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. 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. Journal of Clinical Research 1998, Vol.1, pp. 87-102. PZ 12 (16-08-1). Allergist / Phlebologist / Sports Medicine, Egenhofenstrasse 18, D-82152. Planegg, Germany.
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