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DMSO Transforms The Treatment of Infectious Diseases

https://www.midwesterndoctor.com/p/dmso-transforms-the-treatment-of?

DMSO Transforms The Treatment of Infectious Diseases

How DMSO can treat many challenging infections

A Midwestern Doctor
Dec 29, 2024

Story at a Glance:

•Dimethyl Sulfoxide (DMSO) is a remarkably safe naturally occurring substance that has a variety of remarkable properties that make it well suited to treating a variety of challenging medical conditions (e.g., pain, injuries, wounds, strokes, spine injuries, autoimmune conditions, cancer, and internal organ diseases).

•DMSO has broad antimicrobial properties, protects the body from microbial toxins (e.g., from C. diff), eliminates antibiotic resistance, and serves as a vehicle that can bring antimicrobials deep into the body and treat otherwise inaccessible infections.

•DMSO significantly enhances the treatment of many common bacterial infections (e.g., of the head, mouth, and skin) and many severe bacterial infections that require hospitalization (e.g., tuberculosis, sepsis, peritonitis, severe lung infections, osteomyelitis). In many cases, this has allowed an individual requiring an amputation of a chronically infected area to instead fully recover.

•DMSO has significant antiviral properties, which have most extensively been studied for herpes and shingles (both of which it excels in treating), but also in a variety of other conditions (e.g., feline panleukopenia, one of the most deadly conditions cats face.

•DMSO has significant value in treating challenging fungal and parasitic infections. Additionally, evidence suggests its utility in treating cancer and autoimmune disorders arise from DMSO’s unique antimicrobial properties.

•In this article, we will review the body of evidence showing DMSO’s remarkable contributions to the treatment of infectious diseases and provide guidance on how DMSO can be used to treat many of the conditions listed in this article.

Introduction

DMSO is a remarkably safe and naturally occurring substance (provided you use it correctly) that rapidly improves a variety of conditions medicine struggles with — particularly chronic pain. For reference, those conditions included:

  • Strokes, paralysis, a wide range of neurological disorders (e.g., Down Syndrome and dementia), and many circulatory disorders (e.g., Raynaud’s, varicose veins, hemorrhoids), which I discussed here.
  • A wide range of tissue injuries such as sprains, concussions, burns, surgical incisions, and spinal cord injuries (discussed here).
  • Chronic pain (e.g., from a bad disc, bursitis, arthritis, or complex regional pain syndrome), which I discussed here.
  • A wide range of autoimmune, protein, and contractile disorders such as scleroderma, amyloidosis, and interstitial cystitis (discussed here).
  • A variety of head conditions, such as tinnitus, vision loss, dental problems, and sinusitis (discussed here).
  • A wide range of internal organ diseases such as pancreatitis, infertility, liver cirrhosis, and endometriosis (discussed here).
  • A wide range of skin conditions such as burns, varicose veins, acne, hair loss, ulcers, skin cancer, and many autoimmune dermatologic diseases (discussed here).

In turn, since I started this series, it struck a cord and has now been seen by millions of people, and I have received over 1400 reports of remarkable responses to DMSO many readers have had (which can be read here).

This begs an obvious question — if a substance capable of doing all of that exists, why does almost no one know about it? Simply put, like many other promising therapies, it fell victim to a pernicious campaign by the FDA which kept it away from America despite decades of scientific research, Congressional protest, and thousands of people pleading for the FDA to reconsider their actions. Consider for example, this 60 Minutes program about DMSO that aired on March 23, 1980.  (Go to top link to watch program)

DMSO and Infectious Diseases

DMSO has a variety of unique properties that make it incredibly well suited to addressing microbial infections (e.g., bacteria, fungi, viruses, and parasites).

These include:

  • While non-toxic, it has an antiseptic effect that is harmful to microorganisms, especially the smallest ones (mycobacteria, cell wall deficient bacteria, and viruses). This property appears to be the most beneficial for herpes, shingles, and other complex conditions, which I believe have a microbiological component (e.g., cancer and autoimmunity).
  • It can remove the antibiotic resistance of bacteria. This is particularly helpful in widespread problematic infections that have gradually developed a resistance to many existing antibiotics (e.g., tuberculosis) and challenging infections that are not responding to antibiotics (e.g., ones that would otherwise require an amputation).
  • It can further increase the sensitivity of already susceptible microorganisms to antimicrobial agents.
  • It can deliver antimicrobial agents to areas that are typically difficult to reach (e.g., deep in a bone) and also directly to regions that would otherwise require a systemic application of the medication.
  • It can increase circulation to many parts of the body, something which is often critical for resolving illnesses (as a healthy blood supply allows the immune system to enter and heal diseased areas). Likewise, pretreatment with DMSO has been shown to increase the immune system’s ability to resist a subsequent infection.
  • Much in the same way DMSO protects cells from a wide variety of lethal stressors, it can also protect them from the harmful effects of bacterial toxins (e.g., with the most pertinent applications studied being for sepsis and clostridium difficile). Likewise, it can also mitigate the toxicity of antimicrobial agents taken for a prolonged period.

DMSO and Bacterial Infections

DMSO has six properties that make it useful in treating bacterial infections.

  1. Data suggests DMSO increases bacterial cell membrane permeability and concurrently creates changes in the cell indicative of damage to its membrane. In addition to directly eliminating bacteria, it also reduces their ability to prevent antibiotics from entering them. In turn, existing data shows DMSO has a much greater ability to increase the potency of antibiotics that target structures inside bacteria rather than ones that target their cell wall (e.g., penicillin).
    Note: this property is particularly important for tuberculosis as it has a robust external barrier that impairs antibiotic entry.
  2. By increasing membrane permeability, it can also make bacteria more susceptible to taking up the nucleic acids of lethal bacteriophages (viruses that kill bacteria and have been extensively researched outside of America due to their efficacy in treating a wide range of bacterial infections).
  3. DMSO can often simply dissolve bacteria and cause their contents to leak out.
  4. DMSO can interfere with the normal functioning of bacteria. A 1977 study, for instance, found that it interferes with the production of membrane proteins that E. coli (and other bacteria) need for metabolism.
  5. As discussed throughout a previous article, DMSO greatly improves circulation (which, when impaired often leads to chronic infections).
  6. In the same way DMSO can protect cells from various lethal stressors (discussed here), DMSO effectively mitigates the harmful effects of many bacterial toxins.

Cancer and Autoimmunity

One of DMSO’s widely recognized properties is that it causes cancerous cells to revert to normal. In researching that, I came across a fascinating study that tested cancer patients for pleomorphic bacteria (something many previous pioneers of successful but suppressed alternative cancer therapies like Rife and Naessens also believed caused many cancers). While difficult to culture, pleomorphic bacteria were eventually isolated from the blood of some of them, in the blood of some of those who had been around those who had recently died from cancer for a prolonged period.

Note: the morphology of the bacteria is extensively described in the paper, but essentially matches what many other pleomorphic researchers have found over the years.

The pleomorphic model of bacteria (discussed further here) essentially states that bacteria can significantly change their morphology (to the point they are almost unrecognizable from their original form), that these changes are often done in response to their environment, and that some forms are relatively harmless to the body, while others cause disease. In turn, since things that kill bacteria often transform them into ones that are more pathogenic, a longtime belief within certain schools of natural medicine is that the goal should be to change the terrain of the body to encourage a benign morphology of bacteria rather than trying to kill them all off.

A large group of modern researchers studied this subject for decades (e.g., hundreds of research studies they conducted are summarized in this wonderful textbook by Lida Mattman). Five of their key observations were:

  1. Antibiotics will often fail to kill every bacteria present and then trigger those that survive to enter a primitive survival state known as a “cell wall deficient” (CWD) form resembling a mycoplasma. This process in turn, was most commonly triggered by antibiotics that attack bacterial cell walls (which characterizes many commonly used antibiotics).
  2. CWD bacteria are very hard to detect (most standard microbial methods will determine that no organisms are there when CWDs are present).
  3. When conditions are more optimal for survival, CWD organisms can revert to the active form and cause an infection that had been eliminated with antibiotics to suddenly and inexplicably recur (which, for example, we frequently see with urinary tract infections).
  4. Once present, CWD bacteria will often enter cells and cause chronic inflammation because the immune system will attack cells with the CWD bacteria.
  5. Many different unexplained autoimmune disorders (e.g., sarcoidosis) have characteristic CWD bacteria present that can be repeatedly identified from their inflamed tissue (the textbook cites an exhaustive amount of data substantiating this).

While standard antibiotics are ineffective in treating CWD infections, non-standard ones (e.g., erythromycin or minocycline) often are, but the sensitivity to those antibiotics is highly variable depending on the causative organism.

In practice, we find 10-15% of chronic illnesses (including blood clots and cancers) have a pleomorphic etiology, but rather than try to eliminate those organisms with antibiotics (which always have side effects), we instead give signaling products derived from healthy bacteria that cause the pathologic bacteria to transform into a non-harmful form, which in those applicable cases, frequently yields remarkable results (e.g., this approach is very useful for lupus and many cancers). Likewise, I believe this model explains a longstanding belief within natural medicine that giving antibiotics for an acute infection often transforms it into a chronic illness down the road.

Note: ultraviolet blood irradiation is also quite effective at eliminating these organisms and the diseases they cause. 

Lastly, Individuals with chronic fatigue syndrome often find relief from DMSO, which some have attributed to its antiviral properties (e.g., towards Epstein Barr). This for example, is a letter Stanley. Jacob received from a patient.

Note: Readers have also reported to me (e.g., here, here, and here) that DMSO helped their chronic fatigue.  (See link for article)

______________

**Comment**

Please note that DMSO did best when it was coupled with antibiotics or other antimicrobials.

For more:

  • https://madisonarealymesupportgroup.com/2018/03/02/dmso-msm-for-lyme-msids/
  • https://madisonarealymesupportgroup.com/2024/11/01/how-dmso-cures-eye-ear-nose-throat-and-dental-disease/
  • https://madisonarealymesupportgroup.com/2024/10/25/how-dmso-treats-incurable-autoimmune-and-contractile-disorders/
  • https://madisonarealymesupportgroup.com/2024/09/16/dmso-its-remarkable-properties/
  • https://madisonarealymesupportgroup.com/2024/12/18/dmso-protects-heals-organs-and-revolutionizes-the-skin/

Category:

C-diff, Cancer, Dentistry, Eye Issues, Inflammation, Lyme, Pain Management, Parasites, research, Treatment, Viruses

Holistic Healing From Lyme Disease

https://open.spotify.com/episode/6NrQSPu2G1mLXey82vETIY?si=38cLPjQXSsOvDcijvgNqcw&nd=1&dlsi=060f76815c2e45d7  Go here to listen on Spotify (Approx. 1 hour)

https://podcasts.apple.com/us/podcast/holistic-healing-from-lyme-disease-with-theresa/id1771868024?i=1000681031732  Go here to listen on Apple Podcasts

Holistic Healing From Lyme Disease

Theresa Haselmayer/Foundations Wellness

12/19/24

Co-host Dan Wagner sits down with the founder of Foundations Wellness, Theresa Haselmayer, R.N., to discuss her journey from patient to healer.  With over 33 years of varied clinical experience, Theresa trained for 4 years at the Uprooting Lyme Clinic in Hudson Valley NY, a hotbed of Lyme Disease.  She is currently one of dozens of highly knowledgable certified Uprooting Lyme practitioners nationwide.  Theresa is also a member of ILADS, the International 
Lyme and Associated Diseases Society, as well as ISEAI – The International Society of Environmentally Acquired Illness.  

For more:

  • https://madisonarealymesupportgroup.com/2016/02/13/lyme-disease-treatment/

Category:

Herbs, Lyme, Treatment

Advances in Lyme & Babesiosis Research

https://www.globallymealliance.org/news/from-diagnostics-to-disease-mechanisms-advances-in-lyme-and-babesiosis-research?

From Diagnostics to Disease Mechanisms: Advances in Lyme and Babesiosis Research

by Cara DeAngelis, Ph.D. on January 3, 2025

<span id="hs_cos_wrapper_name" class="hs_cos_wrapper hs_cos_wrapper_meta_field hs_cos_wrapper_type_text" style="" data-hs-cos-general-type="meta_field" data-hs-cos-type="text" >From Diagnostics to Disease Mechanisms: Advances in Lyme and Babesiosis Research</span>
Cutting-edge research funded by GLA advances diagnostics and insights into Lyme disease and babesiosis, identifying key biomarkers and genetic risk factors.

Three GLA-funded investigators have been making exciting progress. Dr. Rafal Tokarz’s team has been uncovering key insights into the immune response to specific proteins of Lyme bacteria, paving the way for more accurate diagnostics. Dr. Ben Mamoun has achieved an important milestone by developing the first diagnostic tests for detecting active Babesia duncani infections.  Dr. Klemen Strle’s research suggests that specific genetic factors may increase the risk of developing chronic Lyme arthritis. Meanwhile, Dr. Strle’s new findings are shedding light on how certain genetic factors may heighten the risk of developing chronic Lyme arthritis. 

Summary: 

GLA-funded research continues to shed light on key aspects of Lyme and tick-borne diseases, from diagnostic biomarkers to genetic factors influencing disease outcomes. 

Dr. Rafal Tokarz and his team at Columbia University used peptide arrays and machine learning to identify immune reactive proteins in Borrelia burgdorferi to differentiate between phases of Lyme disease. These insights could enhance the accuracy of antibody-based diagnostic tests by improving their sensitivity and specificity (Tokarz et al., 2024). 

At Yale University, Dr. Choukri Ben Mamoun and his team developed the first antigen detection tests for Babesia duncani, a parasite often responsible for severe babesiosis. These assays, validated with over 1,700 samples, can detect active infections with high sensitivity and specificity, paving the way for early diagnosis, reservoir animal screening, and improved blood safety (Chand et al., 2024).  

Research by Dr. Klemen Strle and his group at Tufts University identified genetic variations associated with chronic Lyme arthritis. These variations are linked to increased inflammation and autoantibody responses, suggesting that some patients may have a genetic predisposition to persistent arthritis in Lyme disease. These findings may guide future biomarker development to predict disease risk (Ehrbar et al., 2024). 

These studies reflect GLA’s unwavering commitment to support research that addresses critical challenges in diagnosing and managing tick-borne diseases. 

Publications: 

Tokarz, R., Guo, C., Sanchez-Vicente, S., Horn, E., Eschman, A., Turk, S. P., Lipkin, W. I., & Marques, A. (2024). Identification of reactive Borrelia burgdorferi peptides associated with Lyme disease. mBio, 15(10). https://doi.org/10.1128/mbio.02360-24   

Chand, M., Vydyam, P., Pal, A. C., Thekkiniath, J., Darif, D., Li, Z., Choi, J. Y., Magni, R., Luchini, A., Tonnetti, L., Horn, E. J., Tufts, D. M., & Ben Mamoun, C. (2024). A set of diagnostic tests for detection of active Babesia duncani infection. International Journal of Infectious Diseases, 147, 107178. https://doi.org/10.1016/j.ijid.2024.107178  

Ehrbar, D., Arvikar, S. L., Sulka, K. B., Chiumento, G., Nelson, N. L. J., Hernandez, S. A., Williams, M. A., Strle, F., Steere, A. C., & Strle, K. (2024). Variants in the late cornified envelope gene locus are associated with elevated T-helper 17 responses in patients with postinfectious Lyme arthritis. The Journal of Infectious Diseases, 230(Supplement_1), S40–S50. https://doi.org/10.1093/infdis/jiae164  

https://www.globallymealliance.org/news/decoding-chronic-lyme-investigating-epigenetic-signatures?

Decoding Chronic Lyme: Investigating Epigenetic Signatures

by Admin at Global Lyme Alliance on January 3, 2025

<span id="hs_cos_wrapper_name" class="hs_cos_wrapper hs_cos_wrapper_meta_field hs_cos_wrapper_type_text" style="" data-hs-cos-general-type="meta_field" data-hs-cos-type="text" >Decoding Chronic Lyme: Investigating Epigenetic Signatures</span>
Pictured: Tanja Petnicki-Ocwieja, PhD, courtesy of Tufts University School of Medicine
Tufts University, with support from GLA, is leading research to uncover epigenetic mechanisms behind chronic Lyme disease. Dr. Tanja Petnicki-Ocwieja’s work could improve treatments and reveal commonalities with other post-infectious syndromes like long COVID.

By Mase Peterson

In the fight against Lyme disease, cutting-edge research is essential for advancing treatment and prevention strategies. Tanja Petnicki-Ocwieja, PhD, a research assistant professor at Tufts University School of Medicine, is a key contributor to this effort through her work with the Tufts Lyme Disease Initiative. This collaborative group of faculty, staff, and students is dedicated to eliminating the public health threat of Lyme disease by 2030.

Tufts is home to one of the world’s most comprehensive groups of tick-borne disease researchers. Led by co-directors Linden Hu, Paul and Elaine Chervinsky Professor of Immunology, and Robert P. Smith, a physician at Maine Medical Center and professor of medicine, the team recently secured a $20.7 million federal grant, further solidifying Tufts’ position as a global leader in Lyme disease research.

In this Q&A, part of a feature series spotlighting members of the Initiative, Professor Petnicki-Ocwieja discusses her research on the immunological and epigenetic mechanisms underlying chronic Lyme disease and its potential to transform patient outcomes…

Read the rest from Tufts School of Medicine

_____________

**Comment**

I’d love to be hopeful, but when the moniker PTLDS continues to be used it shows an inherent bias that ongoing infections aren’t to blame for people’s ongoing symptoms.  This must change.

For more:

  • https://madisonarealymesupportgroup.com/2020/08/13/slyme-an-interview-we-need-to-drop-the-term-ptld-like-a-bad-habit/
  • https://madisonarealymesupportgroup.com/2020/08/16/70-post-treatment-lyme-disease-syndrome-publications-ignore-infection/
  • https://madisonarealymesupportgroup.com/2023/08/02/nih-funds-ptlds-research-more-deception/
  • https://madisonarealymesupportgroup.com/2019/03/25/the-shortfalls-of-h-r-220-national-lyme-and-tick-borne-diseases-control-and-accountability-act-of-2019-the-devil-is-in-the-details/  Very important article laying out the sordid details controlling Lymeland that are imperative to know.
  • https://madisonarealymesupportgroup.com/2023/03/17/iv-antibiotics-helpful-for-ptlds/
  • https://madisonarealymesupportgroup.com/2022/06/22/efficacy-of-short-term-high-dose-pulsed-dapsone-combination-therapy-in-the-treatment-of-chronic-lyme-disease-post-treatment-lyme-disease-syndrome-ptlds-associated-coinfections-a-report-of-3-c/
  • https://madisonarealymesupportgroup.com/2021/03/10/how-ptlds-aca-affect-lyme-patients/
  • https://madisonarealymesupportgroup.com/2021/03/15/part-2-ptld-insurance-coverage/
  • https://madisonarealymesupportgroup.com/2021/03/18/part-3-ptld-insurance-coverage/

Category:

Babesia, Lyme, research, Uncategorized

Lyme Disease Research in Review: Triumphs, Trials, and the Path Forward

https://www.lymedisease.org/lyme-disease-research-review/

Lyme disease research in review: triumphs, trials, and the path forward

As always, the world of Lyme is complicated with both good news and bad. Looking back over the past year, I want to highlight a few of the biggest scientific advances that stand out in my mind.

Co-Infections

First I want to share something that science keeps validating—the majority of patients with persistent symptoms following a diagnosis of Lyme disease have co-infections.

This means they are infected with two or more pathogens (such as bacteria, viruses, or fungi) at the same time. These co-infections (including COVID-19) complicate the immune response and likely increase the chance of developing chronic Lyme.

As I wrote about previously, North America is “ground zero” for babesiosis, which is likely playing a much greater role in patients with chronic Lyme than we know. In the MyLymeData study, over 60% of patients report they were diagnosed with an additional tick-borne infection along with Lyme. For most of them, it’s Babesia.

In July 2024, researchers conducting a Lyme disease pilot study at North Carolina State University discovered that all seven participants were infected with Babesia, and six out of the seven were co-infected with at least one (sometimes two or more) species of Bartonella.

Babesia is a parasite, similar to malaria. It requires a separate test and special anti-parasitic medications outside of the standard tests and antibiotics used for Lyme disease alone.

Diagnostics

As I wrote about in December 2023, Borrelia (Lyme) has some unique features allowing it to hide from our immune system. That stealth technique, which keeps the number of bacteria low in the blood stream, also makes it difficult for standard blood tests to detect Lyme disease. In April of 2024, Dr. Michal Tal and her team published another clue as to how Borrelia hides from the immune system.

Right now, all eyes are on the six teams competing in the LymeX diagnostic challenge as they move forward with their innovations. These will hopefully result in a more accurate test becoming available to the public than the standard outdated test that has been around since 1994. (Note: Lyme X Phase 3 winners will be announced soon.)

While an accurate Lyme diagnostic is absolutely needed, I cannot ignore the fact that ticks in North America are known to transmit over 18 different pathogens.

In August of 2024, a team of biologists at City University of New York Graduate Center produced a genetic analysis of 47 different strains of Borrelia. This may pave the way for improved diagnosis, treatment, and prevention of Lyme disease.

I hope that with this new genetic mapping, we will finally be able to take advantage of the next-generation metagenomic testing which is capable of detecting multiple pathogens.

Treatment

One of the top priorities of patients with chronic Lyme disease is finding an effective treatment.

Two recent studies have shown that combination therapy for Lyme, and combination therapy for Babesia work better than monotherapy.

But not everyone responds favorably to pharmaceuticals. One reason for this, may be a condition called alpha-gal syndrome (AGS).

AGS is triggered by the bite of a tick and causes an allergy to anything derived from red meats including some medications. An estimated 450,000 people have AGS in the U.S., making it the tenth most common food allergen.

If enacted, the Alpha-Gal Inclusion Act would require the FDA to list alpha-gal as a major allergen and require labeling to include it as an ingredient.

Mast cell activation syndrome

Another complicating factor common in patients with chronic Lyme is mast cell activation syndrome (MCAS). MCAS can make patients extremely sensitive to certain types of chemicals, foods and additives.

In fact, MCAS is such an important topic, in 2024 we devoted an entire issue of the Lyme Times to Mast Cell Activation Syndrome which you can download and read for free.

Alas, there is nothing simple about treating complex medical conditions triggered by the bite of a tick. Many of the patients I know who’ve gotten better took years before they found the root cause of their misery followed by the right combination of treatment that worked.

In 2023 we devoted an entire issue of the Lyme Times trying to answer the question: What does it take to get better?

My hope is that we continue to see scientific progress in finding better diagnostics and treatment. And if you are struggling with a chronic illness, please do not give up hope.

LymeSci is written by Lonnie Marcum, a physical therapist and mother of a daughter with Lyme. She served two terms on a subcommittee of the federal Tick-Borne Disease Working Group. Follow her on X: @LonnieRhea   Email her at: lmarcum@lymedisease.org.

_______________

**Comment**

To my knowledge, treating this complex illness has hardly moved forward in over 40 years.  The medical industrial complex is myopically focused on ‘vaccines,’ which are big money makers for both Big Pharma and the government, which owns patents on many aspects of them.  As long as this remains the singular focus, patients will not be treated properly.  Further, as long as ‘consensus based‘ medicine reigns, innovative doctors who dare to use their God-given brains to help patients will continue to be persecuted, leaving patients to suffer.  As it is, the only true help for Lyme/MSIDS is to get to an independent, trained, and experienced Lyme literate doctor.

For more:

  • https://madisonarealymesupportgroup.com/2016/02/13/lyme-disease-treatment/
  • https://madisonarealymesupportgroup.com/2016/01/16/babesia-treatment/
  • https://madisonarealymesupportgroup.com/2016/01/03/bartonella-treatment/
  • https://madisonarealymesupportgroup.com/2016/03/08/anaplasmosis/
  • https://madisonarealymesupportgroup.com/category/ehrlichiosis-treatment/
  • https://madisonarealymesupportgroup.com/2022/03/23/complete-guide-to-lyme-disease-coinfection-tests/
  • https://madisonarealymesupportgroup.com/2017/07/01/one-tick-bite-could-put-you-at-risk-for-at-least-19-different-diseases/

Category:

Lyme, Mast Cell Activation Syndrome (MCAS), research, Testing, Ticks, Treatment

Optimizing Exclusion Criteria For Clinical Trials of Persistent Lyme Disease Using Real-World Data

https://www.mdpi.com/2227-9032/13/1/20

Optimizing Exclusion Criteria for Clinical Trials of Persistent Lyme Disease Using Real-World Data

by Lorraine Johnson1, Mira Shapiro2, Deanna Needell3 and Raphael B. Stricker4,*
1LymeDisease.org, Los Angeles, CA 91040, USA
2Analytic Designers LLC, Bethesda, MD 20817, USA
3Department of Mathematics, University of California, Los Angeles, CA 90025, USA
4Union Square Medical Associates, 595 Buckingham Way, Suite 350, San Francisco, CA 94132, USA
*Author to whom correspondence should be addressed.
Healthcare 2025, 13(1), 20; https://doi.org/10.3390/healthcare13010020
Submission received: 15 October 2024 / Revised: 19 December 2024 / Accepted: 21 December 2024 / Published: 25 December 2024
(This article belongs to the Topic Public Health and Healthcare in the Context of Big Data)

Abstract

Background/Objectives: Although eligibility criteria for clinical trials significantly impact study outcomes, these criteria are often established without scientific justification, leading to delayed recruitment, small sample sizes, and limited study generalizability. Persistent Lyme disease (PLD) presents unique challenges due to symptom variability, inconsistent treatment responses, and the lack of reliable biomarkers, underscoring the need for scientifically justified eligibility criteria.
Objective: This study examines the effects of commonly used enrollment criteria on sample yield in PLD clinical trials using real-world data (RWD) from the MyLymeData patient registry. The study also compares the effects of these criteria on enrollment for PLD versus acute Lyme disease (ALD) trials and evaluates the scientific rationale for each criterion.
Methods: Data from 4183 Lyme disease patients enrolled in the MyLymeData registry were analyzed to assess the prevalence and cumulative impact of various criteria on sample yield. A comparative analysis of cohorts with PLD (n = 3589) versus ALD (n = 594) was conducted to identify differences in sample attrition.
Results: In a large PLD cohort study, we found that current commonly used eligibility criteria would exclude approximately 90% of patients, significantly limiting study generalizability. Substantial differences in sample attrition between PLD and ALD cohorts highlight the need for tailored criteria. The strength of scientific justification varied widely among criteria.
Conclusions: This study demonstrates the importance of using RWD to optimize eligibility criteria in PLD clinical trials. By providing insights into the balance between sample attrition and scientific justification, researchers can enhance trial feasibility, generalizability, and robustness. Our RWD sample demonstrates that researchers could substantially increase the sample yield from 10% to 64% by loosening restrictions on coinfections and misdiagnoses of chronic fatigue syndrome, fibromyalgia syndrome, and psychiatric conditions.

Category:

Lyme, research

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