Intragastric injection of botulinum toxin A for weight loss: A systematic review and meta‐analysis of randomized controlled trials

Yen, Yi-An; Wang, Chi‐Chih; Sung, Wen‐Wei; Fang, Kuan‐Chieh; Huang, Shih‐Ming; Lin, Chung‐Yen; Tsai, Ming‐Chang; Yang, Tzu‐Wei

doi:10.1111/jgh.15847

Cited by 13 publications

(11 citation statements)

References 54 publications

(116 reference statements)

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“…The cause of the severe adverse effects in the reported cases remains speculative. Yen et al reviewed six RCTs with 192 cases and identified doses of ≥200 MU Ona‐BoNT/A or Inco‐BoNT/A as adequate and safe for the intragastric injection, with the highest reported dose being 500 MU in one trial [1]. In our patients, 1500 MU of Abo‐BoNT/A had been applied.…”

Section: Discussionmentioning

confidence: 89%

“…However, not all eligible patients decide to undergo this invasive procedure. Endoscopic intragastric injection of botulinum neurotoxin A (BoNT/A) was proposed as an alternative obesity treatment, achieving weight loss by delayed gastric emptying and speeded satiety [1]. However, this approach lacks authorization by the European Medicines Agency.…”

Section: Introductionmentioning

confidence: 99%

“…Nonetheless, BoNT/A can safely and effectively treat disabling medical conditions with excessive muscular activity, such as dystonia or spasticity [2]. Studies on using intragastric injections of BoNT/A as obesity treatment have yielded conflicting results as reviewed in a current meta‐analysis, but this reported no serious adverse events [1].…”

Section: Introductionmentioning

confidence: 99%

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Botulism after intragastric botulinum toxin injections for weight reduction

Hennen

Demir

Dafsari

et al. 2023

Euro J of Neurology

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Although—considering the risk–benefit ratio—botulinum neurotoxin A (BoNT/A) is unequivocally recommended to treat severe neurological diseases such as dystonia, this has not yet been determined for its endoscopic intragastric injection aimed at weight reduction in obesity. However, severe adverse effects of intragastric BoNT/A had not yet been reported, prompting some European countries to endorse its (off‐label) use and treat patients transnationally. We here present three cases of botulism after intragastric BoNT/A injections for obesity treatment in a Turkish hospital. Patients presented with cranial nerve affection, bulbar symptoms, and descending paresis, and benefited from treatment with BoNT antitoxin and pyridostigmine. We assume that iatrogenic botulism was induced by overdosing in combination with toxin spread via the highly vascularized gastric tissue. Of note, within a few weeks, more than 80 cases of iatrogenic botulism were reported across Europe after identical intragastric BoNT/A injections. These cases demonstrate the risks of BoNT/A injections if they are not applied within the limits of evidence‐based medicine. There is a need for international guidelines to define the indication and a safe dosing scheme, especially in the context of medical tourism.

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Section: Discussionmentioning

confidence: 89%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Botulism after intragastric botulinum toxin injections for weight reduction

Hennen

Demir

Dafsari

et al. 2023

Euro J of Neurology

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“…IGBI doses ranged from 100 units to 500 units and were administered to the antrum; antrum and body; or antrum, body, and fundus of the stomach for a total tracked period from 5 to 24 weeks. In the five RCT groups, the percent of weight loss ranged from 4.9% to 9.0%, indicating that IGBI was effective [ 38 , 39 ].…”

Section: Discussionmentioning

confidence: 99%

Effect of Intragastric Botulinum Type A Injection Combined with a Low-Calorie High-Protein Diet in Adults with Overweight or Obesity

Hsu

Wang³

et al. 2022

JCM

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(1) Background/aims: Intragastric botulinum toxin A injection (IGBI) combined with diet control is a new and effective weight loss method for grade 2 obese patients. However, the application of IGIB on overweight or obese adults still needs further research to confirm its efficacy. (2) Methods: We retrospectively collected medical data from 1 July 2021 to 1 January 2022 from a total of 71 patients without diabetes who participated in the bariatric clinic with a body mass index (BMI) > 25 kg/m2. Forty-nine participants opted for intragastric botulinum injection (IGBI) using 300 units of botulinum injected into the antrum, body, and fundus, followed with a low-calorie high-protein diet course. Another 22 people participated only in the low-calorie high-protein diet course as a placebo group. This study analyzes the weight loss percentage of the two groups. Adverse events after IGBI are also reported in a safety assessment. (3) Results: In terms of the characteristics of the two groups, the mean BMI was 29.3 kg/m2 in the IGBI group and 28.0 kg/m in the placebo group (p = 0.63 without significant difference). Comparing the percent weight loss from baseline in the two groups after 12 weeks, the IGBI group lost 11.5% of their body weight and the placebo group lost 1.8%. In terms of group analysis, the percentages of participants with a weight reduction of at least 5% for the IGBI and placebo groups were 95% and 4%, respectively. For weight reduction of at least 10%, these values for the IGBI and placebo groups were 63% and 4%, respectively. In terms of adverse events after IGBI for 12 weeks, 12 participants (24.4%) had constipation, which was the main side effect. No serious adverse events were observed during the study period. (4) Conclusion: The combination of a low-calorie high-protein diet and IGBI is an effective and safe procedure in overweight or obese adults for weight reduction, but further larger studies are needed.

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“…In a recent systematic review and meta-analysis, IGBI in adequate doses (≥ 200 U) and multiple injections across the gastric various regions, was found to be effective in reducing weight when combined with diet control. [ 3 ] The exact mechanism for weight loss is unclear but is believed to be related to prolonging gastric half-emptying time.…”

mentioning

confidence: 99%