Efficacy and tolerance of oral enzyme therapy in chronic prostatitis
Results of a double-blind therapy study

Schlüter P.

General Practice, Hemsbach, Germany

PZ 15  (5-07-3)

Czech translation of abstract

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.