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Medical Forum / Diseases and Disorders / Prostatitis / October 2003

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Nickel Levaquin study

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Mr. Pubmed - 12 Oct 2003 16:13 GMT
Levaquin was no better than placebo in CPPS patients and the incidence
of mild side effects was barely higher than in the placebo group.
Isn't it great to have real facts rather than misguided opionions on
the newsgroup?

Urology. 2003 Oct;62(4):614-7.


Levofloxacin for chronic prostatitis/chronic pelvic pain syndrome in
men: a randomized placebo-controlled multicenter trial.

Nickel JC, Downey J, Clark J, Casey RW, Pommerville PJ, Barkin J,
Steinhoff G, Brock G, Patrick AB, Flax S, Goldfarb B, Palmer BW, Zadra
J.

Department of Urology, Queen's University, Kingston General Hospital,
Kingston, Ontario, Canada

To perform a Canadian multicenter randomized placebo-controlled trial
to evaluate the safety and efficacy of 6 weeks of levofloxacin therapy
compared with placebo in chronic prostatitis/chronic pelvic pain
syndrome (CP/CPPS). Uncontrolled studies have supported the use of
antibiotics in CP/CPPS.Men with a National Institutes of Health (NIH)
diagnosis of CP/CPPS (specifically, no infection localized to the
prostate) were randomized to levofloxacin (500 mg/day) or placebo for
6 weeks in 11 Canadian centers. Patients were assessed at baseline and
at 3, 6, and 12 weeks with the NIH Chronic Prostatitis Symptom Index
(NIH-CPSI) and global patient assessments (subjective global
assessment and patient assessment questionnaire).Eighty men (average
age 56.0 years, range 36 to 78; duration of symptoms 6.5 years, range
0.6 to 32) were randomized to receive levofloxacin (n = 45) or placebo
(n = 35). All were evaluated in an intent-to-treat analysis. Both
groups experienced progressive improvement in symptoms as measured by
the NIH-CPSI. However, the difference in response was not
statistically or clinically significant at end of treatment (6 weeks)
or at the end of the follow-up visits (12 weeks). No patients withdrew
because of adverse events. One patient withdrew before the 6-week
assessment. Adverse events (all mild) were reported in 20% of the
levofloxacin group and 17% of the placebo group.This pilot
placebo-controlled study showed that 6 weeks of levofloxacin therapy
in men diagnosed with CP/CPPS resulted in symptom improvement that was
not significantly different from that with placebo at end of treatment
or follow-up. The clinical ramifications of these findings need to be
addressed.
Idea Man - 13 Oct 2003 04:38 GMT
> Levaquin was no better than placebo in CPPS patients and the incidence
> of mild side effects was barely higher than in the placebo group.
> Isn't it great to have real facts rather than misguided opionions on
> the newsgroup?

Urology. 2003 Oct;62(4):614-7.
Levofloxacin for chronic prostatitis/chronic pelvic pain syndrome in
men: a randomized placebo-controlled multicenter trial.

(snip rest of study)

TY for the above study. It points to the fact that antibiotic's are not
helpful for many of us. But, with that being said, I have some question's.
What can we really conclude from that multicenter trial when in this older
study below ciprofloxacin, ( which is the most popular antibiotic prescribed
for CPPS patients, and in the very same family as levaquin ), apparently
does not even reach minimal inhibitory concentration's in the prostate to be
effective against Pseudomonas, enterococci and staphylococci? As many of you
are aware, enterococci and staphylococci are two of the most common isolates
cultured from prostatic secretions and is often the main reason men are
prescribed Flouroquinolone's like levaquin in the first place. If it's true,
what can really be learnt from this study, ( besides the need to avoid
recklessy prescribing antibiotics to CPPS patients ), if levaquin acts the
same way as ciprofloxacin and cannot sufficiently meet the minimal
inhibitory concentration level's to be fully fully effective against
Pseudomonas, enterococci and staphylococci?

J Urol. 1993 Nov;150(5 Pt 2):1718-21.  Related Articles, Links

Penetration of ciprofloxacin into prostatic fluid, ejaculate and seminal
fluid in volunteers after an oral dose of 750 mg.

Naber KG, Sorgel F, Kinzig M, Weigel DM.

Urologic Clinic, Elisabeth Hospital, Straubing, Germany.

To evaluate an effective dose for the treatment of bacterial prostatitis the
concentrations of ciprofloxacin were measured in prostatic fluid, ejaculate
and the cell-free seminal fluid of 15 healthy volunteers who received an
oral dose of 750 mg. ciprofloxacin while in a fasting state. Venous blood
samples were taken in all subjects at 1, 2, 3 and 4 hours. In 6 subjects
blood samples were also taken after 8 and 12 hours. Urine was collected in
all subjects during 0 to 4 hours and in the 6 subjects also during 4 to 8
hours and 8 to 12 hours. Prostatic fluid could be obtained in 10 subjects by
prostatic massage 4 hours after drug intake. So as not to contaminate the
urethra with ciprofloxacin the subjects were not allowed to void until 4
hours after drug intake. Iopamidol (3.162 gm.), a renal contrast agent, was
administered intravenously concomitantly with oral ciprofloxacin intake.
After 8 hours iohexol (3.235 gm.) was administered intravenously. These
agents were measured in prostatic fluid, ejaculate and seminal fluid to
assess the contamination of those fluids by urine. All drug measurements
were done by high pressure liquid chromatography. The median plasma
concentrations of ciprofloxacin were 2.1 mg./l. at 1 hour (maximum
concentration), 0.9 mg./l. at 4 hours and 0.2 mg./l. at 12 hours. The median
concentration in prostatic fluid was 0.23 mg./l. with a fluid-to-plasma
concentration ratio of 0.23. The median concentration in the ejaculate
(seminal fluid) after 4 hours was 7.4 mg./l. (6.6 mg./l.) and after 12 hours
it was 2.0 mg./l. (1.9 mg./l.) with corresponding ejaculate (seminal
fluid)-to-plasma concentration ratios of 8.4 (7.7) and 8.0 (6.6),
respectively.

Thus, ciprofloxacin is concentrated several-fold in ejaculate and seminal
fluid but not in prostatic fluid. According to the results the
concentrations of ciprofloxacin in prostatic fluid exceed the minimal
inhibitory concentration-90% for Enterobacteriaceae but not for Pseudomonas,
enterococci and staphylococci, whereas the concentrations in ejaculate and
seminal fluid are sufficiently elevated to include the total spectrum of
sensitive strains causing bacterial prostatis.

PMID: 8411457 [PubMed - indexed for MEDLINE]

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niceshyguymiami - 14 Oct 2003 07:37 GMT
>Thus, ciprofloxacin is concentrated several-fold in ejaculate and seminal
>fluid but not in prostatic fluid. According to the results the
[quoted text clipped - 5 lines]
>
>PMID: 8411457 [PubMed - indexed for MEDLINE]

80% of the ejeculate is made up of prostatic fluid?
niceshyguymiami - 14 Oct 2003 07:26 GMT
>Isn't it great to have real facts rather than misguided opionions on
>the newsgroup?

Yea guess so - that is if you can fken spell  "opinions"

BAHAHAHAHAHAHAHAHA !!!!

Prosta-Q causes anal warts.
AndrewsFunk - 27 Oct 2003 04:45 GMT
>Prosta-Q causes anal warts.

Only if it is inserted directly into the rectum, and I'm sure you would know
all about that.
 
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