title: Insufficient evidence to deny antibiotic treatment to chronic Lyme disease patients.
abstract: BACKGROUND
  The severity, length of illness, and cost of chronic Lyme disease (CLD) have been well described. A number of oral, intravenous, and intramuscular antibiotics have been prescribed for CLD. Surprisingly few antibiotic schedules prescribed for the treatment of CLD have been evaluated in randomized double-blind placebo-controlled clinical trials (RCTs). Physicians have increasingly turned to clinical treatment guideline (CPG) panels to judge the mixed results of the evidence. Two CPG panels have looked at the evidence only to reach opposite conclusions: (1) antibiotic therapy for CLD is not effective and (2) antibiotic therapy for CLD is effective. Physicians have been advised by guideline developers to use clinical discretion in diagnosing and treating CLD. Nevertheless, many health insurers - relying exclusively upon only one CPG - have a policy of automatically denying antibiotics to CLD patients regardless of the specifics of each case or the recommendations of the patient's physician.
  
  
  OBJECTIVE
  This paper examined the eight limitations of the evidence used to conclude that antibiotics therapy for CLD is not effective in forming the following hypothesis: insufficient evidence to deny antibiotic treatment to CLD patients.
  There are eight limitations that support the hypothesis: (1) the power of the evidence is inadequate to draw definite conclusions, (2) the evidence is too heterogeneous to make strong recommendations, (3) the risk to an individual of facing a long-term debilitating illness has not been considered, (4) the risk to society of a growing chronically ill population has not been considered, (5) treatment delay has not been considered as a confounder, (6) co-infections have not been considered as a confounder, (7) the design of RCTs did not address the range of treatment options in an actual practice, and (8) the findings cannot be generalized to actual practice.
  This hypothesis suggests that physicians should consider the limitations of the evidence before denying antibiotic treatment for CLD. Physicians who deny antibiotic treatment to CLD patients might inform their patients that there are some clinicians who disagree with that position, and then offer to refer them for a second opinion to a doctor who could potentially present a different point of view. The hypothesis also suggests that health care insurers should consider the limitations of the evidence before adopting policies that routinely deny antibiotic treatment for CLD patients and should expand coverage of CLD to include clinical discretion for specific clinical situations.
authors.affiliation: First Medical Associates, Medicine, 175 Main Street, Mount Kisco, NY 10549, USA. Cameron@LymeProject.com
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Cameron
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D019317:Evidence-Based Medicine; D006801:Humans; D008193:Lyme Disease / Q000188:drug therapy* / Q000453:epidemiology*; D015995:Prevalence; D016079:Refusal to Treat / Q000706:statistics & numerical data*
chemical_list: D000900:Anti-Bacterial Agents