By: Jean Johnson for Uterus1
Part One | Part Two | Part Three | Part Four
Bioidentical Hormones – Complementary and Alternative Perspective
The previous parts in this series explored mainstream and alternative therapies to treat menopause symptoms– what science knows, what everyday women know and what is still unknown. In this final part of the series we investigate bioidentical hormones from various perspectives.
“After we’ve exhausted all of the herbal formulas and symptoms are still raging and interfering with quality of life,” said Rose Paisley, N.D., “then it’s appropriate to try bioidentical hormones.”
“PREMPRO is a proprietary pharmaceutical and not a naturally found substance in a woman’s body,” said Greg Eckel, N.D., M.S.O.M. “The companies have to make synthetic versions of hormones because they can’t patent the molecular structure that naturally occurs in the body.”
|Choose a treatment once you’re better informed:|
Bioidentical hormones mimic those naturally occurring in the body and are make from plants.
Con: “We don't really have the data to back up the safety or the efficacy because we don't even really know if it works," Dr. Wusun Paek, a gynecologist at Mount Sinai Hospital in Toronto, CBS in January 2006.
Pro: “I think there's enough good, strong literature out there that I'm very comfortable doing bioidentical hormone therapy," said Peter Ford, a pharmacist in Moncton, New Brunswick in the same CBS feature.
Wyeth pharmaceutical company has a petition before the Food and Drug Administration about regulating plant-based bioidentical hormones. At issue, says the company, is lack of federal oversight over compounding pharmacists.
Bioidentical hormones that are the same as those naturally occurring in a woman’s body, however, are available through compounding pharmacies.” Eckel explains that compounding pharmacies are throwbacks to a former era when pharmacists actually made medicines.
“This is where doctors would call in and get specific medicines made for their patient,” said Eckel. “It’s actual medicine making outside of the corporate world.”
Paisley adds that once patients understand how competition and market considerations figure into the production and use of synthetic hormones, they tend to become believers. She also notes that while it’s true that research supporting complementary and alternative medicine’s (CAM) approach to treatment is lacking, once again profit-making figures in.
Jay Meade, M.D. of the Center for Integrative Medicine in Portland, Ore. concurs with Paisley. The polished, silver-haired gentleman is a leading expert in salivary hormone testing and was medical director of the American Red Cross for more than10 years. More, Meade has practiced as a clinician for 20 years, is a board certified pathologist, and a flight surgeon in the United States Air Force Reserve.
“The arguments against bioidenticals are propagated by the drug companies and they push the NIH in the direction they want the government to go,” Meade said. “There is plenty of evidence saying the bioidentical hormones are working, not to mention centuries of success in world populations. The point is that the bioidentical hormones are not patentable and so the drug companies don’t want anything to do with them.”
Meade continues his candid comment. “Did you know that Wyeth is trying to shut down compounding pharmacists? They say they just want the FDA to enact regulations, but it’s just a ploy. I was just back in Washington, D.C. on this.
“I’m definitely pro-bioidentical hormones. I use a saliva testing lab. I’ve done my research. I’m a certified pathologist and a scientist, so I do things that are merited by science and that make sense,” Meade said.
Paisley appreciates Meade’s convictions and willingness to speak out about a subject she thinks is more about money than it is about women’s health. “There is far greater demand for CAM therapies than mainstream organizations are acknowledging. People are dying for alternatives. They come in and say, ‘I’ve tried this and don’t like the way it works. I want to try something natural.’”
Bioidentical Hormones – Traditional Perspective
The NIH SoS paper published in spring of 2005 does not consider the science on bioidentical hormones sufficient to warrant much comment. Thus, the topic is covered in a brief paragraph which is summed up with the observation that, “There is a paucity of data on the benefits and adverse effects of these compounds.”
For its part, the Mayo Clinic takes a similarly cautious, conservative stance. “There is a lot of interest in bioidentical – or so called ‘natural’ – hormone therapy for menopause symptoms. However, there is no evidence that bioidentical hormones are safer or more effective than standard hormone replacement therapy.”
The good folks at Mayo, however, do provide a salient definition for bioidentical hormones for those who feel a little lost in the forest.
“Bioidentical hormones are custom-mixed formulas containing various hormones that are chemically identical to those naturally made by your body. These over-the-counter products are marketed as being tailored to a woman's individual hormone needs, typically determined through saliva hormone testing. Manufacturers claim that bioidentical hormones are safer than standard, FDA-approved hormone therapy.”
The North American Menopause Society (NAMS) joins the NIH and the Mayo Clinic in two thumbs down to using bioidentical hormones for treating symptoms associated with menopause.
“Custom-compounded hormones may provide certain benefits, such as individualized doses and mixtures of products and dosage forms that are not available commercially. However, there may be risks to the consumer,” states the NAMS. “These compounds do not have government approval because individually mixed recipes have not been tested to prove that they are absorbed appropriately or provide predictable levels in blood and tissue. And there is no scientific evidence about the effects of these hormones on the body, both good and bad.”
Further, on the subject of pharmacists making medicines at drug stores, NAMA is equally unenthused:
“Although there is a long history of pharmacies providing a wide range of compounded products, the fact that preparation methods vary from one pharmacist to another, and from one pharmacy to another, means that patients may not receive consistent amounts of medication. In addition, inactive ingredients may vary and there can be batch-to-batch differences. Reliable sterility and freedom from undesired contaminants are also concerns. Expense is also an issue, as many custom-compounded preparations are viewed as experimental drugs and are not covered by insurance plans.”
In short, the NAMS “does not recommend custom-compounded products over well-tested, government-approved products for the majority of women – and does not recommend saliva testing to determine hormone levels.”
We at Uterus1 hope this series has been informative. We understand that women in search of help for menopausal symptoms have navigated uncertain territory ever since the Women’s Health Initiative study demonstrated conventional synthetic hormone replacement therapy has unanticipated risks
However, armed with an understanding of the ongoing debate, our readers should be able to make more informed decisions. Let us know how you fare. Let us know if this series was useful.
If you enjoyed this article, you might also be interested in the following:
Examining Conflicting Views on Hormone Replacement Therapy
Do You Feel the Heat? Hot Flashes – How They Happen and Why
Menopause and Depression – Jury Still Out on the Connection
Alternatives to Hormone Replacement Therapy for Menopause
Click here to send Uterus1 your comments.