Wobenzym®
in the Treatment of Chronic Pelvic Inflammatory Disease
Friedrich, F.
Wobenzym® in the Treatment of Chronic Pelvic Inflammatory
Disease. Study NR.: MU-89210. Germany Report provides through:
PHARMASCRIPT, Kathi Kobus increase 1, W-8190 Wolf-advice-live, to
Germany Report: 30. 5. 1989.
Summary: This study was carried out as a randomised, double blind
clinical trial with parallel groups and active control. The aim was
to prove, whether efficacy and tolerance of WOBENZYM® are comparable
to Diclofenac in patients with chronic pelvic inflammatory disease
(PID).
44 female patients with anamnestically and laparoscopically verified
chronic PID were taken into this study. The data of 40 patients were
evaluable.The study was carried out by Univ. Prof. Prim. Florian
Friedrich, M.D., City Hospital, Spitalgasse 10, A-3580 Horn,
Austria.The patients of the enzyme group were given 5 enteric coated
tablets WOBENZYM® and 2 capsules placebo t.i.d., the patients of the
Diclofenac group 5 tablets placebo and 2 capsules with 50 mg
Diclofenac each t.i.d. ("double dummy" method). The drugs were
randomised and blinded. Duration of therapy was 3 weeks.At start of
the trial the patients were comparable with response to age, height,
weight, pain on motion, pain under pressure, abdominal defence,
abdominal pain, micturition difficulties and painful defecation.
Main criterion for statistical evaluation was a sum score computed
from the symptoms gynecological palpation (pain under motion, pain
under pressure, abdominal defence), ESR score and WBC score at end
of therapy.
Secondary criteria were the objective and subjective variables
according to the CRF like general condition (abdominal pain,
micturition difficulties, painful defecation) and C-reactive
protein. The statistical tests were calculated on equivalence
between both treatment groups.
There was no statistical difference between the both groups after 3
weeks of therapy in the main and secondary criteria (p > 0,05).
The physician judged the efficacy of the therapy after three weeks
in the enzyme group as 1.9 ("good") and in the Diclofenac group as
1.6 ("good"); the judgement of the patients was 2.0 ("good") in each
group. The tolerance of the tested drugs was judged by the physician
as 1.9 ("good") in the enzyme group and as 1.7 ("good") in the
Diclofenac group, by the patients as 2.1 ("good") in the enzyme
group and as 1.8 ("good") in the Diclofenac group.
Adverse events were documented in three patients (13.6%) of the
Diclofenac group only. Two of the adverse events were
gastro-intestinal comp1aints, in one case a blepharedema was
documented. The onset was between the 1st and the 8th day of therapy
and the mean duration was 7.3 days. Severity of the adverse events
was 2.0 ("moderate") on average.
