Efficacy and tolerance of oral enzyme therapy in chronic prostatitis
Results of a double-blind therapy study
Schlüter P.
General Practice, Hemsbach, Germany
European Journal for Infectious and Immunological Diseases 1998, 2, 57-69.
Key words: Chronic prostatitis - bacterial prostatitis - abacterial prostatitis - enzyme preparation
Summary
An orally applied enzyme preparation Phlogenzymâ
of bromelin, trypsin and the flavonoid rutosid was tested for efficacy
and tolerance in chronic prostatitis. The therapy test was conducted
as a randomized double-blind clinical trial in a group of 80 voluntary
men aged between 18 and 72 years who were recruited from the investigating
general practitioner's clientele of patients after they had declared
their informed consent. The group was divided up into two of 40 test
persons each: an ''enzyme group" and a "placebo group". The two groups
were subdivided into strata with bacterial prostatitis and abacterial
prostatitis.
For the test-therapy period of four weeks each patient received 180
"enzyme tablets", either active tablets or placebo in all, to take 2
tablets t.i.d. (6 tablets per day). The patient's compliance to the
test therapy was established by count of the tablets he returned after
four weeks.
Through six examinations altogether - the first at the beginning of
a patient's test period, then four follow-ups every week after baseline
and a final one four further weeks later - the course of pain and symptoms
characteristic of prostatitis was documented. At the same occasions
urinalyses and palpation's of the prostate's consistence were done additionally,
whereas adverse events were recorded and treated only at the four follow-up
recalls in between baseline and final examination.
A sum score calculated from the degrees of severity of the various kinds
of pain and symptoms after two weeks of therapy was defined as the main
endpoint for statistical evaluation. As secondary criteria the courses
of pain and symptoms, also of the prostate's consistency and of the
urinalyses during the four-week test therapy were evaluated descriptively,
together with the global judgements of the therapy's efficacy and tolerance
by the physician and the patient. The laboratory parameters of the patients
at beginning and end of the therapy as well as the patients' outcome
from adverse events which occurred during that period, were documented
and evaluated as safety variables.
A level of 5 % for the significance of differences was defined as model
of the statistical test. The comparability of the groups at baseline
and the differences between them in the reactions to the test therapy
were statistically evaluated by the Wilcoxon-Mann-Whitney U-test.
The main endpoint as well as the secondary-criteria endpoints showed
statistically significant differences (p < 0.05) between the test
groups and the strata within them. The Mann-Whitney estimators allow
the conclusion of a superiority of the enzyme preparation; the relevant
difference was big in all patients and in the patients with abacterial
prostatitis, medium in patients with bacterial prostatitis. Urinalyses
improved in all patients, laboratory parameters remained unchanged mostly
and improved in some cases.
As judged by the physician and the patients, the efficacy of the therapy
was "very good" to "good" in the enzyme group and "moderate" to "unsatisfactory"
in the placebo group. The tolerance was judged as "very good" to "good"
in the enzyme group and "good" in the placebo group. Adverse events
were documented in 25 patients of the enzyme group (mainly gastrointestinal
complaints or inflammations) and in 15 patients of the placebo group
(mainly inflammations), mostly judged as "moderate" and in all cases
treated symptomatically. The patients' outcome was without damage.
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