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The Treatment of Diabetic Gastroparesis with Botulinum Toxin Injection of the Pylorus

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The Treatment of Diabetic Gastroparesis with Botulinum Toxin Injection of the Pylorus Emerging Treatments and Technologies ORIGINAL ARTICLE The Treatment of Diabetic Gastroparesis With Botulinum Toxin Injection of the Pylorus 1 1 BRIAN E. LACY, PHD, MD CAROLE MATHIS, PHD though all of these medications have lim- 2 3 MICHAEL D. CROWELL, PHD PANKAJ J. PASRICHA, MD itations. Pylorospasm is thought to be a 2 ANN SCHETTLER-DUNCAN, RN contributing factor in the development of diabetic gastroparesis (9). Reports of in- trapyloric botulinum toxin injection to re- lieve symptoms of gastroparesis (10–14) prompted us to perform a trial in eight OBJECTIVE — Gastroparesis is a disorder of delayed gastric emptying that is often chronic in patients with severe diabetic gastroparesis nature. Up to 50% of type 1 diabetic subjects have symptoms of gastroparesis, which include who had failed standard therapy. nausea, vomiting, and early satiety. Elevated pyloric pressures may be responsible for delayed The hypothesis was that elevated py- gastric emptying in diabetic subjects. Botulinum toxin inhibits the release of acetylcholine and produces transient paralysis when injected into smooth muscle. The aim of this study was to loric pressures delay gastric emptying, determine whether injection of the pylorus with botulinum toxin in patients with diabetic and thus transient paralysis of the pylorus gastroparesis improves symptoms of gastroparesis, alters gastric emptying scan time, and/or should accelerate gastric emptying and changes weight and insulin use. improve symptoms of nausea and vomit- ing. Preliminary data from this study was RESEARCH DESIGN AND METHODS — This was an open-label trial with age- and presented in abstract form at the Ameri- sex-matched control subjects from a tertiary care referral center for patients with gastroparesis. can College of Gastroenterology meetings Eight type 1 diabetic subjects (six women and two men; mean age 41 years; mean years with in September 2000 (12). diabetes 25.3) who had failed standard therapy were enrolled. Intervention consisted of injection of the pylorus with 200 units of botulinum toxin during upper endoscopy. Symptoms, antro- pyloric manometry, gastric emptying scan times, weight, and insulin use were all recorded before intervention and during a 12-week follow-up period. RESEARCH DESIGN AND METHODS — Pylorospasm was first RESULTS — Seven of the eight patients completed the full 12-week follow-up period. No documented by comparing antropyloric complications were noted. Mean symptom scores declined from 27 to 12.1 (P Ͻ 0.01), whereas manometry findings between diabetic pa- the SF-36 physical functioning domain also improved (P Ͻ 0.05). Four patients noted an tients and age- and sex-matched healthy increase in insulin use of Ͼ5 units/day. Six of the seven patients gained weight (P ϭ 0.05). volunteers. Pylorospasm was not present Gastric emptying scan time improved in four patients. in any of the volunteers. Using a prospec- tive, open-label design, diabetic patients CONCLUSIONS — Botulinum toxin injection of the pylorus is safe and improves symptoms with severe gastroparesis were treated in patients with diabetic gastroparesis. These results warrant further investigation with a large, double-blind, placebo-controlled trial. with intrapyloric injections of botulinum toxin. Effectiveness was assessed by com- Diabetes Care 27:2341–2347, 2004 paring symptoms, weight, insulin use, gastric emptying, and antropyloric ma- nometry recordings at baseline and after botulinum toxin injection. astroparesis is a disorder of gastro- gastric pain. Gastroparesis is a common Eight patients with type 1 diabetes intestinal motility defined as a delay problem in type 1 diabetic subjects (1,2), (six women and two men) were enrolled in gastric emptying in the absence especially in the presence of hyperglyce- G in this study. The mean age was 41 years of mechanical obstruction. Common mia (3). Treatment options include eryth- (range 36–46), with a mean duration of symptoms include early satiety, nausea, romycin (4,5), metoclopramide (6), diabetes of 25.3 years (range 10–40) and vomiting, anorexia, weight loss, and epi- domperidone (7), and cisapride (8), al- mean insulin use of 24.4 years (range 10– ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● 40). All patients had been referred to the From the 1Marvin M. Schuster Center for Digestive and Motility Disorders, Johns Hopkins University, School Marvin M. Schuster Motility Center for of Medicine, Baltimore, Maryland; 2Novartis, East Hanover, New Jersey; and the 3University of Texas at further evaluation due to persistent symp- Galveston, Galveston, Texas. toms of gastroparesis despite the use of Address correspondence and reprint requests to Brian E. Lacy, PhD, MD, Dartmouth-Hitchcock Medical Center, Section of Gastroenterology, 1 Medical Center Dr., Lebanon, NH 03756. E-mail: standard medications. Mechanical ob- [email protected]. struction had been ruled out in all pa- Received for publication 26 March 2004 and accepted in revised form 28 June 2004. tients by the referring physicians using a P.J.P. is a paid consultant for Allergan. number of different tests (upper endos- Abbreviations: LES, lower esophageal sphincter. A table elsewhere in this issue shows conventional and Syste`me International (SI) units and conversion copy [esophagogastroduodenoscopy], factors for many substances. small bowel follow-through, and com- © 2004 by the American Diabetes Association. puted tomography scan of the abdomen DIABETES CARE, VOLUME 27, NUMBER 10, OCTOBER 2004 2341 Botulinum toxin for diabetic gastroparesis and pelvis). A solid-phase gastric empty- Four side holes located at 0, 3, 6, and 9 Symptom questionnaires and ing scan was delayed in all eight patients. cm above the orad end of the sleeve re- weights The control group consisted of age- corded pressure events in the terminal Each patient filled out a symptom ques- and sex-matched control subjects with- and proximal antrum, respectively. The tionnaire (see APPENDIX). Each question out diabetes and without any complaints remaining side hole was located 1 cm dis- asked the patient to rate symptoms from referable to the gastrointestinal system. tal to the aboral end of the sleeve and re- none (0 points) to severe (3 points); the Exclusion criteria for both groups were as corded duodenal pressure events. The maximum score was 36. Patients com- follows: pregnancy; known allergy to manometry assembly was perfused with pleted two standardized questionnaires, eggs, botulinum toxin, or lidocaine; pre- distilled water using a low-compliance SF-36 and SCL-90, at the initiation and vious surgery to the stomach, pylorus, or pneumohydraulic pump (Mui Scientific, completion of the study. Questionnaires small bowel; previous Nissen fundoplica- Ontario, Canada) with a flow rate of 0.8 were included in this study because the tion or other antireflux surgery; known ml/min. After preamplification and low U.S. Food and Drug Administration now pyloric stricture; previous stroke, tran- pass filtration (PC Polygraf HR; Synectics recommends that subjective measures be sient ischemic attack, or chronic diseases Medical, Stockholm, Sweden), pressure included as either primary or secondary involving the central nervous system; events were digitized at 16 Hz on a micro- end points in studies of gastrointestinal concurrent use of opiates or anticholin- computer (Polygram Upper GI Edition; disorders. Patients were asked to record ergics. Women of child-bearing age had Synectics Medical). daily insulin use and to monitor the need both urine and serum human chorionic After topical anesthesia (2% lidocaine for additional insulin. Weights were mea- gonadotropin checked to ensure that they HCl; AstraZeneca, Wilmington, DE) to sured at the initiation of the protocol and were not pregnant before testing and the nose, the catheter assembly was posi- at routine follow-up after treatment. treatment. Prokinetic and antiemetic tioned across the pylorus using fluoro- agents were continued during the trial; scopic guidance. Accommodation time of however, new medications were not initi- ϳ1 h occurred before obtaining3hof Laboratory studies ated during the trial. All patients stayed recordings in a fasting state. The patient A complete blood count, blood urea ni- on a gastroparesis diet (small frequent was then fed a standard liquid meal (Pul- trogen, creatinine, fasting glucose, HbA1c, meals low in both fat and fiber). This pro- mocare; Ross Products, Columbus, OH) albumin, and urinalysis were checked be- tocol was approved by the Institutional (837 ml; 355 kcal; 16.7% protein, 28.2% fore enrollment and again at 8 weeks after Review Board of Johns Hopkins Bayview fat, 55.1% carbohydrate), and recordings injection. Medical Center. were continued for another 2 h. To min- imize exacerbation of gastroparesis (2), Injection of the pylorus Gastric emptying scans blood glucose was monitored during the After informed consent, patients under- Gastric emptying scans were performed test, and insulin or glucose was provided went esophagogastroduodenoscopy to in an identical manner both before and 1 to maintain serum glucose between 80 rule out mechanical obstruction. All pro- week after botulinum toxin injection to and 150 mg/dl. Antropyloric manometry cedures were performed by one physician objectively measure changes in gastric was performed in an identical manner in (B.E.L.). Two hundred units of botulinum emptying. After an overnight fast, patients the week before and 1 week after injection toxin A (Botox; Allergan, Irvine, CA) were were given a standard
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