Martin J. Collen

Double-blind controlled trial of the Garren-Edwards gastric bubble: An adjunctive treatment for exogenous obesity

Since its approval by the Food and Drug Administration in September 1985, the Garren-Edwards gastric bubble has been extensively used as an adjunct to diet and behavioral modification in the treatment of exogenous obesity. In an attempt to evaluate the efficacy of the Garren-Edwards gastric bubble, a double-blind crossover study was undertaken. Ninety patients were randomized into three groups: bubble-sham, sham-bubble, and bubble-bubble in two successive 12-wk periods. Sixty-one patients completed the entire 24-wk study. All groups participated in ongoing diet and behavioral modification therapy in a free-standing obesity program, the members of which were blinded to randomization arms. All patient groups lost weight during this study. The mean cumulative weight loss in pounds at 12 wk was as follows: bubble-sham = 19, sham-bubble = 12, and bubble-bubble = 8; and at 24 wk: bubble-sham = 23, sham-bubble = 16, and bubble-bubble = 18. The mean cumulative change in body mass index (kg/m2) at 12 wk was as follows: bubble-sham = -3.1, sham-bubble = -2.3, and bubble-bubble = -2.9; and at 24 wk: bubble-sham = -3.1, sham-bubble = -3.0, and bubble-bubble = -3.3. Although weight loss occurred more consistently in patients with a Garren-Edwards gastric bubble, there were no significant differences between any of the three groups at 12 or 24 wk with respect to weight loss or change in body mass index. The major part of the weight loss noted during this study occurred during the first 12-wk period, irrespective of therapy (bubble or sham). Side effects observed during this study included gastric erosions (26%), gastric ulcers (14%), small bowel obstruction (2%), Mallory-Weiss tears (11%), and esophageal laceration (1%). We conclude that, in this study, the use of a Garren-Edwards gastric bubble did not result in significantly more weight loss than diet and behavioral modification alone in the management of exogenous obesity, and it may result in significant morbidity.

The effect of Zollinger-Ellison syndrome and omeprazole therapy on gastric oxyntic endocrine cells

In 1983, all trials of omeprazole in humans were stopped because rats given the drug developed gastric endocrine cell hyperplasia and carcinoid tumors. Further studies in rats showed that drug-induced achlorhydria and hypergastrinemia caused these changes. Because data in humans are limited, we compared the numbers of endocrine cells, as judged by silver staining (argyrophilia), in the gastric mucosa of patients with Zollinger-Ellison syndrome, who are hypergastrinemic, and in normogastrinemic patients with idiopathic acid-peptic diseases. In addition, we analyzed the number of gastric endocrine cells in patients with Zollinger-Ellison syndrome given omeprazole for up to 3 years. Patients with Zollinger-Ellison syndrome had 15.7% +/- 6.9% argyrophil cells in biopsies of gastric oxyntic mucosa, and patients with idiopathic acid-peptic disease had 7.8% +/- 2.3% (P less than 0.01). In patients with Zollinger-Ellison syndrome, the percentage of argyrophil cells was not related to serum gastrin concentration, duration of symptoms, time since diagnosis, basal or maximal acid output, extent of tumor, or age. There was a tendency for patients with multiple endocrine neoplasia type 1 to have a greater percent of argyrophil cells than patients with sporadic Zollinger-Ellison syndrome. Considering the biopsies from both normogastrinemic and hypergastrinemic patients, there was a significant relationship between the percentage of argyrophil cells and the serum concentration of gastrin (P less than 0.01). Patients with Zollinger-Ellison syndrome given omeprazole for up to 3 years developed no significant changes in percentage of argyrophil cells, no carcinoid tumors, and no changes in serum concentrations of gastrin. The present study shows that patients with Zollinger-Ellison syndrome have an increased percentage of argyrophil cells in oxyntic mucosa and that omeprazole does not increase this percentage. In periods of up to 3 years, omeprazole had no effects on gastric morphology in patients with Zollinger-Ellison syndrome.

Biphasic solid and liquid gastric emptying in normal controls and diabetics using continuous acquisition in LAO view.

The purpose of this study was to investigate the various phases of gastric emptying using a dual-isotope liquid-solid meal ([99mTc]Sc egg sandwich and [111In]DPTA in water) and continuous acquisition in the left anterior oblique view. The study groups consisted of 10 normal controls and 20 diabetics with symptoms suggestive of diabetic gastroparesis. Solid-phase emptying in both groups almost always had a lag phase followed by linear emptying. Liquid-phase emptying was biexponential in 4/10 normals and 12/20 diabetics, with a short early rapid emptying rate (meanT1/2=48 min in normals and 79 min in diabetics). Solid emptying was delayed in 10, normal in eight, and rapid in two diabetics. Liquid emptying was delayed in 9/10 diabetics who had delayed solid emptying. Diabetics as a group had a significantly delayed solid lag phase (P<0.025), rate of emptying (P<0.05) and percent emptying at 90 min (P<0.025) compared to normal controls. Diabetic liquid emptying was also significantly delayed (P<0.025). The second component of liquid emptying strongly correlated with the solid rate of emptying (r=0.826 in normals and 0.855 in diabetics). Continuous acquisition of gastric emptying studies in the LAO view has allowed us to better define the various phases of solid and liquid gastric emptying.

Limited benefit of atropine as premedication for colonoscopy

A prospective double-blind trial was performed comparing atropine (0.5 mg) by slow intravenous administration to placebo as premedication for colonoscopy, to assess the possible beneficial effects of this vagolytic agent on the performance and safety of the procedure. A total of 77 patients was randomly assigned to receive atropine (38 patients) or placebo (39 patients) before colonoscopy in conjunction with our standard initial medications for conscious sedation (meperidine, 0.4 mg/kg and midazolam, 0.03 mg/kg). Total procedure time was 31 min for the atropine group and 35 min for the placebo group (p greater than 0.05), and there was no overall difference in the total amount of intra-procedural medications required. No statistically significant differences were observed relative to the number or severity of vagal episodes, and neither the endoscopist nor the patients noted any differences in the ease or tolerance of the procedure (p greater than 0.05). Although these results fail to demonstrate a significant benefit of atropine when given routinely as premedication for colonoscopy, this study does not rule out the potential usefulness of atropine in counteracting vagal episodes when they occur.

Pharmacology of peptic ulcer disease

In this book the pathophysiology, diagnosis, and therapy of most aspects of peptic ulcer disease are examined in detail. Covered are the pharmacology of the parietal cell and the latest hypotheses for the development of acid-peptic disease including epidermal growth factor, gastrin and other peptide hormones, fatty acids and prostaglandins, helicobacter pylori, and gastric acid hypersecretion including Zollinger-Ellison syndrome. The book also deals with the newer antisecretory medication such as omeprazole with a review of H2-receptor antagonists. Rounding off the subject are chapters on gastroesophageal reflux disease, upper GI endoscopy, and video-endoscopy including digital imaging. This volume addresses a wide range of physicians who are interested in all aspects of acid-peptic disease. This handbook on pharmacology, toxicology, gastroenterology, internal medicine and biochemistry is intended for clinicians and researchers.

Success of Prolonged Therapy with the Somatostatin Analog, Octreotide Acetate, in Recalcitrant Enterocutaneous Fistulas

The somatostatin analog, octreotide acetate, has been reported to accelerate closure of enterocutaneous fistulas (ECF), and, if the closure does occur, it does so within 10 days of therapy. We report

The effect of the Garren-Edwards Gastric Bubble on solid and liquid gastric emptying

To determine the effect of the Garren-Edwards Gastric Bubble (GEGB) on gastric emptying, radionuclide solid and liquid gastric emptying in 12 obese patients prior to insertion of the GEGB was studied. Four were restudied at one and seven days and ten patients were restudied at twelve weeks with the GEGB in place. There were no significant differences in liquid gastric emptying at one and seven days nor in solid and liquid gastric emptying at twelve weeks. Solid gastric emptying was significantly decreased from a mean of 63% to 31% after one day (P < 0.05) and returned to preplacement baseline by seven days. These results indicate that gastric emptying is not significantly changed after twelve weeks with the GEGB in place. Therefore, the mechanism of action for weight reduction with the GEGB is not likely to be mediated by an effect on gastric emptying. However, the solid food-induced dyspeptic symptoms commonly noted 1-3 days after placement of the GEGB, which resolve within seven days, are probably explained by transiently delayed solid gastric emptying.

Use of endoscopic ultrasound in patients with esophageal motility disorders.

New technology has combined the endoscope with ultrasound in an effort to enhance the visualization of the gastrointestinal tract. With a modified standard endoscope that has an ultrasound transducer built into the tip, high frequency ultrasonic beams can be targeted in close proximity to existing lesions. This results in better quality resolution which enhances the evaluation of the targeted lesion. In addition, esophageal wall thickness can be evaluated and assessed as to its role in esophageal function.