Cognitive function in post-treatment Lyme disease Do additional antibiotics help?
ABSTRACT It is controversial whether additional antibiotic treatment will improve cognitive function in patients with post-treatment chronic Lyme disease (PTCLD).
To determine whether antibiotic therapy improves cognitive function in two randomized double-blind placebo-controlled studies of patients with PTCLD.
A total of 129 patients with a physician-documented history of Lyme disease from three study sites in the northeast United States were studied. Seventy-eight were seropositive for IgG antibodies against Borrelia burgdorferi, and 51 were seronegative. Patients in each group were randomly assigned to receive IV ceftriaxone 2 g daily for 30 days followed by oral doxycycline 200 mg daily for 60 days or matching IV and oral placebos. Assessments were made at 90 and 180 days after treatment. Symptom severity was measured from the cognitive functioning, pain, and role functioning scales of the Medical Outcomes Study (MOS). Memory, attention, and executive functioning were assessed using objective tests. Mood was assessed using the Beck Depression Inventory and Minnesota Multiphasic Personality Inventory.
There were no significant baseline differences between seropositive and seronegative groups. Both groups reported a high frequency of MOS symptoms, depression, and somatic complaints but had normal baseline neuropsychological test scores. The combined groups showed significant decreases in MOS symptoms, higher objective test scores, and improved mood between baseline and 90 days. However, there were no significant differences between those receiving antibiotics and placebo.
Patients with post-treatment chronic Lyme disease who have symptoms but show no evidence of persisting Borrelia infection do not show objective evidence of cognitive impairment. Additional antibiotic therapy was not more beneficial than administering placebo.
SourceAvailable from: Carl L Keen[Show abstract] [Hide abstract]
ABSTRACT: Lyme disease was originally identified in Lyme, Connecticut, based upon an unusual cluster of what appeared to be patients with juvenile rheumatoid arthritis. It was subsequently identified as a new clinical entity originally called Lyme arthritis based on the observation that arthritis was a major clinical feature. However, Lyme arthritis is now called Lyme disease based upon the understanding that the clinical features include not only arthritis, but also potential cardiac, dermatologic and neurologic findings. Lyme disease typically begins with an erythematous rash called erythema migrans (EM). Approximately 4–8% of patients develop cardiac, 11% develop neurologic and 45–60% of patients manifest arthritis. The disease is transmitted following exposure to a tick bite containing a spirochete in a genetically susceptible host. There is considerable data on spirochetes, including Borrelia burgdorferi (Bb), the original bacteria identified in this disease. Lyme disease, if an organism had not been identified, would be considered as a classic autoimmune disease and indeed the effector mechanisms are similar to many human diseases manifest as loss of tolerance. The clinical diagnosis is highly likely based upon appropriate serology and clinical manifestations. However, the serologic features are often misinterpreted and may have false positives if confirmatory laboratory testing is not performed. Antibiotics are routinely and typically used to treat patients with Lyme disease, but there is no evidence that prolonged or recurrent treatment with antibiotics change the natural history of Lyme disease. Although there are animal models of Lyme disease, there is no system that faithfully recapitulates the human disease. Further research on the effector mechanisms that lead to pathology in some individuals should be further explored to develop more specific therapy.Journal of Autoimmunity 10/2014; 57. DOI:10.1016/j.jaut.2014.09.004 · 7.02 Impact Factor
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ABSTRACT: Background Lyme borreliosis, a potentially severe tick-borne infection caused by Borrelia burgdorferi, can cause multi-system inflammatory disease. The incidence has been increasing, as has the number of patients with persistent symptoms attributed to Borrelia. These symptoms, also referred to as post-Lyme disease syndrome, may follow an erythema migrans or other Lyme manifestations, and include pain, fatigue, and cognitive disturbances. The optimal duration of treatment for these symptoms is a subject of controversy. The PLEASE study is designed to determine whether prolonged antibiotic treatment leads to better patient outcome than standard treatment.Methods/DesignThe PLEASE study is a double-blind, randomized, placebo-controlled trial. Based on power analysis and compensating for possible loss to follow-up, a minimum of 255 patients with borreliosis-attributed persistent symptoms are included. These symptoms are either (a) temporally related to an erythema migrans or otherwise proven symptomatic borreliosis, or (b) accompanied by a positive B. burgdorferi IgG or IgM immunoblot. All patients receive open-label ceftriaxone for two weeks. Patients are then randomized (ratio 1:1:1) to blinded oral follow-up treatment for 12 weeks with (I) doxycycline, (II) clarithromycin combined with hydroxychloroquine, or (III) placebo. The primary outcome is the physical component summary score (PCS) of the RAND-36 Health Status Inventory (RAND SF-36) at week 14. Secondary outcomes include physical and mental aspects of health-related quality of life (assessed by the subscales of the RAND SF-36), fatigue, neuropsychological evaluation, physical activity, and cost-effectiveness.DiscussionThis article describes the background and design issues of the PLEASE study protocol. The results of this study may provide evidence for prescribing or withholding prolonged antibiotic treatment.Trial registrationClinicalTrials.gov: NCT01207739, Netherlands Trial Register: NTR2469.BMC Infectious Diseases 10/2014; 14(1):543. DOI:10.1186/s12879-014-0543-y · 2.56 Impact Factor
Article: Borreliosi di Lyme e neuroborreliosi[Show abstract] [Hide abstract]
ABSTRACT: La malattia di Lyme è un’infezione batterica legata alla presenza di Borrelia (B.) burgdorferi, essa stessa trasmessa all’uomo da un morso di zecca. La forma primaria che compare nei giorni successivi al morso è rappresentata dall’eritema migrante. Le forme neurologiche possono essere precoci nelle settimane che seguono il morso o più tardive. Le forme precoci sono dominate dalle meningoradicoliti spinali o craniche, dalle mieliti e dalle encefaliti acute. Più rare sono le encefaliti croniche, le vasculiti cerebrali o le polineuropatie croniche. La diagnosi si basa sul confronto dei dati clinici e laboratoristici. In effetti, la presenza di una sierologia di Lyme positiva in una regione di endemia non è sufficiente per porre la diagnosi. Così, alcuni quadri clinici, anche accompagnati da una sierologia di Lyme positiva, rimangono discussi: malattia del motoneurone, sindromi parkinsoniane e alterazioni cognitive croniche. La presenza di una sintesi intratecale di immunoglobuline G anti-B. burgdorferi è un elemento fondamentale della diagnosi, anche se essa può essere assente nelle forme molto precoci (meningoradicoliti) e nelle polineuropatie croniche. Il trattamento delle forme neurologiche si basa sul ceftriaxone 2 g/die per 21-28 giorni. La sindrome post-Lyme è attualmente molto discussa e non giustifica una ripresa del trattamento antibiotico. Al contrario, le reinfezioni restano possibili in caso di nuove esposizioni a Borrelia, e la prevenzione primaria (protezione cutanea) è raccomandata in una regione di endemia.11/2014; 14(4). DOI:10.1016/S1634-7072(14)68869-3