Francisco José Sánchez Torralvo1, Luis Vázquez Pedreño2, Montserrat Gonzalo Marín3, María José Tapia3, Fuensanta Lima4, Eduardo García Fuentes5, Pilar García2, Javier Moreno Ruiz6, Alberto Rodríguez Cañete6, Sergio Valdés7, Gabriel Olveira7. 1. UGC Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Plaza del Hospital Civil, S/N, 29009, Málaga, Spain; Universidad de Málaga, Málaga, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain. Electronic address: fransancheztorralvo@gmail.com. 2. UGC Aparato Digestivo, Unidad de Endoscopias. Hospital Regional Universitario de Málaga, Málaga, Spain. 3. UGC Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Plaza del Hospital Civil, S/N, 29009, Málaga, Spain; Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain. 4. UGC Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Plaza del Hospital Civil, S/N, 29009, Málaga, Spain. 5. Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain. 6. UGC Cirugía General y Digestiva, Hospital Regional Universitario de Málaga, Málaga, Spain. 7. UGC Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Plaza del Hospital Civil, S/N, 29009, Málaga, Spain; Universidad de Málaga, Málaga, Spain; Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.
Abstract
BACKGROUND & AIMS: Several studies have evaluated the effect of intragastric injection of botulinum toxin A to treat obesity, achieving mixed results. Our objective is to determine the effect of intragastric botulinum toxin A on weight loss, satiety, biomarkers, and quality of life of obese patients prior bariatric surgery. METHODS: Design: single-centre, randomised, double-blind, placebo-controlled clinical trial in 52 obese patients on bariatric surgery waiting lists. Two-arm parallel: the treatment group was administered intragastric botulinum toxin A by endoscopy, whereas the control group was administered physiological saline solution. Weight loss was evaluated at weeks 2, 4, 8, 16, and 24, as well as changes in body composition, satiety (Visual analogue scale (VAS) and GCSI questionnaire), quality of life (GIQLI questionnaire), and biomarkers of satiety and appetite. RESULTS:Weight loss at weeks 2, 4, 8, 16, and 24 after the endoscopy, with respect to the basal visit, was 0.6 ± 2 kg, 0.4 ± 2.7 kg, 0.4 ± 3.1 kg, 0.2 ± 4.5 kg, and 0.6 ± 4.3 kg for the control group vs 1.9 ± 2.1 kg, 2 ± 2.6 kg, 2.8 ± 4.1 kg, 3.5 ± 5.3 kg, and 4.5 ± 7 kg for the treatment group, respectively, being differences between groups significant at all times (p = 0.016, 0.031, 0.014, 0.021, and 0.023, respectively). Treatment group patients obtained a significantly higher score for GIQLI questionnaire compared with baseline (104.4 ± 13.9 points vs 97.7 ± 15.6 points; p = 0.024), showing a significant improvement in the section of subjective physical capacity. No significant differences were found regarding perception of satiety, or biomarkers of satiety and appetite. CONCLUSIONS: Intragastric injection of botulinum toxin A is an effective and safe procedure to achieve a moderate weight loss and improve quality of life. Registered under clinicaltrialsregister.eu Identifier EudraCT number 2015-004391-29 https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-004391-29/ES.
RCT Entities:
BACKGROUND & AIMS: Several studies have evaluated the effect of intragastric injection of botulinum toxin A to treat obesity, achieving mixed results. Our objective is to determine the effect of intragastric botulinum toxin A on weight loss, satiety, biomarkers, and quality of life of obesepatients prior bariatric surgery. METHODS: Design: single-centre, randomised, double-blind, placebo-controlled clinical trial in 52 obesepatients on bariatric surgery waiting lists. Two-arm parallel: the treatment group was administered intragastric botulinum toxin A by endoscopy, whereas the control group was administered physiological saline solution. Weight loss was evaluated at weeks 2, 4, 8, 16, and 24, as well as changes in body composition, satiety (Visual analogue scale (VAS) and GCSI questionnaire), quality of life (GIQLI questionnaire), and biomarkers of satiety and appetite. RESULTS:Weight loss at weeks 2, 4, 8, 16, and 24 after the endoscopy, with respect to the basal visit, was 0.6 ± 2 kg, 0.4 ± 2.7 kg, 0.4 ± 3.1 kg, 0.2 ± 4.5 kg, and 0.6 ± 4.3 kg for the control group vs 1.9 ± 2.1 kg, 2 ± 2.6 kg, 2.8 ± 4.1 kg, 3.5 ± 5.3 kg, and 4.5 ± 7 kg for the treatment group, respectively, being differences between groups significant at all times (p = 0.016, 0.031, 0.014, 0.021, and 0.023, respectively). Treatment group patients obtained a significantly higher score for GIQLI questionnaire compared with baseline (104.4 ± 13.9 points vs 97.7 ± 15.6 points; p = 0.024), showing a significant improvement in the section of subjective physical capacity. No significant differences were found regarding perception of satiety, or biomarkers of satiety and appetite. CONCLUSIONS: Intragastric injection of botulinum toxin A is an effective and safe procedure to achieve a moderate weight loss and improve quality of life. Registered under clinicaltrialsregister.eu Identifier EudraCT number 2015-004391-29 https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-004391-29/ES.
Authors: Francisco José Sánchez-Torralvo; Luis Vázquez-Pedreño; Montserrat Gonzalo-Marín; María José Tapia; Fuensanta Lima; Eduardo García-Fuentes; Pilar García; Javier Moreno-Ruiz; Alberto Rodríguez-Cañete; Sergio Valdés; Gabriel Olveira Journal: J Clin Med Date: 2022-04-11 Impact factor: 4.241
Authors: Raed M Tayyem; Haitham G Qandeel; Hamzeh I Al-Balas; Farah R Tayyem; Jehad Z Fataftah; Mahmoud I Al-Balas Journal: Saudi J Gastroenterol Date: 2022 Jul-Aug Impact factor: 3.214