How Safe Are Oral Hydrolytic Enzyme?

Clinical research and physicians using oral hydrolytic or proteolytic enzymes usually emphasized the relative freedom from serious side effects found after administration of these compounds. After to many physicians and clinical investigators experienced in the use of the oral hydrolytic enzymes, and to patients, the enzymes are exceptionally well tolerated. The side effects generally noted are quite mild and include mild gastrointestinal irritation, such as intestinal bloating, loose bowels, and peculiar acrid smell of stool and in some cases, itching in the perinal area.

Some patient noted mild sedation, loss of appetite and weight lose. No serious and life threatening problem have been observed after oral preparations. Rare allergic reactions have been noted after injectable preparations and after administration via enemas. One patient reported by a Dutch group (De Smet) was treated with an injectable preparation containing and enzyme mixture.

It was reported that the patient developed circulatory socks immediately after the injection and this was interpreted as an allergic reaction to the enzyme reaction to the enzyme mixture. Subsequent evaluation of this incident raised doubts as to the enzymes having caused the reaction and instead incriminated the use of the procaine administered with the enzyme mixture. The patients reportedly refused to participates in a comprehensive evaluation by an allergist and the issue was not resolved any further.

Extensive toxicological studies have been conductive. No median lethal dose (LD50) could be determined when given by mouth. No taratogenic, mutagenic or carcinogenic effect were noted at dosages substantially higher then the standard therapeutic dosages.

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