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, Nr. 1, pp. 9-20
WE 13 (5-03-1) = WE 49 (5-04-1) něm.
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