The criteria for therapeutic efficacy in clinical studies with Remifemin tablets are based on established and validated testing procedures. Clinically standardised and internationally recognised psychometric scales have been employed. In addition to the query of individual symptoms, these scales allow for an overall statement of the degree of severity of the somatic and physical or Neuro vegetative findings, by way of indices or total scores.

Studies employed internationally recognised indexes such as:

The Greene Index
Kupperman index
Hamilton anxiety scale (HAMA)
Self assessment depression scale (SDS)
The CGI-scale (Clinical Global Impression)
Profile of mood states (POMS)
Schmitts graduation of vaginal smears
Karyopyknotic Index
Eosinophil Index

(1) Neurovegetative symptoms have been qualified mainly by the KUPPERMAN Menopause index. This index assigns more significance to the "typical" menopausal complaints, such as hot flushes, by way of higher multiplication constant, than it does to the milder concurrent symptoms. In some clinical studies the KUPPERMAN Index was modified with an modified with an additional evolution of trophic disturbances of the genitals. The Menopause Index gives an indication of the severity of the neurovegetative symptoms of the menopausal syndrome.

During Remifemin therapy the degree of severity decreased (related to the beginning) significantly at the end of treatment from "moderate/mild" to "free of symptoms" or "severe" to "moderate" to "mild". These favorable results clearly demonstrate the therapeutical efficacy in treating neurovegative climacteric symptoms with Remifemin.

(2) Physical symptoms belong to the menopause syndrome and can be quantified by specific scales. Those symptoms have been quantified by:

- Hamilton Anxiety Scale (HAMA) is recorded by the physician. This scale is suitable for the assessment of anxiety states ("physical" and "somatic" anxiety), and is used for the efficacy of psycho pharmaceuticals.

- Self Assessment Depression Scale (SDS) is filled out by the patients. It is suitable for the detection and quantification of depressive moods and therefore also for the comparison of the efficacy or various treatments.

- Profile of Moods States (POMS) is self-evaluation scale for the patient. In the "mood profile" the strength of motivation and degree of weariness, depression and ill-humour is recorded.

A therapy of Remifmein improved the physical symptoms showing and increase in motivation, mood state and a decrease in weariness, despondency and ill-humour. Remifemin significantly reduced symptoms (from "severe" to "mild" and the anxiety states were positively influenced).

(3) Somatic symptoms occur during the increasing ovarian insufficiency and can reduce the quality of life of women in the pre and postmenopausal period. In clinical studies with Remifemin the vaginal cytological control (vaginal smear) has been realised. It indicates whether the vaginal epithelium proliferates in response to medical therapy in the same sense of an oestrogenic stimulation. Besides the degree of proliferation of the vaginal epithelium, the oestrogenic influence can be determined by the karopyknotic and eosinophil indices.