National
Guideline Clearinghouse:
Summary of IDSA Guidelines for Lyme Disease
NGC is
an initiative of the Agency
for Healthcare Research and Quality (AHRQ), U.S. Department
of Health and Human Services. NGC was originally created by
AHRQ in partnership with the American
Medical Association and the American Association of Health
Plans (now America’s
Health Insurance Plans [AHIP]). The NGC
mission is to provide physicians, nurses, and other health
professionals, health care providers, health plans, integrated
delivery systems, purchasers and others an accessible mechanism
for obtaining objective, detailed information on clinical practice
guidelines and to further their dissemination, implementation
and use.
Brief
Summary: Practice guidelines for the treatment of Lyme disease.
(Infectious Disease Society of America)
GUIDELINE
STATUS:
This is the current release of the guideline.
MAJOR
RECOMMENDATIONS: Excerpted by the National Guideline Clearinghouse
(NGC). Each recommendation includes a ranking for the strength
and the quality of evidence supporting it. Definitions of the
levels of evidence (I-III) and grades of recommendation (A-E)
are repeated at the end of the Major Recommendations field.
Note: See Tables 3 and 4 of the original guideline document
for recommended antimicrobial regimens for the treatment of
Lyme disease in adults and children.
Tick
bites and prophylaxis
Primary
Management Options
The best
currently available method for preventing infection with Borrelia
burgdorferi and other Ixodes-transmitted infections is to
avoid vector tick exposure. If exposure to Ixodes scapularis
or Ixodes pacificus ticks is unavoidable, measures recommended
to reduce the risk of infection include using both protective
clothing and tick repellents, checking the entire body for ticks
daily, and promptly removing attached ticks before transmission
of Borrelia burgdorferi can occur (A-III).
Routine
use of either antimicrobial prophylaxis (E-I) or serological
tests (D-III) after a tick bite is not recommended. Some experts
recommend antibiotic therapy for patients bitten by Ixodes
scapularis ticks that are estimated to have been attached
for greater than 48 hours (on the basis of the degree of engorgement
of the tick with blood), in conjunction with epidemiological
information regarding the prevalence of tick-transmitted diseases
(C-III). However, accurate determinations of tick species and
degree of engorgement are not routinely possible, and data are
insufficient to demonstrate efficacy of antimicrobials in this
setting.
Persons
who remove attached ticks should be monitored closely for signs
and symptoms of tick-borne diseases for up to 30 days and specifically
for the occurrence of a skin lesion at the site of the tick
bite (which may suggest Lyme disease) or a temperature >38ºC
(which may suggest human granulocytic ehrlichiosis or babesiosis).
Persons who develop a skin lesion or other illness within 1
month after removing an attached tick should promptly seek medical
attention for assessment of the possibility of having acquired
a tick-borne disease (A-II). Health care practitioners, particularly
those in areas where Lyme disease is endemic, should become
familiar with the clinical manifestations of and recommended
practices for testing and therapy for Lyme disease, as well
as for human granulocytic ehrlichiosis (HGE) and babesiosis
(A-III).
Testing
of ticks for tick-borne infectious organisms is not recommended,
except in research studies (D-III). Prior vaccination with the
recently licensed recombinant outer-surface protein A (OspA)
vaccine preparation reduces the risk of developing Lyme disease
associated with tick bites but should not alter the above recommendations
(A-I).
Early
Lyme disease
Primary
Management Options
Administration
of doxycycline (100 mg twice daily) or amoxicillin (500 mg 3
times daily) for 14–21 days is recommended for treatment
of early localized or early disseminated Lyme disease associated
with erythema migrans, in the absence of neurological involvement
or third-degree atrioventricular heart block (see Tables 3 and
4 of the original guideline document) (A-I). In prospective
studies, these agents have been shown to be effective in treating
erythema migrans and associated symptoms.
Doxycycline
has the advantage of being efficacious for treatment of human
granulocytic ehrlichiosis (HGE), which may occur simultaneously
with early Lyme disease. Doxycycline is relatively contraindicated
during pregnancy or lactation and for children aged less than
8 years. Because of its higher cost, cefuroxime axetil, which
is as effective as doxycycline in the treatment of erythema
migrans (A-I), should be reserved as an alternative agent for
those patients who can take neither doxycycline nor amoxicillin.
For children, amoxicillin or doxycycline (for those aged greater
than or equal to 8 years) is recommended (see Tables 3 and 4
of the original guideline document) (B-II). Cefuroxime axetil
is an acceptable alternative agent (B-III).
Administration
of macrolide antibiotics is not recommended as first-line therapy
for early Lyme disease (E-I). When used, they should be reserved
for patients who are intolerant of amoxicillin, doxycycline,
and cefuroxime axetil (see Tables 3 and 4 of the original guideline
document). Patients treated with macrolides should be closely
followed.
Ceftriaxone
(2 grams intravenously daily), although effective, is not superior
to oral agents and is therefore not recommended as a first-line
agent for treatment of Lyme disease in the absence of neurological
involvement or third-degree atrioventricular heart block (E-I).
The use
of ceftriaxone (2 grams once daily intravenously for 14-28 days)
in early Lyme disease is recommended for acute neurological
disease manifested by meningitis or radiculopathy (see Tables
3 and 4 of the original guideline document) (B-II). Parenteral
therapy penicillin G or cefotaxime may also be a satisfactory
alternative (B-II). For adult patients who are intolerant of
both penicillin and cephalosporins, doxycycline (200-400 mg/day
in 2 divided doses given orally [or intravenously if the patient
is unable to take oral medications]) for 14-28 days may be adequate
(B-II).
For children,
intravenous ceftriaxone (B-II) or cefotaxime (B-III) is recommended;
penicillin G given intravenously is an alternative (B-II).
Patients
with first- or second-degree atrioventricular heart block associated
with early Lyme disease should be treated in the same manner
as patients with erythema migrans without carditis (B-III).
We recommend that patients with third-degree atrioventricular
heart block be treated with parenteral antibiotics such as ceftriaxone
in the hospital, although there are no clinical trial data to
support this recommendation (B-III). A temporary pacemaker may
also be required.
Although
antibiotic treatment does not hasten the resolution of seventh-cranial-nerve
palsy associated with Borrelia burgdorferi infection,
antibiotics should be given to prevent further sequelae (B-II).
There was disagreement among panel members on the neurological
evaluation of patients with seventh-cranial-nerve palsy. Some
members perform a cerebral spinal fluid examination on all patients
with seventh-cranial-nerve palsy, whereas others reserve lumbar
puncture for patients for whom there is strong clinical suspicion
of central nervous system involvement (e.g., severe headache
or nuchal rigidity).
Patients
whose cerebral spinal fluid examinations yield normal findings
may be treated with the same regimens used for patients with
erythema migrans (B-III), whereas patients for whom there is
clinical and laboratory evidence of central nervous system involvement
should be treated with regimens effective against meningitis
(see Tables 3 and 4 of the original guideline document) (B-II).
Treatment
for pregnant patients can be identical to that for nonpregnant
patients with the same disease manifestation, except that tetracyclines
should be avoided (B-III).
Late
Lyme Disease
Lyme
arthritis
Lyme arthritis
usually can usually be treated successfully with antimicrobial
agents administered orally or intravenously. Administration
of doxycycline or amoxicillin, in each instance for 28 days,
is recommended for patients without clinically evident neurological
disease (B-II). For children, doxycycline (for those aged greater
than or equal to 8 years) or amoxicillin (see Tables 3 and 4
of the original guideline document) (B-II). Oral therapy is
easier to administer than intravenous antibiotics, is associated
with fewer serious complications, and is considerably less expensive.
Its disadvantage is that some patients treated with oral agents
have subsequently manifested overt neuroborreliosis, which may
require intravenous therapy for successful treatment. Further
controlled trials are needed to compare oral with intravenous
therapy.
Neurological
evaluation, including lumbar puncture, should be done for patients
for whom there is a strong clinical suspicion of neurological
involvement. Patients with arthritis and objective evidence
of neurological disease should receive intravenous ceftriaxone
(A-II). Alternative parenteral agents include intravenous cefotaxime
(B-III) and intravenous penicillin G (B-II). The long-acting
benzathine preparation of penicillin achieves only low levels
in the blood and therefore is not recommended (D-III). For children,
ceftriaxone intravenously (B-III) or cefotaxime (B-III) is recommended
(see Tables 3 and 4 of the original guideline document); penicillin
G administered intravenously is an alternative.
For patients
who have persistent or recurrent joint swelling after recommended
courses of antibiotic therapy, we recommend repeat treatment
with another 4-week course of oral antibiotics or with a 2-
to 4-week course of ceftriaxone intravenously (see Tables 3
and 4 of the original guideline document) (B-III). Clinicians
should consider waiting several months before initiating repeat
treatment with antimicrobial agents, because of the anticipated
slow resolution of inflammation after treatment. If patients
have persistent arthritis despite 2 courses of oral therapy
or one course of intravenous therapy, symptomatic treatment
with nonsteroidal anti-inflammatory agents is recommended; intra-articular
steroids may also be of benefit (B-III). If persistent synovitis
is associated with significant pain or if it limits function,
arthroscopic synovectomy can reduce the period of joint inflammation
(B-II).
Late
neuroborreliosis affecting the central nervous system or peripheral
nervous system
For patients
with late neurological disease affecting the central nervous
system or peripheral nervous system, treatment with ceftriaxone
(2 grams once a day intravenous for 2-4 weeks) is recommended
(see Tables 3 and 4 of the original guideline document) (B-II).
Alternative parenteral therapy may include administration of
cefotaxime (B-II) or penicillin G (B-II). Response to treatment
is usually slow and may be incomplete. However, unless relapse
is shown by reliable objective measures, repeat treatment is
not recommended. For children, treatment with ceftriaxone is
recommended (see Tables 3 and 4 of the original guideline document)
(B-II). Cefotaxime or penicillin G intravenously are alternatives
(B-II).
Chronic
Lyme disease or post-Lyme disease syndrome
Following
an episode of Lyme disease that is treated appropriately, some
persons have a variety of subjective complaints (such as myalgia,
arthralgia, or fatigue). Some of these patients have been classified
as having “chronic Lyme disease” or “post-Lyme
disease syndrome,” which are poorly defined entities. These
patients appear to be a heterogeneous group. Although European
patients rarely have been reported to have residual infection
(or perhaps reinfection) with Borrelia burgdorferi, this
has yet to be substantiated either in a large series of appropriately
treated European patients or in a study of North American patients.
Residual subjective symptoms that last weeks or months also
may persist after other medical diseases (both infectious and
non-infectious). It has also been recognized that the prevalence
of fatigue and/or arthralgias in the general population is greater
than 10%.
In areas
of endemicity, coinfection with Borrelia microti or the
Ehrlichia species that causes human granulocytic ehrlichiosis
(HGE) may explain persistent symptoms for a small number of
these patients. Randomized controlled studies of treatment of
patients who remain unwell after standard courses of antibiotic
therapy for Lyme disease are in progress. To date, there are
no convincing published data showing that repeated or prolonged
courses of either oral or intravenous antimicrobial therapy
are effective for such patients. The consensus of the Infectious
Diseases Society of America (IDSA) expert-panel members is that
there is insufficient evidence to regard “chronic Lyme
disease” as a separate diagnostic entity.
Definitions
of Strength of Recommendation and Quality of Evidence Ratings:
Quality
of evidence:
I. Evidence
from at least one properly randomized, controlled trial
II. Evidence
from at least one well-designed clinical trial without randomization,
from cohort or case-control analytic studies (preferably from
more than one center), from multiple time-series studies, or from
dramatic results of uncontrolled experiments
III. Evidence
from opinions of respected authorities based on clinical experience,
descriptive studies, or reports of expert committees
Strength
of recommendation:
A. Good evidence
to support a recommendation for use
B. Moderate
evidence to support a recommendation for use
C. Poor evidence
to support a recommendation
D. Moderate
evidence to support a recommendation against use
E. Good evidence
to support a recommendation against use
DATE
RELEASED: 2000 July
GUIDELINE
DEVELOPER(S) : Infectious Diseases Society of America —
Medical Specialty Society
SOURCE(S)
OF FUNDING: Infectious Diseases Society of America (IDSA)
GUIDELINE
COMMITTEE: Infectious Diseases Society of America (IDSA)
Practice Guidelines Committee
COMPOSITION
OF GROUP THAT AUTHORED THE GUIDELINE: Authors: Gary
P. Wormser, Robert B. Nadelman, Raymond J. Dattwyler, David
T. Dennis, Eugene D. Shapiro, Allen C. Steere, Thomas J. Rush,
Daniel W. Rahn, Patricia K. Coyle, David H. Persing, Durland
Fish, and Benjamin J. Luft.
FINANCIAL
DISCLOSURES/CONFLICTS OF INTEREST: Not stated
GUIDELINE
AVAILABILITY: Electronic copies: Available in Portable Document
Format (PDF) from the Infectious
Diseases Society of America (IDSA) Web site. Also available
in HTML
format. Print copies: Available from the University of Chicago
Press; fax: (773) 702-6096. Electronic copies: Available from
the Infectious
Diseases Society of American (IDSA) Web site. Print copies:
Available from Infectious Diseases Society of America, 66 Canal
Center Plaza, Suite 600, Alexandria, VA 22314.
PATIENT
RESOURCES None available
NGC
STATUS This summary was completed by ECRI on May 1, 2001.
The information was verified by the guideline developer as of
June 29, 2001.
[
