI >25 with at least one obesity-related complication or BMI >30 without obesity-related complications 82 (82/NA) 6 mo 200 14/antrum, incisura angularis, body No No IBI is associated with a significant weight loss in obese patients, although the weight loss is not constant NR

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