For them a little "plop, plop, fizz, fizz" or other over-the-counter remedy may bring quick relief.

But for the 14 million Americans who suffer from gastroesophageal reflux disease (GERD), a daily effort is required to keep this condition at bay. Now, researchers at Stanford and the Veterans Affairs Palo Alto Health Care System may be able to offer a new remedy.

Some 85 percent of patients with GERD have experienced relief and have been able to discontinue their daily medications after treatment with a new minimally invasive technique that Stanford and Palo Alto VA researchers are evaluating.

The technique uses radiofrequency energy to tighten the lower esophageal sphincter, a valve designed to prevent stomach acid and digestive enzymes from flowing backward from the stomach into the esophagus.

In people with reflux, this valve may be defective, allowing these irritating substances to drift into the throat and mouth, producing symptoms of chronic heartburn, persistent sore throat, regurgitation, difficulty swallowing, chronic cough, laryngitis, difficulty sleeping and even asthma.

Researchers have tested the approach on some 100 patients nationwide -- including 38 at Stanford -- with encouraging results, said David Utley, MD, clinical instructor of surgery at Stanford and the developer of the technique.

Among patients who have been followed for at least four months, 85 percent no longer take any medication for heartburn and have shown significant improvement in their quality of life, Utley said. Preliminary data suggest increased relief of symptoms in patients who have been followed for six months, he said.

"The advantage of the procedure is that it doesn't involve surgery," said George Triadafilopoulos, MD, a Stanford professor of medicine (gastroenterology) and the principal investigator in the clinical trial. "If it doesn't work, the procedure can be repeated or can be followed by surgery. It's cheaper, it (doesn't require hospitalization), it takes one hour and the patient can play golf the next morning."

Reflux is one of the most common and most costly conditions in the United States today, said Utley, an otolaryngologist and plastic and reconstructive surgeon. Some $7 billion is spent on antacids and other drugs to treat the symptoms of the disease, which is a condition found principally in Western nations.

Until recently, reflux sufferers have had to rely on medications or surgery to control the disease. They've also had to limit their activities, sleep with the upper body elevated and avoid consumption of fatty foods, chocolate, coffee, alcohol and other substances.

While medication may effectively squelch symptoms, it doesn't prevent the continued regurgitation of bile and digestive enzymes into the esophagus, which can cause further injury, Utley said. Moreover, most patients must contend with the need to take medications daily on a permanent basis, he said.

Some patients may opt for a one-time surgical procedure -- known as Nissen fundoplication -- in which doctors wrap a portion of the stomach around the esophagus, like a doughnut, to tighten the valve and prevent backflow into the esophagus. Although this four-hour procedure is done through a laparascope, requiring six tiny incisions in the stomach, it has the risks associated with general surgery and may result in complications, such as difficulty swallowing, Utley said.

Recognizing the limitations of current therapy, Utley approached Triadafilopoulos more than two years ago with the idea of strengthening the valve using radiofrequency energy. Utley had worked with Stanford colleagues who had effectively used this form of energy to reshape the tongue and soft palate to treat sleep apnea.

The two researchers brought Mark Vierra, MD, assistant professor of surgery, into the project and began by testing the approach in pigs. In November 1998, they applied the technique to their first patient under an approved Stanford Human Subjects Protocol.

After the investigators presented their preliminary results in May at the Digestive Disease Week conference, they began to receive calls from gastroenterologists around the country seeking to test the therapy at their own medical centers, Triadafilopoulos said.

The method is now being offered at 17 other sites in a multicenter clinical trial approved by the federal Food and Drug Administration, Utley said. All of the Stanford patients have been treated at the VA Palo Alto Health Care System, where Utley and Triadafilopoulos are based.

The procedure is performed much like a standard endoscopy, in which the patient remains awake but receives a mild sedative. Doctors insert a catheter, a small tube about the size of a pen, into the mouth and down into the esophagus and stomach.

The heat effectively tightens the valve to make it more resistant to reflux events, Utley said. Patients have experienced no significant complications, Triadafilopoulos said. A few patients have had mild difficulty swallowing or have experienced fevers -- symptoms that went away after a day, Utley said.

He said the technique is believed to work through several different mechanisms. It's thought that some patients experience reflux as a result of misfiring nerves in and around the sphincter that signal the brain to relax the muscle. Heat may disrupt those nerves and prevent these misguided signals from getting through, Utley said.

The technique also has been found to effectively shrink the collagen in the valve to make it tighter and less stretchy, he said. Through the natural process of wound healing, thermal hot spots also attract new collagen to the site so that by six months, the area is completely healed and the greatest improvement is seen, he said.

The investigators expect to follow patients for several years to see if the results hold up over time, Triadafilopoulos said.

The clinical trial is supported by Conway Stuart Medical in Sunnyvale, a company Utley founded to support the basic science research and development of the technique.

--30--dc/sf

CONTACT:

Stanford University Medical Center

Melodie Jackson, 650/723-5370 or 723-6911 (MEDIA)

(mjackson@stanford.edu)

To investigate the effectiveness of surgery, the team identified several hundred reports covering GER and asthma. They ultimately examined 24 studies involving 417 asthma patients. Pooled data showed that antireflux surgery improved GER symptoms in 90% of patients, asthma symptoms in 79%, asthma medication use in 88% and pulmonary symptoms in 27%.

The investigators point out that most of the included studies were uncontrolled and had other shortcomings. Nevertheless "...the summarized results are strikingly similar to findings of controlled studies of medical antireflux therapy in asthma."

Both medical and surgical antireflux therapy, they conclude, "...improve asthma symptoms and medication requirements, but not pulmonary function."

COX-2 inhibitors were designed as pain relievers that would not cause ulcers and related damage to the stomach and intestinal lining. Such damage is found in approximately 60 percent of people on long-term treatment with non-steroidal anti-inflammatory drugs — including aspirin and ibuprofen.

Some 12 million prescriptions for COX-2 inhibitors have been written so far this year. Additionally, the medications are being used as part of a drug therapy for some cancer patients.

But when researchers led by Dr. Andrzej Tarnawski, a professor of gastroenterology at the University of California, Irvine, College of Medicine, conducted tests on the tissue of rats, they discovered that the COX-2 inhibitors prevented angiogenesis — the development of certain blood vessels that are normally associated with inducing ulcer healing and helping the body to recover from injury.

The study is published in the December issue of Nature Medicine (medicine.nature.com).

"This finding raises concerns about prescribing COX-2 inhibitors to patients with existing gastrointestinal problems like gastric ulcers and erosion of the lining to protect the gastrointestinal tract," Tarnawski said. These drugs can "produce side effects by delaying healing of ulcers and other intestinal wounds."

Additional research has shown that angiogenesis also is significant in the growth and spread of cancerous tumors throughout the body. Researchers surmise that COX-2 inhibitors may halt angiogenesis and therefore be essential in preventing cancer.

However, Tarnawski found that angiogenesis was inhibited by both NS-398, an experimental COX-2 inhibitor, and indomethacin, an anti-arthritis drug that blocks COX-1 and COX-2 enzymes. This suggests that while either drug may be effective in combating arthritis pain, they also may create damage and prevent wound control in the stomach lining.

The researchers discovered that the pain medications inhibited angiogenesis by interfering with MAP kinase — an enzyme that acts as a messenger in many cells — bypassing both COX-1 and COX-2. MAP kinase activity has never before been associated with pain medications that target the COX-1 and COX-2 enzymes.

"We have demonstrated for the first time that COX-2 plays a crucial role in directly regulated angiogenesis," Tarnawski said. "These findings challenge the premise that selective COX-2 inhibitors will not affect the gastrointestinal tract and ulcer and wound healing,"

He added, however, that he hopes the research will lead to the development of new drugs that can prevent angiogenesis without causing damage to the gastrointestinal lining.

CHICAGO (AP) - Two new drugs relieve arthritis pain as well as traditional, less expensive medicine and are less likely to cause stomach ulcers, researchers reported today.

Experts said it is uncertain whether the extra safety is worth the drugs' higher cost.

The drugs, Celebrex and Vioxx, gained government approval in the past year, generating more than 16 million prescriptions. They cost about eight times as much as older arthritis drugs.

Studies published in today's Journal of the American Medical Association indicate the drugs act comparably to older medicines such as ibuprofen and naproxen in relieving arthritis pain but are far less likely to cause stomach ulcers, bleeding or intestinal obstructions.

One study analyzed eight trials involving 5,435 osteoarthritis patients and found that Vioxx, made by Merck and Co., was 50 percent less likely to cause gut perforations, ulcers and bleeding.

In the other study, involving 1,149 patients with rheumatoid arthritis, Celebrex, made by G.D. Searle & Co., provided comparable pain relief and only a 4 percent rate of tiny stomach sores. The ulcer rate for naproxen was 26 percent.

The studies were funded by the manufacturers and were part of the applications submitted to the Food and Drug Administration.

The new drugs improve on the older drugs, called nonsteroidal anti-inflammatory drugs, or NSAIDs, by acting more selectively. They inhibit only one form of a chemical that contributes to joint swelling but also protects the gut.

The older drugs help many of the estimated 19 million U.S. arthritis sufferers by relieving joint pain, but they also cause bleeding and other complications. An estimated 107,000 NSAID takers are hospitalized and 16,500 die yearly.

Adding such a protective medication drives the low cost of NSAIDs - 30 days of naproxen costs $9 - to as high as $125, said an editorial in JAMA. By contrast, 30 days of Celebrex or Vioxx usually runs $72 to $85.

Dr. Jeffrey Kotzan of The University of Georgia, in Athens, presented results of a 3-year retrospective study of 12,500 Medicaid recipients who were regular users of NSAIDs for osteoarthritis and a similar group of 12,500 controls who did not use NSAIDs. The research team analyzed patient records for signs and symptoms of GERD.

"GERD symptoms were twice as prevalent in the NSAID users," Dr. Kotzan told Reuters Health in an interview during the meeting. "A twofold difference is a very large difference with GERD."

The prevalence was as high as 6% in patients taking six or more NSAID prescriptions during the 3-year study period. Women were 57% more likely to develop GERD symptoms than men, and nonblacks were more likely to develop symptoms than blacks. It took at least 6 continuous months of NSAID use for the association with GERD to become evident.

Dr. Walter Peterson of the University of Texas-Southwestern discussed a case of upper GI bleeding secondary to Helicobacter pylori-related peptic ulcer disease and used an evidence-based approach to indicate appropriate medical therapy following endoscopic evaluation and treatment. He wanted to compare the incidence of further bleeding in those treated with H₂-blockers versus omeprazole following endoscopic treatment of a bleeding ulcer.

The first trial reviewed 220 patients with peptic ulcers that were actively bleeding or had a visible vessel or clot who were randomized to treatment with oral omeprazole or placebo. The patients were not treated endoscopically, although the study was blinded. Of those treated with placebo, 37 of 107 rebled from their ulcers versus 10 of 108 treated with the PPI. A second study reviewed involved 100 patients with bleeding ulcers or visible vessels successfully treated with endoscopic therapy who were randomly assigned to IV omeprazole or IV cimetidine. This study was not blinded. Rebleeding occurred in 12/50 of those receiving the H₂-receptor antagonist and 2/50 of those receiving the PPI. In a final, unpublished study reviewed by Dr. Peterson, 160 patients with ulcers either bleeding or associated with clot or visible vessels received IV omeprazole or placebo after successful endoscopic therapy. This study was performed in a blinded fashion. In those receiving placebo, 18/80 rebled versus 4/80 receiving the PPI.

Based upon these data, Dr. Peterson calculated that an absolute risk reduction of 44%, 28%, and 22% in those treated with some form of a PPI justified the use of these agents following endoscopic therapy for a bleeding ulcer. Even with a critical appraisal and lack of a perfect study on which to base recommendations, the lack of any effect from IV H₂-receptor antagonists, a possible effect from PPIs, and the minimal cost of 3 days of PPI therapy in this setting spoke strongly for their use.

"Stomach ulcers and other GI problems have been a concern for many Americans who treat their osteoarthritis with non-selective NSAIDs," says Dr. Dennis Jensen of the UCLA Center for Health Sciences and co-author of the paper. "In this study, Vioxx significantly reduced the occurrence of serious GI complications in osteoarthritis patients compared to other NSAIDs."

The analysis assessed the GI safety of Vioxx once-daily (12.5 mg, 25 mg or 50 mg) compared to three NSAIDs (ibuprofen 2,400 mg, diclofenac 150 mg or nabumetone 1500 mg) by looking at the combined incidence of three serious upper GI events collectively referred to as "PUBs": perforations in the upper GI tract; symptomatic gastroduodenal ulcers and; bleeding in the upper GI tract.

Because PUBs are uncommon events, the analysis was conducted by combining the results of eight clinical studies with a total of 5435 patients with osteoarthritis, of whom 3357 took Vioxx and 1564 took one of the three comparator NSAIDs. The studies ranged in length from six weeks to one year; because the studies ranged in length, the findings are expressed as the number of events per 100 patients per year(2).

In the study, Vioxx significantly reduced the incidence of serious GI events compared to NSAIDs; 2.6 percent of patients taking the other NSAIDs experienced a PUB versus 1.3 percent of patients taking Vioxx, for a risk reduction of about half (49 percent).

Another analysis in the paper included data only from the four studies in which Vioxx was compared to placebo for up to four months. In this analysis, 7.2 percent of patients taking the other NSAIDs experienced a PUB, 2.7 percent of patients taking placebo experienced a PUB and 2.5 percent of patients taking Vioxx experienced a PUB.

In the paper, the authors point out that most NSAIDs are believed to work by inhibiting two related enzymes: COX-1, the enzyme that helps maintain the stomach lining, and COX-2, the enzyme that triggers pain and inflammation. Therefore, the anti-inflammatory effects of NSAIDs appear to be carried out by inhibition of COX-2, with GI side effects caused by inhibition of COX-1. The authors write that Vioxx works by specifically inhibiting COX-2, without inhibiting the COX-1 enzyme. The study was conducted to evaluate whether the specific inhibition of COX-2 with Vioxx would reduce the incidence of serious GI events compared to non-specific inhibition of COX-1 and COX-2 by three other NSAIDs.

Serious stomach problems, such as bleeding, can occur without warning symptoms. Physicians and patients should remain alert for signs and symptoms of gastrointestinal bleeding.

Common side effects reported in clinical trials with Vioxx were upper- respiratory infection, diarrhea, nausea and high blood pressure. People who have had an allergic reaction to Vioxx, aspirin or other NSAIDs should not take Vioxx. Safety and effectiveness in children below the age of 18 has not been studied.

Osteoarthritis, frequently known as the "wear-and-tear" disease, is the most common type of joint disease worldwide. The condition is characterized by the degeneration of cartilage and results in pain, swelling, stiffness and decreased mobility in sufferers. More than 75 percent of all people over age 60 show signs of osteoarthritis, although a majority do not experience symptoms until after age 75. The prevalence of osteoarthritis rises steeply with age and affects more women than men. An estimated 21 million Americans have osteoarthritis, which is a leading cause of work disability in the United States and a major cause of disability in people aged 65 years or older.

References:

WASHINGTON (AP) -- The doctors were astonished: The 47-year-old Detroit woman's muscle tissue was rapidly dying. She soon needed a feeding tube and ventilation as she lost the ability to swallow or breathe. Yet doctors couldn't find any disease.

"She didn't realize the herbs were the cause of her problem, and compounded it" by taking more, explained Smolinske. The woman eventually recovered.

Then there was the young woman who walked into Smolinske's office covered head-to-toe in an amazing rash. Itchy pustules even coated the soles of her feet. She had just switched from her regular multivitamin to one with added ginkgo. Smolinske's diagnosis: Every so often - it is very rare - ginkgo can be contaminated with a poison ivy-like substance.

Alternative therapy is attractive to cancer patients: One in every three uses some form of it, mostly dietary supplements, in hopes of boosting their immune systems or easing chemotherapy side effects. Yet doctors can't say which of the products is best to try, or which might be dangerous.

So the Journal of the American Medical Women's Association dedicated its fall issue to checking out the science behind the products.

But they also found far too little scientific research on popular remedies, and they urged doctors to take better care of women by talking honestly about what they use.

Studies suggest 40 percent of patients don't tell doctors they use alternative therapies, making a diagnosis of some rare bizarre reaction like those Smolinske sees difficult - and making it hard to learn a remedy's real effects, good or bad.

Some supplements are proven helpful. Folic acid and calcium are highly recommended for many women, for example.

While the supplements industry insists problems are rare, some products are considered risky, especially if taken with other medications. Many herbalists, for example, advise people on blood-thinners to avoid ginkgo and ginseng.

Other remedies simply haven't been studied for safety.

And still others, from curcumin and genistein to St. John's wort, have undergone varying degrees of research, so doctors should help patients evaluate available information, the journal reviewers said.

"Mainstream medicine doesn't have all the answers," stressed Judith Jacobson, a Columbia University epidemiologist who has enrolled 80 breast cancer survivors in a new study to see if the herb black cohosh eases hot flashes. Breast cancer survivors usually avoid the hot-flash medication estrogen.

But there are big differences between test-tube, animal and human research.

"People without medical training ... find that something worked in mice and they get very excited about it," Jacobson cautioned. "'Are you a man or a mouse?"' - or a woman or a mouse - "is a good question."

In addition to checking the American Medical Women's Association's journal review, she offered the following tips:

-Check the product label. Although supplements are largely unregulated, the U.S. Pharmacopeia has developed standards for some, and those bottles should mention "USP," she said.

-The American Botanical Council publishes "HerbalGram," which Smolinske called a "pretty unbiased" source.

-Ask your doctor about possible drug-supplement interactions.

Landmark Study Shows Heart Scan Can Better Rule-Out Heart Attacks in the E.R. Findings Could Keep 250,000 Americans Annually From Unnecessary Hospitalization

ATLANTA, Nov. 10 /PRNewswire/ -- Late-breaking results of a federally- funded clinical study presented today at a special session of the American Heart Association's (AHA) annual meeting showed suspected heart attacks can be more accurately ruled out in the emergency room using a non-invasive heart scan called Cardiolite(R) (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection) as compared to standard evaluation techniques.

Every year, seven million Americans arrive in hospital emergency departments complaining of chest pain, indicating a possible heart attack. Identifying which patients are actually having a heart attack and require hospitalization can be challenging. More than 40% of ER chest pain patients -- estimated at more than 3 million -- are admitted to hospitals unnecessarily, at an estimated annual cost of $10 - $13 billion.

But now, researchers in the Emergency Room Assessment of Sestamibi for Evaluation of chest pain, or ERASE Chest Pain Study, have shown that the use of a Cardiolite test as part of a standard chest pain evaluation protocol in the ER can better distinguish patients who are having a heart attack and need intensive cardiac care from those who are not. Highlighting the study at the AHA meeting, James Udelson, MD, Associate Chief of the Division of Cardiology at New England Medical Center in Boston, reported that unnecessary hospitalizations were reduced by fully 20% among patients whose condition was ultimately diagnosed as non-cardiac in origin -- without increasing mistaken hospital discharges among patients actually having a heart attack.

Principal Investigator of the ERASE Study, Harry Sellker, MD, Chief of the Division of Clinical Care Research at New England Medical Center, explains, "Our findings suggest that nearly a quarter of a million Americans annually could avoid the anxiety of hospitalization and the risks of invasive cardiac testing, by simply adding a Cardiolite scan to the standard ER diagnostic process for chest pain."

The ERASE study, which was led by New England Medical Center in Boston, was funded by a $4.4 million grant from the Agency for Health Care Policy and Research (AHCPR), part of the U.S. Department of Health and Human Services.

This prospective, randomized trial was conducted at seven medical centers around the country. It is the first study of its kind to examine the effectiveness of this imaging technique in the ER.

Dr. Selker adds, "Until now, we didn't know how cardiac imaging could benefit patients in real-life ER practice. A 1997 federal study noted the lack of data to help improve ER triage of chest pain patients, because prior studies had examined cardiac imaging only in teaching hospitals or in patients with known heart disease. What we found in this study are robust, generalizable results that have the potential to revolutionize ER decision- making for chest pain patients nationwide."

ERASE investigators studied some 2,456 ER patients with symptoms suggestive of a heart attack or unstable angina -- a strong risk factor for a heart attack -- based on their history, but without an obvious pattern of either on their initial electrocardiogram (ECG). One half of all patients were tested with Cardiolite while those patients in the control group were not. Patients represented an ethnically diverse group; half were women; and the average age was 53.

Dr. Udelson observes, "A Cardiolite scan allows doctors to non-invasively evaluate the heart's pumping ability and gauge the amount of blood flow to the heart muscle itself -- and thus more quickly assess whether a patient is having a heart attack. These results support the widespread use of this approach to evaluating chest pain in hospital ERs nationwide."

Study highlights include:

 * Of 2,127 patients found not to have acute ischemia (a heart attack or unstable angina), the group who received a Cardiolite scan as part of their initial diagnosis experienced a relative reduction of 20% in unnecessary hospital admissions;

* Unnecessary admissions were reduced even at hospitals that had not previously used Cardiolite imaging -- results were not limited to those centers with prior experience with this technique.

A Cardiolite scan allows doctors to non-invasively evaluate the heart's pumping ability and gauge the amount of blood flow to the heart muscle itself -- and thus more quickly assess whether a patient has already had a heart attack or is at risk for one in the future. Exercise and pharmacologic stress testing should be performed only under the supervision of a qualified physician. Cardiolite has been rarely associated with acute severe allergic event of angioedema and urticaria. The most frequently reported adverse events include headache, chest pain/angina, ST segment changes on ECG, nausea and abnormal taste and smell.

Cardiolite is marketed by the Medical Imaging Division of DuPont Pharmaceuticals Company, a worldwide business that focuses on research, development and delivery of pharmaceuticals and medical imaging products.

DuPont Pharmaceuticals is headquartered in Wilmington, Del. The Medical Imaging Division is headquartered in North Billerica, Mass. For more information on Cardiolite, including the PI, contact 1-800-362-2668 or www.cardiolite.com.

DuPont (NYSE: DD) is a science company, delivering science-based solutions that make a difference in people's lives in food and nutrition; health care; apparel; home and construction; electronics; and transportation. Founded in 1802, the company operates in 65 countries and has 97,000 employees.

SOURCE DuPont Pharmaceuticals Company

Because of the limited depth of injury, these thermal techniques have been mainly applied to patients with nondysplastic Barrett's. Whether they would be similarly effective in dysplastic Barrett's is largely unknown. Until sufficient data are available, these approaches must remain within the research arena pending proof of their efficacy.

NEW YORK, Oct. 14 /PRNewswire/ -- Aciphex(TM) is now available in pharmacies nationwide, announced Eisai Inc. of Teaneck, N.J., and Janssen Pharmaceutica of Titusville, N.J. Aciphex, a new treatment for a common gastrointestinal (GI) condition, has been shown in clinical trials to offer acid suppression with once-daily dosing and consistent symptom control with significantly effective healing rates in erosive GERD.(1)

Aciphex is the first proton pump inhibitor (PPI) to be approved in the United States in more than four years for the treatment of erosive gastroesophageal reflux disease (GERD) and certain other GI conditions. Proton pump inhibitors suppress production of stomach acid and have been shown to be the most effective agents in eliminating symptoms of erosive GERD, which is a severe form of acid reflux disease.(2)

Although acid reflux disease produces symptoms that range from uncomfortable to very painful, results of a recent survey indicate that the impact of this disease is more than just physical. Conducted by Roper Starch Worldwide in conjunction with Eisai Inc. and Janssen Pharmaceutica, the survey polled more than 1,000 sufferers of frequent heartburn that may have been caused by either erosive GERD, for which Aciphex is indicated, or non-erosive GERD.

Aciphex is indicated for healing of erosive gastroesophageal reflux disease (GERD), maintenance of healed erosive GERD, the healing of duodenal ulcers and treatment of related symptoms of these conditions. Aciphex also has been approved for the treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Aciphex is available in easy-to-swallow 20 mg, enteric-coated tablets to be prescribed once daily for most indications.

"Aciphex is an important new treatment alternative for patients who suffer from acid reflux disease," says David Earnest, MD, professor with the Department of Medicine, Gastroenterology Section at the University of Arizona. "By providing consistent symptom relief, Aciphex offers important benefits to these patients."

Roper Starch Survey Findings

-- More than half (51 percent) of the adults who participated in the recent Roper Starch survey said that acid reflux disease keeps them awake at night.(6)

-- 22 percent of people who experience acid reflux disease attacks at work have either called in sick at one time or another or left work early due to symptoms.(8)

-- 28 percent of all sufferers said that acid reflux disease adversely affected their sex lives.(9)

-- 76 percent of acid reflux disease sufferers said that the disease has affected them emotionally.(10)

-- 42 percent said the onset of GERD symptoms has forced them to interrupt exercising or stopped them from working out altogether.(11)

In clinical studies, Aciphex taken once daily was shown to be highly effective in healing erosive GERD; 84 percent of patients treated with Aciphex were healed at eight weeks vs. 12 percent with placebo.(15) The drug also has been shown to consistently maintain healing of erosive GERD for 52 weeks.(16) Aciphex heals duodenal ulcers in as quickly as two to four weeks.(17)

"These data demonstrate that Aciphex heals erosive GERD and also maintains healing and symptom relief with an excellent safety profile over the long term," explains Dr. Earnest. "This is crucial because people with acid reflux disease are often on PPI therapy for long periods of time."

In clinical trials, Aciphex demonstrated a favorable side-effect profile. Headache was the most common side effect assessed as possibly related to Aciphex (2.4% vs. 1.6% for placebo). Aciphex is contraindicated in patients with known sensitivity to rabeprazole, substituted benzimidazoles or any component of the formulation. As is the case for other proton pump inhibitors, symptomatic response to therapy with Aciphex does not preclude the presence of gastric malignancy. Proton pump inhibitors, however, constitute an established class of drugs that has been shown to be safe and well-tolerated.

A second survey, also conducted by Roper Starch Worldwide, interviewed a national sample of more than 1,000 American adults and revealed a significant lack of consumer awareness about acid reflux disease. While only 16 percent of American adults said they had heard of acid reflux disease,(18) 20 percent said they have a recurring condition that causes heartburn and regurgitation of stomach acid and/or a sour taste in the back of their throat.(19) The great majority (78 percent) of these individuals who reported acid reflux symptoms have not even heard of the disease.(20)

A second Roper Starch omnibus survey consisted of telephone interviews with a random cross-section of 1,008 adults, 18 years of age and older. The findings are projectable to this population within a margin of sampling error of +/- 3 percentage points. All interviewing was conducted in May of 1999.

The surveys were funded by Eisai Inc. and Janssen Pharmaceutica.

Eisai Inc. is a subsidiary of Eisai Co., Ltd. of Tokyo, Japan. Eisai Co., Ltd. is a research-based human health care company which discovers, develops and markets products in more than 30 countries. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. The company reported sales of $2.3 billion in 1998 with approximately 15 percent of sales spent for research and development.

Janssen Pharmaceutica is a wholly owned subsidiary of Johnson & Johnson, the world's most comprehensive manufacturer of health-care products and related services. Janssen markets therapies for fungal infections, gastrointestinal disorders, psychiatric conditions and chronic pain. Janssen Pharmaceutica's international operations are headquartered in Beerse, Belgium, with affiliates in 32 countries; Janssen's U.S. headquarters are based in Titusville, NJ.

Please see package insert for full prescribing information.

References

(1) Williams MP et al. A placebo-controlled trial to assess the effects of 8 days of dosing with rabeprazole versus omeprazole on 24-h intragastric activity and plasma gastrin concentrations in young healthy male subjects. Alimentary Pharmacology Therapy. 1998; 12:1079-1089

(2) American College of Gastroenterology Website, www.acg.gi.org/patientinfo/gerd/info10.html

(3) Spechler, S Complications of Gastroesophageal Reflux Disease. The Esophagus, edited by D Castell, 1992;543-553.

(4) Lagergren, J et al Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma. The New England Journal of Medicine. 1999; 340;11: 825-879.

(5) NIH, Gastroesophageal Reflux Disease (Hiatal Hernia and Heartburn). NIH Publication No. 94-882, September 1994

(7) GERD Study, p. 32

(8) GERD Study, p. 31

(9) GERD Study, p. 35

(10) GERD Study, p. 39

(12) GERD Study, p. 5

(13) GERD Study, p. 57

(14) GERD Study, p. 67

(15) Cloud ML et al. Rabeprazole in treatment of acid peptic diseases: results of three placebo-controlled dose-response clinical trials in duodenal ulcer, gastric ulcer, and gastroesophageal reflux disease (GERD). Dig Dis Sci. 1998; 43:993-1000

(16) Caos et al. Rabeprazole for the prevention of pathological and symptomatic relapse of erosive or ulcerative gastroesophageal reflux  disease. Gastroenterology. 1999; 116: G0568 and Birbara et al. Rabeprazole: preventing endoscopic and symptomatic relapse in erosive or ulcerative GERD. American Journal of Gastroenterology. 1998;93:1630

(17) Beker JA et al. Rabeprazole sodium 20 mg once daily is similar to omeprazole 20 mg once daily in the healing of active duodenal ulcer. Gastroenterology. 1997; 112:A70

(18) Roper Starch Omnibus Survey/May, 1999/Executive Summary

(19) Roper Starch Omnibus

(20) Roper Starch Omnibus

SOURCE Eisai Inc. and Janssen Pharmaceutica

CO: Eisai Inc.; Janssen Pharmaceutica

WASHINGTON, Oct. 14 /PRNewswire/ -- At a time when more than 60 million Americans suffer from acid reflux disease, a new national survey reveals that sufferers often endure their condition -- leaving symptoms untreated and depriving themselves of relief. When sufferers finally do seek treatment, the communication between them and their health care professionals is often ineffective in promoting diagnosis and treatment.

The survey suggests that consumers may benefit from being more proactive when it comes to seeking diagnosis and treatment of acid reflux disease. The National Council on Patient Information and Education (NCPIE), which helped develop the survey along with Janssen Pharmaceutica and Eisai Inc., encourages acid reflux disease sufferers to take part in decisions about their treatment, follow their treatment plan, watch for problems and get help solving them.

The survey shows that many people with acid reflux disease lack a fundamental understanding of this disease and are confused about the cause of its symptoms. For instance, the survey reveals that many sufferers (40 percent)(3) don't consider acid reflux disease to be a true disease and are likely to incorrectly believe that their symptoms are caused by something they ate (53 percent) or by stress (34 percent)(4). Consequently, 71 percent of those who waited four months or more before going to a physician did so because they thought they could treat the symptoms themselves(5).

"This survey reinforces the need for patients to take an active part in their health and treatment decision-making," says Ray Bullman, executive vice president, NCPIE. "It's also a call to action for health care professionals to listen to and counsel patients. Active communication about diagnosis, treatment options and appropriate use of medications can better ensure that acid reflux disease sufferers receive the best available treatment."

In an effort to close the communication gap between patients and health care professionals, NCPIE has designated October as "Talk About Prescriptions" Month. This year marks the 14th annual observance. NCPIE, a non-profit coalition of nearly 200 member organizations, also develops numerous programs, educational resources and offers services that stimulate and improve communication of information on the appropriate use of medicines to consumers and health care professionals.

Roper Starch Worldwide conducted phone interviews with 1,017 GERD sufferers, all of whom had an onset of the disease at least once a week. The margin of sampling error is +/- three percentage points. The panel was weighted by geography and demographic factors to be representative of all households in the United States. All interviewing was conducted during March and April of 1999.

(1) Roper Starch Worldwide/GERD Study/May, 1999/p. 7

(2) Roper Starch, p. 57

(3) Roper Starch, p. 5

(4) Roper Starch, p. 26

(5) Roper Starch, p. 43

(6) Roper Starch, p. 49

(7) Roper Starch, p. 10

CO: Janssen Pharmaceutica; Eisai Inc.; National Council on Patient Information and Education

Dr. Wai-Keung Leung and colleagues at the Chinese University of Hong Kong used bacterial culture and polymerase chain reaction to test for H. pylori in the vomitus of 18 children with gastroenteritis. Four children were seropositive for H. pylori.

H. pylori was detected in the vomitus of three of the four seropositive children, the investigators report in the October issue of The American Journal of Gastroenterology. H. pylori was also detected in the vomitus of one seronegative child, who later seroconverted.

According to Dr. Leung's group, although some epidemiologic and anecdotal evidence has indicated that gastro-oral transmission of H. pylori via vomitus may be possible, their report is the first direct evidence of this means of transmission.

The rebate program provides a one-time opportunity for new patients to save up to $10 on a prescription for Prilosec. Patients will either receive a $10 rebate check if paying cash for a prescription or a maximum amount of $10 that can be applied to a co-pay.(1)

"We are pleased to offer this rebate program as a way of introducing a patient, who has been evaluated by a doctor, to Prilosec," said Sharon DeBacco, leader of the direct-to-consumer (DTC) team for Prilosec. "We have heard from many patients and physicians alike about the relief that Prilosec can provide from frequent and persistent heartburn."

Prilosec was the first in a class of drugs known as proton (acid) pump inhibitors. The medication works by blocking the final step of acid production by inhibiting an enzyme system at the secretory surface of the stomach's parietal cell. While Prilosec provides 24-hours of complete heartburn relief for the majority of patients with one daily dose, it is not for everybody. The most common side effects are headache, diarrhea, and abdominal pain.

Based in the United Kingdom, AstraZeneca PLC (NYSE: AZN) is a major $15.8 billion international bioscience business engaged in the research, development, manufacture, and marketing of ethical (prescription) pharmaceuticals and agricultural products, and the supply of health care services. The U.S. operations of AstraZeneca include AstraZeneca, a business unit of Zeneca Inc., AstraZeneca LP, Zeneca Ag Products and Salick Health Care. In the United States, AstraZeneca is a $7.2 billion bioscience business with approximately 11,000 employees.

*Since May, 1997, IMS NPA Plus(TM)

(1) A patient, whose doctor has determined that he or she is an appropriate candidate for treatment with Prilosec, is eligible for a one-time $10 rebate on a prescription for Prilosec. This is a limited time offer and rebate certificates must be redeemed by March 31, 2000. To get a check, a patient must document receiving a prescription for Prilosec by sending along a pharmacy label or bag receipt with a completed rebate certificate and proof of purchase, such as a cash register receipt. Rebates are not valid for prescriptions written through Medicaid, Medicare, or similar federal or state programs. The offer is void in MA, MI, MN and RI, or where prohibited by law.

For more information or a copy of the full prescribing information for Prilosec, contact Jim Coyne at 1-800-942-0424, ext. 1656, or via e-mail at jim.coyne@astrapharmaceuticals.com or reference the World Wide Web at www.acidcontrol.com.

SOURCE AstraZeneca LP

CO: AstraZeneca LP; AstraZeneca PLC

PHOENIX, Ariz., Oct. 20 /PRNewswire/ -- Oral pantoprazole (Protonix(R)), an investigational proton pump inhibitor, prevents relapse of healed erosive esophagitis (EE) more effectively than the popular acid-control drug ranitidine, according to data presented today at the annual meeting of the American College of Gastroenterology.

In the year-long study, which sought to determine how well the two agents prevented relapse and provided symptom relief in patients who had recovered from a bout of EE, investigators found that treatment with the most powerful dose of pantoprazole (40 mg once a day) prevented relapse in 86% of study subjects, compared with 35% who received the standard dose of ranitidine (150 mg twice a day). The difference was highly statistically significant.

"Erosive esophagitis is one of the more serious complications of reflux disease," said Thomas Kovacs, MD, CURE/Veterans Administration West Los Angeles Healthcare Center. "Unfortunately, many patients with EE tend to relapse, even when they continue on therapy with H2 receptor antagonists such as ranitidine. Our results suggest that pantoprazole may be significantly more effective than those agents in preventing relapse and thereby reducing the risk of potentially life-threatening outcomes."

Pantoprazole is an investigational new drug currently being reviewed, in both oral and intravenous (IV) formulations, by the U.S. Food and Drug Administration for the treatment of EE and gastroesophageal reflux disease (GERD). If approved, it will be the first of the popular proton pump inhibitors approved for IV administration.

For further questions please contact Marianne Davis, 310-268-3576, VA West Los Angeles Healthcare Center, VA Greater Los Angeles Healthcare System, 11301 Wilshire Blvd., Los Angeles, CA 90073.

This study was sponsored by Wyeth-Ayerst Laboratories.

SOURCE VA Greater Los Angeles Healthcare System

CO: VA Greater Los Angeles Healthcare System; Wyeth-Ayerst Laboratories

Promising Results for a Disabling Disease

In a North American study, Zelmac significantly reduced the key symptoms of IBS (abdominal pain or discomfort, and bloating) and improved bowel function within one week of starting treatment.

"The lack of a satisfactory treatment for IBS has been both frustrating for doctors, and distressing to patients who have to live with this chronic illness," said study investigator Colleen Schmitt, MD, Southeastern Clinical Research, TN. "These data suggest that Zelmac may offer patients an effective way to better manage the debilitating symptoms of IBS. We look forward to the results of further studies which may confirm these promising findings." European Phase III data for Zelmac, involving over 1,500 patients, will be presented during next month's United European Gastroenterology Week (UEGW) in Rome, Italy.

The study involved 799 patients with constipation predominant IBS (C-IBS) in the US and Canada. Patients were randomized to receive either Zelmac (4 or 12 mg/d) or placebo for 12 weeks. When patients were given a daily dose of 12mg, Zelmac significantly decreased the number of days with abdominal discomfort/pain by 15% and bloating by 17%. These effects were already significant after only one week of Zelmac therapy and were sustained throughout the 12-week study period. The placebo control group only effected a 4% increase and 6% decrease in these symptoms, respectively.

Increasing the frequency of bowel movements and improving stool consistency, in addition to resolving the pain, are important goals in treating C-IBS patients effectively. Zelmac increased the total number of bowel movements by 69%, compared to only 45% with placebo. This difference, which was most apparent after the first month, persisted throughout the study. The mean percentage of days during which patients experienced hard or very hard stools was also lower in patients receiving Zelmac (11%) than placebo (19%). This statistically significant effect also persisted throughout the study.

Zelmac was also well-tolerated by patients. The most common side effects were abdominal pain, diarrhea, nausea, flatulence and headaches; the side effects were mostly mild or moderate in severity. Overall side effects occurred with similar frequency in the Zelmac and placebo groups (37% and 30%, respectively). In two additional studies with data from 1,120 patients, approximately 300 of whom were treated for up to 12 months, the overall percentage of side effects was similar to placebo.

IBS -- A Common Disease

About Zelmac

Novartis plans to file Zelmac for approval with the US Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) for the treatment of constipation-predominant irritable bowel syndrome in early 2000.

Novartis Group is a world leader in Life Sciences with core business in Healthcare, Agribusiness and Consumer Health (Nutrition and Self-Medication). In 1998, Novartis Group sales were CHF 31.7 billion, of which CHF 17.5 billion were in Healthcare, CHF 8.4 billion in Agribusiness, and CHF 5.8 billion in Consumer Health. The group annually invests more than CHF 3.7 billion in R & D. Headquartered in Basel, Switzerland, the Novartis Group employs about 82,000 people and operates in over 140 countries around the world.

References

1. Weber, F. H. and McCallum, R. W. "Clinical approaches to irritable bowel syndrome," Lancet, 1992, 340, pp. 1447-1451

2. Lefkowitz, M. et al. The "5-HT4 receptor partial agonist tegaserod improves abdominal discomfort/pain and normalizes altered bowel function in irritable bowel syndrome (IBS)." Poster presented at the annual meeting of the American College of Gastroenterology, Phoenix, USA, 15-19 October, 1999

4. Talley, N. J, et al. "Medical costs in community subjects with irritable bowel syndrome," Gastroenterology, 1995, 109, pp. 1736-1741

5. Harvey, R. F. et al, "Organic and functional disorders in 2000 gastroenterology outpatients," Lancet, 1983, i, pp. 632-634

6. Grider, J. R. and Foxx-Orenstein, A. E. "A selective 5-HT4 receptor agonist stimulates transmitter release and activates the intestinal peristaltic reflex," Gastroenterology, 1996, 110, A1075

7. Schikowski. A. et al. "Dose-dependent modulation of rectal afferent sensitivity by a 5-HT4 receptor agonist," Gastroenterology, 1999, 116, A643

CONTACT: Geoffrey Cook of Novartis Pharmaceuticals Corporation, 973-781-5486.

SOURCE Novartis Group

CO: Novartis Group

OBJECTIVE: To investigate the effects of hypochlorhydria and acidic drink ingestion on protein-bound vitamin B12 absorption in elderly subjects. METHODS: Absorption of protein-bound vitamin B12 was examined in elderly normal subjects (n = 8), and in hypochlorhydric subjects due to omeprazole treatment (n = 8) or with atrophic gastritis (n = 3). Subjects underwent absorption tests of protein-bound vitamin B12 ingested with water, cranberry juice and 0.1 N hydrochloric acid. RESULTS: Protein-bound vitamin B12 absorption was lower in the omeprazole-treated group (0.50%) compared to the normal group (1.21%; p < 0.001). With cranberry juice ingestion, the omeprazole-treated group showed an increase in absorbed protein-bound vitamin B12 (p = 0.025). With dilute hydrochloric acid ingestion, there was a further increase in vitamin B12 absorption (p < 0.001). CONCLUSION: Omeprazole causes protein-bound vitamin B12 malabsorption, and ingestion of an acidic drink improves protein-bound vitamin B12 absorption.

Publication Types:

• Clinical trial
• Randomized controlled trial

Hi Brian and group,

There are hundreds, maybe thousands of published articles and abstracts about omeprazole, as it relates to achlorhydria (the lack of stomach acid) and any malabsorption syndromes. Welcome to PubMed is just one site you might try. PubMed medline query , PubMed medline query--iron absorption, PubMed medline query - b12 asorp are just three related abstracts that I quickly pulled-up.