title: Effect of a compound containing isoflavones, primrose oil and vitamin E in two different doses on climacteric symptoms.
abstract: The object of this study was to evaluate the effect of different doses of a compound containing isoflavones 60 mg, primrose oil 440 mg and vitamin E 10 mg. (IOVE) on menopausal complaints. This was an open, multicentre, randomised, group comparative, efficacy and safety trial. A total of 1,080 postmenopausal women, with climacteric symptoms, were allocated into one of two treatment groups to receive one (Group 1; n = 562) or two IOVE capsules (Group 2; n = 518) per day. The Blatt - Kupperman scale and safety parameters including weight, body mass index, blood pressure and adverse effects were assessed at the first visit before initiating the treatment, and 3 - 6 months thereafter. In addition, cholesterol, high density lipoprotein (HDL), low-density lipoprotein (LDL) and triglyceride levels were measured at baseline and at the 6th month visit. Finally, at the end of follow-up, the patient's satisfaction was assessed. No differences between groups at the beginning of the study and during the follow-up were observed. A significant reduction in Blatt - Kupperman scores were observed in the two groups. In addition, the reduction of the symptoms was more intense in the first 3 months. Increasing doses of IOVE add no beneficial effects since both studied doses were equally effective in the reduction of climacteric complaints.
authors.affiliation: Hospital Universitario de Guadalajara, Universidad de Alcalá de Henares, Madrid, Spain.
authors.forename: M J
authors.initials: MJ
authors.lastname: Cancelo Hidalgo
authors.forename: C
authors.initials: C
authors.lastname: Castelo-Branco
authors.forename: J E
authors.initials: JE
authors.lastname: Blumel
authors.forename: J L
authors.initials: JL
authors.lastname: Lanchares Pérez
authors.forename: J I
authors.initials: JI
authors.lastname: Alvarez De Los Heros
mesh_terms: D002979:Climacteric / Q000187:drug effects*; D019587:Dietary Supplements; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007529:Isoflavones / Q000008:administration & dosage*; D008875:Middle Aged; D031665:Oenothera biennis; D008517:Phytotherapy; D028321:Plant Preparations / Q000008:administration & dosage; D016896:Treatment Outcome; D014810:Vitamin E / Q000008:administration & dosage*; D017962:alpha-Linolenic Acid / Q000008:administration & dosage*
chemical_list: D004338:Drug Combinations; D007529:Isoflavones; D028321:Plant Preparations; D017962:alpha-Linolenic Acid; D014810:Vitamin E