US EPA

7021094 

Journal Article 

Short-term treatment of painful osteoarthritis of the knee with oral enzymes - A randomised, double-blind study versus diclofenac 

Klein, G; Kullich, W; , 

2000 

Yes 

Clinical Drug Investigation
ISSN: 1173-2563 

ADIS INT LTD 

NORTHCOTE 

15-23 

WOS:000085008700003 

Objective: To compare the short-term efficacy and tolerability of an oral enzyme therapy with the NSAID diclofenac in patients with symptomatic osteoarthritis of the knee (gonarthritis).Methods: In a double-blind clinical trial, 73 patients with painful gonarthritis were randomised to receive 3 weeks of treatment with an oral enzyme preparation (Phlogenzym(R)) containing bromelain, trypsin and rutin (n = 36), or the NSAID diclofenac (n = 37). Efficacy was primarily evaluated using the Lequesne index (measuring pain and function of the affected knee). Other investigations included assessment of pain symptoms using a visual analogue scale (VAS), global assess ment of efficacy and tolerability (by both patients and one physician), and various laboratory parameters. Patients were evaluated at baseline, at weekly intervals throughout the 3-week treatment period, and at 7 weeks (i.e. 4 weeks after discontinuing therapy).Results: The Lequesne index improved continuously in both groups: from 13.56 at baseline to 3.10 after 3 weeks (end of therapy) to 2.05 at 7 weeks (follow-up) in the enzyme group, and from 14.04 to 3.50 to 2.24, respectively, in the diclofenac group. Statistical evaluation showed the treatment groups to be equivalent; the lower bound of the 95% confidence interval of the Mann-Whitney estimator was above 0.44 (the limit for equivalence) at all time points. Global assessment of efficacy and tolerability of the drugs was 'very good' or 'good' for the majority patients.Conclusions: Short-term evaluation indicates that oral enzymes may be considered an effective and safe alternative to NSAIDs such as diclofenac in the treatment of painful gonarthritis.