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Use of oral enzymes in multiple sclerosis patients.

Mertin J.1, Stauder G., and the ESEMS working group. Use of oral enzymes in multiple sclerosis patients. Inter. Journal of  Tissue Reactions 1997, Vol. XIX , No.1/2, pp 95
7th Interscience World Conference on Inflammation, Antirheumatics, Analgesics, Immunomodulators, May 19-21, Geneva, Switzerland
 

Abstract: In 1986, a first report on a cohort of 300 multiple sclerosis (MS) patients treated with hydrolytic enzymes describes stabilizing of the disease and reduction of the relapse rate. These findings have been supported by case reports and by subjective patient reports. Soon it became clear that a stepwise approach was necessary, in order to prove whether oral enzymes are effective and safe in MS. As first step an open multicentric study was performed. An evaluation of the data showed hydrolytic enzymes to stabilize the neurological impairment and to improve activities of daily living. Now a randomized, prospective, double-blind, placebo-controlled study according to the European GCP-guidelines is going on. 300 patients from 23 European centres are included to randomly receive Phlogenzym or placebo in a daily dose of 3 tablets b.i.d. or 2 tablets t.i.d. over a period of 2 years. Progression rate, relapse rate, neurological signs and symptoms (incl. MRI), emotional status and unwanted side effects are main endpoints.
Some have already finished the treatment period. Results of that study will be available in early 1999. In case the enzymes prove to be superior over placebo a safe and inexpensive therapy in the management of MS would be available.