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On HRT for Women BHRT A Perspective on HRT for Women: Picking Up the Pieces After the Women’s Health Initiative Trial — Part 2 George R. Gillson, MD, PhD Rocky Mountain Analytical, Calgary, Alberta, Canada David T. Zava, PhD ZRT Laboratory, Portland, Oregon Note: In this article, bioidentical hormone replacement therapy will be referred to as BHRT, and conventional hormone replacement therapy will be referred to as CHRT. Progestins will be used throughout this article to refer to synthetic compounds that exert an antiproliferative effect on uterine endometrium. By this definition, proges- terone is not a progestin, since it is natural (not synthetic). Testosterone replacement, although relevant, is beyond the scope of our discussion. 330 International Journal of Pharmaceutical Compounding Vol. 7 No. 5 September/October 2003 BHRT Progesterone and Balance Between Estrone and However, the Women’s Health Initiative Progestins Estrogen Sulfate Within (WHI) trial indicated that oral conjugat- Tumor Cells ed estrogens and oral medroxyproges- There has been an almost abysmal fail- Progesterone also impacts the balance terone acetate increased cardiac risk. ure on the part of the medical profession between estrone and estrogen sulfate This apparent paradox is resolved by re- to recognize the difference between pro- within tumor cells. It is well known that alizing that there are many studies that gesterone and synthetic progestins. breast-cancer cells and breast fibroade- indicate that medroxyprogesterone ac- While a detailed comparison of bioiden- nomas accumulate large amounts of es- etate is detrimental to cardiovascular tical progesterone and progestins (syn- trone sulfate, which they then use as a function. Clarkson has reviewed the ad- thetic C-19 and C-21 derivatives) will source of estradiol (the sulfate is hy- verse effects of medroxyprogesterone ac- not be provided here, a book by John drolyzed to estrone, which is then con- etate on cardiovascular health in some Lee, MD, a recognized expert on verted to estradiol).3 Progesterone, detail.7 For examples of such studies, progesterone, discusses this topic in along with some synthetic progestins see sidebar. detail.1 A perusal of the literature indi- such as danazol, blocks the conversion cates that the terms progesterone and of estrone sulfate to estrone and pre- progestins are often used interchangeably. vents the cells from fueling themselves Studies Showing Adverse Effects of Failure to make the crucial distinction with estradiol. Medroxyprogesterone Acetate on between progesterone and progestins Cardiovascular Health has led us to our present position that Protection of Uterine Lining compliance with established forms of The common feature of progesterone ■ A study by Miyagawa demonstrated hormone replacement therapy (HRT) is and progestin is their ability to protect that estradiol plus medroxyprogester- poor (due to side effects) and that the the uterine lining from overgrowth/car- one failed to prevent coronary va- sospasm in response to serotonin plus most commonly prescribed form of cinogenesis caused by estrogens. Both a thromboxane A2 mimetic in rhesus progesterone and progestin, when given combined HRT has been shown to monkeys, whereas estradiol plus pro- be unsafe over the medium term continuously in opposition to estrogen, gesterone was protective against (5 years) in a large controlled trial. produce a dormant or quiescent en- vasospasm.8 Synergy Between Estradiol dometrium. Some critics of progester- ■ A study conducted by Wakatsuki and Progesterone one supplementation have focused on demonstrated that medroxyprogester- studies in which progesterone failed to One rarely considered aspect of the one acetate dose-dependently inhibited produce a secretory endometrium. This use of progesterone versus progestins is improvement in flow-mediated brachial is not a necessary or even desirable end artery vasodilation seen in postmeno- the synergy between estradiol and pro- point. A quiescent endometrium is pausal women who were given oral gesterone; each is required for the opti- 9 both nonproliferative and nonsecretory. estrogen. mal expression of the other’s receptors. However, an atrophic endometrium ■ Kojima demonstrated that medroxypro- Progesterone turns on estradiol receptor (which may arise from progestin thera- gesterone acetate interferes with the expression and has also been shown to py) is also undesirable, as it may lead to assemblage of cholesterol and phos- elevate serum estradiol levels. bleeding and is a degenerate tissue state. pholipids into high-density lipoprotein Nahoul demonstrated that vaginal ad- (HDL) particles by apolipoprotein A-1.10 Progestins were added to estrogen ther- ministration of progesterone resulted in Although progesterone also decreased apy once it was realized that unopposed an elevation of serum estradiol, which HDL, the effect was smaller. estrogen caused uterine cancer, and the was similar in magnitude and duration ■ In the Postmenopausal Estrogen/Pro- focus for many years was only on that to the oral administration of 0.5 mg of gestin Interventions (PEPI) trial, it was aspect. Researchers did not realize that estradiol.2 Therefore, concurrent use of found that at the end of 3 years, oral es- progestins were causing other serious progesterone with estrogen (estradiol or trogen increased HDL cholesterol (net negative effects, such as increased risk of estrone) should allow for lower dosing increase 7%), but this increase was breast cancer and cardiovascular disease. considerably reduced (net increase 2%) of estrogen. Anecdotally, this has been when medroxyprogesterone acetate the experience of many practitioners Impact on Cardiovascular was added.11 working with progesterone. In fact, the Function rule of thumb is to halve the dose of Many human and animal studies have estradiol or estrone when the switch is indicated that estradiol does exert posi- On the other hand, evidence that pro- made from progestins to progesterone. tive effects on parameters influencing gesterone exerts beneficial effects on This is Lee’s opinion, and he prescribed cardiac disease.4-6 These effects include cardiovascular function is accumulating. progesterone skin cream for thousands vasodilation,4 reduction of vascular pro- For examples of such studies, see of women patients for more than liferative and inflammatory responses,5 sidebar. 20 years. and decreased sympathetic activity.6 International Journal of Pharmaceutical Compounding 331 Vol. 7 No. 5 September/October 2003 BHRT Studies Showing Progesterone’s Beneficial Effects on Cardiovascular Function will more closely mimic progesterone. However, if we do find these synthetic ■ With monkeys as test subjects, Adams demonstrated that, whereas medroxyprogester- molecules, they will likely be so close in one acetate substantially blunted the reduction in plaque induced by conjugated estro- effect to progesterone that we might as gens, progesterone had no effect on the reduction in atherosclerotic plaque induced by estradiol.12,13 well use progesterone. ■ A recent study by Rosano has shown that vaginally administered progesterone had a Bioidentical beneficial effect on cardiovascular health. The time to ischemia on a treadmill was in- creased in postmenopausal women who had cardiovascular disease.14 Progesterones ■ In another recent study, Molinari indicated that an intravenous infusion of progester- Oral Bioidentical one increased blood flow in porcine mesenteric, iliac and renal arteries via the release Progesterone 15 of nitrous oxide. Bioidentical progesterone in the form ■ With the use of cynomolgus monkeys, a study has shown that medroxyprogesterone of off-the-shelf progesterone capsules acetate blunts the estradiol-induced release of nitrous oxide, a potent vasodilator.16 (in peanut oil), as well as compounded micronized progesterone capsules, has Although it is reasonably clear that norethindrone acetate improved exercise already been accepted by many physi- some progestins may be deleterious to tolerance, increased time to ST segment cians; and various publications support cardiac health, a recent review article elevation on a treadmill and reduced the the ability of oral progesterone to pro- points out that not all progestins exert total number of ischemic events during duce a quiescent endometrium. For equivalent effects on HDL, triglyc- 24-hour ambulatory electrocardiograph- examples of studies investigating bio- erides, and other relevant parameters.17 ic monitoring in patients with angina.18 identical progesterone, see sidebar. In fact, a recent small study by Sander- Pharmaceutical companies will eventual- son demonstrated that estradiol plus ly find progestins that are safer and that Studies of Bioidentical Progesterone ■ In a 12-month study of 10 women, Hargrove showed that oral micronized progesterone (100 mg/twice a day or 100 mg/mornings and 200 mg/evenings) in conjunction with oral micronized estradiol (0.35 mg/twice a day or 0.35 mg/mornings and 0.7 mg/evenings) HT resulted in a quiescent endometrium.19 doesn’t have to be At 6 months, there was no uterine bleeding in this group, whereas four of confusing... five women in the same study who were on 0.625 mg/day conjugated estrogens Eliminate Guesswork with plus medroxyprogesterone acetate ZRT Lab's Hormone Test Kit (10 mg/day for 10 days each month) continued to have withdrawal bleeding Saliva and bloodspot hormone throughout the study. Track patient progress testing accurately detects hidden ■ 20 with comparative In a study by Gillet, 98 women re- hormone
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