The effect of red clover isoflavones on menopausal symptoms, lipids and vaginal cytology in menopausal women: a randomized, double-blind, placebo-controlled study.
BACKGROUND
The unexpected results of the Women's Health Initiative study have decreased the use of conventional hormone therapy (HT), changing physicians' and patients' attitudes towards HT and increasing their interest in alternative options.


OBJECTIVE
The present study aimed to evaluate the effect of isoflavones contained in red clover extracts (Trifolium pratense) on menopausal symptoms, lipids and vaginal cytology in menopausal women.


METHODS
Sixty postmenopausal women aged >40 years, non-users of HT, with Kupperman index score 15, were double-blindly randomized to receive either a commercially available red clover isoflavone supplement (80 mg/day) or placebo for 90 days. Subsequently, after a 7-day washout period, subjects switched to receive the opposite treatment for a further 90 days. Kupperman index score was determined and fasting blood and vaginal cytologic sampling performed at baseline, 90 and 180 days.


RESULTS
Fifty-three women (88.3%) completed the trial. Mean age was 51.3 +/- 3.5 years, 69.7% of the women were aged 50 years or more. There was no significant effect on body mass index, weight or blood pressure after either treatment phase. Baseline Kupperman index score decreased significantly after each treatment phase, with the decrease more pronounced after the isoflavone phase (baseline: 27.2 +/- 7.7; after isoflavone: 5.9 +/- 3.9; after placebo: 20.9 +/- 5.3, p < 0.05). Red clover isoflavone supplementation significantly decreased the rate of menopausal symptoms and had a positive effect on vaginal cytology as expressed by improvement in karyopyknotic, cornification and basal cell maturation indices. Mean total cholesterol, low-density lipoprotein-cholesterol and triglyceride levels also decreased; however, only the latter was significantly lower compared with placebo.


CONCLUSIONS
Compared with placebo, red clover isoflavone supplementation in postmenopausal women significantly decreased menopausal symptoms and had a positive effect on vaginal cytology and triglyceride levels.
Hidalgo
Luis A
LA
Foundation for Health and Well Being in the Climacteric FUCLIM, Guayaquil, Ecuador.
Chedraui
Peter A
PA
Morocho
Nancy
N
Ross
Susana
S
San Miguel
Glenda
G
D001794:Blood Pressure; D015992:Body Mass Index; D001835:Body Weight; D002784:Cholesterol / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D019587:Dietary Supplements; D004311:Double-Blind Method; D005215:Fasting; D005260:Female; D006801:Humans; D007529:Isoflavones / Q000008:administration & dosage / Q000627:therapeutic use*; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D010919:Placebos; D029921:Trifolium / Q000737:chemistry*; D014280:Triglycerides / Q000097:blood; D014621:Vagina / Q000166:cytology
D008078:Cholesterol, LDL; D007529:Isoflavones; D010919:Placebos; D014280:Triglycerides; D002784:Cholesterol