EVALUATION OF THE REDUCTION OF THE TYPICAL SYMPTOMS OF MENOPAUSE AFTER TREATMENT WITH FITOFLAVON 80

Transcription

1 EVALUATION OF THE REDUCTION OF THE TYPICAL SYMPTOMS OF MENOPAUSE AFTER TREATMENT WITH FITOFLAVON 80 Page 1 di 7

2 INTRODUCTION Even if is not a disease, the menopause may be accompanied by symptoms that are cause to recourse at doctors. The decrease of secretion of estrogens, equipped with anti-oxidant activity, induces an increase of oxidative stress. The oxidative stress is at base of the characteristic symptoms of menopause. The most frequent typical symptoms are vasomotor problems (hot flashes and night sweats) and the complications related at urogenital dystrophy. The atypical symptoms, but frequently present in this period are the arthralgias, the irritability, the sleep disturbances and the mood swings. Frequency, severity and onset vary between different individuals, sometimes extending for a long time. Some of the effects that are determinate following the deficiency of secretion of estrogen may be decreased and/or prevented by increasing the anti-oxidant defenses. The integration with anti-oxidants substances can provide valid answers by minimizing the side effects that accompany the hormonal replacement therapy. OBJECTIVES The purpose of the study described later is verify if the dietary supplementation of calcium, vitamin D3, extracts of papaya and red clover may help to decrease the typical and atypical symptoms of menopause that may interfere with quality of the life. Calcium and Vitamin D3 help to prevent the bones fragility. The papaya is rich in: Anti-oxidant: such selenium, carotene and provitamin A which in the organism it transformed into vitamin A. Flavonoids: those regulate the permeability of blood vessels and are important for the microcirculation. Minerals: potassium, magnesium and calcium, in a natural biological form, easily assimilable, especially useful during menopause to prevent the osteoporosis. The extract of red clover contains phytoestrogen with pro-estrogenic activity. The study was conducted in the private surgery of experimenter doctor. In the study were involved 6 gynecologists (2 in Veneto, 2 in Lazio, 2 in Umbria) who have treated 10 patients each. PATIENTS AND METHODS In the study were included 60 women aged between 44 and 58 years with menopausal symptoms not in treatment with medicines. The most frequent symptoms were: Hot flushing Night sweating Alteration of the sleep Osteo-articular pains The patients have taken a daily dose of 2 tablets of Fitoflavon 80 (equivalent to a 252 mg of Calcium; 10 mg of Vitamin D3; 40 mg of dry extract of Papaya; 12,80 mg of red clover isoflavones). For each patient was compiled a data card at enrollment, was made a telephonic control after 1 month of treatment and a second control after 4 month, at the end of treatment. Page 2 di 7

3 Were collected: Tolerability side effects Reduction of flushing Reduction of night sweating Reduction of alteration of sleep Reduction of osteo-articular pains Not other therapies for the reduction of symptoms have been founded contemporary. RESULTS Study data were controlled: After 1 month of treatment After 4 month at the end of treatment No patient has dropped out the study for reasons of tolerability. Survey of the symptoms reduction at T 1, after 1 month of treatment Yes Partly No Not indicated Reduction of flushing Reduction of night sweating Reduction of alteration of sleep Reduction of osteo-articular pain Tolerability at T 1 Good Discrete Poor Side effects at T 1 No Yes Side effects dyspepsia 1 constipation 1 brest tenderness Page 3 di 7

4 Survey of the symptoms reduction at T 4, after 4 month of treatment Yes Partly No Not indicated Reduction of flushing Reduction of night sweating Reduction of alteration of sleep Reduction of osteo-articular pain Tolerability at T 4 Good Discrete Poor Unwanted effects at T 4 No Yes Side effects dyspepsia DISCUSSION This study was conducted to verify the efficacy and the tolerability of a nutraceutical treatment based of Calcium, Vitamin D3, extract of Red Clover and extract of Papaya, against the most frequent symptoms that accompany menopause. The Calcium and Vitamin D3 have an anti-osteoporotic activity, the extract of Papaya has a high anti-oxidant activity, the Red Clover contains a complete pool of isoflavones (genistein, daidzein, formononetin, biochanin A) characterized by activity pro-estrogenic, by rapid intestinal absorption and increased receptor affinity. The reduction of symptoms reported, the endpoint of the study, is clearly visible in the graphs below, where are underlined the numbers of patient who have demonstrate the reduction of severity of the symptoms, respectively at control at T1 and at T4 Already after one month of treatment 40 patients out 60 confirmed the reduction of the flushes, number which increases after 4 month of treatment. In particular at T1 more than 66% of patients declaring an effect on the reduction of flushes (sum of yes and partly) that at T4 become more than 88%. Page 4 di 7

5 At T1 more than 51% of patient declaring an effect on the reduction of night sweating (sum of yes and partly) that at T4 become more than 76%. As regard the reduction of sleep disorder 38 patients out 60 have confirmed,at the T1, the reduction of this symptoms, number which increases after 4 month of treatment. In particular, at thet1, more than 63% of patients declaring an effect on the reduction of sleep disorder (sum of yes and partly) that, at the T4, become more than 78%. Page 5 di 7

6 At T1 more than 48% of patients declaring an effect on the reduction of osteo-articular pains (sum of yes and partly) that at T4 become more than 55%. The tolerability was judged as good and discrete already at the T1. At T1 7 patients have had collateral effects who have not requested the treatment suspension (5 dyspepsia, 1 constipation, 1 breast tenderness). After treatment 2 patients have manifested dyspepsia. Page 6 di 7

7 CONCLUSIONS The analysis of data relating to the symptoms reduction clearly indicates that the majority of patients has had a benefit, greater on typical symptoms, after use of Fitoflavon 80. Tolerability was judged good and discrete in the 98,3% of patient treated. BIBLIOGRAFIA 1 - Management of the menopausal disturbances and oxidative stress. Pasini F, Mollica G, Bergamini CM. Gynaecologic Obstetric Clinic and Menopause-Osteoporosis Centre, University of Ferrara Medical School, Ferrara, Italy. Curr Pharm Des. 2005; 11(16): Hormone replacement therapy for oxidative stress in postmenopausal women with hot flushes. Leal M, Diaz J, Serrano E, Abellan J, Carbonell LF. Centros de Salud de San Andres y Beniajan, Murcia, Spain. Obstet Gynecol Jun; 95(6 Pt 1): Bone metabolism and oxidative stress in postmenopausal rats with iron overload. Isomura H, Fujie K, Shibata K, Inoue N, Iizuka T, Takebe G, Takahashi K, Nishihira J, Izumi H, Sakamoto W. Departement of Biochemistry, School of Dentistry, Hokkaido University, North 13 West 7 Kita-ku, Hokkaido, Sapporo 060, Japan. Toxicology, 2004 Apr 15; 197(2): Involvement of oxidative stress in age-related bone loss. Zhang YB, Zhong ZM, Hou G, Jiang H, Chen JT. Departement of Orthopedic and Spinal Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China. J Surg Res Jun; 169(1):e Epub 2011 Mar Oxidative status and cardiovascular risk in women: Keeping pink at heart. Vassalle C, Mercuri A, Maffei S. G. Monasterio Foundation & Institute of Clinical Physiology-CNR, I-56124, Pisa. World J Cardiol Dec 31; 1(1): Page 7 di 7