Upstream Health Solutions

The July 12th issue of the New England Journal of Medicine will contain two articles on Lyme Disease, but the Journal made the articles available for early review because of their importance, in view of the onset of summer, the season when the disease is generally transmitted.

The first article describes a study analyzing the benefits, or lack thereof, of prolonged antibiotic treatment for patients who had been previously diagnosed with Lyme disease, but continued to complain of various symptoms, such as muscle and joint pain, memory or concentration problems, or painful “pins-and needles” type discomforts. These symptoms were accompanied, in most cases, by severe fatigue.

Short-term antibiotic treatment in the acute stage of Lyme disease is highly effective in preventing the more disabling later stages, which can involve the joints, nervous system, and heart. But some clinicians and patients believe that vague symptoms can be the result of an entity called “chronic” Lyme disease, and that long-term (i.e., several months) intravenous antibiotic treatment can effectively remedy these complaints. Case reports and small, uncontrolled trials have supported this theory in patients who have been diagnosed with Lyme disease, with or without blood test confirmation via antibody tests looking for evidence of exposure to the bacterium (Borrelia burgdorferei) which causes Lyme disease.

The study authors, led by Mark Klempner, M.D., from the New England Medical Center and Tufts University School of Medicine in Boston, intended to evaluate 260 patients, 194 who had positive antibody tests, and 66 who were negative for anti-borrelia antibodies, and compare their symptomatic response to treatment. There was no evidence of persistent active infection in either of the groups.

The patients were equally divided into two groups: those receiving active therapy, the intravenous antibiotic ceftriaxone for 30 days, followed by 60 days treatment with oral antibiotic doxycycline (which is similar to tetracycline); and the control group, which was to receive identical appearing placebo — inactive intravenous solution and inactive pills — over the same time period.

But the interim analysis led the study authors to discontinue the study after 107 patients had been evaluated, since the results were already clear-cut: the symptoms noted had not changed in those given the active treatment compared to those in the placebo group. While both groups had severe impairment in health-related quality of life assessment at the outset of the study, there were no important differences in the results with antibiotic therapy as compared with those given placebo. In the placebo group, there was improvement in 36% of patients, no change in 25%, and deterioration in 39%. These responses were not significantly different from the treatment group.

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