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ABSTRACT: The aim of this study was to conduct a pilot study for the feasibility of planning a definitive clinical trial comparing traditional acupuncture (TA) with sham acupuncture (SA) and waiting control (WC) on menopause-related vasomotor symptoms (VMS), quality of life, and the hypothalamic-pituitary-adrenal axis in perimenopausal and postmenopausal women.
Thirty-three perimenopausal and postmenopausal women with at least seven VMS daily were randomized to TA, SA, or WC. The TA and SA groups were given three treatments per week for 12 weeks. Outcomes included the number and severity of VMS, Menopause-Specific Quality of Life Questionnaire, Beck Depression Inventory, Spielberg State-Trait Anxiety Instrument, Pittsburgh Quality Sleep Index, 24-hour urine cortisol and metabolites, and adrenocorticotropic hormone stimulation testing.
Both the TA and SA groups demonstrated improved VMS trends compared with the WC group (Δ -3.5 ± 3.00 vs -4.1 ± 3.79 vs -1.2 ± 2.4, respectively; P = 20) and significantly improved Menopause-Specific Quality of Life Questionnaire vasomotor scores (Δ -1.5 ± 2.02 vs -1.8 ± 1.52 vs -0.3 ± 0.64, respectively; P = 0.04). There were no psychosocial group differences. Exit 24-hour urinary measures were lower in the TA versus the SA or WC group in total cortisol metabolites (4,658.9 ± 1,670.9 vs 7,735.8 ± 3,747.9 vs 5,166.0 ± 2,234.5, P = 0.03; respectively) and dehydroepiandrosterone (41.4 ± 27.46, 161.2 ± 222.77, and 252.4 ± 385.40, respectively; P = 0.05). The response data on adrenocorticotropic hormone stimulation cortisol also trended in the hypothesized direction (P = 0.17).
Both TA and SA reduce VMS frequency and severity and improve VMS-related quality of life compared with WC; however, TA alone may impact the hypothalamic-pituitary-adrenal axis. This association is viewed as preliminary and hypothesis generating and should be explored in a large clinical trial.
Menopause (New York, N.Y.) 01/2012; 19(1):54-61. · 3.08 Impact Factor
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ABSTRACT: An increased risk of breast cancer is associated with alcohol consumption; however, it is controversial whether red wine increases this risk. Aromatase inhibitors (AIs) prevent the conversion of androgens to estrogen and occur naturally in grapes, grape juice, and red, but not white wine. We tested whether red wine is a nutritional AI in premenopausal women.
In a cross-over design, 36 women (mean age [SD], 36 [8] years) were assigned to 8 ounces (237 mL) of red wine daily then white wine for 1 month each, or the reverse. Blood was collected twice during the menstrual cycle for measurement of estradiol (E2), estrone (E1), androstenedione (A), total and free testosterone (T), sex hormone binding globulin (SHBG), luteinizing hormone (LH), and follicle stimulating hormone (FSH).
Red wine demonstrated higher free T vs. white wine (mean difference 0.64 pg/mL [0.2 SE], p=0.009) and lower SHBG (mean difference -5.0 nmol/L [1.9 SE], p=0.007). E2 levels were lower in red vs. white wine but not statistically significant. LH was significantly higher in red vs. white wine (mean difference 2.3 mIU/mL [1.3 SE], p=0.027); however, FSH was not.
Red wine is associated with significantly higher free T and lower SHBG levels, as well as a significant higher LH level vs. white wine in healthy premenopausal women. These data suggest that red wine is a nutritional AI and may explain the observation that red wine does not appear to increase breast cancer risk.
Journal of Women s Health 12/2011; 21(3):281-4. · 1.57 Impact Factor
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ABSTRACT: Patients who undergo thyroidectomy often complain of weight gain, which they frequently attribute to inadequate thyroid hormone replacement. To assess the weight changes associated with thyroid hormone replacement or suppressive therapy after thyroidectomy, we measured the weights of patients before and after thyroidectomy and compared them to the weights of euthyroid patients with thyroid nodules who were being followed for many years.
The weights and heights of 67 women and 35 men who underwent total thyroidectomy for thyroid cancer were recorded before and for a mean of 8.3 years after thyroidectomy. All patients received either suppressive or replacement doses of levothyroxine. As a comparison group, 70 women and 22 men with goiter or thyroid nodules and were euthyroid had serial measurements of height and weight. They were followed for a mean of 7.6 years. The body mass index (BMI) and age-adjusted BMI percentiles were calculated. The weight, BMI, and BMI percentile changes were compared both unadjusted and adjusted for age, gender, thyrotropin (TSH) level, and duration between measurements.
At baseline, patients with thyroid nodules were older (mean 50.4 years) than those with thyroid cancer (mean 45.8 years). There were no significant differences in baseline weight, BMI, or BMI percentile. The baseline TSH levels were lower for patients with thyroid cancer (mean 0.8 mIU/L) than for those with nodules (mean 1.8 mIU/L) (p=0.002). There were no significant differences between the changes in weight, BMI, or BMI percentile from the start to the completion of the study whether unadjusted or after adjustment for age, gender, TSH, and duration of follow-up.
Despite the perception of many patients that their thyroidectomy and thyroid hormone replacement or suppressive therapy is responsible for their subsequent weight gain, there were no significant differences in weight gain over time in comparison to a control group of euthyroid patients with thyroid nodules or goiter.
Thyroid: official journal of the American Thyroid Association 11/2011; 21(12):1339-42. · 2.60 Impact Factor
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Puja K Mehta,
Pavel Goykhman,
Louise E J Thomson,
Chrisandra Shufelt,
Janet Wei, Yuching Yang,
Edward Gill,
Margo Minissian,
Leslee J Shaw,
Piotr J Slomka,
Melissa Slivka,
Daniel S Berman,
C Noel Bairey Merz
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ABSTRACT: We conducted a pilot study for a large definitive clinical trial evaluating the impact of ranolazine in women with angina, evidence of myocardial ischemia, and no obstructive coronary artery disease (CAD).
Women with angina, evidence of myocardial ischemia, but no obstructive CAD frequently have microvascular coronary dysfunction. The impact of ranolazine in this patient group is unknown.
A pilot randomized, double-blind, placebo-controlled, crossover trial was conducted in 20 women with angina, no obstructive CAD, and ≥ 10% ischemic myocardium on adenosine stress cardiac magnetic resonance (CMR) imaging. Participants were assigned to ranolazine or placebo for 4 weeks separated by a 2-week washout. The Seattle Angina Questionnaire and CMR were evaluated after each treatment. Invasive coronary flow reserve (CFR) was available in patients who underwent clinically indicated coronary reactivity testing. CMR data analysis included the percentage of ischemic myocardium and quantitative myocardial perfusion reserve index (MPRI).
The mean age of subjects was 57 ± 11 years. Compared with placebo, patients on ranolazine had significantly higher (better) Seattle Angina Questionnaire scores, including physical functioning (p = 0.046), angina stability (p = 0.008), and quality of life (p = 0.021). There was a trend toward a higher (better) CMR mid-ventricular MPRI (2.4 [2.0 minimum, 2.8 maximum] vs. 2.1 [1.7 minimum, 2.5 maximum], p = 0.074) on ranolazine. Among women with coronary reactivity testing (n = 13), those with CFR ≤ 3.0 had a significantly improved MPRI on ranolazine versus placebo compared to women with CFR > 3.0 (Δ in MPRI 0.48 vs. -0.82, p = 0.04).
In women with angina, evidence of ischemia, and no obstructive CAD, this pilot randomized, controlled trial revealed that ranolazine improves angina. Myocardial ischemia may also improve, particularly among women with low CFR. These data document approach feasibility and provide outcome variability estimates for planning a definitive large clinical trial to evaluate the role of ranolazine in women with microvascular coronary dysfunction. (Microvascular Coronary Disease In Women: Impact Of Ranolazine; NCT00570089).
JACC. Cardiovascular imaging 05/2011; 4(5):514-22. · 14.29 Impact Factor
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Chrisandra L Shufelt,
B Delia Johnson,
Sarah L Berga,
Glenn D Braunstein,
Steven E Reis,
Vera Bittner, YuChing Yang,
Carl J Pepine,
Barry L Sharaf,
George Sopko,
Sheryl F Kelsey,
C Noel Bairey Merz
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ABSTRACT: The aim of this study was to assess the relationship of the timing of hormone therapy (HT) use with angiographic coronary artery disease (CAD) and cardiovascular disease (CVD) events in women with natural versus surgical menopause.
We studied 654 postmenopausal women undergoing coronary angiography for the evaluation of suspected ischemia. Timing and type of menopause, HT use, and quantitative angiographic evaluations were obtained at baseline, and the women were followed for a median of 6 years for CVD events.
Ever users of HT had a significantly lower prevalence of obstructive CAD compared with never users (age-adjusted odds ratio, 0.41 [0.28-0.60]). Women with natural menopause initiating HT before age 55 years had lower CAD severity compared with never users (age-adjusted β [SE] = -6.23 [1.50], P < 0.0001), whereas those initiating HT at age 55 years or more did not differ statistically from never users (-3.34 [2.13], P = 0.12). HT use remained a significant predictor of obstructive CAD when adjusted for a "healthy user" model (odds ratio, 0.44 [0.30-0.73]; P = 0.002). An association between HT and fewer CVD events was observed only in the natural menopause group (hazard ratio [95% CI], 0.60 [0.41-0.88]; P = 0.009) but became nonsignificant when adjusted for the presence or severity of obstructive CAD.
Using the quantitative measurements of the timing and type of menopause and HT use, earlier initiation of HT was associated with less angiographic CAD in women with natural but not surgical menopause. Our data suggest that the effect of HT use on reduced cardiovascular event rates is mediated by the presence or absence of angiographic obstructive atherosclerosis.
Menopause (New York, N.Y.) 04/2011; 18(9):943-50. · 3.08 Impact Factor
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Mariko L Ishimori,
Rebecca Martin,
Daniel S Berman,
Pavel Goykhman,
Leslee J Shaw,
Chrisandra Shufelt,
Piotr J Slomka,
Louise E J Thomson,
Jay Schapira, Yuching Yang,
Daniel J Wallace,
Michael H Weisman,
C Noel Bairey Merz
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ABSTRACT: the purpose of this study was to evaluate the presence of myocardial ischemia measured by adenosine stress cardiac magnetic resonance (CMR) using visual myocardial perfusion and a quantitative myocardial perfusion reserve index (MPRI) in the absence of obstructive coronary artery disease (CAD) in women with systemic lupus erythematosus (SLE) with anginal chest pain (CP).
ischemic heart disease is a leading cause of morbidity and mortality in SLE. Previous studies demonstrated the presence of perfusion defects using adenosine stress CMR in patients with CP and no obstructive CAD, consistent with microvascular coronary dysfunction in patients without SLE.
Twenty female SLE patients with typical and atypical anginal CP were prospectively enrolled. Patients with established cardiovascular disease were excluded. CMR was performed with 0.05 mmol/kg gadolinium adenosine stress first-pass perfusion in SLE patients and in 10 asymptomatic reference control women. SLE patients also underwent 64-slice coronary computed tomography angiography. CMR was scored visually and quantitatively (MPRI).
among 18 patients with complete data, no patient had obstructive CAD; however, 8 of 18 (44%) displayed visual perfusion defects on stress CMR compared with 0 in 10 control subjects (p = 0.014). The mean MPRI in patients versus controls was 2.0 ± 0.4 versus 2.4 ± 0.4 (p = 0.031) in the subepicardium and 1.8 ± 0.3 versus 2.1 ± 0.4 (p = 0.24) in the subendocardium. Multivariate linear regression revealed that SLE was the only predictor of subepicardial (p < 0.0025; β = -1.059) and subendocardial (p < 0.05; β = -0.529) MPRIs.
we observed a 44% prevalence of abnormal stress myocardial perfusion by CMR in the absence of obstructive CAD in SLE patients with anginal CP. Compared with controls, reduced MPRI was observed in SLE patients, and SLE presence was a significant predictor of an abnormal MPRI. These findings are consistent with the hypothesis that anginal CP in SLE patients without obstructive CAD is due to myocardial ischemia potentially caused by microvascular coronary dysfunction. Further research in a larger SLE population is warranted.
JACC. Cardiovascular imaging 01/2011; 4(1):27-33. · 14.29 Impact Factor
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ABSTRACT: The onset of menopause has been associated with an increase in cardiovascular risk factors. However, little information is available about the rapidity of the menopausal transition and its relationship to the development of preclinical cardiovascular disease (CVD).
Our objective was to assess whether the rate of carotid intima-media thickness (cIMT) progression over time differs according to 1) menopausal status and 2) rapidity of the menopausal transition.
We evaluated 203 community-based women aged 45-60 yr without previously diagnosed CVD who underwent three repeated measurements of cIMT as a measure of preclinical CVD over 3 yr. Menopausal status was ascertained at each visit based on menstrual cycle parameters and reproductive hormone profiles. Of these, 21 remained premenopausal, 51 transitioned, and 131 were postmenopausal throughout the observation period.
Age-adjusted cIMT progression rates were similar among premenopausal, transitioning, and postmenopausal women. In the 51 transitioning women, age was not related to rate of cIMT progression. However, the rapidity of menopausal transition was related to cIMT progression: women transitioning from pre- to postmenopause within the 3-yr period had a higher rate of cIMT progression compared with women with a slower transition. Statistical adjustments for the significant covariates of systolic blood pressure, body mass index, race, cigarette smoking, or hormone therapy use did not alter the findings.
Among healthy women undergoing repeated cIMT measurement, a more rapid menopausal transition was associated with a higher rate of preclinical CVD progression measured by cIMT. Further work is needed to explore potential mechanisms of this effect.
The Journal of clinical endocrinology and metabolism 09/2010; 95(9):4432-40. · 6.50 Impact Factor
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C Noel Bairey Merz,
B Delia Johnson,
Sarah L Berga,
Glenn D Braunstein,
Ricardo Azziz, Yuching Yang,
Steven E Reis,
Vera Bittner,
T Keta Hodgson,
Carl J Pepine,
Barry L Sharaf,
George Sopko,
Sheryl F Kelsey
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ABSTRACT: It has been suggested that both endogenous reproductive hormones and hormone therapy may play a protective role against coronary artery disease (CAD). However, recent clinical trials have failed to demonstrate the benefit of a variety of forms of hormone therapy. The observational data on the role of endogenous reproductive hormones, using surrogate measures such as number of birth, age at menarche, and age at menopause are inconsistent. In addition, the longer-term associations have not been evaluated. The aim of this study was to evaluate the relationships between detailed measurements of endogenous and exogenous estrogen exposure time with angiographic CAD and major adverse cardiovascular events.
We assessed total estrogen exposure time, quantitative CAD by a core angiography laboratory, and prospectively measured major adverse cardiovascular events in 646 postmenopausal women undergoing coronary angiography for evaluation for suspected ischemia in the Women's Ischemia Syndrome Evaluation (WISE) study.
Timing of postmenopausal exogenous hormone therapy (HT) use was associated with reduced CAD. Two summarized total estrogen time scores (TET and sTET) were not related to angiographic CAD after accounting for HT use. In addition, these scores were not related to cardiovascular events over a median of 6.0 years of follow-up.
There was no independent relation of estrogen exposure time to angiographic CAD or major adverse cardiovascular events in a contemporary cohort of postmenopausal women evaluated for suspected ischemia. Our results suggest that the paradigm of estrogen protection from CAD in women may be more complex than estrogen exposure duration alone.
Journal of Women s Health 09/2009; 18(9):1315-22. · 1.57 Impact Factor
