Characteristics of Clinics Offering Nontraditional Lyme Disease Therapies in Lyme Endemic States of the United States

Abstract

In this cross-sectional analysis, we analyzed 117 US clinics in Lyme endemic states that provide nontraditional care for Lyme disease. We found that unproven therapies are routinely offered, and some therapies raise safety concerns. The cost of care can be high, which may lead to significant out-of-pocket expenditures for patients.

Patients with chronic unexplained symptoms or symptoms that persist after completing Lyme disease treatment sometimes carry the diagnosis of “chronic Lyme disease” (CLD), a catch-all term that lacks an established definition or proven treatment [1]. These patients often have unexplained symptoms despite extensive testing and treatment, which can be unsatisfying for both patients and providers [2]. Misinformation regarding CLD can be found in popular media and is promoted through outreach efforts by certain Lyme disease advocacy and support groups [3, 4]. A study in 2015 identified more than 30 unorthodox therapies that are marketed to patients on the internet for treatment of Lyme disease, many of which have no evidence to support their use [5].

Many patients who are diagnosed with CLD seek care at clinics that offer nontraditional approaches to managing Lyme disease, yet the characteristics of these clinics are poorly understood. In this study, we analyzed clinics in Lyme endemic states of the United States that offer nontraditional Lyme disease therapies to better understand the credentials of clinicians providing care at these clinics, the types of therapies offered, and the cost of services.

METHODS

This cross-sectional study was determined to be nonhuman subjects research by the Minneapolis Veterans Affairs Health Care System. We conducted a Google internet search between February 2024 and April 2024 to identify standalone clinics in US states with a high incidence of Lyme disease that use alternative, integrative, functional, holistic, or naturopathic approaches for diagnosing or treating Lyme disease. We limited our search to clinics in the 14 states with the highest incidence of Lyme disease based on Centers for Disease Control and Prevention data from 2008–2015: Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, and Wisconsin, hypothesizing that the demand for such treatments would be highest in states with the greatest burden of true disease [6].

We used the state's name in combination with “Lyme clinic” or “chronic Lyme disease” as search terms. We stopped our search after reaching 5 consecutive Google search pages (10 search results per page) without a clinic in the state that met inclusion criteria. We did not use filters for the Google searches. We excluded clinics listed as being an urgent care, a foundation, permanently closed, or without a physical address. We also excluded websites if they were marked as being an “advertisement” or “sponsored,” social media pages, news articles, government websites, online healthcare databases, or healthcare provider review websites.

The following data were collected for each clinic: location, provider credentials and specialty, cost of consultations, pricing models, acceptance of health insurance, Lyme disease therapies listed, and the associated cost of the services provided. We identified physician specialties by searching for the specialty name or the associated residency or fellowship training in the provider section of the clinic website. If a physician further specialized within their field, we included the most specialized field. We categorized the cost of a “free” consultation as “not available” because “free” often referred to an informational phone call rather than a formal consultation. If the cost of a clinic visit did not specify whether the cost was for a new or established (follow-up) consultation, the cost was not included in the results. If acceptance of insurance was not clearly stated on the website or not specific enough to accurately categorize it, we categorized insurance for that clinic as “not available.” We considered a clinic to offer a particular therapy for Lyme disease if the clinic website specifically stated that a therapy was used or indicated for Lyme disease.

Two authors (J.D.A. and J.R.S.) independently conducted the review; discrepancies were reviewed and resolved through consensus. A third author (M.K.R.) was used to resolve disagreements. Descriptive statistics were used in Excel (Microsoft).

RESULTS

We identified 117 clinics that met inclusion criteria. Of these, there were 18 clinics in New York, 16 in Virginia, 11 in Maine and Minnesota, 10 in New Hampshire and Vermont, 8 in Massachusetts, 7 in Maryland and Wisconsin, 6 in Connecticut, 4 in Delaware and Pennsylvania, 3 in New Jersey, and 2 in Rhode Island. Fifty-three clinics (45%) were staffed by an MD/DO provider, 37 (32%) by a naturopathic doctor, 36 (31%) by an advanced practice provider, and 21 (18%) by a chiropractor (Table 1). Thirty-three (28%) clinics listed the cost of a new consultation, which ranged from $87 to $3250 (“cost per visit,” N = 31) and $270 to $400 (“cost per specified unit of time,” N = 2). Twenty-three clinics (20%) listed the cost of an established (follow-up) consultation, with costs ranging from $70 to $690 (“cost per visit,” N = 20), and $270 to $550 (“cost per specified unit of time,” N = 3). Ten (9%) clinics provided a package or membership, with 6 listing package costs ranging from $39 to $4837. Of 69 clinics (59%) that specified having a health insurance policy, 34 clinics (49%) required that patients submit a claim to their insurance company, 25 (36%) accepted health insurance, and 10 (14%) did not accept health insurance.

Table 1.

Credentials and Physician Specialties of Providers in Nontraditional Lyme Disease Clinics, 2024

Provider Credentials	Number of Clinics
MD/DOa	53
Family medicineb	26
Internal medicineb	10
Emergency medicineb	4
Psychiatryb	4
Hematology/oncologyb	2
Palliative careb	2
Rheumatologyb	2
Cardiologyb	1
Cardiothoracic surgeryb	1
Dermatologyb	1
Emergency medicine/internal medicineb	1
Endocrinologyb	1
Gastroenterologyb	1
General surgeryb	1
Neurologyb	1
Obstetrics/gynecologyb	1
Pediatric neurologyb	1
Pediatricsb	1
Physical medicine and rehabilitationb	1
Naturopathic Doctor	37
Advanced Practice Providerc	36
Doctor of Chiropractic	21
Otherd	57

Abbreviations: DO, Doctor of osteopathic medicine; MD, Doctor of medicine.

^aSome clinics had multiple physicians from different specialties, or physicians for whom specialty could not be determined. Physician specialty was not available or could not be determined for 3 clinics in which an MD/DO was listed.

^bMD/DO physician specialty.

^cIncludes nurse practitioners and physician assistants.

^dIncludes acupuncturists, aestheticians, social workers, massage therapists, physical therapists, occupational therapists, coaches, nonphysician doctorates, dieticians, registered nurses, and providers with credentials that could not be specified.

Lyme disease therapies were offered by all clinics. Herbs/supplements were most common (N = 53, 45%) followed by nonantibiotic intravenous therapy (N = 30, 26%), unspecified antibiotics (N = 26, 22%), hyperbaric oxygen therapy (N = 17, 15%), and ozone-based therapy (N = 15, 13%). Hyperbaric oxygen therapy was the most expensive therapy ($85 to $6400), followed by bioresonance therapy ($250 to $2950) and oligonucleotide therapy ($2750) (Table 2).

Table 2.

Type and Cost of Lyme Disease Therapies Listed on Nontraditional Lyme Disease Clinic Websites, 2024

Lyme Disease Therapies Listed on Clinic Website	Number of Clinics	Cost Rangea
Herbs/supplements	53	$34.99–$240
Nonantibiotic intravenous therapy	30	$100–$500
Antibiotics, unspecified approach	26	Not available
Hyperbaric oxygen therapy	17	$85–$6400
Ozone-based therapy including major autohemotherapy	15	$70–$400
Electrical/electromagnetic-based therapy	13	$90–$130
Homeopathy	12	Not available
Laser-based therapy	12	$40–$125
Antibiotics, alternative approachb	11	Not available
Acupuncture or acupressure	9	$100–$900
Oligonucleotide therapy	7	$2750
Peptide therapy	6	Not available
Blood irradiation	5	Not available
Disulfiram	4	Not available
Infrared- or red light-based therapy	6	Not available
Osteopathic manipulation, chiropractic therapy, or massage therapy	5	$125–$175
Low-dose immunotherapy	4	Not available
Bioidentical hormone therapy	3	Not available
Heat-based/hyperthermia therapy	3	$220–$300
Methylene blue	3	Not available
Neurotherapy or neurostimulation	3	Not available
Oxygen therapy	3	Not available
Antidepressants	2	Not available
Essential oils	2	Not available
Exosome therapy	2	Not available
Whole body vibration	2	Not available
Otherc	20	See footnote
Not availabled	23	Not applicable

^aWe included cost if at least 1 clinic offering the therapy listed a cost of the therapy.

^bClinics that listed antibiotic regimens not recommended by the 2020 Infectious Diseases Society of America, American Academy of Neurology, and American College of Rheumatology guidelines for the treatment of Lyme disease, including antibiotic combination therapy, antibiotics for tick bites, antibiotics given as a “pulse dose,” or antibiotic protocols associated with International Lyme and Associated Diseases Society.

^cAdditional therapies listed only once included: Allergy Release Technique, bee venom therapy, bioresonance therapy ($250–$2950), colloidal silver, dimethyl sulfoxide, hydrotherapy ($90), intravenous chelation, intravenous hydrogen peroxide, low-dose naltrexone, NAD + therapy, platelet-rich plasma injections, shockwave therapy, thyroid hormone replacement, umbilical cord extract, ultraviolet B light therapy.

^dTreatment was listed as being offered but a specific therapy for Lyme disease was not mentioned.

DISCUSSION

Many clinics in Lyme endemic states in the United States provide nontraditional care for Lyme disease, utilizing providers with a wide range of subspecialty training and backgrounds reflecting both conventional and complementary and alternative medicine approaches to care. Many of the therapies offered by these clinics are unproven against Lyme disease, and we identified some therapeutic approaches that raise safety concerns. The cost of care is variable and can be high, suggesting that patients with limited health insurance coverage may have significant out-of-pocket expenditures.

Our finding that approximately one-third of clinics had naturopathic doctors and approximately one-fifth had chiropractic providers was not unexpected considering we focused our analysis on clinics that self-identify as providing alternative, integrative, functional, holistic, or naturopathic approaches to treating Lyme disease. The lack of formal infectious diseases training identified among physicians was also not surprising and may explain the high number of offered therapies that conflict with the 2020 Infectious Diseases Society of America, American Academy of Neurology, and American College of Rheumatology guidelines for the management of Lyme disease [7]. For example, we found that about one-half of clinics offered herbs or supplements and about 1 in 10 clinics offered ozone-based therapy, electrical- or electromagnetic-based therapy, homeopathy, laser-based therapies, and antibiotic regimens that are not supported by guidelines. These findings add to a prior study by showing that non–evidenced-based therapies for Lyme disease are not just marketed to patients on the internet, but appear to be offered routinely by clinics [5].

Some of the therapies we found also expose patients to unnecessary risks. For example, non–evidenced-based antibiotic regimens—particularly those that are prolonged or administered intravenously via a central venous catheter—have been associated with life-threatening complications, including fatal cases of catheter-associated bloodstream infections and Clostridioides difficile infection [8–10]. Major autohemotherapy (a subset of “ozone-based therapy” that involves drawing blood from a patient via a venous catheter then infusing blood back in after being mixed with ozone) is an unproven therapy offered at some clinics, and it may also increase a patient's risk for bloodstream infections. Additionally, although limited to a minority of clinics, our finding that some clinics offer “hyperthermia protocols” and intravenous hydrogen peroxide (1 clinic) also raises safety concerns [11].

Finally, the cost of care at these clinics is highly variable and, at times, exceedingly expensive when considering the cost of both the clinic visit and therapies. For clinics that do not accept health insurance, patients should expect significant out-of-pocket expenditures. For example, some oligonucleotide therapies and hyperbaric oxygen therapy packages cost >$2000 and >$6000, respectively. This is noteworthy considering that many Americans already have difficulty affording healthcare, including 1 in 4 that have skipped healthcare in the past 12 months due to cost [12].

Our study has several limitations. First, we relied on the accuracy of clinic websites for our data, which does not fully capture the actual cost of care or therapies offered to individual patients. Similarly, we relied on self-attestation with respect to provider credentials and specialty, which may have led to mischaracterization. We may have missed clinics in Lyme endemic states with our search criteria and did not analyze clinics in states not considered endemic for Lyme disease. In summary, our findings suggest that many clinics in the United States provide care for Lyme disease that is unproven, potentially risky, and can lead to high out-of-pocket expenditures for patients. Further research is needed to determine clinical outcomes following receipt of non–evidenced-based therapy for Lyme disease and to assess whether similar therapies are being offered to patients in states that are not endemic for Lyme disease.

Notes

Acknowledgments. This material is the result of work supported with resources and the use of facilities at the Minneapolis VA Healthcare System. The contents do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

Author Contributions. J.R.S.: writing (original draft; review and editing). M.K.R: writing (review and editing). J.D.A.: writing (original draft; review and editing)

Financial support. This research received no specific grant from any funding agency.