The 2002 Official Patients Sourcebook on Lyme Disease

The 2002 Official Patients Sourcebook On Lyme Disease
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Ask for written instructions. Your doctor may also have brochures and audio and videotapes that can help you. If you have questions, call. If your symptoms get worse or if you have problems with your medication, call. If you had tests and do not hear from your doctor, call for your test results. If your doctor recommended that you have certain tests, schedule an appointment to get them done.

If your doctor said you should see an additional specialist, make an appointment. By following these steps, you will enhance the relationship you will have with your physician. Coagulation is usually irreversible. In humans the disease is caused by ehrlichia chaffeensis, in dogs it is caused by E. Its organisms are parasites and pathogens, found on the mucous membranes of humans, animals, and birds. It is accompanied by pain and stiffness, particularly after prolonged activity.

This condition persists due to its firm entrenchment in sylvatic rodent-flea ecosystems throughout the world. Bubonic plague is the most common form. The basic treatment guidelines that your physician has discussed with you, or those that you have found using the techniques discussed in Chapter 1, may provide you with all that you will require.

The 2002 Official Patient\'s Sourcebook On Lyme Disease

For some patients, current treatments can be enhanced with new or innovative techniques currently under investigation. In this chapter, we will describe how clinical trials work and show you how to keep informed of trials concerning Lyme disease. What Is a Clinical Trial? Most medical research begins with studies in test tubes and on animals.

Treatments that show promise in these early studies may then be tried with people. The only sure way to find out whether a new treatment is safe, effective, and better than other treatments for Lyme disease is to try it on patients in a clinical trial. Researchers first conduct Phase I trials with small numbers of patients and healthy volunteers. If the new treatment is a medication, researchers also try to determine how much of it can be given safely. Researchers conduct Phase II trials in small numbers of patients to find out the effect of a new treatment on Lyme disease.

Finally, researchers conduct Phase III trials to find out how new treatments for Lyme disease compare with standard treatments already being used. Phase III trials also help to determine if new treatments have any side effects. These trials--which may involve hundreds, perhaps thousands, of people--can also compare new treatments with no treatment. How Is a Clinical Trial Conducted? Various organizations support clinical trials at medical centers, hospitals, universities, and doctors' offices across the United States.

Most clinical trial researchers are medical doctors, academic researchers, and specialists. All doctors and researchers who take part in the study on Lyme disease carefully follow a detailed treatment plan called a protocol. This plan fully explains how the doctors will treat you in the study. Clinical trials are controlled.

This means that researchers compare the effects of the new treatment with those of the standard treatment. In some cases, when no standard treatment exists, the new treatment is compared with no treatment. Patients who receive the new treatment are in the treatment group. In some clinical trials, patients in the treatment group get a new medication while those in the control group get a placebo. This is like flipping a coin to decide which patients are in each group.

If you choose to participate in a clinical trial, you will not know which group you will be appointed to. The chance of any patient getting the new treatment is about 50 percent. You cannot request to receive the new treatment instead of the placebo or sham treatment. Often, you will not know until the study is over whether you have been in the treatment group or the control group. In some trials, neither doctors nor patients know who is getting which treatment. These types of trials help to ensure that the perceptions of the patients or doctors will not affect the study results.

Natural History Studies Unlike clinical trials in which patient volunteers may receive new treatments, natural history studies provide important information to researchers on how Lyme disease develops over time. A natural history study follows patient volunteers to see how factors such as age, sex, race, or family history might make some people more or less at risk for Lyme disease. A natural history study may also tell researchers if diet, lifestyle, or occupation affects how a disease or disorder develops and progresses.

Results from these studies provide information that helps answer questions such as: How fast will a disease or disorder usually progress? How bad will the condition become? Will treatment be needed? Not everyone can take part in a clinical trial for a specific disease or disorder. Each study enrolls patients with certain features or eligibility criteria. These criteria may include the type and stage of disease or disorder, as well as, the age and previous treatment history of the patient. You or your doctor can contact the sponsoring organization to find out more about specific clinical trials and their eligibility criteria.

If you are interested in joining a clinical trial, your doctor must contact one of the trial's investigators and provide details about your diagnosis and medical history. If you participate in a clinical trial, you may be required to have a number of medical tests. Depending upon the treatment and the examination procedure, you may be required to receive inpatient hospital care.

Or, you may have to return to the medical facility for follow-up examinations. These exams help find out how well the treatment is working. Follow-up studies can take months or years. However, the success of the clinical trial often depends on learning what happens to patients over a long period of time. Only patients who continue to return for follow-up examinations can provide this important long-term information. Recent Trials on Lyme Disease The National Institutes of Health and other organizations sponsor trials on various diseases and disorders.

Because funding for research goes to the medical areas that show promising research opportunities, it is not possible for the NIH or others to sponsor clinical trials for every disease and disorder at all times. The following lists recent trials dedicated to Lyme disease. If it is no longer recruiting or has been completed, then you can contact the sponsors to learn more about the study and, if published, the results. Further information on the trial is available at the Web site indicated. Please note that some trials may no longer be recruiting patients or are otherwise closed.

Before contacting sponsors of a clinical trial, consult with your physician who can help you determine if you might benefit from participation. Sponsor s : National Institute of Neurological Disorders and Stroke NINDS Purpose - Excerpt: The purpose of this study is to determine whether patients with persistent memory problems after Lyme disease benefit from an additional longer course of IV antibiotic therapy; to use modern brain imaging technology to determine whether the problem in the central nervous system is primarily one of poor blood flow or one of impaired nerve cell functioning; and to try to identify biological markers prior to treatment that will identify patients who are more or less likely to respond to the study treatment.

Study chairs or principal investigators: Brian Fallon, M. Sponsor s : National Institute of Allergy and Infectious Diseases NIAID Purpose - Excerpt: This study will determine whether patients who have been infected with the Lyme bacteria, Borrelia burgdorferi, and treated with antibiotics still have the bacteria alive inside them and whether it is causing their symptoms. The information from this study may serve as a basis for developing stringent diagnostic criteria for Lyme disease and the establishment of future treatment trials. Individuals in the following categories may be eligible for this study: chronic Lyme disease; chronic Lyme arthritis; seropositive control are infected with the bacteria that causes Lyme disease but do not have disease symptoms ; recovered control have been sick with Lyme disease but were treated successfully and are currently well ; control with multiple sclerosis patients with multiple sclerosis ; and healthy volunteers.

Patients in the chronic Lyme disease category must be between 13 and 65 years of age; all others must be between 18 and 65 years of age. Candidates will be screened with blood and urine tests. Participants will have a physical examination and the following tests: Blood tests - Includes HLA-typing, a genetic test of immune system markers; Leukapheresis - Collection of large numbers of white blood cells Whole blood is collected through a needle in an arm vein.

The blood circulates through a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the body, either through the same needle used to draw the blood or through another needle in the other arm. Alternatively, patients will cc about 7 tablespoons of blood drawn.

A local anesthetic is administered and a needle is inserted in the space between the bones in the lower back where the 52 Lyme Disease cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle; Magnetic resonance imaging MRI of the brain - Imaging of the brain using a strong magnetic field and radio waves instead of X-rays. During the scan, the patient lies on a table in a narrow cylinder containing a magnetic field.

He or she can speak with a staff member via an intercom at all times during the procedure; Neuropsychologic testing; Some participants may also have a hearing test and urine collection. Participants whose test results are positive for Borrelia burgdorferi will be followed at NIH at intervals of 3 to 6 months until it is determined whether there is infection. Those who are infected will be offered treatment with the antibiotic ceftriaxone. Following treatment, patients will return to the NIH Clinical Center for follow-up visits 1 week after treatment and again at 3, 6 and 12 months.

The lumbar puncture, hearing examination, blood and urine tests will be repeated at these visits to evaluate the response to treatment, and the leukapheresis will be repeated for research purposes. All participants with chronic Lyme disease, chronic Lyme arthritis, seropositive controls and recovered controls may be reevaluated at intervals of 6 to 12 months.

Patients with active Lyme disease may be eligible for this study. Participants will have a medical history and physical examination and diagnostic evaluations as appropriate to their individual condition. Laboratory tests may include routing blood and urine tests, X-rays, or other imaging studies, body fluid or tissue cultures, skin biopsy and tests for allergic or immune responses. Treatment will include only medications approved by the Food and Drug Administration, given according to accepted dose schedules and ways of Clinical Trials 53 taking the medicines.

All diagnostic tests and treatments will be according to standard medical practice for the disease. No experimental procedures will be offered under this protocol. Patients will be followed as needed for evaluation and treatment of their condition. In general, they will be asked to return at the end of therapy, then 3, 6 and 12 months later, and then every 6 to 12 months. More frequent visits may be required or less frequent visits may be allowed, depending on the individual's condition. Participants may be asked to undergo the following additional procedures for research purposes: - Extra blood draws to study Lyme disease and other inflammatory conditions.

Blood will be drawn from arm veins. Whole blood is collected through a needle in an arm vein, similar to donating blood. The blood circulates through a machine that separates it into its components, and the white cells are removed. The rest of the blood is returned to the body through the same needle. Only adults 18 years of age and older will be asked to undergo leukapheresis.

It is caused by the spirochete Borrelia burgdorferi. It may exist in an acute and chronic form. The purpose of this study is to determine the safety and effectiveness, in seronegative patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease CLD. Lyme disease is the most common tick-borne disease in the United States.

It may exist in a chronic form and be the result of: 1 persistent infection by B. Some boats provide passengers with the experimental program and the other boats provide a "control" program that the researchers can compare to the experimental program. The experimental program uses live performances by entertainers to teach people about Lyme disease prevention, and also uses additional printed materials.

People on the control boats receive education on injury prevention and road safety while bicycling, rollerblading, and using mopeds. The main result we will look for is Lyme disease identified by a followup survey and confirmed by reviewing medical records. We will also ask some people to take part in a smaller study of behavior change. In this study, we will ask people to complete forms on self-efficacy a person's belief in his or her ability to reach a certain goal , their plans to take preventive steps, and actual prevention behaviors.

We also ask participants who report doctor visits or illness to provide confirmation of their use of health services. Study chairs or principal investigators: Matthew H. Liang, M. Fatigue is a common symptom of Lyme Disease. The chronic fatigue seen in these patients appears to be related to the initial infection which causes Lyme Disease. It is believed, but not proven, that treatment with antibiotics may be effective in relieving chronic fatigue in PLS patients. It may exist in a chronic form and be the result of: 1 active infection by B.

The purpose of this study is to determine the safety and effectiveness, for seropositive patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease CLD. Although only half of the participants in a clinical trial receive the experimental treatment, if the new treatment is proved to be more effective and safer than the current treatment, then those patients who did not receive the new treatment during the clinical trial may be among the first to benefit from it when the study is over.

Experts watch them closely during the study and may continue to follow them after the study is over. In cases where certain diseases or disorders run in families, your participation may lead to better care or prevention for your family members. What Are the Risks?

Clinical trials may involve risks as well as benefits. Whether or not a new treatment will work cannot be known ahead of time.

The 2002 Official Patient's Sourcebook on Lyme Disease

There is always a chance that a new treatment may not work better than a standard treatment. There is also the possibility that it may be harmful. The treatment you This section has been adapted from ClinicalTrials. How Is Patient Safety Protected? Clinical trials can raise fears of the unknown. Understanding the safeguards that protect patients can ease some of these fears. Before a clinical trial begins, researchers must get approval from their hospital's Institutional Review Board IRB , an advisory group that makes sure a clinical trial is designed to protect patient safety.

During a clinical trial, doctors will closely watch you to see if the treatment is working and if you are experiencing any side effects. All the results are carefully recorded and reviewed.

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In many cases, experts from the Data and Safety Monitoring Committee carefully monitor each clinical trial and can recommend that a study be stopped at any time. You will only be asked to take part in a clinical trial as a volunteer giving informed consent. If you are eligible for a clinical trial, you will be given information to help you decide whether or not you want to participate. Participation is strictly voluntary. However, you should not enroll if you do not plan to complete the study. Your name will not appear in any reports based on the study. What about Costs?

In some clinical trials, the research facility pays for treatment costs and other associated expenses. You or your insurance provider may have to pay for costs that are considered standard care. These things may include inpatient hospital care, laboratory and other tests, and medical procedures. You also may need to pay for travel between your home and the clinic. You should find out about costs before committing to participation in the trial. If you have health insurance, find out exactly what it will cover.

If you don't have health insurance, or if your insurance company will not cover your costs, talk to the clinic staff about other options for covering the cost of your care. Why do researchers think the new treatment may be better? What is likely to happen to me with or without the new treatment? Will I need surgery? How often will I have to come back for follow-up exams? What are the short- and long-term risks?

What are the possible side effects? Will it make me feel sick? If so, for how long? How will I get there? What costs are covered by the study? How much will my health insurance cover? Who will be in charge of my care?

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Do I have time to participate? Are there family members or friends who may benefit from my contributions to new medical knowledge? Keeping Current on Clinical Trials Various government agencies maintain databases on trials. The U. The site was launched in February and currently contains approximately 5, clinical studies in over 59, locations worldwide, with most studies being conducted in the United States.

To access this database, simply go to their Web site www. While ClinicalTrials. The database is updated regularly, so clinical trials are continually being added. They have been selected to ensure that they are likely to be available from your local or online bookseller or university medical library. The following includes some of the most readily available references sorted alphabetically by title; hyperlinks provide rankings, information and reviews at Amazon.

Anderson; Paperback - pages , CenterWatch, Inc. It does not include therapy which requires more than one administration of a therapeutic agent or regimen. Retreatment is often used with reference to a different modality when the original one was inadequate, harmful, or unsuccessful. All too often, patients who conduct their own research are overwhelmed by the difficulty in finding and organizing information.

The purpose of the following chapters is to provide you an organized and structured format to help you find additional information resources on Lyme disease.

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Rather, our goal is to give you access to original research and to increase your awareness of sources you may not have already considered. In this way, you will come across the advanced materials often referred to in pamphlets, books, or other general works. Once again, some of this material is technical in nature, so consultation with a professional familiar with Lyme disease is suggested. Broadly speaking, there are two types of studies.

The first are peer reviewed. Generally, the content of these studies has been reviewed by scientists or physicians. Peer-reviewed studies are typically published in scientific journals and are usually available at medical libraries. The second type of studies is non-peer reviewed.

These works include summary articles that do not use or report scientific results. These often appear in the popular press, newsletters, or similar periodicals. In this chapter, we will show you how to locate peer-reviewed references and studies on Lyme disease. We will begin by discussing research that has been summarized and is free to view by the public via the Internet.

We then show you how to generate a bibliography on Lyme disease and teach you how to keep current on new studies as they are published or undertaken by the scientific community. To limit your investigation to research studies and Lyme disease, you will need to use the advanced search options. March-April Summary: This journal article provides the general public and people who have arthritis with information on Lyme disease. This tick borne disease causes symptoms that can mimic those of mononucleosis, meningitis, multiple sclerosis, rheumatoid arthritis, and other diseases.

The early localized stage of Lyme disease occurs 7 to 10 days after infection and is characterized by an expanding red rash and viral type symptoms. The early disseminated stage occurs after several weeks or months of infection. Additional symptoms, including nervous system problems, may appear. The late stage of the disease can occur from months to years after the initial infection. In this stage, arthritis pain and swelling may occur in a few large joints. Lyme disease is usually diagnosed from the signs and symptoms in the earlier stages.

A blood test may help confirm the diagnosis. Treatment involves taking antibiotics. Although two vaccines have been developed, people should still take precautions such as clearing brush from a yard, wearing long sleeved shirts and long pants tucked into socks when walking through woods or high grasses, checking exposed skin regularly, and removing a tick gently.

February Summary: This journal article provides health professionals with information on a vaccine for Lyme disease, the most common tick borne illness in the United States. Lyme disease is endemic to the Northeast, upper Midwest, and Pacific coastal States.

It is a multisystem, multistage disorder typically presenting as a red papule that expands to an enlarging patch of erythema migrans. Flu like symptoms often accompany the rash. If the disease is left untreated neurologic and myocardial abnormalities may develop within weeks or months of infection. Arthritis occurs in approximately half of those with untreated Studies 67 Lyme disease.

The vaccine is formulated from a lipoprotein, OspA, that stimulates the production of antibodies against Borrelia burgdorferi in vaccinated patients. A 20 month randomized, multicenter, placebo controlled trial of the vaccine indicated a 78 percent efficacy rate against definite Lyme disease and a percent effectiveness rate against asymptomatic infection.

The article provides information on dosage and reactions, identifies candidates for vaccination, and outlines precautions people should take to prevent tick bites. May-June Summary: This journal article provides the general public with information on a vaccine for Lyme disease, a bacterial infection transmitted by tick bites. The vaccine stimulates the human immune system to produce antibodies against Borrelia burgdorferi, but unlike the process with typical vaccines that fight bacteria in a person's body, the antibodies from a vaccinated person enter the tick and kill the bacteria there.

The vaccine is not percent effective, so people still need to take preventive measures against infection. The article explains how ticks become infected with the Lyme disease bacteria and how the disease is transmited to humans. Symptoms, including a skin rash called erythema migrans and flu-like symptoms, are identified. The article also discusses the diagnosis of Lyme disease using an enzyme-linked immunosorbent assay technique and the PreVue B. In addition, the article provides guidelines on removing and disposing of ticks and protecting household pets from Lyme disease.

June 15, Summary: This patient information sheet uses a question and answer format to provide the public with information about the Lyme disease vaccine, which has been approved only for people over 15 years old. The vaccine is suggested for those who are at high or moderate risk of getting Lyme disease. Factors placing people at high risk include living in a county where Lyme disease is common, having deer on residential property, and working or spending leisure time outdoors on a frequent 68 Lyme Disease or prolonged basis where Lyme disease is common.

The vaccine should be given in three doses. The first dose should be followed by a second one a month later. The third dose should be administered 12 months after the second one. The vaccine is very effective, but it may not protect everyone. Therefore, people who receive the vaccine should still take precautions to protect themselves against tick bites. December 21, Summary: This journal article provides health professionals with information on a population based, retrospective cohort study that determined clinical and functional outcomes in persons who were treated for Lyme disease in the late s.

The study population consisted of Nantucket Island, MA, residents who had a history of Lyme disease and residents who did not. Measurements included a standardized medical history, a physical examination, a functional status measure, a mood state assessment, neurocognitive tests, and a serologic examination. The study found that the prevalence of Lyme disease among adults on Nantucket Island was estimated to be In multivariate analyses, persons with previous Lyme disease had more joint pain, more symptoms of memory impairment, and poorer functional status due to pain than persons without previous Lyme disease.

However, on physical examination, case patients and controls did not differ in musculoskeletal abnormalities, neurologic abnormalities, or neurocognitive performance. Persons with previous Lyme disease who had persistent symptoms after receiving treatment were more likely than those who had completely recovered to have had fever, headache, photosensitivity, or neck stiffness during their acute illness; however, the performance of the two groups on neurocognitive tests did not significantly differ.

The article concludes that, although musculoskeletal and neurocognitive outcomes seem to be favorable among persons with previous Lyme disease, long term impairment of functional status can occur. May Summary: This journal article provides health professionals with information on the clinical manifestations, and diagnosis of Lyme disease, as well as its treatment. This disease, which is a tick-borne multisystem infectious syndrome, is the most frequently reported vector- Studies 69 borne illness in the United States.

The causative organism, Borrelia burgdorferi, is a flagellated spirochete transmitted from small-mammal reservoirs to humans through bites from infected ixodid ticks. The symptoms of Lyme disease are categorized according to organ system involvement and duration of infection. The hallmark of early localized Lyme disease is an expanding erythematous patch or ring appearing within 30 days after the infected tick inoculates the skin with the spirochete. A minority of patients with the erythematous patch also report various systemic symptoms. Supportive laboratory data can help confirm the diagnosis.

Serologic testing is the only routinely available laboratory diagnostic aid for Lyme disease. After a period of localized skin infection at the site of the tick bite, infection may spread hematogenously to various target organs. Disseminated Lyme disease occurs 1 to 4 months after an infected tick bite. Features may include cutaneous, rheumatic, neurologic, and cardiac manifestations. Serologic testing should be used only in patients who are considered to be at risk epidemiologically and have clinical features truly suggestive of disseminated Lyme disease. Late Lyme disease is used for manifestations occurring more than 4 months after disease onset.

Features include persistent skin inflammation, encephalopathy, and chronic inflammatory arthritis. All stages of Lyme disease are treated with an antibiotic regimen. Antibiotic therapy should be tailored to the extent of the disease and should be limited to 4 weeks. The article includes a discussion of issues in disease management. August Summary: This journal article provides health professionals with information on laboratory tests available to help the clinician confirm the diagnosis of Lyme disease.

A variety of laboratory tests detect specific antibodies to the spirochete Borrelia burgdorferi. Incorrect use of serologic tests for Lyme disease often results in overdiagnosis and overtreatment. Serologic testing is indicated only when the patient demonstrates clinical findings suggestive of Lyme disease, and it is most likely to be useful when done at 6 weeks after the tick bite. It is not indicated when the patient has erythema migrans or nonspecific symptoms. Determining the pretest probability of Lyme disease requires consideration of various factors, including geography, time of year, and previous tick bite.

The most accurate and widely available and used are the enzyme-linked immunosorbent assay ELISA and the immunoblot Western blot analysis. Several weeks after 70 Lyme Disease infection, specificity increases but sensitivity declines. There are currently no standard criteria for a positive test result. The Western blot is more sensitive than ELISA for detecting the presence of antibodies, but may be less sensitive for establishing the diagnosis and is used to corroborate positive or equivocal ELISA results.

A positive result on the Western blot confirms infection and is an indication for treatment; a negative result greatly decreases the probability of Lyme disease. The immunoblot assay identifies specific antibodies against different Borrelia proteins. Clinical indications for serologic testing include history of tick bite more than 4 to 6 weeks earlier and neurologic, cardiac, and musculoskeletal symptoms.

Physicians need to consider other explanations for patient symptoms before considering a diagnosis of Lyme disease. Contact: American Academy of Family Physicians. Summary: This journal article for health professionals provides guidelines for recognizing and managing Lyme disease. This multisystem disorder, which is the most common tick-borne illness in the United States, has an annual incidence of 0. It most commonly occurs in the Northeast and upper Midwest, in areas that encourage and harbor the deer tick.

The tick transmits an infection of the spirochete Borrelia burgdorferi that typically manifests as a localized skin lesion, erythema migrans. Rarely, Lyme disease manifests as localized arthritis, heart block, or disease of the nervous system. Lyme disease is a clinical diagnosis, and laboratory tests should only be used to clarify diagnostic issues. The current standard for laboratory diagnosis includes a two-step approach using an initial immunoassay with a confirmatory Western blot.

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Treatment includes 10 to 21 days of oral doxycycline in nonpregnant adults or a similar course of amoxicillin in children or pregnant women. Overdiagnosis and overtreatment of Lyme disease have become common. Summary: This journal article for health professionals describes a prospective, longitudinal, community-based cohort study of children Studies 71 with Lyme disease in an area of southeastern Connecticut in which the disease is highly endemic. The researchers obtained clinical and demographic information and performed serial antibody tests and followup evaluations. Results indicate that the initial clinical manifestations of Lyme disease were a single erythema migrans lesion in 66 percent of the patients, multiple erythema migrans lesions in 23 percent, arthritis in 6 percent, facial-nerve palsy in 3 percent, aseptic meningitis in 2 percent, and carditis in 0.

At presentation, 37 percent of the patients with a single erythema migrans lesion and 89 percent of those with multiple erythema migrans lesions had antibodies against Borrelia burgdoferi. All but 3 of the patients were treated for 2 to 4 weeks with conventional antimicrobial therapy, which was administered orally to 96 percent of the patients. All had prompt clinical responses. After 4 weeks, 94 percent were completely asymptomatic.

At followup, none of the patients had evidence of either chronic or recurrent Lyme disease. Six patients subsequently had a new episode of erythema migrans. The article concludes that the prognosis for children with early Lyme disease who are treated with appropriate antimicrobial therapy is excellent. August 15, Summary: This letter to the editor responds to Leonard H. Sigal's editorial entitled Lyme Disease Over-diagnosis: Causes and Cure, which focused on the overdiagnosis of Lyme disease within the nonpsychiatric context, and as a result of this overdiagnosis diagnosis by exclusion , subjecting patients to long-term and unnecessary antibiotic therapy.

The letter's author indicates that there is a closed system of thinking that contributes to diagnostic error and that there is actually more underdiagnosis than overdiagnosis. Such underdiagnosis is laying the ground work for a large scale epidemic of neuropsychiatric Lyme disease in the future.

Sigal responds that while diagnosis by exclusion may be imprecise, and that he does not known of any of the psychiatric signs and symptoms described by the letter's author, he suggests the only way to settle the questions raised is to perform scientific studies to demonstrate that the form of Lyme disease described in the author's letter does actually exist.

This condition, which has been reported in 48 States, is fairly easy to cure, and serious complications rarely develop when the disease is treated promptly. Questions address issues related to the diagnosis and treatment of Lyme disease. Diagnosis is complicated by the fact that the pathognomonic skin lesion, erythema migrans, is absent in up to 40 percent of infected persons. Also roughly half of patients with erythema migrans are seronegative at the time of presentation.

All specimens submitted for testing should be evaluated in two steps: if results of ELISA or IFA testing are negative, no further testing is needed, but if results are borderline or positive, Western blot analysis is needed to confirm the diagnosis. Prophylactic therapy with amoxicillin or doxycycline should be considered if a tick has been attached more than 24 hours and the patient was exposed in an area with an infectivity rate of more than 30 percent.

In addition, other questions deal with the risk, diagnosis, and prevention of reinfection; the treatment of a pregnant woman who has Lyme disease; the management of patients who continue to be symptomatic after being treated for Lyme disease; the reduction of the risk of Lyme disease; and the progress made in the development of a vaccine. Summary: This journal article for health professionals offers guidelines for identifying and managing pediatric Lyme disease and its complications.

The evaluation of a child with new onset of joint swelling for the possibility of Lyme disease should include consideration of the epidemiology of the disease, the history other than joint involvement, the type of joint disease, and laboratory data. The fact the Lyme disease is much more common in certain geographic areas affects the level of clinical suspicion when a child presents with typical complaints.

The only pathognomonic feature is the erythematous ring-shaped skin lesion that appears 1 to 3 weeks following tick attachment and can expand to a large diameter within hours. An acute flu-like illness develops 1 to 4 weeks after the tick bite. The most common late complication is join inflammation.

Inflammation may be classically episodic and monarticular, which may cause a delay is diagnosis.

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One third of children present with an acute arthritis. Various laboratory tests may useful in evaluating patients, including serologic tests and synovial fluid analysis. Treatment options include oral antibiotic agents for manifestations of uncomplicated disease. AA- M. April Contact: Available from W. Summary: This article discusses ways to differentiate orofacial pain related to Lyme disease from other dental and facial pain disorders. The author notes that the facial pain of Lyme disease may simulate dental pathology, temporomandibular joint or masticatory muscle pain, headache, and neuropathic disorders.

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The author discusses the cause and diagnosis of odontogenic pain, normal and pathologic function of the temporomandibular joints, myofascial trigger points, and pain referral patterns. A screening examination of the odontogenic and masticatory structures as well as a summary of headache disorders is provided. These conditions are compared with their presentation in a patient with Lyme disease to facilitate the diagnostic process. Summary: This journal article provides health professionals with information on a LYMErix, the newly approved Lyme disease vaccine.

The vaccine is given in three doses over 1 year to achieve maximum efficacy. The initial dose should be followed by a second dose 1 month later and the third dose 12 months after the second. Although the duration of protection following the third dose has not yet been established, it is likely that boosters will be needed at 1 to 2 year intervals. Unresolved concerns about the vaccine include its safety and efficacy in children and the elderly, its link to Lyme arthritis, and its effect on laboratory tests used to detect Lyme disease.

Physicians need to ask patients to assess their risk for Lyme disease based on their place of residence; the terrain of their property; and their occupational, recreational, and leisure activities. Despite progress made on the vaccination front, detecting Lyme disease often remains a challenge. Early recognition is important because progression can lead to serious complications. Early localized infection is characterized by erythema migrans, which develops about 1 to 4 weeks after a tick bite.

Early disseminated infection may develop within weeks to months in untreated patients. Late persistent infection may develop months to years after the initial infection. To determine whether serologic testing is warranted, 74 Lyme Disease physicians should first assess the pretest probability of disease and the predictive value of the serologic test results.

For most patients, antibiotic therapy is an effective cure, and when used early, it prevents progression to more serious complications. Summary: This journal article provides health professionals with information on the musculoskeletal manifestations of Lyme arthritis.

The article begins by briefly reviewing the history of Lyme disease in the United States and Europe and the evolution of investigators' sense of Lyme disease in the United States and Europe. This is followed by a discussion of the ecology and epidemiology of Lyme disease, the life cycle of ixodid ticks, and the types of proteins expressed after Borrelia burgdorferi is transmitted into the mammalian host. The article then presents the features of early localized, early disseminated, and late Lyme disease.

The hallmark of early localized Lyme disease is an expanding erythematous patch or ring appearing within roughly a week after an infected tick inoculates the skin with the spirochete. After a period of localized skin infection at the site of the bite, infection may spread hematogenously to various target organs. The symptoms of disseminated Lyme disease include cardiac and neurologic manifestations.

The features of late Lyme disease are encephalopathy, axonal polyneuropathy, and leukoencephalitis. The musculoskeletal features of untreated Lyme disease are arthralgia, intermittent episodes of arthritis, or chronic arthritis. Other topics include B. The article describes some of the techniques used in laboratory evaluation, including the enzyme-linked immunosorbent assay, the Western blot analysis, polymerase chain reaction, and the borreliacidal antibody assay.

Tests of unproven value in Lyme disease include urinary antigen detection, T cell proliferative responses, and autoantibody testing. The article presents caveats on the use of testing in Lyme disease, discusses treatment with antibiotics, and comments on prevention strategies. In addition, the article identifies factors in the immunopathogenesis of Lyme disease, examines the potential role of autoimmunity in the pathogenesis of Lyme neurologic disease, and discusses psychopathogenetic factors that may have a role in chronic Lyme disease.

The article concludes with recommendations on diagnosis and treatment. Government supports a variety of research studies relating to Lyme disease and associated conditions. You can perform targeted searches by various criteria including geography, date, as well as topics related to Lyme disease and related conditions.

As opposed to clinical trial research using patients, many federally-funded studies use animals or simulated models to explore Lyme disease and related conditions. In some cases, therefore, it may be difficult to understand how some basic or fundamental research could eventually translate into medical practice.

One manifestation of the disease is arthritis, which can result in treatment-resistant chronic arthritis in a small subset of exposed individuals. The prevalence of HLA. DR4 related alleles in these patients is an indication of an autoimmune process. They have explored the role of T helper cells in the development of Lyme arthritis, and the investigators hypothesize that patients with these particular HLA. DR alleles are at risk of developing chronic disease as a result of a vigorous inflammatory Th response to Bb.

Based upon homology to a highly antigenic epitope of outer surface protein A Osp A of Bb, the applicants have identified a candidate autoantigen, hLFA The aim of this application is to verify this hypothesis by creating in vitro and in vivo test systems. The functional similarity between the homologous epitopes and Osp A Bb and human LFA-1, but not mouse LFA-1, will be analyzed by three in vitro approaches: a T cell hybridomas will be generated from DR4 transgenic mice after immunization with Osp A, and the resulting clones will be tested for reactivity to human LFA If double-reactive hybridomas are identified, the antigenic epitopes will be mapped; b synovial fluid T cells from chronic Lyme patients will be transformed and tested at the single-cell level for reactivity to Osp A and human LFA-1; c Osp A will be tested for binding to ICAM These mice will contain the non-immune lymphocytes of the susceptible genotype, allowing a detailed analysis of the acquisition of chronic Lyme arthritis after injection with Bb.

These investigations, they propose, should provide a vigorous test of their working hypothesis, and will lead to new insights into the mechanism of treatment-resistant chronic Lyme arthritis. Her goal is to become a clinical researcher, focusing on the epidemiology, prognosis and management of Lyme disease. The applicant's sponsor, Dr. This project, combined with course work and regular participation in conferences, will prepare her for a career as an independent clinical investigator.

Computer facilities in the Center's Biometry Core are available to the candidate. The resources of the Brigham and Women's Hospital allow the opportunity to collaborate with members of other departments and to participate in graduate school courses at the Harvard School of Public Health. The overall goal of the present study is to improve our understanding of the long term outcomes of Lyme disease. Specific aims include l determination of the chronicity of musculoskeletal and neurologic impairment in a well characterized population-based cohort of individuals with prior Lyme disease and 2 development of a predictive model of chronic Lyme disease with particular attention to potentially modifiable biological and psychosocial risk factors in order to define an intervention strategy to reduce chronic Lyme disease.

A retrospective cohort of Lyme subjects and community controls on Nantucket Island, MA, will receive a standardized and blinded physical examination, symptom review, health status measure, psychometric test battery, and serologic analysis at a three year follow-up interval to assess outcomes.

Baseline clinical and psychosocial variables will be evaluated as risk factors for objective and subjective morbidity. This study will help develop better treatment and management guidelines for people with Lyme disease. Encephalopathy is the core syndrome of chronic neurologic Lyme disease.

The primary goal of this project is to characterize Lyme encephalopathy. We will test specific hypotheses related to the major clinical 78 Lyme Disease features and pathogenesis of chronic neurologic Lyme disease. A longitudinal design over an 18 month period will allow the course and key risk factors of Lyme encephalopathy to be defined. Specific Aim 1. To define the neurobehavioral and psychological sequelae of chronic Lyme disease Specific Aim 2.

To determine the pathogenesis for neurobehavioral deficits in chronic Lyme disease Specific Aim 3. Neurologic involvement is now recognized as the major morbidity of Lyme disease, but has not been studied in a systematic fashion. This Program Project has assembled an interdisciplinary team of investigators to study neurologic Lyme disease. All components of this Program Project are linked by shared methodologies, conceptual frameworks, and common Cores.

The three Clinical Projects will provide materials for the Pathogenesis Project: Project 1 will look at the role of host factors the T cell response and organism factors neurotropism, antigenic variation. Project 2 will determine the frequency, correlates, and outcome of central nervous system invasion in early Lyme disease. Project 3 will characterize the neurobehavioral syndromes of chronic Lyme disease.

Project 4 will study neurologic Lyme disease in children. The primary scientific goals of this Program Project are 1 to identify and characterize prospectively the neurologic, neuropsychologic, and psychosocial manifestations of Lyme disease in children and adults; and 2 to identify pathogenetic mechanisms involved in neurologic Lyme disease. The secondary goals are 3 to characterize associated cerebrospinal fluid changes; and 4 to identify risk factors for poor outcome.

This Program Project will support a structured interdisciplinary effort to study the neurologic aspects of Lyme disease. It will provide Studies 79 information to guide development of rational and cost-effective public health policy for this important infection. It was originally recognized in children, and children continue to have a high rate of infection.

Major issues concerning neurologic aspects of the disease in children and adolescents remain unresolved. Failure to understand the full spectrum of neurologic features has led to health care practices which may be both costly and ineffective. The objective of this proposal is to characterize the neurologic, cognitive, and behavioral aspects of pediatric disseminated Lyme disease. Three groups of children will be evaluated in a prospective longitudinal 18 month study.

All three groups will have comprehensive neurologic, neuropsychologic, behavioral.

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Subjects with neurologic involvement will have cerebrospinal fluid [CSF] studies. Disseminated Lyme disease subjects will receive currently recommended antibiotic treatment. All three groups will be followed prospectively with full re-evaluation at 18 months. Hypothesis 1: Neurologic involvement is common in pediatric disseminated Lyme disease. Hypothesis 2: Behavioral changes [dysphoria, irritability, fatigue] and cognitive problems [deficits of attention and memory] are frequent in children with neurologic Lyme disease.

These problems will have remitted by 18 month follow up. Hypothesis 3: Persistent post-treatment complaints at the 18 month follow-up are more common in children with psychosomatic problems, and those with parents who reinforce illnessrelated behavior. This project will: A establish the relative frequency, 80 Lyme Disease severity, and progression of neurologic and neurobehavioral disturbances associated with pediatric Lyme disease; B provide needed data to optimize diagnosis, evaluation, and management of neurologic Lyme syndromes in children. It is caused by the bite of a tick infected with the spirochete, Borrelia burgdorferi, the etiologic agent of the disease.

Evaluation of the potential for development of disease from a tick bite is complicated by incomplete knowledge of the diversity of spirochete genotypes in nature and their pathogenic capacities. Money transfers. Health insurance. Money Deals. The Independent Books.

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