Fallon in print

[Guest guest]

I have the abstract only. From it I can't make out whether there are

any statistically significant findings or no. Anyway, from my personal

study of anecdotal reports, I think ten weeks is a marginal treatment

duration at best, especially for a monotherapy, given the need to

achieve significance at 0.05 with only 37 patients. I'm strongly

inclining for now towards not taking the results very seriously.

Whereas the disappointing (barely-)negative results of the quite

large, hard-hitting (three-drug) P Gibson Crohn's study I take very

seriously, so far, though I still haven't read it in full.

1: Neurology. 2007 Oct 10; [Epub ahead of print]Click here to read Links

A randomized, placebo-controlled trial of repeated IV antibiotic

therapy for Lyme encephalopathy.

Fallon BA, Keilp JG, Corbera KM, Petkova E, Britton CB, Dwyer E,

Slavov I, Cheng J, Dobkin J, DR, Sackeim HA.

From the Department of Psychiatry (B.A.F., J.G.K., K.M.C., E.P.,

I.S., J.C., H.A.S.), Department of Biostatistics (E.P.), Department of

Neurology (C.B.B.), Department of Medicine (E.D., J.D.), and New York

State Psychiatric Institute (B.A.F., J.G.K., K.M.C., E.P., I.S., J.C.,

H.A.S.), Columbia University, New York; and Department of Cell and

Molecular Biology, University of Rhode Island, Kingston (D.R.N.).

BACKGROUND: Optimal treatment remains uncertain for patients with

cognitive impairment that persists or returns after standard IV

antibiotic therapy for Lyme disease. METHODS: Patients had

well-documented Lyme disease, with at least 3 weeks of prior IV

antibiotics, current positive IgG Western blot, and objective memory

impairment. Healthy individuals served as controls for practice

effects. Patients were randomly assigned to 10 weeks of double-masked

treatment with IV ceftriaxone or IV placebo and then no antibiotic

therapy. The primary outcome was neurocognitive performance at week

12-specifically, memory. Durability of benefit was evaluated at week

24. Group differences were estimated according to longitudinal

mixed-effects models. RESULTS: After screening 3368 patients and 305

volunteers, 37 patients and 20 healthy individuals enrolled. Enrolled

patients had mild to moderate cognitive impairment and marked levels

of fatigue, pain, and impaired physical functioning. Across six

cognitive domains, a significant treatment-by-time interaction favored

the antibiotic-treated group at week 12. The improvement was

generalized (not specific to domain) and moderate in magnitude, but it

was not sustained to week 24. On secondary outcome, patients with more

severe fatigue, pain, and impaired physical functioning who received

antibiotics were improved at week 12, and this was sustained to week

24 for pain and physical functioning. Adverse events from either the

study medication or the PICC line were noted among 6 of 23 (26.1%)

patients given IV ceftriaxone and among 1 of 14 (7.1%) patients given

IV placebo; these resolved without permanent injury. CONCLUSION: IV

ceftriaxone therapy results in short-term cognitive improvement for

patients with posttreatment Lyme encephalopathy, but relapse in

cognition occurs after the antibiotic is discontinued. Treatment

strategies that result in sustained cognitive improvement are needed.

PMID: 17928580 [PubMed - as supplied by publisher]