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


METHODS
Double blind controlled study.


METHODS
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.


METHODS
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.
Foschi
D
D
I Unit of Surgery, Department of Clinical Sciences L Sacco, San Siro Clinical Institute, University of Milan, Milan, Italy. diego.foschi@unimi.it
Corsi
F
F
Lazzaroni
M
M
Sangaletti
O
O
Riva
P
P
La Tartara
G
G
Bevilacqua
M
M
Osio
M
M
Alciati
A
A
Bianchi Porro
G
G
Trabucchi
E
E
D000328:Adult; D015992:Body Mass Index; D049628:Body Size / Q000502:physiology; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D001944:Breath Tests / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D005746:Gastric Emptying / Q000502:physiology; D005748:Gastric Fundus; D005773:Gastroscopy; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D009767:Obesity, Morbid / Q000188:drug therapy* / Q000503:physiopathology; D011706:Pyloric Antrum; D012528:Satiety Response / Q000502:physiology; D013270:Stomach / Q000503:physiopathology; D016896:Treatment Outcome; D015431:Weight Loss / Q000502:physiology
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A