Severity of Lyme disease with persistent symptoms.

Insights from a double-blind

placebo-controlled clinical trial.

Cameron D.

Northern Westchester Hospital, Mount Kisco, NY, USA cameron@lymeproject .com.

Lyme disease is a global health concern and is the world's leading tick borne infection caused by the spirochete, Borrelia burgdorferi, that has been associated with numerous neurologic, rheumatologic and psychiatric manifestations.

The symptoms of Lyme disease have been characterized as either

severe or ''related to the aches and pains of daily living.''

A randomized double-blind, placebo-controlled clinical trial (RCT) was conducted in a primary internal medicine practice in Westchester County, New York, USA. A total of 84 adults with Lyme disease with persistent symptoms (LDPS) were studied; 52 received amoxicillin and 34 received placebo.

The subjects received either placebo or amoxicillin 3 g per day orally for 3 months. The SF-36 was used as the outcome measure of the patient's perceived Quality of Life (QOL).

For subjects enrolling in this RCT, the average SF-36 physical component summary (PCS) of QOL (40+/-9, range 29-44) and mental component summary (MCS) of QOL (39+/-14, range 23-46) were worse than the general USA population and worse than individuals with diabetes, heart disease, depression, osteoarthritis or rheumatoid arthritis.

The improvements in the SF-36 measure of QOL for subjects

randomized to amoxicillin vs. placebo was significant (46% vs 18%, P=0.007). It is important for clinicians to be aware that LDPS can be severe.

A significant gain in the QOL for subjects randomized to amoxicillin in this RCT without serious adverse events is consistent with the goal of improving patient's QOL and consequently worthy of further study.

PMID: 18971914 [PubMed - in process]

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This means: a good start towards the measurable reporting of Lyme patients who have persistent symptoms.

Of course, IDSAers could say that since it was 'patient reported' (subjective?) then they would throw it out.

However, since the SF 36 QOL is used in a wide variety of diseases other than Lyme, could we then tell those IDSAers---- that the medical establishment would have to deny all those other diseases????

"More studies needed". Yes indeed. But this is a start.

[cave note:

snip...

One of the most straightforward ways of measuring quality of life (QOL) is through the use of health status measures where patients are asked to rate different aspects of their life.

Perhaps the most commonly used measure in QOL research is the Short-Form 36 or SF-36, a generic measure developed and validated in the Medical Outcomes Study to assess important QOL domains relevant to patients suffering from a wide range of medical conditions [1].

The SF-36 consists of eight QOL domains that comprise two summary measures – the physical component summary and the mental component summary.

end snip]