Effect of Polyvitaminics (Pyridoxine Hydrochloride, Folic Acid and Cyanocobalamin) in the Concentration of Homocysteine and Lipid Profile in Postmenopausal Women: a Randomized Controlled, Double-blind Clinical Trial

Subjects The study protocol and informed consent was approved by the Ethics Committee of the Hospital Santa Marcelina, Sao Paulo, Brazil (Process nº 09/08, CAAE nº 0016.0.270.000-08).Sixty women (figure 1) were postmenopausal selected from the outpatient Gynecology - Endocrine Hospital Santa Marcelina that passed by routine consultations and fulfilling the inclusion criteria were invited to the study.

Inclusion criteria were: a year of amenorrhea, FSH (follicle stimulating hormone) greater than 30mUI/ml and submit dyslipidemia, defined as LDL> 150 mg / dl15. Women with diabetes difficult to control or with recent myocardial infarction or thromboembolic diseases, severe hepatic impairment or activity were excluded. In addition, patients who had any form of cancer were excluded from the group.

Study Design The women were randomly allocated to control or experimental group (30 in each group) in a double-blind controlled clinical trial. The experimental group received one tablet of Tenavit®(pyridoxine hydrochloride 4.00mg + folic acid 0.80mg + cyanocobalamin 0.40mg) daily and the placebo group received the same tablet with the organoleptic characteristics of Tenavit® for a period of 4 months. After this period of treatment, the women were assessed.

Procedures During clinical examination, a self-report questionnaire to assess quality of life (QSF-36) that demonstrates how the individual feels regarding your activities, your health and disposition on a daily, always referring to the last month15, was applied. The Framingham Score was also applied. Framingham predictions was good in the low- to intermediate cardiovascular risk16,17.Anthropometric measurements of blood pressure, weight, height, body mass index, waist and hip were evaluated by the same medical team. Venous blood was collected on two different occasions during the study (at baseline and at end of treatment), while maintaining the 12-hour fast and the interval of 4 months between tests, both in the experimental and in the control group. Total cholesterol and fractions, triglycerides, fasting glucose, homocysteine and cysteine were performed. The dosage of plasma homocysteine and cysteine was performed by high performance liquid chromatography (HPLC).