The safety, efficacy and pharmaceutical quality of male enhancement nutraceuticals bought online: Truth versus claim.

OBJECTIVE: Nutraceutical products are widely used for their claimed therapeutic benefits. However, falsified or adulterated nutraceuticals present a major health threat to consumers. This study investigates the pharmaceutical quality, safety and anti-inflammatory effects of six male enhancement nutraceuticals that claim to be 100% natural. METHODS: Three batches of six male enhancement products were tested to detect the presence and levels of adulterants via high-performance liquid chromatography (HPLC). The pharmaceutical quality of the selected nutraceuticals was tested with near infrared spectroscopy (NIR) and SeDeM. The cytotoxic effects of these products on HepG2 cells were determined through cell proliferation (XTT) and lactate dehydrogenase (LDH) cytotoxicity assays. Lastly, the in vitro inflammatory effects of these products were investigated using murine J774 macrophages through cytokine release analysis. RESULTS: HPLC analysis detected the presence of sildenafil citrate, a vasodilator, and the active ingredient in Viagra and Revatio, in all batches of the products we analyzed. Amount of sildenafil citrate ranged from 0.45 mg to 51.85 mg among different batches. NIR assessment showed inter- and intra-batch heterogeneity in product composition. Results of the XTT and LDH assays showed significant cytotoxic effects of the analyzed products. XTT analysis revealed that the viability of HepG2 treated with tested products varied from 27.57% to 41.43%. Interestingly, the male enhancement products also showed anti-inflammatory effects. CONCLUSION: Despite their labeling as 100% natural, all products tested in this study contained levels of sildenafil citrate, which was not reported on the packaging. There was a lack of pharmaceutical uniformity among products of the same batch and across different batches. Additionally, the products we tested had cytotoxic effects. These study findings highlight the adulteration, poor quality and hazard of these nutraceuticals. Therefore, strict regulation of these products and standardization of the definition of nutraceuticals are urgently needed. Further, these falsely advertised products should be withdrawn from the market due to potential adverse effects on the health of their consumers.

Current Topical Strategies for Skin-Aging and Inflammaging Treatment: Science versus Fiction.

Aging is a natural phenomenon that affects the whole body, including the skin. As we age, endogenous and exogenous factors cause our skin to become thinner, paler, and wrinkled. Although the underlying mechanisms of the pathogenesis of skin aging are not entirely known, multiple pathways have been proposed. Inflammaging has recently emerged as a pathway that correlates aging and age-related diseases with inflammation. This review discusses the role and pathways of inflammaging that lead to skin aging. Moreover, strategies and current topical approaches for skin-aging treatment are discussed. Studies over the past 10 years suggested that DNA damage and oxidative stress are the most critical mechanisms in skin aging, and both are interlinked with inflammaging. Several treatments for skin aging have been considered such as antioxidants, hormone replacement therapy, and vitamins. To deliver anti-aging agents topically, researchers adopted numerous approaches to enhance skin penetration including physical, chemical, or biomaterial enhancers and carrier-based formulations. In recent years, consumers' demands for anti-aging products have considerably risen, leading to robust growth in the anti-aging market. Therefore, further in-depth studies are necessary to understand skin-aging mechanisms and evaluate the efficacy of anti-aging products to protect consumers worldwide by providing them safe and effective over-the-counter skin-aging formulations.

Relationship between lifestyle and health factors and severe lower urinary tract symptoms (LUTS) in 106,435 middle-aged and older Australian men: population-based study.

BACKGROUND: Despite growing interest in prevention of lower urinary tract symptoms (LUTS) through better understanding of modifiable risk factors, large-scale population-based evidence is limited. OBJECTIVE: To describe risk factors associated with severe LUTS in the 45 and Up Study, a large cohort study. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional analysis of questionnaire data from 106,435 men aged ≥ 45 years, living in New South Wales, Australia. OUTCOME MEASURES AND STATISTICAL ANALYSIS: LUTS were measured by a modified version of the International Prostate Symptom Score (m-IPSS). The strength of association between severe LUTS and socio-demographic, lifestyle and health-related factors was estimated, using logistic regression to calculate odds ratios, adjusted for a range of confounding factors. RESULTS: Overall, 18.3% reported moderate, and 3.6% severe, LUTS. Severe LUTS were more common among men reporting previous prostate cancer (7.6%), total prostatectomy (4.9%) or having part of the prostate removed (8.2%). After excluding men with prostate cancer or prostate surgery, the prevalence of moderate-severe LUTS in the cohort (n = 95,089) ranged from 10.6% to 35.4% for ages 45-49 to ≥ 80; the age-related increase was steeper for storage than voiding symptoms. The adjusted odds of severe LUTS decreased with increasing education (tertiary qualification versus no school certificate, odds ratio (OR = 0.78 (0.68-0.89))) and increasing physical activity (high versus low, OR = 0.83 (0.76-0.91)). Odds were elevated among current smokers versus never-smokers (OR = 1.64 (1.43-1.88)), obese versus healthy-weight men (OR = 1.27 (1.14-1.41)) and for comorbid conditions (e.g., heart disease versus no heart disease, OR = 1.36 (1.24-1.49)), and particularly for severe versus no physical functional limitation (OR = 5.17 (4.51-5.93)). CONCLUSIONS: LUTS was associated with a number of factors, including modifiable risk factors, suggesting potential targets for prevention.

Is psychological distress in people living with cancer related to the fact of diagnosis, current treatment or level of disability? Findings from a large Australian study.

OBJECTIVE: To investigate whether the observed elevated levels of psychological distress in cancer survivors relate specifically to aspects of cancer diagnosis, to treatment or to disability. DESIGN, PARTICIPANTS AND SETTING: Self-reported questionnaire data on demographic, health and lifestyle factors and mental health from 89574 Australian men and women aged 45 years or older, sampled from the Medicare database for the 45 and Up Study from 1 February 2006 to 30 April 2008. Logistic regression was used to examine the risk of high levels of psychological distress in relation to cancer diagnosis and disability, adjusting for age, sex, income and education. MAIN OUTCOME MEASURE: High psychological distress (Kessler Psychological Distress Scale score > or = 22). RESULTS: Overall, 7.5% of participants had high levels of psychological distress. Among cancer survivors, the median time since diagnosis was 7.3 years. Compared with people without cancer, the odds ratios (95% CIs) for psychological distress were: 1.17 (1.09-1.26) in people reporting having had any cancer apart from non-melanoma skin cancer; 1.34 (1.08-1.67) in those with cancer diagnosed in the previous year; 1.53 (1.33-1.76) for those reporting treatment for cancer in the previous month and 1.11 (1.03-1.19) for those with cancer but without recent treatment. Using individuals with neither cancer nor disability as the reference group, the adjusted odds ratio (95% CI) for psychological distress was 6.51 (5.95-7.12) in those reporting significant disability but no cancer, 1.14(1.04-1.24) in those without disability but with cancer and 5.81(4.88-6.91) in those with both cancer and disability. CONCLUSION: The risk of psychological distress in individuals with cancer relates much more strongly to their level of disability than it does to the cancer diagnosis itself.