The Ruggiero-Klinghardt (RK) Protocol for the Diagnosis and Treatment of Chronic Conditions with Particular Focus on Lyme Disease
Dietrich Klinghardt and Marco Ruggiero
Sophia Health Institute and Klinghardt Academy, Woodinville, WA., USA
Abstract: Here we describe the Ruggiero-Klinghardt (RK) Protocol that is based on integration of Autonomic Response Testing (ART) with diagnostic ultrasonography and on application of therapeutic ultrasounds; the latter are used as a provocation tool and as an instrument to optimize drug uptake and utilization in specific areas of the body. This protocol consists of a precise sequence of diagnostic and therapeutic procedures with the ultimate goal of improving sensitivity and specificity of diagnosis at the same time evaluating and optimizing efficacy of treatments in chronic conditions including, but not limited to, persistent Lyme disease. The RK Protocol represents a paradigm shift in diagnostics and therapeutics: Thus, compartmentalized microbes, transformed cells, toxins and metabolites could be detected using a safe and non-invasive method. In addition, the RK Protocol allows optimization of efficacy of drugs and other therapeutic interventions. Although the RK Protocol was initially developed for persistent Lyme disease, it shows significant potential in conditions ranging from cancer to neurodegenerative diseases and autism. In oncology, the RK Protocol may serve to facilitate early diagnosis and to increase sensitivity of cancer cells to the killing effects of a variety of remedies ranging from conventional radio- and chemotherapy to more recent forms of immunotherapy. Thus, the 1st goal of the RK Protocol is diagnostic: That is, to make pathogens, toxins, transformed cells and cells infected by viruses that are inaccessible to conventional diagnostic and therapeutic tools, “visible” to the therapist who can detect them with laboratory methods and deal with them with appropriate interventions; and also to make them “visible” to the immune system that can fight them in a physiological manner. The 2nd goal is to optimize drug uptake and utilization in the organs and tissues studied and targeted with these procedures.
**An example was given of a patient with a history of angina who could not be causally diagnosed with classic cardiology tests. A urine example was collected before therapeutic ultrasounds which did NOT show any pathogen presence despite a positive Bartonella presence with ART. This patient also tested negative on the Western Blot (CDC criteria) from IgeneX lab; however, the DNA test performed on the urine sample 1 hour after therapeutic ultrasounds identified Bartonella bacilliformis, a well-known cause of endocarditis, commonly diagnosed only post-mortem. “The patient responded rapidly and favorably to targeted biological treatment involving daily therapeutic ultrasound application and sever anti-microbial agents.”
Last summer Felicia Keesing returned from a long trip and found that her home in upstate New York had been subjected to an invasion.
Rick Ostfeld and Felicia Keesing have been studying Lyme disease and ways to stop it for more than 20 years. The couple has come up with a way to predict how bad a Lyme season will be a full year in advance.
“There was evidence of mice everywhere. They had completely taken over,” says Keesing, an ecologist at Bard College.
It was a plague of mice. And it had landed right in Keesing’s kitchen.
“Not only were there mouse droppings on our countertops, but we also found dead mice on the kitchen floor,” says Keesing’s husband, Rick Ostfeld, an ecologist at the Cary Institute of Ecosystem Studies in Millbrook, N.Y.
The Hudson River Valley experienced a mouse plague during the summer of 2016. The critters were everywhere. For most people, it was just a nuisance. But for Keesing and Ostfeld, the mouse plague signaled something foreboding.
“We’re anticipating 2017 to be a particularly risky year for Lyme,” Ostfeld says.
Keesing and Ostfeld, who have studied Lyme for more than 20 years, have come up with an early warning system for the disease. They can predict how many cases there will be a year in advance by looking at one key measurement: Count the mice the year before.
The number of critters scampering around the forest in the summer correlates to the Lyme cases the following summer, they’ve reported.
The explanation is simple: Mice are highly efficient transmitters of Lyme. They infect up to 95 percent of ticks that feed on them. Mice are responsible for infecting the majority of ticks carrying Lyme in the Northeast. And ticks love mice. “An individual mouse might have 50, 60, even 100 ticks covering its ears and face,” Ostfeld says.
So that mouse plague last year means there is going to be a Lyme plague this year. “Yep. I’m sorry to say that’s the scenario we’re expecting,” Ostfeld says.
Mice and ticks get along swimmingly. Other animals, such as possums, groom away ticks — and sometimes kill them. But white-footed mice tolerate ticks covering their faces and ears. Blacklegged ticks, like the adult female on the right, are tiny — about the size of a sesame seed.
He’s not exactly sure which parts of the Northeast will be at highest risk.
But wherever Lyme exists, people should be vigilant, says epidemiologist Kiersten Kugeler at the Centers for Disease Control and Prevention.
“Whether it’s a bad season or not, there’s still going to be a lot of human cases of tick-borne diseases,” she says. “What’s important for people to know is that the ticks are spreading to new areas — and tick-borne diseases are coming with them.”
Back in the early ’80s, the disease wasn’t that big a problem. Cases were confined to two small regions: western Wisconsin and the area from Connecticut to New Jersey.
Did You Get Bit By a Lyme-Infested Tick? Here’s What To Do
Since then, Lyme cases have shot up in number and spread in all directions: “The only place that they haven’t really spread is into the Great Lakes and the Atlantic Ocean, for obvious reasons,” says biologist Rebecca Eisen, who’s also at the CDC.
Now Lyme is present in more than 260 counties, the CDC reported in 2015. The disease shows up in Maine, swoops down the East Coast into Washington, D.C., and southern Virginia. Then it hops to the Midwest into northern Indiana, Illinois, Wisconsin and Minnesota. There are also small pockets of Lyme on the West Coast.
Since the early ’90s, reported cases of Lyme disease have tripled, to about 30,000 cases each year. The CDC thinks the actual number is 10 times higher.
“We think the true burden of Lyme disease in the U.S. is about 300,000 cases,” Kugeler says. “Lyme disease is quite a big public health problem.”
The reasons for this Lyme explosion are many, Ostfeld says. Climate change is part of it. The surge in deer — which feed ticks and spread them around — has also been a factor.
But Ostfeld has found another reason, something that happened more than 200 years ago.
Today the Hudson River Valley in upstate New York is gorgeous. The hills are covered with oak forests, and the valleys are patchworks of hayfields and farms.
But Ostfeld says the area didn’t always look like this. When the Europeans came here hundreds of years ago, they clear-cut nearly all of the forests to plant crops and raise livestock.
“They also cut down trees for commercial use,” Ostfeld says, “to make masts for ships, and for firewood.”
Since then a lot of the forest has come back — but it’s not the same forest as before, he says. Today it’s all broken up into little pieces, with roads, farms and housing developments.
For mice, this has been great news.
“They tend to thrive in these degraded, fragmented landscapes,” Ostfeld says, because their predators need big forests to survive.
Without as many foxes, hawks and owls to eat them, mice crank out babies. And we end up with forests packed with mice — mice that are chronically infected with Lyme and covered with ticks.
So all these little patches of forest dotting the Northeast have basically turned into Lyme factories, spilling over with infected ticks.
Then people come along and do the darndest thing, Keesing says: They build their dream homes right next door. “So we see that humans are putting themselves in these areas where they’re most at risk,” she says.
To figure out why Lyme has become more prevalent, researchers at the Cary Institute of Ecosystem Studies in Millbrook, N.Y., have trapped hundreds of thousands of rodents in the woods over the past 20 years. Research assistant Francesca Rubino checks a squirrel for ticks.
And that means people, in some areas, may be putting themselves at risk for Lyme every single day without even knowing it, says the CDC’s Kiersten Kugeler. “In the Northeast, most people catch Lyme around their homes,” she says. “People out gardening. People playing in their backyard. Mowing the lawn.”
So what can you do to keep from getting infected? Add a tick check to your daily routine, Kugeler says. When you’re in the shower check your body for tiny ticks, especially the places they like to hide.
“That’s the scalp, behind the ears, the armpits and in the groin area,” she says.
If you do find a tick, get it off as quickly as possible. The longer an infected tick stays on your skin, the greater the chance it will pass the Lyme bacteria on to you. Generally, it takes about 24 hours for the tick to infect a person after it starts biting.
Then be on the lookout for Lyme symptoms — like a red rash or a fever. It anything crops up, go see a doctor immediately. Don’t wait: The earlier you get treated, the better chance you’ll have for a full recovery.
First, the new 2017 Lyme Case Definition as defined by the CDC below, then the petition started by Carl Tuttle who rightly has an issue with the fact that the following is missing:
“This surveillance case definition was developed for national reporting of Lyme disease; it is not intended to be used in clinical diagnosis”
Lyme Disease (Borrelia burgdorferi) 2017 Case Definition
CSTE Position Statement(s)
16-ID-10
Clinical Description
A systemic, tick-borne disease with protean manifestations, including dermatologic, rheumatologic, neurologic, and cardiac abnormalities. The most common clinical marker for the disease is erythema migrans (EM), the initial skin lesion that occurs in 60%-80% of patients.
For purposes of surveillance, EM is defined as a skin lesion that typically begins as a red macule or papule and expands over a period of days to weeks to form a large round lesion, often with partial central clearing. A single primary lesion must reach greater than or equal to 5 cm in size across its largest diameter. Secondary lesions also may occur. Annular erythematous lesions occurring within several hours of a tick bite represent hypersensitivity reactions and do not qualify as EM. For most patients, the expanding EM lesion is accompanied by other acute symptoms, particularly fatigue, fever, headache, mildly stiff neck, arthralgia, or myalgia. These symptoms are typically intermittent. The diagnosis of EM must be made by a physician. Laboratory confirmation is recommended for persons with no known exposure.
For purposes of surveillance, late manifestations include any of the following when an alternate explanation is not found:
Musculoskeletal system . Recurrent, brief attacks (weeks or months) of objective joint swelling in one or a few joints, sometimes followed by chronic arthritis in one or a few joints. Manifestations not considered as criteria for diagnosis include chronic progressive arthritis not preceded by brief attacks and chronic symmetrical polyarthritis. Additionally, arthralgia, myalgia, or fibromyalgia syndromes alone are not criteria for musculoskeletal involvement.
Nervous system . Any of the following signs that cannot be explained by any other etiology, alone or in combination: lymphocytic meningitis; cranial neuritis, particularly facial palsy (may be bilateral); radiculoneuropathy; or, rarely, encephalomyelitis. Headache, fatigue, paresthesia, or mildly stiff neck alone, are not criteria for neurologic involvement.
Cardiovascular system . Acute onset of high-grade (2nd-degree or 3rd-degree) atrioventricular conduction defects that resolve in days to weeks and are sometimes associated with myocarditis. Palpitations, bradycardia, bundle branch block, or myocarditis alone are not criteria for cardiovascular involvement.
Laboratory Criteria for Diagnosis
For the purposes of surveillance, laboratory evidence includes:
A positive culture for B. burgdorferi, OR
A positive two-tier test. (This is defined as a positive or equivocal enzyme immunoassay (EIA) or immunofluorescent assay (IFA) followed by a positive Immunoglobulin M1 (IgM) or Immunoglobulin G 2 (IgG) western immunoblot (WB) for Lyme disease) OR
A positive single-tier IgG2 WB test for Lyme disease3.
1 IgM WB is considered positive when at least two of the following three bands are present: 24 kilodalton (kDa) outer surface protein C (OspC)*, 39 kDa basic membrane protein A (BmpA), and 41 kDa (Fla). Disregard IgM results for specimens collected >30 days after symptom onset.
2 IgG WB is considered positive when at least five of the following 10 bands are present: 18 kDa, 24 kDa (OspC)*, 28 kDa, 30 kDa, 39 kDa (BmpA), 41 kDa flagellin (Fla), 45 kDa, 58 kDa (not GroEL), 66 kDa, and 93 kDa.
3 While a single IgG WB is adequate for surveillance purposes, a two-tier test is still recommended for patient diagnosis.
*Depending upon the assay, OspC could be indicated by a band of 21, 22, 23, 24 or 25 kDA.
Criteria to Distinguish a New Case from an Existing Case
Case not previously reported to public health authorities.
Exposure
Exposure is defined as having been (less than or equal to 30 days before onset of EM) in wooded, brushy, or grassy areas (i.e., potential tick habitats) of Lyme disease vectors. Since infected ticks are not uniformly distributed, a detailed travel history to verify whether exposure occurred in a high or low incidence state is needed. An exposure in a high-incidence state is defined as exposure in a state with an average Lyme disease incidence of at least 10 confirmed cases/ 100,000 for the previous three reporting years. A low-incidence state is defined as a state with a disease incidence of <10 confirmed cases/100,000 (see https://www.cdc.gov/lyme/stats/tables.html). A history of tick bite is not required.
Case Classification
Suspected
A case of EM where there is no known exposure (as defined above) and no laboratory evidence of infection (as defined above), OR
A case with evidence of infection but no clinical information available (e.g., a laboratory report).
Probable
Any other case of physician-diagnosed Lyme disease that has laboratory evidence of infection (as defined above).
Confirmed
A case of EM with exposure in a high incidence state (as defined above), OR
A case of EM with laboratory evidence of infection and a known exposure in a low incidence state, OR
Any case with at least one late manifestation that has laboratory evidence of infection.
Case Classification Comments
Lyme disease reports will not be considered cases if the medical provider specifically states this is not a case of Lyme disease, or the only symptom listed is “tick bite” or “insect bite.”
Federal Public Law 107-116 passed by the Senate and House and signed by President Bush on January 10, 2002; Wording on that bill states that the CDC’s case surveillance definition is “misused as a standard of care for healthcare reimbursement, product (test) development, medical licensing hearings, and other legal cases.” It also instructs the CDC to correct this misuse.
Please sign petition at the change.org site above.
1st nomination for entire 22 minute special report. 2nd nomination for “Gone in a Heartbeat,” Dr. Spector’s story of how undiagnosed Lyme necessitated a heart transplant. 3rd nomination in the category of “Interactivity,” due to how Fox5NY impacted the entire country by these Lyme broadcasts.
Here they are again
Lyme & Reason: The Cause & Consequence of Lyme Disease. June 30,2016
Brian A. Fallon, MD, Steven Phillips, MD, Paul Mead, MD, singer and songwriter Dana Parish, Lyme patient and advocate Susan Green, oncologist Neil Spector, MD, actress and TV personality Marla Maples, author, artist and designer Ally Hilfiger, Patricia De La Mora, Associate Professor, Lawrence Putter, MD, and 12-year-old Julia Bruzzese all speak on MSIDS.
Lyme & Reason 2.0: The Voices of Change. Nov 18, 2016
Focuses on the use of social media as a tool to inform and open the door to change on the Lyme disease front, and how patients, advocates, physicians and others are moving the conversation forward. Plus, host Teresa Priolo sits down with TV personality and Lyme disease patient and advocate Yolanda Hadid about her ongoing battle with Lyme.
LymeDisease.org CEO Lorraine Johnson’s extended “Lyme & Reason” interview
where she discusses the power of social media and technology to help change the national conversation about Lyme disease.
Only parts of her interview were included in Lyme & Reason 2.0. However, Fox5NY has generously made the uncut interview available to the public as well.
Published on Jul 1, 2016
“LYME AND REASON: THE CAUSE AND CONSEQUENCE OF LYME DISEASE” presents an in-depth look at the cause and effect of Lyme disease, including the controversy over testing, the issues of misdiagnosis, and the personal struggles of medical professionals and patients contending with this life-changing illness.
-Brian A. Fallon, MD, MPH, Director of the Center for Neuroinflammatory of the Lyme and Tick-Borne Diseases Research Center at Columbia University talks about the cause of Lyme disease and what you should do if you’re bitten by a tick!
-Yale-trained Lyme disease expert Steven Phillips, MD, addresses the controversy surrounding Lyme disease, while Paul Mead, MD, Chief of Epidemiology and Surveillance Activity of The Bacterial Diseases Branch of the Centers for Disease Control and Prevention, offers the perspective from the country’s lead public health agency.
-Singer and songwriter Dana Parish describes how Lyme disease temporarily derailed her music career during the prime of her life, and how she is now raising awareness about this debilitating illness!
-Lyme patient and advocate Susan Green of the non-profit The National Capital Lyme and Tick-Borne Disease Association (NatCapLyme) talks about the burden placed on families in terms of costs for the treatment of Lyme disease!
-Renowned oncologist Neil Spector, MD, shares his own personal story of his transition from doctor to patient, and how Lyme disease led to an emergency heart transplant!
-Actress and TV personality Marla Maples talks about her own diagnosis of Lyme disease, and how she is encouraging other celebrities to share their stories to put the spotlight on Lyme!
-Author, artist and designer Ally Hilfiger, the daughter of fashion icon Tommy Hilfiger, reflects on how Lyme disease stole her childhood, and her mind after being committed to a psychiatric hospital!
-Patricia De La Mora, Associate Professor of Clinical Pediatrics, Weill Cornell Medical College talks about prevention and how to keep your children safe, while Lawrence Putter, MD – Medical Director Lenox Hill Veterinarians discuss pet safety when it comes to ticks!
-12-year-old Julia Bruzzese shares her heartbreaking story of how Lyme disease has left her unable to walk, and how a blessing from Pope Francis on his visit to NYC last year has given her and her family hope for recovery!
Madison Area Lyme Support Group 