Phlogenzym as a pre- and postoperative anti-edematous therapy in patients with surgery for an implantation of an artificial knee joint (MU-692402)
Principal Investigator: Hans-Martin Fritsche,
M.D., Oberarzt. Phlogenzym® as a Pre- and Postoperative
Anti-Edematous Therapy in Patients with Surgery for an Implantation
of an Artificial Knee Joint. Efficacy and Tolerance. Study No.:
MU-692402. Clinical Study Report.
Double-blind randomized clinical trial phase III with parallel
groups versus diclofenac. Names of Test Drugs: Phlogenzym
enteric-coated tablets,diclofenac capsules. Study Initiation Date:
First patient entered study at November 22, 1994. Study Completion
Date: Last patient completed study at February 12, 1997. Name and
Affiliation of Principal Investigator: Hans-Martin Fritsche, M.D.,
Oberarzt.Kreiskrankenhaus Auenstrasse 6 D-82467.
Garmisch-Partenkirchen, Germany. Date of Report: September 30, 1998.
Reference (8)
Discussion and overall conclusion
In surgery for implantation of an artificial knee joint, the
post-operative course (swelling, motility, pain) can be improved by
application of anti-inflammatory and/or analgesic drugs. As
standard, non-steroidal anti-inflammatory drugs (NSAIDs) are used
very frequently. These drugs, however, often have (even severe)
side-effects. Sometimes they are not detected immediately, but can
lead to severe damage of the patients after some time, even deaths
are reported (e.g. several thousand per year due to
gastro-intestinal bleeding after oral intake of NSAIDs). Therefore,
alternatives are necessary which have similar effects, but a lower
risk for side-effects. As oral enzyme combination preparations have
already been tested against NSAIDs in other indications [8], and in
pilot studies also in knee surgery [3,5], we investigated the effect
of Phlogenzym® as compared with diclofenac.
Due to the small number of patients who could be recruited during an
acceptable time, only 40 patients could be included into the study.
Nevertheless, it was possible to prove statistical equivalence
between the two drug regimens. The course of the symptoms showed
also obviously that Phlogenzym® is comparable to diclofenac with
respect to all symptoms tested.
The better tolerability of Phlogenzym® was not seen in
this study. Diclofenac was also very well tolerated. It is known
that a short-term diclofenac treatment with the dose chosen does not
lead to obvious side-effects. As it was not possible to investigate
the patients by gastric tubes, hidden (and dangerous) side-effects
could not be detected.
The excellent tolerance of Phlogenzym® is known from
various studies and experience. With the same efficacy, the
benefit/risk-ratio has to be judged better for Phlogenzym®.
This enzyme preparation could be an effective and safer alternative
to NSAIDs in the post-operative rehabilitation phase.