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.
M.W. Kleine
Allergist / Phlebologist / Sports Medicine, Egenhofenstrasse 18, D-82152 Planegg, Germany.
Journal of Clinical Research 1, 1998, 87-102
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 (Phlogenzym®) 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.
Keywords: hematoma, enzymes, pain, trauma, anti-inflammatory, analgesic
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