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 investigator
Contact: Laurie K. Doepel
NIH/National Institute of Allergy and Infectious Diseases