Treatment of fibrocystic mastopathy with hydrolytic enzymes
F.-W. Dittmar
1, W. Luh 2. Treatment of fibrocystic mastopathy
with hydrolytic enzymes. 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) nìm.
1. Department of Obstetrics and Gynecology, Starnberg District Hospital,
Academic Teaching Hospital of the Ludwig-Maximilians-University
Munich, D-82319 Starnberg, FRG. 2. Department of Gynecology, Central
Hospital "Links der Weser", D-28277 Bremen, FRG
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 studies, including biopsies and determination of
hormonal parameters, will clarify whether causal treatment of
fibrocystic mastopathy is possible.
Key words: Fibrocystic mastopathy - enzyme therapy - enzyme
combination
preparation vs. placebo
