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Treatment of Early Lyme Disease

Treatment of Early Lyme Disease,Raphael B. Stricker,Andrea Gaito,Nick S. Harris,Joseph J. Burrascano

Treatment of Early Lyme Disease   (Citations: 4)
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TO THE EDITOR: Wormser and colleagues (1) reported the results of very short-term (10-day) versus short-term (20-day) antibiotic treat- ment for patients with early Lyme disease who presented with an erythema migrans rash. Using an on-study analysis, the authors claimed that 84% to 90% of patients had a complete response to one or the other treatment after 30 months of follow-up. These results represent "creative mismanagement" of the study data (2). Although the study enrolled 180 patients in 3 treatment groups, only 99 patients were evaluable after 30 months of observation, yielding a dropout-plus-exclusion rate of 45% (25% of patients were excluded, and 20% dropped out). Since almost half of the patients were not included in the final analysis of this observational trial, the on-study results are virtually meaningless because the uncounted par- ticipants must be considered potential treatment failures (2). Fur- thermore, an exclusion rate of 25% invalidates the study randomiza- tion, and a dropout rate of 20% invalidates the overall study results (2). In the more appropriate intention-to-treat analysis, which we present in the Table, the least stringent response rates (complete response plus partial response) ranged from 49% to 62%, while the most stringent response rates (complete response only) ranged from 44% to 53% at 30 months of follow-up. These results are a far cry from the response rates trumpeted by the authors, and they indicate potential failure of both the short-term and very short-term regimens in a significant number of patients. An illustrative problem with the analysis was the exclusion of the 5% to 10% of patients who developed a recurrent erythema migrans rash. Although the authors excluded these patients because of the possibility of a new spirochetal infection, a more likely expla- nation is that the patients had recurrent rashes because of failure of their initial treatment and persistent Lyme disease (3). Thus, manip- ulation of the study results turned an intention-to-treat failure into an on-study success, and this outcome highlights the problematic data interpretation embraced by the authors. Furthermore, by con- servative estimate, at least 41% of patients with early Lyme disease never develop an erythema migrans rash (4). Thus, the study by Wormser and colleagues included only patients whose conditions were easiest to diagnose, making the poor treatment results of short- term therapy even more disappointing. Over the past 3 years, undertreatment of Lyme disease has be- come institutionalized in the United States. This unfortunate trend has evolved on the heels of a highly flawed study of chronic Lyme disease therapy (5) and publication of manipulated data from early Lyme disease treatment, as seen in the report by Wormser and col- leagues and elsewhere (6). It is time to start using well-designed studies and more appropriate statistics in the analysis of Lyme disease therapy in order to assess the gravity and risk of this protean illness. In contrast to the current national trend, we need to examine longer courses of antibiotics to treat persistent spirochetal infection and obtain better clinical outcomes for patients with Lyme disease (6).
Published in 2004.
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    • ...I would like to thank Dr. Dumler for his reply to my letter expressing concerns regarding the Coulter et. al. study evaluating Lyme disease testing (4)...

    Joel Spinhirne. Statement for IDSA Lyme Disease Review Panel

    • ...Furthermore, the authors used development of an EM rash as an endpoint in the study. Since 41–65% of Lyme disease patients do not develop an EM rash, the study may have missed more than half the patients who eventually came down with Lyme disease after receiving single-dose prophylaxis. The use of single-dose doxycycline also raises concern about antibiotic resistance following this microbiologically unsound therapy. A more recent study of ultrashort course doxycycline therapy (10 days) for early Lyme disease had significant design flaws and showed efficacy in less than 50% of patients [,...

    Raphael B. Strickeret al. Lyme Disease: The Quest for Magic Bullets

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