APPENDIX C
Selected Studies of Women’s Health

This appendix presents a selection of major studies that have looked at a wide variety of end points and issues related to women’s health. Much has been done over the years and this appendix is not a complete or comprehensive review. Rather, it is an overview of a few selected large ongoing multi-publication studies that look at a variety of risk factors and outcomes related to women’s health. The studies included here are all based in the United States and funded by the National Institutes of Health (NIH).

WOMEN’S HEALTH INITIATIVE

Study Objective and Design

The Women’s Health Initiative (WHI) included clinical trials, observational studies, and a community prevention study.

Three clinical trials were designed to test the effects of calcium and vitamin D supplements, diet modification, and postmenopausal hormone therapy on heart disease, fractures, and breast and colorectal cancer in healthy postmenopausal women 50–79 years old. Specific objectives of the trials were as follows:

  1. Calcium and vitamin D (CaD) study—To examine the effects of calcium plus vitamin D supplements (1,000 mg of calcium carbonate and 400 IU of vitamin D daily) compared with placebo on fractures and colorectal cancer in postmenopausal women. (The study also looked at effects of CaD on weight gain.)



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appendix C Selected Studies of Women’s Health This appendix presents a selection of major studies that have looked at a wide variety of end points and issues related to women’s health. Much has been done over the years and this appendix is not a complete or comprehensive review. Rather, it is an overview of a few selected large ongoing multi-publication stud- ies that look at a variety of risk factors and outcomes related to women’s health. The studies included here are all based in the United States and funded by the National Institutes of Health (NIH). WOMEN’S HEALTH INITIATIVE Study Objective and Design The Women’s Health Initiative (WHI) included clinical trials, observational studies, and a community prevention study. Three clinical trials were designed to test the effects of calcium and vitamin D supplements, diet modification, and postmenopausal hormone therapy on heart disease, fractures, and breast and colorectal cancer in healthy postmenopausal women 50–79 years old. Specific objectives of the trials were as follows: 1. Calcium and vitamin D (CaD) study—To examine the effects of cal- cium plus vitamin D supplements (1,000 mg of calcium carbonate and 400 IU of vitamin D daily) compared with placebo on fractures and colorectal cancer in postmenopausal women. (The study also looked at effects of CaD on weight gain.) 0

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0 WOMEN’S HEALTH RESEARCH 2. Dietary-modification trial—To examine the effects of a low-fat diet (20% of daily calories from fat), increased fruit and vegetable consump- tion (5 or more servings per day), and increased grain consumption (6 or more servings per day) compared with usual diet on breast cancer, colorectal cancer, and heart disease in postmenopausal women. (The trial also looked at effects of this diet modification on Type 2 diabetes and ovarian cancer.) 3. Hormone trial1—To examine the effects on coronary heart disease and osteoporotic fractures and associated risk of breast cancer of (1) estrogen plus progestin2 compared with placebo in postmenopausal women with a uterus, and (2) of estrogen alone3 compared with placebo in postmeno- pausal women without a uterus. A prospective observational study was also conducted to produce reliable estimates of the extent to which known risk factors predict heart disease, can - cers, and fractures; to identify “new” risk factors for these and other diseases in women; to compare risk factors, presence of disease at the start of the study, and new occurrences of disease during the WHI in all study components; and to create a future resource for identifying biologic indicators of disease, especially substances and factors found in blood. A WHI Extension Study to encompass 5 years of additional followup (from 2005–2010) includes participants from both the clinical trial and observational WHI components. The purposes of the additional followup are to describe the longer-term effects of the original interventions, to document change in hormone use in participants from the hormone therapy trials, to expand the list of scientific questions that can be reliably addressed in the WHI, and to provide an infrastruc - ture able to support additional investigations that require some of the unique features of a very large longitudinal study of postmenopausal women. A community prevention study to develop carefully evaluated, model pro - grams that could be implemented in a wide variety of communities throughout the United States was also conducted but will not be described here. Participant Enrollment Participants were recruited at 40 clinical centers around the United States over a 5-year period—September 1993–December 1998—with a planned average of 8 years of followup and 2 years for data analysis. A total of 161,808 generally healthy postmenopausal women 50–79 years old were enrolled. 1The hormone trials have ended but the women who were enrolled in these trials participated in a followup phase, which concluded in 2010. 2 Consisting of 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate. 3 Consisting of 0.625 mg of conjugated equine estrogens.

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0 APPENDIX C A total of 68,132 women were enrolled in the clinical trials. Women could enroll in one or more of the clinical trials. The final enrollment breakdown was as follows: • CaD study, 36,282 • Dietary-modification trial, 48,835 • Hormone trial, 27,347; 16,608 women were enrolled in the estrogen-plus- progestin study and 10,739 in the estrogen-alone study In both hormone trials and in the CaD trial there was a 1:1 randomized and double-blind allocation between active and placebo study pills. In the dietary- modification trial, 40% of enrollees were assigned to the low-fat eating pattern and 60% to the comparison group.4 The observational study enrolled 93,676 women who were determined to be ineligible or unwilling to participate in the clinical trials. The WHI Extension Study enrolled 115,400 consenting participants from each of the original WHI study components for an additional 5 years of followup, from 2005 to 2010. Data Collection5 Data on participants’ past hormone use at baseline, with current medi- cations and current supplements, were collected for participants in both the clinical trial and the observational study through in-person interviews. Physical measurements and blood samples were taken at baseline, and thereafter physi - cal measurements were taken annually for clinical-trial participants and at year 3 for observational-study participants. Data on clinical-trial patients’ current medications and supplements were assessed for clinical-trial participants at years 1, 3, 6, and 9, and on observational-study participants’ medications and supplements at year 3. Twice a year, all clinical-trial participants completed a medical-history ques- tionnaire to assess outcomes, such as hospitalizations, heart disease, stroke, frac - tures, and cancer. Observational-study participants completed a medical history questionnaire annually to assess outcomes. Observational-study participants also completed a self-administered followup survey each year except study year 2. The survey was modified each year. In general, it asked participants to provide information about their weight and any changes in weight; respond to questions about health behaviors, such as physical activity, alcohol and caffeine consump - 4The imbalanced randomization was set to reduce the higher staff and material costs associated with implementing the intervention while maintaining statistical power for testing hypotheses. 5 S ee the frequency-of-data collection table at h ttp://www.whiscience.org/data/collection_ frequency_grid.pdf (accessed April 8, 2010) for a more detailed description of the data that were captured and when for each study component.

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0 WOMEN’S HEALTH RESEARCH tion, and smoking status; and provide information about exposures, such as use of hormone therapy and other medications.6 Both clinical-trial and observational-study participants completed a base - line food-frequency questionnaire (FFQ). A rotating sample of one-third of dietary-modification–trial participants completed annual followup FFQs and observational-study participants completed a followup FFQ at year 3. For CaD participants, management and safety interviews to assess symp - toms, adherence, and pill tolerance were conducted 4 weeks after randomization and repeated semi-annually thereafter while the participants were taking study pills. Management and safety interviews were conducted for hormone-therapy participants 6 weeks after randomization and semiannually thereafter. Physi - cal and gynecological examination data were collected at annual clinic visits for hormone-therapy participants and reviewed for safety concerns. Hormone- therapy participants were also required to have a mammography annually, and study pills were not dispensed if a benign mammography report had not been received in the previous 18 months. Participants in the CaD and dietary-modification trials were followed over an average of 7 years and 8.1 years, respectively. Participants in the estrogen-plus- progestin and the estrogen-only trials were followed over an average of 5.6 years and 7.1 years, respectively. In the WHI Extension Study, annual updates on health outcomes are col - lected by mail from all enrolled participants. Women who report study outcomes that require documentation are contacted by field-center staff to document details of the outcome. All participants also receive an annual activities-of-daily-life as - sessment and complete a one-time medical-history–update addendum. A 4.6% subsample of women who were in the WHI dietary-modification–trial are asked to complete one 24-hour recall during the Extension Study. Half of the subsample completed the recall toward the start of the Extension Study (around 2006–2007) and half toward the end (2009–2010). Participants who were in the hormone- therapy trial also complete a “Hormone Use Update” form annually. For the first 2 years of extension followup, WHI field centers collected annual mammography reports for hormone therapy participants. 6The annual followup response rate was over 94% each year for those who were due for a fol - lowup contact. At the year 3 clinic visit, 96% completed medical-history updates and 83% provided blood samples. At the end of the closeout period, 4.1% were either lost to followup or had stopped followup, and 6.1% were deceased.

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0 APPENDIX C Findings The WHI has yielded numerous publications. The portions of the abstracts dealing with results, organized by study component and health condition, are presented in Tables C-1–C-6. TABLE C-1 Publications on Women’s Health Initiative Calcium and Vitamin D Study Colorectal Cancer Wactawski- A total of 322 women were diagnosed with invasive colorectal cancer during the Wende study period. There were no significant differences in colorectal cancer diagnoses et al., 2006 between participants who took the active CaD supplements and those who took placebo pills (168 and 154 cases; hazard ratio, 1.08; 95 percent CI, 0.86 to 1.34; P = 0.51). There were also no differences between the two groups in types of colorectal cancers or reported number of colon polyps. No differences were found when analysis was limited to participants taking most of their study pills and when taking into account participants’ personal calcium and vitamin D intakes. Fractures Jackson “Calcium with vitamin D supplementation resulted in a small but significant et al., 2006 improvement in hip bone density and did not significantly reduce hip fracture. . . . Hip bone density was 1.06 percent higher in the calcium plus vitamin D group than in the placebo group (P < 0.01). Intention-to-treat analysis indicated that participants receiving calcium plus vitamin D supplementation had a hazard ratio of 0.88 for hip fracture (95 percent confidence interval, 0.72 to 1.08), 0.90 for clinical spine fracture (0.74 to 1.10), and 0.96 for total fractures (0.91 to 1.02). The risk of renal calculi increased with calcium plus vitamin D (hazard ratio, 1.17; 95 percent confidence interval, 1.02 to 1.34). Censoring data from women when they ceased to adhere to the study medication reduced the hazard ratio for hip fracture to 0.71 (95 percent confidence interval, 0.52 to 0.97). Effects did not vary significantly according to prerandomization serum vitamin D levels.” Weight Gain Caan et al., At the end of the study, women in the group taking CaD supplements weighed an 2007 average of 0.28 pounds less than those taking the placebo pills, which is a small but statistically significant difference in weight change. Women taking active pills were also less likely to gain weight. The greatest benefits were seen in women whose total calcium intakes at the start of the study were below 1,200 mg/day, which is the current recommended dietary intake for women this age. These women, compared to women taking placebo, had a lower risk of gaining weight and had a higher likelihood of maintaining a stable weight (within 2.2 pounds of their starting weight) or losing weight (more than 2.2 pounds), after three years in the study. ABBREVIATIONS: CaD, calcium plus vitamin D; CI, confidence interval.

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0 WOMEN’S HEALTH RESEARCH TABLE C-2 Publications on Women’s Health Initiative Dietary Modification Trial Breast Cancer Prentice “Dietary fat intake was significantly lower in the dietary modification intervention et al., group compared with the comparison group. The difference between groups in change 2006 from baseline for percentage of energy from fat varied from 10.7% at year 1 to 8.1% at year 6. Vegetable and fruit consumption was higher in the intervention group by at least 1 serving per day and a smaller, more transient difference was found for grain consumption. The number of women who developed invasive breast cancer (annualized incidence rate) over the 8.1-year average follow-up period was 655 (0.42%) in the intervention group and 1072 (0.45%) in the comparison group (hazard ratio, 0.91; 95% confidence interval, 0.83–1.01 for the comparison between the 2 groups). Secondary analyses suggest a lower hazard ratio among adherent women, provide greater evidence of risk reduction among women having a high-fat diet at baseline, and suggest a dietary effect that varies by hormone receptor characteristics of the tumor.” Cardiovascular Disease (Heart Attack and Stroke) Howard “By year 6, mean fat intake decreased by 8.2% of energy intake in the intervention et al., vs the comparison group, with small decreases in saturated (2.9%), monounsaturated 2006 (3.3%), and polyunsaturated (1.5%) fat; increases occurred in intakes of vegetables/ fruits (1.1 servings/d) and grains (0.5 serving/d). Low-density lipoprotein cholesterol levels, diastolic blood pressure, and factor VIIc levels were significantly reduced by 3.55 mg/dL, 0.31 mm Hg, and 4.29%, respectively; levels of high-density lipoprotein cholesterol, triglycerides, glucose, and insulin did not significantly differ in the intervention vs comparison groups. . . . The numbers who developed CHD, stroke, and CVD (annualized incidence rates) were 1,000 (0.63%), 434 (0.28%), and 1,357 (0.86%) in the intervention and 1,549 (0.65%), 642 (0.27%), and 2,088 (0.88%) in the comparison group. The diet had no significant effects on incidence of CHD (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.90–1.06), stroke (HR, 1.02; 95% CI, 0.90–1.15), or CVD (HR, 0.98; 95% CI, 0.92–1.05). Excluding participants with baseline CVD (3.4%), the HRs (95% CIs) for CHD and stroke were 0.94 (0.86–1.02) and 1.02 (0.90–1.17), respectively. Trends toward greater reductions in CHD risk were observed in those with lower intakes of saturated fat or trans fat or higher intakes of vegetables/fruits.”

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 APPENDIX C TABLE C-2 Continued Colorectal Cancer Beresford “A total of 480 incident cases of invasive colorectal cancer occurred during a mean et al., follow-up of 8.1 (SD, 1.7) years. Intervention group participants significantly reduced 2006 their percentage of energy from fat by 10.7% more than did the comparison group at 1 year, and this difference between groups was mostly maintained (8.1% at year 6). Statistically significant increases in vegetable, fruit, and grain servings were also made. Despite these dietary changes, there was no evidence that the intervention reduced the risk of invasive colorectal cancer during the follow-up period. There were 201 women with invasive colorectal cancer (0.13% per year) in the intervention group and 279 (0.12% per year) in the comparison group (hazard ratio, 1.08; 95% confidence interval, 0.90–1.29). . . . Secondary analyses suggested potential interactions with baseline aspirin use and combined estrogen-progestin use status (P = .01 for each). Colorectal examination rates, although not protocol defined, were comparable between the intervention and comparison groups. Similar results were seen in analyses adjusting for adherence to the intervention.” Diabetes Tinker 3,342 participants developed diabetes mellitus that was treated by insulin or et al., medications over the study period. There was a 4% reduced risk (not statistically 2008 significant) of developing diabetes in the low-fat dietary change group compared to participants in the usual diet comparison group. Participants who reported greater reductions in fat intake after the first year had greater reductions in risk of diabetes (statistically significant). The trend of reduced risk was not statistically significant after accounting for weight loss. Ovarian Cancer Prentice There were 160 cases of ovarian cancer reported during the 8.1 years of the study’s et al., intervention phase, with statistically significant fewer new cases of ovarian cancer 2007 identified among the dietary change participants than usual diet participants. For the equivalent of every 100,000 low-fat dietary change participants per year there were 36 cases of ovarian cancer diagnosed, compared to 43 cases among usual diet participants. After the first four years of the study, there was a statistically significant 40% risk reduction in ovarian cancer among participants in the low-fat dietary change group compared to the usual diet group. The greatest reduction in cases was among dietary change participants who started with higher intakes of total fat as a percentage of calories and made the greatest reductions in fat intake. The reduced risk of ovarian cancer among the dietary change group compared to the usual diet group did not appear to be effected by the modest weight loss experienced by the dietary change group or by family history of ovarian cancer. ABBREVIATIONS: CHD, coronary heart disease; CI, confidence interval; CVD, cardiovascular disease; d, day; R, hazard ratio; SD, standard deviation.

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 WOMEN’S HEALTH RESEARCH TABLE C-3 Publications on Women’s Health Initiative Estrogen-Alone Triala Main Findings Anderson “Estimated hazard ratios (HRs) (95% confidence intervals [CIs]) for CEE [conjugated et al., equine estrogen] vs placebo for the major clinical outcomes available through 2004 February 29, 2004 (average follow-up 6.8 years), were: CHD [coronary heart disease], 0.91 (0.75–1.12) with 376 cases; breast cancer, 0.77 (0.59–1.01) with 218 cases; stroke, 1.39 (1.10–1.77) with 276 cases; PE [pulmonary embolism], 1.34 (0.87–2.06) with 85 cases; colorectal cancer, 1.08 (0.75–1.55) with 119 cases; and hip fracture, 0.61 (0.41–0.91) with 102 cases. Corresponding results for composite outcomes were: total cardiovascular disease, 1.12 (1.01–1.24); total cancer, 0.93 (0.81–1.07); total fractures, 0.70 (0.63–0.79); total mortality, 1.04 (0.88–1.22), and the global index, 1.01 (0.91–1.12). For the outcomes significantly affected by CEE, there was an absolute excess risk of 12 additional strokes per 10000 person-years and an absolute risk reduction of 6 fewer hip fractures per 10000 person-years. The estimated excess risk for all monitored events in the global index was a non-significant 2 events per 10,000 person-years.” Breast Cancer and Abnormal Mammograms Stefanick “After a mean (SD) follow-up of 7.1 (1.6) years, the invasive breast cancer hazard et al., ratio (HR) for women assigned to CEE vs placebo was 0.80 (95% confidence interval 2006 [CI], 0.62–1.04; P = .09) with annualized rates of 0.28% (104 cases in the CEE group) and 0.34% (133 cases in the placebo group). In exploratory analyses, ductal carcinomas (HR, 0.71; 95% CI, 0.52–0.99) were reduced in the CEE group vs placebo group; however, the test for interaction by tumor type was not significant ( P = .054). At 1 year, 9.2% of women in the CEE group had mammograms with abnormalities requiring follow-up vs 5.5% in the placebo group (P < .001), a pattern that continued through the trial to reach a cumulative percentage of 36.2% vs 28.1%, respectively ( P < .001); however, this difference was primarily in assessments requiring short interval follow-up.” Cognitive Impairment and Dementiab Shumaker The results from the CEE part of WHIMS (n = 2,947, only women 65 to 79 years et al., old enrolled) showed that 76 women in the CEE group developed mild cognitive 2004 impairment compared to 58 women in the placebo group. CEE participants tested slightly worse over time on yearly cognitive function questions, although the differences were small. The greatest cognitive decline was seen in women who had lower cognitive function when WHIMS began. Women taking CEE appeared to be at somewhat higher risk for developing dementia than those taking placebo. 47 women in WHIMS were found to have probable dementia—28 were taking CEE and 19 were taking placebo pills. An analysis of both CEE and CEE plus MPA (estrogen plus progestin) together showed that more women taking active hormones developed either dementia or mild cognitive impairment.

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 APPENDIX C TABLE C-3 Continued Coronary-Artery Calcification Manson Cardiac CT (computed tomography) scans were used to measure CAC in 1,064 et al., participants in the estrogen-alone trial at 28 of 40 WHI centers an average of 8.7 years 2007 after joining (7.4 years after they started study pills and 1.3 years after study pills were stopped). CAC scores were lower in women in the CEE estrogen group compared to those in the placebo group. The mean CAC score was 83.1 for CEE and 123.1 for placebo. After taking into account other heart disease risk factors, the risk of having mild-to-moderate CAC was 20–30% lower and the risk of severe CAC was 40% lower in the CEE group compared to placebo. Among only women who were taking their study pills regularly (at least 80% of the time), the risk of mild-to-moderate CAC was 40–50% lower and the risk of severe CAC was 60% lower in the CEE group compared to placebo. Diabetes Bonds “The cumulative incidence of treated diabetes was 8.3% in the oestrogen-alone group et al., and 9.3% in the placebo group (hazard ratio 0.88, 95% CI 0.77–1.01, p=0.072). During 2006 the first year of follow-up, a significant fall in insulin resistance (homeostasis model assessment of insulin resistance) in actively treated women compared with the control subjects (Year 1 baseline between-group difference −0.53) was seen. However, there was no difference in insulin resistance at the 3- or 6-year follow-up.” aNIH stopped the estrogen alone trial ahead of schedule in February 2004 primarily because of an increase in stroke risk in women taking study pills with estrogen alone. bConducted as part of the Women’s Health Initiative Memory Study (WHIMS), an ancillary study to the WHI that included women 65 years old and older. ABBREVIATIONS: CAC, coronary artery calcification; CEE, conjugated equine estrogen; CHD, coronary heart disease; CI, confidence interval; CT, computed tomography; HR, hazard ratio; MPA, medroxyprogesterone acetate; PE, pulmonary embolism; SD, standard deviation; WHIMS, Women’s Health Initiative Memory Study.

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 WOMEN’S HEALTH RESEARCH TABLE C-4 Publications on Women’s Health Initiative Estrogen-Plus- Progestin Trial Main Findings Rossouw “Estimated hazard ratios (HRs) (nominal 95% confidence intervals [CIs]) were as et al., 2002 follows: CHD [coronary heart disease], 1.29 (1.02–1.63) with 286 cases; breast cancer, 1.26 (1.00–1.59) with 290 cases; stroke, 1.41 (1.07–1.85) with 212 cases; PE [pulmonary embolism], 2.13 (1.39–3.25) with 101 cases; colorectal cancer, 0.63 (0.43–0.92) with 112 cases; endometrial cancer, 0.83 (0.47–1.47) with 47 cases; hip fracture, 0.66 (0.45–0.98) with 106 cases; and death due to other causes, 0.92 (0.74–1.14) with 331 cases. Corresponding HRs (nominal 95% CIs) for composite outcomes were 1.22 (1.09–1.36) for total cardiovascular disease (arterial and venous disease), 1.03 (0.90–1.17) for total cancer, 0.76 (0.69–0.85) for combined fractures, 0.98 (0.82–1.18) for total mortality, and 1.15 (1.03–1.28) for the global index. Absolute excess risks per 10,000 person-years attributable to estrogen plus progestin were 7 more CHD events, 8 more strokes, 8 more PE [pulmonary embolisms], and 8 more invasive breast cancers, while absolute risk reductions per 10,000 person-years were 6 fewer colorectal cancers and 5 fewer hip fractures. The absolute excess risk of events included in the global index was 19 per 10,000 person-years.” 3-Year Followup After Discontinuing Estrogen Plus Progestin Heiss et al., “The risk of cardiovascular events after the intervention was comparable by initial 2008 randomized assignments, 1.97% (annualized rate) in the CEE plus MPA (343 events) and 1.91% in the placebo group (323 events). A greater risk of malignancies occurred in the CEE plus MPA than in the placebo group (1.56% [n = 281] vs 1.26% [n = 218]; hazard ratio [HR], 1.24; 95% confidence interval [CI], 1.04–1.48). More breast cancers were diagnosed in women who had been randomly assigned to receive CEE plus MPA vs placebo (0.42% [n = 79] vs 0.33% [n = 60]; HR, 1.27; 95% CI, 0.91–1.78) with a modest trend toward a lower HR during the follow-up after the intervention. All-cause mortality was somewhat higher in the CEE plus MPA than in the placebo group (1.20% [n = 233] vs 1.06% [n = 196]; HR, 1.15; 95% CI, 0.95– 1.39). The global index of risks and benefits was unchanged from randomization through March 31, 2005 (HR, 1.12; 95% CI, 1.03–1.21), indicating that the risks of CEE plus MPA exceed the benefits for chronic disease prevention.” Abnormal Mammograms and Breast Biopsies Chlebowski “Mammograms showing abnormal results were more common among women et al., 2008 taking hormones than among women taking placebo (35% vs 23%). Women taking hormones had a 4% greater risk of having a mammogram with abnormalities after one year of starting the hormones and an 11% greater risk after five years. After the hormones were stopped, the adverse effect on mammograms decreased somewhat, but remained significantly different from that of placebo for at least 12 months after stopping.” “Breast biopsies also were more common among women taking hormones than among those taking placebo (10% vs 6.1%). Breast cancers were significantly increased and were diagnosed at higher stages in the estrogen plus progestin group than in the placebo group; however, biopsies in the estrogen plus progestin group were less frequently diagnosed as cancer (14.8% vs 19.6%).”

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 APPENDIX C TABLE C-4 Continued Cognitive Functioning and Dementiaa Rapp et al., “A total of 4,381 participants provided at least 1 valid cognitive function score 2003 between June 1995 and July 8, 2002. . . .The mean total scores in both groups increased slightly over time (mean follow-up of 4.2 years). Women in the estrogen plus progestin group had smaller average increases in total scores compared with women receiving placebo (P = .03), but these differences were not clinically important. Removing women by censoring them after adjudicated dementia, mild cognitive impairment, or stroke, and nonadherence to study protocol, did not alter the findings. Prior hormone therapy use and duration of prior use did not affect the interpretation of the results, nor did timing of prior hormone therapy initiation with respect to the final menstrual period. More women in the estrogen plus progestin group had a substantial and clinically important decline (≥ 2 SDs) in total score (6.7%) compared with the placebo group (4.8%) (P = .008).” Shumaker Over an average of 4.05 years, 61 women were diagnosed with probable dementia, et al., 2004 40 (66%) in the estrogen plus progestin group compared with 21 (34%) in the placebo group. The hazard ratio (HR) for probable dementia was 2.05 (95% confidence interval [CI], 1.21–3.48; 45 vs 22 per 10,000 person-years; P = 0.01). This increased risk would result in an additional 23 cases of dementia per 10,000 women per year. Alzheimer disease was the most common classification of dementia in both study groups. Treatment effects on mild cognitive impairment did not differ between groups (HR, 1.07; 95% CI, 0.74–1.55; 63 vs 59 cases per 10,000 person- years; P = 0.72). Diabetes Margolis After an average of 5.6 years, 277 of the 8,014 women in the intervention group et al., 2004 (3.5%) and 324 of the 7,627 women taking placebo (4.2%) developed treated diabetes. This difference was not significant. Estrogen plus progestin produced a small decrease in glucose (blood sugar) and insulin levels in the blood and slightly reduced weight and waist size after one year in the study. Weight was not a major factor in the lower diabetes rate. continued

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