#367 - The estrogen therapy debate. The FDA’s removal of black box warnings vs what the studies actually show. Prepare to be shocked with Kate Deering

The FDA recently asked drug companies to remove the black box warnings from estrogen therapy..

and the internet exploded.

Suddenly everyone is saying

“Estrogen will protect your brain”

“Estrogen prevents dementia”

“Estrogen saves your heart”

“Every woman should be on it”

But when you actually look at the research...

the story is very different.

In the latest episode with Kate Deering and we unpack

👉 Why observational studies make estrogen look safer than it is

👉 What randomised controlled trials show about dementia

👉 Why the heart health claims fall apart when you look at absolute risk

👉 The truth about estrogen and bone density

👉 Why symptom relief gets mistaken for disease prevention

👉 The real risks no one is talking about

👉 What actually drives hot flashes and how to fix them without jumping straight to hormones

Women deserve the full picture not fear based messaging.

If you want to understand the FDA decision and what the evidence really says, this episode will give you more clarity than any headline ever will.

STUDY LINKS

This is the study the FDA references to say women who do not take hormones have a 35% greater risk of Alzheimers. This was a retrospective case-control study within a retirement community in Southern California.

Paganini-Hill A, Henderson VW. Estrogen replacement therapy and risk of Alzheimer disease. Archives of internal medicine. 1996 Oct 28;156(19):2213-7.

They compared estrogen replacement therapy (ERT) use among cases vs controls (i.e. users vs non-users). They found a significantly lower risk of Alzheimer’s-related dementia in women who used ERT (OR 0.65; 95% CI 0.49–0.88). This design only shows associations not causation

However, lets look at the other case-control studies done more recently:

1.Pourhadi N, Mørch LS, Holm EA, Torp-Pedersen C, Meaidi A. Menopausal hormone therapy and dementia: nationwide, nested case-control study. bmj. 2023 Jun 28;381. 

Conclusions: Women n combination therapy had a significantly higher rate of dementia The risk increased the longer they were on the therapy

2.Vinogradova Y, Dening T, Hippisley-Cox J, Taylor L, Moore M, Coupland C. Use of menopausal hormone therapy and risk of dementia: nested case-control studies using QResearch and CPRD databases. bmj. 2021 Sep 30;374.

Conclusions.  Short term use no association with dementia. But, longer-term use WAS associated with increased dementia

3.Savolainen-Peltonen H, Rahkola-Soisalo P, Hoti F, Vattulainen P, Gissler M, Ylikorkala O, Mikkola TS. Use of postmenopausal hormone therapy and risk of Alzheimer’s disease in Finland: nationwide case-control study. bmj. 2019 Mar 6;364.

Conclusions: Systemic hormone therapy was associated with an increased risk of Alzheimers

4.Sung YF, Tsai CT, Kuo CY, Lee JT, Chou CH, Chen YC, Chou YC, Sun CA. Use of hormone replacement therapy and risk of dementia: a nationwide cohort study. Neurology. 2022 Oct 25;99(17):e1835-42.

Conclusions: Hormone therapy was associated with a significant increased risk of dementia

RCT on dementia

1. WHIMS from WHI-- on women 65-79

Those on estrogen and progestins had increased risk of dementia

Estrogen only --somewhat of an increase with estrogen only--estrogen DID not protect

limitations--age of women

2. Nerattini et al., Frontiers in Aging Neuroscience 2023 looked at all RCTs that reported dementia/AD risk. Studied 6 RCT

Showed HT increased dementia risks by 38%

RCT on cognition:

1. KEEPS: No clear harm of benefit on cognition. Limitation --4 and 10 year follow up only--dementia can occur much later

2. ELITE-Cog

Overall: no strong cognition protection, but no red flags either

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