| Posted 14 July 2020 An ad hoc committee convened by the National Academies of Sciences, Engineering, and Medicine has concluded that there is insufficient evidence to support the clinical utility of custom-compounded bioidentical hormone therapy (cBHT). Unlike the dozens of hormone therapy products that have been reviewed for safety and efficacy and are FDA-approved for treating symptoms resulting from natural, age-related hormone changes or other endocrine-based disorders, cBHT preparations are not required to be proven safe or effective before they are dispensed to patients. The NAS committee recommends: (a) restricting the use of cBHT preparations, (b) assessment of their difficulty to compound, and (c) additional education, oversight, and research. An estimated 26 to 33 million prescriptions for cBHT preparations cost upwards of $2 billion annually. Reference: National Academies of Sciences, Engineering, and Medicine. Highlights: The clinical utility of compounded bioidentical hormone therapy (cBHT): A review of safety, effectiveness, and use… Read the rest Posted 17 January 2019 By Rowan Jacobsen – Published Jan 10, 2019 in OutsideOnline.com Current guidelines for sun exposure are unhealthy and unscientific, controversial new research suggests-and quite possibly even racist. How did we get it so wrong? These are dark days for supplements. Although they are a $30-plus billion market in the United States alone, vitamin A, vitamin C, vitamin E, selenium, beta-carotene, glucosamine, chondroitin, and fish oil have now flopped in study after study. If there was one supplement that seemed sure to survive the rigorous tests, it was vitamin D. People with low levels of vitamin D in their blood have significantly higher rates of virtually every disease and disorder you can think of: cancer, diabetes, obesity, osteoporosis, heart attack, stroke, depression, cognitive impairment, autoimmune conditions, and more. The vitamin is required for calcium absorption and is thus essential for bone health, but as evidence mounted that … Read the rest Posted 06 September 2018 This is an important and interesting perspective of Vitamin D supplementation. It is written by Prof Tim Spector, Professor of Genetic Epidemiology, King’s College London, and published in The Conversation. He concludes: About half the population take vitamins daily, despite zero benefits, with increasing evidence of harm. The worldwide trend of adding unregulated vitamins to processed food has now to be seriously questioned. While vitamin D treatment still has a rare medical role in severe deficiency, or those bed bound, the rest of us should avoid being “treated” with this steroid for this pseudo-disease and focus on having a healthy lifestyle, sunshine and importantly save your money and energy on eating a rich diversity of real food.
… Read the rest Posted 27 August 2018 Bioidentical hormones has remained controversial for many years. For example, Solal a manufacturer of these products, claims on their website: “Saliva testing of steroid hormones, which is the truest reflection of your tissue levels of steroid hormones” [1] whereas the recent article (below) from the Medical Journal Australia states “In fact, saliva tests are not considered a reliable method for establishing hormone levels”. 1. http://solal.co.za/integrative-medical-centre/ The article continues with: “Overall the scientific studies are positive regarding women with menopausal symptoms taking HRT. The same cannot be said for bioidentical hormones because they have not been widely or appropriately researched”. Bioidentical Hormone Therapy: Myths Versus FactsMedical Journal Australia MJA Issue 33 / 27 August 2018 … Read the rest Posted 20 March 2017 Six sets of defendants are being sued for inappropriate marketing of testosterone-replacement therapy (TRT) with misleading claims. Separate cases have been consolidated into a master complaint that is proceeding in proceeding in Illinois Federal Court. The third amended master complaint summarizes the case this way: “TRTs were approved for use in the treatment of a medical condition known as hypogonadism, but widely marketed by Defendants for off-label use for a condition invented by Defendants and referred to as “Low T.” . . . Defendants marketed TRTs as safe and effective for this off-label use, when in fact (a) TRTs confer little or no benefit for so-called “Low T” in the absence of”classical hypogonadism”; and (b) the drugs cause serious medical problems, including life-threatening cardiac, cerebrovascular, and thromboembolic events, for which Defendants failed to provide adequate warnings.” The fact that testosterone levels normally decline as men get … Read the rest Posted 21 June 2016 The Endocrine Society has updated its statement on compounded “bioidentical hormones” and is urging clinicians not to prescribe them. [Santoro N and others. Compounded bioidentical hormones in endocrinology practice: An Endocrine Society scientific statement. Journal of Endocrinology and Metabolism 101:1318-1343, 2016] The document states: “Much of the advertising associated with these custom-compounded preparations implies that naturally occurring hormones are superior to synthetic hormones and compounded formulations are better than FDA-approved formulations. In some instances, the purveyors . . . claim to produce combinations of hormones that mimic the circulating hormonal milieu of young adulthood and therefore prevent various ravages of aging. In the most extreme cases, advertisers imply that compounded natural hormones are risk-free when compared with conventional menopausal hormone therapy that uses bioidentical and/or synthetic hormones. . . . However, very few (if any) of these claims are supported by research, and in fact, … Read the rest Posted 26 January 2016 This article, written by Prof. Tim Spector, Professor of Genetic Epidemiology, King’s College London, argues that evidence to support the claims for Vitamin D is lacking, and that taking Vitamin D may even be dangerous. Solal made outrageous claims for its Vitamin D supplements, including that it was more effective than vaccines! [quote]However, a new paper on the risks that vitamin D may pose finally has convinced me that I was wrong. My view on vitamin supplements and the multi-billion dollar industry behind them altered radically after I began researching my book, The Diet Myth, in 2013. The industry and its PR is supported by celebrities who reportedly have high-dose vitamins drip fed into their veins, and around 50% of Americans and Britons take them regularly. But surprisingly, there is a lack of evidence to support the health benefit claims of virtually all vitamin supplements… Read the rest Posted 13 January 2016 This editorial published in the Annals of Internal Medicine, and titled, Enough Is Enough: Stop Wasting Money on Vitamin and Mineral Supplements, makes the point that studies show that there is no clear evidence of a beneficial effect of supplements on all-cause mortality, cardiovascular disease, or cancer, that a study conducted for 12 years, found no differences between the multivitamin and placebo groups in overall cognitive performance or verbal memory, and a study evaluating the potential benefits of a high-dose, 28-component multivitamin supplement with a previous heart attack, found that there was no significant difference in recurrent cardiovascular events with multivitamins compared with placebo. [quote]Other reviews and guidelines that have appraised the role of vitamin and mineral supplements in primary or secondary prevention of chronic disease have consistently found null results or possible harms. Evidence involving tens of thousands of people randomly assigned in many clinical… Read the rest Posted 13 January 2016 This article by Clare Allan and published in The Guardian, argues that that supplement peddlers prey on our vulnerabilities. They prey on our desire for change and on our lack of confidence in our own ability to effect it. [quote]It won’t make the slightest difference. We believe because we want, or sometimes need, to believe. We feel powerless in the face of poor health, intractable external demands or our seeming inability to stick to a sensible diet plan. Sometimes we don’t even believe, that raspberry ketones, for example, will transform our bodies for us, but wouldn’t it be great if they did? It’s a lottery-ticket mentality. In it to win it. You never know, and besides what harm can it do?[/quote]
[quote]In the case of raspberry ketones, it seems that there is potential for considerable harm. In 2013, 24-year-old Cara Reynolds died after taking an… Read the rest Posted 06 October 2015 This article, below, published in Times Live, draws attention to Vigro (a Natura product) trying to prevent arbitration on whether the claims that the product can regrow hair was supported by adequate evidence. The ASA ruled against the claims, and following an appeal by Natura, was referred for arbitration to Prof Nonhlanhla Khumalo, head of the Department of Dermatology, University of Cape Town. The article also highlights USN’s High Court Action against Dr Harris Steinman. USN alleges that Steinman had defamed them. Steinman is defending the action. More than 40 complaints have been laid against USN with the ASA. … Read the rest | |