Source: http://relative-risk.blogspot.com/2010/ ... y-who.html
23 March 2010
i.v. infusion: Safe? Maybe. Necessary? Who knows?
Well, Stricker’s paper on i.v. treatments for Lyme disease isn’t much more enlightening than the earlier abstract.
As a reminder, the authors of this trial are 1) people who believe in long-term antibiotic use for the persistent symptoms of presumptive Lyme disease, 2) people who are members of an organization (ILADS) dedicated to the use of long-term antibiotics for presumptive Lyme disease, 3) people from a home infusion company who market themselves as a “Lyme literate” pharmacy*, and 4) people who are members of a patient advocacy group dedicated to the belief in chronic antibiotic usage for chronic Lyme disease. Therefore, expect some serious bias.
So Stricker et al. gathered up some data on 200 patients (in 18 states) who had been diagnosed and treated for Lyme disease.
According to the authors, “all patients had significant neuropsychiatric symptoms,” which the authors and the treating physicians apparently attributed solely to Lyme disease. No inclusion criteria for patient selection are provided in the text. There’s no case definition for persistent neurologic Lyme disease. There is only a reference to Fallon’s 2008 clinical trial in which he famously had so much trouble finding well-defined chronic Lyme patients. (After screening 3,368 potential patients, he found 37 with some convincing evidence of Lyme disease. They got treated with 10 weeks of iv ceftriaxone after which Fallon concluded: “10 weeks of iv ceftriaxone…is not an effective strategy.” I wonder why he’s not on this particular study?)
All of the patients also tested positive for B. burgdorferi, but again, they don’t say how they were tested or where. (I’m guessing the various treating physicians in the unnamed 18 states had Igenex do some serology.)
The patients were largely middle-aged (mean 41 years) women (141 women vs. 59 men), plugged into some manner of i.v. device for an average of 118 days. (Interesting sex ratio. According to the CDC surveillance data, men and women contract Lyme in about equal numbers. Then why so many women with “significant neuropsychiatric symptoms”?)
The i.v. devices include PICC lines, peripheral catheters, s.c. ports, c.v. catheters, and midline catheters. The particular device was selected by the various treating physicians, along with the particular antibiotic and dosage. Table 1 in the paper lists 13 different antibiotics used among 200 patients.
So we have 200 people who may or may not have an active borreliosis, enrolled based on vague criteria from an unknown number of primary care physicians using five different i.v. devices and 13 different kinds of antibiotics over a period of time that ranged from 7 to 750 days.
What a mess of variables and unknowns. The stats software must have imploded trying to make sense of this trial. But then some of the virtues of InStat software are 1) that it “does not assume that you are a statistics whiz,” 2) “you don’t have to know the name of the test you need," and 3) “all prompts to the user are in plain English and simple to follow.” Stats for Dummies.
Table 2 lists complications from the i.v. devices and the medication. There were 24 patients with complications. So that’s 12% of the study population who experienced an adverse event. Is that considered safe? Stricker says so.
Is it effective? Stricker writes, “It remains to be seen whether this length of treatment was able to reduce or eliminate an underlying infection.” (Assuming one ever existed.) Apparently we have to wait for the sequel in the form of another bad paper in an obscure foreign journal. He writes, “The present study…makes no comment about the efficacy of this treatment.”
Was this really ethical? Lining up a bunch of people (with significant neuropsychiatric symptoms) to see if procedure X is not therapeutic but merely safe? Sounds like something you’d do with guinea pigs.
*"The QMedRx Clinical Staff and Medical Advisory Committee have prepared a web based patient outcome questionnaire. Our goal is to help your physician maximize your response to treatment, make data easier for you to document and easier for your physician to retrieve. Some benefits may include the collection and publishing of data to document the positive outcome of IV antibiotic treatment."