From the British Columbia Cancer Agency, Vancouver Cancer Centre, Vancouver Hospital and Health Sciences Centre, and University of British Columbia, Vancouver, British Columbia, Canada.
Vasomotor symptoms, such as hot flashes and night sweats, in breast cancer survivors are often worsened by chemotherapy and tamoxifen, and/or the discontinuation of hormone replacement therapy at diagnosis. This study evaluated the acceptability and effectiveness of a soy beverage containing phytoestrogens as a treatment for hot flashes in postmenopausal women with breast cancer.
Methods
A randomized, placebo-controlled, double-blind clinical trial was conducted in postmenopausal women with moderate hot flashes who were previously treated for early-stage breast cancer. Women were stratified for tamoxifen use and randomized to a soy beverage (n = 59) containing 90 mg of isoflavones or to a placebo rice beverage (n = 64). Women recorded the number and severity of hot flashes daily with a daily menopause diary for 4 weeks at baseline and for 12 weeks while consuming 500 mL of a soy or placebo beverage.
Results
There were no significant differences between the soy and placebo groups in the number of hot flashes or hot flash scores. However, presumably because of a strong placebo effect, both groups had significant reductions in hot flashes. Mild gastrointestinal side effects were experienced by both groups but occurred with greater frequency and severity with soy. The mean serum genistein concentration at 6 weeks was significantly higher in women who consumed soy (0.61 +/- 0.43 micromol/L) compared with placebo (0.43 +/- 0.37 micromol/L) (P =.02). Overall acceptability and compliance were high and similar in both groups.
Conclusion
The soy beverage did not alleviate hot flashes in women with breast cancer any more than did a placebo. Future research into other compounds is recommended to identify safe and effective therapies for hot flashes in breast cancer survivors.
soy phytoestrogens hot flashes postmenopausal breast cancer randomized trial, Prior JC soy isoflavones vasomotor symptoms breast cancer, isoflavone supplementation hot flash reduction placebo effect, phytoestrogen soy beverage menopausal symptoms breast cancer survivors, genistein serum levels hot flash treatment efficacy, tamoxifen chemotherapy vasomotor symptoms non-hormonal treatment, soy vs placebo hot flashes double-blind clinical trial, alternative therapy hot flashes breast cancer hormone replacement, postmenopausal vasomotor symptoms breast cancer safe treatment options, menopause diary hot flash score soy intervention outcome
PMID 11896091 11896091 DOI 10.1200/JCO.2002.20.6.1449 10.1200/JCO.2002.20.6.1449
Cite this article
Van Patten, C. L., Olivotto, I. A., Chambers, G. K., Gelmon, K. A., Hislop, T. G., Templeton, E., Wattie, A., & Prior, J. C. (2002). Effect of soy phytoestrogens on hot flashes in postmenopausal women with breast cancer: a randomized, controlled clinical trial. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 20(6), 1449-1455. https://doi.org/10.1200/JCO.2002.20.6.1449
Van Patten CL, Olivotto IA, Chambers GK, Gelmon KA, Hislop TG, Templeton E, et al. Effect of soy phytoestrogens on hot flashes in postmenopausal women with breast cancer: a randomized, controlled clinical trial. J Clin Oncol. 2002;20(6):1449-1455. doi:10.1200/JCO.2002.20.6.1449
Van Patten, C. L., et al. "Effect of soy phytoestrogens on hot flashes in postmenopausal women with breast cancer: a randomized, controlled clinical trial." Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol. 20, no. 6, 2002, pp. 1449-1455.
This study aims to evaluate the effects of myo-inositol supplementation on gestational diabetes mellitus (GDM) rates and body water distribution in overweight non-obese women. 223 overweight non-obese women pregnant were randomly assigned to the treatment group (2 g of myo-inositol plus 200 µg of folic acid) or to the placebo one (200 µg of folic acid). The treatment lasted until three weeks after delivery. A tetrapolar impedance analyser was used to study body composition. The incidence of GDM was significantly reduced in the myo-inositol group compared with the placebo group. There was a significant increase in TBW, ECW and ICW values in the placebo group compared to the myo-inositol group. We have recorded a significant reduction in the overall incidence of pregnancy-induced hypertension in the myo-inositol group compared with the placebo group. Our results demonstrate the effectiveness of myo-inositol supplementation in preventing GDM in overweight non-obese pregnant women.
InfertilityThyroid Autoimmunity TreatmentThyroid AntibodiesRandomized Controlled Trial
Open Access
Thyroid autoantibodies, specifically thyroid peroxidase antibodies, have been associated with miscarriage and pre-term birth in women with a normal thyroid function. Small randomised controlled trials have found that treatment with levothyroxine may reduce such adverse outcomes in pregnancy. The Thyroid AntiBodies and LEvoThyroxine (TABLET) trial was conducted to explore the effects of levothyroxine in euthyroid women with thyroid peroxidase antibodies. This was a randomised, double-blind, placebo-controlled, multicentre study conducted in 49 hospitals across the UK between 2011 and 2016. Euthyroid women who tested positive for thyroid peroxidase antibodies, were aged between 16 and 41 years and were trying to conceive either naturally or through assisted conception were eligible. Participants were randomised to levothyroxine at a dose of 50 mcg daily or placebo. The primary outcome was live birth at >= 34 completed weeks of gestation. Of the 19,556 women screened, 1420 were eligible and 952 were randomised. The live birth rate was 37% in the levothyroxine group and 38% in the placebo group (relative risk 0.97, 95% CI 0.83 to 1.14; p = 0.74). Levothyroxine therapy in a dose of 50 mcg per day does not improve live birth rate in euthyroid women with thyroid peroxidase antibodies.
PregnancyModifiable Risk FactorsDietary ExposuresRandomized Controlled Trial
Open Access
Purdue‐Smithe A et al., 2019·Current Developments in Nutrition
The association between caffeine and pregnancy loss remains controversial due to limitations of prior studies such as relying on self-reported intake only, exposure measurement after clinical confirmation of pregnancy, and potential time-varying confounding by nausea/vomiting and lifestyle factors, which may be affected by prior caffeine exposure. Thus, our aim was to evaluate associations of preconception and early pregnancy serum caffeine, paraxanthine, and theobromine, self-reported intake of caffeinated beverages, and risk of pregnancy loss among 1228 reproductive-age women attempting pregnancy in the EAGeR trial during 2007–2011. We estimated HRs and 95% CIs for any pregnancy loss, hCG loss (prior to ultrasound confirmation), and clinical loss (after ultrasound confirmation) according to caffeinated beverage intake and caffeine biomarkers measured at preconception and the 8(th) week of gestation using weighted adjusted Cox proportional hazards models. At preconception, 67%, 28%, and 9% of women reported any intake of caffeinated sodas, coffee, and tea, respectively. Preconception total caffeinated beverage intake of ≥3 vs. 0 cups/day was associated with 85% (95% CI: 1.18, 2.94) higher risk of any pregnancy loss, driven primarily by associations for hCG loss (HR: 2.88 (95% CI: 1.20, 6.91)). Caffeinated soda intake was associated with hCG loss (≥2 vs. 0.2 vs. ≤0.2 ng/mL) at preconception was strongly associated with hCG loss (HR: 4.51 (95% CI: 1.36, 14.91)). Serum caffeine, paraxanthine, and theobromine measured at the 8th week of gestation were not associated with risk of loss. Collectively, these data suggest that caffeine intake prior to pregnancy may increase risk of pregnancy loss, particularly in early gestation. Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, Bethesda, MD.
Body LiteracyFertility Knowledge InterventionsYoung Adult AwarenessRandomized Controlled Trial
Conceição C et al., 2017·Eur J Contracept Reprod Health Care
Recent evidence has shown that young adults have poor knowledge about reproductive health and fertility, and that interventions are needed to increase fertility awareness. The aim of this study was to assess the effectiveness of a brief video in increasing knowledge about fertility and infertility in young adults. We carried out a two-arm, parallel-group, randomised controlled trial with a pre-test/post-test design (NCT02607761, ClinicalTrials.gov). The sample was composed of 173 undergraduates who completed a self-report questionnaire. Participants were randomly assigned to exposure or no exposure to an educational video about reproductive health and infertility (intervention group, n = 89; control group, n = 84). At baseline, participants revealed poor knowledge of infertility risk factors and fertility issues, and average knowledge of the definition of infertility. Interaction effects between group and time were found for all variables targeted in the video. Participants in the intervention group significantly increased their knowledge of fertility issues, infertility risk factors and the definition of infertility. No significant differences in post-test knowledge were observed in the control group, except for the age at which there is a marked decrease in female fertility. A short video intervention is effective in increasing short-term knowledge about reproductive health and infertility. If future research using longer intervals corroborates our findings, video intervention could be a useful tool in public health prevention campaigns.