Beyond hot flashes: Navigating menopause with safer supplement strategies

The Fundamental Fact is that dietary supplements are not medications but fall under the category of foods.

IMPORTANT: We cannot attribute medicinal effects to dietary supplements and their ingredients, nor present them as medications - not even visually. Consumers should not and cannot expect them to have effects on improving diseases and health conditions. However, we can expect an improvement in the quality of life.

The realm of dietary supplements and over-the-counter (OTC) medications is full of ambiguities and contradictions. Through this mind-map, I aim to bring you closer to the differences and commonalities between dietary supplements and OTC medications. What links these two categories are the ingredients and substances and the safety required by regulatory authorities. The regulatory bodies are different: for medications, it is the EMA=European Medicines Agency; for dietary supplements, which fall under foods, it is the EFSA=European Food Safety Authority. The standards are different, though in many respects similar. Proving effectiveness is reserved for medications; for dietary supplements, proving the effect focuses on substantiating health claims whose ultimate goal is improving QOL.

The European Food Safety Authority (EFSA), overseeing dietary supplements, has prepared a list of approved health claims for each ingredient. Only these health claims may be listed on the packaging. Interestingly, or as healthcare professionals, we must be aware of the generalisation of health claims. To explain easily: if a dietary supplement with several ingredients that do not have approved health claims is supplemented, for example, with Vit. C, we can list all 15 claims approved for Vit. C on the product. Thus, the user links these claims to all substances in the product.

How do substances in dietary supplements obtain health claims?

 The manufacturer of dietary supplements proposes a health claim to the EFSA for the desired substance. The EFSA approves a health claim only if it is substantiated with scientific research. The table shows differences between clinical research for dietary supplements and medications. It is important to realise that research for dietary supplements:

- is conducted on healthy volunteers,

- aims to obtain SCIENTIFIC JUSTIFICATION FOR A SPECIFIC MARKETING CLAIM,

- the goal is to demonstrate an impact on general health.

Changes in hormonal balance affect the quality of life for women.

Research still supports that the best OPTION FOR ALLEVIATING SEVERE MENOPAUSAL ISSUES is still achieved with HORMONE REPLACEMENT THERAPY, which is the gold standard of treatment. However, many women reject HRT mainly due to fear of side effects. Data shows that less than 30% of women in menopause use HRT, and only 15% continue the therapy for an extended time. It is evident that women often demand a "natural" approach for their symptoms.

Research in the USA and Great Britain shows that 80% of women in the period of perimenopause, menopause, and postmenopause use dietary supplements and OTC medications. In Slovenia, we have two registered non-prescription medications. One medication contains an extract of black cohosh (Actaea racemosa) and the other contains an extract of sage (Salvia officinalis). If I pause for a moment at black cohosh - recent research indicates a positive effect of black cohosh extract also on cognitive abilities and confirms its safety of use. At the same time, a combination of black cohosh extract with St. John's Wort has achieved very good results in mood disorders, as proven in appropriate clinical research. Although we have two registered non-prescription medications for alleviating vasomotor symptoms, PHYTOESTROGENS, alongside hormone replacement therapy, are currently the most popular form of alternative therapy. I would like to emphasise that not a single ingredient used in dietary supplements for alleviating menopausal issues has an approved health claim, and that claims for these plants focus mainly on vasomotor symptoms. We all know that peri- and post-menopause encompasses much more than just vasomotor symptoms.

The opinion of the EFSA and the National Institute of Public Health in Slovenia is that there is insufficient evidence to confirm a link between consuming isoflavones and maintaining bone density in postmenopausal women; likewise, they have not proven a link between consuming isoflavones and reducing symptoms associated with menopause. (That is, there is not enough evidence for a causal link between isoflavones and the impact on vasomotor symptoms.) The long-term safety of isoflavones at exposures up to 150 mg per day and intake up to three (3) years has been confirmed (in hormone-dependent tissues of the breast, endometrial lining, and thyroid).

Meanwhile, the safety of some other substances remains questionable. An excerpt from the monograph (for medicinal plants) for black cohosh, accessible on the website of the European Medicines Agency, shows that the Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency has given an assessment based on 20 clinical studies involving more than 6000 patients.

The Noteworthy Case of DHEA, Known Also as Prasterone

You've probably noticed the ingredient for alleviating menopausal troubles, dehydroepiandrosterone (DHEA), also called prasterone. DHEA is an endogenous steroid hormone and is an active ingredient used locally in gels for treating symptoms of vaginal atrophy. According to the definition of dietary supplements, the use of prasterone in these products is prohibited.

However, it is present in dietary supplements, often disguised in the natural form in the plant Wild Yam (Dioscorea villosa).

Wild yam is promoted by some as a natural source of DHEA since it contains a compound that can be used in the laboratory to synthesise estrogen and DHEA.

A Telling Case Report by Dr. Bojana Pinter from 2023

Specifically, the use of DHEA in a menopausal woman led to serious hyperandrogenism. To summarise briefly: a 52-year-old woman, due to perimenopausal symptoms such as hot flashes and insomnia, began taking DHEA on the advice of an 'expert.' After two and a half years of taking DHEA, her symptoms worsened, and a significant increase in testosterone and DHEA levels was discovered.

The gynecologist advised her to stop taking DHEA and to continue treatment with estradiol and progesterone. The condition improved after the intervention. This case beautifully illustrates the risks of inappropriate and uncontrolled DHEA use and emphasises the importance of professional advice in menopause. The 2021 professional recommendations on menopausal medicine state that existing research has not proven the beneficial effects of prasterone (DHEA) (level A).

Without a doubt, there are quality dietary supplements and non-prescription drugs intended to support women through peri-, and post-menopause.

With a holistic approach and a broader offering that includes not just dietary supplements and non-prescription medications for alleviating hot flashes, we can ease the lives of women in menopause. So ALONGSIDE EXTRACTS FROM SOY, BLACK COHOSH, SAGE, it is sensible to consider ADAPTOGENS. These are extracts from plants such as RHODIOLA, COMMON OATS, MACA, ASHWAGANDHA, which affect sleep, energy levels, and mood. In pharmacies, we have good experiences with advising VALERIAN, and this category could also include PASSIONFLOWER, HOPS, ST. JOHN'S WORT. If we pause for a minute at HOPS EXTRACT, which contains the strongest known phytoestrogen to date,

8-PRENILNARINGENIN, whose potency has been evaluated IN VITRO. Studies suggest a beneficial effect on bone mass, it is also advertised as an agent for breast enlargement, but further research is needed. Each of these plants has its limitations.

We can also add micro and macro nutrients: calcium, magnesium, zinc, vitamin D, unsaturated fatty acids, probiotics, digestive enzymes. Proteins are also very important, and of course useful for maintaining muscle mass, where we can also consider collagen due to influence on connective tissue. The effect of taking dietary supplements and non-prescription medications should be assessed after six, and in most cases, after twelve weeks. The basis for all supplements is a healthy diet, physical activity, and maintaining mobility.

In summary, it is essential to consume

- high-quality,

- microbiologically impeccable dietary supplements,

- free of toxic impurities,

- and illegal medicinal additives,

because only such are consequently safe!

Often, we women in menopause are alone with our problems and stigmatized. Frequently, uncomfortable feelings of tension, insomnia, digestive issues, and various discomforts sneak into our lives and relationships gradually, so that these changes, even before we notice them, are observed by the people around us—our close ones. Therefore, let's help each other. I would conclude with the thought of Dr. Mary Claire Haver:

"Menopause is inevitable, but suffering through it is not!"