>From the National Library of Medicine:

Clinical Alert: Chronic Lyme Disease Symptoms Not Helped by Intensive
Antibiotic Treatment

National Institute of Allergy and Infectious Disease (NIAID)


Results of the first randomized, placebo-controlled, double-blind
trials testing antibiotics in patients with a stubborn form of Lyme
disease those whose symptoms persist after standard courses of
antibiotics validate that these patients suffer significant pain and
other disabling symptoms. The two trials found, however, that a 90-day
course of intravenous and oral antibiotics was no better than placebo
at improving these chronic symptoms.

Because of their potential importance to Lyme disease treatment, The
New England Journal of Medicine is publishing these findings today
online at http://www.nejm.org. The report will appear in the July 12th
print edition of the journal. The studies were funded by a National
Institute of Allergy and Infectious Diseases (NIAID) contract to Mark
S. Klempner, M.D., of Boston University School of Medicine.

"Our results suggest that we need to define the cause or causes of the
debilitating, persisting symptoms experienced by some patients with
Lyme disease. Understanding the origin of these symptoms should lead
to more effective therapeutic approaches to ameliorate these
symptoms," says Dr. Klempner. "Based on experience with other chronic
infectious diseases caused by persisting bacteria syphilis,
tuberculosis, and ulcers, for example we think it is unlikely that a
longer course of treatment or different antibiotic combination would
result in greater improvement than what we found in these studies."

Significantly, more than 700 different blood and cerebrospinal fluid
samples were collected from the study volunteers. None of the samples
showed evidence of persistent infection with the Lyme agent, Borrelia
burgdorferi. This suggests, Dr. Klempner says, that researchers should
investigate autoimmune and other processes to determine whether they
play a role in a least some of the symptoms of chronic Lyme disease.
The trials were carried out by primary investigators and their staffs
at three centers: New England Medical Center in Boston (Dr. Klempner's
former affiliation); New York Medical College in Valhalla (Arthur
Weinstein, M.D.); and Yale-New Haven Hospital in Connecticut (Janine
Evans, M.D.) Volunteers were recruited through hundreds of screening
clinics set up in schools, hospitals, and town halls located in these
areas where Lyme disease is highly endemic.

A total of 129 volunteers enrolled in the two studies. All
participants had well-documented Lyme disease and had previously
received at least one course of recommended antibiotics. Despite prior
antibiotic treatment, the volunteers currently suffered from
persisting muscle or joint pains and complained of memory and thinking
problems, often associated with fatigue.

Although both trials were identical in design, one trial enrolled 78
chronic Lyme disease patients who tested positive for antibodies to
the Lyme bacterium, while the other trial enrolled 51 people with
chronic symptoms but no evidence of antibodies.

In each study, volunteers were assigned at random to receive either
antibiotic treatment or an inactive placebo. Treatment consisted of
intravenous ceftriaxone, 2 grams daily, for 30 days, followed by oral
doxycycline, 200 milligrams daily, for 60 days. The investigators
evaluated symptom improvement based on the patients' responses to a
health-related quality-of-life questionnaire given 90 days after they
completed the course of antibiotic treatment or placebo.

An interim data analysis planned into the design of the trials was
carried out last November by a Data and Safety Monitoring Board
(DSMB), an independent group of doctors and researchers. The DSMB
unanimously recommended that NIAID stop the treatment arm of both
trials because the data showed no significant difference in the
percentage of patients who received either antibiotic treatment or
placebo who felt their symptoms had improved, worsened, or stayed the
same: a little more than one-third felt better, about one-third felt
worse, and slightly less than one-third felt the same. The DSMB's
review suggested that even with continued accrual of another 131
patients, the number needed to reach full enrollment, there was only a
slight chance a difference between the antibiotic treatment and
placebo groups would be found. NIAID agreed with the DSMB's
recommendation, as well as their recommendation that the investigators
continue to follow the patients to monitor them for safety and to
learn more about possible causes of chronic Lyme disease.

"Although we still have much to learn," says Dr. Klempner, "we know
much more about chronic Lyme disease now than we did when these
studies began." Besides the information obtained about the efficacy of
intensive antibiotic treatment, the investigators found that the
impact of Lyme disease on physical health was at least equal to the
disability of patients with congestive heart failure and
osteoarthritis. Some patients were also found to have cognitive
impairment.

"The antibiotic treatment component is only one piece of NIAID's
comprehensive clinical studies on chronic Lyme disease," adds Phillip
J. Baker, Ph.D., who oversees NIAID's Lyme disease program. "These
studies have yielded a considerable amount of new information. We
intend to characterize the patients enrolled in the study as
thoroughly as possible to learn more about the mechanisms involved in
chronic Lyme disease," Dr. Baker adds. "The knowledge obtained from
such studies should be of immense value in developing new, more
promising approaches for treating this disease."


--
Regards,
Catherine


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