Efficacy and tolerance of oral enzyme therapy in chronic prostatitis: Results of a double-blind therapy study.
Schlüter P. Efficacy and tolerance of
oral enzyme therapy in chronic prostatitis: Results of a
double-blind therapy study. European Journal for Infectious and
Immunological Diseases 1998, Vol. 2, pp. 57-69
Summary: An orally applied enzyme preparation Phlogenzym®
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.
Key words: Chronic prostatitis - bacterial prostatitis - abacterial prostatitis - enzyme preparation