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» LymeNet Flash » Questions and Discussion » Medical Questions » Oral Doxy vs IV ceftriaxone-Euro Study - What's wrong with this picture?!!!!

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Author Topic: Oral Doxy vs IV ceftriaxone-Euro Study - What's wrong with this picture?!!!!
AliG
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[confused]


Oral doxycycline versus intravenous ceftriaxone for European Lyme neuroborreliosis: a multicentre, non-inferiority, double-blind, randomised trial

Unn Ljstad MD,Eirik Skogvoll PhD, Randi Eikeland MD, Rune Midgard PhD, Tone Skarpaas MD, se Berg MD and se Mygland PhD

Department of Neurology, Srlandet Hospital HF, Kristiansand, Norway

Unit for Applied Clinical Research, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway

Department of Neurology, Srlandet Hospital HF, Arendal, Norway

Department of Neurology, Molde Hospital, Molde, Norway

Microbiology Unit, Division of Laboratory Medicine, Srlandet Hospital HF, Kristiansand, Norway

Department of Medicine, the University Hospital of Stavanger, Stavanger, Norway

Institute of Clinical Medicine, University of Bergen, Bergen, Norway

Hospital of Rehabilitation, Rikshospitalet University Hospital, Kristiansand, Norway

Available online 21 June 2008.


Refers to: Oral doxycycline for neuroborreliosis
The Lancet Neurology, In Press, Corrected Proof, Available online 21 June 2008
Gary P Wormser, John J Halperin



Referred to by: Oral doxycycline for neuroborreliosis
The Lancet Neurology, In Press, Corrected Proof, Available online 21 June 2008
Gary P Wormser, John J Halperin



Summary:

Background

Use of intravenous penicillin and ceftriaxone to treat Lyme neuroborreliosis is well documented, although oral doxycycline could be a cost-effective alternative.

We aimed to compare the efficacy of oral doxycycline with intravenous ceftriaxone for the treatment of Lyme neuroborreliosis.


Methods

From April, 2004, to October, 2007, we recruited consecutive adult patients from nine hospitals in southern Norway into a non-inferiority trial.

Inclusion criteria were neurological symptoms suggestive of Lyme neuroborreliosis without other obvious causes, and presence of any of the following: a CSF white-cell count of more than five per mL; intrathecal production of specific Borrelia burgdorferi antibodies; or acrodermatitis chronicum atrophicans.

Patients were randomly allocated to receive 200 mg oral doxycycline or 2 g intravenous ceftriaxone once per day for 14 days, in a double-blind, double-dummy design.

A composite clinical score (range 0 to 64, 0=best) was based on standardised interviews and clinical neurological examination.

The primary outcome was reduction in clinical score at 4 months after the start of treatment.

Analysis was per protocol.

This trial is registered with ClinicalTrials.gov, number NCT00138801.


Findings

Of 118 patients who underwent randomisation, 102 completed the study (mean clinical score at baseline 85 [SD 41]).

4 months after the start of treatment, mean score improvement in the doxycycline group (n=54) was 45 (95% CI 36 to 55) points and that in the ceftriaxone group (n=48) was 44 (34 to 54) points (95% CI for difference between groups −09 to 11; p=084).

26 (48%) patients in the doxycycline group and 16 (33%) in the ceftriaxone group had total recovery (95% CI for difference between groups −4% to 34%; p=013).

Side-effects possibly related to treatment were reported in 21 (37%) and 26 (46%) patients in these groups, respectively (−28% to 9%; p=030). Three patients discontinued ceftriaxone treatment owing to adverse events.


Interpretation

Oral doxycycline is as efficient as intravenous ceftriaxone for the treatment of European adults with Lyme neuroborreliosis.


Funding

Srlandet Kompetansefond.

[confused]
Thoughts please.

[ 27. June 2008, 08:28 AM: Message edited by: AliG ]

--------------------
Note: I'm NOT a medical professional. The information I share is from my own personal research and experience. Please do not construe anything I share as medical advice, which should only be obtained from a licensed medical practitioner.

Posts: 4881 | From Middlesex County, NJ | Registered: Jul 2006  |  IP: Logged | Report this post to a Moderator
AliG
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14 days?
200 mg Doxy vs 2gm Rocephin?
followed for 4 months?
inclusion criteria?

Thoughts anyone???????

Another one of THOSE studies?

It refers to Worm & Halparin's study & is referred to BY the same study?!!! How did the Worm swing that one?

UNREAL!!! [shake]

--------------------
Note: I'm NOT a medical professional. The information I share is from my own personal research and experience. Please do not construe anything I share as medical advice, which should only be obtained from a licensed medical practitioner.

Posts: 4881 | From Middlesex County, NJ | Registered: Jul 2006  |  IP: Logged | Report this post to a Moderator
northstar
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There is not enough info in this report to qualify this study in accuracy. However, based on what is presented here:

Stated:
14 days treatment
presence of neurological symptoms

At least one of following:
a CSF white-cell count of more than five per mL; or
intrathecal production of specific Borrelia burgdorferi antibodies; or,
or acrodermatitis chronicum atrophicans.

Measurement of effectiveness:
The primary outcome was reduction in clinical score at 4 months
Where clinical score (0-64) was based on interview and neuro exam
Baseline pre-treatment of clinical score was 8.5 (imo, 8.5 on a scale
of 0-64 does not sound like they "are heavily" symptomatic)

Not stated:
how did they test for antibodies? What test? What were levels?
what else causes a white cell count? (inadvertent mixing of group?)
how serious was the neuro involvement? what were symptoms?

Post Treatment Results:
Both groups dropped about 50% in symptoms (note: not clear improvement, though)


Recovery: depends on how you define "recovered"
Almost half of doxy group were considered totally recovered
About 1/2 of ceft group were considered totally recovered

Their conclusion: doxy is as good as iv ceft.

Problem: most (maybe all?) llmd's will not use iv unless there is a serious problem.
So, in the above study, the use of iv ceft was inappropriate, and bound to be
looked at as comparable to doxy, since the symptoms were not that severe.
And what about the other 50% who did not recover? What were remaining
symptoms? What about 6 months, one year follow ups?


My thoughts: Try doxy and i.v. on a severe neuro case, and see which one excels. Of course, these iv studies have been done as a monotherapy (Klempner, etc), but we all know there are weaknesses in those studies...serious weaknesses.

What will happen: they have overgeneralized their results again. Some drs. will read this, or it will be referenced, as a 100% truth for 100% of all cases.

Consequences: avoid all use of iv for any neuroborreliosis, and now the insurance co's dont have to pay i.v.

This is overly simplistic thinking on the part of the researchers. And insurance co's gobble this stuff up.

Posts: 1331 | From hither and yonder | Registered: Sep 2005  |  IP: Logged | Report this post to a Moderator
lou
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We also don't know how long those people had been sick and that is a major determinant in outcome. They may be comparing apples and oranges.

Plus, the conclusion patients will probably draw from this is not that doxy is as good as rocephin, but that neither was very effective for that length of time. Isn't it amazing how the researchers can look at something like these results and ignore the most important conclusion?

Also, in some cases orals will not stop very bad neuro progression, but IV will. Dangerous for these researchers to extrapolate these results far beyond what is justified.

I think they did a poor job on this study.

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achey
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regarding your comment AliG abt Dr. j's comment abt IVdoxy, not oral Doxy helping in neuro cases,

My son got remission of severe neurocognitive symptoms on IV doxy 400mg bid.

Hope this helps

It had nothing to do with the study with looks very flawed, and I agree that ins co will love it.

Posts: 663 | From NH USA | Registered: Sep 2004  |  IP: Logged | Report this post to a Moderator
   

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