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New hormone therapy sparks debate

Our Review Summary

The story presents bioidentical hormones as a new option for relieving bothersome symptoms of menopause such as hot flashes, cold sweats and vaginal discomfort. The story accurately reports that the active ingredients of these supposedly “natural” hormones are the same ones used in synthetic hormone replacement therapy (HRT). However, these hormones are not as well-regulated or well-tested as synthetic versions. 
 
The story provides no evidence that bioidentical hormones are more effective or safer than traditional HRT.  Positive testimonials from a physician employee of a bioidentical hormone supplier, a celebrity and women who have experienced reduced menopausal symptoms with  bioidentical hormones are not a substitute for quantitative evidence. The comment that a hormone product can be tailored to a woman's chemistry is not proven.  Additionally, the story does not mention the cost of bioidenticals, which are typically about $50/month, similar to the cost of conventional HRT.  Any physician can provide a prescription for bioidentical hormones in a routine office visit.
 
The story appropriately stresses that menopause is a natural part of aging and not a disease which necessitates medical intervention. The story also mentions that short-term use of HRT in any form should be evaluated on a case-by-case basis. Unless symptoms are very bothersome, many women do not need to take HRT to ease symptoms common in menopause.

While the bioindentical hormones are marketed as a natural alternative to balancing hormones and easing bothersome symptoms of hormonal fluctuations during menopause, the story fails to mention the least risky “natural” interventions for managing symptoms of menopause, such as exercise and wearing loose, cool clothing to prevent discomfort from hot flashes and cold sweats.  The story also does not mention non-hormonal, evidence-based pharmaceutical options for managing symptoms. However, using these medications for treatment of hot flashes would be considered an off-label prescription.   (See a previous review of a story on this topic.)

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not mention the cost of bioidenticals, which are typically about $50/month, similar to the cost of conventional HRT. On the website of a company mentioned, BodyLogicMD, costs are estimated at $200-400 for an initial visit, $125 to $250  for a follow-up visit (recommended every 3 months) and $30-$100 a month for the hormones themselves, this is not a good benchmark for costs of bioidentical hormone treatment.  The BodyLogicMD site touts specific physicians in 6 states who provide an exam, testing, and prescription, but any physician can provide a prescription for bioidentical hormones at a routine office visit. 

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The story provides no quantitative data about the safety or efficacy of bioidentical hormones.  Positive testimonials from a physician employee of a bioidentical supplier, a celebrity and women who have experienced fewer menopausal symptoms are not a substitute for quantitative evidence.  The comment that a unique "natural" hormone product can be tailored to a woman's chemistry is not proven.

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

The story provides appropriate caveats that the bioidentical hormones are not carefully regulated by the FDA and they may pose the same health risks to some women as synthetic HRT (i.e. increased risk of breast cancer and heart disease). The story mentions that until  definitive data exist, we do not know if these hormones are safe.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story provides no evidence that bioidentical hormones are more effective or less risky than synthetic hormone replacement medications. There is poor balance – not even an expert to counter the claims of the proponents, let alone other evidence.  (For example, the North American Menopause Society's official published position is that bioidentical hormones should not be assumed to be any safer than conventional HRT.)

Does the story commit disease-mongering?

Satisfactory

The story appropriately stresses that menopause is a natural part of aging and not a disease which necessitates medical intervention. Unless symptoms are very bothersome, many women do not need to take hormone therapy replacement (HRT) to ease symptoms common in menopause, such as hot flashes, cold sweats and vaginal dryness and discomfort.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

Susan Love is the only unbiased expert commenting on safety.  There are two other highly biased experts speaking in favor of bioidentical hormones.  The reporter's comments provide important counterweight.  But the balance of the piece is thrown off by the inclusion of two  quotes from a representative of BodyLogicMD, a distributor of bioidentical hormone therapy. And the story never mentions that the company is, indeed, a distributor of bioidentical hormone therapy.  

 

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story does mention that traditional hormone therapy should be evaluated on a case by case basis. Short-term use is not risky for every woman if the benefits of reduced symptoms outweigh increased risks of breast cancer and heart disease.  What is not mentioned are less risky lifestyle changes and evidence-based, non-hormonal pharmaceutical options for dealing with menopausal symtoms. In randomized controlled trials, certain anti-depressant and anti-seizure medications have been shown to reduce hot flashes and other symptoms of menopause in some women. (See a review of a previous story on this topic.) Specifically, the story does not talk about the least invasive  treatments for managing symptoms of menopause such as exercise, vaginal creams, and wearing loose, cool clothing to prevent discomfort from hot flashes and cold sweats.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story does not mention where bioindentical hormones are available. However, the story mentions that 3,000 pharmacies in the U.S. fill orders for custom-made hormonal compounds. The story mentions these hormones are not well-regulated and we are not told if you need a prescription.  

 

Does the story establish the true novelty of the approach?

Satisfactory

The story presents bioidentical hormones as a newer option to relieve bothersome symptoms of menopause. The story accurately reports that the active ingredients of these "newer" hormones are the same ones used in synthetic hormone replacement therapy (HRT).

Does the story appear to rely solely or largely on a news release?

Not Applicable

We can't judge if the story relied solely or largely on a news release.  Several sources were quoted, although two of the quotes came from a representative of a company promoting these products.

Total Score: 4 of 9 Satisfactory

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