Oct. 26, 2009 -- A new, four-drug regimen to wipe out bacteria associated with peptic ulcers and stomach inflammation banished the bugs better than the standard three-drug treatment often used, according to research presented at ACG 2009, the annual meeting of the American College of Gastroenterology in San Diego.
The new, four-drug treatment is "tolerable, and there is excellent compliance," says researcher P. Patrick Basu, MD, an assistant professor of medicine at Columbia University College of Physicians and Surgeons, New York, and chief of the division of gastroenterology and endoscopy at North Shore University Hospital at Forest Hills, N.Y.
Unchecked, the bacteria Helicobacter pylori can lead to irritation of the stomach lining and inflammation of the lining (gastritis) and peptic ulcers, and boost the risk for certain types of stomach cancer.
Detecting Ulcers From H. pylori
An estimated 40% of U.S. residents are infected with H. pylori, according to Basu, but most have no problems with it. Those who are bothered may report a burning pain in the abdomen, nausea, vomiting, burping, bloating, and weight loss.
When the symptoms are bad enough, they prompt a visit to the doctor, who may order a test for the bacteria. The bacteria are detected in a number of ways, including a blood test that looks for antibodies in the blood to indicate exposure, a stool test that looks for evidence of infection, a breath test that checks for the presence of a gas the bacteria produces, or other ways.
Once the bacteria are found in those with troublesome symptoms, the goal is to eradicate them to avoid future problems. Several drug treatment approaches are available, but compliance is often poor, experts say, and the bacteria aren't always eliminated. Resistance to the antibiotics is sometimes a problem, too.
Ulcer Treatment: Study Details
Basu and his colleagues compared a new four-drug regimen -- a seven-day course and a 10-day course -- with a standard 10-day, three-drug treatment. The study was not funded by any drug company.
The three-drug regimen, a standard approach, is called LAC because it included:
- Lansoprazole ( Prevacid), a proton pump inhibitor (PPI) to reduce stomach acid
- Amoxicillin (Amoxil), an antibiotic
- Clarithromycin ( Biaxin), another antibiotic
The four-drug regimen, called LOAD, included:
- Levofloxacin (Levaquin), an antibiotic
- Omeprazole ( Prilosec), a proton pump inhibitor
- Nitazoxanide (Alinia), an antibiotic
- Doxycycline (Vibramycin), another antibiotic
In all, 135 patients were evaluated, with 45 in each of the three regimens. The average age in all three groups was 46. Some had peptic ulcers, others had gastritis or other gastric conditions linked to the bacteria. All had been off antibiotic or PPI use for six weeks before beginning the new ulcer treatments. None had undergone treatment to eradicate H. pylori before.
Ulcer Treatment Study Results
The four-drug approach eliminated bacteria in more than 95% of all these patients, with the seven-day plan achieving it in 95.3% and the 10-day 95.2%. The three-day approach eliminated it in 80.9%. Physicians say compliance is often a problem, with patients not taking prescribed pills, but Basu found high compliance, with 93.3% of the 10-day LOAD patients and the 10-day LAC patients completing the treatment and 95.6% of the LOAD seven-day patients finishing.
When the analysis was computed to include everyone who began the study, including the eight who discontinued the treatments, the four-drug, seven-day plan eliminated bacteria in 91.1%, the four-drug 10-day plan eliminated it in 88.9%, and the three-drug, 10-day plan eradicated bacteria in 75.6%.
All patients he studied had not received treatment before, so Basu can't yet say whether the new plan might be worth a try for those who have failed previous treatment.
Costs are comparable, Basu says. "LAC is about $400 for 10 days, and LOAD is about $400 for seven days. LOAD 10 is about $535."
''It's a completely new regimen," says William Chey, MD, professor of medicine at the University of Michigan, Ann Arbor, who reviewed the study findings for WebMD.
He views the results as promising. "This is exciting news about a potential new therapy," he says. New treatment regimens have been few in recent years, he says, as the percentage of people with H. pylori in the U.S. has dropped steadily.
What strengthens the study finding that the four-day approach is more effective, he says, is that "the eradication rate he got with [the three-day approach] is exactly what you would expect based on other studies from the U.S." In his recent review of published studies, Chey found an eradication rate of about 77% with three-drug treatment plans, close to the 80% found in the new study.
Physicians should consider the new four-drug regimen, he says, adding that further studies are needed. "The results are encouraging, and the eradication rates with standard therapy are not very good."