Enzyme Therapy with Wobenzym® or Phlogenzym® in Ankle Joint Distortion (MU-91411)
Principal Investigator: Rahn
Hans-Dieter, M.D. Enzyme Therapy with Wobenzym® or Phlogenzym® in
Ankle Joint Distortion. Efficacy and Tolerability. Study-No.:
MU-91411. Three-armed randomized double-blind parallel group study vs. Placebo.
Integrated statistical and medical final report according to FDA and
CPMP guidelines. Surgical Clinic of Dr.-Horst-Schmidt Hospitals,
Ludwig-Erhard-Strasse 100, D-65199 Wiesbaden, Germany. Evaluation
by: MUCOS Pharma GmbH & Co, Clinical Research Dept., Kirchplatz 8,
D-82538 Geretsried, Germany. Report prepared by: PharmaScript,
Kathi-Kobus-Steig 1, D-82515 Wolfratshausen, Germany
Summary
This study was a randomised double blind clinical trial with three
parallel groups. The aim was to prove the antiinflammatory and
antiedematous efficacy and the tolerance of Wobenzym® and
Phlogenzym® compared with placebo in patients with
lateral ankle joint distortions.
60 (3x20) patients with traumatic induced swelling and pain of an
ankle joint were taken into this study. The data of all patients
were evaluable.
The study was carried out by Hans-Dieter Rahn, M.D., Chirurgische
Klinik der Dr. Horst-Schmidt-Kliniken, Ludwig Erhard-Strasse 100,
D-65199 Wiesbaden, Germany.
The patients got 10 enzyme tablets t.i.d. In the Wobenzym®
group they received actually 30 enteric coated tablets Wobenzym®, in
the Phlogenzym® group 6 enteric coated tablets of
Phlogenzym® plus 24 tablets placebo and in the placebo group 30
tablets of placebo.
The drugs were randomized and blinded. The therapy lasted ten days.
At baseline the patients were comparable with response to age, sex,
height, weight. swelling, joint effusion, rest pain, pain on motion,
extension and flexion of the ankle joints (p > 0.05).
As main criterion for the statistical evaluation the swelling at the
7th day was chosen. For evaluation the differences of the swelling
of the injured to the healthy ankle joint at the 7th day were
evaluated statistically.
Secondary criteria were the variables motility, joint effusion and
pain at the 7th day.
There was a significant difference after seven days of therapy for
the enzyme treated groups in the main and secondary criteria. The
swelling was reduced in the Wobenzym® group by 52.4%, in
the Phlogenzym® group by 58.3% and in the placebo group
by 19.0%. At the start of the trial there was no statistical
difference between the three groups (p > 0,05), therefore the
significant difference at the 7th day (Phlogenzym®/placebo:
p = 0.012; Wobenzym®/placebo: p = 0.006; Wobenzym®/Phlogenzym®
: p 0.47) could be judged as significant better reduction of the
swelling in the enzyme treated groups than under placebo, whereas
there was no difference between the two enzyme preparations.
The motility improved until the 7th day by 63.1 % (Wobenzym®
group), by 72.7% (Phlogenzym® group) and by 39.1 %
(placebo group). The joint effusion was reduced by 61.5% (Wobenzym®
group), 73.3% (Phlogenzym® group) and 41.7% (placebo
group). The rest pain improved by 73.3% (Wobenzym®
group), 70.6% (Phlogenzym® group), 47.1 % (placebo group)
and the pain on motion improved by 46.2% (Wobenzym®
group), 57.1% (Phlogenzym® group), and 25.9% (placebo
group),
respectively.
The physician judged the efficacy of the drugs after seven days
therapy in the Wobenzym® group as 2.0 ("good"), in the
Phlogenzym® group as 1.7 ("good") and in the placebo
group as 3.0 ("moderate"); the patients judged it in the Wobenzym®
group as 2.0 ("good"), in the Phlogenzym® group as 1.8
("good") and in the placebo group as 2.9 ("moderate").
The tolerance of the drugs was judged by the physician after seven
days therapy in the Wobenzym® group as 2.1 ("good"), in
the Phlogenzym® group as 2.0 ("good") and in the placebo
group as 2.2 ("good") and by the patients in the Wobenzym®
group as 2.1 ("good"), in the Phlogenzym® group as 2.0
("good") and in the placebo group as 2.1 ("good").
Adverse events were documented in all three treatment groups. In the
Wobenzym® group five events were documented, in the
Phlogenzym® group six events and in the placebo group
four events. They were
located mostly in the gastrointestinal tract. The onset was between
the 1st and the 3rd day of therapy (Wobenzym® group = 2.4
days, Phlogenzym® group = 3.0 days and placebo group =
2.0 days), the mean duration 3.4 days (Wobenzym® group),
2.3 days (Phlogenzym® group) and 2.3 days (placebo
group). The severity of the adverse events was in all three groups
"mild" on average.