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Re: search
From: anonymous (anonymous@obgyn.net)
Sun Sep 22 23:43:00 2002
Victoria! Lots of time spent in doing that research! Thank you for
sharing your insight with us.
Although I haven't tried the progesterone cream, I must admit that I
wonder if it could be helpful re endometriosis, acne, etc.. Re my endo,
I chose to have surgery with a specialist, and to modify my diet.
Hey, your research mentioned something about "...5 alpha reductase in
the skin which will metabolize up to 98% of any P administered
topically...." -- excuse my ignorance, but does that mean that (should
it have an effect) the progesterone cream would likely lessen or worsen
acne?
At Sat, 21 Sep 2002, Victoria wrote:
>
>Natural progesterone:
>=====================
>
>Is it legal?:
>-------------
>
>1) http://www.fda.gov/cder/warn/cyber/cyber2002.htm
>Cyber letters issued from CFSAN are to Internet Website Operators promoting
>dietary supplement products that claim to diagnose, mitigate, treat, cure, or
>prevent a specific disease or class of diseases.
>
>2) http://www.fda.gov/cder/warn/cyber/2002/CFSANnewhorizons.htm
>In addition, only products that are intended for ingestion may be lawfully
>marketed as dietary supplements. Topical products and products intended to enter
>into the body directly through the skin or mucosal tissues, such as transdermal
>or sublingual products, are not dietary supplements. For these products, both
>disease and structure/function claims may cause them to be new drugs.
>
>Canada's Health Products and Food Branch on progesterone creams.:
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>
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>http://hc-sc.gc.ca/english/protection/warnings/1999/99_134e.htm
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>
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>FDA letters to companies on progesterone cremes:
>------------------------------------------------
>
>------------------------------------------------
>1) http://forums.obgyn.net/endo/ENDO.0207/0472.html
>------------------------------------------------
>------------------------------------------------
>2) http://forums.obgyn.net/womens-health/WHF.0208/0104.html
>------------------------------------------------
>------------------------------------------------
>
>FDA comments on dietary supplements:
>------------------------------------
>
>------------------------------------
>1) http://www.cfsan.fda.gov/~dms/qa-top.html
>------------------------------------
>------------------------------------
>2) http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm Dietary Supplements
>------------------------------------
>------------------------------------
>3) http://www.cfsan.fda.gov/~dms/supplmnt.html U.S. FDA Food Safety & Applied
>Nutrition Dietary Supplements
>4) http://www.cfsan.fda.gov/~dms/ds-oview.html#getinfo
>5) http://www.cfsan.fda.gov/~dms/ds-savvy.html (includes information on
>evaluating research/health info online)
>6) http://www.cfsan.fda.gov/~dms/hclaims.html Conventional Foods and Dietary
>Supplements Claims list
>
>7) Is it legal to market a dietary supplement product as a treatment or cure for
>a specific disease or condition? No, a product sold as a dietary supplement and
>promoted on its label or in labeling* as a treatment, prevention or cure for a
>specific disease or condition would be considered an unapproved--and thus
>illegal--drug. To maintain the product's status as a dietary supplement, the
>label and labeling must be consistent with the provisions in the Dietary
>Supplement Health and Education Act (DSHEA) of 1994.
>
>What do doctors say about this?:
>--------------------------------
>
>--------------------------------
>1) http://forums.obgyn.net/ob-gyn-l/OBGYNL.0205/0317.html
>--------------------------------
>--------------------------------
>Topical progesterone can be wonderful. 95% is metabolized to
>--------------------------------
>--------------------------------
>hydroxyprogesterones with little protective effect. Yet, these metabolites can
>bind to the Cl ion channel, like valium. Salivary and serum progesterone
>correlations tend to be quite high. (Dr. Mark Perloe, http://www.ivf.com, reproductive
>endocrinologist):
>
>2) http://forums.obgyn.net/ob-gyn-l/OBGYNL.0207/0039.html
>Giving topical progesterone is worthless plain and simple. There are very large
>amounts of 5 alpha reductase in the skin which will metabolize up to 98% of any
>P administered topically. But they will feel good, since the 5 alpha reduced
>progesterone will bind to the Cl ion channel receptor, the same place valium
>binds.
>
>3) http://forums.obgyn.net/womens-health/WHF.0209/1286.html (Dr. William D.
>McIntosh, MD, FACOG)
>Just because a medication is prescribed does not mean that it is not a placebo,
>and just because it is not prescribed does not mean it is not an active drug.
>Placebos are prescribed routinely, though the prescriber may not always
>recognize that it IS a placebo. Progesterone cream has about the same response
>rate as placebo, so the inference is that its benefits are primarily those of a
>placebo. This inference is not a necessarily a fact, just a probability.
>
>4) http://forums.obgyn.net/womens-health/WHF.0209/1079.html (R.Daniel Braun, MD
>FACOG)
>The studies show an 85% success rate with NOTHING. AND an 85% success rate with
>the cream.
>
>5) http://www.obgyn.net/newsheadlines/womens_health-Gynecology-20020808-8.asp
>(Dr. Michael Kettel's work)
>Dr. Michael Kettle and others have found Mifepristone (an anti-progesterone) to
>help with endometriosis. If this is true in science studies, then how can
>endometriosis be helped by more progesterone? Please see: (or do a search on
>'endometriosis mifepristone' or 'endometriosis ru486' or 'endometriosis ru-486'
>at http://www.ncbi.nlm.nih.gov, Pubmed)
>a) Fertil Steril 2002 May;77(5):995-1000, Effect of mifepristone on estrogen and
>progesterone receptors in human endometrial and endometriotic cells in vitro.
>b) Ann N Y Acad Sci 2002 Mar;955:159-73; discussion 199-200, 396-406, Regulation
>and modulation of abnormal immune responses in endometriosis.
>c) Tidsskr Nor Laegeforen 2001 Nov 20;121(28):3286-91 Mifepristone--a
>controversial drug with great potential
>d) Zhonghua Fu Chan Ke Za Zhi 2001 Apr;36(4):218-21 Effects of mifepristone on
>expression of estrogen receptor and progesterone receptor in cultured human
>eutopic and ectopic endometria.
>e) Orv Hetil 2001 Apr 22;142(16):827-31 Effect of antigestagens on human
>reproduction
>f) J Med Chem 2000 Dec 28;43(26):5010-6 Synthesis and biological activity of a
>novel, highly potent progesterone receptor antagonist.
>g) Steroids 2000 Oct-Nov;65(10-11):807-15 Progesterone receptor modulators and
>progesterone antagonists in women's health.
>h) Presse Med 1999 Dec 4;28(38):2123-31 [Anti-progesterones] Hum Reprod Update
>1998 Sep-Oct;4(5):584-93
>Mechanism of action and clinical effects of antiprogestins on the non-pregnant
>uterus.
>i) J Reprod Med 1998 Jul;43(7):551-60 Mifepristone. Auxiliary therapeutic use in
>cancer and related disorders.
>j) Am J Obstet Gynecol 1998 Jun;178(6):1151-6 Preliminary report on the
>treatment of endometriosis with low-dose mifepristone (RU 486).
>
>Medline data (medical research results), Sept. 15, 2002 search on 'progesterone
>cream':
>--------------------------------------------------------------------------------
>
>--------------------------------------------------------------------------------
>--
>--------------------------------------------------------------------------------
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>
>--------------------------------------------------------------------------------
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>1) It doesn't appear effective in changing the endometrium
>2) Absorption is low
>3) Salivary levels had contradicting outcomes: one said it wasn't any good,
>another said that it did show it was absorbed, a small increase but with wide
>variation. What was absorbed though, does not come to the same levels as that of
>the oral/vaginal medications.
>4) Short term treatment in one study was free of side effects, it had little
>effect on menopausal symptoms
>5) The one study on breast pain showed major side effects, no improvement in
>breast nodularity, but pain was reduced. (According to Dr. Mark Perloe, the
>binding of these molecules is done in the same way as Valium. I'd be interested
>to know if that might be the effect seen in that study, since there was no
>change in the breast tissue composition.)
>
>a) Hammarback S, Backstrom T, Holst J, von Schoultz B, Lyrenas S. Cyclical mood
>changes as in the premenstrual tension syndrome during sequential
>estrogen-progestagen postmenopausal replacement therapy. Acta Obstet Gynecol
>Scand. 1985;64(5):393-7.
>
>b) Climacteric 2000 Sep;3(3):155-60, Climacteric 2000 Sep;3(3):153-4. Effect of
>sequential transdermal progesterone cream on endometrium, bleeding pattern, and
>plasma progesterone and salivary progesterone levels in postmenopausal women.
>Wren BG, McFarland K, Edwards L, O'Shea P, Sufi S, Gross B, Eden JA. Sydney
>Menopause Centre, Royal Hospital for Women, Barker Street, Randwick, New South
>Wales 2031, Australia.
>
>INTERPRETATION: Pro-Feme transdermal progesterone administered in a 16-, 32- or
>64-mg daily dose for 14 days in a sequential regimen does not appear to be
>effective in inducing a secretory change in a proliferative endometrium.
>Salivary progesterone levels were not of value in managing the therapy of
>postmenopausal women.
>
>c) Maturitas 2002 Jan 30;41(1):1-6, Caution on the use of saliva measurements to
>monitor absorption of progesterone from transdermal creams in postmenopausal
>women. Lewis JG, McGill H, Patton VM, Elder PA., Steroid and Immunobiochemistry
>Laboratory, Canterbury Health Laboratories, P.O. Box 151, Christchurch, New
>Zealand. john.lewis@cdhb.govt.nz
>
>CONCLUSION: The absorption of progesterone from transdermal creams is low and we
>caution against the use of saliva measurements to monitor progesterone
>absorption. The low systemic absorption of progesterone may not be due to
>peripheral conversion by 5 alpha-reductase(s). We also conclude that the low
>level of progesterone associated with red cells suggests they are not important
>in the delivery of progesterone to target tissues.
>
>d) Climacteric 2001 Jun;4(2):144-50, Effects of wild yam extract on menopausal
>symptoms, lipids and sex hormones in healthy menopausal women. Komesaroff PA,
>Black CV, Cable V, Sudhir K., Baker Medical Research Institute, PO Box 6492, St
>Kilda Central, Melbourne 8008, Victoria, Australia.
>
>CONCLUSIONS: This study suggests that short-term treatment with topical wild yam
>extract in women suffering from menopausal symptoms is free of side-effects, but
>appears to have little effect on menopausal symptoms. It emphasizes the
>importance of careful study of treatments for menopausal symptoms if women are
>to be adequately informed about the choices available to them.
>
>e) Clin Endocrinol (Oxf) 2000 Nov;53(5):615-20, Salivary, but not serum or
>urinary levels of progesterone are elevated after topical application of
>progesterone cream to pre-and postmenopausal women. O'Leary P, Feddema P, Chan
>K, Taranto M, Smith M, Evans S., Biochemistry Department, Royal Perth Hospital,
>Western Australia, Australia. peteolea@rph.health.wa.gov.au
>
>CONCLUSIONS: Salivary progesterone measurements confirm that topically applied
>progesterone is absorbed, despite the lack of change in serum progesterone
>concentrations. However, at the dose administered, serum progesterone levels do
>not reach those observed after oral or vaginally delivered progesterone
>preparations. Higher doses may be required to induce biological responses within
>the endometrium.
>
>f) BJOG 2000 Jun;107(6):722-6, A study to evaluate serum and urinary hormone
>levels following short and long
>term administration of two regimens of progesterone cream in postmenopausal
>women. Carey BJ, Carey AH, Patel S, Carter G, Studd JW. Department of Obstetrics
>and Gynaecology, Chelsea and Westminster Hospital, London, UK.
>
>CONCLUSIONS: Transdermal progesterone (40 mg) per day for 42 days causes a small
>increase in serum progesterone concentration, although there is wide variation.
>Whether such levels are of clinical benefit remains to be seen.
>
>g) Harv Womens Health Watch 1999 Oct;7(2):7, Scant evidence for progesterone
>cream., Micronised transdermal progesterone and endometrial response, Barry G
>Wren, Kathy McFarland, Lyndall Edwards. Sequential transdermal progesterone
>administered with continuous transdermal oestrogen was insufficient to increase
>circulating blood progesterone concentrations or induce a secretory response in
>proliferating endometrium.
>
>h) J Endocrinol Invest 1992 Dec;15(11):801-6, Double-blind controlled trial of
>progesterone vaginal cream treatment for cyclical mastodynia in women with
>benign breast disease. Nappi C, Affinito P, Di Carlo C, Esposito G, Montemagno
>U., Cattedra di Endocrinologia Ginecologica, Universita di Torino, Italy.
>
>Vaginal progesterone resulted significantly more efficacious than placebo in
>reducing mean ratings of breast pain on VAS and mean scores of breast tenderness
>to touch. Success of treatment, defined as reduction greater than 50% of basal
>mean score of breast pain on VAS, was achieved in the 64.9% of patients treated
>with progesterone and in the 22.2% of patients receiving placebo (p < 0.01).
>Conversely, at the end of treatment, the improvement in breast nodularity showed
>a not statistically significant difference between the two groups. No major
>side-effects were detected.
>
>i) Systemic absorption of progesterone from Pro-GestŪ cream in postmenopausal
>women by A Cooper, C Spencer, M I Whitehead, D Ross, G J R Barnard, W P Collins,
>The Lancet Volume 351, Number 9111 25 April 1998.
>Your post is a very timely one, The Lancet has just published a study comparing
>Pro-GestŪ to placebo and also comparing both to Uterogestan, an oral natural
>progesterone known as Prometrium in Canada. The findings were that progesterone
>levels from Pro-GestŪ were much much lower than the levels from the oral
>progesterone, though they were higher than placebo. The levels found were not
>high enough to use to oppose estrogen and protect the endometrium as a part of
>HRT nor were they considered high enough to conserve bone density.
>
>Medline data, Sept. 16, 2002 search on 'lee jr':
>------------------------------------------------
>
>------------------------------------------------
>1) Out of the 8 pages with 146 entries, I found 2 entries that I could associate
>------------------------------------------------
>------------------------------------------------
>with Dr. John Lee.
>------------------------------------------------
>------------------------------------------------
>2) The first was a response to 'Use of Pro-Gest cream in postmenopausal women'
>in the Lancet, 1998 Sep 12;352(9131):905; discussion 906. No abstract was
>available to see what Dr. Lee sent in, but this would have been in the form of
>an opinion.
>3) The second was an erratum in Medical Hypothesis in 1991 Oct;36(2):178. This
>is where his original hypothesis was made concering progesterone being
>clinically tested and was 'extraordinarily effective' in reversing osteoporosis.
>I clicked on the related articles, and of the 6 pages of 108 items, none of this
>was corroborated by any other study. I have listed only a few of those articles
>that were done around the time that Dr. Lee's abstract was listed and after.
>Note that the 1994 Calcium, estrogen, and progestin in the treatment of
>osteoporosis study stated that "Progesterone, often given with estrogen to
>prevent endometrial carcinoma, may itself have a trophic influence on bone."
>
>a) Erratum in: Med Hypotheses 1991 Oct;36(2):178 (see also Med Hypotheses 1991
>Aug;35(4):316-8), Is natural progesterone the missing link in osteoporosis
>prevention and treatment? Lee JR.
>
>Conventional treatment with vitamin D, calcium, and estrogen will delay but not
>reverse osteoporosis. The addition of fluoride may increase bone mass but fails
>to increase bone strength; fracture incidence is actually increased in
>non-vertebral bone by fluoride. Clearly, successful treatment of osteoporosis
>remains an unsolved problem. In women, osteoporosis coincides with menopause.
>The hypothesis that progesterone and not estrogen is the missing factor was
>tested in a clinical setting and was found to be extraordinarily effective in
>reversing osteoporosis.
>
>b) Lancet 1990 Nov 24;336(8726):1327, Osteoporosis reversal with transdermal
>progesterone, Lee JR., Publication Types: Comment, Letter. Comment on: Lancet.
>1990 Aug 4;336(8710):265-9.
>
>c) Am J Pharmacogenomics 2001;1(1):11-9, Candidate genes for osteoporosis.
>Therapeutic implications. Niu T, Xu X., Program for Population Genetics, Harvard
>School of Public Health, Boston, Massachusetts, USA. xu@hohp.harvard.edu
>
>d) Radiologe 1999 Mar;39(3):228-34, [Pathophysiology and therapy of
>osteoporosis], [Article in German], Pietschmann P, Peterlik M., Institut fur
>Allgemeine und Experimentelle Pathologie, Universitat Wien.
>
>e) Rheum Dis Clin North Am 1994 Aug;20(3):691-716, Calcium, estrogen, and
>progestin in the treatment of osteoporosis., Breslau NA., University of Texas
>Southeastern Medical Center, Dallas.
>
>Progesterone, often given with estrogen to prevent endometrial carcinoma, may
>itself have a trophic influence on bone.
>
>f) Curr Opin Rheumatol 1992 Jun;4(3):402-9, Treatment of osteoporosis,
>Burckhardt P., Department of Internal Medicine, Centre Hospitalier Universitaire
>Vaudois, Lausanne, Switzerland.
>
>Estrogen replacement therapy is still the most effective prevention of
>postmenopausal bone loss.
>
>g) Prim Care 1990 Sep;17(3):647-66, Estrogen therapy during menopause and the
>treatment of osteoporosis., Noyes MA, Demmler RW., College of Pharmacy,
>University of Houston, Texas.
>
>Estrogen remains the single most effective agent in the treatment of menopausal
>symptoms and prevention of bone loss.
>
>h) Drugs 1989 Feb;37(2):205-11, A rational approach to the prevention and
>treatment of postmenopausal osteoporosis., Spector TD, Huskisson EC., Department
>of Rheumatology, St Bartholomew's Hospital, London, England.
>
>Combination therapy with oestrogens and progestogens is currently the treatment
>of choice for prevention, in conjunction with calcium supplementation and
>changes in lifestyle. Treatment of existing disease is less effective, although
>oestrogens should be tried first, with calcitonin as a second choice. There is
>no place at present for vitamin D, anabolic steroids or parathyroid hormone. The
>use of fluoride or diphosphonates cannot be recommended outside research centres
>until further long term studies are completed, which will enable a comparison of
>the relative risks and benefits.
>
>Investigating the claims (one website):
>---------------------------------------
>
>---------------------------------------
>Here is a progesterone cream product
>---------------------------------------
>---------------------------------------
>(http://www.mineralmagic.com/frames/inprcr.htm,
>---------------------------------------
>---------------------------------------
>http://www.wallach-colloidal.net/INVProgesterone.htm, and
>http://www.american-nutrition.com/progesterone.html) and its marketing/sales
>page.
>
>1) Review some of the wording and the claims on the product.
>2) Check the statements regarding skin absorption and how it is taken up into
>the body, then the bloodstream and its final effects.
>3) Read the section on what the pros are of using natural progesterone.
>4) Read the section on the survey presented to the FDA almost 20 years ago.
>5) Note the claims regarding hypoglycemia and obesity.
>
>Now find the disclaimers under the section starting with 'Reason'. It states
>that the information has NOT been checked out by the FDA and that the product
>was not made to "diagnose, treat, or prevent any disease". So what is its
>purpose? Doesn't the effect work the same as prescription drugs? What about the
>comments just listed on teh webpage in regards to the claims? Review my
>information on wild yam, one of the ingredients.
>
>So if the product is not made to diagnose, treat, cure or prevent any disease,
>what does it do?
>
>Rumors:
>-------
>
>1) That Dr. John Lee owned Aviary Labs, a testing lab to measure progesterone
>levels, before being sold to an 'ally'. Any reliable confirmation places? Please
>
>let me know!
>
>2) That Dr. John Lee sold or has recommended specific creams in which he
>received compensation for. Any reliable confirmation places? Please let me know!
>
>Regarding wild yam creams:
>--------------------------
>
>--------------------------
>1) http://www.quackwatch.com/04ConsumerEducation/QA/wyc.html
>--------------------------
>--------------------------
>2) http://www.quackwatch.com/01QuackeryRelatedTopics/wildyam.html
>--------------------------
>--------------------------
>
>3) General Comments from doctors, myself and others:
>
>http://forums.obgyn.net/womens-health/WHF.0209/1079.html
>http://forums.obgyn.net/womens-health/WHF.0208/2668.html
>http://forums.obgyn.net/endo/ENDO.0207/0472.html
>http://forums.obgyn.net/womens-health/WHF.0207/0786.html
>http://forums.obgyn.net/womens-health/WHF.0207/0826.html
>http://forums.obgyn.net/womens-health/WHF.0207/1966.html
>http://forums.obgyn.net/womens-health/WHF.0207/2350.html
>http://forums.obgyn.net/womens-health/WHF.0208/0205.html
>http://www.foxnews.com/story/0,2933,58769,00.html
>http://www.hc-sc.gc.ca/english/protection/warnings/2002/2002_01e.htm
>http://www.reuters.com/news_article.jhtml?type=healthnews&StoryID=1281830
>http://www.healthwatcher.net/Quackerywatch/Alternative-medicine/ltr990417chatela
>ine.html
>
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