Lothar Häberle

Nephrotoxicity of Iso-osmolar Iodixanol Compared with Nonionic Low-osmolar Contrast Media: Meta-analysis of Randomized Controlled Trials

PURPOSE To compare the nephrotoxicity of iso-osmolar iodixanol with that of nonionic low-osmolar contrast media (CM) (LOCM) in randomized clinical trials. MATERIALS AND METHODS This meta-analysis was conducted with a systematic search of MEDLINE, EMBASE, BIOSIS, Web of Science, ISI Web of Knowledge, Current Contents Medizin, Cochrane Library (until August 2007), trial registers, conference proceedings, and reference lists to identify studies and with requests from all manufacturers of CM for unidentified studies. Randomized controlled trials assessing serum creatinine levels before and after intravascular application of iodixanol or LOCM were included. The primary outcome measures were the incidence of contrast medium-induced nephropathy (CIN) and change in serum creatinine levels. RESULTS Twenty-five trials were included. Iodixanol did not significantly reduce the risk of CIN (relative risk [RR], 0.80; 95% confidence interval [CI]: 0.61, 1.04; weighted mean difference in serum creatinine increase, 0.01 mg/dL [0.88 mumol/L]; 95% CI: -0.01, 0.03). There was no significant risk reduction after intravenous administration of the CM (RR, 1.08; 95% CI: 0.62, 1.89); subgroup with preexisting renal insufficiency (RR, 1.07; 95% CI: 0.56, 2.02) or after intraarterial administration (RR, 0.68; 95% CI: 0.46, 1.01); subgroup with preexisting renal insufficiency (RR, 0.59; 95% CI: 0.33, 1.07). However, in patients with intraarterial administration and renal insufficiency, the risk of CIN was greater for iohexol than for iodixanol (RR, 0.38; 95% CI: 0.21, 0.68), whereas there was no difference between iodixanol and the other (noniohexol) LOCM (RR, 0.95; 95% CI: 0.50, 1.78). CONCLUSION Iodixanol is not associated with a significantly reduced risk of CIN compared with the LOCM pooled together. However, in patients with intraarterial administration and renal insufficiency, iodixanol is associated with a reduced risk of CIN compared with iohexol, whereas no significant difference between iodixanol and other LOCM could be found.

Long-Term Effects of Three Multicomponent Exercise Interventions on Physical Performance and Fall-Related Psychological Outcomes in Community-Dwelling Older Adults: A Randomized Controlled Trial

To determine the long‐term effects of three strength and balance exercise interventions on physical performance, fall‐related psychological outcomes, and falls in older people.

Exercise Effects on Bone Mineral Density, Falls, Coronary Risk Factors, and Health Care Costs in Older Women: The Randomized Controlled Senior Fitness and Prevention (SEFIP) Study

BACKGROUND Physical exercise affects many risk factors and diseases and therefore can play a vital role in general disease prevention and treatment of elderly individuals and may reduce costs. We sought to determine whether a single exercise program affects fracture risk (bone mineral density [BMD] and falls), coronary heart disease (CHD) risk factors, and health care costs in community-dwelling elderly women. METHODS We conducted a randomized, single-blinded, controlled trial from May 1, 2005, through July 31, 2008, recruiting women 65 years or older who were living independently in the area of Erlangen-Nuremberg, Germany. In all, 246 women were randomly assigned to an 18-month exercise program (exercise group) or a wellness program (control group). The exercise group (n = 123) performed a multipurpose exercise program with special emphasis on exercise intensity; the controls (n = 123) focused on well-being with a low-intensity, low-frequency program. The main outcome measures were BMD, the number of falls, the Framingham-based 10-year CHD risk, and direct health care costs. RESULTS For the 227 women who completed the 18-month study, significant exercise effects were observed for BMD of the lumbar spine (mean [95% confidence interval (CI)] percentage of change in BMD [baseline to follow-up] for the exercise group: 1.77% [1.26% to 2.28%] vs controls: 0.33% [-0.24% to 0.91%]; P < .001), femoral neck (exercise group: 1.01% [0.37% to 1.65%] vs controls: -1.05% [-1.70% to -0.40%]; P < .001), and fall rate per person during 18 months (exercise group: 1.00 [0.76 to 1.24] vs controls: 1.66 [1.33 to 1.99]; P = .002). The 10-year CHD risk was significantly affected in both subgroups (absolute change for the exercise group: -1.96% [95% CI, -2.69% to -1.23%] vs controls: -1.15% [-1.69% to -0.62%]; P = .22), with no significant difference between the groups. The direct health care costs per participant during the 18-month intervention showed nonsignificant differences between the groups (exercise group: 2255 euros[95% CI, 1791 euros-2718 euros] vs controls: 2780 euros [2187 euros-3372 euros]; P = .20). CONCLUSION Compared with a general wellness program, our 18-month exercise program significantly improved BMD and fall risk, but not predicted CHD risk, in elderly women. This benefit occurred at no increase in direct costs. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00267839.

Quality Assured Health Care in Certified Breast Centers and Improvement of the Prognosis of Breast Cancer Patients

Background: Increasing effort has been put in the implementation and certification of breast centers in order to establish standardized, quality assured health care for breast cancer patients. The aim of this analysis was to investigate whether patients treated in certified breast centers (CBC) have a favorable prognosis as compared to patients treated outside of certified breast treatment units. Patients and Methods: The data of 3,940 patients with invasive nonmetastatic breast cancer were analyzed with regard to differences in patient and tumor characteristics and crude overall survival according to diagnosis in or outside CBC in Middle Franconia, Germany. Patient, tumor, and follow-up data were obtained from the clinical cancer registry. Results: Patients in CBC were younger, and had lower disease stages and lower grading. Independent of the effects of these variables on overall survival, being treated at a CBC added to the prediction of overall survival. Patients treated at a CBC had a hazard ratio of 0.70 (95% confidence interval 0.52–0.93) in the adjusted Cox model. Conclusions: Independent from common prognostic factors, diagnosis and treatment of breast cancer at a CBC improves the prognosis of patients. It can be hypothesized that this effect is mediated through quality assured health care provided by the certification process.

Characterizing mammographic images by using generic texture features

IntroductionAlthough mammographic density is an established risk factor for breast cancer, its use is limited in clinical practice because of a lack of automated and standardized measurement methods. The aims of this study were to evaluate a variety of automated texture features in mammograms as risk factors for breast cancer and to compare them with the percentage mammographic density (PMD) by using a case-control study design.MethodsA case-control study including 864 cases and 418 controls was analyzed automatically. Four hundred seventy features were explored as possible risk factors for breast cancer. These included statistical features, moment-based features, spectral-energy features, and form-based features. An elaborate variable selection process using logistic regression analyses was performed to identify those features that were associated with case-control status. In addition, PMD was assessed and included in the regression model.ResultsOf the 470 image-analysis features explored, 46 remained in the final logistic regression model. An area under the curve of 0.79, with an odds ratio per standard deviation change of 2.88 (95% CI, 2.28 to 3.65), was obtained with validation data. Adding the PMD did not improve the final model.ConclusionsUsing texture features to predict the risk of breast cancer appears feasible. PMD did not show any additional value in this study. With regard to the features assessed, most of the analysis tools appeared to reflect mammographic density, although some features did not correlate with PMD. It remains to be investigated in larger case-control studies whether these features can contribute to increased prediction accuracy.

Exercise, Body Composition, and Functional Ability: A Randomized Controlled Trial

CONTEXT In women, age and the menopausal transition contribute to an increase of body fat and a reduction of lean body mass associated with functional decline, affecting independent living. BACKGROUND Sarcopenia and adiposity in the elderly has been associated with increased mortality and functional decline affecting independent living. PURPOSE This study was conducted to determine the effect of a multipurpose exercise program on the body composition and functional ability of elderly women living in a community. DESIGN An 18-month single-blinded RCT comparing participants in an exercise program with an active control group was conducted from May 2005 through December 2007. Analyses were conducted from January 2008 to July 2008. SETTING/PARTICIPANTS Two hundred forty-six women (aged 69.1+/-4.0 years) living independently in the area of Erlangen-Nürnberg (Germany) participated in the study. INTERVENTION Subjects (n=123) performed a multipurpose exercise program with special emphasis on exercise intensity but with low-level requirements for training facilities and materials. The 123 women in the control group focused primarily on well-being. MAIN OUTCOME MEASURES Body composition was assessed by dual-energy x-ray absorptiometry. Further, strength was evaluated using isometric techniques for the back and legs. Aerobic fitness was determined from a progressive-intensity treadmill test. RESULTS After 18 months, significant effects in favor of the exercise program for body composition were increases in appendicular skeletal muscle mass and lean body mass along with reductions in abdominal fat and total body fat. Significant performance effects also favored the exercise program and included enhanced isometric maximum trunk-extensor and leg press strength, leg press power, timed up-and-go test, and aerobic fitness. CONCLUSIONS A high-intensity multipurpose exercise program produced significant improvements in body composition and functional ability in a cohort of elderly women living in a community.

Thyroid-stimulating hormone is associated with insulin resistance independently of body mass index and age in women with polycystic ovary syndrome

BACKGROUND The aim of this study was to evaluate the association between thyroid function, reflected by thyroid-stimulating hormone (TSH) levels, and insulin resistance (IR) in 337 women suffering from polycystic ovary syndrome (PCOS). METHODS Clinical, metabolic and endocrine parameters were obtained and an oral glucose tolerance test was performed, with calculation of IR indices. The association between thyroid function and IR was evaluated with classification analysis using logistic regression and 10-fold cross-validation to identify a possible TSH threshold for IR. Parameters were then compared between women above and below the TSH threshold using two-sample tests. One-way analyses of covariance were performed to explore whether the impact of TSH on IR is independent of other variables. RESULTS A TSH cut-off value around 2 mIU/l had the best sensitivity and specificity for identifying women with IR. Women with TSH >or= 2 mIU/l were younger, had a higher body mass index (BMI) and were more insulin-resistant compared with women with TSH < 2 mIU/l. This effect of TSH on IR was independent of age and BMI. CONCLUSIONS In women with PCOS, a significant association between thyroid function, as reflected by TSH >or= 2 mIU/l, and IR was found and the association appeared to be independent of age and BMI.

Hysterectomy—A Comparison of Approaches

BACKGROUND The advantages and disadvantages of the various surgical techniques for hysterectomy are currently a topic of debate, with particular controversy over leaving the cervix in situ in the laparoscopic supracervical hysterectomy (LASH) procedure. METHODS In a retrospective single-center study, medical history and clinical characteristics were compared in patients who had undergone hysterectomy for benign disease in the period 2002-2008 at the Department of Obstetrics and Gynecology, Erlangen University Hospital. Postoperative satisfaction and the frequency of secondary operations for prolapse or incontinence in women with surgery between 2002 and 2007 were surveyed by means of a questionnaire. RESULTS The longest hospital stay was observed after abdominal hysterectomy (AH; 10 days), followed by vaginal hysterectomy (VH; 7.8 days) and laparoscopy-assisted vaginal hysterectomy (LAVH; 7.2 days). The shortest stays in hospital were seen after LASH (5.9 days) and total laparoscopic hysterectomy (TLH; 5.7 days). The shortest operating time was noted with VH (87 min) and the longest with LAVH (122 min). The lowest rates of blood loss were with LASH (1.38 g/dL) and TLH (1.51 g/dL). The highest rate of postoperative complications occurred after AH (8.9%). No differences were found in relation to postoperative satisfaction or surgery for prolapse or incontinence. CONCLUSION No postoperative benefits were found for leaving the cervix in situ when performing LASH. However, this was not a controlled randomized study.

Association of mammographic density with hormone receptors in invasive breast cancers: results from a case-only study.

For many breast cancer (BC) risk factors, there is growing evidence concerning molecular subtypes for which the risk factor is specific. With regard to mammographic density (MD), there are inconsistent data concerning its association with estrogen receptor (ER) and progesterone receptor (PR) expression. The aim of our study was to analyze the association between ER and PR expression and MD. In our case‐only study, data on BC risk factors, hormone receptor expression and MD were available for 2,410 patients with incident BC. MD was assessed as percent MD (PMD) using a semiautomated method by two readers for every patient. The association of ER/PR and PMD was studied with multifactorial analyses of covariance with PMD as the target variable and including well‐known factors that are also associated with MD, such as age, parity, use of hormone replacement therapy, and body mass index (BMI). In addition to the commonly known associations between PMD and age, parity, BMI and hormone replacement therapy, a significant inverse association was found between PMD and ER expression levels. Patients with ER‐negative tumors had an average PMD of 38%, whereas patients with high ER expression had a PMD of 35%. A statistical trend toward a positive association between PMD and PR expression was also seen. PMD appears to be inversely associated with ER expression and may correlate positively with PR expression. These effects were independent of other risk factors such as age, BMI, parity, and hormone replacement therapy, possibly suggesting other pathways that mediate this effect.

Smoking is associated with increased free testosterone and fasting insulin levels in women with polycystic ovary syndrome, resulting in aggravated insulin resistance

OBJECTIVE To evaluate the impact of smoking on endocrine, metabolic, and clinical parameters in women with polycystic ovary syndrome (PCOS). DESIGN Cohort analysis. SETTING University hospital. PATIENT(S) 346 women with PCOS, including 98 smokers and 248 nonsmokers. INTERVENTION(S) Screening panel, including physical examination, weight and height measurement, and ultrasound examination of the ovaries, and hormone and insulin measurements. MAIN OUTCOME MEASURE(S) Clinical, metabolic, and endocrine parameters, oral glucose tolerance test, calculation of insulin resistance indexes. RESULT(S) In women with PCOS, smoking was associated with statistically significantly increased levels of fasting insulin and calculated free testosterone (cFT) and with a raised free androgen index (FAI) score, which resulted in aggravated scores on the homeostatic model for assessment of insulin resistance (HOMA-IR). However, no differences were observed between the smoking and nonsmoking groups with regard to the clinical parameters for hirsutism, acne, ovulatory function (classified as eumenorrhea, oligomenorrhea, and amenorrhea), or polycystic ovaries using the ultrasound criteria recommended according to the Rotterdam definition. CONCLUSION(S) In women with PCOS, smoking is associated with increased free testosterone and fasting insulin levels, resulting in aggravated insulin resistance. However, there were no differences between smokers and nonsmokers when clinical parameters were compared.