A double blind, randomised, parallel group study on the efficacy and safety of treating acute lateral ankle sprain with oral hydrolytic enzymes.
Kerkhoffs GM, Struijs PA,
de Wit C, Rahlfs VW, Zwipp H, van Dijk CN. A double blind,
randomised, parallel group study on the efficacy and safety of
treating acute lateral ankle sprain with oral hydrolytic enzymes. Br
J Sports Med. 2004 Aug;38(4):431-5.
Orthopaedic Research Center Amsterdam, Department of Orthopaedic Surgery,
Academic Medical Center, University of Amsterdam, the Netherlands.
OBJECTIVE: To compare the effectiveness and safety of the triple
combination Phlogenzym (rutoside, bromelain, and trypsin) with
double combinations, the single substances, and placebo.
DESIGN: Multinational, multicentre, double blind, randomised,
parallel group design with eight groups structured according to a
factorial design.
SETTING: Orthopaedic surgery and emergency departments in 27European
hospitals.
PARTICIPANTS: A total of 721 patients aged 16-53 years presenting
with acute unilateral sprain of the lateral ankle joint.
PRIMARYEFFICACY CRITERIA: (a) Pain on walking one or two steps, as
defined by the patient on a visual analogue scale. (b) The range of
motion, as measured by the investigator and expressed as a sum of
flexion and extension. (c) The volume of the injured ankle measured
with a volometer.
RESULTS: At the primary end point at seven days, the greatest
reduction in pain was in the bromelain/trypsin group(73.7%). The
Phlogenzym group showed a median reduction of 60.3%, and the
showed a median reduction of
73.3%. The largest increase in range of motion median) was in the
placebo group (60% change from baseline). The Phlogenzym group
showed a median increase of 42.9%. The biggest decrease in swelling
was in the trypsin group (3.9% change from baseline). The Phlogenzym
group showed a-2.30% change from baseline and the placebo group a
-2.90% change. In the subgroup analysis of patients who did not use
a Caligamed brace, Phlogenzym was superior to placebo for the
summarising directional test of the primary efficacy criteria (MW =
0.621; LB-CI 0.496; p = 0.029; one sided Wei-Lachin procedure).The
vast majority of doctors and patients rated the tolerability of all
treatments tested as very good or at least good.
CONCLUSIONS: Phlogenzym was not found to be superior to the three
two-drug combinations, the three single substances, or placebo for
treatment of patients with acute unilateral sprain of the lateral
ankle joint. The small subgroup of patients treated without the
support of a Caligamed brace showed evidence of superiority of
Phlogenzym over placebo. Further research is warranted to study this
effect of Phlogenzym in patients treated without ankle support.
PMID:
15273178
Link to Full text Article
on PubMed Central:
PMC 15273178