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A study on the effectiveness of transdermal progesterone cream.

Introduction:

It is becoming more evident that hormone balance is not only vital to a healthy lifestyle, but necessary for health, vitality and longevity. Men and women alike suffer from hormone imbalances now more than ever, due to stress, environment, poor diet, toxins and lifestyle choices. As a health care provider, it is necessary to understand how hormones affect the health of the patient and their quality of life.

"Estrogen dominance," which is another term for progesterone deficiency (coined by the late Dr. John Lee (MD), (1) is very common. Progesterone deficiency is not only due to excess exposure to estrogenic substances like xenoestrogens, but due to long term stress and its effect on the adrenals, which is compounded by the body's inability to rid itself of excess hormones. Stress can be either emotional or physiological; pain, lack of sleep, blood sugar imbalances, digestive weakness and toxins.

In women, progesterone deficiency is a key factor in PMS management and menopausal symptoms, as well as, estrogen receptor positive (ER+) breast cancers. Typically, allopathic medicine leans on synthetic hormones to manage symptoms related to hormone imbalances. Synthetic hormones such as birth control or synthetic hormone replacement therapy (HRT) are not readily excreted from the body as natural hormones should be. This can cause long term estrogen dominance, and/or exacerbate existing symptoms of mood, weight, sleep or menstrual irregularity. (2)

Balance is the key to hormonal health. Estrogen receptors can become less sensitive when progesterone is low for long periods of time. Supplementing with natural progesterone balances the ratio of estrogen to progesterone and increases the sensitivity of estrogen receptors. (1)

In conclusion, this study shows that topical transdermal progesterone therapy does raise progesterone levels in the body and can be a viable way to relieve symptoms of PMS and menopause without the dangerous side effects reported from utilizing synthetic hormone replacement therapy or birth control.

Study Criteria:

This clinical study was performed to determine the effectiveness of a natural transdermal progesterone cream in raising progesterone levels in women between the ages of 35-55, who are either peri-menopausal or full menopausal. Participants were not involved in any other health regimens, nor were they under the care of any physician or had consumed hormone supplements or prescriptions in the last 6 months. Each participant submitted a saliva sample before and after the study to confirm progesterone levels at that time. Symptom questionnaires and vitals were collected every two weeks for the majority of participants, with a couple who only provided a before and after symptom questionnaire. Only the before and after symptom questionnaires were used for chart two on page 123.

The supplements used for this study were provided by Professional Health Products (PHP) and are; Transdermal PRO SOOTHE STRESS ADRENAL SUPPORT CREAM with the ingredients: Water, Maca Extract, Glycerine, Octyl Salyclate, Glycerol Monolaurate, Glycerol Stearate/PEG 100, Cetearyl, Alcohol/Cocoa Glucoside, Caprillic Triglyceride, Safflower Oil, Purified Lecithin, 7-Keto DHEA, DiIndolylmethane, Thioctic Acid, Vitamin E, Glutamine, Pregnenolone, Cellulose Gum, Peg 30, Glycerol Cocoate Phenoxyethanol, and Methisothiazolinone. This cream aims to balance the adrenal glands and provide ingredients to support the adrenals as they produce cortisol so as not to convert progesterone to cortisol.

The progesterone cream used was the Transdermal PRO FEMME SUPPORT + FEMALE SUPPORT CREAM with the ingredients: Water, Wild Yam Extract, Black Cohosh Extract, Glycerine, Octyl Salyclate, Glycerol Monolaurate, Glucerol Stearate/PEG 100, Cetearyl Alcohol/Cocoa Glucoside, Progesterone, Capryllic/Capric Tryglyceride, Dafflower Oil, 7-Keto DHEA, Purified Lecithin, Evening Primrose Oil. DI-Indolylmethane, Cellulose Gum, PEG-30 Glyceryl Cocoate, Phenoxyethanol, Methisothiazolinone. This cream was used to raise natural progesterone levels in the body. Dosage was one metered pump AM and one metered pump PM of Pro Femme Support + Female Support and one metered pump AM of Pro Soothe Stress Adrenal Support each day for about 5-6 weeks or until the Pro Femme cream was gone.

Hormone Imbalance

When addressing female hormone levels it is important to consider the reason(s) for imbalance. Even women who do not display troublesome symptoms may experience symptoms which a well trained health provider can detect. Patients with liver congestion, poor sugar management, high stress, etc., are candidates for hormone imbalances and conditions such as; PCOS, weight gain, memory problems, migraines and other symptoms (which many people assume are "normal") can be related to hormone imbalance as well. Adequate progesterone is necessary for regular menses, pregnancy, regulating PMS, fat burning, reducing water retention, and protecting against certain female--related cancers as well as preventing the conversion of testosterone to DHT (dihydrotesterone), which prevents acne, facial and body hair, thinning of the hair and oily skin. Proper levels of progesterone also ease the transition into menopause, and reduce the symptoms that many American women experience. Menopause is not typically as serious of a condition for women in other countries where processed foods and a high stress lifestyle are not as common.

In times of stress, the adrenals "steal" progesterone to make additional cortisol. (3), (4) In a perfect world, additional cortisol is only needed to get through a period of stress, but in our high-stress world many people never get through the short burst of stress. It becomes a constant part of their lives which depletes progesterone long term. Treating low progesterone without addressing adrenal insufficiency can be very difficult. In order to raise progesterone, the adrenal issue must also be addressed. This may include lifestyle modifications and overall health evaluation. See Figure 1 for more information on these pathways. (3) (page 122)

During this study each participant was provided with an adrenal support cream as well as a natural progesterone cream to support the adrenals and aid in raising progesterone levels.

Delivery System of Hormones

When taken in tablet form, any supplement (including natural progesterone) is often not fully absorbed due to a less than efficient digestive system. Topical creams are a more reliable option and allow progesterone and other nutrients to be delivered directly to the blood stream, bypassing the digestive system. Many topical creams require the patient to apply them to fatty areas and to rotate the area of application daily to avoid build up in the tissues. Build up over time will drastically reduce the effectiveness of the cream, which will allow the "estrogen dominance" symptoms to return, because excess progesterone produces the same symptoms as too little progesterone. This is due to progesterone receptor sites becoming "numb" to the hormone, which is similar to the body's response with insulin resistance. It is not necessary to rotate a true transdermal cream that uses a liposomal delivery system because it does not build up in the tissue. These creams are applied to thin skinned areas and require no rotation. (5)

For this study, women were advised to collect the final saliva sample 36 hours after the last dose of cream. Due to the nature of this study other health concerns were not factored in. It is unknown which of these women suffered adrenal insufficiency or had other health concerns that may have contributed to their final results. The goal of the study was to prove the liposomal delivery of topical progesterone would raise progesterone in this particular group of women.

Testing

Saliva testing was utilized in this study because progesterone is readily measured by saliva testing. Serum levels of progesterone are not bioavailable, therefore serum testing is not accurate for this purpose. (6)

Healthy levels of progesterone measured as pg/ml are 300-500 in saliva, but during supplementation due to the necessity to saturate the tissues with the proper amount of progesterone, levels above that are acceptable. Variation of progesterone in the body is typically well tolerated up to 1500 pg/m1. (6)

Conclusion

Based on the saliva results we did find that progesterone levels were raised in all of the women who participated. Some were small increases and others were much more dramatic. This suggests that the overall health of the individual is a factor and should be taken into consideration when creating an individualized program. (See Chart 1: page 123.)

Of the 13 participants who completed the study, 4 of them were still cycling, 9 were menopausal and 4 of those reported surgically induced menopause.

Out of the 13 participants; 5 participants showed an improvement in hot flashes, 1 noted no hot flashes prior to the study, 6 noted an improvement in insomnia, with two stating they had no trouble sleeping prior, 7 showed an improvement in energy, night sweats and libido with 2 showing none of those symptoms prior, and with 5 stating no night sweats prior to the study, 8 participants showed an improvement in depression and fluid retention, with 2 stating they had no previous symptoms of depression and 4 stating that fluid retention was not a problem, 9 showed an improvement in anxiety with one stating no anxiety prior to the study, and 11 stated that their mind raced less, with one person stating she had no mind racing issues previously.

Over half of the participants showed an improvement of 25% or more in all symptoms recorded except hot flashes and 5 of them reported an improvement. This study shows that all women who participated experienced some increase in progesterone by saliva testing. (See Chart 2: page 123.)

References

(1.) Lee, John. What Your Doctor Didn't Tell You About Menopause (2004)

(2.) Cutillo, Dawn M, The Hormone Shift. (2012) Print. p. 26-27

(3.) William G Timmins The Chronic Stress Crisis, (2011) p.49

(4.) Hormones and Chronic Stress Bio Health Laboratory Web; http://biohealthlab.com/test-menu/hormones/hormones-and-chronic-stress/ 8/2013

(5.) Cutillo, Dawn M, The Hormone Shift. (2012) Print. p. 158

(6.) Saliva vs, Serum or Plasma Testing for Progesterone The John R. Lee MD Medical Letter Web www.johnleemd.com/store/saliva_serum.html#absorb 8/2013

Notice charts on fillowing page.

by: Annette Copeland, CNHP
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Author:Copeland, Annette
Publication:Original Internist
Article Type:Report
Date:Sep 1, 2013
Words:1635
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