Nonspecific side effects of oral contraceptives: nocebo or noise?

Side effects of combined oral contraceptives are the most common reason why women discontinue them. Over the past half century, an elaborate mythology about these ill effects has evolved, fueled by rumor, gossip and poor-quality research. In contrast, placebo-controlled randomized trials document that nonspecific side effects are not significantly more common with combined oral contraceptives than with inert pills. These reported nonspecific side effects may reflect the nocebo phenomenon (the inverse of a placebo): if women are told to expect noxious side effects, these complaints occur because of the power of suggestion. Alternatively, nonspecific complaints may simply reflect their background prevalence in the population. Because Level I evidence documents no important increase in nonspecific side effects with oral contraceptives, counseling about these side effects or including them in package labeling is unwarranted and probably unethical. When in doubt, clinicians should err on the side of optimism.     

Time on my side? Life course trajectories of poverty and health

This study examines the relationship between poverty and health in time. Following the argument that time is significant for shaping the experience of being poor or not poor and growing evidence of heterogeneity in long-term patterns of poverty, we investigate whether different kinds of poverty have distinct consequences for long-term health. Using data from the 1968-1996 annual waves of the United States Panel Study of Income Dynamics Data, we estimate a general growth mixture model to assess the relationship between the longitudinal courses of poverty and health. The model allows us to first estimate latent poverty classes in the data and then determine their effects on latent self-rated health. Four types of long-term poverty patterns characterized as stable nonpoor, exiting poverty, entering poverty and stable poor were evident in the data. These different kinds of poverty affected self-rated health trajectories in distinct ways, but worked in concert with age, education and race to create gaps in initial health status that were constant over time.     

The impact of CE marking: is there a down side?

In summary, the IVDD was never intended to include in house assays produced within healthcare institutions, and it was clear to the authors that it would be impractical for them to comply with the Directive. The above points apply to all pathology specialties, all of which will be profoundly affected if the MHRA's interpretation of the Directive is upheld. It must be appreciated that, as well as affecting a large number of specialist and reference laboratories, many NHS laboratories perform in house assays on samples provided by other trusts. The costs involved in complying with the IVDD, if the present MHRA interpretation is upheld, will divert funds away from other healthcare initiatives and will inevitably stifle further development of specialist in house assays which make an immense contribution to our health services. The principles of the Directive are sound and its introduction will have a beneficial affect on pathology due to better regulation of IVDs, which are placed on the market. However, applying the Directive to in house assays can only be detrimental to the efficacy of pathology services across the UK and therefore have a negative affect on the health of the nation.     

Distressed or relieved? Psychological side effects of breast cancer screening in The Netherlands.

STUDY OBJECTIVES: To assess the psychological impact of mammographic screening on women with non-malignant outcomes after attending the Netherlands' National Breast Cancer Screening Programme. DESIGN: During one year all women with false positive test results (95) in a screening area were invited for the study. Each false positive was matched with two women with normal mammograms with respect to age and municipality. A random reference group of 400 was drawn from the female population in an area not yet included in the screening programme. Experiences with screening and psychological status of subjects were assessed 8-10 weeks after screening (T1) and again after six months (T2), by interviews as well as questionnaires. References completed two questionnaires with a six months' interval. PARTICIPANTS: 74 (78%) women with false positive outcomes and 113 (59%) women with negative outcomes participated at T1, of these 65 (88%) and 105 (93%) at T2, respectively; 238 references returned questionnaires at T1 (59%), of these 143 (60%) at T2. MAIN RESULTS: At 8-10 weeks after the screening, the women who received false positive test results scored higher on most of the variables indicating psychological disfunctioning than women with normal mammograms, but did not notably differ on the same variables from the non-screened reference group. Women with normal mammograms had the lowest scores on all the variables in the study at both assessments. The same situation was observed six months later. Although 61% of the women who received false positive mammograms reported that they had experienced the "false alarm" as a stressful event, this experience had apparently no adverse effects on their psychological functioning, as assessed 8-10 weeks after screening. CONCLUSIONS: Overall, breast screening is not likely to generate adverse psychological effects in "healthy" women, even if the outcome is false positive. Differences in psychological functioning between false positives and negatives are more likely ascribable to feelings of relief in the negative group than to raised anxiety and distress in the false positive group.     

Whose side are you on? Interdependence and its consequences in management of healthcare delivery

Healthcare employees who are committed to the organization and go the extra mile are especially needed today. An empirical study of visiting nurse agency employees showed that a sense of being "in the same boat" with management, or perceiving outcome interdependence, contributed to positive behaviors. Supervisors were generally more inclined than were their subordinates to perceive this interdependence, to be committed, and to exhibit good citizenship behavior. Unexpectedly, physical therapists who worked as hourly part-time contractors reported even stronger feelings of being in the same boat with management and being more committed than the supervisors. Such a sense of partnership could have been a result of the therapists' long-term relationship with the agency over an indefinite time. They might have also felt that they worked voluntarily and autonomously, rather than under close supervision. These findings point to various management actions that can engender a feeling of interdependence, pride in the organization, and fairness of treatment. One step is to involve employees in joint goal setting, organized around "our problems," not just the person's own concerns. Authentic downward communication and the sharing of operating results can convey to employees the major issues that challenge the organization. Such information makes it possible for employees to provide vital input, if not actually take on more decisions themselves. Executives can expect less commitment and less inclination from employees to go above and beyond what is expected if they fail to acknowledge good performance and if they accentuate differences between the most-senior leaders and lower-level employees.     

EPA: airing on the side of caution or pulling standards out of thin Air?

In May 1999, a federal appeals court ruled that the U.S. Environmental Protection Agency (EPA) had violated the Constitution when it strengthened regulations for ground-level ozone and particulate matter (PM). Although the court did not question the validity of the EPA's scientific basis for establishing the PM and ozone standards, it did challenge how the EPA selected the particular levels since the scientific record in both rules did not indicate unequivocally where the standards should be set. The agency failed to identify an "intelligible principle" that would guide such choices, the court said, and thereby exceeded the power it was granted by Congress. Because scientific uncertainty attends so much rule making, the ruling leaves open the question of when the EPA may make what is essentially a policy determination versus when those determinations must be made by Congress. For this reason, observers consider the ruling to have potentially significant implications beyond just the ozone and PM standards that may affect other EPA regulations and regulations by other agencies.     

Research report: do general practitioners tell their patients about side effects to common treatments?

The principle of respect for patients' autonomy, or right to self-determination, has gained increasing importance in health care legislation during the last decade. To respect this principle the patients' informed consent to a proposed treatment is required. In relation to ordinary treatments in general practice, where several reasonable alternatives may be available and where non-treatment may be an acceptable alternative, this requirement is at least as strong as in other parts of the health care system. In this context, information about side effects may be crucial for the patient's decision to accept a proposed treatment or not. The aims of this study were to investigate the extent to which general practitioners in Denmark inform their patients about possible side effects without being asked when a common treatment is proposed. We also wished to examine the relation between physicians' estimation of the severity and frequency of these side effects, and their willingness to inform patients spontaneously as well as their preferred reasons for choosing to inform or not inform the patients. A questionnaire was sent to a random sample of 450 Danish general practitioners. The respondents differed considerably with regard to their willingness to inform patients about side effects but they were significantly more likely to give the information spontaneously if they considered the side effects frequent than when side effects were considered rare. In contrast, estimations of severity did not seem to be of any importance. The majority of the respondents informed their patients primarily to enable them to react appropriately to the side effects in question or to make sure that the patient would comply with the treatment. These findings indicate that the information given to patients about side effects by Danish general practitioners is not in accordance with the principle of respect for the patients' autonomy and not in accordance with the requirements of Danish legislation.     

Risk assessment of the potential side effects of long–term creatine supplementation in team sport athletes

Summary Background Use of creatine has become widespread among sportsmen and women, although there are no conclusive evidences concerning possible health risks of long–term creatine supplementation. The aim of the study To investigate long–term effects of creatine monohydrate supplementation on clinical parameters related to health. Methods Eighteen professional basketball players of the first Spanish Basketball League participated in the present longitudinal study. The subjects were ingesting 5 g creatine monohydrate daily during three competition seasons. Blood was collected in the morning after an overnight fast, five times during each of the three official competition seasons of the first National Basketball League (September 1999–June 2000, September 2000–June 2001 and September 2001–June 2002) and the European League. Standard clinical examination was performed for 16 blood chemistries. Results The plasma concentrations of all clinical parameters did not alter significantly during the analyzed time frames of creatine supplementation. All of these parameters were, with the exception of creatinine and creatine kinase, within their respective clinical ranges at all time points. Conclusion Our data shows that low–dose supplementation with creatine monohydrate did not produce laboratory abnormalities for the majority of the parameters tested.     

Mulberry leaf extract reduces postprandial hyperglycemia with few side effects by inhibiting α-glucosidase in normal rats

Mulberry (Morus alba L.) leaf extract (MLE) was investigated as a potent plant-derived α-glucosidase inhibitor with low α-amylase inhibitory activity. MLE was prepared by heating in an autoclave at 121 °C for 15 minutes, and its in vitro and in vivo antihyperglycemic activities were investigated. The adverse side effects of MLE were analyzed by measuring the weight and volume of the cecum, stool color, starch content in the cecum, and the integrity of intestinal transporting capacity. The in vitro inhibitory activity of MLE on intestinal α-glucosidase was potent and that on intestinal α-amylase was very weak compared with acarbose. Sugar loading tests with starch, maltose, and sucrose showed that MLE may reduce postprandial increases in blood glucose by acting as an intestinal α-glucosidase inhibitor. Feeding tests suggested that MLE may exhibit fewer adverse side effects than other α-glucosidase inhibitors, such as abdominal flatulence and meteorism, which are attributed to the impaired digestion of starch by strong inhibition of intestinal α-amylase. These results suggest that MLE could be used in the development of pharmaceutical foods to control the blood glucose levels of diabetic patients by inhibiting intestinal α-glucosidase with reduced side effects.     

On the wrong side of the tracts? Evaluating the accuracy of geocoding in public health research.

OBJECTIVES: This study sought to determine the accuracy of geocoding for public health databases. METHODS: A test file of 70 addresses, 50 of which involved errors, was generated, and the file was geocoded to the census tract and block group levels by 4 commercial geocoding firms. Also, the "real world" accuracy of the best-performing firm was evaluated. RESULTS: Accuracy rates in regard to geocoding of the test file ranged from 44% (95% confidence interval [CI] = 32%, 56%) to 84% (95% CI = 73%, 92%). The geocoding firm identified as having the best accuracy rate correctly geocoded 96% of the addresses obtained from the public health databases. CONCLUSIONS: Public health studies involving geocoded databases should evaluate and report on methods used to verify accuracy.     

Efficacy and side effects of praziquantel against Schistosoma mansoni in a community of western Côte d'Ivoire

Praziquantel is efficacious against the adult stages of all human schistosome parasites, and has become the drug of choice for morbidity control of schistosomiasis. There is concern that resistance to praziquantel might develop or already exists, and could be further facilitated through new control initiatives relying on large-scale administration of praziquantel. Therefore, monitoring praziquantel efficacy in different epidemiological settings is required. We assessed the efficacy and side effects of praziquantel against Schistosoma mansoni in a rural community of western C?te d'Ivoire. Three consecutive stool specimens from 545 children and adults were examined by the Kato-Katz technique, revealing an overall prevalence of 40.9%. S. mansoni-infected individuals were treated with a single oral dose of praziquantel at 40 mg/kg. The most frequent side effects were abdominal pain, dizziness and diarrhoea. The overall cure rate, assessed 6 weeks post-treatment, was 60.9%. Moderate or heavy infections were only cleared in half or one-third of the individuals, respectively. The total egg count reduction was 61.4%. Infection intensity pre-treatment was significantly associated with age, cure rate, reported diarrhoea and dizziness. Our findings call for additional studies that rigorously evaluate the efficacy of praziquantel against different schistosome species in entire communities, using similarly sensitive diagnostic approaches as employed here.