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EUS-Guided Intragastric Injection of Botulinum Toxin A in the Preoperative Treatment of Super-Obese Patients: a Randomized Clinical Trial

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Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

Intragastric injection of BTX-A does not appear to be an effective method of achieving preoperative weight loss in super-obese patients.

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Acknowledgments

We are grateful to Creusa Maria Roveri Dal Bó, for contributing to the statistical analysis.

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Authors and Affiliations

  1. Gastrointestinal Endoscopy Unit - Hospital das Clínicas - HC/FMUSP, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, São Paulo, SP, CEP 05403-000, Brazil

    Eduardo Guimarães Hourneaux de Moura, Igor Braga Ribeiro, Mariana Souza Varela Frazão, Luiz Henrique Mazzonetto Mestieri, Diogo Turiani Hourneaux de Moura, Creusa Maria Roveri Dal Bó, Vitor Ottoboni Brunaldi, Eduardo Turiani Hourneaux de Moura, Gabriel Cairo Nunes, Fábio Alberto Castillo Bustamante, Sergio Eiji Matuguma & Wanderley Marques Bernardo

  2. Endoscopy Unit, Gastro Obeso Center, São Paulo, Brazil

    Manoel dos Passos Galvão Neto

  3. Bariatric and Metabolic Surgery Unit, Hospital das Clínicas, University of Sao Paulo School of Medicine, São Paulo, Brazil

    Marco Aurélio Santo

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  1. Eduardo Guimarães Hourneaux de Moura
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Contributions

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.

Corresponding author

Correspondence to Igor Braga Ribeiro.

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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.

Ethical Statement

The study was approved by the Research Ethics Committee of the University of São Paulo School of Medicine Hospital das Clínicas.

Consent Statement

Informed written consent was obtained from all participants.

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de Moura, E.G.H., Ribeiro, I.B., Frazão, M.S.V. et al. EUS-Guided Intragastric Injection of Botulinum Toxin A in the Preoperative Treatment of Super-Obese Patients: a Randomized Clinical Trial. OBES SURG 29, 32–39 (2019). https://doi.org/10.1007/s11695-018-3470-y

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