page 13 Re: Dr. B protocol/guidelines

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APPENDIX

RATIONALE FOR TREATING TICK BITES

The Medical Advisory Committee of the Lyme Disease Foundation now recommends

antibiotic prophylactic treatment upon a known tick bite for:

1. People at higher health risk bitten by an unknown type of tick or tick

capable of transmitting Borrelia burgdorferi, e.g., pregnant women, babies

and young children, people with serious health problems, and those who are

immunodeficient.

2. Persons bitten in an area endemic for Lyme Borreliosis by an unidentified

tick or tick capable of transmitting B. burgdorferi.

3. Persons bitten by a tick capable of transmitting B. burgdorferi, where

the tick is engorged, or the attachment duration of the tick is greater than

four hours, and/or the tick was improperly removed. This means when the tick

is squeezed between the fingers, irritated with toxic chemicals in an effort

to get it to back out, or disrupted in such a way that it's contents were

allowed to contact the bite wound. Such practices increase the risk of

disease transmission.

4. A patient, when bitten by a known tick, clearly requests oral prophylaxis

and understands the risks. This is a case-by-case decision.

The physician cannot rely on a laboratory test or clinical finding at the

time of the bite to definitely rule in or rule out Lyme Disease infection,

so must use clinical judgment as to whether to use antibiotic prophylaxis.

Testing the tick itself for the presence of the spirochete, even with PCR

technology, is not reliable enough to guide your decision to treat, as false

positives and false negatives occur.

An established infection by B. burgdorferi can have serious, long-standing

or permanent, and painful medical consequences, and be expensive to treat.

Since the likelihood of harm arising from prophylactically applied

spirochetal antibiotics is low, and since treatment is inexpensive and

painless, it follows that the risk benefit ratio favors tick bite

prophylaxis.

It is the Medical Advisory Committee's recommendation that antibiotic

prophylactic treatment for tick bite in many circumstances is not only

justified but warranted. The ultimate decision for treatment on tick bite

should be determined jointly between the physician and patient.

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RATIONALE FOR TREATMENT RECOMMENDATIONS:

When I began treating Lyme Borreliosis (LB) in the mid 1980s, I recognized

that in disseminated disease, the then recommended ten to fourteen day

courses of antibiotics would either result in only a lessening of the

illness, or an initial good outcome followed by a relapse of symptoms. These

patients would then respond again to a repeat course of antibiotics.

Published studies by Steere and others (1) had, at that time, defined

success as the elimination of the " major " symptoms of Lyme (arthritis,

carditis, and Bell's Palsy) even though they usually resolve over time

without treatment. These same studies go on to report the persistence of

" minor symptoms " of Lyme even after antibiotic therapy, and the authors call

it the " post Lyme syndrome " .

In 1987 I participated in a study in which twenty six patients with active

disseminated LB, who were culture positive for Borrelia burgdorferi (Bb),

were treated with ceftriaxone I.V. for fourteen days, using either two or

four grams a day. Although culture negative at the immediate end of therapy,

all patients became culture positive again within several weeks, which

corresponded to the time when their symptoms recurred. I concluded then that

the persistence of symptoms after this type of therapy in fact represented

ongoing infection. The results of this study were presented in 1989 at the

national meeting of the Lyme Borreliosis Foundation.

Upon the advice of colleagues who for years have been involved in seminal LB

research (2), I then studied the effects of lengthened duration of

treatment. I found a direct correlation between treatment duration and the

ultimate outcome of patients' symptoms. Using amoxicillin 3g/day plus

probenecid 1.5g/day in divided doses, the per cent success was tabulated for

therapies lasting for from one through six months. Success here is defined

as the elimination of all LB symptoms, both major and minor, without a

relapse by three months after completion of treatment.

The data clearly demonstrated a direct relationship between duration and

success, starting at 17% for one month of therapy, and reaching a plateau at

67% at five months duration. These data were also presented at the 1989

meeting mentioned above.

Next, using ceftriaxone, results of therapy were tabulated based on

duration. Even with 45 days of continuous antibiotic, none of the patients

returned to or maintained their well, pre-Lyme state. However, if oral

medications were continued after ceftriaxone, to the endpoint of being free

of signs and symptoms of active disease, then relapses did not occur. Again,

the average duration of antibiotic treatment necessary to achieve this was

at least four months.

Further culture studies involving 74 patients confirmed that the patients

had to be free of signs and symptoms of active Borreliosis before

antibiotics were discontinued in order to be both culture negative, and not

experience a relapse during three months of follow up.

There are now a growing number of published reports utilizing various forms

of Bb antigen detection that demonstrate the persistence of infection in

antibiotically treated patients (3,4,5,6,7,8), confirming my earlier work.

Even Steere has proposed this as a mechanism for chronic arthritis in Lyme

(9).

Although syphilis perhaps is not a synonymous spirochetosis to Lyme, similar

findings of organism persistence despite presumed adequate (short course)

therapy has been reported in those who later became immune deficient (10).

Indeed, Wassermann in 1936 recommended a minimum of twenty six weeks of

treatment for established infection, based upon generation-time studies.

I had participated in an NIH study utilizing the antigen detection method of

Dorward et al (11). In testing over 130 patients with Chronic Persistent LB,

in whom symptoms of active disease continued despite even prolonged

treatment (indeed, some would describe as excessive the treatment given to

several participants), Bb could be recovered from blood, CSF, urine, and

tears. Indeed, many of these patients had received months to years of

aggressive, often parenteral therapy for LB. For example, one had received

continual antibiotics for three years, while another was treated for 18

months with repeated courses of parenteral therapy. As a matter of record,

neither one was a patient of mine.

These examples clearly indicate what researchers have recognized as the

ability of Bb to evade host defenses (1,12,13,14,15) even in the presence of

antibiotics (5,6,7,8).

I do not now recommend treatment forever, but I point out the above results

to be able to make several points:

1. There has never been a study in the history of this illness that even in

the simplest way proves that currently recognized short-course (two to four

week) therapy results in a bacteriologic cure.

2. There has never been a consensus in patients still symptomatic after

short treatment courses as to what constitutes the post Lyme syndrome, how

Bb induces it, and what perpetuates it if bacteriologic cure is indeed

presumed.

3. Patients must be kept on therapy until free of active symptoms or they

either will never recover fully, or suffer a relapse.

4. Extended durations of antibiotic therapy clearly have helped literally

thousands of patients who were not helped by short courses of treatment.

5. Finally, we have to recognize that in some patients, LB may not be

curable in a strict bacteriologic sense.

Until sensitive and specific antigen detection tests become widely

available, treatment of LB will remain difficult, controversial, and the

subject of much discussion.

J.J. Burrascano, Jr., M.D.