Colon cancer risk and different HRT formulations: a case-control study.

BACKGROUND: Most studies have found no increased risk of colon cancer associated with hormone replacement therapy (HRT), or even a decreased risk. But information about the effects of different HRT preparations is lacking. METHODS: A case-control study was performed within Germany in collaboration with regional cancer registries and tumor centers. Up to 5 controls were matched to each case of colon cancer. Conditional logistic regression analysis was applied to estimate crude and adjusted odds ratios (OR) and 95% confidence intervals (95% CI). Stratified analyses were performed to get an impression of the risk associated with different estrogens and progestins. RESULTS: A total of 354 cases of colon cancer were compared with 1422 matched controls. The adjusted overall risk estimate for colon cancer (ColC) associated with ever-use of HRT was 0.97 (0.71-1.32). No clinically relevant trends for ColC risk were observed with increasing duration of HRT use, or increasing time since first or last HRT use in aggregate. Whereas the overall risk estimates were stable, the numbers in many of the sub-analyses of HRT preparation groups (estrogens and progestins) were too small for conclusions. Nevertheless, if the ColC risk estimates are taken at face value, most seemed to be reduced compared with never-use of HRT, but did not vary much across HRT formulation subgroups. In particular, no substantial difference in ColC risk was observed between HRT-containing conjugated equine estrogens (CEE) or medroxyprogesterone acetate (MPA) and other formulations more common in Europe. CONCLUSION: Ever-use of HRT was not associated with an increased risk of colon cancer. In contrary, most risk estimates pointed non-significantly toward a lower ColC risk in HRT ever user. They did not vary markedly among different HRT formulations (estrogens, progestins). However, the small numbers and the overlapping nature of the subgroups suggest cautious interpretation.

Breast cancer risk associated with different HRT formulations: a register-based case-control study.

BACKGROUND: Previous epidemiological studies have inconsistently shown a modestly increased breast cancer risk associated with hormone replacement therapy (HRT). Limited information is available about different formulations--particularly concerning different progestins. METHODS: A case-control study was performed within Germany in collaboration with regional cancer registries and tumor centers. Up to 5 controls were matched breast cancer cases. Conditional logistic regression analysis was applied to estimate crude and adjusted odds ratios (OR) and 95% confidence intervals (95% CI). Stratified analyses were performed to compare the risk of different estrogens, progestins, and combinations. RESULTS: A total of 3593 cases of breast cancer were identified and compared with 9098 controls. The adjusted overall risk estimate for breast cancer (BC) associated with current or past use of HRT was 1.2 (1.1-1.3), and almost identical for lag times from 6 months to 6 years prior to diagnosis. No significant trend of increasing BC risk was found with increasing duration of HRT use, or time since first or last use in aggregate. Many established BC risk factors significantly modified the effect of HRT on BC risk, particularly first-degree family history of BC, higher age, lower education, higher body mass index (BMI), and never having used oral contraceptives (OCs) during lifetime. Whereas the overall risk estimates were stable, the numbers in many of the sub-analyses of HRT formulation groups (estrogens, progestins, and combinations) were too small for strong conclusions. Nevertheless, the BC risk seems not to vary much across HRT formulation subgroups. In particular, no substantial difference in BC risk was observed between HRT containing conjugated equine estrogens (CEE) or medroxyprogesterone acetate (MPA) and other formulations more common in Europe. CONCLUSION: The BC risk of HRT use is rather small. Low risk estimates for BC and a high potential for residual confounding and bias in this observational study do not permit causal conclusions. Apparently, there is not much variation of the BC risk across HRT formulations (estrogens, progestins). However, the small numbers and the overlapping nature of some of the subgroups suggest cautious interpretation.

The Aging Males' Symptoms scale (AMS) as outcome measure for treatment of androgen deficiency.

INTRODUCTION: No clinical study data in which the AMS scale was applied as outcome measure has been reported until today. METHOD: An open post-marketing study was performed by office-based urologists in Germany in 2000/01. We analysed data of 1174 androgen-deficient males who were treated with testosterone enanthate. The AMS scale was applied prior to and after 12 weeks treatment. RESULTS: The improvement of complaints during treatment relative to the baseline score was 32% on average. Patients with little or no symptoms before therapy improved by 11%, those with mild complaints at entry by 24%, with moderate by 31%, and with severe symptoms by 39% compared with the baseline score. We showed that the distribution of complaints of testosterone-deficient men before therapy almost returned to norm values after 12 weeks of testosterone treatment. We also demonstrated that the AMS results can predict the independent (physician's) opinion about the individual treatment effect. The positive predictive value was 89%, the negative predictive value 59%, sensitivity (correct prediction of a positive assessment by the urologist) 96%, however, the specificity (correct prediction of a negative assessment by the physician) was only 30%. CONCLUSION: The AMS scale showed a convincing ability to measure treatment effects on quality of life across the full range of severity of complaints. In addition, results of the scale can predict the subjective clinical expert opinion on the treatment efficiency.

The Aging Males' Symptoms (AMS) scale: review of its methodological characteristics.

BACKGROUND: The current paper reviews data from different sources to get a closer impression on the psychometric and other methodological characteristics of the Aging Males' Symptoms (AMS) scale gathered recently. The scale was designed and standardized as self-administered scale to (a) to assess symptoms of aging (independent from those which are disease-related) between groups of males under different conditions, (b) to evaluate the severity of symptoms over time, and (c) to measure changes pre- and post androgen replacement therapy. The scale is in widespread use (14 languages). METHOD: Original data from different studies in many countries were centrally analysed to evaluate reliability and validity of the AMS. RESULTS: Reliability measures (consistency and test-retest stability) were found to be good across countries, although the sample size was sometimes small. VALIDITY: The internal structure of the AMS in healthy and androgen deficient males, and across countries was sufficiently similar to conclude that the scale really measures the same phenomenon. The sub-scores and total score correlations were high (0.8-0.9) but lower among the sub-scales (0.5-0.7). This however suggests that the subscales are not fully independent. The comparison with other scales for aging males or screening instruments for androgen deficiency showed sufficiently good correlations, illustrating a good criterion-oriented validity. The same is true for the comparison with the generic quality-of-life scale SF36 where also high correlation coefficients have been shown. Methodological analyses of a treatment study of symptomatic males with testosterone demonstrated the ability of the AMS scale to measure treatment effect, irrespective of the severity of complaints before therapy. It was also shown that the AMS result can predict the independently generated (physician's) opinion about the individual treatment effect. CONCLUSION: The currently available methodological evidence points towards a high quality of the AMS scale to measure and to compare HRQoL of aging males over time or before/after treatment, it suggests a high reliability and high validity as far as the process of construct validation could be pressed ahead yet. But certainly more data will become available, particularly from ongoing clinical studies.