Prostatitis
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In men, Wobenzym® is a very efficient therapy for both bacterial and abacterial prostatitis, and also relieves the sexual dysfunction that typically accompanies prostate diseases. From FREQUENTLY ASKED QUESTIONS, with answers by Joseph J Collins, RN, NDRead the special section: HORMONES & WOBENZYM® |
What
the literature says about Systemic Enzyme Support and:
Prostatitis
& Copulatory Dysfunction due to Prostatitis
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
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).
Poster Reference number 57.
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. PZ 15 (5-07-3)
[Czech]
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
Special treatment of patients suffering from a mixed copulatory
dysfunction with interoreceptive syndrome.
Izbasarov A.I., Ismoldaev E.S., Khusainov T.E. Special treatment of
patients suffering from a mixed copulatory dysfunction with
interoreceptive syndrome. 3rd Urology Congress of Khazakhstan May
25-26, 2000, Almaty. [Russian, Czech]
A total of 38 patients suffering from a mixed copulatory dysfunction
were recruited into the trial. Twelve of them were at the age
ranging from 20 up to 30 years, fourteen at the age from 31 to 40
years, eight at the age from 41 to 50 years and four at the age from
51 to 60 years. Microbiological investigation of a prostate secreta
revealed following microbial agents: E.coli in 14 patients (36,8%),
Trich. vaginalis in 10 patients (26,3%), Staph. aureus in 5 patients
(13,2%), Str.faecalis in 4 patients (10,6%), Proteus in 3 patients
(7,8%) and Klebsiella in 2 patients (5,3%). An impaired copulatory
function was observed. Libido was reduced in 8 patients, erection
was impaired in 38 patients (100%), ejaculation was impaired in 12
patients (31,6%). At the first stage of the treatment, antibiotics
were administered according to the results of the investigation of a
microbial agents susceptibility.
In order to minimize the ts of antibiotic side effects, a
combination enzyme preparation Wobenzym was included into the
treatment. Its antiflogistic and immunomodulatory effects have been
reported (Repina A.M., 1997). The patients were divided into two
groups, each consisting of 19. The first group was treated with
antibiotic ( and in some cases antiprotozoic ) drugs in combination
with Wobenzym in doses 3 - 5 tablets three times a day 30 - 40
minutes before meals for 2 - 3 weeks. The second one group was
treated without Wobenzym. The treatment was more succesful in the
enzyme group ( 89,5% of recovery) in comparison to the control one (
68,4% of recovery). The second stage of the treatment was concerned
in a removal of psychogenic syndrome by means of psychotherapy and
psychotropic drugs.
In summary the libido increased in all 38 (100%) patients, erection
was improved in 32 (84,2%) patients and a positive therapeutic
effect was achieved in 29 (75%) patients suffering from the impaired
erection.
Poster Reference number 59.
Systemic and local enzyme therapy used in combination with
transurethral drainage of prostate in patients with obstructive
forms of chronic prostatitis.
Guskov A.R., Bogatcheva I.D., Iatsevitch G.B. Systemic and local
enzyme therapy used in combination with transurethral drainage of
prostate in patients with obstructive forms of chronic prostatitis.
Urologia i nefrologia 1998, No. 6, pp. 37- 42. [Russian and Czech]
In our study, we focused on the complex treatment by a transurethral
drainage and use of proteolytic enzymes, thus aiming to lyse the
"plugs" and to diminish the viscosity of inflammatory products. This
could, by our opinion, significantly accelerate restoration process
of the affected organ. Aim of the presented work - to study the
effect of combined systemic (Wobenzym) and local (in situ
electrophoresis of trypsin and chymotrypsin) enzyme therapy on the
efficacy of transurethral prostate drainage (electrostimulator-aspirator
"Intraton-4") in patients with chronic prostatitis and to
investigate its mechanism.
530 patients with chronic prostatitis were observed. Examinations
and treatment were done at the out-patient clinic. All patients
underwent, besides general clinical examinations, analysis of urine
in two portions, test on pathogenic microflora, gonococcus,
trichomonad, chlamydia, mycoplasma, ureaplasma using direct and
indirect fluorescence, and also diagnostics of urethral infections
using PCR. Patients with clinical signs of acute urethritis received
anti-inflammatory therapy with regard to the manifested pathogenic
microflora.All patients were subject to the ultrasound (US)
examination of prostate using polypositional rectal apparatus "Pie
Medical" (transurethral ultrasound examination) (8). Patients were
US monitored during treatment. Patients with the presence of
microabscesses and "pseudomicroabscesses" in the prostate were
subject to the complex therapy including transurethral vacuum
drainage of prostate ("Intraton-4") combined with in situ
electrophoresis (urethral, rectal, or urethro-rectal) of trypsin and
chymotrypsin and Wobenzym administration - 5 dragees 3 times a day.
A positive restoration dynamics in patients without Wobenzym reached
100% after 30 days of treatment, while in Wobenzym-treated patients
the same result was obtained after 20 days.
A complete prostate drainage (disappearance of microcavities of
irregular and drop-like form on US) after 20 days of treatment
without systemic enzyme therapy was achieved in 52% of patients,
while in Wobenzym-treated patients - in 88.2%. We show a case report
of US data - patient X., aged 28 years.
The most important are comparison results of prostate drainage
intensity in both groups of patients over the first 10 days of
treatment. In the group without systemic enzyme therapy, a complete
drainage of prostate was achieved in just 5% of patients, while in
the Wobenzym-treated group - in 47.2 % of patients, i.e. nearly 10
fold.