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Dear Group:

In my attempts to pursue " correct " treatment, I may be getting a bit

neurotic. Each time I add/delete medication, is it best to try to cycle it

in before, during or after a scheduled Herxheimer? I have had very timely

Herxheimers with the Babesia treatment of Mepron and Zithromax (less duration

and severity, a perfect straight line decline). My concern would be that I

do not want to be creating multiple 28 day cycles. Is there a recommended

way to manage the introduction of new meds? Thank you.

Sincerely,

Annie

Note: I've included part of this to print -- much more is on the web site.

Bonnie H.

Click Here: <A

HREF= " http://dwp.bigplanet.com/eojlyme/data/folders/Lyme%20Treatment%20Guideli

nes/Lyme%20Guidelines%20May%202000.htm " >MANAGING LYME DISEASE</A>

http://dwp.bigplanet.com/eojlyme/data/folders/Lyme%20Treatment%20Guidelines/Ly

me%20Guidelines%20May%202000.htm

ADVANCED TOPICS IN LYME DISEASE

DIAGNOSTIC HINTS AND TREATMENT GUIDELINES

FOR LYME AND OTHER TICK BORNE ILLNESSES

JOSEPH J. BURRASCANO JR., M.D.

 

Thirteenth Edition

Copyright May, 2000

TABLE OF CONTENTS

INTRODUCTION 3

BACKGROUND INFORMATION 4

DIAGNOSTIC HINTS

PIROPLASMOSIS (Babesiosis) 5

EHRLICHIOSIS 5

LYME BORRELIOSIS

ERYTHEMA MIGRANS 5

DIAGNOSING LATE DISEASE 6

DIAGNOSTIC CRITERIA 7

SYMPTOM CHECKLIST 8

LYME DISEASE TREATMENT GUIDELINES

PIROPLASMOSIS (Babesiosis). 9

EHRLICHIOSIS. 9

LYME BORRELIOSIS 9

GENERAL INFORMATION 9

COURSE DURING THERAPY 10

TREATMENT INFORMATION 11

ANTIBIOTICS 11

MONITORING OF THERAPY 12

ANTIBIOTIC CHOICES 12

TREATMENT CATEGORIES

PROPHYLAXIS 13

FOR KNOWN TICK BITES 13

EARLY LOCALIZED DISEASE 13

DISSEMINATED DISEASE 13

1. early 13

2. late 14

ALTERNATE SCHEDULING OF ANTIBIOTIC TREATMENTS 14

ADVANCED TOPICS 14

1. Cystic form 14

2. Borrelia Neurotoxin 15

REFRACTORY DISEASE 15

1. responsive to antibiotic therapy 15

2. non-responsive to antibiotic therapy 16

ADJUNCTIVE THERAPY 16

SAFETY 16

NUTRITIONAL SUPPLEMENTS IN CHRONIC LYME DISEASE 17

LYME DISEASE REHABILITATION 18

REHAB THERAPY PRESCRIPTION 19

MANAGING YEAST INFECTIONS 20

PATIENT INSTRUCTIONS ON TICK BITE PREVENTION AND TICK REMOVAL 21

APPENDIX

Rationale for treating tick bites 22

Rationale for treatment recommendations 23

SUGGESTED READING 25

 

INTRODUCTION

The pace of new discoveries in Lyme has accelerated, with many important

clinical implications. I will attempt to familiarize you with the latest

information. Because this is a rapidly evolving field, keep up your efforts

at continuing education and communication with other experienced clinicians.

This is an exciting time indeed!

Much new information is included in this edition of the Guidelines, including

new sections. Nearly every page has been revised.

To me, " Lyme Disease " is not simply an infection with Borrelia burgdorferi,

but a complex illness potentially consisting of multiple tick-derived

co-infections. In later stages, it also includes collateral conditions that

result from being ill with multiple pathogens, each of which can have

profound impact on the person's overall health. Together, damage to virtually

all bodily systems can result. In addition, it is possible to see latent

infections reactivate, especially viruses of the Herpes type.

We also have new information that B. burgdorferi exists in at least three

different forms: bacterial (the well known, cell wall-containing spirochete),

spheroplast or l-form, and the newly discovered cystic form. The importance

is that only the spirochete form can be killed by beta lactam antibiotics.

Spheroplasts seem to be susceptible to tetracyclines and erythromycins, yet

the cyst so far has been proven to be susceptible only to metronidzole.

It is clear that in the great majority of patients, chronic Lyme is a disease

affecting predominantly the nervous system. Thus the value of careful

evaluation that often includes neuropsychiatric testing, SPECT and MRI brain

scans, CSF analysis when appropriate, regular input from Lyme-aware

neurologists, pain clinics, and occasionally specialists in

psychopharmacology.

Two different researchers have provided recent evidence that B. burgdorferi,

like many other pathogenic bacteria, can produce neurotoxins. Early clinical

trials aimed at removing these toxins have proven quite promising! I will

discuss this in more detail in a later section.

More evidence has accumulated indicating the severe detrimental effects of

immunosuppressants including steroids in the patient with active B.

burgdorferi infection. Never give steroids to any patient who may even

remotely be suffering from Lyme, or serious, permanent damage may result,

especially if given for anything greater than a short course.

The concept of a " therapeutic alliance " between the caregiver and patient

must again be emphasized. This means that the patient has to work with and

become part of the medical team, and must take responsibility for complying

with the recommendations given, maintaining the best possible health status,

reporting promptly any problems or new symptoms, and especially in realizing

that despite all our best efforts, success in diagnosis and treatment is

never assured. The medical team must make great efforts to listen carefully

to the patient and not be too quick to dismiss seemingly bizarre or illogical

complaints.

I once again extend my best wishes to the many patients and caregivers who

deal with Lyme, and a sincere thank you to my colleagues whose endless

contributions have helped me shape my approach to tick borne illnesses. I

hope that my new edition proves to be useful. Happy reading!

BACKGROUND INFORMATION

CO-INFECTION

A huge body of research and clinical experience has demonstrated the nearly

universal phenomenon in Lyme patients of co-infection with multiple

tick-borne pathogens. As many have heard me say, coinfection is not

surprising, for ticks are arachnids that literally live in dirt and drink the

blood of wild animals. To think that a significant tick bite transmits only

one infection is narrow minded indeed. Studies have shown that concurrent

Borrelial and Ehrlichial and/or Babesial infections result in a change in

their individual clinical presentations, with different symptoms, atypical

signs, decreased reliability of standard diagnostic tests, and most

importantly, the creation of chronic, persistent forms of each of these

infections. As time goes by, I am convinced that more pathogens will be found.

Therefore, Lyme, as we had come to know it, probably represents a mixed

infection. I will leave to the reader the implications of how this may

explain the discrepancy between laboratory study of pure Borrelia infections,

and what front line physicians have been seeing for years in real patients.

The evaluation of a Lyme patient must begin with testing for all currently

known tick borne pathogens. Serological studies for Borrelia, Babesia and

Ehrlichia should be combined where appropriate with direct antigen assays.

Antigen detection tests (antigen capture and PCR) are especially helpful in

evaluating the seronegative patient and those still ill or relapsing after

therapy. Unfortunately, over a dozen protozoans other than Babesia microti

can be found in ticks, yet commercial tests for only B. microti are available

at this time, so as in Borrelia, clinical assessment is the primary

diagnostic tool. In Ehrlichiosis, test for both the monocytic and

granulocytic forms. Many presently uncharacterized Ehrlichia-like organisms

can be found in ticks and may not be picked up by currently available assays,

so in this illness too, serologies are only an adjunct in making the

diagnosis.

Babesia are parasites, and I suggest that if a coinfection is found involving

this organism, treat this first, so that subsequent therapy for Borrelia and

Ehrlichia will be more effective.

GENERAL MEASURES

Experience has shown that collateral conditions exist in those who have been

ill a long time. Test B12 levels, and be prepared to aggressively treat with

parenteral formulations of the B-vitamins: 100mg each of B1 and B6 and 1000

mcg of B12 IM at least weekly in the more ill patient.

Magnesium deficiency is very often present and quite severe. Hyperreflexia,

muscle twitches, myocardial irritability, and recurrent tight muscle spasms

are clues to this deficiency. Magnesium is predominantly an intracellular

ion, so blood level testing is of little value. Oral preparations are

acceptable for maintenance, but most need additional, parenteral dosing: 1

gram IV or IM at least once a week until neuromuscular irritability has

cleared.

Activation of the inflammatory cascade has been implicated in blockade of

cellular receptors. One example of this is insulin resistance, which may

partly account for the dyslipidemia and weight gain that is noted in 80% of

chronic Lyme patients. Clinical hypothyroidism can result from receptor

blockade and thus hypothyroidism can exist despite normal serum hormone

levels. Also, because the Lyme syndrome has been associated with faulty

activation of T4, measure free T3 levels by RIA, and basal A.M. body

temperatures. If hypothyroidism is found, you will need to treat with T3

preparations.

SPECT scanning of the brain, if done by knowledgeable radiologists using

high-resolution equipment, will show characteristic abnormalities in Lyme

encephalopathy. This not only helps with the differential diagnosis, but if

done before and after acetazolamide, it will guide in the use of

vasodilators, which may clear some cognitive symptoms. Therapy can also

include serotonin agonists, pentoxiphylline and even Ginkgo biloba.

Therapeutic trials may be needed.

Tilt table testing is another powerful tool which, just as in CFIDS, may

demonstrate neurally mediated hypotension (NMH). If NMH is present, treatment

can dramatically lessen fatigue, palpitations and wooziness, and increase

stamina. This test should be done by a cardiologist and include Isuprel

challenge. This will demonstrate not only if NMH is present, but also the

relative contributions of hypovolemia and sympathetic dysfunction. Therapy is

based on blood volume expansion (increased sodium and fluid intake and

possibly Florinef plus potassium). If not sufficient, beta blockade may be

added based on response to the Isuprel challenge.

DIAGNOSTIC HINTS

Lyme is diagnosed clinically, as no currently available test, no matter the

source or type, is definitive in ruling in or ruling out infection with these

pathogens, or whether these infections are responsible for the patient's

symptoms. The entire clinical picture must be taken into account, including a

search for concurrent conditions and alternate diagnoses, and other reasons

for some of the presenting complaints. Often, much of the diagnostic process

in late, disseminated Lyme involves ruling out other illnesses and defining

the extent of damage that might require separate evaluation and treatment.

Consideration should be given to tick exposure, rashes (even atypical ones),

evolution of typical symptoms in a previously asymptomatic individual, and

results of tests for tick borne pathogens. Another very important factor is

response to treatment- presence or absence of Jarisch Herxheimer-like

reactions, the classic four week cycle of waxing and waning of symptoms, and

improvement with therapy.

PIROPLASMOSIS (Babesiosis)

Classic teachings state that acute infections are usually only seen in those

with some form of immune compromise. Flu-like symptoms rapidly evolve to

include shaking chills, high fevers, hemolysis and pancytopenia. Fatalities

have been reported. Visualizing Babesial forms on peripheral smears can make

the diagnosis in this situation. In those with intact immune systems, a mild

flu-like illness appears one to two weeks after exposure and clears without

treatment over six to eight weeks. In either case, it is imperative to also

test for Borrelia and Ehrlichia.

However, when coinfection exists, this acute presentation is much less

common, and it is rare to see parasite forms on smear. Suggestions of

coinfection include severe headaches, dyspnea, dry cough, dizziness, and

encephalopathy out of proportion to the other Borrelial symptoms. Testing is

not at all definitive, yet should include CBC, Babesia smear (very low

yield), serologies (IgG and IgM) and if necessary, PCR of peripheral blood.

Newer direct assays are currently being researched, as this is an active area

of investigation. Always consider coinfection in your current Lyme patients

who are not responding fully and be prepared to treat cased on clinical

presentation even with negative tests.

EHRLICHIOSIS

While it is true that this illness can have a fulminant presentation, I am

convinced that milder forms do exist especially when other tick-borne

organisms were transmitted. When present in a Lyme patient, persistent

leucopenia is an important clue. Thrombocytopenia is much less common, but

likewise should not be ignored. Headaches, myalgias, and ongoing fatigue seem

to relate to this illness, but are extremely difficult to separate from

symptoms caused by Bb. At this time, we have to rely on serologies for

laboratory diagnosis, as currently available PCR assays are of unknown

sensitivity and specificity, and direct visualization of leucocytes is of low

yield. As there may be a variety of pathogenic Ehrlichia-like organisms that

will not be picked up by current testing technology, clinical diagnosis

remains the primary diagnostic tool. Again, consider this diagnosis in a Lyme

Borreliosis (LB) patient not responding well to therapy.

LYME BORRELIOSIS

ERYTHEMA MIGRANS

Erythema migrans (EM) is diagnostic of Bb infection, but is present in fewer

than half. Even if present, it may go unnoticed by the patient. It is an

erythematous, centrifugally expanding lesion that is raised and warm.

Sometimes there is mild stinging or pruritus. The EM rash will begin four

days to several weeks after the bite, and may be associated with

constitutional symptoms. Multiple lesions are present less than 10% of the

time, but do represent disseminated disease. Some lesions have an atypical

appearance and skin biopsy specimens may be helpful. When an ulcerated or

vesicular center is seen, this may represent a mixed infection, involving

other organisms besides B. burgdorferi.

After a tick bite, serologic tests (ELISA. IFA, western blots, etc.) are not

expected to become positive until several weeks have passed. Therefore, if EM

is present, treatment must begin immediately, and one should not wait for

results of Borrelia tests. You should not miss the chance to treat early

disease, for this is when the success rate is the highest. Indeed, many

knowledgeable clinicians will not even order a Borrelia test in this

circumstance.

DIAGNOSING LATE DISEASE

When reactive, serologies indicate exposure only and do not directly indicate

whether the spirochete is now currently present. Because Bb serologies often

give inconsistent results, test at more than one laboratory using if possible

different methods. I recommend ordering IgM and IgG western blots. Be aware

that in late disease there may be repeatedly peaking IgM's and therefore a

reactive IgM may not differentiate early from late disease, but it does

suggest an active infection. When late cases of LB are seronegative, 36% will

transiently become seropositive at the completion of successful therapy.

Western blots are reported by showing which bands are reactive. 41KD bands

appear the earliest but can cross react with other spirochetes. The 18KD,

23-25KD (Osp C), 31KD (Osp A), 34KD (Osp B), 37KD, 39KD, 83KD and the 93KD

bands are the most specific but appear later or may not appear at all. You

need to see at least the 41KD and one of the specific bands. 55KD, 60KD,

66KD, and 73KD are nonspecific and nondiagnostic.

Antigen detection tests including PCR are now available, and although they

are very specific, sensitivity remains poor, possibly less than 30%. This is

because Bb causes a deep tissue infection and is only transiently found in

body humors. Therefore, multiple specimens must be collected to increase

yield; a negative result does not rule out infection, but a positive one is

significant. The patient must be antibiotic free for at least six weeks

before testing to obtain the highest yield. Antigen capture can be done on

urine, CSF, and synovial fluid. PCR can be done on blood (buffy coat is

best), urine, CSF, any other body fluid including breast milk, and on tissue

biopsy specimens.

I strongly urge you to biopsy all unexplained skin lesions/rashes and perform

PCR and careful histology. You will need to alert the pathologist to look for

spirochetes.

Spinal taps are not routinely recommended, as a negative tap does not rule

out Lyme. Antibodies to Bb can be detected in the CSF in just 20% of patients

with late disease. Therefore, spinal taps are only performed on patients with

pronounced neurological manifestations, if they are seronegative, or are

still significantly symptomatic after completion of treatment. When done, the

goal is to rule out other conditions, and to determine if Bb antigens are

present. It is especially important to look for elevated protein and

mononuclear cells, which would dictate the need for more aggressive therapy,

as well as the opening pressure, which can be elevated and add to headaches,

especially in children.

DIAGNOSTIC CHECKLIST

To aid the clinician, a workable set of diagnostic criteria were developed

with the input of dozens of front line physicians. The resultant document has

proven to be extremely useful not only to the clinician, but it also can help

clarify the diagnosis for third party payers and utilization review

committees. It is important to note that the CDC's published reporting

criteria are for surveillance only, not for diagnosis

LYME BORRELIOSIS DIAGNOSTIC CRITERIA RELATIVE VALUE

Tick exposure in an endemic region 1

Historical facts and evolution of symptoms consistent with Lyme 2

Systemic signs & symptoms consistent with Bb infection (other potential

diagnoses excluded):

Single system, e.g., monoarthritis 1

Two or more systems, e.g., monoarthritis and facial palsy 2

Erythema migrans, physician confirmed 7

Acrodermatitis Chronica Atrophicans, biopsy confirmed 7

Seropositivity 3

Seroconversion on paired sera 4

Tissue microscopy, silver stain 3

Tissue microscopy, monoclonal immunofluorescence 4

Culture positivity 4

B. burgdorferi antigen recovery 4

B. burgdorferi DNA/RNA recovery 4

DIAGNOSIS

Lyme Borreliosis Highly Likely........ 7 or above

Lyme Borreliosis Possible...... 5-6

Lyme Borreliosis Unlikely....... 4 or below

I suggest that when using these criteria, you state Lyme Borreliosis is

" unlikely " , " possible " , or " highly likely " based upon the following

criteria " - then list the criteria.

 

SYMPTOM CHECK LIST

This is not meant to be used as a diagnostic scheme, but is provided to

streamline the office interview. Note the format- complaints referable to

specific organ systems are clustered to better display multisystem

involvement.

NAME_______________________________________DATE__________________

RISK PROFILE (PLEASE CHECK)

Tick infested area__ Frequent outdoor activities__ Hiking__ Fishing__

Camping__ Gardening__ Hunting__ Ticks noted on pets__

Do you remember being bitten by a tick?............. No__ Yes__ when________

Do you remember having the " bull's eye rash " ? ..No__ Yes__

Any other rash?.................................................... No__ Yes__

Have you had any of the following? CIRCLE ALL YES ANSWERS

1.Unexplained fevers, sweats, chills, or flushing

2.Unexplained weight change- (loss or gain)

3.Fatigue, tiredness, poor stamina

4.Unexplained hair loss

5.Swollen glands: list areas_________________________________________

6.Sore throat

7.Testicular pain/pelvic pain

8.Unexplained menstrual irregularity

9.Unexplained milk production; breast pain

10.Irritable bladder or bladder dysfunction

11.Sexual dysfunction or loss of libido

12.Upset stomach

13.Change in bowel function- (constipation, diarrhea)

14.Chest pain or rib soreness

15.Shortness of breath, cough

16.Heart palpitations, pulse skips, heart block

17.Any history of a heart murmur or valve prolapse?

18.Joint pain or swelling: list

joints_________________________________________________

19.Stiffness of the joints, neck, or back

20.Muscle pain or cramps

21.Twitching of the face or other muscles

22.Headache

23.Neck creaks and cracks, neck stiffness, neck pain

24.Tingling, numbness, burning or stabbing sensations, shooting pains

25.Facial paralysis (Bell's Palsy)

26.Eyes/Vision: double, blurry, increased floaters, light sensitivity

27.Ears/Hearing: buzzing, ringing, ear pain, sound sensitivity

28.Increased motion sickness, vertigo, poor balance

29.Lightheadedness, wooziness

30.Tremor

31.Confusion, difficulty in thinking

32.Difficulty with concentration, reading

33.Forgetfulness, poor short term memory

34.Disorientation: getting lost, going to wrong places

35.Difficulty with speech or writing; word block

36.Mood swings, irritability, depression

37.Disturbed sleep-too much, too little, fractionated, early awakening

38.Exaggerated symptoms or worse hangover from alcohol

LYME DISEASE TREATMENT GUIDELINES

PIROPLASMOSIS (BABESIOSIS)

Piroplasms are not bacteria, they are protozoans. Therefore, they will not be

eradicated by any of the currently used Lyme treatment regimens. Therein lies

the significance of coinfections- if a Lyme patient has been extensively

treated yet is still ill, suspect a piroplasm.

Just as in Lyme Borreliosis, the longer one has been infected, the longer the

course of therapy must be. Similarly, clinical assessment is the only guide

to treatment endpoint.

Treatment choices are limited. Pentamidine is a treatment given as daily IM

shots- very painful, and they cause sterile abscesses and permanent fibrous

scars on the buttocks. More importantly, response is poor, and the patient

risks development of glucose intolerance. Clearly, not a first choice.

Clindamycin, 600 mg qid plus Quinine, 650 mg qid has been the published

standard but the suggested two week course is nearly impossible to tolerate

(hearing loss, rash, fever, headache) and treatment failures have been

reported.

Gentamicin has been used in treating livestock infected with piroplasms.

There are only anecdotal reports of efficacy in Humans, where a 14-day course

at standard doses has proven effective in early disease. Experience with this

antibiotic in late disease is limited, and the optimal regimen has not been

well worked out. The main side effect is potential hearing loss from the

gentamicin, and the need for IM or IV doses.

Mepron (atovaquone), 750 mg bid, has demonstrated efficacy, but should be

given concurrently with azithromycin, 250 to 600 mg daily, or resistance may

develop. Efficacy is by far the best with this combination, but surprisingly,

Herxheimer-like reactions are almost always seen at the fourth day, and at

the fourth week of therapy. Does this represent a newly described phenomenon

in treating Piroplasms, or does this combination have heretofore unrecognized

efficacy in killing Bb? Although I do not have the answer, I suspect the

latter simply based on the familiar (in Bb) four-week cycle. In late,

longstanding cases, one month of treatment is the minimum, and four or more

months are often needed. Problems during therapy include diarrhea, mild

nausea, the expense of Mepron ($600.00 per bottle- enough for one month of

treatment), and rarely, a temporary yellowish discoloration of the vision.

Regular blood counts and liver panels are recommended during any prolonged

course of therapy. Patients who are not cured with this regimen can be

retreated but with higher doses, as this has proven effective in many of my

patients.

EHRLICHIOSIS

Treatment recommendations at this time are still preliminary, mainly due to

the lack of direct detection methods needed to guide us in developing a solid

clinical feel. The mainstay of treatment is doxycycline, either orally or IV,

given for at least two weeks for an early infection, or at least four weeks

in a longstanding one. Interestingly, the unexpected efficacy of IV

doxycycline in treating Lyme cases which had previously responded poorly to

cell wall agents, may in fact reflect concurrent therapy of coinfection of Bb

with Ehrlichial species. The new concern for Ehrlichia is the main reason

that doxycycline is now the first choice in treating tick bites and early

Lyme, before serologies can become positive.

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Dear Everyone:

Quick background: I have Lyme, Babesiosis (B) and Ehrlichiosis (E). Two

other family members have blood positive Lyme. My B and E were only detected

via a Bone Marrow Biopsy (BMB). I really pushed my loved ones to get a BMB,

in spite of much resistance. Lo and behold, the results are positive for B.

Even with daily Rocephin, treatment was not progressing as hoped or expected.

It all makes sense now! It is my understanding that B has to be eradicated

to make the Lyme treatment be successful. By the way, BMBs are not as

painful as people claim, a few second and it is all over. Done by someone

who has done several, makes a big difference.

Please, if treatment for Lyme appears to be hampered, please go the last yard

and rule out the co-infections. My family are now true believers. I

suspected this for a while, yet couldn't get resolution for this concern.

The good news is that the Lyme treatment was not a waste, but the process is

just that much more challenging. I am mildly taken aback, but we're better

off knowing than not!

Sincerely,

Annie

Dear Group:

In my attempts to pursue " correct " treatment, I may be getting a bit

neurotic. Each time I add/delete medication, is it best to try to cycle it

in before, during or after a scheduled Herxheimer? I have had very timely

Herxheimers with the Babesia treatment of Mepron and Zithromax (less duration

and severity, a perfect straight line decline). My concern would be that I

do not want to be creating multiple 28 day cycles. Is there a recommended

way to manage the introduction of new meds? Thank you.

Sincerely,

Annie

Note: I've included part of this to print -- much more is on the web site.

Bonnie H.

Click Here: <A

HREF= " http://dwp.bigplanet.com/eojlyme/data/folders/Lyme%20Treatment%20Guideli

nes/Lyme%20Guidelines%20May%202000.htm " >MANAGING LYME DISEASE</A>

http://dwp.bigplanet.com/eojlyme/data/folders/Lyme%20Treatment%20Guidelines/Ly

me%20Guidelines%20May%202000.htm

ADVANCED TOPICS IN LYME DISEASE

DIAGNOSTIC HINTS AND TREATMENT GUIDELINES

FOR LYME AND OTHER TICK BORNE ILLNESSES

JOSEPH J. BURRASCANO JR., M.D.

 

Thirteenth Edition

Copyright May, 2000

TABLE OF CONTENTS

INTRODUCTION 3

BACKGROUND INFORMATION 4

DIAGNOSTIC HINTS

PIROPLASMOSIS (Babesiosis) 5

EHRLICHIOSIS 5

LYME BORRELIOSIS

ERYTHEMA MIGRANS 5

DIAGNOSING LATE DISEASE 6

DIAGNOSTIC CRITERIA 7

SYMPTOM CHECKLIST 8

LYME DISEASE TREATMENT GUIDELINES

PIROPLASMOSIS (Babesiosis). 9

EHRLICHIOSIS. 9

LYME BORRELIOSIS 9

GENERAL INFORMATION 9

COURSE DURING THERAPY 10

TREATMENT INFORMATION 11

ANTIBIOTICS 11

MONITORING OF THERAPY 12

ANTIBIOTIC CHOICES 12

TREATMENT CATEGORIES

PROPHYLAXIS 13

FOR KNOWN TICK BITES 13

EARLY LOCALIZED DISEASE 13

DISSEMINATED DISEASE 13

1. early 13

2. late 14

ALTERNATE SCHEDULING OF ANTIBIOTIC TREATMENTS 14

ADVANCED TOPICS 14

1. Cystic form 14

2. Borrelia Neurotoxin 15

REFRACTORY DISEASE 15

1. responsive to antibiotic therapy 15

2. non-responsive to antibiotic therapy 16

ADJUNCTIVE THERAPY 16

SAFETY 16

NUTRITIONAL SUPPLEMENTS IN CHRONIC LYME DISEASE 17

LYME DISEASE REHABILITATION 18

REHAB THERAPY PRESCRIPTION 19

MANAGING YEAST INFECTIONS 20

PATIENT INSTRUCTIONS ON TICK BITE PREVENTION AND TICK REMOVAL 21

APPENDIX

Rationale for treating tick bites 22

Rationale for treatment recommendations 23

SUGGESTED READING 25

 

INTRODUCTION

The pace of new discoveries in Lyme has accelerated, with many important

clinical implications. I will attempt to familiarize you with the latest

information. Because this is a rapidly evolving field, keep up your efforts

at continuing education and communication with other experienced clinicians.

This is an exciting time indeed!

Much new information is included in this edition of the Guidelines, including

new sections. Nearly every page has been revised.

To me, " Lyme Disease " is not simply an infection with Borrelia burgdorferi,

but a complex illness potentially consisting of multiple tick-derived

co-infections. In later stages, it also includes collateral conditions that

result from being ill with multiple pathogens, each of which can have

profound impact on the person's overall health. Together, damage to virtually

all bodily systems can result. In addition, it is possible to see latent

infections reactivate, especially viruses of the Herpes type.

We also have new information that B. burgdorferi exists in at least three

different forms: bacterial (the well known, cell wall-containing spirochete),

spheroplast or l-form, and the newly discovered cystic form. The importance

is that only the spirochete form can be killed by beta lactam antibiotics.

Spheroplasts seem to be susceptible to tetracyclines and erythromycins, yet

the cyst so far has been proven to be susceptible only to metronidzole.

It is clear that in the great majority of patients, chronic Lyme is a disease

affecting predominantly the nervous system. Thus the value of careful

evaluation that often includes neuropsychiatric testing, SPECT and MRI brain

scans, CSF analysis when appropriate, regular input from Lyme-aware

neurologists, pain clinics, and occasionally specialists in

psychopharmacology.

Two different researchers have provided recent evidence that B. burgdorferi,

like many other pathogenic bacteria, can produce neurotoxins. Early clinical

trials aimed at removing these toxins have proven quite promising! I will

discuss this in more detail in a later section.

More evidence has accumulated indicating the severe detrimental effects of

immunosuppressants including steroids in the patient with active B.

burgdorferi infection. Never give steroids to any patient who may even

remotely be suffering from Lyme, or serious, permanent damage may result,

especially if given for anything greater than a short course.

The concept of a " therapeutic alliance " between the caregiver and patient

must again be emphasized. This means that the patient has to work with and

become part of the medical team, and must take responsibility for complying

with the recommendations given, maintaining the best possible health status,

reporting promptly any problems or new symptoms, and especially in realizing

that despite all our best efforts, success in diagnosis and treatment is

never assured. The medical team must make great efforts to listen carefully

to the patient and not be too quick to dismiss seemingly bizarre or illogical

complaints.

I once again extend my best wishes to the many patients and caregivers who

deal with Lyme, and a sincere thank you to my colleagues whose endless

contributions have helped me shape my approach to tick borne illnesses. I

hope that my new edition proves to be useful. Happy reading!

BACKGROUND INFORMATION

CO-INFECTION

A huge body of research and clinical experience has demonstrated the nearly

universal phenomenon in Lyme patients of co-infection with multiple

tick-borne pathogens. As many have heard me say, coinfection is not

surprising, for ticks are arachnids that literally live in dirt and drink the

blood of wild animals. To think that a significant tick bite transmits only

one infection is narrow minded indeed. Studies have shown that concurrent

Borrelial and Ehrlichial and/or Babesial infections result in a change in

their individual clinical presentations, with different symptoms, atypical

signs, decreased reliability of standard diagnostic tests, and most

importantly, the creation of chronic, persistent forms of each of these

infections. As time goes by, I am convinced that more pathogens will be found.

Therefore, Lyme, as we had come to know it, probably represents a mixed

infection. I will leave to the reader the implications of how this may

explain the discrepancy between laboratory study of pure Borrelia infections,

and what front line physicians have been seeing for years in real patients.

The evaluation of a Lyme patient must begin with testing for all currently

known tick borne pathogens. Serological studies for Borrelia, Babesia and

Ehrlichia should be combined where appropriate with direct antigen assays.

Antigen detection tests (antigen capture and PCR) are especially helpful in

evaluating the seronegative patient and those still ill or relapsing after

therapy. Unfortunately, over a dozen protozoans other than Babesia microti

can be found in ticks, yet commercial tests for only B. microti are available

at this time, so as in Borrelia, clinical assessment is the primary

diagnostic tool. In Ehrlichiosis, test for both the monocytic and

granulocytic forms. Many presently uncharacterized Ehrlichia-like organisms

can be found in ticks and may not be picked up by currently available assays,

so in this illness too, serologies are only an adjunct in making the

diagnosis.

Babesia are parasites, and I suggest that if a coinfection is found involving

this organism, treat this first, so that subsequent therapy for Borrelia and

Ehrlichia will be more effective.

GENERAL MEASURES

Experience has shown that collateral conditions exist in those who have been

ill a long time. Test B12 levels, and be prepared to aggressively treat with

parenteral formulations of the B-vitamins: 100mg each of B1 and B6 and 1000

mcg of B12 IM at least weekly in the more ill patient.

Magnesium deficiency is very often present and quite severe. Hyperreflexia,

muscle twitches, myocardial irritability, and recurrent tight muscle spasms

are clues to this deficiency. Magnesium is predominantly an intracellular

ion, so blood level testing is of little value. Oral preparations are

acceptable for maintenance, but most need additional, parenteral dosing: 1

gram IV or IM at least once a week until neuromuscular irritability has

cleared.

Activation of the inflammatory cascade has been implicated in blockade of

cellular receptors. One example of this is insulin resistance, which may

partly account for the dyslipidemia and weight gain that is noted in 80% of

chronic Lyme patients. Clinical hypothyroidism can result from receptor

blockade and thus hypothyroidism can exist despite normal serum hormone

levels. Also, because the Lyme syndrome has been associated with faulty

activation of T4, measure free T3 levels by RIA, and basal A.M. body

temperatures. If hypothyroidism is found, you will need to treat with T3

preparations.

SPECT scanning of the brain, if done by knowledgeable radiologists using

high-resolution equipment, will show characteristic abnormalities in Lyme

encephalopathy. This not only helps with the differential diagnosis, but if

done before and after acetazolamide, it will guide in the use of

vasodilators, which may clear some cognitive symptoms. Therapy can also

include serotonin agonists, pentoxiphylline and even Ginkgo biloba.

Therapeutic trials may be needed.

Tilt table testing is another powerful tool which, just as in CFIDS, may

demonstrate neurally mediated hypotension (NMH). If NMH is present, treatment

can dramatically lessen fatigue, palpitations and wooziness, and increase

stamina. This test should be done by a cardiologist and include Isuprel

challenge. This will demonstrate not only if NMH is present, but also the

relative contributions of hypovolemia and sympathetic dysfunction. Therapy is

based on blood volume expansion (increased sodium and fluid intake and

possibly Florinef plus potassium). If not sufficient, beta blockade may be

added based on response to the Isuprel challenge.

DIAGNOSTIC HINTS

Lyme is diagnosed clinically, as no currently available test, no matter the

source or type, is definitive in ruling in or ruling out infection with these

pathogens, or whether these infections are responsible for the patient's

symptoms. The entire clinical picture must be taken into account, including a

search for concurrent conditions and alternate diagnoses, and other reasons

for some of the presenting complaints. Often, much of the diagnostic process

in late, disseminated Lyme involves ruling out other illnesses and defining

the extent of damage that might require separate evaluation and treatment.

Consideration should be given to tick exposure, rashes (even atypical ones),

evolution of typical symptoms in a previously asymptomatic individual, and

results of tests for tick borne pathogens. Another very important factor is

response to treatment- presence or absence of Jarisch Herxheimer-like

reactions, the classic four week cycle of waxing and waning of symptoms, and

improvement with therapy.

PIROPLASMOSIS (Babesiosis)

Classic teachings state that acute infections are usually only seen in those

with some form of immune compromise. Flu-like symptoms rapidly evolve to

include shaking chills, high fevers, hemolysis and pancytopenia. Fatalities

have been reported. Visualizing Babesial forms on peripheral smears can make

the diagnosis in this situation. In those with intact immune systems, a mild

flu-like illness appears one to two weeks after exposure and clears without

treatment over six to eight weeks. In either case, it is imperative to also

test for Borrelia and Ehrlichia.

However, when coinfection exists, this acute presentation is much less

common, and it is rare to see parasite forms on smear. Suggestions of

coinfection include severe headaches, dyspnea, dry cough, dizziness, and

encephalopathy out of proportion to the other Borrelial symptoms. Testing is

not at all definitive, yet should include CBC, Babesia smear (very low

yield), serologies (IgG and IgM) and if necessary, PCR of peripheral blood.

Newer direct assays are currently being researched, as this is an active area

of investigation. Always consider coinfection in your current Lyme patients

who are not responding fully and be prepared to treat cased on clinical

presentation even with negative tests.

EHRLICHIOSIS

While it is true that this illness can have a fulminant presentation, I am

convinced that milder forms do exist especially when other tick-borne

organisms were transmitted. When present in a Lyme patient, persistent

leucopenia is an important clue. Thrombocytopenia is much less common, but

likewise should not be ignored. Headaches, myalgias, and ongoing fatigue seem

to relate to this illness, but are extremely difficult to separate from

symptoms caused by Bb. At this time, we have to rely on serologies for

laboratory diagnosis, as currently available PCR assays are of unknown

sensitivity and specificity, and direct visualization of leucocytes is of low

yield. As there may be a variety of pathogenic Ehrlichia-like organisms that

will not be picked up by current testing technology, clinical diagnosis

remains the primary diagnostic tool. Again, consider this diagnosis in a Lyme

Borreliosis (LB) patient not responding well to therapy.

LYME BORRELIOSIS

ERYTHEMA MIGRANS

Erythema migrans (EM) is diagnostic of Bb infection, but is present in fewer

than half. Even if present, it may go unnoticed by the patient. It is an

erythematous, centrifugally expanding lesion that is raised and warm.

Sometimes there is mild stinging or pruritus. The EM rash will begin four

days to several weeks after the bite, and may be associated with

constitutional symptoms. Multiple lesions are present less than 10% of the

time, but do represent disseminated disease. Some lesions have an atypical

appearance and skin biopsy specimens may be helpful. When an ulcerated or

vesicular center is seen, this may represent a mixed infection, involving

other organisms besides B. burgdorferi.

After a tick bite, serologic tests (ELISA. IFA, western blots, etc.) are not

expected to become positive until several weeks have passed. Therefore, if EM

is present, treatment must begin immediately, and one should not wait for

results of Borrelia tests. You should not miss the chance to treat early

disease, for this is when the success rate is the highest. Indeed, many

knowledgeable clinicians will not even order a Borrelia test in this

circumstance.

DIAGNOSING LATE DISEASE

When reactive, serologies indicate exposure only and do not directly indicate

whether the spirochete is now currently present. Because Bb serologies often

give inconsistent results, test at more than one laboratory using if possible

different methods. I recommend ordering IgM and IgG western blots. Be aware

that in late disease there may be repeatedly peaking IgM's and therefore a

reactive IgM may not differentiate early from late disease, but it does

suggest an active infection. When late cases of LB are seronegative, 36% will

transiently become seropositive at the completion of successful therapy.

Western blots are reported by showing which bands are reactive. 41KD bands

appear the earliest but can cross react with other spirochetes. The 18KD,

23-25KD (Osp C), 31KD (Osp A), 34KD (Osp B), 37KD, 39KD, 83KD and the 93KD

bands are the most specific but appear later or may not appear at all. You

need to see at least the 41KD and one of the specific bands. 55KD, 60KD,

66KD, and 73KD are nonspecific and nondiagnostic.

Antigen detection tests including PCR are now available, and although they

are very specific, sensitivity remains poor, possibly less than 30%. This is

because Bb causes a deep tissue infection and is only transiently found in

body humors. Therefore, multiple specimens must be collected to increase

yield; a negative result does not rule out infection, but a positive one is

significant. The patient must be antibiotic free for at least six weeks

before testing to obtain the highest yield. Antigen capture can be done on

urine, CSF, and synovial fluid. PCR can be done on blood (buffy coat is

best), urine, CSF, any other body fluid including breast milk, and on tissue

biopsy specimens.

I strongly urge you to biopsy all unexplained skin lesions/rashes and perform

PCR and careful histology. You will need to alert the pathologist to look for

spirochetes.

Spinal taps are not routinely recommended, as a negative tap does not rule

out Lyme. Antibodies to Bb can be detected in the CSF in just 20% of patients

with late disease. Therefore, spinal taps are only performed on patients with

pronounced neurological manifestations, if they are seronegative, or are

still significantly symptomatic after completion of treatment. When done, the

goal is to rule out other conditions, and to determine if Bb antigens are

present. It is especially important to look for elevated protein and

mononuclear cells, which would dictate the need for more aggressive therapy,

as well as the opening pressure, which can be elevated and add to headaches,

especially in children.

DIAGNOSTIC CHECKLIST

To aid the clinician, a workable set of diagnostic criteria were developed

with the input of dozens of front line physicians. The resultant document has

proven to be extremely useful not only to the clinician, but it also can help

clarify the diagnosis for third party payers and utilization review

committees. It is important to note that the CDC's published reporting

criteria are for surveillance only, not for diagnosis

LYME BORRELIOSIS DIAGNOSTIC CRITERIA RELATIVE VALUE

Tick exposure in an endemic region 1

Historical facts and evolution of symptoms consistent with Lyme 2

Systemic signs & symptoms consistent with Bb infection (other potential

diagnoses excluded):

Single system, e.g., monoarthritis 1

Two or more systems, e.g., monoarthritis and facial palsy 2

Erythema migrans, physician confirmed 7

Acrodermatitis Chronica Atrophicans, biopsy confirmed 7

Seropositivity 3

Seroconversion on paired sera 4

Tissue microscopy, silver stain 3

Tissue microscopy, monoclonal immunofluorescence 4

Culture positivity 4

B. burgdorferi antigen recovery 4

B. burgdorferi DNA/RNA recovery 4

DIAGNOSIS

Lyme Borreliosis Highly Likely........ 7 or above

Lyme Borreliosis Possible...... 5-6

Lyme Borreliosis Unlikely....... 4 or below

I suggest that when using these criteria, you state Lyme Borreliosis is

" unlikely " , " possible " , or " highly likely " based upon the following

criteria " - then list the criteria.

 

SYMPTOM CHECK LIST

This is not meant to be used as a diagnostic scheme, but is provided to

streamline the office interview. Note the format- complaints referable to

specific organ systems are clustered to better display multisystem

involvement.

NAME_______________________________________DATE__________________

RISK PROFILE (PLEASE CHECK)

Tick infested area__ Frequent outdoor activities__ Hiking__ Fishing__

Camping__ Gardening__ Hunting__ Ticks noted on pets__

Do you remember being bitten by a tick?............. No__ Yes__ when________

Do you remember having the " bull's eye rash " ? ..No__ Yes__

Any other rash?.................................................... No__ Yes__

Have you had any of the following? CIRCLE ALL YES ANSWERS

1.Unexplained fevers, sweats, chills, or flushing

2.Unexplained weight change- (loss or gain)

3.Fatigue, tiredness, poor stamina

4.Unexplained hair loss

5.Swollen glands: list areas_________________________________________

6.Sore throat

7.Testicular pain/pelvic pain

8.Unexplained menstrual irregularity

9.Unexplained milk production; breast pain

10.Irritable bladder or bladder dysfunction

11.Sexual dysfunction or loss of libido

12.Upset stomach

13.Change in bowel function- (constipation, diarrhea)

14.Chest pain or rib soreness

15.Shortness of breath, cough

16.Heart palpitations, pulse skips, heart block

17.Any history of a heart murmur or valve prolapse?

18.Joint pain or swelling: list

joints_________________________________________________

19.Stiffness of the joints, neck, or back

20.Muscle pain or cramps

21.Twitching of the face or other muscles

22.Headache

23.Neck creaks and cracks, neck stiffness, neck pain

24.Tingling, numbness, burning or stabbing sensations, shooting pains

25.Facial paralysis (Bell's Palsy)

26.Eyes/Vision: double, blurry, increased floaters, light sensitivity

27.Ears/Hearing: buzzing, ringing, ear pain, sound sensitivity

28.Increased motion sickness, vertigo, poor balance

29.Lightheadedness, wooziness

30.Tremor

31.Confusion, difficulty in thinking

32.Difficulty with concentration, reading

33.Forgetfulness, poor short term memory

34.Disorientation: getting lost, going to wrong places

35.Difficulty with speech or writing; word block

36.Mood swings, irritability, depression

37.Disturbed sleep-too much, too little, fractionated, early awakening

38.Exaggerated symptoms or worse hangover from alcohol

LYME DISEASE TREATMENT GUIDELINES

PIROPLASMOSIS (BABESIOSIS)

Piroplasms are not bacteria, they are protozoans. Therefore, they will not be

eradicated by any of the currently used Lyme treatment regimens. Therein lies

the significance of coinfections- if a Lyme patient has been extensively

treated yet is still ill, suspect a piroplasm.

Just as in Lyme Borreliosis, the longer one has been infected, the longer the

course of therapy must be. Similarly, clinical assessment is the only guide

to treatment endpoint.

Treatment choices are limited. Pentamidine is a treatment given as daily IM

shots- very painful, and they cause sterile abscesses and permanent fibrous

scars on the buttocks. More importantly, response is poor, and the patient

risks development of glucose intolerance. Clearly, not a first choice.

Clindamycin, 600 mg qid plus Quinine, 650 mg qid has been the published

standard but the suggested two week course is nearly impossible to tolerate

(hearing loss, rash, fever, headache) and treatment failures have been

reported.

Gentamicin has been used in treating livestock infected with piroplasms.

There are only anecdotal reports of efficacy in Humans, where a 14-day course

at standard doses has proven effective in early disease. Experience with this

antibiotic in late disease is limited, and the optimal regimen has not been

well worked out. The main side effect is potential hearing loss from the

gentamicin, and the need for IM or IV doses.

Mepron (atovaquone), 750 mg bid, has demonstrated efficacy, but should be

given concurrently with azithromycin, 250 to 600 mg daily, or resistance may

develop. Efficacy is by far the best with this combination, but surprisingly,

Herxheimer-like reactions are almost always seen at the fourth day, and at

the fourth week of therapy. Does this represent a newly described phenomenon

in treating Piroplasms, or does this combination have heretofore unrecognized

efficacy in killing Bb? Although I do not have the answer, I suspect the

latter simply based on the familiar (in Bb) four-week cycle. In late,

longstanding cases, one month of treatment is the minimum, and four or more

months are often needed. Problems during therapy include diarrhea, mild

nausea, the expense of Mepron ($600.00 per bottle- enough for one month of

treatment), and rarely, a temporary yellowish discoloration of the vision.

Regular blood counts and liver panels are recommended during any prolonged

course of therapy. Patients who are not cured with this regimen can be

retreated but with higher doses, as this has proven effective in many of my

patients.

EHRLICHIOSIS

Treatment recommendations at this time are still preliminary, mainly due to

the lack of direct detection methods needed to guide us in developing a solid

clinical feel. The mainstay of treatment is doxycycline, either orally or IV,

given for at least two weeks for an early infection, or at least four weeks

in a longstanding one. Interestingly, the unexpected efficacy of IV

doxycycline in treating Lyme cases which had previously responded poorly to

cell wall agents, may in fact reflect concurrent therapy of coinfection of Bb

with Ehrlichial species. The new concern for Ehrlichia is the main reason

that doxycycline is now the first choice in treating tick bites and early

Lyme, before serologies can become positive.

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