ALDF article fails to mention flaws in Lyme disease trials

patient with doctor

In his article "Is It Possible to Make a Correct Diagnosis of Lyme Disease on Symptoms Alone?" published in the American Journal of Medicine, Dr. Phillip J. Baker, executive director of the American Lyme Disease Foundation (ALDF) cites five Lyme disease trials to support the organization's position that extended antibiotics are not useful in the treatment of Lyme disease. [1] Unfortunately, Dr. Baker fails to mention several flaws with those clinical trials.

Dr. Baker, who is responsible for overseeing The National Institute of Allergy and Infectious Diseases’ (NIAID) Lyme disease program, writes in his article, “The results of 5 placebo-controlled clinical trials on the efficacy of extended antibiotic therapy for the treatment of post-Lyme disease symptoms provided no evidence of a persistent infection by culture and/or other laboratory tests, and showed no significant lessening of symptoms, which one would expect to occur if symptoms were caused by a persistent infection.”¹

Unfortunately, Dr. Baker fails to mention that these trials, sponsored by the National Institutes of Health (NIH), were rife with flaws. They were small, under-powered and typically enrolled the sickest Lyme disease patients, who had already failed other treatments.

An article by the American Lyme Disease Foundation fails to address flaws in Lyme disease trials which advocate short-term use of antibiotics, even when symptoms persist. Click To Tweet

The largest study included only 70 subjects. The smallest enrolled 37. The subjects had been ill an average of 4.7 to 9 years in 3 of the 5 studies. And their quality of life and functioning was already poor. The Berende trial subjects had been ill for 2 years on average and also presented with a poor quality of life.

Read more: At least 50% of patients with Lyme neuroborreliosis remain ill years after treatment

Furthermore, Dr. Baker failed to give credit to positive results with extended antibiotic treatment. The Krupp trial revealed a significant reduction in Lyme fatigue, as did the Fallon trial.

Finally, Dr. Baker has not considered the poor reliability of the culture or laboratory test for Lyme disease in identifying whether a persistent infection has cleared.

Editor’s Note: Lyme disease treatment should not be based on results from flawed clinical trials.

References:
  1. Baker PJ. Is It Possible to Make a Correct Diagnosis of Lyme Disease on Symptoms Alone? Review of Key Issues and Public Health Implications. Am J Med. 2019.
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1 Reply to "ALDF article fails to mention flaws in Lyme disease trials"

  • Angela Berry Koch
    03/04/2020 (7:18 am)
    Reply

    NHI research seems biased toward insurance and managed care entities; and not to solving the health care needs of chronic cases. Asking the question of “ how long to pay for antibiotic treatments”’ seems silly when you have not defined adequately the illness. Rarely is it one infection, by virtue of what the tick carries, and immune system being manipulated by these pathogens, with opportunistic infections abounding. A functional medicine approach would include the likely role of co infections, an integrated approach which would include immunotherapy as well as antimicrobials, recognition of genetic predisposition to poor outcomes such as mast cell disorders, and then look at treatment outcomes as compared with groups who either are not infected, or show no symptoms. Finally, the culture test would not be reliable if not performed for at least four months. As was the case for my own family member who was infected 15 years earlier, could not generate an IgM response to any test; but did get a positive culture for active infection only at the end of 16 weeks. Prior to that at 8, 10, and 12 weeks it was negative.


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