The New York
Times - Wednesday, June 13, 2001 Lyme Disease Is Hard to Catch and Easy to Halt, Study FindsBy GINA KOLATA Lyme disease is very difficult to catch, even from a deer tick in a Lyme-infested area, and can easily be stopped in its tracks with a single dose of an antibiotic, a new study shows. And two other studies conclude that prolonged and intensive treatment with antibiotics, a course of care advocated by a small group of doctors, does nothing for people with symptoms often attributed to chronic Lyme disease. These findings are in keeping with the assertions of researchers who say that in most cases, such symptoms have nothing at all to do with the disorder. The three studies, scheduled to be published on July 12 in The New England Journal of Medicine, were released yesterday because the journal's editors thought they were so important, with the onset of summer and the accompanying fear of Lyme disease. "This is reassuring information for people who make decisions based on evidence," said Dr. Jeffrey M. Drazen, the journal's editor in chief. Researchers, both those associated with the studies and others who were not, said they hoped the findings would ease what they called inflated public fear of Lyme disease, which is widely perceived as a grave illness that is easy to catch. A total of 16,019 cases were reported to the Centers for Disease Control and Prevention in 1999; 92 percent of those cases were in nine states, most of which are in the Northeast, including New York and Connecticut. Dr. Leonard H. Sigal, a Lyme disease expert at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical Center in New Brunswick, who was not associated with the studies, said the message from them was that "Lyme disease, although a problem, is not nearly as big a problem as most people think." "The bigger epidemic," Dr. Sigal said, "is Lyme anxiety." The study to see whether a single dose of the antibiotic doxycycline could prevent Lyme disease was directed by Dr. Robert B. Nadelman, a professor of medicine at New York Medical College and attending physician at the Westchester Medical Center, both in Valhalla, N.Y. Dr. Nadelman said many doctors, in hopes of heading off Lyme disease infection, had been giving 10-to-21- day courses of the antibiotic to people who had found deer ticks on their bodies. "They would be treating people as if they actually had the disease," he said. He and his colleagues wondered whether one dose would be enough. They recruited 482 people in Westchester County, N.Y., where the incidence of Lyme disease is among the highest in the world. All had found deer ticks on their bodies. (The insects were identified by entomologists.) Half got a single dose of doxycycline, taken in the form of two capsules, and the others got two dummy capsules. The investigators found that the drug did prevent Lyme disease: just one person, 0.4 percent of those who took it, came down with the illness. But even among those who took the placebo, the chances of getting the disease was just 3 percent. Dr. Eugene Shapiro of Yale University School of Medicine, who wrote an accompanying editorial, noted that the antibiotic often caused nausea, vomiting and abdominal pain and that among those who took it, there would have been very little chance of getting Lyme disease in any case. People who are bitten can watch the site where the tick fed, Dr. Shapiro said, and if they develop a rash within a few weeks, they can take a full course of antibiotics. "Give that person 10 to 21 days of antibiotics," he said, "and they will be fine." Dr. Sigal agreed. He added that deer ticks crawl around the body for hours before settling down to feed, and during that time are easily washed off with a washcloth. And, he said, "even if you get the disease, it is easily treatable and it is curable." But Dr. Jesse L. Goodman, a Lyme disease expert at the University of Minnesota, said some people were so horrified by the possibility of getting Lyme disease that even a 3 percent risk was too much for them. "As a physician, I could respect that," Dr. Goodman said, adding that he would offer those people doxycycline. Lyme disease researchers emphasized, however, that previous studies had shown that most people with the infection get better on their own, without antibiotics. And while a small percentage develop serious symptoms, like arthritis or heart disorders, even the vast majority of these get better, the researchers said. Dr. Raymond Dattwyler, director of the Lyme Disease Center at the State University of New York at Stony Brook, said the typical Lyme disease patient has a rash but no other symptoms, takes an antibiotic and is cured. The two other studies released yesterday, financed by the National Institutes of Health, addressed the question of how to treat people who had Lyme disease and later developed symptoms like fatigue, aches and pains, and memory loss. Both were conducted by Dr. Mark S. Klempner of Boston University School of Medicine and his colleagues. One study enrolled patients who had antibodies to the Lyme disease microorganism, Borrelia burgdorferi, an indicator that they had been infected. The other enrolled patients who no longer had antibodies but had had a documented case of Lyme disease. Half the patients in both studies received an intravenous antibiotic, ceftriaxone, for a month, followed by oral doxycycline for 60 days; the others received dummy medications. The question was, Would this intensive antibiotic treatment make the patients better? The studies were meant to enroll 260 patients, but they ended early, after enrolling just 129 patients, because an independent committee overseeing them said it had become clear that the antibiotics were no more effective than the placebos. Dr. Shapiro said he was not surprised. Although a small group of doctors and patients insist that symptoms like fatigue and memory loss after a bout with Lyme disease are due to chronic infection with the disease organism, those symptoms are very common among the general public, leading Dr. Shapiro and others to believe there is some other cause. "Whatever is going on with these patients," he said, "if it is unresponsive to antibiotics, it is unlikely that it is untreated Lyme disease." In contrast, antibiotics have been shown to work extraordinarily well when, for instance, the Lyme organism has demonstrably infected the brain, Dr. Dattwyler said. But some who have treated hundreds of patients with long-term antibiotics, like Dr. Sam L. Donta of Boston University Medical Center, were not convinced. The antibiotics in the studies were not given for a long enough time, Dr. Donta said, and he would have chosen different ones. Perhaps all that the studies show, he said, is "that this particular treatment doesn't work." Dr. Brian Fallon, an associate professor of psychiatry at Columbia University, is directing another study of chronic Lyme disease that focuses on patients who have problems with fatigue, their memory and their ability to think. In his study, also supported by the National Institutes of Health, the patients receive intravenous antibiotics for 10 weeks, or a placebo. Dr. Fallon said he saw many such patients in his private practice and would continue to refer them to colleagues for long-term treatment with intravenous antibiotics. Dr. Sigal said, however, that in addition to the expense of long-term intravenous antibiotics and some patients end up taking them for years the drugs are dangerous. Some patients have died of infections caused by the catheters in their bodies, and others have experienced side effects from the drugs, including destruction of bone marrow, requiring a bone marrow transplant. "These are not benign drugs they're all poisons," Dr. Sigal said. When they are needed to fight an infection, their risks, of course, are outweighed by their benefits. But when there are no benefits, he added, the risks are naturally unacceptable. The Journal News - Wednesday, June 13, 2001 Antibiotic found to block Lyme disease after tick bite By MELISSA
KLEIN A single dose of an antibiotic costing about a dollar has been shown to prevent Lyme disease in 87 percent of people if taken within three days of finding and removing a tick, according to a study released yesterday. The 10-year study focused on people bitten by deer ticks in Westchester County and was conducted by researchers at Westchester Medical Center and New York Medical College, both in Valhalla. "This is the first time that anyone has showed that antibiotics can prevent Lyme disease after a tick bite," said Dr. Robert Nadelman, the study's lead author and an infectious-disease specialist at the medical center. "Not only that, but that a single dose is effective." The New England Journal of Medicine, which will publish the study in its July 12 edition, released it and other Lyme disease articles ahead of schedule yesterday, citing the potential importance in treating the illness. The articles are on the journal's Web site, www.nejm.org. Currently, the only way to medically prevent Lyme disease is with a vaccine, LYMErix, which is about 80 percent effective. Antibiotics are the standard treatment once the illness is recognized, but previous studies have shown no success in warding off infection with a 10- to 14-day course of antibiotics. The potential impact of Nadelman's research is limited by several factors, perhaps none more important than the fact the treatment depends on finding a tick and that Lyme disease comes as a surprise to most people. "It was a tick bite they never knew about," Nadelman said. In an editorial accompanying the study, Dr. Eugene Shapiro of Yale University cautioned against a broad application of the treatment because the chance of getting Lyme disease from a tick bite, even in endemic areas like Westchester, was low. Just 3.2 percent of people in the study's control group developed the illness. State statistics show 280 people contracted Lyme disease in Westchester last year, 290 in Putnam County and 70 in Rockland County. Another roadblock to receiving the prescription antibiotic is the correct identification of the deer tick, which is often confused with other tick species, insects and even specks of debris. "The study had the expertise of medical entomologists who could identify the ticks," said David Weld, executive director of the Somers-based American Lyme Disease Foundation, which works to prevent the disease. "I can identify ticks. Most people cannot." Nadelman and fellow researchers recruited about 500 people between May 1987 and December 1996 who had a deer tick removed from their bodies within 72 hours. The subjects were at least 12 years old, had no signs of Lyme when they enrolled and had not had the Lyme vaccine. About half of the participants received 200 milligrams of the antibiotic doxycycline, while the other group took a placebo. Side effects of the antibiotic included nausea and vomiting, but Nadelman said those likely could be decreased by taking the medication with food. The patients were watched for up to six weeks to see if they developed a rash, a telltale sign of Lyme disease present in most people who contract the illness. Eight of the 247 people in the placebo group developed the rash, while one among the 235 people who took the antibiotic had a rash. Nadelman said researchers did not look for other symptoms of Lyme disease because those could have been the result of another tick bite, and the rash was considered the most reliable indicator of the bite in question. He said all the people in the study who developed Lyme were infected by nymphal ticks, or young ticks the size of poppy seeds, that had been partially engorged with blood, indicating they had begun to feed on the subject and potentially transmit the Lyme bacteria. "What we can say for people who remove a deer tick, if the tick can be reliably identified as a nymphal tick that's at least partially engorged by blood, doxycycline would have an excellent chance of decreasing development of Lyme disease even further," Nadelman said. Also released yesterday was a large study conducted at New York Medical College and other centers that was designed to settle the debate over whether antibiotic treatment was effective in people with lingering Lyme disease symptoms. The research concluded there was no difference between antibiotics and placebos in improving symptoms. While most people with Lyme disease get better after a short course of antibiotics, some go on to have persistent neurological and arthritic symptoms. Dr. Arthur Weinstein, a study author who is an adjunct professor at New York Medical College, said the study results opened up new areas for research to determine why people were still sick. "What we don't want it to do is to dismiss these patients," said Weinstein, who heads the rheumatology department at Washington Hospital Center in Washington, D.C. "What we're saying is it's not active Lyme infection, but we believe in some way it was triggered by their original Lyme disease." |