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Novel Research on Emerging Hot Flash Supplement

Alex Fulton

Written by Alex Fulton

Alex Fulton

Written by Alex Fulton

Of the 34 currently recognized symptoms of menopause, hot flashes and night sweats are among the most notorious. Along with heart palpitations and changes in blood pressure,1 hot flashes and night sweats fall under the umbrella of vasomotor symptoms of menopause—and they affect up to 80% of women during the menopausal transition.2

There’s no shortage of treatment options available for the many women dealing with hot flashes and night sweats. These include everything from hormone replacement therapy and SSRIs to over-the-counter dietary supplements and novel prescription medications, like fezolinetant –  which works through non-hormonal pathways in the body to address these symptoms.

As a company dedicated to research and scientific discovery, Bonafide has been hard at work on the development and testing of an exciting new, hormone-free botanical blend formulated to safely and effectively relieve hot flashes and night sweats. Called ThermellaTM, this patented combination of ingredients is designed to work in a similar fashion to prescription fezolinetant —with comparable results, but without a prescription.

Causes of Vasomotor Symptoms in Perimenopause and Menopause

As common as hot flashes and other vasomotor symptoms are during perimenopause and menopause, their cause is complex and multifactorial. Experts believe they occur because of changes in the hypothalamus – the part of the brain that is responsible for regulating body temperature – which are triggered by hormonal changes occurring during the menopausal transition.

When the hypothalamus senses a person is too warm, it signals blood vessels near the surface of the skin to dilate and increase blood flow, in an attempt to dissipate the heat. It may also trigger perspiration in an effort to cool the body down. During a hot flash, women may sense their hearts beating faster, and/or feel a chill once the symptom has subsided.

Hot flashes, and other vasomotor symptoms, typically begin to affect women around the age of 50,3 but they may also be experienced earlier, during perimenopause, or the years leading up to menopause and postmenopause. The average duration of vasomotor symptoms is 7.4 years, with some experiencing them for up to 15+ years.4

How Can You Manage Vasomotor Symptoms?

A surprisingly large number of women—73%, according to our 2020 State of Menopause Survey—don’t seek treatment for menopause symptoms, including hot flashes and night sweats, choosing to instead just “deal” with them.5 Some may turn to prescription treatments such as hormone replacement therapy, SSRIs or other pharmaceuticals, while others may opt for a more natural, non-drug approach to vasomotor symptom management through the use of herbal remedies, vitamins and supplements, or dietary changes.

Because every woman is different, there is no universal approach to managing menopausal hot flashes and night sweats. Not every prescription medication is a definite fix for everyone, and not all over-the-counter products on the market are backed by sufficient scientific evidence to support their efficacy and/or safety.

Clinical Research Reveals an Exciting Innovation in Vasomotor Symptom Management

Clinical research is the study of the safety and effectiveness of promising advances in healthcare and treatment options. It’s different from benchtop laboratory research in that it involves the use of people, versus animals or cell cultures, who volunteer to participate. Clinical research is essential for gathering a complete understanding of how potential treatments options work in humans,6 in addition to determining side effects or drug interactions.

Bonafide shared clinical research from an on-going, open-label (i.e. participants were given information on the supplement they were taking) study back in September 2023 at The Menopause Society annual meeting, assessing the effects of a proprietary, botanical blend, Thermella, on its ability to reduce the frequency of menopause-related vasomotor symptoms. Similar to fezolinetant, Thermella is a hormone-free management option that works through modifying the over-activity of certain neurons in the brain that are related to body temperature regulation.

To put it more simply, there are receptors in the brain that are called NK3 receptors. These receptors are responsive to neurokinins, a chemical messenger in the brain, as well as estrogen. When estrogen declines during menopause, these neurokinins become more active. Increased activity at the NK3 receptors results in more hot flashes and/or night sweats. 

In our clinical study, 30 perimenopausal and postmenopausal women were asked to take the supplement Thermella, for eight weeks. They were instructed to keep diaries of the details of their vasomotor symptoms and completed validated questionnaires regarding their symptoms at two-or four-week intervals.

The results have been promising so far. Thermella was shown to significantly reduce the participant’s total vasomotor occurrences in as little as two weeks, and by week four, symptoms decreased by 50%. These positive effects were maintained throughout the duration of the study. Study participants also reported significant improvements in sleep and overall quality of life, with 25 out of 30 women studied saying they’d continue using Thermella even after the study ended.

No major adverse side effects have been reported alongside the use of this supplement during the clinical trial, to date.

Why Ongoing Clinical Research Matters

Bonafide is thrilled to share these results and plans to continue the scientific pursuit of hormone-free products designed to effectively support women through menopause and beyond. What’s more, Bonafide is undertaking additional randomized, controlled clinical trials, in order to further support these exciting initial results.

“We are steadfast in our commitment to not only meet but exceed the standards for safety and efficacy through evidence-based solutions tailored to address women’s distinct needs,” says Trisha VanDusseldorp, Director of Clinical Research at Bonafide. “At the core of our research and development mission lies an unwavering focus on understanding the diverse and multifaceted requirements of women, empowering us to forge pathways to innovative solutions that address unmet needs and champion women’s wellbeing in groundbreaking ways.”

Dr. Alyssa Dweck, Chief Medical Officer at Bonafide adds, "This study is important since both patients and providers benefit from the availability of a variety of safe and effective tools to manage vasomotor symptoms; there is no one size fits all solution."

Stay tuned for more information about this exciting product development!

Resources

  1. https://www.medicalnewstoday.com/articles/317801
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6226273/
  3. https://newsinhealth.nih.gov/2010/06/too-young-hot-flashes#:~:text=Hot%20flashes%2C%20night%20sweats%2C%20loss,most%20women%20around%20age%2050.
  4. https://pubmed.ncbi.nlm.nih.gov/25686030/
  5. https://www.forbes.com/sites/debgordon/2021/07/13/73-of-women-dont-treat-their-menopause-symptoms-new-survey-shows/?sh=340d3be4454f
  6. https://www.hopkinsmedicine.org/research/understanding-clinical-trials/clinical-research-what-is-it

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