Raphael B. Stricker, MD; Andrea Gaito, MD; Nick S. Harris, PhD; Joseph J. Burrascano, MD
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Stricker R., Gaito A., Harris N., Burrascano J.; Treatment of Early Lyme Disease. Ann Intern Med. 2004;140:577. doi: 10.7326/0003-4819-140-7-200404060-00022
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Published: Ann Intern Med. 2004;140(7):577.
TO THE EDITOR:
Wormser and colleagues (1) reported the results of very short-term (10-day) versus short-term (20-day) antibiotic treatment 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 participants must be considered potential treatment failures (2). Furthermore, an exclusion rate of 25% invalidates the study randomization, and a dropout rate of 20% invalidates the overall study results (2).
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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