Re: Lyme disease: summary of NICE guidance. Are opinion-based guidelines what health professionals expect?
Much of the advice in NICE guideline NG95 for Lyme disease is based on the ‘experience and expertise’ of committee members, without supporting evidence. However, neither the BMJ article or guideline explain what this expertise is or where it came from. Furthermore, where published evidence was used to inform the recommendations, it is often found that NICE had graded the evidence as being of ‘low’ or ‘very low quality’.
Examination of the profiles of committee members provides no information which might allow doctors to form a judgement, about how much credence they deem it appropriate to assign to these opinions. Some members obviously have no clinical experience. None appear to have professional profiles suggesting substantial hands-on experience of Lyme disease, which might qualify them as ‘experts’.
If these issues are insufficient to raise concerns in the minds of those expected to take NICE guidelines “fully into account” when making clinical decisions, then perhaps the “Recommendations for research” included in the guideline might. NICE have called for research to answer absolutely basic questions about Lyme disease, relating to testing, diagnosis, treatment and prognosis and these recommendations are described as ‘high priority’.
Therefore many of the guideline’s recommendations do not appear to be grounded in either evidence or specific expertise. One example of opinion-based advice, is the recommendations to: “Explain to people with ongoing symptoms after antibiotic treatment for Lyme disease that:… Symptoms of Lyme disease may take months or years to resolve even after treatment.”
This opinion-based advice suggests to doctors that neither they nor their patient need to be concerned about ongoing symptoms following treatment. It assumes that the treatment must have been effective and implies that no further action is required regarding the infection.
While we are aware of patients improving in weeks or months after treatment, we are not aware of any evidence, either published or anecdotal, which indicates that ongoing symptoms of Lyme disease spontaneously resolve without further treatment after a matter of years. On the contrary, notwithstanding fluctuating remission and relapse which can occur with many chronic infections (and which the NICE guideline does not even mention), patients often report an overall trend of deterioration of their symptoms, as well as developing entirely new symptoms, another matter overlooked by the guideline.
As for the presumption that treatment must have cured the infection, in 2017, Embers et al published in Plos One, the results of their 16 month long experiment. Ten macaque monkeys were infected with B. burgdorferi (Lyme) by nymphal Ixodes scapularis tick feeding. At 12 weeks the monkeys were given four weeks treatment with doxycycline, matching target blood levels for the treatment of human Lyme disease. At autopsy ranging from 40 to 69 weeks post-infection, every monkey was found to remain infected. In 8 of the 10 monkeys, a substantial immune response was maintained right up to necrosis, yet neither this nor the antibiotic treatment had eradicated the infection.(1)
This evidence of post-treatment persistence appears to be of higher quality than the committee opinion that, “Symptoms of Lyme disease may take months or years to resolve even after treatment”, with its implied notion that ongoing symptoms are not due to continued infection.
Given that the NICE guideline is based on low quality evidence and opinion, it is questionable whether NG95 meets the requirements of doctors who are expected to rely on it, and patients whose health may depend on it.
Peter Kemp MA
Cofounder member of VIRAS
Embers ME, Hasenkampf NR, Jacobs MB, Tardo AC, Doyle-Meyers LA, Philipp MT, et al. (2017) Variable manifestations, diverse seroreactivity and post-treatment persistence in non-human primates exposed to Borrelia burgdorferi (B.b) by tick feeding. PLoS ONE 12(12): e0189071. https://doi.org/10.1371/journal.pone.0189071
Competing interests: No competing interests