Application and factor analysis of the menopause rating scale [MRS] in a post-marketing surveillance study of Climen (R)

Objectives: The menopause rating scale (MRS) has been developed as a modern tool for the assessment of menopausal complaints. It combines in practice excellent applicability and a good reliability, and there are normal values for the population available. For further practical evaluation, the MRS wa s applied in order to define the course of menopausal profiles in a large p ost-marketing surveillance study of a sequential oral hormone replacement t herapy (HRT) preparation, Materials and methods: A total of 10 904 pre- and postmenopausal women (median age 49 years) with menopausal symptoms who so far had not used the sequential preparation (Climen(R)) were included in t he study. Patients were admitted who were experienced with previous HRT (45 .2%) or could be classified as never-users (54.8%). Users commonly switched over to Climen(R) due to signs of androgenisation, irregular bleeding, oth er adverse drug effects as well as inadequate efficiency. Demographic data and medical history were recorded together with a listing of body weight, b lood pressure, waist and hip circumference and any skin lesions. Following 3 and 6 months of application, the observation parameters were rechecked an d data on tolerability, cycle pattern and adverse drug effects were recorde d. Efficacy, tolerability, and reasons for withdrawal were documented. A to tal of 1801 gynaecologists took part, recruiting an average of six patients in each practice. Pre- and postmenopausal cases with a median age of 49 ye ars were represented with similar frequency. A factorial analysis known as the varimax method was used to define the 'all-or-none' structure of the lo adings in order to determine the structure of the variables and their relat ionship to the menopausal factors. Results: The pre-treatment profile of th e menopausal complaints by factor analysis splits up into four independent subscores of the MRS with the factors HOT FLUSHES, ATROPHY, psychological s ymptoms (PSYCHE), and somatic symptoms (SOMA). Current or ever-HRT did not alter the factorial profile of the MRS. Differences were observed in the in tensity of the subscores with a tendency towards weaker symptoms following previous treatment with sequential preparations. SOMA appears to be related to increasing age, postmenopausal status, or co-morbidity requiring treatm ent. After six months of treatment, factorial loading of HOT FLUSHES, ATROP HY, PSYCHE and SOMA all dropped significantly. Conclusion The MRS in its or iginal ten-item profile suitably characterizes menopause-specific symptoms both with regard to profile and; intensity of the symptoms. The MRS adequat ely monitors differentiated symptom variation with and without hormone repl acement. Climen(R) confirmed a wide spectrum of activity in all aspects of the MRS. The subscore structure of the factors remained stable during treat ment. Only slight modulations were seen with marked emphasis on psychic asp ects and sexual complaints. (C) 237 Elsevier Science Ireland Ltd. All right s reserved.