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Efficacy and tolerance of oral hydrolytic enzymes in ankylosing spondylitis as compared with indomethacin: a controlled double-blind prospective clinical trial

Baerwald CH., Willeke A., Lies S., GoebelK-M.1

1 Clinic for Rheumatic Diseases, Bad Endbach, Germany

Journal of Clinical Research 1999, Vol. 2, pp. 17-34, ISSN 1369-5207

MU 16 (3-13-1)

Summary

The high prevalence of ankylosing spondylitis, the burden of suffering patients, socio-economically relevant disability times up to premature retirement, side-effects of present therapies as well as first positive results of a pilot study on the complaints encouraged us to start a randomised double-blind clinical trial with two parallel groups.

 Our aim was to compare an oral enzyme combination preparation with indomethacin in terms of efficacy (clinical symptoms, especially pain), tolerance and side effects. Two groups of 20 patients were treated for six months. They were examined clinically and questioned for efficacy and tolerance at baseline (day of inclusion), then after one week, one month, two, four and six months. There was a significant difference for the Mann-Whitney statistic (95% confidence interval 0.73 - 1.00; p<0.0001) in favour of the enzyme group with the main criterion being the sum score of pain items after six months. The most important descriptively evaluated single pain data, also showed similar differences at end of therapy. It was noticeable that indomethacin demonstrated a marked initial improvement, which lessened afterwards, whereas the enzyme combination showed a continuous improvement until the end of therapy, with superiority over indomethacin. These results permit the assumption that the tested clinical symptoms are positively influenced by the enzymes. The merely mild and transient adverse events with enzyme therapy suggest that it is suitable for long-term treatment. As efficacy becomes apparent after some time, but then substantially better, a combination with NSAIDs might be considered during the first two months.