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Antibiotics offer little help in category IIIb patients

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May 2, 2001, 6:09:05 PM5/2/01
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Antibiotics offer little help in category IIIb
patients : Cure rate of 53% at 6 weeks drops
to 3% at 18 months following antibiotic
therapy.

Scott Tennant 04/01/2001 Urology Times

Arlington, VA--Patients with noninflammatory
chronic pelvic pain syndrome (category IIIb
prostatitis) showed little improvement over
placebo and experienced a high rate of
adverse reactions when treated with
antibiotics, a European study found.

Therefore, says one of the study's authors,
antibiotics should not be used in these
patients when 16S rDNA polymerase chain
reaction (PCR) is negative for the presence of
bacteria. "Perhaps we should re-think our
initial approach to category IIIb chronic pelvic
pain syndrome," said Jordan Dimitrakov, MD,
PhD, assistant professor of urology at the
Higher Medical Institute in Plovdiv, Bulgaria,
and currently a visiting professor at Justus-
Liebig University in Giessen, Germany.
"Before giving antibiotics, we might consider
a trial of antioxidants, such as quercetin."

There is little disagreement that chronic pelvic
pain can be frustrating for both patients and
clinicians. Opinions in the field vary widely.
Some experts believe the majority of patients
with category IIIb prostatitis, considered a
nonbacterial form of the condition, do in fact
have a microbial etiology for their disease,
while others contend that microbial invasion
is rarely to blame for the disorder, particularly
in patients with no demonstrable
inflammation.

Further confusing matters, Dr. Dimitrakov
noted, are clinical findings that many
asymptomatic patients not yet diagnosed with
prostatitis have had inflammation and
microorganisms identified in prostate tissue
specimens.

Adverse reactions

In an attempt to clear the air, Dr. Dimitrakov
and colleagues from the Higher Medical
Institute enrolled 100 patients in their study.
The patients had a median age of 21 years
(range, 18 to 45 years) and met the criteria
for category IIIb prostatitis.

Subjects were randomized to receive either
ciprofloxacin, 500 mg twice daily, or placebo.
Both treatments were administered for 6
weeks in combination with prostatic massage.
No patient received antibiotics in the 8 weeks
leading up to the study.

Culturing techniques and subsequent
analyses were fairly extensive. Patients were
evaluated using the Meares-Stamey four-
glass technique and a urethral swab. Samples
were then cultured aerobically for bacteria on
blood sheep and McConkey agar for 1 week,
and on Sabourad's media for detection of
fungal growth for 30 days.

To exclude the presence of fastidious and
non-culturable bacteria, all samples were
then immediately evaluated for the presence
of bacterial signal using three different
detection/assay kits--16S rDNA and RDA
(representational difference analysis) in
conjunction with mycoplasma-specific and
Mycoplasma genitalium-specific protocols.
Commercial ELISA kits evaluated
inflammatory activity.

"By definition, all patients had negative
microbiological results," Dr. Dimitrakov said.
"We found that the cure rate for ciprofloxacin
in these category IIIb patients dropped
dramatically from 53% at 6 weeks to just 3%
at 18 months. In fact, the percentage of
patients who benefited from placebo at 18
months was actually higher [5%] than the
antibiotic [2%]."

Even more striking was the incidence of
adverse reactions: 65% in patients taking the
antibiotic against 9% in those receiving
placebo. The most frequent side effects were
abdominal pain (25% of patients), arthralgia
(15%), diarrhea (10%), and vomiting (10%).

"This is an unacceptably high rate," said Dr.
Dimitrakov. "When you couple that with the
statistically insignificant overall improvement
versus placebo, we believe it's best to avoid
antibiotics in patients with noninflammatory
chronic pelvic pain syndrome."
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