1. The Treatment of Diabetic Gastroparesis With Botulinum Toxin Injection of the Pylorus Brian E. Lacy, PHD, MD, Michael D. Crowell, PHD, Ann Schettler-Duncan, RN, Carole Mathis, PHD and Pankaj J. Pasricha, MD Diabetes Care 27:2341-2347, 2004

2. Background Gastroparesis is a disorder of gastrointestinal motility defined as a delay in gastric emptying in the absence of mechanical obstruction. Common symptoms include early satiety, nausea, vomiting, anorexia, weight loss, and epigastric pain. Treatment options include erythromycin, metoclopramide, domperidone, and cisapride. Pylorospasm is thought to be a contributing factor in the development of diabetic gastroparesis.

3. Design 8 patients with type 1 diabetes(6 women / 2 men) mean age : 41 years (range 36–46) mean duration of diabetes : 25.3 years (range 10–40) mean insulin use : 24.4 years (range 10–40) The control group consisted of age- and sex-matched control subjects without diabetes and without any complaints referable to the gastrointestinal system

4. Design Effectiveness Gastric emptying scans Antropyloric manometry Symptom questionnaires Weights Insulin use

5. Method Gastric emptying scans were performed in an identical manner both before and 1 week after botulinum toxin injection. Images were taken every minute for a minimum of 120 min using a gamma camera. Symptom questionnaires and weights. SF-36 and SCL-90 Each question asked : none (0 points) to severe (3 points). Patients were asked to record daily insulin use and to monitor the need for additional insulin. Weights were measured at the initiation of the protocol and at routine follow-up after treatment.

6. Method Antral and pyloric intraluminal pressures were recorded using a manometric assembly. Antropyloric manometry was performed in an identical manner in the week before and 1 week after injection of the pylorus with botulinum toxin. insulin or glucose was provided to maintain serum glucose between 80 and 150 mg/dl. Pyloric pressure activity was classified into one of three groups. Tonic pattern : baseline elevation of the pyloric pressure wave >3 mmHg for >1 min. Phasic pattern : antral-type phasic pressure activity mixed with duodenal phasic activity. Combined tonic-phasic pattern : phasic pattern superimposed on tonic activity.

7. Method Injection of the pylorus EGD to rule out mechanical obstruction. Performed by one physician. Two hundred units of botulinum toxin A. Patients were seen in follow-up at 1, 2, 4, 6, 8, and 12 weeks after the injection therapy. Statistics Pre- and postinjection weights Gastric emptying scan times Symptom scores SF-36, and SCL-90 data were compared Pyloric manometry was analyzed by comparing the area under the curve in the pre- and postinjection period

8. Result

9. Result Symptoms SF-36 : total scores did not change significantly(subscores for the physical functioning domain improved. SCL-90 : no significant differences. Gastric emptying scans Mean solid-phase (before injection) : 339.1 min (range 74–999). Mean solid-phase (1 week after injection) : 227.3 min (range 74–906). Antropyloric manometry pylorospasm was significantly reduced compared with baseline

10. Result

11. Result

12. Result Insulin use 3 patients : at least 5 units more of NPH insulin Medication use 3 patients stoped or decreased 5 patients remained on the same dose Weight 7patients : gained 1patient : no change Complication No complication

13. Conclusions Botulinum toxin injection of the pylorus Safe. Improves symptoms in patients with diabetic gastroparesis.