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Arabpour E, Golmoradi H, Tape PMK, Sadeghi A, Abdehagh M, Moghadam PK, Zali MR. Intragastric botulinum toxin injection for weight loss: current trends, shortcomings and future perspective. Clin Endosc 2025; 58:10-24. [PMID: 39722145 PMCID: PMC11837562 DOI: 10.5946/ce.2024.153] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/08/2024] [Revised: 06/22/2024] [Accepted: 06/27/2024] [Indexed: 12/28/2024] Open
Abstract
The administration of botulinum toxin A (BTA) into the gastric wall has emerged as a novel endoscopic bariatric procedure. Although over 20 years have elapsed since the initial human trial of intragastric BTA injection, considerable debate remains surrounding the safety, efficacy, and procedural instructions of this approach. The current literature exhibits discrepancies in the methodologies employed across studies, including differences in the dosage of BTA administered, injection site, number and depth of injections, post-procedural dietary modifications, and follow-up duration. This study reviewed the state-of-the-art use of BTA for weight loss and focused on the clinical evidence of the therapeutic applications of BTA for obesity. Studies with consistent outcome measures and methodologies are necessary to thoroughly assess the potential effects of BTA on weight management.
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Affiliation(s)
- Erfan Arabpour
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Hadi Golmoradi
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Parya Mozafari Komesh Tape
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Amir Sadeghi
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Mohammad Abdehagh
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Pardis Ketabi Moghadam
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Mohammad Reza Zali
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
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Balbaloglu H, Tasdoven I, Yorgancioglu I. Intragastric botulinum toxin injection: a promising alternative for obesity treatment? Arch Med Sci 2024; 20:1400-1406. [PMID: 39649282 PMCID: PMC11623158 DOI: 10.5114/aoms/178334] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/20/2023] [Accepted: 01/06/2024] [Indexed: 12/10/2024] Open
Abstract
Introduction Over the past 50 years, the rise in obesity has prompted a search for new treatments. Intragastric injections of botulinum toxin A (BT-A), a safer alternative to surgery, show promise in reducing weight and caloric intake by inducing early satiety. This study examines their efficacy for weight loss. Material and methods From 2021 to 2023, we conducted a retrospective analysis of patients who underwent intragastric BT-A injections in a general surgery endoscopy unit. The inclusion criteria were being aged 18-65 and having a body mass index (BMI) over 25 kg/m2. Patients with specific medical conditions or incomplete records were excluded. We monitored patient weight and BMI values before the procedure and at monthly intervals, with further assessments conducted in the sixth month, including appetite and patient satisfaction. Results Our study on 67 patients, predominantly female (82.1%), aged 35.5 ±9.0 years with a mean BMI of 33.5 ±3.3 kg/m², examined BT-A injections' effectiveness. 58.2% received injections in both gastric antrum and fundus regions, showing greater weight loss (mean: 10.7 ±7.0 kg) than those treated in the antrum alone. Side effects occurred in 16.4%, with various symptoms. High dietary compliance (80.6%) correlated with weight loss, especially among those reporting intense satiety. Patient satisfaction positively correlated with weight loss, highlighting treatment efficacy and patient response to dual-region injections. Conclusions Our study suggested that intragastric BT-A injections in the antrum and fundus are effective and safe for satiety and weight loss, with few side effects. Individual responses vary, and diet adherence is crucial. More studies are needed to assess the treatment's efficacy in obesity.
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Affiliation(s)
- Hakan Balbaloglu
- Department of General Surgery, Bülent Ecevit University School of Medicine, Zonguldak, Turkey
| | - Ilhan Tasdoven
- Department of General Surgery, Bülent Ecevit University School of Medicine, Zonguldak, Turkey
| | - Ipek Yorgancioglu
- Department of General Surgery, Bülent Ecevit University School of Medicine, Zonguldak, Turkey
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Köseoğlu HT, Kenarli K, Akbay A, Erdoğan Ç, Macif A, Göktaṣ MD, Hamamci M, Kalkan Ç, Sarialtin F, Yüksel M. Intragastric injection of botulinum toxin in the treatment of obesity: a single-center study. Ther Adv Gastrointest Endosc 2024; 17:26317745241233083. [PMID: 38476126 PMCID: PMC10929057 DOI: 10.1177/26317745241233083] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/14/2023] [Accepted: 01/31/2024] [Indexed: 03/14/2024] Open
Abstract
Background In recent years, various novel surgical and non-surgical therapeutic options have been developed for treating obesity. Due to its disputed success, intragastric botulinum toxin A (BTX-A) injection is still being debated. Objectives We aim to contribute to this controversial issue in the literature by sharing our center's findings regarding intragastric BTX-A injections in the treatment of obesity. Design Patients with a body mass index (BMI) of greater than 25 kg/m2 and at least one obesity-related complication, or a BMI of greater than 30 kg/m2 without complications, were eligible for the study if they were between the ages of 18 and 65. Methods Following the same procedure, two endoscopists administered BTX-A to all patients. All patients were evaluated for obesity by measuring their lipid profile, hormone profile, and insulin resistance level before treatment. Results In our study on 82 patients, we saw a significant mean weight loss (-9.2 kg, p < 0.001) in the second month, and there was no additional mean weight loss in the sixth month of follow-up. In addition, this result seems to be independent of the patient's insulin resistance. We did not see any serious side effects in any of the patients. Conclusion Although the use of intragastric injection of BTX-A in the treatment of obesity is a controversial issue, we showed in our study that it causes significant weight loss. Further studies are needed on this subject, as it can be a safe method when the ideal dose and application site are combined with appropriate patient selection.
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Affiliation(s)
- Hasan Tankut Köseoğlu
- Department of Gastroenterology, Ankara Bilkent City Hospital, Üniversiteler Mah. 1604. Cd. No: 9, Çankaya, Ankara 06800, Turkey
| | - Kerem Kenarli
- Department of Gastroenterology, Ankara Bilkent City Hospital, Çankaya, Turkey
| | - Ahmet Akbay
- Department of Gastroenterology, Ankara Bilkent City Hospital, Çankaya, Turkey
| | - Çağdaṣ Erdoğan
- Department of Gastroenterology, Ankara Bilkent City Hospital, Çankaya, Turkey
| | - Alper Macif
- Department of Gastroenterology, Ankara Bilkent City Hospital, Çankaya, Turkey
| | - Meryem Didem Göktaṣ
- Department of Internal Medicine, Ankara Bilkent City Hospital, Çankaya, Turkey
| | - Mevlüt Hamamci
- Department of Gastroenterology, Ankara Bilkent City Hospital, Çankaya, Turkey
| | - Çağdaṣ Kalkan
- Department of Gastroenterology, Ankara Bilkent City Hospital, Çankaya, Turkey
| | | | - Mahmut Yüksel
- Department of Gastroenterology, Ankara Bilkent City Hospital, Çankaya, Turkey
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Dorner MB, Wilking H, Skiba M, Wilk L, Steinberg M, Worbs S, Çeken S, Kaygusuz S, Simon S, Becher F, Mikolajewska A, Kornschober C, Bütler T, Jourdan-Da-Silva N, An der Heiden M, Schaade L, Stark K, Dorner BG, Frank C. A large travel-associated outbreak of iatrogenic botulism in four European countries following intragastric botulinum neurotoxin injections for weight reduction, Türkiye, February to March 2023. Euro Surveill 2023; 28:2300203. [PMID: 37289431 PMCID: PMC10318948 DOI: 10.2807/1560-7917.es.2023.28.23.2300203] [Citation(s) in RCA: 11] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/05/2023] [Accepted: 05/14/2023] [Indexed: 06/09/2023] Open
Abstract
In March 2023, 34 associated cases of iatrogenic botulism were detected in Germany (30 cases), Switzerland (two cases), Austria (one case), and France (one case). An alert was rapidly disseminated via European Union networks and communication platforms (Food- and Waterborne Diseases and Zoonoses Network, EpiPulse, Early Warning and Response System) and the International Health Regulation mechanism; the outbreak was investigated in a European collaboration. We traced sources of the botulism outbreak to treatment of weight loss in Türkiye, involving intragastric injections of botulinum neurotoxin. Cases were traced using a list of patients who had received this treatment. Laboratory investigations of the first 12 German cases confirmed nine cases. The application of innovative and highly sensitive endopeptidase assays was necessary to detect minute traces of botulinum neurotoxin in patient sera. The botulism notification requirement for physicians was essential to detect this outbreak in Germany. The surveillance case definition of botulism should be revisited and inclusion of cases of iatrogenic botulism should be considered as these cases might lack standard laboratory confirmation yet warrant public health action. Any potential risks associated with the use of botulinum neurotoxins in medical procedures need to be carefully balanced with the expected benefits of the procedure.
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Affiliation(s)
- Martin Bernhard Dorner
- Biological Toxins (ZBS3), Centre for Biological Threats and Special Pathogens, Robert Koch Institute, Berlin, Germany
| | - Hendrik Wilking
- Department for Infectious Disease Epidemiology, Robert Koch Institute, Berlin, Germany
| | - Martin Skiba
- Biological Toxins (ZBS3), Centre for Biological Threats and Special Pathogens, Robert Koch Institute, Berlin, Germany
| | - Laura Wilk
- Biological Toxins (ZBS3), Centre for Biological Threats and Special Pathogens, Robert Koch Institute, Berlin, Germany
| | - Maximilian Steinberg
- Biological Toxins (ZBS3), Centre for Biological Threats and Special Pathogens, Robert Koch Institute, Berlin, Germany
| | - Sylvia Worbs
- Biological Toxins (ZBS3), Centre for Biological Threats and Special Pathogens, Robert Koch Institute, Berlin, Germany
| | - Sabahat Çeken
- General Directorate of Public Health, Ministry of Health, Ankara, Türkiye
| | - Sedat Kaygusuz
- General Directorate of Public Health, Ministry of Health, Ankara, Türkiye
| | - Stéphanie Simon
- Université Paris Saclay, Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Institut national de recherche pour l'agriculture, l'alimentation et l'environnement (INRAE), Département Médicaments et Technologies pour la Santé (DMTS), SPI, Gif-sur-Yvette, France
| | - François Becher
- Université Paris Saclay, Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Institut national de recherche pour l'agriculture, l'alimentation et l'environnement (INRAE), Département Médicaments et Technologies pour la Santé (DMTS), SPI, Gif-sur-Yvette, France
| | - Agata Mikolajewska
- Strategy and Incident Response (ZBS7), Centre for Biological Threats and Special Pathogens, Robert Koch Institute, Berlin, Germany
| | | | - Timo Bütler
- National International Health Regulation (IHR) Focal Point for Switzerland, Swiss Federal Office of Public Health, Division of Communicable Diseases, Bern, Switzerland
| | | | - Maria An der Heiden
- Department for Infectious Disease Epidemiology, Robert Koch Institute, Berlin, Germany
| | - Lars Schaade
- Centre for Biological Threats and Special Pathogens, Robert Koch Institute, Berlin, Germany
| | - Klaus Stark
- Department for Infectious Disease Epidemiology, Robert Koch Institute, Berlin, Germany
| | - Brigitte Gertrud Dorner
- Biological Toxins (ZBS3), Centre for Biological Threats and Special Pathogens, Robert Koch Institute, Berlin, Germany
- These authors contributed equally to the work and share the last authorship
| | - Christina Frank
- These authors contributed equally to the work and share the last authorship
- Department for Infectious Disease Epidemiology, Robert Koch Institute, Berlin, Germany
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Aliyev SA, Mamedova SY, Aliyev ES. [Endoscopic intragastric injection of botulinum toxin in the treatment of patients with morbid obesity: opportunities and prospects]. Khirurgiia (Mosk) 2023:81-88. [PMID: 36583498 DOI: 10.17116/hirurgia202301181] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/31/2022]
Abstract
The authors consider modern epidemiological and demographic data on morbid obesity. Literature review is devoted to non-surgical treatment of patients with morbid obesity. The authors analyze the results of experimental and clinical studies on endoscopic intragastric injection of botulinum toxin and bariatric efficacy of this approach. The indications for endoscopic intragastric injection of botulinum toxin and advantages of this technique are clearly formulated. The authors identified the most significant criteria for objective assessment of clinical effectiveness of endoscopic intragastral injection of botulinum toxin, as well as scientific and methodological principles necessary for this technique. Clinical efficacy of intragastric injection of botulinum toxin including overweight loss, anorexigenic and gastroparetic effects indicates inconsistent results and certain unresolved problems. Thus, large-scale multiple-center randomized controlled trials and multivariate analysis are required to determine the role of endoscopic intragastric injection of botulinum toxin in complex treatment of patients with morbid obesity.
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Affiliation(s)
- S A Aliyev
- Azerbaijan Medical University, Baku, Azerbaijan
| | | | - E S Aliyev
- Azerbaijan Medical University, Baku, Azerbaijan
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The Multispecialty Toxin: A Literature Review of Botulinum Toxin. Plast Reconstr Surg Glob Open 2022; 10:e4228. [PMID: 35402123 PMCID: PMC8987218 DOI: 10.1097/gox.0000000000004228] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/21/2021] [Accepted: 01/31/2022] [Indexed: 11/26/2022]
Abstract
Botulinum toxin (BoNT) is a potent biological exotoxin produced from Clostridium botulinum. Although it was first used therapeutically to treat strabismus, its clinical role has since expanded rapidly over the years to include treatment of a variety of head and neck, gastrointestinal, urogenital, musculoskeletal, neurological, dermatological, and cosmetic disorders. The main purpose of this review is to provide a brief updated overview of the history, mechanism of action, and clinical applications of BoNT therapy across multiple medical specialties, including the most common adverse effects and recommended Botox dosages.
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Tayyem RM, Qandeel HG, Al-Balas HI, Tayyem FR, Fataftah JZ, Al-Balas MI. Comparison of safety and efficacy of intragastric botulinum toxin-A versus gastric balloon. Saudi J Gastroenterol 2022; 28:276-281. [PMID: 35083975 PMCID: PMC9408739 DOI: 10.4103/sjg.sjg_534_21] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/04/2022] Open
Abstract
BACKGROUND A prospective case-matched study was conducted to compare the safety and efficacy of endoscopic intragastric botulinum toxin-A (EIBT) versus endoscopically planned gastric balloon (EPGB), as a treatment for obesity. METHODS A total of 176 patients (matched for age and sex) were equally divided to undergo EIBT (n = 88) or EPGB (n = 88). Patients who received EIBT were restricted to a body mass index (BMI) of 25 to 35 kg/m2, whereas a BMI >25 kg/m2 was allowed in the EPGB group. The main measured outcomes were weight loss, procedure duration, complications, early satiety, and quality of life (QoL). RESULTS The patients were followed up for a mean of 6 months. The mean weight loss was greater in the EPGB group than in the EIBT group (15.6 kg vs. 9.3 kg, P < 0.001). However, the percentage excess weight loss and the satiety score were greater in the EIBT group (59.1% vs. 42.2%, P < 0.001; and 3.5 vs. 2.3, P < 0.001) respectively. The procedure duration was shorter for EIBT patients (10 min vs. 15 min, P < 0.001). The postoperative complication rate recorded in the EPGB group was significantly higher (30% vs. 9%, P = 0.001). Adverse symptoms lasted longer in EPGB (5.2 days vs. 0.7 days, P < 0.001). Both groups enjoyed similar improvements in QoL. CONCLUSION EIBT is a safe and effective treatment for mild obesity. Although the weight loss was greater in the EPGB group, the percentage excess weight loss, procedure duration, postoperative complications, and symptom duration were significantly better in the EIBT group. QoL improvement was comparable between the two groups.
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Affiliation(s)
- Raed M. Tayyem
- Department of General and Special Surgery, Faculty of Medicine, The Hashemite University, Zarqa, Jordan,Address for correspondence: Dr. Raed M. Tayyem, Department of General Surgery, The Hashemite University, Zarqa, Jordan. E-mail:
| | - Haitham G. Qandeel
- Department of General and Special Surgery, Faculty of Medicine, The Hashemite University, Zarqa, Jordan
| | - Hamzeh I. Al-Balas
- Department of General and Special Surgery, Faculty of Medicine, The Hashemite University, Zarqa, Jordan
| | - Farah R. Tayyem
- Department of Dental Surgery, Faculty of Dentistry, Jordanian University of Science and Technology, Irbid, Jordan
| | | | - Mahmoud I. Al-Balas
- Department of General and Special Surgery, Faculty of Medicine, The Hashemite University, Zarqa, Jordan
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Ferhatoglu MF, Kartal A, Filiz AI, Kebudi A. Outcome of Gastric Fundus and Pylorus Botulinum Toxin A Injection in Obese Patients Class I–II with Normal Pyloric Orifice Structure: A Retrospective Analysis. Bariatr Surg Pract Patient Care 2021. [DOI: 10.1089/bari.2020.0112] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022] Open
Affiliation(s)
- Murat Ferhat Ferhatoglu
- Department of General Surgery, Faculty of Medicine, Istanbul Okan University, Istanbul, Turkey
| | | | - Ali Ilker Filiz
- Department of General Surgery, Baskent University Faculty of Medicine, Ankara, Turkey
| | - Abut Kebudi
- Department of General Surgery, Faculty of Medicine, Istanbul Okan University, Istanbul, Turkey
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Aliev S, Mamedova S, Aliev E. The use of intragastral botulinum toxin in the treatment of patients with morbid obesity: realities and perspectives. ENDOSKOPICHESKAYA KHIRURGIYA 2021; 27:48. [DOI: 10.17116/endoskop20212705148] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/03/2025]
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Gameel A, Bahgat M, Seif S, Habeeb M, Abd El-Ghany M, Altonbary AY. Evaluation of endoscopic ultrasound-guided gastric botulinum toxin injections in the treatment of obesity. THE EGYPTIAN JOURNAL OF INTERNAL MEDICINE 2020. [DOI: 10.1186/s43162-020-00027-8] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/22/2022] Open
Abstract
Abstract
Background
Obesity is rapidly emerging as one of the greatest challenges of human health. Many randomized trials and open-label human studies described conflicting results of gastric intra-muscular injections of botulinum toxin type A (BTA). Endoscopic ultrasound (EUS) guidance can assure BTA injection into the subserosal layer and muscularis propria of the gastric wall which may optimize the efficacy of injection. The aim of the study is to assess the efficacy and safety of EUS-guided gastric BTA injections in weight reduction for obese subjects.
Results
The present study included 25 patients (2 males and 23 females with mean age 35.84 ± 7.776). For nutrient drink tests, median maximum tolerated volumes (MTVs) decreased from 720 cc (range 480–1680) as a baseline value 2 weeks before BTA injection to 360 cc (range 140–820) at 16 weeks after injection. Mean body weight reduction was 11.92 kg (10.8%) after 16 weeks of BTA injection. Mean body weight continued to decrease during the study period from a baseline value of 110 to 98 kg with significant reduction of mean BMI from baseline value of 41.2 to 36.7 at 16 weeks after BTA injection (p < 0.001). The study was completed without major adverse events.
Conclusion
EUS-guided BTA injection into the antral subserosa and muscularis propria could be an effective technique for weight reduction, or as a bridge for surgery, which can be done safely with minimal complications.
Trial registration
NCT03901040
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Sánchez Torralvo FJ, Vázquez Pedreño L, Gonzalo Marín M, Tapia MJ, Lima F, García Fuentes E, García P, Moreno Ruiz J, Rodríguez Cañete A, Valdés S, Olveira G. Endoscopic intragastric injection of botulinum toxin A in obese patients on bariatric surgery waiting lists: A randomised double-blind study (IntraTox study). Clin Nutr 2020; 40:1834-1842. [PMID: 33092901 DOI: 10.1016/j.clnu.2020.10.008] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/08/2020] [Revised: 09/15/2020] [Accepted: 10/02/2020] [Indexed: 12/28/2022]
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.
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Affiliation(s)
- Francisco José Sánchez Torralvo
- 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.
| | - Luis Vázquez Pedreño
- UGC Aparato Digestivo, Unidad de Endoscopias. Hospital Regional Universitario de Málaga, Málaga, Spain
| | - Montserrat Gonzalo Marín
- 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
| | - María José Tapia
- 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
| | - Fuensanta Lima
- UGC Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Plaza del Hospital Civil, S/N, 29009, Málaga, Spain
| | - Eduardo García Fuentes
- 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
| | - Pilar García
- UGC Aparato Digestivo, Unidad de Endoscopias. Hospital Regional Universitario de Málaga, Málaga, Spain
| | - Javier Moreno Ruiz
- UGC Cirugía General y Digestiva, Hospital Regional Universitario de Málaga, Málaga, Spain
| | | | - Sergio Valdés
- 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
| | - Gabriel Olveira
- 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
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Kaya B, Esen Bulut N, Fersahoglu M. Is Intragastric Botulinum Toxin A Injection Effective in Obesity Treatment? Surg Res Pract 2020; 2020:2419491. [PMID: 33062839 PMCID: PMC7547330 DOI: 10.1155/2020/2419491] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/24/2020] [Revised: 07/31/2020] [Accepted: 08/01/2020] [Indexed: 11/30/2022] Open
Abstract
AIMS The objective of this prospective study was to evaluate the efficacy of intragastric botulinum toxin A (BTX-A) injection for the treatment of obesity. MATERIALS AND METHODS The study was performed between January and August 2019. This is a prospective study. After 6-12 hours of fasting, the patients were submitted to upper GI endoscopy under sedation for the injection of BTX-A. A total of 250 U of BTA-X was diluted with 10 ml of 0.9% saline. Injections were administered into the gastric antrum, each containing 1 ml of prepared solution (25 U BX-A + 1 ml saline). Continuous data were compared using a two-sample t-test. Statistical significance was determined as P ≤ 0.05. All statistical analysis was performed using SPSS for Windows 22.1 software (SPSS, Chicago, IL, USA). RESULTS A total of 56 patients were studied. Mean weight before gastric Botox was 85.25 ± 14.02, and mean weight after gastric Botox was 76.98 ± 12.68. Mean weight loss was approximately 9 kg in studied patients. BMI decreased about 3 units. The mean time for maximum weight loss was 60.39 ± 37.43 days. A total of 49 patients (87.5%) had reported decrease in appetite and early satiety. About 53.6% of patients were satisfied. No complications resulting from the endoscopic procedure were observed in this series. CONCLUSIONS Intragastric BTX-A injection can be beneficial in weight loss. It is a minimally invasive, cost-effective procedure, without serious side effects.
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Affiliation(s)
- Bulent Kaya
- Hisar Intercontinental Hospital, Department of General Surgery, Istanbul, Turkey
| | - Nuriye Esen Bulut
- Fatih Sultan Mehmet Training and Research Hospital, Department of General Surgery, Istanbul, Turkey
| | - Mahir Fersahoglu
- Fatih Sultan Mehmet Training and Research Hospital, Department of General Surgery, Istanbul, Turkey
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Ferhatoglu MF, Kartal A, Filiz AI, Kebudi A. The Positive Effects of a Calorie-Restricting High-Protein Diet Combined with Intragastric Botulinum Toxin Type A Application Among Morbidly Obese Patients: A Prospective, Observational Analysis of Eighty-Seven Grade 2 Obese Patients. Obes Surg 2020; 30:3472-3479. [PMID: 32306298 DOI: 10.1007/s11695-020-04597-y] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
PURPOSE Many studies evaluating the effect of intragastric botulinum toxin type A injection (IG-BTxA) for the treatment of obesity have been published. However, none of these studies combined this procedure with a calorie-restricting high-protein diet. Herein, we aimed to evaluate the effects of IG-BTxA application combined with a calorie-restricting high-protein diet. MATERIALS AND METHODS This prospective cohort study is conducted with eighty-seven grade 2 obese patients treated between January 2019 and August 2019. Group 1: IG-BTxA + refused to consult the dietitian; group 2: IG-BTxA + get calorie-restricting high-protein diet; group 3: only get a calorie-restricting high-protein diet. Loss of weight, treatment adaptation (visual analog scale score), the status and changes of comorbid conditions, and changes in eating behaviors (Self-Regulation of Eating Behaviour Questionnaire score) were assessed. RESULTS Loss of weight, treatment adaptation, and positive behavioral change in eating preferences were significantly higher in group 2 (p = 0.01; p = 0.001; p < 0.01, respectively). Additionally, the decrease in medication requirement for diabetes and hypertension was higher in group 2 (p < 0.05). CONCLUSION IG-BTxA application before calorie-restricting high-protein diet facilitates adaptation to the new diet style and helps to lose weight faster in grade 2 obese patients. Also, more positive results were achieved in terms of controlling comorbid diseases.
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Affiliation(s)
- Murat Ferhat Ferhatoglu
- Department of General Surgery, Faculty of Medicine, Istanbul Okan University, Istanbul, Turkey
| | - Abdulcabbar Kartal
- Department of General Surgery, Faculty of Medicine, Istanbul Okan University, Istanbul, Turkey.
| | - Ali Ilker Filiz
- Department of General Surgery, Faculty of Medicine, Istanbul Okan University, Istanbul, Turkey
| | - Abut Kebudi
- Department of General Surgery, Faculty of Medicine, Istanbul Okan University, Istanbul, Turkey
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14
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Cariati M, Chiarello MM, Cannistra' M, Lerose MA, Brisinda G. Gastrointestinal Uses of Botulinum Toxin. Handb Exp Pharmacol 2020; 263:185-226. [PMID: 32072269 DOI: 10.1007/164_2019_326] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
Botulinum toxin (BT), one of the most powerful inhibitors that prevents the release of acetylcholine from nerve endings, represents an alternative therapeutic approach for "spastic" disorders of the gastrointestinal tract such as achalasia, gastroparesis, sphincter of Oddi dysfunction, chronic anal fissures, and pelvic floor dyssynergia.BT has proven to be safe and this allows it to be a valid alternative in patients at high risk of invasive procedures but long-term efficacy in many disorders has not been observed, primarily due to its relatively short duration of action. Administration of BT has a low rate of adverse reactions and complications. However, not all patients respond to BT therapy, and large randomized controlled trials are lacking for many conditions commonly treated with BT.The local injection of BT in some conditions becomes a useful tool to decide to switch to more invasive therapies. Since 1980, the toxin has rapidly transformed from lethal poison to a safe therapeutic agent, with a significant impact on the quality of life.
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Affiliation(s)
- Maria Cariati
- Department of Surgery, "San Giovanni di Dio" Hospital, Crotone, Italy
| | | | - Marco Cannistra'
- Department of Surgery, "San Giovanni di Dio" Hospital, Crotone, Italy
| | | | - Giuseppe Brisinda
- Department of Surgery, "San Giovanni di Dio" Hospital, Crotone, Italy. .,Department of Surgery, "Agostino Gemelli" Hospital, Catholic School of Medicine, Rome, Italy.
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15
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Abstract
Objective: With the evolution of society and changes in human lifestyle, obesity is becoming increasingly prevalent worldwide, and obesity-related comorbidities such as diabetes, hyperlipidemia, hypertension, and coronary heart disease are more common. As a result, new devices and methods for bariatric and metabolic endoscopy are being developed for clinical use, offering new options for patients. This review discussed the progress in bariatric and metabolic endoscopy. Data Sources: This review was based on data in articles published in the PubMed database up to September 2017, with the following keywords: “obesity”, “endoscopy”, “weight loss”, and “metabolism”. Study Selection: Original articles about various endoscopic methods of weight loss and other reviews of bariatric and metabolic endoscopy were included and analyzed. Results: The technology of bariatric and metabolic endoscopy has advanced rapidly in recent years. The intragastric balloon (IGB), with its comparatively long period of development, is the most mature and widely used instrument. Multiple new endoscopic devices have been created in recent years, with different targets to achieve weight loss. Despite the proliferation of new devices, the lack of clinical data results in a shortage of clinical experience and instruction in the use of this new equipment. Conclusions: Bariatric and metabolic endoscopy would help obese people lose weight or prepare for bariatric surgery and hopefully alleviate some of the complications of bariatric procedures. Adequate studies and data are still needed for the new endoscopic devices.
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Affiliation(s)
- Shi-Han Li
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
| | - Yong-Jun Wang
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
| | - Shu-Tian Zhang
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
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16
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Espinet Coll E, López-Nava Breviere G, Nebreda Durán J, Marra-López Valenciano C, Turró Arau R, Esteban López-Jamar JM, Muñoz-Navas M. Spanish consensus document on bariatric endoscopy. Part 2: specific endoscopic treatments. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2019; 111:140-154. [PMID: 30654612 DOI: 10.17235/reed.2019.4922/2017] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
During the last years we have been witnessing a significant increase in the number and type of bariatric endoscopic techniques: we have different types of balloons, suture systems, injection of substances and malabsorptive prosthesis, etc. Also, some endoscopic revisional procedures for patients with weight regain after bariatric surgery have been incorporated. This makes it necessary to protocolize, position and regularize all these techniques, through a consensus that allows their clinical application with the maximum medical rigor and scientific evidence available.
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17
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Abstract
PURPOSE OF REVIEW In this review, we describe the FDA-approved and investigational devices and endoscopic bariatric therapies for the treatment of obesity. We focus on literature published in the past few years and present mechanisms of action as well as efficacy and safety data. RECENT FINDINGS Devices and endoscopic procedures are emerging options to fill the significant treatment gap in the management of obesity. Not only are these devices and procedures minimally invasive and reversible, but they are potentially more effective than antiobesity medications, often safer for poor surgical candidates and possibly less expensive than bariatric surgery. As many patients require a variety of management strategies (medications, devices, procedures, and/or surgery) in addition to lifestyle modifications to achieve clinically significant weight loss, the future of obesity treatment involves a multidisciplinary approach. Combinations of advanced treatment strategies can lead to additive or synergistic weight loss. This is an area that requires further investigation.
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Affiliation(s)
- Katherine H Saunders
- Comprehensive Weight Control Center, Division of Endocrinology, Diabetes and Metabolism, Weill Cornell Medicine, 1165 York Avenue, New York, NY, 10065, USA.
| | - Leon I Igel
- Comprehensive Weight Control Center, Division of Endocrinology, Diabetes and Metabolism, Weill Cornell Medicine, 1165 York Avenue, New York, NY, 10065, USA
| | - Monica Saumoy
- Divison of Gastroenterology and Hepatology, Weill Cornell Medicine, 1305 York Avenue, 4th Floor, New York, NY, 10021, USA
| | - Reem Z Sharaiha
- Divison of Gastroenterology and Hepatology, Weill Cornell Medicine, 1305 York Avenue, 4th Floor, New York, NY, 10021, USA
| | - Louis J Aronne
- Comprehensive Weight Control Center, Division of Endocrinology, Diabetes and Metabolism, Weill Cornell Medicine, 1165 York Avenue, New York, NY, 10065, USA
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18
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Abstract
Obesity prevalence has been increasing with devastating health and economic consequences. Botulinum toxin type A (BTX-A), a neurotoxin, is used clinically for conditions characterized by prolonged muscular contraction. Its inhibitory effects on gastric smooth muscles, in theory, make it a potential agent for obesity treatment through delayed gastric emptying and increased satiety. This review aims to examine the evidence for the use of endoscopic BTX-A injection for treating obesity. The literature search identified 60 articles with 11 primary studies as relevant for the scope of the review. Several studies have been conducted to examine the effect of BTX-A injections on obesity, including both animal and human studies. Current evidence from identified studies does not demonstrate sustained weight loss through the use of endoscopic BTX-A injection.
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19
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Park JS, Zheng HM, Kim JM, Kim CS, Jeong S, Lee DH. The Effect of Intragastric Administration of Botulinum Toxin Type A on Reducing Adiposity in a Rat Model of Obesity Using Micro-CT and Histological Examinations. Gut Liver 2017; 11:798-806. [PMID: 28750487 PMCID: PMC5669595 DOI: 10.5009/gnl16557] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/16/2016] [Revised: 01/31/2017] [Accepted: 02/07/2017] [Indexed: 01/29/2023] Open
Abstract
Background/Aims Botulinum toxin type A (BTX), a long-acting inhibitor of muscular contraction in both striated and smooth muscles, is responsible for gastric motility. The aim of this study was to investigate the effects of an endoscopic intragastric BTX injection on weight loss, body fat accumulation, and gastric emptying time. Methods The BTX group consisted of 15 obese rats in which 20 U of BTX were injected into the gastric antrum. The saline group consisted of 15 obese rats injected with 20 U of saline, and the control group included 10 obese rats that did not receive a surgical intervention. The gastric emptying time, biochemical parameters, and body fat volume were evaluated using micro-computed tomography (micro-CT) and histologic evaluations. Results The postoperative body weight of the BTX group was significantly lower than those of the other groups (p<0.001) at 6 weeks after the operation. The gastric emptying time (156±54 minutes) was significantly delayed in the BTX group. The BTX group showed significantly lower lipid levels than the other groups. A reduction in body fat volume was observed in the BTX group using micro-CT and histological evaluations. Conclusions BTX application to the gastric antrum represents a potentially effective treatment for obesity and may help improve the lipid profile by increasing the gastric emptying time.
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Affiliation(s)
- Jin-Seok Park
- Digestive Disease Center, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea
| | - Hong-Mei Zheng
- National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders (NCEED), Incheon, Korea
| | - Jae-Min Kim
- National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders (NCEED), Incheon, Korea
| | - Chung Sei Kim
- Bio R&D Center, Daewoong Pharmaceutical, Yongin, Korea
| | - Seok Jeong
- Digestive Disease Center, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea.,National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders (NCEED), Incheon, Korea
| | - Don Haeng Lee
- Digestive Disease Center, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea.,National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders (NCEED), Incheon, Korea.,Utah-Inha DDS & Advanced Therapeutics Research Center, Incheon, Korea
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20
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Bustamante F, Brunaldi VO, Bernardo WM, de Moura DTH, de Moura ETH, Galvão M, Santo MA, de Moura EGH. Obesity Treatment with Botulinum Toxin-A Is Not Effective: a Systematic Review and Meta-Analysis. Obes Surg 2017; 27:2716-2723. [PMID: 28812212 DOI: 10.1007/s11695-017-2857-5] [Citation(s) in RCA: 35] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Abstract
The effectiveness of gastric injections of botulinum toxin-A (BTA) as primary treatment for obesity is not well known since results in literature are discrepant. Hence, we aimed to systematically review and meta-analyze the available data to assess the real effect of BTA therapy. We searched MEDLINE, Embase, Cochrane, SCOPUS, EBSCO, LILACS, and BVS. We considered eligible only randomized controlled trials enrolling obese patients comparing BTA versus saline injections. Our initial search identified 8811 records. Six studies fulfilled eligibility criteria. After critical appraisal, two articles were excluded and we meta-analyzed the remainder. The mean difference for absolute weight loss and BMI reduction were 0.12 [CI 95%, - 1.14, 1.38] and - 0.06 [95% CI, - 0.92, 0.81], respectively. Therefore, we concluded that treatment of obesity with BTA is not effective.
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Affiliation(s)
- Fabio Bustamante
- Gastrointestinal Endoscopy Unit, Hospital das Clinicas, University of São Paulo Medical School, Dr. Arnaldo Av, 455, São Paulo, 01246-903, Brazil
| | - Vitor Ottoboni Brunaldi
- Gastrointestinal Endoscopy Unit, Hospital das Clinicas, University of São Paulo Medical School, Dr. Arnaldo Av, 455, São Paulo, 01246-903, Brazil.
| | - Wanderley Marques Bernardo
- Gastrointestinal Endoscopy Unit, Hospital das Clinicas, University of São Paulo Medical School, Dr. Arnaldo Av, 455, São Paulo, 01246-903, Brazil
| | - Diogo Turiani H de Moura
- Gastrointestinal Endoscopy Unit, Hospital das Clinicas, University of São Paulo Medical School, Dr. Arnaldo Av, 455, São Paulo, 01246-903, Brazil
| | - Eduardo Turiani H de Moura
- Gastrointestinal Endoscopy Unit, Hospital das Clinicas, University of São Paulo Medical School, Dr. Arnaldo Av, 455, São Paulo, 01246-903, Brazil
| | - Manoel Galvão
- Unit of Endoscopy - Gastro Obeso Center, Barata Ribeiro St. 237, Sao Paulo, Brazil
| | - Marco Aurélio Santo
- Bariatric and Metabolic Surgery Unit, Hospital das Clinicas, University of Sao Paulo Medical School, São Paulo, Brazil
| | - Eduardo Guimarães H de Moura
- Gastrointestinal Endoscopy Unit, Hospital das Clinicas, University of São Paulo Medical School, Dr. Arnaldo Av, 455, São Paulo, 01246-903, Brazil
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21
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Hill C, Khashab MA, Kalloo AN, Kumbhari V. Endoluminal weight loss and metabolic therapies: current and future techniques. Ann N Y Acad Sci 2017; 1411:36-52. [PMID: 28884820 DOI: 10.1111/nyas.13441] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/22/2017] [Revised: 06/18/2017] [Accepted: 06/28/2017] [Indexed: 12/18/2022]
Abstract
Obesity is a public health epidemic associated with a number of comorbidities, most notably type 2 diabetes and hypertension, as well as elevated all-cause mortality. The treatment for obesity and its associated comorbidities has most recently expanded into the field of bariatric endoscopy. This field bridges a gap between lifestyle counseling with or without pharmaceutical treatment and the most effective treatment of obesity, bariatric surgery. Because of its minimally invasive nature, bariatric endoscopic therapy has the potential to appeal to the large sector of the obese population that resists surgery, as well as those early in the onset of obesity. To date, five endoscopic devices have been approved by the U.S. Food and Drug Administration for the treatment of obesity, and many more are in development, undergoing clinical trials, or being used around the world. Here, we present the current state of the field, highlight recent developments, and describe the clinical outcomes of these minimally invasive procedures in terms of weight loss, improvement in metabolic profile, and reduction in comorbidities.
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Affiliation(s)
- Christine Hill
- Diversity Summer Internship Program, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland
| | - Mouen A Khashab
- Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, Maryland
| | - Anthony N Kalloo
- Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, Maryland
| | - Vivek Kumbhari
- Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, Maryland
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22
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Jirapinyo P, Thompson CC. Endoscopic Bariatric and Metabolic Therapies: Surgical Analogues and Mechanisms of Action. Clin Gastroenterol Hepatol 2017; 15:619-630. [PMID: 27989851 PMCID: PMC5444453 DOI: 10.1016/j.cgh.2016.10.021] [Citation(s) in RCA: 75] [Impact Index Per Article: 9.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/31/2016] [Revised: 10/24/2016] [Accepted: 10/24/2016] [Indexed: 02/07/2023]
Abstract
Obesity is a worsening pandemic with numerous related comorbid illnesses. Conservative management including lifestyle modification and medications have limited efficacy. In contradistinction, bariatric surgery is effective, however, with substantial cost and non-negligible morbidity and mortality. As such, a small percentage of eligible patients undergo surgery. Over the past decade, endoscopic bariatric and metabolic therapies have been introduced as a less invasive option for the treatment of obesity and its related comorbid illnesses. This article reviews major endoscopic bariatric and metabolic therapies, their surgical analogues, and proposed mechanisms of action. Clinical trial data for each device also are discussed.
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23
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Abstract
This article focuses on the stomach target devices that are currently in various stages of development. Approved intragastric balloons, devices targeting small bowel and aspiration techniques, are described in other contributions to this issue. Bariatric endoscopic devices targeting the stomach directly alter gastric physiology and promote weight loss by potentially changing functional gastric volume, gastric emptying, gastric wall compliance, neurohormonal signaling, and, thereby, satiety. Many stomach-targeting devices are on the horizon for clinical use, and further study will determine the safety and efficacy for clinical use.
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Affiliation(s)
- Kartik Sampath
- Section of Gastroenterology and Hepatology, Department of Medicine, Dartmouth-Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, One Medical Center Drive, Lebanon, NH 03756, USA.
| | - Richard I Rothstein
- Section of Gastroenterology and Hepatology, Department of Medicine, Dartmouth-Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, One Medical Center Drive, Lebanon, NH 03756, USA
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24
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Pero R, Coretti L, Lembo F. Botulinum Toxin A for Controlling Obesity. Toxins (Basel) 2016; 8:E281. [PMID: 27681739 PMCID: PMC5086641 DOI: 10.3390/toxins8100281] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/31/2016] [Revised: 09/20/2016] [Accepted: 09/20/2016] [Indexed: 01/09/2023] Open
Abstract
Rapid growth of the overweight population and the number of obese individuals in recent decades suggests that current strategies based on diet, exercise, and pharmacological knowledge are not sufficient to address this epidemic. Obesity is the result of a high caloric intake and energy storage, not counterbalanced by an equally important energy expense. Botulinum toxin type A (BoNT-A) use is rapidly expanding to include treatment of a variety of ophthalmological, gastrointestinal, urological, orthopedic, dermatological, secretory, painful, and cosmetic disorders. Many studies evaluating the effect of BoNT-A in gastric antrum e/o fundus for the treatment of obesity have been published. This treatment modality was based on the observation that gastric injection of BoNT-A in laparatomized rats induced a significant reduction of food intake and body weight. These studies have been published yielding debated results. Differences in the selection of patients, the doses of BoNT-A, the method of administration of the toxin, and the instruments of evaluation of some parameters among these studies may be the cause. In this review, it will study the state-of-the-art use of BoNT-A in obesity basic science models and review the clinical evidence on the therapeutic applications of BoNT-A for obesity.
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Affiliation(s)
- Raffaela Pero
- Department of Molecular Medicine and Medical Biotechnology, University of Naples "Federico II", Naples 80131, Italy.
| | - Lorena Coretti
- Department of Molecular Medicine and Medical Biotechnology, University of Naples "Federico II", Naples 80131, Italy.
| | - Francesca Lembo
- Dipartimento di Farmacia, Università degli Studi di Napoli "Federico II", via D. Montesano 47, Naples 80131, Italy.
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Brisinda G, Sivestrini N, Bianco G, Maria G. Treatment of gastrointestinal sphincters spasms with botulinum toxin A. Toxins (Basel) 2015; 7:1882-1916. [PMID: 26035487 PMCID: PMC4488680 DOI: 10.3390/toxins7061882] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/15/2015] [Revised: 05/10/2015] [Accepted: 05/21/2015] [Indexed: 02/05/2023] Open
Abstract
Botulinum toxin A inhibits neuromuscular transmission. It has become a drug with many indications. The range of clinical applications has grown to encompass several neurological and non-neurological conditions. One of the most recent achievements in the field is the observation that botulinum toxin A provides benefit in diseases of the gastrointestinal tract. Although toxin blocks cholinergic nerve endings in the autonomic nervous system, it has also been shown that it does not block non-adrenergic non-cholinergic responses mediated by nitric oxide. This has promoted further interest in using botulinum toxin A as a treatment for overactive smooth muscles and sphincters. The introduction of this therapy has made the treatment of several clinical conditions easier, in the outpatient setting, at a lower cost and without permanent complications. This review presents current data on the use of botulinum toxin A in the treatment of pathological conditions of the gastrointestinal tract.
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Affiliation(s)
- Giuseppe Brisinda
- Department of Surgery, University Hospital "Agostino Gemelli", Largo Agostino Gemelli 8, 00168 Rome, Italy.
| | - Nicola Sivestrini
- Department of Surgery, University Hospital "Agostino Gemelli", Largo Agostino Gemelli 8, 00168 Rome, Italy.
| | - Giuseppe Bianco
- Department of Surgery, University Hospital "Agostino Gemelli", Largo Agostino Gemelli 8, 00168 Rome, Italy.
| | - Giorgio Maria
- Department of Surgery, University Hospital "Agostino Gemelli", Largo Agostino Gemelli 8, 00168 Rome, Italy.
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Advances in the Endoscopic Management of Obesity. Gastroenterol Res Pract 2015; 2015:757821. [PMID: 26106413 PMCID: PMC4461770 DOI: 10.1155/2015/757821] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/03/2014] [Accepted: 04/25/2015] [Indexed: 12/13/2022] Open
Abstract
Obesity has become a worldwide epidemic with significant impact on quality of life, morbidity, and mortality rates. Over the past two decades, bariatric surgery has established itself as the most effective and durable treatment for patients with obesity and its associated comorbidities. However, despite the use of minimally invasive techniques, bariatric surgery is associated with complications in approximately 15% of patients, has a substantial cost, and is used by only 1% of patients who are eligible. Therefore, there is a need for effective minimally invasive therapies, which will be utilized by the large proportion of obese patients who are in desperate need of treatment but are not receiving any. Endoscopic approaches to the management of obesity have been developed, with the aim of delivering more effective, durable, and safer methods of weight reduction. In this paper, we review currently available and future endoscopic therapies that will likely join the armamentarium used in the management of obesity.
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27
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Bang CS, Baik GH, Shin IS, Kim JB, Suk KT, Yoon JH, Kim YS, Kim DJ. Effect of intragastric injection of botulinum toxin A for the treatment of obesity: a meta-analysis and meta-regression. Gastrointest Endosc 2015; 81:1141-9.e97. [PMID: 25765772 DOI: 10.1016/j.gie.2014.12.025] [Citation(s) in RCA: 38] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/17/2014] [Accepted: 12/01/2014] [Indexed: 02/08/2023]
Abstract
BACKGROUND Controversies persist regarding the effect of intragastric injection of botulinum toxin A for the treatment of obesity. OBJECTIVE To assess the efficacy of intragastric botulinum toxin injection for the treatment of obesity. DESIGN A systematic literature review was conducted by using the core databases. Pre- and posttreatment body weight data were extracted and analyzed by using Hedges' g. A random-effects model was applied. The methodological quality of the enrolled studies was assessed by the risk of bias table and Newcastle-Ottawa Scale. Publication bias was evaluated via the funnel plot, trim and fill method, Egger's test, and rank correlation test. SETTING Meta-analysis of 8 studies. PATIENTS A total of 115 patients (79 treated vs 36 placebo). INTERVENTION Intragastric botulinum toxin A injection. MAIN OUTCOME MEASUREMENTS Hedges' g, calculated from pre- and posttreatment body weight data and comparison of body weight changes between treatment and placebo group. RESULTS The treatment group was associated with weight loss in a pre/post comparative approach and compared with the placebo group (Hedges' g: -0.443; 95% confidence interval, -0.845 to -0.040; P = .031; and Hedges' g: -0.521; 95% confidence interval, -0.956 to -0.085; P = .019). Wide area injection including the fundus or body rather than the antrum only was associated with weight loss. Multiple injections (>10) were associated with weight loss. However, a large amount of botulinum toxin A (500 IU) was not associated with weight loss. Sensitivity analyses showed consistent results. Meta-regression for the botulinum toxin A dose and number of injections showed consistent results. Publication bias was not detected. CONCLUSION In this analysis, intragastric injection of botulinum toxin A is effective for the treatment of obesity.
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Affiliation(s)
- Chang Seok Bang
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
| | - Gwang Ho Baik
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
| | - In Soo Shin
- College of Education, Jeonju University, Jeonju, South Korea
| | - Jin Bong Kim
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
| | - Ki Tae Suk
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
| | - Jai Hoon Yoon
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
| | - Yeon Soo Kim
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
| | - Dong Joon Kim
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
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Rashti F, Gupta E, Ebrahimi S, Shope TR, Koch TR, Gostout CJ. Development of minimally invasive techniques for management of medically-complicated obesity. World J Gastroenterol 2014; 20:13424-13445. [PMID: 25309074 PMCID: PMC4188895 DOI: 10.3748/wjg.v20.i37.13424] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/30/2014] [Revised: 06/15/2014] [Accepted: 07/16/2014] [Indexed: 02/06/2023] Open
Abstract
The field of bariatric surgery has been rapidly growing and evolving over the past several decades. During the period that obesity has become a worldwide epidemic, new interventions have been developed to combat this complex disorder. The development of new laparoscopic and minimally invasive treatments for medically-complicated obesity has made it essential that gastrointestinal physicians obtain a thorough understanding of past developments and possible future directions in bariatrics. New laparoscopic advancements provide patients and practitioners with a variety of options that have an improved safety profile and better efficacy without open, invasive surgery. The mechanisms of weight loss after bariatric surgery are complex and may in part be related to altered release of regulatory peptide hormones from the gut. Endoscopic techniques designed to mimic the effects of bariatric surgery and endolumenal interventions performed entirely through the gastrointestinal tract offer potential advantages. Several of these new techniques have demonstrated promising, preliminary results. We outline herein historical and current trends in the development of bariatric surgery and its transition to safer and more minimally invasive procedures designed to induce weight loss.
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Topazian M, Camilleri M, Enders FT, Clain JE, Gleeson FC, Levy MJ, Rajan E, Nehra V, Dierkhising RA, Collazo-Clavell ML, Talley NJ, Clark MM. Gastric antral injections of botulinum toxin delay gastric emptying but do not reduce body weight. Clin Gastroenterol Hepatol 2013; 11:145-50.e1. [PMID: 23063681 PMCID: PMC3552074 DOI: 10.1016/j.cgh.2012.09.029] [Citation(s) in RCA: 29] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/21/2012] [Revised: 09/12/2012] [Accepted: 09/20/2012] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS Gastric injections of botulinum toxin A (BTA) have been reported to delay gastric emptying, increase satiation, and reduce body weight, but there are few data from randomized, placebo-controlled studies. METHODS We enrolled 60 obese participants in a 24-week, double-blind, randomized, placebo-controlled, concealed allocation trial to compare the effects of gastric antral injections of BTA (100, 300, or 500 U) and saline placebo. The study was conducted at an outpatient clinical research unit. Participants were given one set of injections of BTA or placebo into the gastric antral muscularis propria by using endoscopic ultrasound guidance. Gastric emptying of solids was measured by scintigraphy; we also measured body weight, satiation (maximum tolerated volume in a caloric liquid drink test), calorie intake (by food frequency questionnaire), gastrointestinal symptoms, and psychological aspects of eating behavior (by rating scale). RESULTS Compared with baseline values, 2 weeks after injections, the mean half-time for gastric emptying of solids increased by 0.8, 14, 24, and 14 minutes among subjects given placebo, 100, 300, or 500 U BTA, respectively (P = .24 overall, P = .04 for the group given 300 U vs placebo); 16 weeks after the injections, mean body weights were reduced by 2.2, 0.2, 2.3, and 3.0 kg in these groups, respectively. There were no statistically significant differences in mean body weight change, satiation volume, caloric intake, gastrointestinal symptoms, or psychological aspects of eating behavior among groups. CONCLUSIONS Gastric antral injections of BTA may delay gastric emptying at a dose of 300 U but do not cause early satiety, altered eating behaviors, or loss of body weight. Clinicaltrials.gov identifier: NCT00976443.
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Affiliation(s)
- Mark Topazian
- Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, Minnesota 55905, USA.
| | | | - Felicity T. Enders
- Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota
| | | | | | | | | | | | - Ross A. Dierkhising
- Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota
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Dolz Abadía C. Tratamiento endoscópico de la obesidad. GASTROENTEROLOGIA Y HEPATOLOGIA 2012; 35:708-18. [DOI: 10.1016/j.gastrohep.2012.09.001] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/16/2012] [Accepted: 09/05/2012] [Indexed: 12/16/2022]
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Endoscopic treatment of obesity. CANADIAN JOURNAL OF GASTROENTEROLOGY = JOURNAL CANADIEN DE GASTROENTEROLOGIE 2012; 25:627-33. [PMID: 22059171 DOI: 10.1155/2011/174163] [Citation(s) in RCA: 24] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Abstract
BACKGROUND The increasing incidence of obesity and overweight among children and adolescents will be reflected by the imminent increase in the number of obese patients who require more definitive methods of treatment. There is great interest in new, safe, simple, nonsurgical procedures for weight loss. OBJECTIVE To provide an overview of new endoscopic methods for the treatment of obesity. METHODS An English-language literature search on endoscopic interventions, endoscopically placed devices and patient safety was performed in the MEDLINE and Cochrane Library databases. RESULTS The literature search yielded the following weight loss methods: space-occupying devices (widely used), gastric capacity reduction, modifying gastric motor function and malabsorptive procedures. A commercially available intragastric balloon was the most commonly used device for weight loss. In specific subgroups of patients, it improved quality of life, decreased comorbidities and served as a bridge to surgery. More evidence regarding the potential benefits and safety of other commercially available intragastric balloons is needed to clarify whether they are superior to the most commonly used one. Moreover, early experiences with transoral gastroplasty, the duodenal-jejunal bypass sleeve and an adjustable, totally implantable intragastric prosthesis, indicate that they may be viable options for obesity treatment. Other agents, such as botulinum toxin and a device known as the 'butterfly', are currently at the experimental stage. CONCLUSION New endoscopic methods for weight loss may be valuable in the treatment of obesity; however, more clinical experience and technical improvements are necessary before implementing their widespread use.
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Verdam FJ, Schouten R, Greve JW, Koek GH, Bouvy ND. An update on less invasive and endoscopic techniques mimicking the effect of bariatric surgery. J Obes 2012; 2012:597871. [PMID: 22957215 PMCID: PMC3432381 DOI: 10.1155/2012/597871] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/20/2012] [Revised: 04/02/2012] [Accepted: 04/30/2012] [Indexed: 12/11/2022] Open
Abstract
Obesity (BMI 30-35 kg/m(2)) and its associated disorders such as type 2 diabetes, nonalcoholic fatty liver disease, and cardiovascular disease have reached pandemic proportions worldwide. For the morbidly obese population (BMI 35-50 kg/m(2)), bariatric surgery has proven to be the most effective treatment to achieve significant and sustained weight loss, with concomitant positive effects on the metabolic syndrome. However, only a minor percentage of eligible candidates are treated by means of bariatric surgery. In addition, the expanding obesity epidemic consists mostly of relatively less obese patients who are not (yet) eligible for bariatric surgery. Hence, less invasive techniques and devices are rapidly being developed. These novel entities mimic several aspects of bariatric surgery either by gastric restriction (gastric balloons, gastric plication), by influencing gastric function (gastric botulinum injections, gastric pacing, and vagal nerve stimulation), or by partial exclusion of the small intestine (duodenal-jejunal sleeve). In the last decade, several novel less invasive techniques have been introduced and some have been abandoned again. The aim of this paper is to discuss the safety, efficacy, complications, reversibility, and long-term results of these latest developments in the treatment of obesity.
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Affiliation(s)
- Froukje J. Verdam
- Department of General Surgery, Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands
| | - Ruben Schouten
- Department of Surgery, Bariatric Centre Lievensberg Hospital, P.O. Box 135, 4600 AC Bergen op Zoom, The Netherlands
| | - Jan Willem Greve
- Department of General Surgery, Atrium Medical Parkstad Centre, 6401 CX Heerlen, The Netherlands
| | - Ger H. Koek
- Department of Gastroenterology, Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands
| | - Nicole D. Bouvy
- Department of General Surgery, Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands
- *Nicole D. Bouvy:
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Osio M, Mailland E, Muscia F, Nascimbene C, Vanotti A, Bana C, Corsi F, Foschi D, Mariani C. Botulinum neurotoxin-A does not spread to distant muscles after intragastric injection: A double-blind single-fiber electromyography study. Muscle Nerve 2010; 42:165-9. [PMID: 20564593 DOI: 10.1002/mus.21662] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/07/2022]
Abstract
The purpose of this study was to perform a careful neurophysiological examination to identify subclinical signs of botulinum toxin spread distant to the injection site following intragastric injection for obesity treatment. Single-fiber electromyography of extensor digitorum communis and repetitive stimulation of abductor digiti minimi were performed before and 8 days after multiple intragastric injections of botulinum toxin A (Botox, 200 U per patient) or placebo. The study was performed in a randomized double-blind fashion. No patient in either group displayed results indicative of neuromuscular dysfunction either before or after the treatment. No significant change in muscle jitter was observed when comparing baseline with the after-treatment evaluation in either group, and no significant differences between groups were observed. After intragastric botulinum toxin injection no subclinical sign of distant spread was observed.
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Affiliation(s)
- Maurizio Osio
- Clinica Neurologica, Università degli Studi di Milano, Luigi Sacco Hospital, via G.B. Grassi, 74, (IT)-20157 Milan, Italy.
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Foschi D, Lazzaroni M, Sangaletti O, Corsi F, Trabucchi E, Bianchi Porro G. Effects of intramural administration of Botulinum Toxin A on gastric emptying and eating capacity in obese patients. Dig Liver Dis 2008; 40:667-72. [PMID: 18420471 DOI: 10.1016/j.dld.2008.02.040] [Citation(s) in RCA: 26] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/18/2007] [Revised: 02/17/2008] [Accepted: 02/18/2008] [Indexed: 02/08/2023]
Abstract
BACKGROUND Intraparietal gastric administration of Botulinum Toxin A has been studied in open trials to induce satiety and increase weight loss of obese patients with contradictory results. In previous studies only the antrum was the target for Botulinum Toxin A, whereas the fundus, which exerts important activity on gastric accommodation, was excluded. In this study we report the effects of injection into both gastric regions on solid gastric capacity and emptying of the stomach. MATERIALS AND METHODS In this study we extended our previous investigations to include 30 obese patients who received Botulinum Toxin A (120 U into the antrum and 80 U into the fundus) or saline by intraparietal endoscopic injection. The two groups were homogeneous for age, gender, body weight and body mass index. Body weight and body mass index, solid gastric emptying (T(1/2) and T(lag) at the octanoic acid breath test) and maximal gastric capacity for solids (kcal) were determined before injection and 2 months later. The results were expressed as mean values (S.E.M.). t-Test or Wilcoxon test was used for statistical analysis, p<0.05 being considered significant. RESULTS Both treatments induced a significant reduction of body weight and body mass index but Botulinum Toxin A exerted a significantly greater effect (body weight -11.8+/-0.9 kg vs. -5.5+/-1.1 kg, p<0.0002; body mass index -4.1+/-0.2 vs. -2.2+/-0.4, p<0.001). The maximal gastric capacity for solids was also reduced by both Botulinum Toxin A and placebo, the former being significantly more effective (679+/-114 kcal vs. 237+/-94 kcal, p<0.008). Botulinum Toxin A also significantly increased T(1/2) from 83.4+/-3.9 to 101.6+/-9.9 min, p<0.03) but T(lag) was unchanged. Placebo had no effect on either of these parameters. CONCLUSIONS Our results demonstrated that Botulinum Toxin A makes weight loss easier in obese patients. It acts by increasing the solid gastric emptying time and reducing the solid eating capacity of the stomach.
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Affiliation(s)
- D Foschi
- Department of Clinical Sciences, L Sacco Hospital, University of Milan, Milan, Italy.
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Garcia-Compean D, Garza HM. Intragastric injection of botulinum toxin for the treatment of obesity. Where are we? World J Gastroenterol 2008; 14:1805-9. [PMID: 18350615 PMCID: PMC2700424 DOI: 10.3748/wjg.14.1805] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
Obesity has reached epidemic proportions particularly in western countries. Most non-surgical treatments of this condition are disappointing. Since 2005, several studies evaluating the effect of Botulinum Toxin type A (BT-A) in gastric antrum by means of endoscopy for the treatment of obesity have been published. This treatment modality was based on the observation that gastric injection of BT-A in laparatomized rats induced a significant reduction of food intake and body weight. Nowadays, 6 studies have been published yielding conflicting results. Differences in selection of patients, doses of BT-A, method of administration of the toxin and instruments of evaluation of some parameters among these studies may be the cause of divergent results. We discuss herein some important features of these studies pointing out on differences among them. At the same time, based on the knowledge of physiological characteristics of normal and abnormal gastric function related with feeding, we discuss the probable causes of failure observed in these trials. Finally, we give some guidelines concerning the way that future research in this field may follow, not without calling attention to disadvantages of this treatment.
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Topazian M, Camilleri M, De La Mora-Levy J, Enders FB, Foxx-Orenstein AE, Levy MJ, Nehra V, Talley NJ. Endoscopic ultrasound-guided gastric botulinum toxin injections in obese subjects: a pilot study. Obes Surg 2008; 18:401-7. [PMID: 18286347 DOI: 10.1007/s11695-008-9442-x] [Citation(s) in RCA: 26] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/10/2007] [Accepted: 01/17/2008] [Indexed: 12/27/2022]
Abstract
BACKGROUND Gastric injections of botulinum toxin A (BTA) may induce changes in gastric emptying and body weight, but results vary. BTA dose and depth of injection may affect efficacy. This study assessed changes in gastric emptying, satiation, symptoms, and body weight after endoscopic ultrasound (EUS)-guided injection of 100 or 300 U BTA into gastric antral muscularis propria of obese subjects. METHODS Open label study of ten healthy, obese adults (age = 29-49 years, body mass index = 31-54 kg/m(2)) who received 100 U (n = 4) or 300 U (n = 6) BTA and were followed for 16 weeks. Measures included gastric emptying of solids (by scintigraphy), satiation (by maximum tolerated volume [MTV] during nutrient drink test), gastrointestinal symptoms (by the Gastrointestinal Symptom Rating Scale), caloric intake (by food frequency questionnaire), and body weight. RESULTS For the entire cohort, MTV decreased from 1,380 cc (range: 474-2,014) at baseline to 620 cc (range: 256-1,180) 2 weeks after BTA injection; decreases were statistically significant in the subjects receiving 300 U BTA (p = 0.03). Average body weight loss was 4.9 (+/-6.3) kg after 16 weeks. Gastric emptying T(1/2) was prolonged in the 300 U BTA group, but not significantly different from baseline (p = 0.17). BTA injections were well tolerated without significant adverse effects. CONCLUSION EUS-guided injection of BTA into gastric muscularis propria can be performed safely with minimal adverse effects. A dose of 300 U BTA significantly enhances satiation, is associated with weight loss, and may slow gastric emptying. Further study of higher dose BTA in obese subjects is warranted.
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Affiliation(s)
- Mark Topazian
- Miles and Shirley Fiterman Center for Digestive Diseases, Department of Medicine, Division of Gastroenterology and Hepatology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA.
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Foschi D, Corsi F, Lazzaroni M, Sangaletti O, Riva P, La Tartara G, Bevilacqua M, Osio M, Alciati A, Bianchi Porro G, Trabucchi E. Treatment of morbid obesity by intraparietogastric administration of botulinum toxin: a randomized, double-blind, controlled study. Int J Obes (Lond) 2006; 31:707-12. [PMID: 17006442 DOI: 10.1038/sj.ijo.0803451] [Citation(s) in RCA: 53] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
OBJECTIVE The stomach is the main target organ for bariatric surgery, but no medical treatment has been developed to increase satiety and decrease food intake via gastric pathways. The aim of our study was to investigate whether or not the intraparietogastric administration of botulinum toxin A (BTX), able to modify the motility patterns of the stomach, could be useful for treatment of obesity. DESIGN Double blind controlled study. SUBJECTS Twenty-four morbidly obese patients (mean weight (s.e.m.) 116.1+/-4.89 kg, mean body mass index (BMI) 43.6+/-1.09 kg/m(2)) were blindly randomized to receive 200 IU BTX or placebo into the antrum and fundus of the stomach by intraparietal endoscopic administration. MEASUREMENTS We evaluated weight loss, BMI changes, satiety score, the maximal gastric capacity for liquids and the gastric emptying time (octanoic acid breath test). RESULTS The two groups were homogeneous for anthropometric characteristics. Eight weeks after treatment, BTX patients had significantly higher weight loss (11+/-1.09 vs 5.7+/-1.1 kg, P<0.001) and BMI reduction (4+/-0.36 vs 2+/-0.58 kg/m(2), P<0.001) and a higher satiety score on a visual analogic scale (7.63+/-0.38 vs 4.72+/-0.44, P<0.001) than controls. Furthermore, BTX patients showed a significantly greater reduction in maximal gastric capacity for liquids (266.6+/-48 vs 139+/-31, P<0.001) and a greater prolongation in gastric emptying time (+18.93+/-8 vs -2.2+/-6.9 min, P<0.05). No significant side effects or neurophysiologic changes were found. CONCLUSIONS Topical intragastric BTX was effective in reducing food intake and body weight in morbidly obese patients.
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Affiliation(s)
- D Foschi
- I Unit of Surgery, Department of Clinical Sciences L Sacco, San Siro Clinical Institute, University of Milan, Milan, Italy.
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Abstract
Botulinum toxin for facial enhancement is currently the most popular aesthetic procedure performed in the United States. New developments have occurred within the last few years. Patients prefer having multiple areas of the upper face treated which increases patient satisfaction. Treatment of the forehead is now being accomplished with fewer units of botulinum toxin. This helps preserve the natural look of some movement of the forehead. Men require more units of botulinum toxin than women. Combination therapy using botulinum toxin along with lasers or filler substances is ideal. Aesthetic medicine knowledge has progressed, contributing a greater understanding of botulinum treatment for advanced areas of the face. The orbicularis oris, mentalis, and depressor anguli oris are now routinely treated and help improve overall facial appearance. Other forms of botulinum toxins (additional type A or type B toxins) are available, each with advantages and disadvantages.
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Vittal H, Pasricha PF. Botulinum toxin for gastrointestinal disorders: therapy and mechanisms. Neurotox Res 2006; 9:149-59. [PMID: 16785113 DOI: 10.1007/bf03033934] [Citation(s) in RCA: 16] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/09/2023]
Abstract
Botulinum toxin has gained widespread acceptance as a treatment option for various spastic gastrointestinal disorders such as achalasia, gastroparesis, sphincter of Oddi dysfunction, chronic anal fissures, and pelvic floor dyssnergia, despite the lack of strong evidence supporting its use in many of these diseases. This review summarizes the trials investigating the use of BoNT since it was first utilized as a treatment in achalasia. BoNT has proven to be safe, but long-term efficacy in many disorders has not been observed, primarily due to is relatively short duration of action. BoNT may be most useful in confirming a diagnosis which can lead to a more definitive treatment modality. Furthermore, its safety profile allows it to be a useful alternative in patients who are at high risk for invasive procedures.
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Affiliation(s)
- H Vittal
- Enteric Neuromuscular Disorders and Pain (END Pain) Program, Division of Gastroenterology and Hepatology, University of Texas Medical Branch, Galveston, 77555-0764, USA
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