Efficacy and tolerability of proteolytic enzymes as an anti-inflammatory
agent in lymphoedema after axillary dissection due to mammary cancer
Lymphoedema is a chronic disease
caused by the damage of lymphatic vessels due to surgical treatment
and/or radiotherapy (secondary). Another cause is the malformation or
lack of lymphatic vesels (primary).
The aim of the study was to demonstrate the efficacy and tolerability
of the proteolytic enzyme combination preparation Wobenzym in additional
reduction of arm volume (primary criterion) in patients with secondary
lymphedema after dissection of axillary nodes due to mammary cancer.
Secondary criteria were improvement of the skinfold thickness, CRP values,
tension, and global judgement of the efficacy by both investigator and
patient.
The study population comprised of 88 female patients aged between 30
and 80 with one sided secondary arm lymphedema after dissection of the
axillary lymph nodes (level I or II according to the St. Gallen consensus
conference) due to mammary cancer, who have been treated with combined
decongestive therapy. All patients received the standard treatment -
a combined decongestive therapy, comprising the manual lymphatic drainage
on affected sites with consecutive bandaging of the affected arm and
specially designed exercises and skin care from day 1 to day 20. The
test group of patients received additionally Wobenzym at a dose of 5
coated tablets three times daily over 6.5 weeks.
Both treatment groups were well comparable. The median time between
the lymph node dissection and the baseline visit was 47.5 months in
the Wobenzym group and 48 months in the placebo group.
For measuring the indicator
volume reduction in arm lymphedema, a Volometer was used. For the indicator
tension, a four point rating scale was used. All the measurements were
carried out on days 1, 9, 19, and 45 (final visit). CRP value was measured
on days 1 and 19.
On the ill arm both groups showed a decrease of volume until visit 4
(day 45). Both groups showed an almost identical course of the volumetric
development between baseline visit and final end point visit, although
there was a slight superiority of Wobenzym for the development between
visit 3 and 4 with regard to the percent changes of –5% and more without
statistical significance.
Both groups showed the greatest decrease of skinfold thickness between
visits 2 and 3 with a very similar development between baseline visit
and final visit with regard to the results of the ill arm.
The results of the percent changes from baseline with regard
to visit 2, 3, and 4 showed a mean reduction by –29.84% for the verum
group and –15.73% for placebo group. The development between visit 3
and 4 showed only slight superiority for the verum group.
Both groups showed an almost similar decrease of tension in the ill
arm until visit 4. A percent change of 100 % (total improvement) was
reached by 62.79 % patients in the Wobenzym group and by 47.62 % patients
in the placebo group. The percent changes between visits 3 and 4 – time
where no concomitant combined decongestive therapy was applied – showed
a clear superiority of the Wobenzym treated patients.
CRP was measured at visit 1 (baseline) and 3 (day 19). Wobenzym group
showed better results than placebo group with regard to the CRP development
between baseline visit and visit 3: out of 15 patients with high baseline
findings five patients normalized in the Wobenzym group. Out of 13 patients
with high baseline findings in the placebo group, only one patient normalized.
For patients with high CRP-values at baseline there has been mean percent
change from baseline of –39.8%, while in the placebo group –17.4%. There
was a clear superiority for the verum group with regard to the CRP development
between visit 1 and 3.
Overall, 15 adverse events were recorded, 7 for the verum group and
8 for the placebo group. The adverse events in the verum group were
all gastrointestinal complaints of moderate intensity and rated as possibly
(6 cases) or definitely (1 case) related to the study medication. All
the patients showing adverse events completely recovered without sequelae.
All in all, the study failed to demonstrate efficacy in edema-related
criteria (most likely due to extensive concomitant physical therapy
in all patients) but demonstrated efficacy of Wobenzym with regard to
the inflammation-related criteria. The inflammation-related criteria
showed more than small superiority of Wobenzym. Moreover, for the subgroup
“no chemotherapy” the inflammation-related criteria showed more than
medium-sized superiority of Wobenzym. Reduced inflammatory tissue conditions
are the basis for minimizing fibrosis thus preventing further inflammation
and infection.
Source: The European Journal of Lymphology,
2002-2003, 10 (37-38), 18-26,
author:
Lék pro vnitřní užití. Čtěte pečlivě příbalovou
informaci.
Inzertní stránky společnosti MUCOS Pharma CZ, s.r.o. - tel: (+420)-267 750
003