PMS and menopause 

Hormonal changes caused by PMS and menopause can cause a wide variety of symptoms, including cramps, irritability, mood swings, weight gain and bloating. Some of these symptoms may be managed by taking vitamins, minerals or supplements. But you should be aware that information on these products can be sketchy and incomplete. In addition, quality can be poor, inconsistent, and even dangerous. For example, while tryptophan has been shown to alleviate some PMS symptoms, there have been instances of tryptophan contamination in the past, and the safety of tryptophan’s manufacturing process is still in question.

How could this happen?

Unfortunately, government oversight of supplements is extremely lenient, due to permissive regulations and the FDA’s limited resources. While pharmaceutical drugs must demonstrate safety and effectiveness before they go on sale, there is no such process for supplements. In fact, because supplements are considered neither a food nor a drug, there is no government approval process at all for dietary supplements. The FDA can act only after consumers get sick or a safety issue is reported.

Mystery Ingredients

Certain supplements have been found to contain not enough or too much of various ingredients. Some contain undeclared and potentially dangerous ingredients such as bacteria, toxic plant material and heavy metals. Even more alarming has been the presence of prescription medications, controlled substances and untested experimental compounds. These substances have included everything from diuretics, which can cause dehydration and potassium deficiency, to amphetamines, which can lead to depression and addiction.

Untested chemical modifications

Some companies that make these kinds of products have also been known to modify ingredients’ chemical structures in order to evade detection or reduce the risk of patent infringement lawsuits. This kind of chemical tinkering has allowed some companies to disguise drugs such as fenfluramine, which was used in Fen-Phen and was withdrawn from the U.S. market in 1997 after reports of heart disease.

How can you identify contaminated supplements?

Unless you have a clinical lab at your disposal, it’s very difficult to identify contaminated supplements. Although many are manufactured in China, they aren’t just made overseas or found only on the Internet. Earlier this year, a California-based company pleaded guilty to selling anabolic steroids labeled as weight loss supplements. Many supplements that were found to be contaminated were purchased in mainstream retail stores in the United States.

Why should I tell my doctor?

There are several reasons why you should let your doctor know if you’re taking or considering dietary or nutritional supplements, even if they’re labeled as “Natural” or are made by a reputable company. If your physician knows what you’re taking, he or she will be more likely to correctly diagnose any related side effects and let you know any potential adverse interactions with pre-existing conditions or other drugs you might be taking. More importantly, your physician may be more likely to identify a suspicious or dangerous product. 

More information

If you need additional information, you can click on any of the links below or you can contact my office directly.

U.S. Food and Drug Administration Q&A

The New England Journal of Medicine article

Informed Choice supplement contamination study results

Dr. John Garofalo, M.D., is a certified OB/GYN in Fairfield County, Connecticut. For more information on Dr. Garofalo and his medical practice, go to www.garofaloobyn.com. Dr. Garofalo can be reached for a personal consultation at 203.803.1098.

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Patients occasionally ask me about the safety and effectiveness of  Bioidentical Hormone Replacement Therapy (“BHRT”). They point out that they can get natural hormones in personalized doses based upon levels of hormones in their saliva. They are told by compounding pharmacies and their marketers that BHRT

• is a safer, natural alternative to dangerous prescription drugs
• is superior to FDA-approved hormone therapies
• can slim you down by reducing hormone imbalances
• can prevent senility, Alzheimer’s disease, stroke, and various cancers

It sounds great, doesn’t it?

The truth is that there is no scientific evidence supporting the safety or effectiveness of compounded bioidentical hormones. There is also no scientific support for the use of hormone assays from salivary, urine or blood for the adjustment of hormone replacement dosage.

With the approach of menopause, decreasing estrogen levels may be associated with hot flashes, vaginal dryness, poor memory, insomnia and osteoporosis. Treatment with estrogen and progesterone (HRT) can relieve these symptoms and help prevent osteoporosis. The benefits of HRT are accompanied by an increase in the risk of cardiovascular disease and breast cancer. Because of these risks, the FDA requires that pharmaceutical companies manufacturing HRT include appropriate warning labels within the packaging of all these medications. The American College of Obstetricians and Gynecologists (ACOG) recommends that HRT should only be used for relief of severe menopausal symptoms that do not respond to natural methods or non-hormonal medications. HRT should be used at the lowest effective dosage for the shortest possible period of time.

In order to get initial FDA approval for sale and marketing of HRT preparations, pharmaceutical companies were required to produce scientific evidence supporting the safety and efficacy of their product. The FDA also mandates ongoing monitoring of the manufacturing processes and reporting of adverse drug events. BHRT, on the other hand, is not made by pharmaceutical companies; it is made by compounding pharmacies that are not subject to the rigors of FDA regulation. The bottom line is that because BHRT preparations have not undergone rigorous clinical testing for safety or efficacy, we really do not know if these preparations are either safe or efficacious. Important decisions about one’s health should not be based on what seems like a good idea. Safety and efficacy claims must be based on the best available scientifically derived evidence and must be reevaluated in the light of emerging data.

Your decision of whether or not to take hormone therapy for menopausal symptoms is highly individualized, based on your health, risk factors, and personal wishes. You should be sure to have all the information you need in order to make an informed decision.

For more information on bioidentical hormones:

Click here for an article from the FDA   http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049311.htm

Click here for an article from the American College of Obstetricians and Gynecologists http://www.acog.org/from_home/publications/press_releases/nr02-03-09.cfm)

For more information about salivary testing for hormone levels:

Fugh-Berman A et al. Bioidentical Hormones for Menopausal Hormone Therapy: Variation on a Theme. J. Gen. Internal Med. 22: 2007.  http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2219716

Chatterton RT Jr, Mateo ET, Hou N, et al. Characteristics of salivary profiles of oestradiol and progesterone in premenopausal women. J Endocrinol 2005;186:77-84.  http://www.ncbi.nlm.nih.gov/pubmed/16002538

John M. Garofalo, MD