Clinician satisfaction and insertion characteristics of a new applicator to insert radiopaque Implanon: an open-label, noncontrolled, multicenter trial

Background

The etonogestrel (ENG) implant Implanon® is a progestin-only contraceptive that provides effective contraception for up to 3 years. A new radiopaque ENG implant has been developed to extend the diagnostic modalities of Implanon and a next-generation applicator (NGA) was designed to facilitate correct subdermal insertion of Implanon.

Study Design

In this open-label study, 23 investigators, experienced and inexperienced with Implanon, performed 301 insertions of the new radiopaque implant using the NGA. Primary outcome measurements were obtained from clinician satisfaction questionnaires completed after the 4th, 8th and 12th insertions. Additionally, insertion characteristics and X-ray visibility were assessed.

Results

Almost all investigators were satisfied with the NGA from the first insertion onward, and all were satisfied or very satisfied after 12 insertions. The most frequently reported advantages included ease of use, one-handed action and fast insertion time; 2% of insertions were considered difficult in skin puncturing and/or sliding the needle subdermally. Three incorrect insertions occurred due to noncompliance with instructions. All assessed implants were visible on plain X-ray imaging.

Conclusions

The NGA was well accepted by investigators with or without prior experience with Implanon. The results stressed the importance of correctly following implant insertion instructions.     

The Comparative Efficacy of Plant Sterols and Stanols on Serum Lipids: A Systematic Review and Meta-Analysis

Background

Plant sterols and stanols are plant steroids with a similar chemical structure and cellular function to human cholesterol, and are recommended as dietary modifiers of serum lipids. Plant sterols have a higher degree of absorption than plant stanols, suggesting differential efficacy between the two.

Design

A meta-analysis of randomized controlled trials was performed to summarize direct comparisons between the effect of plant sterols vs plant stanols on serum lipid levels in healthy patients and patients with hypercholesterolemia.

Methods

A systematic literature search of MEDLINE, EMBASE, Cochrane CENTRAL, and the Natural Medicines Comprehensive Database was conducted from January 1950 through January 2009. Trials were included in the analysis if they were randomized controlled trials evaluating the effect of plant sterols vs plant stanols in healthy patients or patients with hypercholesterolemia who reported efficacy data on total, low-density lipoprotein, and high-density lipoprotein cholesterols or triglycerides. The weighted mean difference (WMD) of the change from baseline (in mg/dL) with 95% confidence interval was calculated as the difference between the means in the plant sterol and plant stanol groups using a random-effects model.

Results

Fourteen studies (n=531 patients) met the inclusion criteria. Upon meta-analysis, the results showed that there is no statistically or clinically significant difference between plant sterols and plant stanols in their abilities to modify total cholesterol (WMD −1.11 mg/dL [−0.0286 mmol/L], 95% confidence interval [CI] −4.12 to 1.90, P=0.47), low-density lipoprotein cholesterol (WMD −0.35 mg/dL [−0.0091 mmol/L], 95% CI −2.98 to 2.28, P=0.79), high-density lipoprotein cholesterol (WMD −0.28 mg/dL [-0.00073 mmol/L], 95% CI −1.18 to 0.62, P=0.54), or triglycerides (WMD −1.80 mg/dL [−0.0203 mmol/L], 95% CI −6.80 to 3.21, P=0.48).

Conclusions

Plant sterols and plant stanols do not have statistically or clinically relevant differing effects on total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, or triglyceride levels. The selection of plant sterols vs plant stanols should then be based on potential differences in safety parameters and further study is required to elucidate such differences.     

Peer Reviewed: Chronic Disease Risk Factors Among Alaska Native and American Indian People,Alaska, 2004-2006

Introduction

The Alaska Education and Research Towards Health (EARTH) Study is being conducted to determine the prevalence of clinically measured chronic disease risk factors in a large population of American Indian/Alaska Native people (AI/AN). We report these estimates and compare them with those for the overall US population, as assessed by the National Health and Nutrition Examination Survey (NHANES).

Methods

We measured blood pressure, height, weight, and fasting serum lipids and glucose in a prospective cohort of 3,822 AI/AN participants who resided in Alaska during 2004 through 2006. We categorized participants as having chronic disease risk factors if their measurements exceeded cutoffs that were determined on the basis of national recommendations. We analyzed the prevalence of risk factors by sex and age and compared the age-adjusted prevalence with 1999-2004 NHANES measurements.

Results

EARTH participants were significantly more likely than NHANES participants to be overweight or obese and to have impaired fasting glucose, low high-density lipoprotein cholesterol, high low-density lipoprotein cholesterol, and hypertension. The prevalence of high total cholesterol and triglycerides was not significantly different between the 2 study populations.

Conclusion

We provide baseline clinical measurements for chronic disease risk factors for a larger study sample than any previous study of AI/AN living in Alaska. The prevalence of most risk factors measured exceeded national rates. These data can be used to tailor health interventions and reduce health disparities.     

Characteristics of Food Industry Web Sites and “Advergames” Targeting Children

ObjectiveTo assess the content of food industry Web sites targeting children by describing strategies used to prolong their visits and foster brand loyalty; and to document health-promoting messages on these Web sites.DesignA content analysis was conducted of Web sites advertised on 2 children's networks, Cartoon Network and Nickelodeon. A total of 290 Web pages and 247 unique games on 19 Internet sites were examined.ResultsGames, found on 81% of Web sites, were the most predominant promotion strategy used. All games had at least 1 brand identifier, with logos being most frequently used. On average Web sites contained 1 “healthful” message for every 45 exposures to brand identifiers.Conclusions and ImplicationsFood companies use Web sites to extend their television advertising to promote brand loyalty among children. These sites almost exclusively promoted food items high in sugar and fat. Health professionals need to monitor food industry marketing practices used in “new media.”     

A novel model of HPV infection in meshed human foreskin grafts

The present study describes a novel meshing procedure that provided successful low-risk papillomavirus propagation and reproducible wart induction in human foreskin xenografts. The initial HPV6 and/or 11 inocula were collected from clinically excised human wart tissues and confirmed to be free of HPV16, 18 and 31 by PCR analysis. Human foreskin grafts were collected from a circumcision clinic, and pre-inoculated with HPV virions by scarification. Meshing was carried out with a Zimmer Skin Grafter Mesher. Grafts were cut to appropriate size (1cm x 1cm or 5mm x 5mm) for cutaneous or subcutaneous grafting to NIH-nu-bg-xid mice under halothane anesthesia. Cutaneous xenografts were dressed with antibiotics and protective band-aids for 3 weeks. In the paralleled experiment using the same viral stock containing both HPV6 and 11, and matched grafts, no visible papillomas were observed in non-meshed cutaneous xenografts (n = 4 up to 6 months). In comparison, six of eight cutaneous xenografts treated with the meshing procedure formed visible papillomas within 4 months. This high frequency of distinct papilloma induction over the surface of meshed xenografts were reproduced in subsequent experiments with viral stocks containing both HPV11 and 6 (8 out of 10 grafts), or with a single-type HPV11 inoculum (80-100%). In contrast, an initial viral stock of single-type HPV6 provided lower frequency and more delayed papilloma induction. Serial passage of HPV6 in the meshed xenograft appeared to improve both the induction frequency and growth rate up to the 3rd generation. Histology, in situ hybridization, and immunohistochemical analysis revealed similarity of xenograft warts to those observed in the clinic. The highly reproducible papilloma induction rate and successful viral stock propagation associated with the meshing procedure provide a novel feature in the HPV xenograft model.     

Oral picropodophyllin (PPP) is well tolerated in vivo and inhibits IGF-1R expression and growth of uveal melanoma

PURPOSE: The cyclolignan picropodophyllin (PPP) efficiently blocks the activity of insulinlike growth factor-1 receptor (IGF-1R) and inhibits the growth of uveal melanoma cells in vitro and in vivo. In this study, the authors investigated the efficiency of orally administered PPP on the growth of uveal melanoma xenografts. In addition, they focused on the effect of PPP on vascular endothelial growth factor (VEGF) in vivo and evaluated its effects in combination with other established antitumor agents in vitro. METHODS: Four different uveal melanoma cell lines (OCM-1, OCM-3, OCM-8, 92-1) were treated with PPP alone and in combination with imatinib mesylate, cisplatin, 5-fluorouracil, and doxorubicin. Cell viability was determined by XTT assay. SCID mice that underwent xenografting with uveal melanoma cells were used to determine antitumor efficacy of oral PPP in vivo. Five mice were used per group. Tumor samples obtained from the in vivo experiments were analyzed for VEGF and IGF-1R expression by Western blotting. RESULTS: PPP was found to be superior to the other antitumor agents in killing uveal melanoma cells in all four cell lines (IC50 < 0.05 microM). Oral PPP inhibited uveal melanoma growth in vivo in OCM-3 (P = 0.03) and OCM-8 (P = 0.01) xenografts and was well tolerated by the animals. PPP decreased VEGF expression in the OCM-1 (P = 0.006) and OCM-8 (P = 0.01) tumors. CONCLUSIONS: Oral PPP was well tolerated in vivo, caused total growth inhibition of uveal melanoma xenografts, and decreased VEGF levels in the tumors.     

Reaching low-income families: Focus group results provide direction for a behavioral approach to WIC services

Supplemental Nutrition Program for Women, Infants, and Children (WIC) families were asked to identify motivators and barriers to health behavior change and preferred approaches to nutrition education in WIC. Six focus groups involved a total of 41 English-speaking WIC participants and addressed parenting, family meals, food preparation, and physical activity. The discussions were audiotaped, transcribed, and analyzed using NUD*IST software (Non-Numerical Unstructured Data Indexing, Searching, and Theorizing, version 4.0. Thousand Oaks, CA: Sage Publications Software, 1997). Key barriers to behavior change included inadequate parenting skills, lack of knowledge, unhealthy social environments, lack of time, and lack of social or financial support. Key motivators included feelings of responsibility, concern for child health and development, and positive social support. Participants identified facilitated discussions, support groups, cooking classes, and a WIC Web site as preferred methods of nutrition education. Results provided the foundation for the Healthy Habits nutrition education modules implemented in the Washington State WIC program and can be used to improve future nutrition education in WIC.     

Synthesis and biological evaluation of 2‐acylbenzofuranes as novel α‐glucosidase inhibitors with hypoglycemic activity

A series of benzofuran derivatives was synthesized as analogues of known natural α‐glucosidase inhibitors. Their activity was evaluated in enzymatic assay and in rat model of diabetes mellitus. Newly identified inhibitors demonstrate significant potency with IC₅₀ values ranging from 6.50 to 722.2 μm , as well as hypoglycemic activity exceeding the reference drug acarbose. Docking simulations provided insight into structure‐activity relationships to direct further development of these novel hypoglycemic agents.     

Women's body dissatisfaction, social class, and social mobility

Several studies indicate that socially advantaged women are more dissatisfied with their bodies than socially disadvantaged women. These findings have been based on women's current social class, and no attention has been paid to the social class of her family of origin or to intergenerational social mobility. In the present research 912 54-year-old women from a prospective birth cohort study provided self-report data on current body esteem (appearance and weight dimensions). Childhood and adult social class (manual versus non-manual) were defined based on father's occupation and own or partner's occupation, respectively. This information and the highest educational qualifications recorded by age 26 were gathered prospectively. Indicators of current and adolescent body mass index (BMI) were computed from height and weight values collected at ages 15 (or 11) and 53-54 years. Multiple regression was used to examine the relationship between midlife body esteem and childhood social class, adult social class, educational qualifications, and social mobility, unadjusted and adjusted for BMI. Women from the non-manual classes as adults were more dissatisfied with their weight than women from the manual classes as adults, for a given BMI. Adjusting for BMI, downwardly mobile women were more satisfied with their appearance than stable non-manual women. Adjusting for BMI, higher educational qualifications were associated with more dissatisfaction with weight and with appearance, and education appears to be more important than occupationally defined social class in explaining body dissatisfaction. A clearer understanding of the relationship between socio-economic position and body dissatisfaction demands that the following distinctions are made: weight versus appearance satisfaction, education versus occupation, and current social class versus intergenerational social mobility.