EUS-Guided Intragastric Injection of Botulinum Toxin A in the Preoperative Treatment of Super-Obese Patients: a Randomized Clinical Trial
Obesity is a disease that is highly prevalent in Brazil, and the associated comorbidities represent a major global public health challenge. Botulinum toxin type A (BTX-A) is a potent neurotoxin and inhibitor of gastric smooth muscle activity. In theory, BTX-A administration should promote early satiety and weight loss because it delays gastric emptying by inhibiting acetylcholine-mediated peristalsis, which is primarily responsible for gastric motility. Because results in the literature are discrepant, the efficacy of intragastric injections of BTX-A as a primary treatment for obesity remains unknown. The objective of this prospective, double-blind, single-center randomized study was to evaluate the effects of endoscopic ultrasound-guided intragastric BTX-A injections, as a bridge to bariatric surgery, in super-obese patients.
Thirty-two super-obese patients were randomized to one of two groups: BTX-A, in which 200 units of BTX-A were injected into the gastric antrum and body; and control, in which the same injections were performed with 0.9% saline. Weight, body mass index (BMI), and loss of excess weight were measured monthly over a 6-month period. Gastric emptying scintigraphy was performed before and after the procedure.
The patients in both groups showed significant weight loss over the course of the study (p < 0.001). There were no statistically significant differences between the groups regarding weight loss, excess weight, total loss of excess weight, total weight loss, or change in BMI.
Intragastric injection of BTX-A does not appear to be an effective method of achieving preoperative weight loss in super-obese patients.
KeywordsObesity Botulinum toxins US endoscopy Gastric emptying
We are grateful to Creusa Maria Roveri Dal Bó, for contributing to the statistical analysis.
IBR wrote the manuscript; MSVF, LHMM, DTHdM, ETHdM, FACB, and SEM performed the procedures; VOB, MdPGN, WMB, and EGHdM critically reviewed the article for important intellectual content; MAS followed the patients at the bariatric surgery outpatient clinic; GCN monitored the nutritional status of the patients; CMRDB carried out the statistical analysis; and EGHdM, IBR, MSVF, LHMM, DTHdM, CMRDB, VOB, ETHdM, GCN, FACB, MdPGN, SEM, WMB, and MAS approved the final draft of the article.
Compliance with Ethical Standards
Conflict of Interest
One author reports receiving personal fees from Apollo Endo Surgery, Fractyl Labs, GI Windows, GI Dynamics, Ethicom Endosurgery, and Alacer Biomedica, all unrelated to the submitted work. All other authors declare that they have no conflict of interest.
The study was approved by the Research Ethics Committee of the University of São Paulo School of Medicine Hospital das Clínicas.
Informed written consent was obtained from all participants.
- 1.Kumar N, Thompson CC. Endoscopic solutions for weight loss. Curr Opin Gastroenterol 2011. p. 407–11.Google Scholar
- 3.Ribeiro IB, Gestic MA, Utrini MP, et al. Drain amylase levels may indicate gastrojejunostomy leaks after Roux-en-Y gastric bypass. Arq Gastroenterol, Available from. 2018;55:66–72. http://www.ncbi.nlm.nih.gov/pubmed/29561980.
- 5.Madruga Neto AC, Bernardo WM, de Moura DT, et al. The effectiveness of endoscopic gastroplasty for obesity treatment according to fda thresholds: systematic review and meta-analysis based on randomized controlled trials. Gastrointest Endosc. 2018;87:AB601. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0016510718325690. CrossRefGoogle Scholar
- 9.Ribeiro IB, Rezende DT, Madruga Neto AC, et al. Endoscopic dual therapy for giant peptic ulcer hemorrhage. Endoscopy. 2018:1–2. https://doi.org/10.1055/a-0665-4142.
- 10.Hallett M, Albanese A, Dressler D, Segal KR, Simpson DM, Truong D, et al. Evidence-based review and assessment of botulinum neurotoxin for the treatment of movement disorders. Toxicon. 2013;94–114.Google Scholar
- 12.Xing J, Chen JDZ. Alterations of gastrointestinal motility in obesity. Obes Res; 2004. p. 1723–32.Google Scholar
- 18.Orsini M, Leite MAA, Chung TM, et al. Botulinum neurotoxin type A in neurology: update. Neurol Int. 2015;7:31–5.Google Scholar
- 23.Meunier FA, Schiavo G, Molgó J. Botulinum neurotoxins: from paralysis to recovery of functional neuromuscular transmission. J Physiol Paris. 2002. p. 105–13.Google Scholar
- 25.Jankovic J. Botulinum toxin: state of the art. Mov Disord. 2017. p. 1131–8.Google Scholar
- 27.Albanese A, Bentivoglio Ar, Cassetta E, Viggiano A, Maria G, Gui D. Review article: the use of botulinum toxin in the alimentary tract. Aliment Pharmacol Ther 1995;9:599–604.Google Scholar
- 33.Vargas EJ, Rizk M, Bazerbachi F, et al. Medical devices for obesity treatment: endoscopic bariatric therapies. Med Clin North Am, Available from. 2018;102:149–63. http://www.ncbi.nlm.nih.gov/pubmed/29156183.
- 34.Brunaldi VO, Jirapinyo P, de Moura DTH, et al. Endoscopic treatment of weight regain following Roux-en-Y gastric bypass: a systematic review and meta-analysis. Obes Surg Obesity Surgery. 2017:1–11.Google Scholar
- 36.Ribeiro IB, Bernardo WM, Martins C, et al. Colonic stent versus emergency surgery as treatment of malignant colonic obstruction in the palliative setting: a systematic review and meta-analysis. Endosc Int Open. 2018;5:1–10.Google Scholar
- 39.Sahebally SM, Meshkat B, Walsh SR, et al. Botulinum toxin injection vs topical nitrates for chronic anal fissure: an updated systematic review and meta-analysis of randomized controlled trials. Colorectal Dis. 2018;20:6–15. Available from: http://www.ncbi.nlm.nih.gov/pubmed/29166553. CrossRefPubMedGoogle Scholar
- 40.Dorizas A, Krueger N, Sadick NS. Aesthetic uses of the botulinum toxin. Dermatol Clin. 2014. p. 23–36.Google Scholar
- 41.Gart MS, Gutowski KA. Overview of botulinum toxins for aesthetic uses. Clin Plast Surg; 2016. p. 459–71.Google Scholar
- 42.Chagas TF, de Almeida NV, Lisboa CO, et al. Duration of effectiveness of botulinum toxin type A in excessive gingival display: a systematic review and meta-analysis. Braz Oral Res. 2018;32:1–11. Available from: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1806-83242018000100951&lng=en&tlng=en. CrossRefGoogle Scholar
- 45.Sánchez Torralvo FJ, Valdés Hernández S, Tapia MJ, Abuín Fernández J, Olveira G. Inyección intragástrica de toxina botulínica mediante endoscopia, ¿una alternativa para el tratamiento para la obesidad? Una revisión sistemática. Nutr Hosp. 2017; Available from: http://revista.nutricionhospitalaria.net/index.php/nh/article/view/1220.
- 47.Oficial Ó, Federación DELA, Sociedades EDE, et al. Nutr Hosp. 2015;31:1–145.Google Scholar