Magnetic Ring Helps Reduce Reflux in Patients With GERD
Feb 21, 2013
A magnetic device that improved the function of the lower esophageal sphincter helped to reduce patients' exposure to esophageal acid, improved their symptoms of gastroesophageal reflux disease (GERD), and reduced their reliance on proton-pump inhibitors, according to an industry-funded prospective study.
Robert A. Ganz, MD, from Minnesota Gastroenterology in Plymouth, and colleagues reported the 3-year results of their 5-year study online February 20 in the New England Journal of Medicine.
The device's manufacturer was involved in the design of the prospective, multicenter study. Thirteen centers in the United States and 1 in the Netherlands enrolled 100 patients aged 18 to 75 years with a 6-month history of GERD and partial response to proton-pump inhibitors in the first 9 months of 2009. The patients were fitted with bracelet-like magnetic beads that circled their lower esophageal sphincter and closed, using magnetic attraction, to aid the sphincter in resisting abnormal opening and subsequent reflux. The beads opened with food transport or increased pressure associated with burping or vomiting. Patients' proton-pump-inhibitor dose, frequency of use, quality of life, and foregut symptoms were recorded when the study began and 1 week, 3 months, 6 months, and annually after their operations.
"The primary efficacy end point, normalization of or at least a 50% reduction in esophageal acid exposure, was achieved in 64% of patients (64 of 100; 95% confidence interval [CI], 54 to 73)," Dr. Ganz and colleagues write. "The secondary efficacy end point, a 50% reduction in the quality-of-life score, as compared with the score without proton-pump inhibitors at baseline, was achieved in 92% of patients (92 of 100; 95% CI, 85 to 97)," the authors add.
In addition, after 3 years, 87% of the patients (72/83) had completely stopped using proton-pump inhibitors.
Promising, but Preliminary
Thomas M. Deas Jr, MD, MMM, president of the American Society for Gastrointestinal Endoscopy, told Medscape Medical News that the device appears to be minimally invasive and, depending on its long-term control of symptoms and additional confirmatory trials, could help to treat a condition that affects a growing number of patients. Dr. Deas was not involved in the study.
The study's objective measurement of reduction in acid exposure "was not as impressive" as the subjective measures of patients' symptoms, he says.
"The limitation there is this was not a randomized, controlled study," Dr. Deas told Medscape Medical News. "It's hard, without randomizing patients, to differentiate what is truly a benefit from the intervention and what is perhaps a placebo effect."
The study authors report that 6 patients suffered adverse effects serious enough to require device removal for 4 of them. Overall, device removal was required for 6 patients.
Study limitations included the lack of a control group and a study design that precludes direct comparisons with other therapies. The authors recommend follow-up prospective, randomized trials.
"[T]his single-group trial showed that a magnetic device designed to augment the lower esophageal sphincter can be implanted with the use of standard laparoscopic techniques," the authors conclude. "The device decreased exposure to esophageal acid, improved reflux symptoms, and allowed cessation of proton-pump inhibitors in the majority of patients."
Support for this study was provided by Torax Medical. Thirteen of the 15 study authors disclosed various financial relationships, including receiving institutional grants from, being paid consultants for, receiving travel support from, and owning stock or stock options in Torax Medical and being paid to participate in review activities or to implant the device and perform follow-up visits. One author also disclosed being a paid consultant for EndoGastric Solutions and Covidien. One author disclosed receiving a training fellowship from U.S. Surgical/Covidien. One author disclosed being a paid consultant for Medtronics and Novartis. One author disclosed being a paid consultant for Johnson & Johnson and receiving institutional payments and personal travel expenses for giving lectures for Johnson & Johnson and Lifecell. Four authors disclosed having or expecting personal or institutional grants from Accuray, Covidien, EndoGastric Solutions, GlaxoSmithKline, Johnson & Johnson, Nutricia, Precision Therapeutics, Synovix, and VisionGate. Dr. Deas has disclosed no relevant financial relationships.
N Engl J Med. Published online February 20, 2013. Abstract
I think you mean - "gastroesophageal reflux disease" commonly refereed to as "acid reflux disease".
"Gastroesophageal reflux disease
Peptic esophagitis; Reflux esophagitis; GERD; Heartburn - chronic; Dyspepsia - GERD
Last reviewed: August 11, 2011.
Gastroesophageal reflux disease (GERD) is a condition in which the stomach contents (food or liquid) leak backwards from the stomach into the esophagus (the tube from the mouth to the stomach). This action can irritate the esophagus, causing heartburn and other symptoms.
Causes, incidence, and risk factors
When you eat, food passes from the throat to the stomach through the esophagus (also called the food pipe or swallowing tube). Once food is in the stomach, a ring of muscle fibers prevents food from moving backward into the esophagus. These muscle fibers are called the lower esophageal sphincter, or LES.
If this sphincter muscle doesn't close well, food, liquid, and stomach acid can leak back into the esophagus. This is called reflux or gastroesophageal reflux. Reflux may cause symptoms, or it can even damage the esophagus.
The risk factors for reflux include:
Hiatal hernia (a condition in which part of the stomach moves above the diaphragm, which is the muscle that separates the chest and abdominal cavities)
More common symptoms are:
Feeling that food is stuck behind the breastbone
Heartburn or a burning pain in the chest (under the breastbone)
Increased by bending, stooping, lying down, or eating
More likely or worse at night
Relieved by antacids
Nausea after eating
Less common symptoms are:
Bringing food back up (regurgitation)
Cough or wheezing
Hoarseness or change in voice
Signs and tests
You may not need any tests if your symptoms are not severe.
If your symptoms are severe or they come back after you have been treated, one or more tests may help diagnose reflux or any complications:
Esophagogastroduodenoscopy (EGD) is often used to find the cause and examine the esophagus (swallowing tube) for damage. The doctor inserts a thin tube with a camera on the end through your mouth. The tube is then passed into your esophagus, stomach, and small intestine.
Continuous esophageal pH monitoring
A positive stool occult blood test may diagnose bleeding that is coming from the irritation in the esophagus, stomach, or intestines...."
See the following link for more information.
The hospital told me it could be Gastroesophageal reflex disease???? Ring a bell?
I think you're doing the right thing.
Thank you Mike, the pain will not stop and im going to the E.R. today. Thanks again illl let you know what they say
Dark stools can be a result of internal bleeding. This can be a serious situation.
There are test kits available that claim to detect occult blood in the stool. These kits are for home use and are available at pharmacies or online. Amazon sells several different test kits. I have never used these and have no idea how accurate or sensitive they are. If I was worried I might try an at-home test.
And, of course you should definitely schedule an appointment with either your PCP or a gastroenterologist. You are having pain and that warrants professional attention. That would be my recommendation whether or not you do test with one of the home testing kits. The kit might tell you whether you're bleeding but it will not tell you the cause - if you are bleeding. And, if you're not bleeding you still have pain and that requires a physician's care.