Unorthodox Clinical and Laboratory Practices Related to Lyme borreliosis

Background

There has been an increasing trend in recent years for some medical practitioners to make diagnoses of Lyme borreliosis unorthodox and unvalidated laboratory tests in patients who have a range of serious but non-specific symptoms. Many of these patients have not had any significant risk of exposure to ticks. The consequences of these mis-diagnoses have included recommendations for a range of inappropriate and potentially hazardous treatments, such as prolonged courses of parenteral cephalosporins and other antibiotics. In some cases, other medically significant causes of the patients’ symptoms were overlooked, and opportunities for appropriate treatment missed.

A report on these unorthodox and unvalidated laboratory tests was prepared by Professor Brian Duerden, Inspector of Microbiology and Infection Control, UK Department of Health (available here) [1].

Unorthodox testing

There are a number of unorthodox tests available in certain commercial laboratories (mainly in the USA) that have been proven in independent studies not to be of value. One is the Lyme urinary antigen test (LUAT), which purports to detect B. burgdorferi antigens in urine from patients with suspected Lyme borreliosis. It is very unreliable, with a high incidence of false-positive results [2]. Claims have also been made for the QRIBb test, a rapid method using fluorescent microscopy to identify borreliae in blood and other fluids and tissues. This unvalidated test is highly unreliable and has no adequate scientific basis [3]. Other unreliable tests include the lymphocyte transformation test (LTT), and unorthodox applications and interpretations of immunoblots [4].

Seronegative Lyme borreliosis

Antibody tests are likely to be negative in the first few weeks of infection, but it is very uncommon for patients with late stage Lyme borreliosis to be seronegative. None of the features of later stage Lyme borreliosis is unique to the infection, and the patient’s history should be carefully re-evaluated for other diagnostic possibilities before a diagnosis of seronegative late-stage Lyme borreliosis is accepted [5,7]. Additional specialised antibody and PCR tests to look for evidence of B. burgdorferi infection may be helpful.

Post Lyme syndrome

A small percentage of patients may continue to have subjective symptoms after appropriate treatment, similar to chronic fatigue syndrome or fibromyalgia [6,7]. Their past treatment history should be reviewed and they should be carefully evaluated and re-treated if they have objective evidence of active infection. Other conditions, infectious and non-infectious, may also trigger similar symptoms [8]. A large American study showed that the frequency of pain and fatigue was no greater in patients who had had Lyme disease than in age-matched controls who had not had B. burgdorferi infection [6]. Another study showed that patients with post-Lyme syndrome who were re-treated with prolonged courses of antibiotics had similar outcomes to those who received placebo for the same duration [2]. Such patients are best treated symptomatically rather than with prolonged antibiotics, which can be associated with serious or life-threatening complications [8,9]. Other spirochaetal infections, such as leptospirosis, relapsing fever, and syphilis do not require prolonged or repeated course of antibiotics, and there is no scientific evidence to suggest that B. burgdorferi requires prolonged treatment.

Chronic Lyme Disease

Some fringe medical and other practitioners diagnose this condition in patients who have serious but nonspecific symptoms and no previous history to suggest Lyme borreliosis. Other patients diagnosed with “chronic Lyme disease” have had serious conditions such as motor neurone disease, Addison’s disease, and systemic lupus erythematosis (SLE), and they required very different types of treatment to those that had been recommended by the fringe practitioners concerned. Some practitioners use unorthodox tests as discussed above, and follow the guidance of a group whose website was shown to contain inaccurate information [10, 12]. Their guidelines are not supported by good quality scientific evidence and are likely to lead to a high rate of misdiagnosis. An international expert group recently reviewed issues related to the diagnosis and management of 'chronic Lyme disease' [13]. Patients are strongly recommended to seek advice from their own general practitioners and experts such as accredited infectious disease specialists before embarking on potentially hazardous and expensive treatments.

Information on the Internet

The web has a great deal of material on Lyme borreliosis, but extracting medically and scientifically valid information requires much more than casual browsing. Some websites give excellent information about Lyme borreliosis, others are grossly inaccurate, promoting potentially harmful unorthodox approaches to diagnosis and treatments. Much poor quality and potentially dangerous information is readily available on the internet [10,11,12]. The best all-round initial sources of information include the EUCALB website and the CDC’s home page on Lyme borreliosis [11,12].

Reference list

1. Duerden BI. Unorthodox and unvalidated laboratory tests in the diagnosis of Lyme borreliosis and in relation to medically unexplained symptoms. Department of Health, London, UK, 2006.
http://www.dh.gov.uk/assetRoot/04/13/89/17/04138917.pdf 
2.Klempner MS, Schmid CH, Hu L et al. Intralaboratory reliability of serologic and urine testing of Lyme disease. Am J Med. 2001;110(3):217-9
3 . Caution regarding testing for Lyme disease. MMWR 2005;54(05):125 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5405a6.htm
4. Halperin JJ, Logigian EL, Finkel MF et al. Practice parameters for the diagnosis of nervous system Lyme borreliosis. Neurology 1996;46(3):619-27
5. Sigal LH. Anxiety and persistence of Lyme disease. Am J Med 1995;98(4A):74S-78S
6. Steere AC. Lyme disease. New Engl J Med 2001;345(2):115-25
7. Stanek G, Strle F. Lyme borreliosis. Lancet 2003;362(9396):1639-47
8. Wormser G P, Dattwyler R J, Shapiro E D, et al. The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis and Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America. Clin Infect Dis 2006; 43: 1089-34. Available free at http://www.journals.uchicago.edu/CID/journal/issues/v43n9/40897/40897.html
9. Patel R, Grogg KL, Edwards WD et al. Death from inappropriate therapy for Lyme disease. Clin Infect Dis 2000;31:1107-9
10. Cooper JD, Feder HM. Inaccurate information about Lyme disease on the Internet. Pediatr Infect Dis J 2004;23(12):1105-8
11. Sood S K. Effective retrieval of Lyme disease information on the Web. Clin Infect Dis 2002; 35(4):451-64 http://www.journals.uchicago.edu/CID/journal/issues/v35n4/020270/020270.html
12. Feder HM. Inaccurate information about lyme disease on the internet. Pediatr Infect Dis J 2005; 24(6):578-9
13. Feder HM, Johnson BJB, O'Connell S, Shapiro ED, Wormser GP and the ad-hoc International Lyme Disease Group. A critical appraisal of "chronic Lyme disease".  New England J Med. 2007;357:1422-30

Additional information

1. FDA Warns Consumers and Health Care Providers Not to Use Bismacine, also known as Chromacine. July 21, 2006. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01415.html
2. "Lyme Inc." by David Whelan, Forbes Magazine, March 12 2007. Available at http://www.forbes.com/forbes/2007/0312/096.html
3. Aguero-Rosenfeld ME, Wang G, Schwartz I, Wormser GP. Diagnosis of lyme borreliosis. Clin Microbiol Rev. 2005 Jul;18(3):484-509. (Available free at http://cmr.asm.org/cgi/reprint/18/3/484)
4. Wilske B, Fingerle V, Schulte-Spechtel U. Microbiological and serological diagnosis of Lyme borreliosis. FEMS Immunol Med Microbiol. 2007 Feb;49(1):13-21

Last reviewed: 23 February 2010