duncan, you've also raised good points.
First for anyone who has had problems accessing the full text to "Development of a foundation for a case definition of post-treatment Lyme disease syndrome" using the link I provided, there is an easier way to access this. I have no idea why that link doesn't work and the text wouldn't fully activate as a link, but this new link will take you to the abstract. When there, click on the open access box on the top right side of the page.
On the question of treatment. In the case of the Aucott studies, what they were treated with as the first line protocol is clearly stated:
The current study is part of a larger cohort study of Lyme disease and PTLDS in which participants were treated with a 3-week course of oral doxycycline and followed post-treatment for a period of up to 2 years.6 The current study focused on the time period from time of diagnosis of Lyme disease through 6 months post-treatment, including visits immediately post-treatment (approximately 3 weeks after the first), 4 weeks post-treatment, and 3 months post-treatment. During the initial visit, at time of diagnosis, demographic information and medical history were recorded. At all study visits, participants underwent a physical exam, a clinical interview that included symptom reporting, interval medical history and medication usage, and self-administered the 36-item Short Form Health Survey, Version 2 (SF-36).
You will note that this length of treatment is the longest treatment period recommended in the 2006 IDSA Lyme Guidelines, which advise 10 to 21 days. If one were to set out to demonstrate that the recommended treatment is ineffective, you need to study patients who have been treated to the maximum limit of the guidelines. Then you can begin to delineate just how many patients don't have their symptoms resolve and how many of those are so debilitated that they can then be categorized as having "PTLDS". In this case:
Only 60% of patients returned to their pre-Lyme health status when measured at six months post-treatment, leaving 40% of patients with either residual symptoms or functional impact, or both.
To determine the impact on life functioning specific to individuals with PTLDS, we created a composite score based upon our previous research using the SF-36 in an early Lyme cohort.15 An ANOVA revealed that the three groups differed on this composite score (F(2) = 7.46, p = 0.001), with post-hoc analyses demonstrating that the PTLDS symptom-positive group differed significantly from the PTLDS symptom-negative group (p < 0.001) and the control group (p = 0.01); however the PTLDS symptom-negative group did not differ significantly from the control group (p = 0.83). Using this composite score, there were eight individuals who were PTLDS symptom-positive who were below the cut-off of T = 45, and there was a clearer division between patients with symptoms who endorsed impact on life functioning and those who did not (see Figure 2b). Using these criteria, twenty (28%) patients had either residual symptoms or functional impact, but not both, and did not meet criteria for PTLDS. Forty-three (60%) patients returned to their pre-Lyme health status when measured at six months post-treatment. When compared to using the physical component score and mental component score provided by the SF-36, our composite score performed better in distinguishing between the three patient populations (see Figures 2c and 2d); no significant differences between the three groups were seen in either the physical component score (p = 0.1381) or the mental component score (p = 0.1766). There was an even distribution of those individuals who were retreated with a second course of antibiotics among all three outcome groups.
That only 11% in this study were so debilitated as to qualify as having PTLDS (some of whom were 're-treated' based on the most liberal interpretations of the guidelines) shows how stringent the definition is. In the real world, patients even with outright treatment failure are often not recognized and provided with the full amount of treatment suggested as being advisable. Treatment protocols that demonstrably leave 40% of early acute stage patients without symptom resolution need to be revisited and changed. In order to change things in the real world, it needs to be demonstrated unequivocally that the much touted fixes just don't work.
The IDSA is ubiquitous, powerful and unwilling to do studies that will prove that their recommendations are wrong (for obvious reasons). So, how do you think any researcher could go about proving
that the IDSA has been consistently wrong about treatment, if not how Aucott is proceeding?
The only way to do this, as far as I can see, is by doing solid evidence-based scientific research on well characterized human cases.This won't happen with just one or two studies and would have to be a methodical process that moves from step A to B. I have no idea whether Aucott actually does think that Lyme is (or might be in 'some' patients) persistent or not because he is careful not to suggest any answer at all. Nonetheless, each patient he studies provide more and more clues into individual patient circumstances and whatever he believes will be influenced by the weight of his findings.
duncan, you wrote:
Word choice matter. If one's narrative assumes a bias, even an inadvertent one, that bias can influence readers. With most clinicians reading only abstracts (if they read this stuff at all), every inference or impression that works against a particular stance in the debated Lyme quarter counts.
I couldn't agree more! I sometimes think that study authors don't recognize just how their words will be interpreted. I also think that in many cases, for those trying to create the "middle ground" in research, they could very well believe that if they openly show a particular hand, they might justifiably feel that it could get chopped off. I suspect that in order to actually get funding and get published many researchers pander to the IDSA. If they want to work and advance the science, I don't see that they have any choice in this. Maybe he truly believes the IDSA dogma but, only he would know for sure. However, I do sometimes wonder how open-minded researchers feel when they look into a mirror.