Phlogenzym® in
the Treatment of Chronic Prostatitis
Schlüter, P. Phlogenzym® in the
Treatment of Chronic Prostatitis. PharmaScript, Primelweg 2, D-82538
Geretsried, Germany Date of report: October 30th, 1997.
Synopsis
Objectives: To test efficacy and tolerance of Phlogenzymâ as
compared with placebo.
Methodology: Double-blind, randomised study with parallel groups.
Sum score calculated of different kinds of pain and symptoms (perineal
pain, lumbar pain, inguinal pain, testicular pain, defecation pain,
fever, miction, stranguria, dysuria, nycturia, burning when
urinating) after two weeks of treatment. Stratum 1: patients with
bacterial prostatitis; stratum 2: patients with abacterial
prostatitis.
Number of patients: Planned 80; included 80; evaluated 80
Diagnosis and main criteria for inclusion: Patients with bacterial
or abacterial chronic prostatitis.
Test product, dose and mode of administration: Phlogenzym: 90 mg
bromelin, 48 mg trypsin, 100 mg rutosid x 3 H20, 2 tablets orally
t.i.d. (= 6 tbl. per day).
Duration of treatment: 4 weeks
Reference therapy, dose and mode of administration: Placebo tablets,
2 tablets orally t.i.d. (= 6 tbl. per day)
EFFICACY: Main endpoint: sum score after 2 weeks of treatment
SAFETY: Global judgement of tolerance (by physician and patients);
laboratory findings, adverse events
STATISTICAL METHODS: To test comparability of groups: Wilcoxon-Mann-Whitney
(two-tailed); to test difference of endpoints: Wilcoxon-Mann-Whitney
with Mann-Whitney estimator (one-tailed) calculated with 95%Cl;
diff. in number of adverse events: Fisher`s exact test (two-tailed).
SUMMARY - CONCLUSIONS
EFFICACY RESULTS:
Evaluating all patients the difference between the groups was
statistically significant on the 0.01% level. The
Mann-Whitney-statistics P(X<Y)+0.5P(X=Y) was 0.7987 and showed a big
relevant difference for the enzyme preparation. In patients which
bacterial prostatitis the statistical significant difference was on
the 1 % level in favor of the enzyme preparation. The Mann-Whitney-stastistics
(0.7833) has proven big superiority. In patients with abacterial
prostatitis the difference was statistically significant on the 0.01
% level, the Mann-Whitney-stastistics (0.8333) showed big
superiority of Phlogenzymâ.
SAFETY RESULTS:
The tolerance of the enzyme preparation was assumed better than
placebo, in all judgements was a statistically signficant
difference. Nevertheless, in the enzyme group more adverse events
occurred than in the placebo group (enzyme group: 25 a.e., placebo
group: 15 a.e.). The difference was statistically significant in
favor of the placebo group on the 5% level. In laboratory findings
no remarkable deteriorations were noticed.
CONCLUSIONS
The results of this study show that the enzyme preparation
Phlogenzym® is an efficient and excellently tolerated drug in
treatment of both bacterial and abacterial prostatitis.
Date of the report: October 30th, 1997
SUMMARY
In this double-blind clinical study efficacy and tolerance of
Phlogenzym® was tested in patients with chronic prostatitis. It was
compared with placebo.80 patients were planned, 40 patients received
the enzyme preparation Phlogenzym® (enzyme group), and 40 patients
placebo (placebo group). The recruited patients were subdivided into
strata with bacterial prostatitis and abacterial prostatitis. In the
enzyme group 17 patients had a bacterial and 23 an abacterial
prostatitis and in the placebo group 19 patients were treated
because of a bacterial and 21 because of an abacterial prostatitis.
The data of all patients was evaluable.
The trial was carried out by Peter Schlüter, M.D., Gartenstrasse 16,
D69502 Hemsbach, Germany.
Each patient received 2 tablets t.i.d. (i.e. 6 tablets per day) of
the "enzyme tablets". In one group (enzyme group) the patients
received Phlogenzym® and in the other group (placebo group) placebo
tablets.
At baseline the patients were comparable with regard to age, height,
weight (except the patients with abacterial prostatitis),
manifestation of current prostatitis, last relapse, manifestation of
the 1st prostatitis, and frequency of relapses in the previous year
(except the patients with bacterial prostatitis): p > 0.05, Wilcoxon-Mann-Whitney-U-test.
As main endpoint for statistical evaluation a sum score calculated
from perineal pain, lumbar pain, inguinal pain, testicular pain,
defecation pain, fever, miction, strangury, dysuria, nycturia and
burning when urinating after two weeks of therapy was defined.
As secondary criteria the various kinds of pain and symptoms, the
consistency of the prostate, the state of the urine, the adverse
events, and the global judgements by the physician and by the
patients were evaluated descriptively.The main endpoint showed
statistically significant differences (p > 0.05) in the evaluation
of all patients and of the strata with both bacterial prostatitis
and abacterial prostatitis. The Mann-Whitney statistics allow the
conclusion of superiority of the enzyme preparation, in all patients
and in patients with abacterial prostatitis there was a big relevant
difference (Mann-Whitney statistics: > 0.71 ), and in patients with
bacterial prostatitis there was a medium relevant difference
(Mann-Whitney statistics: > 0.64).
The secondary endpoints perineal pain, testicular pain, miction,
strangury, and nycturia were significantly better in the enzyme
group in all patients, and in both strata. Inguinal pain and dysuria
were significantly better in the enzyme group in all patients and in
abacterial prostatitis. Defecation pain was better in the enzyme
group in all patients and in bacterial prostatitis. Inguinal pain
was significantly better in the placebo group in bacterial
prostatitis.
The urinalysis (tested by test strips: leukocytes, erythrocytes,
protein, and sediment) improved in all patients. In the tested
laboratory parameters (creatinine, urea, Quick-value, gGT, AST, ALT,
a1-antitrypsin, a2-macroglobulin, C-reactive protein, ceruloplasmin,
a1-glycoprotein, haptoglobin, fibrinogen, total protein, albumin,
a1-globulin, a2-globulin, b-globulin, g-globulin, IgG, IgA, IgM)
only seven values deteriorated within a limit of ± 15%, all other
values remained unchanged or improved.
The efficacy of the drug was judged in the enzyme group by the
physician and by the patients as "very good" to "good". In the
placebo group the physician and the patients judged the efficacy of
the drug as "moderate" to "unsatisfactory".
There were statistically significant differences between the groups
(p < 0.0001 ).
The tolerance of the drugs was judged by the physician and by the patients in the enzyme group as "very good" to "good" and in the placebo group as "good". There were statistically significant differences between the groups (p < 0.05).Adverse events were documented in 25 patients in the enzyme group (mainly gastro-intestinal complaints or inflammations), and in 15 patients in the placebo group (mainly inflammations), most of them not related to the test drug. They started on average after 16.8 days in the enzyme group and after 18.3 days in the placebo group. The duration was 6.4 days in the enzyme group and 7.5 days in the placebo group. They were judged as "moderate" in both groups. The patient's outcome was without damage. The difference between the groups was statistically significant in favor of the placebo group (p < 0.05).