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

　　Hermann P.G. Schneider a,*, Hans Peter Rosemeier b, Jo¨ rg Schnitker c, Silvia Gerbsch d, Roland Turck d

　　a Department of Obstetrics and Gynaecology, University of Muenster, Von -Esmarch -Street 56, ZMBE, 48149 Muenster, Germany
　　b Institut fu¨ r Medizinische Psychologie, Freie Universita¨ t Berlin, Habelschwerdter Allee 45, 14195 Berlin, Germany
　　c Institut fu¨ r Angewandte Statistik, Dr. Jo¨ rg Schnitker GmbH, Artur -Ladebeck -Street 155, 33647 Bielefeld, Germany
　　d Schering Deutschland GmbH, Medizin /Marketing Gyna¨ kologie, Max -Dohrn -Street 10, 10589 Berlin, Germany

　　Received 16 March 2000; accepted 10 October 2000

　　Abstract

　　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 was applied in order to define the course of menopausal profiles in a large post-marketing surveillance study of a sequential oral hormone replacement therapy (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?) were included in the 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? due to signs of androgenisation, irregular bleeding, other adverse drug effects as well as inadequate efficiency. Demographic data and medical history were recorded together with a listing of body weight, blood pressure, waist and hip circumference and any skin lesions. Following 3 and 6 months of application, the observation parameters were rechecked and data on tolerability, cycle pattern and adverse drug effects were recorded. Efficacy, tolerability, and reasons for withdrawal were documented. A total of 1801 gynaecologists took part, recruiting an average of six patients in each practice. Pre- and postmenopausal cases with a median age of 49 years were represented with similar frequency. A factorial analysis known as the varimax method was used to define the ‘all-or-none’ structure of the loadings in order to determine the structure of the variables and their relationship to the menopausal factors. Results: The pre-treatment profile of the menopausal complaints by factor analysis splits up into four independent subscores of the MRS with the factors HOT FLUSHES, ATROPHY, psychological symptoms (PSYCHE), and somatic symptoms (SOMA). Current or ever-HRT did not alter the factorial profile of the MRS. Differences were observed in the intensity 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 treatment. After six months of treatment,factorial loading of HOT FLUSHES, ATROPHY, PSYCHE and SOMA all dropped significantly. Conclusion: The MRS in its original ten-item profile suitably characterizes menopause-specific symptoms both with regard to profile and intensity of the symptoms. The MRS adequately monitors differentiated symptom variation with and without hormone replacement. Climen? confirmed a wide spectrum of activity in all aspects of the MRS. The subscore structure of the factors remained stable during treatment. Only slight modulations were seen with marked emphasis on psychic aspects and sexual complaints. ? 237 Elsevier Science Ireland Ltd. All rights reserved.

　　Keywords: Menopause; Menopause rating scale; Post-marketing surveillance; Factor analysis; Validation; Hormone substitution; Sequential preparation; Climen; Oestradiol valerate; Cyproterone acetate