PubMed Research Feed
Coffee, tea, caffeine and risk of breast cancer: a 22-year follow-up.
Coffee, tea, caffeine and risk of breast cancer: a 22-year follow-up.
Int J Cancer. 2008 May 1;122(9):2071-6
Authors: Ganmaa D, Willett WC, Li TY, Feskanich D, van Dam RM, Lopez-Garcia E, Hunter DJ, Holmes MD
The relation between consumption of coffee, tea and caffeine and risk of breast cancer remains unsettled. We examined data from a large, long-term cohort study to evaluate whether high intake of coffee and caffeine is associated with increased risk of breast cancer. This was a prospective cohort study with 85,987 female participants in the Nurses' Health Study. Consumption of coffee, tea and caffeine consumption was assessed in 1980, 1984, 1986, 1990, 1994, 1998 and the follow-up continued through 2002. We documented 5,272 cases of invasive breast cancer during 1,715,230 person-years. The multivariate relative risks (RRs) of breast cancer across categories of caffeinated coffee consumption were: 1.0 for <1 cup/month (reference category), 1.01 (95% confidence interval: 0.92-1.12) for 1 month to 4.9 week, 0.92 (0.84-1.01) for 5 week to 1.9 days, 0.93 (0.85-1.02) for 2-3.9 days, 0.92 (0.82-1.03) for >or=4 cups per day (p for trend = 0.14). Intakes of tea and decaffeinated coffee were also not significantly associated with risk of breast cancer. RRs (95% CI) for increasing quintiles of caffeine intake were 1.00, 0.98 (0.90-1.07), 0.92 (0.84-1.00), 0.94 (0.87-1.03) and 0.93 (0.85-1.01) (p for trend = 0.06). A significant inverse association of caffeine intake with breast cancers was observed among postmenopausal women; for the highest quintile of intake compared to the lowest RR 0.88 (95% CI = 0.79-0.97, p for trend = 0.03). We observed no substantial association between caffeinated and decaffeinated coffee and tea consumption and risk of breast cancer in the overall cohort. However, our results suggested a weak inverse association between caffeine-containing beverages and risk of postmenopausal breast cancer.
PMID: 18183588 [PubMed - indexed for MEDLINE]
Soy isoflavones as safe functional ingredients.
Soy isoflavones as safe functional ingredients.
J Med Food. 2007 Dec;10(4):571-80
Authors: Song WO, Chun OK, Hwang I, Shin HS, Kim BG, Kim KS, Lee SY, Shin D, Lee SG
In recent years, isoflavones have increased in popularity as an alternative to estrogen therapy, particularly after the Women's Health Initiative demonstrated an increased risk of breast cancer, stroke, and heart attacks in response to estrogen and progesterone intervention. Isoflavones are heterocyclic phenols with structural similarity to estradiol-17beta and selective estrogen receptor modulators. Actions at the cellular level depend on the target tissue, receptor status of the tissue, and the level of endogenous estrogen. Clinical studies of soy-based diets evaluating the relation between soy consumption and serum lipid concentrations revealed that soy consumption significantly decreased total cholesterol, low-density lipoprotein cholesterol, and triglyceride levels. Epidemiological studies suggest a protective effect of soy protein on breast tissue as evidenced by the lower rates of breast cancer in East Asian countries where soy is a predominant part of the diet. Soy products also alleviate menopausal symptoms by reducing hot flashes. However, whether these biological effects of soy products originated from isoflavones is not clear. Furthermore, data available from human studies on the effect of isoflavones on osteoporosis are limited, and additional studies are needed to support a role in osteoporosis prevention. To date, no adverse effects of short- or long-term use of soy proteins are known in humans, and the only adverse effects known are those reported in animals. In conclusion, isoflavones are biologically active compounds, and current data are insufficient to draw definitive conclusions regarding the use of isoflavones as an alternative to estrogen for hormone replacement in postmenopausal women. Large, long-term intervention studies examining adverse effects and disease outcomes are needed before definitive conclusion can be drawn.
PMID: 18158825 [PubMed - indexed for MEDLINE]
Dietary restraint and low bone mass in female adolescent endurance runners.
Dietary restraint and low bone mass in female adolescent endurance runners.
Am J Clin Nutr. 2008 Jan;87(1):36-43
Authors: Barrack MT, Rauh MJ, Barkai HS, Nichols JF
BACKGROUND: Because disordered eating (DE) has been related to menstrual irregularity (MI) and low bone mineral density (BMD) in some studies of female athletes but not in others, it seems beneficial to assess the DE attitudes and behaviors most associated with these conditions. OBJECTIVE: We aimed to determine the relation between Eating Disorder Examination Questionnaire (EDE-Q) subscale scores, pathologic behaviors, MI, and low BMD in adolescent female runners. DESIGN: Participants were 93 female competitive cross-country runners 13-18 y old. The EDE-Q, composed of subscales for weight concern, shape concern, eating concern, and dietary restraint, was used to assess DE. Menstrual history was determined by using a questionnaire derived from a medical history form administered before participation in high school athletics. The International Society for Clinical Densitometry and the World Health Organization criterion of <or=-2 or <or=-1 SD, respectively, was used to categorize runners as having low BMD. RESULTS: Runners with elevated restraint had a significantly (P<0.001) greater incidence of low BMD than did runners with elevated weight and shape concern. After adjustment for possible confounding variables (including menstrual history), lumbar spine BMD, bone mineral content, and BMD z score values were lowest in runners with elevated restraint. In addition, total-body BMD and total-body BMD z scores were significantly (P<0.05) lower in runners with elevated restraint than in those with elevated weight or shape concern. Elevated EDE-Q scores for weight or shape concern, pathologic behaviors, or any combination of the 3 without concurrent dietary restraint were not significantly associated with low bone mass. CONCLUSION: These findings suggest that, in adolescent female runners, dietary restraint may be the DE behavior most associated with negative bone health effects.
PMID: 18175735 [PubMed - indexed for MEDLINE]
Soy isoflavones improve bone metabolism in postmenopausal Japanese women.
Soy isoflavones improve bone metabolism in postmenopausal Japanese women.
Clin Exp Pharmacol Physiol. 2004 Dec;31 Suppl 2:S44-6
Authors: Mori M, Sagara M, Ikeda K, Miki T, Yamori Y
1. This study examines whether the supplementation of isoflavones (ISO) exerts beneficial effects on serum and urinary biomarkers of bone metabolism. 2. A total of 102 women were randomly assigned to three groups taking either ISO (40 mg) tablets, tablets containing vitamins C (25 mg) and E (5 mg) (V) or placebo tablets (vehicle only) (P) daily for 4 weeks, in a double-blind parallel placebo controlled design. 3. Among the 67 women who completed the study (24 on ISO, 24 on V, 19 on P), only ISO tablets were proven to decrease significantly urinary deoxypyridinoline (Dpd) excretion (P < 0.05 vs before), a specific biomarker of bone resorption, but there was no significant difference in serum bone gamma-carboxyglutamic acid-containing protein (BGP), a specific serum biomarker of bone formation. 4. Among the 67, 25 women were postmenopausal (8 on ISO, 12 on V, 8 on P) and only ISO tablets decreased significantly urinary Dpd excretion (P < 0.05 vs before) in them. The reduction rate of Dpd in ISO group was also significantly greater than that in P group (P < 0.01). 5. Dietary supplementation of vitamins C 25 mg and E 5 mg did not affect urinary Dpd.
PMID: 15649287 [PubMed - indexed for MEDLINE]
Soy isoflavone tablets reduce osteoporosis risk factors and obesity in middle-aged Japanese women.
Soy isoflavone tablets reduce osteoporosis risk factors and obesity in middle-aged Japanese women.
Clin Exp Pharmacol Physiol. 2004 Dec;31 Suppl 2:S39-41
Authors: Mori M, Aizawa T, Tokoro M, Miki T, Yamori Y
1. This study examines whether the supplementation of isoflavones (ISO) exerts beneficial effects on the bone mineral density (BMD) measured by dual energy X-ray absorptiometry (DEXA). 2. Eighty-one healthy Japanese pre- and postmenopausal women were randomly assigned to the following two groups taking either ISO (100 mg) tablets (ISO group) or placebo tablets (P group) containing vitamins C (25 mg) and E (5 mg) daily for 24 weeks in a double-blind placebo controlled parallel design. 3. Seventy women completed the intervention study (34 on ISO, 36 on P), only ISO group was proven to increase significantly BMD (P < 0.05 vs before) and to significantly decrease body fat measured by the DEXA (P < 0.0001 vs before and P < 0.05 vs P group), while BMI was maintained in ISO group despite significant BMI increase in P group. Thus, percent changes in BMI were significantly different between ISO and P groups (P < 0.05) 24 weeks after the intervention. 4. This prospective DEXA study confirmed a long-term ISO supplementation, 100 mg/day could not only prevent menopausal bone resorption but also increase BMD and decrease body fat concomitantly with BMI reduction. Enough ISO supplementation may contribute to the risk reduction of osteoporosis and obesity and, thus to overall health promotion in menopausal women.
PMID: 15649285 [PubMed - indexed for MEDLINE]
[Clinical application of undercarboxylated osteocalcin]
[Clinical application of undercarboxylated osteocalcin]
Clin Calcium. 2007 Nov;17(11):1709-16
Authors: Yasui T, Yamada M, Irahara M
Undercarboxylated osteocalcin (ucOC) is a sensitive marker of vitamin K (VK) status. Serum ucOC concentration in perimenopausal women is significantly higher than that in premenopausal women. In addition, serum ucOC concentration is closely associated with not only FSH concentration but also estradiol concentration. Serum ucOC concentration rapidly increases in women after bilateral oophorectomy. The effect of hormone therapy (HT) on alternate days on ucOC concentration is weaker than the effect of HT daily and ucOC concentration after 12 months of HT daily may be decreased due to the conversion of ucOC to carboxylated OC by the effect of VK through increased TG induced by oral conjugated equine estrogen (CEE) . Additionally, the effect of HT with transdermal estradiol on ucOC concentration in women is weaker than the effect of HT with oral CEE.
PMID: 17982191 [PubMed - indexed for MEDLINE]
Dietary intervention versus metformin to improve the reproductive outcome in women with polycystic ovary syndrome. A prospective comparative study.
Dietary intervention versus metformin to improve the reproductive outcome in women with polycystic ovary syndrome. A prospective comparative study.
Saudi Med J. 2007 Nov;28(11):1694-9
Authors: Qublan HS, Yannakoula EK, Al-Qudah MA, El-Uri FI
OBJECTIVE: To compare the clinical results and reproductive outcome in obese women with polycystic ovary syndrome (PCOS) following dietary intervention or treatment with metformin. METHODS: Forty-six patients with PCOS were studied prospectively in Prince Rashed Hospital, Irbid, Jordan, between January 2003 and April 2005. The women were randomly divided into 2 groups: Group 1 (n=24) was prescribed with 1200-1400 kcal/day diet (25% proteins, 25% fat, and 50% carbohydrates plus 25-30 gm of fiber per week). Group 2 (n=22) was assigned to take 850 mg of metformin twice in a continuous manner. Both treatments continued for 6 months. Clinical and biochemical data, before and after both treatments along with the reproductive outcome were compared between the 2 groups. RESULTS: There were no significant differences between the 2 groups in terms of age, body mass index (BMI) and duration of infertility. Both groups had a significant improvement after treatment in the menstrual cyclicity (66.7% and 68.2% versus 12.5% and 18.2%) and significant reduction in BMI (mean of 27.4 and 27.8 versus 32.2 and 31.9), luteinizing hormone levels (7.9+/-1.7 and 6.9+/-1.8 versus 11.8+/-2.2 and 11.5+/-1.8), and androgen (testosterone, androstenedione, dehydroepiandrosterone sulfate) concentration. The clinical, biochemical, and reproductive outcome including menstrual cycle pattern, ovulation, and pregnancy rates were similar in both groups after treatment. CONCLUSION: Amelioration of hyperinsulinemia and hyperandrogenemia with dietary intervention or metformin treatment improves significantly the clinical features and reproductive function in overweight PCOS women.
PMID: 17965792 [PubMed - indexed for MEDLINE]
Analytical and biological variation of biomarkers of oxidative stress during the menstrual cycle.
Analytical and biological variation of biomarkers of oxidative stress during the menstrual cycle.
Biomarkers. 2008 Mar-Apr;13(2):160-83
Authors: Browne RW, Bloom MS, Schisterman EF, Hovey K, Trevisan M, Wu C, Liu A, Wactawski-Wende J
Little information is available on the intra-individual variability of oxidative stress biomarkers in healthy individuals and even less in the context of the menstrual cycle. The objective of this study was to characterize the analytical and biological variability of a panel of 21 markers of oxidative damage, antioxidant defence and micronutrients in nine healthy, regularly menstruating women aged 18-44 years. Analyses included measurement of lipid peroxidation, antioxidant enzymes and antioxidant vitamins. Blood specimens were collected, processed and stored using standardized procedures on days 2, 7, 12, 13, 14, 18, 22 and 28 in one cycle for each subject. Replicate analyses of markers were performed and two-way nested random effects ANOVA was used to describe analytical, intra-individual and inter-individual variability. No statistically significant differences at alpha=0.05, or temporal effects across the menstrual cycle were observed. Analytical variability was the smallest component of variance for all variables. The ICC among replicates ranged from 0.80 to 0.98. Imprecision based on quality control materials ranged from 1 to 11%. The critical differences between serial results varied greatly between assays ranging from 6 to 216% of the mean level. These results provide important initial information on the variability of biomarkers of oxidative stress, antioxidant defence and micronutrients across the menstrual cycle.
PMID: 18270869 [PubMed - in process]
Safety and efficacy of chastetree (Vitex agnus-castus) during pregnancy and lactation.
Safety and efficacy of chastetree (Vitex agnus-castus) during pregnancy and lactation.
Can J Clin Pharmacol. 2008;15(1):e74-9
Authors: Dugoua JJ, Seely D, Perri D, Koren G, Mills E
BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs used during pregnancy and lactation. This is one article in a series that systematically reviews the evidence for herbs commonly used during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety and pharmacology of chastetree, focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS In pregnancy, there is poor evidence based on theoretical and expert opinion and in vitro studies that chastetree may have estrogenic and progesteronic activity, uterine stimulant activity, emmenagogue activity and prevent miscarriages. In lactation, theoretical and expert opinion conflict as to whether chastetree increases or decreases lactation. CONCLUSIONS: Given its relatively common use amongst women of childbearing age, it is likely that some women may consume chastetree while unknowingly pregnant. Complementary and alternative medicine, midwifery and medical practitioners should be aware of this fact when prescribing chastetree to women of childbearing age, particularly when the patient is planning a family. Key words: Chastetree, vitex agnus-castus, pregnancy, lactation, breastfeeding, systematic review.
PMID: 18204102 [PubMed - indexed for MEDLINE]
The effects of raloxifene and tibolone on homocysteine and vascular histopathological changes.
The effects of raloxifene and tibolone on homocysteine and vascular histopathological changes.
Clin Exp Med. 2007 Dec;7(4):149-53
Authors: Bayram M, Ozer G, Kalender H, Kabakci N, Kisa U, Ozkan Y
The aim of the present study was to examine the effects of raloxifene (RLX) and tibolone (TBN) on plasma homocysteine (Hcy) levels and their relationship with atherosclerotic changes in the walls of the carotid artery in ovariectomised rats. Thirty surgically ovariectomised Wistar albino rats after a menopausal period of 6 cycles were randomly assigned to receive RLX 0.01 mg/kg/day (n=10), TBN 0.04 mg/kg/day (n=10) and the same dose of placebo (n=10) for 6 cycles. Serum levels of vitamin B12, folate and Hcy were measured and carotid arteries were examined histopathologically following the termination of treatment. Hcy levels were 3.27+/-0.97, 2.57+/-0.32 and 2.28+/-0.12 micromol/l, Vitamin B12 levels were 901.90+/-239.76, 694.70+/-112.20 and 631+/-309.44 pg/ml and folate levels were 73.80+/-12.71, 72.51+/-7.05 and 84.79+/-20.82 ng/ml in receiving RLX, TBN and placebo respectively. Hcy levels were increased by RLX vs. placebo (P=0.006) but not by TBN vs. placebo (P=0.070). Vitamin B12 levels were found to be elevated by TBN vs. the control group (P=0.041) but not by RLX vs. placebo (P=0.059). Histopathological examination of carotid arteries from rats receiving both RLX and TBN revealed no difference vs. placebo. Data obtained from the study support the view that neither RLX nor TBN appears to have a primary protective effect on vascular disease by effecting the metabolism of Hcy at menopause.
PMID: 18188527 [PubMed - indexed for MEDLINE]
Gynecologic and hormonal effects of raloxifene in premenopausal women.
Gynecologic and hormonal effects of raloxifene in premenopausal women.
Fertil Steril. 2007 Dec;88(6):1637-44
Authors: Premkumar A, Venzon DJ, Avila N, Johnson DV, Remaley AT, Forman MR, Eng-Wong J, Zujewski J, Stratton P
OBJECTIVE: To assess the effects of raloxifene on the ovaries, uterus, and serum hormone levels in premenopausal women. DESIGN: Prospective study comparing pretreatment findings with findings for those on treatment. SETTING: Government research hospital. PATIENT(S): Thirty women 35 to 47 years of age who were at high risk of breast cancer and had regular, ovulatory menstrual cycles. INTERVENTION(S): Raloxifene (60 mg) and calcium (1,200 mg) daily for 2 years. MAIN OUTCOME MEASURE(S): Sonographic evidence of ovarian stimulation (>or=2 corpora lutea, or follicular cysts of >2 cm, or single follicular cyst of >3 cm). Changes in endometrial thickness, fibroid size, hormone levels, and menstrual-cycle length. RESULT(S): Fifteen subjects developed some cycles with asymptomatic ovarian stimulation, and 9 developed benign endometrial polyps, compared with 2 subjects and 1 subject pretreatment, respectively. Uterine fibroid size was unchanged during raloxifene use in 16 subjects with fibroids. On treatment, E(2) levels increased significantly only during the follicular phase, with peak E(2) levels significantly higher in cycles showing ovarian stimulation compared with those without. Sex hormone-binding globulin increased, but levels of LH, FSH, P, DHEAS, and T did not. Endometrial thickness and cycle length were unchanged. CONCLUSION(S): Premenopausal subjects receiving raloxifene showed sonographic and hormonal evidence of ovarian stimulation. Endometrial thickness, cycle length, and fibroid size were unchanged. Benign asymptomatic endometrial polyps developed in some.
PMID: 17662283 [PubMed - indexed for MEDLINE]
Relationships between selenium, lipids, iron status and hormonal therapy in women of the SU.VI.M.AX cohort.
Relationships between selenium, lipids, iron status and hormonal therapy in women of the SU.VI.M.AX cohort.
J Trace Elem Med Biol. 2007;21 Suppl 1:66-9
Authors: Arnaud J, Arnault N, Roussel AM, Bertrais S, Ruffieux D, Galan P, Favier A, Hercberg S
Significant differences in serum selenium concentration according to contraceptive treatment and age have been evidenced in women of the SU.VI.M.AX cohort. This study aimed at verifying the physiopathological hypothesis that the observed increase in serum selenium concentration could be related to serum lipid increase and/or bleeding decrease. Women were divided into six groups: menopausal with or without hormonal replacement therapy; non-menopausal using contraceptive pills; intrauterine device; other contraceptive treatment or no contraceptive treatment. Adjusted linear regression indicated positive associations between selenium and apolipoprotein A1 (r(2) from 0.038 to 0.074, p<0.07 depending on groups) or ferritin in serum (r(2) from 0.032 to 0.075, p<0.07 depending on groups). These relationships could explain the differences observed according to hormonal treatment and age in the SU.VI.MAX study.
PMID: 18039502 [PubMed - indexed for MEDLINE]
[Observation on effect of combined therapy of neiyi pill and neiyi enema on endometriosis]
[Observation on effect of combined therapy of neiyi pill and neiyi enema on endometriosis]
Zhongguo Zhong Xi Yi Jie He Za Zhi. 2006 Jun;26(6):557-9
Authors: Wu SZ, Chen XL, Huang YC
OBJECTIVE: To observe the effect of combined therapy of Neiyi pill (NP) and Neiyi enema (NE) on endometriosis and its effect on serum levels of endometrial antibody (EMAB) and carcinoembryonic antigen 125 (CA125). METHODS: Fifty-eight cases with endometriosis were divided into 3 groups randomly, group A (n = 16) treated by NP, group B (n = 24) treated by NP and NE, and group C (n = 18) treated by danazol, all for 3 menstrual cycle with single blind method. The effect was observed and the serum levels of EMAB and CA125 were detected before and after treatment. RESULTS: Comparison of the efficacy between the 3 groups showed: there was no remarkable difference between group A and B (P >0.05), both of group A and group B were superior to that of group C (P<0.05). The levels of EMAB and CA125 had no significant changes in all the three groups after treatment. CONCLUSION: Combined therapy of NP and NE could improve the curative effect on endometriosis, and without obvious effects on serum levels of EMAB and CA125.
PMID: 16841679 [PubMed - indexed for MEDLINE]
The effect of Chinese herbal medicines (CHM) on menopausal symptoms compared to hormone replacement therapy (HRT) and placebo.
The effect of Chinese herbal medicines (CHM) on menopausal symptoms compared to hormone replacement therapy (HRT) and placebo.
Maturitas. 2007 Sep 20;58(1):83-90
Authors: Kwee SH, Tan HH, Marsman A, Wauters C
OBJECTIVE: To evaluate within the Traditional Chinese Medicine (TCM) setting, the effect of CHM-formulae on menopausal symptoms. DESIGN: A double-blind and double-dummy randomised placebo-controlled trial. METHOD: Between February and June 2002 and June and October 2004, 31 peri- and postmenopausal Dutch women were recruited to complete 12 weeks of treatment with either CHM formulae (n=10), HRT (n=11) or placebo (n=10) medications plus 4 weeks of non-treatment follow-up observation. Hereby a double-dummy setting is applied, i.e. the medications and placebo's taken were both capsules and liquid extracts. Appropriate to the TCM setting, the CHM-prescriptions could be adjusted according to the symptoms and signs of the individuals for that moment. MAIN OUTCOME MEASURES: The primary end-point was the reduction in frequency of vasomotor symptoms (hot flushes and night sweats). Secondary end-point were the improvements measured in quality of life questionnaire SF-36 and other symptoms and signs related to the peri- and postmenopausal period. RESULTS: Placebo had a score of 30%. Compared to Placebo, on average CHM is 29% significantly (p<0.05) more effective in reducing the amount of hot flushes, while HRT is almost 50%. Although quantitatively there was a significant difference in the reduction of hot flushes between groups, qualitatively there was no overall improvement. CONCLUSIONS: This pilot study proved clearly that CHM could help women with their menopausal problems. The chosen trial methodology with its TCM differential diagnosis after orthodox medicine diagnosis is fully compatible with TCM practice and hence acceptable for western and Chinese medical practitioners. For a place in the western health care system, we need to conduct a larger trial with a more menopause specific questionnaire.
PMID: 17689896 [PubMed - indexed for MEDLINE]
Efficacy and tolerability of a medicinal product containing an isopropanolic black cohosh extract in Chinese women with menopausal symptoms: a randomized, double blind, parallel-controlled study versus tibolone.
Efficacy and tolerability of a medicinal product containing an isopropanolic black cohosh extract in Chinese women with menopausal symptoms: a randomized, double blind, parallel-controlled study versus tibolone.
Maturitas. 2007 Sep 20;58(1):31-41
Authors: Bai W, Henneicke-von Zepelin HH, Wang S, Zheng S, Liu J, Zhang Z, Geng L, Hu L, Jiao C, Liske E
OBJECTIVE: To investigate the efficacy-safety balance of the isopropanolic extract of Actaea (=Cimicifuga) racemosa (iCR, Remifemin) in comparison with tibolone in Chinese women with climacteric complaints. METHOD: The randomized, double-blind, controlled 3-month study in 5 centers of 3 cities in China enrolled 244 menopausal patients aged 40-60 years and with a Kupperman Menopause Index (KMI)>or=15. The participants were assigned to either iCR corresponding to 40 mg crude drug/day (N=122) or tibolone 2.5mg/day (N=122) orally. The primary endpoint was the combination of the Mann-Whitney values (MWV) of the KMI and the frequency of adverse events (benefit-risk balance) at end of treatment (MWV>0.5 shows superiority; MWV>0.36 shows non-inferiority). RESULTS: KMI decreased from 24.7+/-6.1 to 11.2+/-6.2 and 7.7+/-5.8 (iCR) and to 11.2+/-7.2 and 7.5+/-6.8 (tibolone) at 4 and 12 weeks. This remarkable and clinically relevant improvement was similar in both treatment groups (MWV=0.47; 95% CI=0.39-0.54; p(non-inferiority)=0.002) showing statistical significant non-inferiority of iCR to tibolone. The KMI-responder rate was similar in both groups (84% and 85%). The safety evaluation showed for both groups a good safety and tolerability profile, however, there is a significant lower incidence of adverse events (p<0.0001) in favor of the herbal treatment. None of the postmenopausal iCR patients experienced vaginal bleeding in contrast to tibolone (17 cases). Breast and abdominal pain as well as leukorrhea was mostly observed in the tibolone group (p=0.015, p=0.008, p=0.002). No serious adverse event was observed in the iCR-group, however, two occurred in the tibolone-group. The benefit-risk balance for iCR was significantly (p=0.01) superior to tibolone (MWV=0.56; 95% confidence interval [0.51-0.62]). CONCLUSION: The efficacy of iCR (medicinal product Remifemin) is as good as tibolone for the treatment of climacteric complaints, even for moderate to severe symptoms, whereby iCR is clearly superior regarding the safety profile. This iCR containing medicinal product is an excellent option for treatment of climacteric complaints which has now for the first time been verified in Asian women.
PMID: 17587516 [PubMed - indexed for MEDLINE]
The effect of vitamin E on hot flashes in menopausal women.
The effect of vitamin E on hot flashes in menopausal women.
Gynecol Obstet Invest. 2007;64(4):204-7
Authors: Ziaei S, Kazemnejad A, Zareai M
BACKGROUND: Hot flashes affect as many as 75% of menopausal women. Estrogen reliably reduces the severity of hot flashes and remain the single most effective treatment. Today, however, more and more women are seeking alternatives. Instead of hormonal therapy, women are turning to vitamins, and other over-the-counter products for relief from hot flashes. This study was undertaken to assess the effect of vitamin E on hot flashes. METHOD: A placebo double blind-controlled trial was conducted. After 1 week baseline period, the enrolled patients (n = 51) received placebo (identical in appearance to vitamin E softgel) daily for 4 weeks, followed by 1 week wash out and 400 IU vitamin E (softgel cap) daily for the next 4 weeks. Diary was used to measure hot flashes before and at the end of the study. RESULT: There were statistical significant differences in hot flashes severity score (2.37 +/- 0.74, 1.80 +/- 0.87) and their daily frequency (5.00 +/- 3.34, 3.19 +/- 2.74) after the treatments between the placebo and vitamin E therapies (p < 0.0001). CONCLUSION: Based on our trial, vitamin E is recommended for the treatment of hot flashes.
PMID: 17664882 [PubMed - indexed for MEDLINE]
Pilot evaluation of flaxseed for the management of hot flashes.
Pilot evaluation of flaxseed for the management of hot flashes.
J Soc Integr Oncol. 2007;5(3):106-12
Authors: Pruthi S, Thompson SL, Novotny PJ, Barton DL, Kottschade LA, Tan AD, Sloan JA, Loprinzi CL
The objective of this study was to evaluate, in a phase 2 pilot study, tolerability and the effect of 6 weeks of flaxseed therapy on hot flash scores in women not wishing to receive estrogen therapy. Eligibility included 14 hot flashes per week for at least 1 month. In the baseline week, participants took no study medication and documented the characteristics of their hot flashes. Thereafter, crushed flaxseed was administered at 40 g daily. Participants provided weekly toxicity reports and health-related quality of life information. The primary end point was a change in hot flash score prospectively reported in a daily hot flash diary. Thirty women were enrolled between June 17 and November 8, 2005. The mean decrease in hot flash scores after flaxseed therapy was 57% (median decrease 62%). The mean reduction in daily hot flash frequency was 50% (median reduction 50%), from 7.3 hot flashes to 3.6. Fourteen of the 28 participants (50%) experienced mild or moderate abdominal distention. Eight participants (29%) experienced mild diarrhea, one experienced flatulence, and six (21%) withdrew because of toxicities. This study suggests that dietary therapy decreases hot flash activity in women not taking estrogen therapy. This reduction is greater than what would be expected with placebo.
PMID: 17761129 [PubMed - indexed for MEDLINE]
The safety and benefits of soybean isoflavones. A natural alternative to conventional hormone therapy?
The safety and benefits of soybean isoflavones. A natural alternative to conventional hormone therapy?
Menopause. 2007 Sep-Oct;14(5):958; author reply 958-9
Authors: Messina M
PMID: 17667149 [PubMed - indexed for MEDLINE]
Sensitive and rapid method to quantify icaritin and desmethylicaritin in human serum using gas chromatography-mass spectrometry.
Sensitive and rapid method to quantify icaritin and desmethylicaritin in human serum using gas chromatography-mass spectrometry.
J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Sep 15;857(1):47-52
Authors: Shen P, Wong SP, Yong EL
The prenyl-flavones, icaritin and desmethylicaritin, are bioactive compounds from the traditional Chinese medicinal herb, Epimedium, extracts of which can enhance bone health in animal models. In order to examine their bioavailability in humans, we have developed and validated a sensitive method to quantify icaritin and desmethylicaritin in human sera, using gas chromatography-mass spectrometry. The serum samples were extracted with ethyl acetate and then derivatized with BSTFA in pyridine (4:1). With genistein as internal standard, calibration curves with good linearity (R(2)>0.99) within the concentration range of 0.15-10nM in the selective ion monitoring mode were obtained. The limits of detection and quantization were 11 and 33 pM for icaritin, and 23 and 70 pM for desmethylicaritin, respectively; inter- and intra-assay variabilities were <15%, and accuracies were between 89 and 110%. Icaritin, but not desmethylicaritin, was detected from 1h, increasing to a peak at 8h (1.51+/-1.6 nM) in sera of human volunteers after ingestion of an aqueous decoction of Epimedium. This sensitive method can be used to quantify serum levels of icaritin and desmethylicaritin for pharmacokinetic studies.
PMID: 17632044 [PubMed - indexed for MEDLINE]
Effect of Pueraria mirifica on vaginal health.
Effect of Pueraria mirifica on vaginal health.
Menopause. 2007 Sep-Oct;14(5):919-24
Authors: Manonai J, Chittacharoen A, Theppisai U, Theppisai H
OBJECTIVE: To evaluate the effect of Pueraria mirifica on vaginal symptoms, vaginal health index, vaginal pH, and vaginal cytology in healthy postmenopausal women. DESIGN: A randomized, double-blind, placebo-controlled study. Healthy postmenopausal women, age 45 to 60 years old, were enrolled voluntarily and randomly received 20, 30, or 50 mg of Pueraria mirifica in capsules or placebo in identical capsules once daily for 24 weeks. RESULTS: After 24 weeks of treatment, 71 women were evaluated. Fifty-one of 71 randomly received one of the three doses of Pueraria mirifica, and the remaining 20 received placebo. The mean vaginal dryness symptom in the Pueraria mirifica group decreased after 12 weeks of treatment. Pueraria mirifica increased vaginal maturation index (parabasal:intermediate:superficial cells) from 46:43:11 to 11:65:24 after 24 weeks of treatment. There was no significant difference of adverse effects between the Pueraria mirifica and placebo groups in this study. CONCLUSIONS: Pueraria mirifica was proven to exhibit estrogenicity on vaginal tissue, to alleviate vaginal dryness symptoms and dyspareunia, to improve signs of vaginal atrophy, and to restore the atrophic vaginal epithelium in healthy postmenopausal women.
PMID: 17415017 [PubMed - indexed for MEDLINE]
