Dave6002
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Generalizability in two clinical trials of Lyme disease. � Cameron DJ.
ABSTRACT: OBJECTIVE: To examine the generalizability of two National Institutes of Health (NIH) funded double-blind randomized placebo-controlled clinical trials in patients with chronic Lyme disease and to determine whether selection factors resulted in the unfavorable outcomes. DESIGN: Epidemiologic review of the generalizability of two trials conducted by Klempner et al. This paper considers whether the study group was representative of the general chronic Lyme disease population. RESULTS: In their article in The New England Journal of Medicine, Klempner et al. failed to discuss the limitations of their clinical trials. This epidemiologic review argues that their results are not generalizable to the overall Lyme disease population. The treatment failure reported by the authors may be the result of enrolling patients who remained ill after an average of 4.7 years and an average of 3 previous courses of treatment. The poor outcome cited in these trials may be explained by having selected patients who had undergone delayed treatment or multiple treatments unsuccessfully. These selection factors were not addressed by the studies authors, nor have they been discussed by reviewers. The trials have been over-interpreted by the NIH and widely publicized in a press release. The results have been extrapolated to other groups of Lyme disease patients by commentators, by a case discussant in an influential medical journal, and by health insurance companies to deny antibiotic treatment. CONCLUSIONS: The Klempner et al. trials are assumed to be internally valid based on a Randomized Control Trial (RCT) design. However, this review argues that the trials have limited generalizability beyond the select group of patients with characteristics like those in the trial. Applying the findings to target populations with characteristics that differ from those included in these trials is inappropriate and may limit options for chronic Lyme disease patients who might benefit from antibiotic treatment. PMID: 17044928 [PubMed - as supplied by publisher]
Posts: 1078 | From Fairland | Registered: Apr 2006
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Yes a very good article.But these people need too tell the CDC,THERE findings,and see if the CDC will buy it.But for now,all they listen to is the IDSA,guidliness.And in the article,the words MAY BE,need replaced.
Posts: 510 | From NEVERLAND.USA | Registered: Jul 2005
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It is a good article and glad it was published but I doubt if the NIH, the insurance cos or anyone in that camp will admit it is true.
Posts: 8430 | From Not available | Registered: Oct 2000
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