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The side effects of natural progesterones

MagazineMarch 1996 (Vol. 6 Issue 12)The side effects of natural progesterones

Dear WDDTY: I am a registered medical herbalist and have been consulted about the use of progesterone

Dear WDDTY: I am a registered medical herbalist and have been consulted about the use of progesterone.

Several things are still unclear to me. Firstly, Dr Lee seems to be using the term "natural" progesterone because although it is true that the plant extracts have undergone some synthetic chemical processing, the progesterone which is the end product is, according to him, chemically identical in every way to human progesterone, unlike synthetic progestagens. This is clearly in contradiction to your reply. Lee suggests that because "natural" progesterone is identical to human progesterone, it is familiar to the body and easily metabolized, unlike the synthetic progestagens which are not familiar to the body and probably difficult to metabolize and accumulate to toxic levels.

When a patient on Cyclogest recently consulted me complaining of severe side efects and looking for an alternative, I assumed that this was the case because it contained synthetic progestogens. However I was surprised and rather perplexed to see that it was actually progesterone and had a significant number of side effects. I was aware that progesterone or its analogues usually are derived from horses in Europe, unlike in the US, where they are all derived from yams.

Perhaps horse is different from human progesterone and would explain the list of accompanying side effects.

Dr Lee claims that "natural" progesterone in physiological doses (of 2-30mg/day) is an effective supplement for treating a variety of female hormonal disorders without the inherent risk of side effects. According to Dr Lee, side effects resulting from overdosing on natural progesterone even from levels as high as 300-400per day would be unlikely because it is short lived, easily metabolized and excreted.

Besides being horrifically expensive, the "natural" hormone addresses the hormone imbalance in just as mechanistic a fashion as conventional hormone therapy. It is not a cure, and it doesn't try to tackle the underlying causes, whether they be nutritional, environmental, emotional or stress related. R J Collisson, Wimbledon, London......

WDDTY replies: Our return to the natural progesterone debate was prompted by our discovery that one woman who'd used rub on progesterone went on to develop breast cancer and is attempting to sue the American medical centre which prescribed the gel to "prevent" cancer. In our investigation of her case, we also learned that progesterone is being used in America with virtually no regulation and therefore no examination of potential side effects.

We are not on anybody's "side". We are on the side of disclosing whether treatments, whether "natural" or not, have proof of safety and benefit. Given the appalling track record of all supplemental female hormones, both natural and synthetic whether for birth control, miscarriage prevention, infertility or menopause and their indisputable association with cancer, it is essential that the safety issue be addressed.

At the moment, natural progesterone is being purchased by mail order all across America, and used for everything from PMS and menopause to infertility and miscarriage prevention, without one shred of published evidence that it is safe to do so. If this situation concerned a drug produced by a pharmaceutical company, we'd all be picketing the Medicines Control Agency.

It's impossible to discuss the appropriate dosage because manufacturers are not obliged to tell you how much progesterone you're getting in a cream. Because there are no regulations, any manufacturer can put in any amount of the hormone he wishes.

One laboratory, which analyzed 19 body creams containing progesterone, found that the creams contained anything from less than 2 mg to 700 mg per ounce! Most fell into the category of 2-15 mg per oz; the cream sold in the UK contains between 400-700 mg per ounce.

Although progesterone is being classified and therefore sold as a "cosmetic" in the US, the literature which is given with one brand we sent for arrived with instructions explaining how to use it for PMS, during menopause and for osteoporosis. The manufacturer also states that the cream can cause "incidental spotting" and potentially increase thyroid activity. To us, this smacks of a drug with potential side effects.

All the progesterones to which we referred in our article were true progesterone, not progestogens. Because natural yam derived progesterone is not regulated by the FDA and therefore has undergone no testing, we had no choice but to look to the two progesterones approved by the UK's Committee on Safety of Medicines: Gestone and Cyclogest.

According to the manufacturers of both drugs, they are made from plants, not animals Cyclogest from soya and Gestone from sisal, a fibrous root. Dr Michael Telford, medical advisor to Paines & Byrne, which produces Gestone, explained that our bodies produce a basic steroid skeleton, or molecular blueprint, from which all hormones are derived. This skeleton goes through a number of natural processes, governed by enzymes from different organs, to transform into individual hormones like progesterone.

Chemists making so called "natural" hormones imitate this process by extracting a substance from a plant, which resembles our basic steroid skeleton, and then putting it through a number of chemical processes in the test tube, tacking on extra parts of molecules here and there, to end up with a substance with more or less the same molecular structure as what our bodies produce. Tony Eaton of Hoechst Roussel, which makes Cyclogest, says that yam is a rich source of the skeleton steroid for both yam and estrogen; his company produces Estrogel, an HRT preparation from the yam. The point is, they say, all such progesterones, including the rub on variety, are made in the test tube and have similar side effects.

Celia Wright of Higher Nature has kindly supplied us with one of the few studies on progesterone breast gel produced in France. A randomized, double blind study of 36 premenopausal women undergoing breast surgery for the removal of a lump discovered that those applying 25 mg of progesterone for 10 to 13 days reduced proliferation of normal breast tissue which would appear to suggest prevention of cysts or cancer. However, this study is far from conclusive about anything, as the authors themselves admit, since it only looked at use of very short duration and doesn't examine what happens when you use this stuff over time. "It is not known whether or not progesterone may influence [cell growth] and the occurence of ductal hyperplasia [as in cancer]," they conclude. It's also worth noting that the study was sponsored by the French company which makes the gel (Fertil Steril, 1995; 63 (4): 785-91).

We recommend caution on progesterone because absence of proof is not proof of absence. That is and always will be our editorial stance, whether concerning natural products or drugs.

As for women with hysterectomies, some of our panellists assure us that, with proper diet, allergy avoidance and nutritional supplements, if needed, many can live healthily without hormone supplementation.


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