Use of Fermented Red Clover Isoflavones in the Treatment of Overactive Bladder in Postmenopausal Women: A Randomized, Double-Blinded, Placebo-Controlled Trial.

Postmenopausal women are at risk of developing an overactive bladder (OAB). Conventional vaginal estrogen has shown promise for symptom relief. Isoflavones have proven effective as an alternative to estrogen treatment against menopause-related symptoms. However, its effect on OAB symptoms has not been studied. This study investigates if fermented red clover isoflavones reduce OAB symptoms in postmenopausal women. In this randomized, double-blinded, placebo-controlled trial, women were administered red clover extract (RCE) or a placebo twice daily for three months. Women filled out the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) and Urinary Incontinence Short Form (ICIQ-UI-SF), together with a fluid intake and voiding diary. A total of 33 women (16 in the RCE group and 17 in the placebo group) were included in the analysis. Baseline demographics and OAB characteristics were comparable across groups. Intake of RCE did not lead to significant relief in most urinary bladder symptom measures, although a significant reduction in the bother of urinary urgency (p = 0.033) and a tendency towards a decreased ICIQ-OAB score were observed (p = 0.056). In contrast, the placebo exhibited a significant decrease in the ICIQ-OAB score (p = 0.021) and in some diary outcomes. We found that an intake of isoflavones did not relieve OAB symptoms in postmenopausal women.

Cancer Risk and Prognosis after a Hospital Contact for an Elevated Erythrocyte Sedimentation Rate.

BACKGROUND: An elevated erythrocyte sedimentation rate (ESR) may be a marker of occult cancer. METHODS: We linked Danish medical databases to examine cancer incidence in patients with a first-time hospital contact for elevated ESR during 1980 to 2013. We calculated standardized incidence ratios (SIR) of cancer compared with the general population, and comorbidity-adjusted HRs (aHR) versus matched population comparisons without elevated ESR. We also compared survival among patients with cancer with elevated ESR with that among patients with cancer without elevated ESR. RESULTS: During median follow-up of 4.9 years, we observed 3,926 cancers among 18,540 patients with a first-time hospital contact for elevated ESR. The risk for any cancer diagnosed during the first year following the contact for elevated ESR was 8.5% [95% confidence interval (CI), 8.1%-8.9%]. The overall 1-year cancer incidence was markedly elevated [SIR 5.3 (95% CI, 5.1-5.6); aHR 5.8 (95% CI, 5.4-6.3)] and was more than 3-fold elevated for most hematologic cancers and for cancers of the peritoneum and connective tissue in the abdominal wall, kidney, and adrenal glands. After the first year, patients were at increased risk of developing especially hematologic cancers. Patients diagnosed with cancer within 1 year after a contact for elevated ESR had poorer survival compared with matched cancer comparisons [adjusted mortality rate ratio 1.2 (95% CI, 1.1-1.3)]. CONCLUSIONS: Elevated ESR is a strong marker of undiagnosed cancer and is associated with poorer survival. IMPACT: Our findings may help clinicians in assessing absolute risk, common sites, and prognosis of cancers discovered after hospital contact with elevated ERS.

Diabetes, glycemic control, and risk of tuberculosis: a population-based case-control study.

OBJECTIVE: To examine the association between diabetes, glycemic control, and risk of tuberculosis (TB). RESEARCH DESIGN AND METHODS: We conducted a population-based case-control study in Northern Denmark. Cases of active TB were all individuals with a first-time principal hospital diagnosis of TB between 1980 and 2008. Each case subject was matched with up to five population control subjects with similar age, sex, place and length of residence in Denmark, and country of emigration. We computed odds ratios (ORs) for a first-time TB diagnosis among people with and without diabetes using regression to control for other comorbidities, alcoholism, immunosuppressive medications, and socioeconomic markers. RESULTS: We identified 2,950 patients, including 156 diabetic individuals (5.3%), with active TB, and 14,274 population control subjects, of which 539 had diabetes (3.8%). The adjusted OR for active TB among subjects with diabetes was 1.18 (95% CI 0.96-1.45) compared with nondiabetic individuals. We found a similar risk increase from diabetes in the 843 (29%) TB case subjects who were immigrants; adjusted OR = 1.23 (95% CI 0.78-1.93). In a subset with laboratory data, diabetic individuals with an HbA(1c) <7.0, 7-7.9, and ≥8.0% had ORs of 0.91 (0.51-1.63), 1.05 (0.41-2.66), and 1.19 (CI 0.61-2.30), respectively, compared with individuals without diabetes. CONCLUSIONS: In the low TB-burden country of Denmark, the TB risk increase associated with diabetes is substantially lower than previously suggested. We found no evidence for any association between TB and dysglycemia.

Predictors for pathologically confirmed aortitis after resection of the ascending aorta: a 12-year Danish nationwide population-based cross-sectional study.

INTRODUCTION: Assessing the prevalence of, and predictors for, pathologically-confirmed inflammation of the aorta in Denmark, using a nationwide population-based study design. METHODS: We identified all adults with first-time surgery on the ascending aorta between January 1, 1997 and March 1, 2009 in Denmark. Presence of aortic inflammation was ascertained through linkage to a nationwide pathology registry. We used logistic regression to compute prevalence odds ratios (ORs) for sex, age at surgery, cardiovascular risk factors, cancer, connective tissue disease, and infectious diseases associated with the presence of aortitis. RESULTS: A total of 1,210 adults underwent resection of the ascending aorta, of who 610 (50.4%) had tissue submitted for pathological examination. Aortitis was found in 37 (6.1%) patients whose tissue was examined. Ten of the 37 patients were diagnosed with conditions known to be associated with aortitis or aortic aneurysm: five patients with temporal arteritis, one with Crohn's disease, one with rheumatoid arthritis, one with systemic lupus erythematosus, one with infectious aortitis, and one with Marfan's disease. Twenty-seven patients had idiopathic aortitis. Predictors of aortitis included history of connective tissue disease (adjusted OR 4.7, 95% confidence interval (CI) 1.6, 13.6), diabetes (OR 5.2, 95% CI 0.9, 29.7), advanced age (> 67 years OR 2.5, 95% CI 0.8, 7.6), and aortic valve pathology (OR 2.3, 95% CI 1.1, 4.9). CONCLUSIONS: Aortitis was present in 6.1% of adults in Denmark who had pathological examination after resection of the ascending aorta. Predictors of inflammation included connective tissue disease, diabetes, advanced age, and aortic valve pathology.

Use of selective serotonin-reuptake inhibitors during early pregnancy and risk of congenital malformations: updated analysis.

BACKGROUND: Data on the safety of selective serotonin-reuptake inhibitors (SSRIs) in pregnancy are inconsistent. We examined associations between SSRI use during early pregnancy and risk of congenital malformations in infants. METHODS: Set in Northern Denmark, our population-based prevalence study included 216,042 women who had a live birth after the 20th week of gestation. We compared the prevalence of malformation in infants born to women who redeemed at least one SSRI prescription during early pregnancy with the prevalence in infants born to women who redeemed no SSRI prescriptions during their pregnancies. Drug use data were extracted from prescription databases, while data on congenital malformations were obtained from the National Registry of Patients. RESULTS: The 2,062 women with SSRI prescriptions during early pregnancy gave birth to 105 (5.1%) infants with malformations, while the 213,712 women with no SSRI prescriptions gave birth to 7,449 (3.5%) infants with malformations. SSRI use was associated with an increased risk of malformations overall (odds ratio [OR] = 1.3; 95% confidence interval (CI): 1.1-1.6) and cardiac malformations (OR = 1.7; 95% CI: 1.1-2.5). For specific SSRIs, we found an increased risk for septal defects associated with sertraline. CONCLUSIONS: We found little overall association between use of SSRIs during pregnancy and congenital malformations, but our findings suggest an association between maternal SSRI use in early pregnancy and cardiac malformations which could be causal.

The incidence of interstitial lung disease 1995-2005: a Danish nationwide population-based study.

BACKGROUND: Current data on incidence of interstitial lung diseases (ILDs) are sparse and concerns about an increasing trend have been raised. We examined incidence rates (IRs) of ILDs and changes in IRs between 1995 and 2005. METHODS: All persons with a first-time hospital discharge or outpatient diagnosis of ILD were identified through the Danish National Registry of Patients, which covers all Danish hospitals. Crude and age-standardised IRs were computed for ILD overall, as well as stratified by ILD subcategories. RESULTS: A total of 21,765 patients with ILD were identified. Between 1995 and 1998 the overall standardised IR of ILD decreased from 27.14 (95% CI 25.82-28.46) per 100,000 person-years to 19.36 (95% CI 18.26-20.46) per 100,000 person-years. After 1998 the IR increased considerably, peaking at 34.34 (95% CI 32.84-35.85) per 100,000 person-years in 2002. Subsequently there was a slight decrease. The highest IR was observed in the non-specific category "Respiratory disorders in diseases classified elsewhere". By ILD subcategory, the greatest average increase during the study period was observed in "Respiratory disorders in diseases classified elsewhere". CONCLUSION: The incidence rate of ILD in Denmark increased during the study period, most pronounced for ILDs associated with systemic diseases.

Preadmission use of statins and outcomes after hospitalization with pneumonia: population-based cohort study of 29,900 patients.

BACKGROUND: While some experimental and clinical research suggests that statins improve outcomes after severe infections, the evidence for pneumonia is conflicting. We examined whether preadmission statin use decreased risk of death, bacteremia, and pulmonary complications after pneumonia. METHODS: We conducted a population-based cohort study of 29,900 adults hospitalized with pneumonia for the first time between January 1, 1997, and December 31, 2004 in northern Denmark. Data on statin and other medication use, comorbidities, socioeconomic markers, laboratory findings, bacteremia, pulmonary complications, and death were obtained from medical databases. We used regression analyses to compute adjusted mortality rate ratios within 90 days and relative risks of bacteremia and pulmonary complications after hospitalization in both statin users and nonusers. RESULTS: Of patients with pneumonia, 1371 (4.6%) were current statin users. Mortality among statin users was lower than among nonusers: 10.3% vs 15.7% after 30 days and 16.8% vs 22.4% after 90 days, corresponding to adjusted 30- and 90-day mortality rate ratios of 0.69 (95% confidence interval, 0.58-0.82) and 0.75 (0.65-0.86). Decreased mortality associated with statin use remained robust in various subanalyses and in a supplementary analysis using propensity score matching. In contrast, former use of statins and current use of other prophylactic cardiovascular drugs were not associated with decreased mortality from pneumonia. In statin users, adjusted relative risk for bacteremia was 1.07 (95% confidence interval, 0.69-1.67) and for pulmonary complications was 0.69 (0.42-1.14). CONCLUSION: The use of statins is associated with decreased mortality after hospitalization with pneumonia.

Diabetes, glycemic control, and risk of hospitalization with pneumonia: a population-based case-control study.

OBJECTIVE: To examine whether diabetes is a risk factor for hospitalization with pneumonia and to assess the impact of A1C level on such risk. RESEARCH DESIGN AND METHODS: In this population-based, case-control study we identified patients with a first-time pneumonia-related hospitalization between 1997 and 2005, using health care databases in northern Denmark. For each case, 10 sex- and age-matched population control subjects were selected from Denmark's Civil Registration System. We used conditional logistic regression to compute relative risk (RR) for pneumonia-related hospitalization among subjects with and without diabetes, controlling for potential confounding factors. RESULTS: The study included 34,239 patients with a pneumonia-related hospitalization and 342,390 population control subjects. The adjusted RR for pneumonia-related hospitalization among subjects with diabetes was 1.26 (95% CI 1.21-1.31) compared with nondiabetic individuals. The adjusted RR was 4.43 (3.40-5.77) for subjects with type 1 diabetes and 1.23 (1.19-1.28) for subjects with type 2 diabetes. Diabetes duration >or=10 years increased the risk of a pneumonia-related hospitalization (1.37 [1.28-1.47]). Compared with subjects without diabetes, the adjusted RR was 1.22 (1.14-1.30) for diabetic subjects whose A1C level was <7% and 1.60 (1.44-1.76) for diabetic subjects whose A1C level was >or=9%. CONCLUSIONS: Type 1 and type 2 diabetes are risk factors for a pneumonia-related hospitalization. Poor long-term glycemic control among patients with diabetes clearly increases the risk of hospitalization with pneumonia.

Type 2 diabetes and pneumonia outcomes: a population-based cohort study.

OBJECTIVE: We sought to examine whether type 2 diabetes increases risk of death and complications following pneumonia and to assess the prognostic value of admission hyperglycemia. RESEARCH DESIGN AND METHODS: This was a population-based cohort study of adults with a first-time hospitalization for pneumonia between 1997 and 2004 (n = 29,900) in northern Denmark. Information on diabetes, comorbidity, laboratory findings, pulmonary complications, and bacteremia was obtained from medical databases. We used regression to compute adjusted relative risks of pulmonary complications, bacteremia, and mortality rate ratios (MRRs) within 90 days following hospitalization among patients with and without type 2 diabetes. The prognostic impact of admission hyperglycemia was studied in a subcohort (n = 13,574). RESULTS: In total, 2,931 (9.8%) pneumonia patients had type 2 diabetes. Mortality among diabetic patients was greater than that among other patients: 19.9 vs. 15.1% after 30 days and 27.0 vs. 21.6% after 90 days, respectively, corresponding to adjusted 30- and 90-day MRRs of 1.16 (95% CI 1.07-1.27) and 1.10 (1.02-1.18). Presence of type 2 diabetes did not predict pulmonary complications or bacteremia. Adjustment for hyperglycemia attenuated the association between type 2 diabetes and mortality. High glucose level on admission was a predictor of death among patients with diabetes and more so among those without diagnosed diabetes: adjusted 30-day MRRs for glucose level >or=14 mmol/l were 1.46 (1.01-2.12) and 1.91 (1.40-2.61), respectively. CONCLUSIONS: Type 2 diabetes and admission hyperglycemia predict increased pneumonia-related mortality.