Background
In 2023, the intrepid journalists at Polish broadcaster TOK FM exposed the destructive and cult-like “Lyme Underground” in their Podziemie podcast series. Like other journalists, they discovered how patients are cheated and abused by quacks who sell fake diagnoses and treatments.
Naturally, anti-science activists protested attempts to protect the public from “Lyme literate” scammers. In a January 2024 response to the activists, the Polish Health Ministry incorporated part of a report by infectious disease expert Prof. Ph.D. n. med. Miłosz Parczewski.
In February 2024, the Polish Ministry posted on Twitter/X about the full report. Here is a translation:
❗️ Do you know the principles of diagnosis and treatment of Lyme disease? 🩺🔬 Find out why the “ILADS method” should not be used. Read More: Gov.pl
Below is a translation of the report:
Szczecin, Poland, January 30, 2024
To: Ms. Dominika Janiszewska-Kajka, Department of Medicine, Ministry of Health
Opinion of the National Consultant on the principles of diagnosis and treatment of Lyme disease in accordance with the letter DLG.741.99.2023.WN of January 10, 2024
According to the current state of knowledge, Lyme disease is a disease transmitted by ticks, the number of cases of which is increasing in Poland and Europe, which is partly due to climate change – it is expected that in the coming years there will be a further increase in the number of diagnosed cases. Poland remains an endemic area for Lyme disease (1). The clinical course of Lyme disease is clearly defined and includes early Lyme disease with localized forms (erythema migrans – the most frequently diagnosed form of Lyme disease and borrelial lymphocytoma), early disseminated infection (multiple erythema, neuroborreliosis, acute arthritis, acute inflammation of the heart muscle (Lyme carditis) and late Lyme disease under forms of neuroborreliosis, Lyme arthritis and chronic atrophic dermatitis (2). For all the above-mentioned forms, clinical symptoms defining each stage and form of Lyme disease are described. The diagnostic standard remains a two-stage diagnosis in the first stage with an immunofluorescence test with quantitative assessment of antibodies (tests based on ELISA method and its modifications – high sensitivity) followed by a Western-blot test and assessment of the characteristics of the produced antibodies (qualitative test, high specificity) (3).
The European Parliament resolution (4) cited in the cover letter underscores the importance of Lyme disease issues expressing concern about the growing prevalence of the problem. The resolution stresses the importance of research into the detection and treatment of Lyme disease, calls for the commitment of additional resources and the promotion of research efforts and international cooperation on the disease, as well as the collection of data and reporting of cases, the facilitation of cooperation and the promotion of best practices in monitoring, diagnosis and treatment. At the same time, the resolution calls on the European Commission to introduce measures for prevention and control of tick populations, develop evidence-based guidelines for clinical and laboratory tests for diagnosing Lyme disease, calls for the introduction of a separate ICD code for early- and late-stage Lyme disease. The resolution also calls for the adoption of individual ICD codes for the different symptoms of late-stage Lyme disease, calls for the publication of relevant guidelines, expanded access to clinical tests so that doctors can accurately diagnose Lyme disease, and help address the problem of missed treatments. It also calls for improved access to epidemiological data: assessing the number of patients who have long sought appropriate diagnosis and treatment of Lyme disease, and developing and innovative projects that can improve data collection and make education and awareness campaigns more effective. The resolution also refers to the implementing decision on the epidemiological surveillance of infectious diseases, which includes neuroborreliosis in the list of infectious diseases, and emphasizes the importance of epidemiological surveillance, information campaigns, and notes the need to develop a plan to combat Lyme disease and a European network on this disease, calling at the same time for the publication of prevention guidelines in the group vulnerable people, especially those working professionally in the agroforestry sector and scientists involved in collecting data in the field. It should be noted that the resolution does not describe medical recommendations for the treatment of Lyme disease, including neuroborreliosis, but de facto describes the need for supervision, consistent and evidence-based therapy guidelines, and conducting reliable research on Lyme disease (including neuroborreliosis)..
The current ICD-10 classification distinguishes the following clinical forms of Lyme disease (Lyme disease): A69.2 Lyme disease Erythema chronic migrans caused by Borrelia burgdorferi, allowing, at the same time, supplements with code A69.2 in the following recognized cases:
– G01 – Meningitis due to bacterial diseases classified elsewhere,
– G63.0 – Polyneuropathy in infectious and parasitic diseases classified elsewhere,
– M01.2 – Arthritis due to Lyme disease
In turn, the newer ICD-11 classification developed by WHO specifies the clinical forms in the following codes:
1G Lyme borreliosis
- 1C1G.0 Early cutaneous Lyme borreliosis
1C1G.1 Disseminated Lyme borreliosis:
- 1C1G.10 Lyme neuroborreliosis
- 1C1G.11 Lyme carditis
- 1C1G.12 Ophthalmic Lyme borreliosis
- 1C1G.13 Lyme arthritis (arthritis in the course of Lyme disease)
- 1C1G.14 Late cutaneous Lyme borreliosis
1C1G.1Y Other specified disseminated Lyme borreliosis
1C1G.1Z Disseminated Lyme borreliosis, unspecified
1C1G.Y Other specified Lyme borreliosis.
It is important to note that none of the above clinical classifications classify Lyme disease as a chronic disease. As I described above, there are early and late, localized and disseminated forms, but according to current knowledge and the WHO classification, there is no “chronic Lyme disease”. The incorrect term “chronic Lyme disease” also implies the long-term nature of therapy, as in the case of Lyme disease and long-term (often many months) incorrect use of antibiotics, which is not included in the recommendations.
It is also worth emphasizing that in accordance with the guidelines of the Polish Society of Epidemiologists and Infectious Disease Physicians (3) (published in 2023), as well as in the detailed international IDSA (Infectious Diseases Society of America) guidelines published in 2020 (5) for the different forms of Lyme disease, the length of antibiotic treatment is clearly defined and does not exceed 30 days for any clinical stage, with the possibility of possibly repeating intravenous antibiotic therapy once for 2-4 weeks in special cases (e.g. arthritis without improvement after oral antibiotic therapy).
On the other hand, the “ILADS method” quoted in the cover letter (published in 2014, so a long time ago), which is based on the publication titled “Evidence Assessments and Guideline Recommendations in Lyme Disease: The Clinical Management of Known Tick Bites, Erythema Migrans Rashes and Persistent Disease” (6) is very often the basis for long-term (chronic) antibiotic therapy, often lasting many months or even more than a year.
Below is a brief analysis of the document regarding the “ILADS method” (6) and a comparison to the Polish recommendations (3) and IDSA (5):
– The use of one dose of 200 mg of doxycycline as a prevention of Lyme disease after tick bites is not recommended (it is also not recommended in the recommendations and IDSA, and in Polish recommendations it can be used in exceptional cases of high-risk needlestick injuries for people from outside endemic areas)
– Treatment of erythema migrans should be extended to 4-6 weeks (in Polish and IDSA recommendations it is a maximum of 21 days with a tendency to shorten antibiotic therapy) and the treatment should include doxycycline, amoxicillin or cefuroxime (similarly to the Polish and IDSA recommendations).
– The document presented by ILADS allows for the extension of antibiotic therapy (the length is not specified) if necessary after assessing the effectiveness (NO recommended in Polish or IDSA recommendations) and as an alternative, 21 days of azithromycin is given (also not recommended in other guidelines).
– ILADS recommends that patients with long-term symptoms be assessed before additional antibiotic therapy is instituted (which is also described in the Polish and IDSA guidelines)
– ILADS recommends antibiotic retreatment if Lyme disease is judged to be a possible cause of prolonged symptoms and decreased quality of life. In this case, the length of retreatment is specified (4-6 weeks) and the need to individualize antibiotic therapy is emphasized, Combination therapies with oral antibiotics (it is not specified precisely which ones or in what sequence) or an intravenous antibiotic (benzathine penicillin or ceftriaxone) used in monotherapy or in combination with another oral antibiotic (which is not specified) are also allowed. In addition, further prolongation of antibiotic therapy was allowed based on duration, clinical response, severity of symptoms and their recurrence, if any. (Recommendations 3a,b,c, (6)). This point of the ILADS document is vague and leads to abuse of antibiotic therapy – the exact conditions for implementing retreatment with antibiotics are not specified, there is no definition of how antibiotics should be associated, nor is any scientific evidence given for the use of such associations. Even the ILADS guidelines themselves do not provide Evidence-based medicine data on the long-term use of antibiotics and their possible associations. Such retreatment is also not recommended in any other recommendations.
In summary, the “ILADS method” referred to in the cover letter has become a common basis in clinical practice in Poland for long-term (even over a year and several years!) use of many antibiotics, often in combinations (including drugs from the Beta-lactams, rifampicin, metronidazole, macrolides and others ). This approach does not result from any recommendations (as I mentioned above, even in the “ILADS recommendations” there are no guidelines on how to combine antibiotics or the target length of antibiotic therapy). The effectiveness of long-term antibiotic therapy has not been confirmed in randomized clinical trials on large enough groups and may lead to significant side effects and result in the selection of antibiotic resistance in the general Polish population. Medical literature precisely describes cases of complications after long-term antibiotic therapy used in cases of Lyme disease (7). Additionally, there is scientific evidence in a randomized clinical trial (published after the publication of the “ILADS method” in 2016) describing the lack of benefit from long-term antibiotic therapy (12 weeks) compared to shorter therapy (8).
Concluding the analysis of the guidelines and scientific data presented above, I have a negative opinion of the use of the “ILADS method” in the treatment of Lyme disease. This method is overused and leads to chronic and combined use of antibiotics with abandonment of the search for other causes (including non-specific) symptoms, often by people without specialization in infectious diseases, which constitutes a significant risk for patients and the population in the context of selection of antibiotic resistance and therefore should not be used. Treatment of Lyme disease should be carried out by specialists and doctors specializing in infectious diseases in clinics and hospital departments dedicated to this specialization.
Due to frequent limited availability and a small number of specialists and appropriate hospital clinics/subdepartments, we should strive to increase access to Infectious Disease Clinics as well as improve the valuation of diagnostic and therapeutic procedures related to Lyme disease, so as to take into account the possibility of conducting differential diagnosis (including degenerative and rheumatological diseases). Currently, the treatment of Lyme disease should be carried out in accordance with the principles of evidence-based medicine and recommendations consistent with the current state of knowledge specifying precisely the type and length of treatment used, for example the recommendations of the Polish Society of Epidemiologists and Infectious Disease Physicians (3).
Finally, in accordance with the above-mentioned resolution of the European Parliament, efforts should be made to increase the number of clinical trials on the diagnosis and treatment of Lyme disease in order to reliably and based on evidence-based medicine improve the care of people diagnosed with Lyme disease in the future.
Kind regards
Prof. Miłosz Parczewski
Literature:
1. National Institute of Public Health/PZH, “Infectious diseases and poisonings in Poland in 2022“
2. Stanek G, Wormser GP, Gray J, Strle F. Lyme borreliosis. Lancet 2012;379:461– 73. (mirror)
3. Recommendations for the diagnosis and treatment of Lyme borreliosis of the Polish Society of Epidemiologists and Infectious Disease Physicians. 2023, doi: 10.32394/pe.77.25
4. European Parliament resolution of 15 November 2018 on Lyme neuroborreliosis (Lyme disease) (2018/2774(RSP))(2020/C 363/13)(OJ C of 28 October 2020 )
5. AAN/ACR/IDSA 2020 Guidelines for the Prevention, Diagnosis and Treatment of Lyme Disease
7. Marzec NS, Nelson C, Waldron PR, et al. Serious Bacterial Infections Acquired During Treatment of Patients Given a Diagnosis of Chronic Lyme Disease — United States. MMWR Morb Mortal Wkly Rep 2017;66:607–609. DOI: https://dx.doi.org/10.15585/mmwr.mm6623a3
8. Berende A, ter Hofstede HJ, Vos FJ, van Middendorp H, Vogelaar ML, Tromp M, van den Hoogen FH, Donders AR, Evers AW, Kullberg BJ. Randomized Trial of Longer-Term Therapy for Symptoms Attributed to Lyme Disease. N Engl J Med. 2016 Mar 31;374(13):1209-20. doi: 10.1056/NEJMoa1505425
Other resources
LymeScience: Scientists blast unscientific & dangerous EU Lyme resolution, call for addressing misinformation
LymeScience: UK watchdog condemns ILADS propaganda
Auwaerter PG, et al. Antiscience and ethical concerns associated with advocacy of Lyme disease. Lancet Infect Dis. 2011.