Shoild Your Lyme Disease Levels Get Checked Again After Antibiotic

Abstract

Background. The length of antibiotic therapy and long-term outcomes in patients with early Lyme disease are incompletely described. Nosotros study the long-term clinical outcomes of patients with early localized and early disseminated Lyme disease based on the duration of antibiotic therapy prescribed.

Methods. A retrospective cohort report and follow-upward survey of patients diagnosed as having early localized and early on disseminated Lyme disease from 1 Jan 2000 through 31 December 2004 was conducted in a Lyme disease–hyperendemic expanse.

Results. Six hundred vii patients met the written report inclusion criteria. Most patients (93%) were treated with doxycycline for handling durations of ⩽ten days, 11–xv days, or ⩾sixteen days in 17%, 33%, and 47% of doxycycline-treated patients, respectively. Treatment failure criteria, defined earlier performing the report, were met in merely vi patients (1%). Although these 6 patients met a priori treatment failure criteria, iv of these patients' clinical details suggested reinfection, 1 was treated with an inappropriate antibody, and one developed facial palsy early in therapy. Reinfection adult in 4% of patients. The 2-year treatment failure–free survival rates of patients treated with antibiotics for ⩽10 days, eleven–fifteen days, or ⩾16 days were 99.0%, 98.ix%, and 99.2%, respectively. Patients treated with antibiotics for ⩾sixteen days had lower 36-item Curt-Form Health Survey social functioning scores on the follow-up survey. No other differences were found in follow-upward clinical status or 36-item Short-Form Health Survey scores by duration of antibody treatment.

Conclusions. Patients treated for ⩽ten days with antibiotic therapy for early Lyme affliction take long-term outcomes similar to those of patients treated with longer courses. Treatment failure later appropriately targeted short-course therapy, if it occurs, is exceedingly rare.

Lyme disease is the most common tickborne illness in the Us. In North America it is caused by the spirochete Borrelia burgdorferi sensu stricto. Lyme affliction usually presents with the characteristic erythema migrans lesion (∼80% of cases) or a systemic febrile affliction [one, 2]. Untreated patients may develop belatedly manifestations, including arthritis and various neurologic complications [iii]. Yet, if diagnosed early and treated appropriately with antibiotics, tardily objective complications of infection are rare [four]. Persistent subjective complaints are relatively common, occurring in 35% of patients 20 days later antibiotic therapy in 1 prospective study [5]. Some suggest, without convincing scientific testify, that these persistent symptoms are due to persistent B. burgdorferi infection despite targeted antibiotic therapy [6, vii]. Thus, physicians may prescribe prolonged or repeated courses of antibiotics for early Lyme disease despite prove of the effectiveness of short-class doxycycline. Not only do published studies report no proven clinical benefit of prolonged treatment of early Lyme disease [5, 8], just also antibiotic overuse contributes to higher rates of antibody-related complications and antibiotic resistance. We sought to determine clinically documented or patient-perceived long-term differences in outcomes of patients with early Lyme illness treated with short, me-dium, and prolonged courses of antibiotics in a Lyme disease hyperendemic area.

Methods

Study pattern. After institutional review board approval, we conducted this retrospective cohort study of patients with early localized and early disseminated Lyme disease diagnosed during the study years 2000–2004. Through International Classification of Diseases, Ninth Revision (ICD-ix), codes associated with Lyme disease and review of inpatient and outpatient medical records, we identified patients who met our criteria for early Lyme disease, co-ordinate to our case definitions. We sent a clinical status questionnaire along with the 36-item Short-Grade Health Survey (SF-36) to these patients to assess their current health status. Patients were grouped into three categories for analysis: those treated with targeted antibiotics for ⩽10 days, 11–15 days, and ⩾16 days. Long-term outcomes equally adamant through medical record review and patient survey results were then collected for all patients.

Patient population and definitions. The study was conducted at a regional health system based in La Crosse, Wisconsin. An electronic inpatient and outpatient medical record aided in the capture of long-term clinical follow-up data. La Crosse is an area of Lyme hyperendemicity [ix, 10]. The medical records of all adult patients (age, ⩾18 years) in our health arrangement with Lyme disease–related ICD-ix codes from 1 January 2000 through 31 December 2004 were reviewed. Patients were included in the study for further data collection if the following criteria were met: (1) dr.- or medico associate–confirmed erythema migrans or (2) systemic symptoms uniform with Lyme disease (eg, fever, myalgias, arthralgias, and headache) plus laboratory confirmation (results of an immunofluorescence assay or enzyme-linked immunosorbent assay and/or Western blot test positive for Lyme affliction). Patients with documented erythema migrans lesions were considered to take definite cases of Lyme disease, and patients without documented erythema migrans were considered to have probable cases of Lyme disease. Only patients with early on localized or early disseminated Lyme disease were included in this report. Early localized Lyme disease was defined every bit either a single erythema migrans skin lesion or systemic symptoms compatible with early Lyme disease plus laboratory confirmation. Early disseminated Lyme affliction was defined equally multiple erythema migrans lesions, Lyme carditis, Lyme acute aseptic meningitis, or Lyme-associated seventh nerve paralysis. Patients were excluded from the written report for the following reasons: (1) historic period <eighteen years, (ii) history of Lyme disease earlier the study years, (3) history of receiving the Lyme disease vaccine, and (4) presentation with belatedly Lyme illness (eg, arthritis and late neurologic disease).

Outcomes measured. The main outcome was treatment failure. Treatment failure was considered to have occurred if a patient adult (1) persistent erythema migrans, defined as persistence of the erythema migrans lesion(southward) despite antibody therapy resulting in additional medical evaluation; or (two) objective clinical and laboratory findings of progressive Lyme disease not present on initial diagnosis and non explained past an alternative diagnosis after antibiotic therapy for early on Lyme illness. Progressive Lyme disease syndromes included pauciarticular arthritis, aseptic meningitis, and confirmed neurologic deficits (eg, facial paralysis and radiculopathy) Patients who developed a second episode characterized past erythema migrans peel lesion(s) during a subsequent tick season were considered to have a reinfection non treatment failure.

The secondary outcome measured was possible treatment failure. Physician- or doctor acquaintance–diagnosed treatment failure in the absence of objective examination findings was considered possible treatment failure. During patient follow-upward, patients additionally treated with antibiotics based on a laboratory test result positive for Lyme disease were considered to have possible handling failure because serologic assays for Lyme disease do not reliably distinguish betwixt active and previous infection [11].

Data collection. Information drove was performed retrospectively by medical record review using the predetermined definitions described herein and a standardized data collection canvas. A standardized clinical status questionnaire and an SF-36 health assessment survey were sent to each living patient included in the study. The SF-36 is a validated wellness assessment tool widely used to appraise current health condition [12]. Any potential instance of handling failure was independently reviewed by 3 of the written report authors (W.B., T.J.K., and Southward.T.) and classified as reinfection, handling failure, possible treatment failure, or no treatment failure. In cases where the reviewers' classifications were discordant, consensus was reached before data entry and assay. This determination was performed blinded to the survey results.

Statistical analysis. Descriptive statistics were used to summarize the demographic and handling data for patients included in the study. Assay of variance was used to detect whether statistical differences were nowadays by antibiotic treat-ment duration. Kaplan-Meier graphs were used to visualize treat-ment failure–complimentary survival, with log-rank statistics used to test for survival differences among groups. Comparison of survey responders and nonresponders was completed using the t exam for continuous variables and the χⁱⁱ test for categorical variables. Data from the definite and probable Lyme disease cohorts were start analyzed separately, and then the cohorts were combined and the data analyzed together. Patients whose duration of antibiotic therapy could not exist definitively ascertained from review of the medical record were included in the study'southward descriptive statistics for completeness but were excluded from the comparative analysis of the survey results.

Results

Patient characteristics and treatment. A full of 607 patients met the report inclusion criteria, of whom 458 had early on localized Lyme illness and 149 had early on disseminated Lyme affliction. Baseline patient characteristics are given in table 1. Sixty-9 percent of patients reported tick exposure, only simply 30% of patients recalled a tick bite. Hateful elapsing of clinical retrospective medical record review follow-up from diagnosis was 2.ix years.

Table 1

Demographic and Infection Characteristics in 607 Patients with Early Lyme Affliction

Antibody treatment information is given in tabular array 2. Most patients (93%) were treated with oral doxycycline. Mean antibody duration was 17.ane days in patients with early Lyme disease and 18.four days in patients with early disseminated Lyme disease. Eight percent of patients were treated for longer than 21 days. Twenty-4 patients did not have sufficient information in the medical record to determine the duration of antibiotic handling. Of the 100 patients who received ⩽x days of antibiotic therapy, 95 received 10 days of therapy and only ane patient received fewer than 7 days of treatment.

Table ii

Antibiotic Handling Data in 607 Patients with Early Lyme Affliction

Treatment failure. Treatment failure criteria, every bit divers in Methods, were met past vi patients (1%). Of these 6 patients, four patients' clinical courses were uniform with reinfection, 1 patient was treated with an inappropriate antibiotic (cefadroxil), and one patient adult facial paralysis early in the treatment course. Brief descriptions of each treatment failure follow to fully characterize their course. Patient one was initially diagnosed as having early localized Lyme illness based on an erythema migrans lesion. Three years afterward and with continuous tick exposure and bites, she developed a seventh nerve palsy during a subsequent tick season. Her Lyme illness titer was positive at initial diagnosis, reverted to negative on follow-up testing, and then turned strongly positive again with the facial paralysis, suggestive of reinfection. Patient ii was initially diagnosed equally having Lyme disease on the ground of an erythema migrans lesion. One twelvemonth afterward, with continuous tick exposure, he presented with 7th nerve paralysis and laboratory testify of Lyme disease. Patient 3 initially had a systemic febrile disease and headache with laboratory evidence of Lyme affliction. Subsequently treatment with doxycycline for ten days, systemic symptoms improved. Another deer tick was identified and removed from the patient ∼ii weeks after her initial diagnosis. She subsequently had a recurrence of headache and a mild, transient facial palsy that lasted <five days on objective examination. Patient 4 was initially diagnosed as having Lyme carditis with heart cake and clinically responded to antibiotics. The adjacent summer, with continuous tick exposure, he developed another systemic febrile illness and again developed middle block. Laboratory evidence of Lyme disease was persistently present. Patient v was initially diagnosed every bit having early on Lyme disease based on an erythema migrans lesion. He was treated with cefadroxil for 20 days, afterward refusing to take doxycycline. Three weeks later he developed facial palsy with aseptic meningitis that promptly responded to doxycycline therapy. Patient six was initially diagnosed as having early Lyme disease based on an erythema migrans lesion with a systemic delirious illness. After 12 days of doxycycline therapy and while all the same receiving therapy, he developed a seventh nerve paralysis.

table 3 summarizes cases of treatment failure, possible handling failure, and reinfection stratified by duration of antibiotic therapy in patients with definite and probable Lyme affliction. Twenty-4 patients (iv%) developed reinfection with Lyme disease. As would be expected for reinfection, equally opposed to infection relapse, all of these patients developed their symptoms and were diagnosed equally having reinfection betwixt April and Nov of a subsequent tick season. Possible handling failure, as divers in Methods, occurred in 36 patients (6%). Figures ignore 1 and ignore two demonstrate Kaplan-Meier treatment failure–free survival curves by elapsing of antibiotics received in the entire accomplice of patients. In this combined accomplice the 2-year treatment failure–free survival rates of patients treated with antibiotics for ⩽10 days, eleven–15 days, or ⩾xvi days were 99.0%, 98.9%, and 99.2% using the master stop bespeak of treatment failure and 93.8%, 92.0%, and 90.four% using the secondary cease betoken of possible treatment failure, respectively.

Table 3

Handling Failure Stratified by Antibiotic Treatment Elapsing in 607 Patients with Early Lyme Disease after a Mean Clinical Follow-Upwards Duration of ii.9 Years

Survey results. Of the 607 patients included in the written report, 12 were deceased at the time the clinical status questionnaire and SF-36 survey were sent. Of the 595 questionnaires and surveys sent, 299 (50%) were completed and included in the analysis. Mean elapsing from diagnosis to survey results was 4.v years in the combined cohort. Questionnaire and survey results of patients with definite and probable early Lyme illness, stratified by duration of antibiotic treatment, are given in Tables 4 and 5. Presence of persistent symptoms was non significantly different based on duration of antibiotic treatment in the definite, probable, or combined cohorts (table 4). Furthermore, SF-36 scores were similar among handling elapsing groups for all dimensions in the independent analysis of the definite and probable cohorts. When information from the definite and probable cohorts were combined and analyzed, scores of social functioning were lower for patients who received longer durations of antibody treatment (P=.012) (table five).

Table 4

Survey Results Comparing Follow-Up Clinical Complaints by Antibody Treatment Duration in 299 Patients with Early on Lyme Disease after a Mean Follow-Up Elapsing of 4.5 Years from Diagnosis to Survey

Table 5

Survey Scores on the 36-detail Curt-Form Wellness Survey (SF-36), by Antibiotic Handling Duration in 299 Patients with Early Lyme Disease

To appraise selection bias in survey returners versus nonreturners, we compared clinical characteristics, treatment regimens, and treatment outcomes between the two groups. The only pregnant difference was that patients with handling failure had a higher rate of survey return than those without (P=.028).

Word

The optimal antibody treatment for early Lyme disease continues to be controversial for some physicians and the public at large [half dozen, seven]. We sought to appraise the long-term outcomes of patients with well-divers early localized and early on disseminated Lyme disease by duration of antibiotic treatment in an area of Lyme hyperendemnicity. This clinical result study, which is to our knowledge the largest reported series of patients with early localized and early disseminated Lyme disease, suggests no difference in treatment failure rates or long-term health function amid patients treated with targeted antibiotics for ⩽10 days, 11–15 days, and ⩾16 days.

Handling failure every bit divers for this report was rare. Furthermore, although 6 patients met our predetermined criteria for treatment failure, four of these had ongoing tick exposure and periods of feeling well earlier redeveloping symptoms accompanied past objective testify of disease; thus, these cases were more compatible with reinfection than with treatment failure. One patient who developed treatment failure was treated with an ineffective antibiotic, which readily explains the "treatment failure." Finally, i patient who met our definition of treatment failure adult seventh nerve palsy 12 days into a grade of doxycycline therapy merely no other clinical bear witness of progressive disease. Progression of facial paralysis in the absence of any other clinical evidence of treatment failure is well described even in patients all the same receiving potent intravenous antibiotics and may well be related more to inflammation than to progressive infection [13]. Taking these factors into account, our study provides strong evidence that persistent active infection with Lyme disease after appropriately targeted antibiotic confronting borreliosis is exceedingly rare, if it occurs at all.

Reinfection was much more than common than treatment failure. Subsequent infection with B. burgdorferi is a well-described phenomenon. In our cohort, iv% of patients developed subsequent infection with early Lyme disease, consistent with previous reports [fourteen]. This finding highlights the importance of counseling patients on the risk of subsequent infection with Lyme or other tickborne illness and instituting appropriate preventive measures, peculiarly in an area of Lyme hyperendemicity. Such natural reoccurrences likewise highlight the difficulty of developing an effective Lyme vaccine, similar to syphilis infections in humans.

We defined possible treatment failure as being md-directed boosted treatment for Lyme disease for subjective complaints in the absence of objective findings of persistent disease. This grouping of patients, as we have defined it, falls under the broad category of post–Lyme disease syndrome [4]. No disarming prove has been reported that antibiotic therapy beyond the initial course provides benefit in this patient population [4, 6]. Despite that, in our accomplice, 6% of patients received additional antibiotics for these complaints. These patients had no objective evidence of persistent infection; it is probable that the subsequent handling of these patients was unnecessary.

Antibody treatment guidelines for early Lyme affliction were developed by our infectious disease physicians and used in our health system for many years, including the years encompassed by this study. The guidelines take consistently recommended a 10-day course of doxycycline for elementary early Lyme illness. Thus, nosotros anticipated that a relatively high pct of patients with early on Lyme disease would have treatment durations of ⩽ten days; nevertheless, but 16% of patients were given ⩽ten days of doxycycline treatment, whereas 44% of patients received ⩾sixteen days of doxycycline treatment. This written report supports short-course therapy with doxycycline.

We have observed, then, 2 interesting treatment patterns in our cohort. First, despite treatment guidelines both locally in our wellness system and nationally that recommend curt-grade doxycycline for early on Lyme disease, longer courses of therapy were routinely prescribed. Second, despite a paucity of bear witness for do good and the certain attendant adverse issue risks [5, 6, eight], many physicians chose to care for patients again for Lyme disease based on persistent or recurrent subjective complaints. In our opinion, the apply and misuse of antibiotics in this circumstance are not justified.

Reasons for medico nonadherence to the treatment guidelines were non studied; however, at our institution guideline nonadherence may be unique to treating Lyme disease. Group A streptococcal pharyngitis is another common infectious disease problem for which both our local health organisation and national guidelines are equally available to physicians. Even so, although 93% of pharyngitis patients are treated in accordance with local guidelines (internal data), just 19% of patients with early on simple Lyme affliction are and then treated. On the basis of years of clinical conversations with patients and physicians, we speculate that both patients and physicians perceive a need for more prolonged courses of antibiotics to finer treat both early and tardily Lyme disease. This study and others suggest otherwise [4, five, fifteen, xvi].

Our report has a number of strengths. Get-go, to our knowledge, ours is the largest accomplice of patients with early Lyme disease to take long-term follow-upward data on health status afterward therapy. Second, our health system is from an area of Lyme hyperendemicity [ix, 12]. Thus, both patients and physicians are relatively aware of Lyme disease, which helps expedite patient presentation, diagnosis, and treatment. Furthermore, we used strict case criteria for report inclusion. This, combined with a relatively high pretest probability of Lyme affliction in an area of hyperendemicity, strongly predicted a accomplice that had early on infection with B. burgdorferi.

Our study limitations are primarily those inherent to a retrospective study design. To minimize data ascertainment bias, however, definitions were developed earlier information collection. In addition, cases were classified as treatment failures or subsequent infection only after being independently reviewed past at least 3 of the authors, and in areas of differing classification, consensus was reached with the authors masked to the survey results. The survey return rate was 50%. We analyzed for base of operations-line differences in survey returners and nonreturners and establish no bear witness of a selection bias in returners. Because all patients in the report were diagnosed as having early Lyme affliction, the likelihood of differential recall bias based on elapsing of antibody handling is likely low compared with a case-control report. Finally, our report was focused on cases of early Lyme disease. Results cannot necessarily be extrapolated to cases of late Lyme disease.

In conclusion, we have studied the long-term outcomes of a large cohort of patients with early Lyme disease and constitute no differences in outcome according to duration of antibiotic treatment. Future studies should try to identify reasons physicians prescribe prolonged antibiotics for patients with Lyme illness in the absenteeism of peer-reviewed information and confronting the recommendations of local and national handling guidelines.

Acknowledgments

Potential conflicts of interest. All authors: no conflicts.

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Figures and Tables

Figure 1

Kaplan-Meier treatment failure–free survival curves in 607 patients with early Lyme disease, by duration of antibiotics received.

Effigy 2

Kaplan-Meier possible treatment failure–free survival curves in 607 patients with early Lyme illness, by duration of antibiotics received. Meet Methods for the definition of possible treatment failure.

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Source: https://academic.oup.com/cid/article/50/4/512/351811

Shoild Your Lyme Disease Levels Get Checked Again After Antibiotic

Abstract

Methods

Results

Word

Acknowledgments

References

Figures and Tables

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