Flaws in Lyme Disease Clinical Trials: ALDF Article Critiqued
Debate continues over whether persistent symptoms after Lyme disease treatment may reflect ongoing infection. An article from the American Lyme Disease Foundation (ALDF) argues that clinical trials show no evidence of persistent infection, but important limitations of those trials are often overlooked.
Dr. Phillip Baker, former director of the American Lyme Disease Foundation and former overseer of the National Institute of Allergy and Infectious Diseases’ (NIAID) Lyme disease program, wrote that “the results of five 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.”1
However, Dr. Baker does not address several important limitations of these National Institutes of Health (NIH)-sponsored trials.
[bctt tweet=”An ALDF article fails to address flaws in Lyme disease clinical trials used to argue against extended antibiotic treatment.” username=”DrDanielCameron”]
Why Lyme Disease Clinical Trials Are Controversial
The trials often cited to argue against persistent infection were relatively small and enrolled patients who had been ill for many years.
The largest study included only 70 participants, while the smallest enrolled just 37 subjects.
In three of the five studies, participants had been ill for an average of 4.7 to 9 years before enrollment. By that time many had already experienced significant disability and had failed prior treatments.
In the Berende trial, subjects had been ill for approximately two years on average and also reported poor quality of life at enrollment.
These factors make it difficult to apply the findings broadly to Lyme disease patients who are diagnosed and treated earlier in the course of illness.
Read more: At least 50% of patients with Lyme neuroborreliosis remain ill years after treatment
Evidence of Benefit in Some Trials
Dr. Baker’s discussion also overlooks evidence suggesting that some patients may benefit from additional antibiotic treatment.
For example, the Krupp trial demonstrated a significant reduction in fatigue among Lyme disease patients receiving antibiotic therapy.
Similarly, the Fallon trial reported improvements in fatigue and cognitive function in some patients treated with intravenous antibiotics.
Challenges in Detecting Persistent Infection
Another important issue involves the limitations of currently available laboratory tests.
Culture techniques and other laboratory tests used in these trials are not sensitive enough to determine whether a persistent infection has been completely eradicated.
Current diagnostic tests are not designed to confirm that infection has been fully cleared. As a result, the absence of laboratory evidence does not necessarily prove that infection has been eliminated.
Many patients continue to report fatigue, cognitive symptoms, and chronic pain after treatment. Whether these symptoms reflect immune effects, tissue damage, coinfections, or persistent infection remains an area of ongoing research.
Some individuals continue to experience persistent Lyme disease symptoms even after antibiotic therapy.
Clinical Takeaway
Small and methodologically limited trials should not be used alone to determine treatment strategies for complex Lyme disease cases. More rigorous research is needed to better understand persistent symptoms and treatment responses.
Editor’s Note: Lyme disease treatment decisions should not rely solely on results from small or methodologically limited clinical trials.
Related Articles:
Level with Lyme disease patients: at least 1 in 3 fail treatment
Lyme disease treatment: one size does not fit all
Diversity of Borrelia burgdorferi strains may explain treatment failures
References:
- 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.
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.