Treatment of morbid obesity by intraparietogastric administration of botulinum toxin: a randomized, double-blind, controlled study

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.) 116.174.89 kg, mean body mass index (BMI) 43.671.09 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 (1171.09 vs 5.771.1 kg, Po0.001) and BMI reduction (470.36 vs 270.58 kg/m 2 , Po0.001) and a higher satiety score on a visual analogic scale (7.6370.38 vs 4.7270.44, Po0.001) than controls. Furthermore, BTX patients showed a significantly greater reduction in maximal gastric capacity for liquids (266.6748 vs 139731, Po0.001) and a greater prolongation in gastric emptying time ( þ 18.9378 vs À2.276.9 min, Po0.05). 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.

Endoscopic Ultrasound-Guided Gastric Botulinum Toxin Injections in Obese Subjects: A Pilot Study

“…The average body weight loss after BTA injection in this study compares favorably to that obtained with pharmacologic interventions for obesity [26,27], but was less than the 11-kg body weight loss reported in one recent double-blind randomized trial of gastric BTA injections [11]. We noted that gradual body weight loss continued throughout the 16 week study period, and satiation was increased at 16 weeks compared to baseline.…”

“…Most open-label studies and two randomized trials exploring doses of 100 to 300 U showed little effect of gastric BTA injections [5,6,8,9,24], although a randomized, placebo-controlled trial of 200 U BTA demonstrated increased satiety in response to a standard meal, delayed gastric emptying, decreased maximal gastric capacity, and increased weight loss when compared to saline control [11]. Potential explanations for these discordant results include not only BTA dose but also depth of injection into the gastric wall.…”

“…Subsequent open-label human studies and three small randomized trials have reported conflicting results, with some studies finding little or no body weight loss after gastric BTA injection [5][6][7][8][9][10], and one randomized controlled trial showing statistically significant decreases in gastric emptying and body weight [11]. These trials differed in BTA dose (100 to 300 U in Botox formulation equivalents) and location of injections (antrum alone vs. antrum, body, and cardia).…”

Updates on gastric electrical stimulation to treat obesity: Systematic review and future perspectives

“…All these data suggest that reducing gastric emptying could be beneficial for weight loss in patients who follow a strict hypocaloric diet. Modulation of gastric motility could well be a potential target to treat obesity and can be achieved through several means such as volume-occupying devices, intraparietal botox injection and induction of stomach "stiffness" [46][47][48][49] . Gastric electrical stimulation (GES) or gastric pacing data from animal models and preliminary data from human trials suggest that the gut-brain axis plays a role in the GES mechanism.…”

Intragastric injection of botulinum toxin for the treatment of obesity. Where are we?

“…In the last two years, 6 studies evaluating this novel treatment have been published [23][24][25][26][27][28] . Three were open pilot and 3 were randomized double blind controlled trials (one of them performed by our group [23] ) of which in only one, beneficial effect of BT-A on body weight reduction was observed [27] . Nevertheless, important differences among these studies deserve to be discussed in detail ( Table 1).…”