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Treatment of fibrocystic mastopathy with hydrolytic enzymes

F.-W. Dittmarl, W. Luh2

lDepartment of Obstetrics and Gynecology, Starnberg District Hospital, Academic Teaching Hospital of the Ludwig-Maximilians-University Munich, D-82319 Starnberg, FRG

2Department of Gynecology, Central Hospital "Links der Weser", D-28277 Bremen, FRG

International J. of Experimental and Clinical Chemotherapie 1993: Vol. 6, No. 1, pp. 9-20

WE 13 (5-03-1) = WE 49 (5-04-1) nem.
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Abstract

Fibrocystic mastopathy affects about 50 % of all women in the course of their lives. Because of subjective symptoms, the risk of malignant degeneration (5 % of all cases), and ensuing physical and psychological stress, treatment of fibrocystic mastopathy is indispensable. So far, there is no causal therapy. Most common therapeutical regimens are associated with severe side effects.
Therefore, the effect of treatment with an enzyme combination preparation was compared with that of placebo in a randomized double blind study in 96 patients with mastopathy over a study period of 6 weeks.
At the start of the study both groups were well comparable with respect to all relevant study parameters. At the end of the study period there were significant differences regarding the parameters of effectiveness "diameter of the largest cyst" (p = 0.003), "subjective disturbance by symptoms" (p = 0.001) and "cumulative score of complaints" (p < 0.001). As far as the number of cysts is concerned, there was no significant difference at the end of the study period (p = 0.695). Bearing in mind, however, that the initial condition was somewhat worse in the group treated with enzymes, a tendency towards better effectiveness of the enzyme combination preparation was observed with respect to this criterion, too. The difference of absolute change was significant (p = 0.008). The assessment of effectiveness by physician and patient showed clear advantages of the enzyme therapy over placebo.
There was a higher number of mostly mild side effects in the enzyme group, but only stomach complaints and loose stool. Since tolerance was also comparable with that of placebo, the results obtained lead to the conclusion that the enzyme combination preparation lends itself to the symptomatic treatment of fibrocystic mastopathy. Further longer-term

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