A comparative study of Klimakt-Heel® and Femolene Ultra in the management of typical climacteric symptoms

Abstract

The climacteric is described as the physiological cessation of menses due to a decrease in ovarian function. Typically, women between the ages of 44 and 57 years old are symptomatically affected by it. During this stage of life, a woman may experience what is referred to as ‘typical climacteric symptoms’ of varying intensity, including vasomotor reactions, increased perspiration, sleeping problems, mood changes, headaches, joint pains and urogenital problems.The aim of this study was to determine the effectiveness of Femolene Ultra (phytotherapeutic preparation) and Klimakt-Heel® (homeopathic preparation) in the treatment of typical climacteric symptoms.Thirty female volunteers between the ages of 44 and 57 years suffering from climacteric symptoms were recruited and asked to complete the Patient Profile and Case History Form and to sign a Patient Information and Consent Form. These participants were randomly placed in two groups of fifteen. One group received Femolene Ultra and the other received Klimakt-Heel® for a period of 12 weeks. The trial was blinded as neither the researcher nor the participant was aware of which treatment was being administered. Blood samples were taken to ascertain the 17ß oestradiol levels before and after the 12-week period. The Kupperman Menopause Index (KMI) was used as a self-report measure and completed at four-weekly intervals. For statistical purposes, the Wilcoxon Signed Rank Test, from the class of non-parametric distribution-free tests, was used.Both products served to decrease the typical climacteric symptoms significantly within the 12-week period. Femolene Ultra decreased the average Kupperman Menopause Index (KMI) score by 63% (26.2 to 16.4) and Klimakt-Heel® decreased the average score by 54% (28.4 to 15.28), although more participants in the Klimakt-Heel® group experienced amelioration of climacteric symptoms. The results are not conclusive, but they do provide an interesting base-line on which further research can be built.OpsommingDie oorgangsleeftyd word beskryf as die fisiologiese einde van menstruasie weens verminderde eierstokfunksie. Oor die algemeen gesproke sal alle vroulike persone tussen die ouderdomme van 44 en 57 daardeur geraak word. Gedurende hierdie tydperk mag hulle ervaar waarna verwys word as ‘tipiese simptome van die oorgangsleeftyd’ insluitend vasomotoriese reaksies, vermeerderde sweet, slaapprobleme, gemoedsveranderinge, hoofpyne, gewrigspyne en urogenitale probleme.Die doel van die studie was om vas te stel hoe doeltreffend Femolene Ultra (phytotherapeutiese preparaat) and Klimakt-Heel® (homeopathiese preparaat) is vir die behandeling van tipiese oorgangsimptome.Dertig vroulike vrywilligers tussen die ouderdomme 44 en 57 jaar wat aan die simptome van die oorgangsleeftyd gely het het die pasiëntprofiel en -gevallegeskiedenis voltooi en het 'n pasiëntinligtings- en toestemmingsvorm geteken. Hierdie deelnemers is lukraak in twee verskillende groepe van vyftien geplaas. Een groep het Femolene Ultra vir 'n tydperk van 12 weke ontvang en die ander groep het Klimakt-Heel® vir dieselfde tydperk ontvang. Bloedmonsters is geneem om die 17 ß oestradiolvlakke voor en na die 12-weekperiode vas te stel. Die Kupperman Menopouse Indeks is as 'n selfrapportmaatreël gebruik en met vier-weeklikse intervalle voltooi. Statisties is die Wilcoxon rangsomtoets van die klas van nie-parametriese verspreidingsvrye toetse gebruik.Albei produkte het bewys dat dit die tipiese simptome van die oorgangsleeftyd betekenisvol tydens die 12-weekperiode verminder het. Femolene Ultra het die gemiddelde Kupperman Menopouse Indekstelling met 63% verminder en Klimakt-Heel® het die gemiddelde telling met 54% verminder, alhoewel meer deelnemers in die Klimakt-Heel®-groep 'n verbetering in die simptome van die oorgangsleeftyd ervaar het. Die resultate is nie afdoende nie maar dit verskaf tog 'n interessante basis waarop verdere navorsing gegrond kan word.