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WAM Essentials, Inc.
Systemic Enzyme Therapy
... Allowing You to Live Your Passion!™ |
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Evidence of
the efficacy of an enzyme combination preparation using the
method of artificial hematomas in combination with a pressure
meter: A placebo controlled, randomised, prospective, double
blind study.
Kleine M.W.
Allergist / Phlebologist / Sports Medicine, Egenhofenstrasse
18, D-82152 Planegg, Germany.
Journal of Clinical Research 1998, Vol.1, pp. 87-102
PZ 12 (16-08-1)
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Summary
In a double-blind, placebo controlled, randomised study in
46 volunteer subjects with an artificially produced hematoma,
efficacy and tolerability of an oral enzyme combination
preparation was investigated. The hematoma
was produced by injecting 2 ml of the subject's own blood
just under the skin in the inner part of the forearm. Study
medication (2 tablets of the enzyme combination or placebo
t.i.d.) was given over 10 days. Tenderness and colouring
of the hematoma were measured during the entire study.
Numerous studies have proven that an artificial hematoma
is a reliable study model to provide evidence of the efficacy
of systemic antiinflammatory and analgesic drugs. Providing
evidence is very much improved by using a calibrated tonometer
to measure the individual threshold of tenderness. As to
the investigated primary endpoint, "difference of
the sums of the individual values of the thresholds of
pressure tenderness between the healthy and the hematoma
induced arm (kp/cm2) on days 1-10" there was a significant
difference in the mean value (p < 0.0001) in favour
of the enzyme therapy among the groups. Likewise, regarding
the descriptively evaluated secondary criteria "hematoma
remission", significant differences in favour of the
enzyme preparation were observed beginning with the 2nd
day of therapy. All in all tolerability was judged to be
very good. No adverse events were observed in either group.
Along with its very good tolerability the investigated
enzyme preparation accelerates the reduction of tenderness
and hematoma remission in the hematoma induced subjects.
On the one hand the results once more provide evidence
of the efficacy of the enzyme therapy. On the other hand
these results allow one to conclude that the investigated
preparation is an effective therapeutic agent for injuries
resulting in pain and hematoma. Apart from this the excellent
tolerability is an essential advantage compared with non-steroidal
antiinflammatory drugs which cause substantial side effects.
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Inc. All Rights Reserved.
None of the material contained herein may be reproduced without
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