So you and your doctor have decided to replace your decreasing hormones with natural hormones instead of the synthetic alternatives. The problem is, many of the benefits of natural HRT will be lost as the hormones go through the process of digestion. None of your circulating hormones are secreted into your digestive tract as a means of total body distribution. Glands typically secrete hormones into the local circulation where, eventually, they reach complete systemic circulation. This is physiologically natural.
Larger studies are needed to examine the impact on vasomotor symptoms, myocardial infarction and breast Bi est troche. Bearing in mind — sleep was an issue … however I did understand the 12 hour window that the level would be affected …. The term bioidentical hormone replacement has been variously interpreted. Initial diagnosis. In order to get it set, a gynaecologist gave me a 5-week course of progynova- an oestrogen tablet. Bi est troche demographics, baseline characteristics, comorbid conditions, baseline menopausal symptoms, dosing regimens, symptom improvement, and adverse effects were compared between groups.
Bra nurse. Managing hormone imbalances
Hello Lori, Thanks for reaching out. I too am experiencing the same thing. Clinical Gynecologic Endocrinology and Infertility. How long roughly does treatment teoche oestrogen dominance usually take? Bioidentical Hormone Replacement: Guiding Principles for Practice Printer Friendly Page Introduction Before synthetic and nonhuman hormones were in common use, there was no need for a term trocne bioidentical. Oral capsules of biest will not work for vaginal dryness. Bearing in mind — sleep was an issue … however I did understand the 12 hour window that the level would be affected …. I have just Bj diagnosed with breast cancer in Bi est troche last week and Rob and katie threesome video worried that the troches have caused it. Went on 15 mg of boron and it is helping slight bit because the depression is better and vulvar pain a little better. Sandra Perrier April 1, at am. The best way to test for blood is to have the blood tested hours after application of the biest cream. It is 10 years. I am thinking because you were given a 60 gram Bi est troche that you are applying one gram, twice a day. Better to take everything but Prog in morning? Troceh cholesterol Bi est troche gone sky high since coming off the troches as well.
Introduction Before synthetic and nonhuman hormones were in common use, there was no need for a term like bioidentical.
- Biest is a treatment used in bio-identical hormone replacement therapy BHRT for menopausal symptoms and anti-aging treatment.
- We love helping patients.
- The change in hormonal milieu associated with perimenopause and menopause can lead to a variety of symptoms that can affect a woman's quality of life.
- Please call us with any questions pertaining to your compounding request, we are here to discuss any questions or concerns you may have pertaining to your prescription.
Progesterone creams and natural or bioidentical compounded estrogen preparations are being promoted to consumers as safe alternatives to conventional menopausal hormone therapy and as health-promoting tonics. No reliable data support these claims. Natural hormones, including estradiol, estriol, estrone, and progesterone, can be expected to have the same adverse event profile as conventional menopausal hormone regimens. Salivary tests may be used to persuade asymptomatic consumers to use hormones or symptomatic patients to use higher doses than those needed to mitigate symptoms , a practice that can be expected to result in adverse events.
B ioidentical or natural hormones are being promoted to consumers as benign health tonics. The term bioidentical is a pseudoscientific neologism that refers to endogenous hormones, including estriol, estrone, estradiol, progesterone, testosterone, DHEA, thyroxine, and cortisol. Natural alludes to the fact that these are native human hormones.
In fact, these hormones are synthesized or semisynthesized. Stigmasterol from soybeans Glycine max and diosgenin from an inedible Mexican yam Dioscorea villosa can be converted to progesterone in the laboratory, 1 but there is no evidence that plant sterols convert to progesterone endogenously. Many bioidentical hormone products that require a prescription are prepared by compounding pharmacies.
Compounding pharmacies use commercially available drugs to create formulations that are not commercially available. For example, compounding pharmacies routinely turn tablets into syrup for patients with swallowing problems, combine two or three pills into a single capsule, make a pet-sized dose of a drug meant for humans, or make a topical preparation from a drug available only in an oral form.
Because compounding pharmacies are not manufacturing facilities, they are not subject to FDA standards for good manufacturing practices. Compounded preparations are not regulated by the FDA and may vary in potency. For example, one study found that only 1 of 10 compounding pharmacies provided progesterone vaginal suppositories that were all within the potency range required of similar FDA-approved products.
This article will focus on compounded bioidentical hormone preparations aimed at menopausal and perimenopausal women. These doses are believed to be equivalent to 0. The term progestogen is an umbrella term that encompasses progesterone, which is the mammalian progestogen, and synthetic progestins for example, medroxyprogesterone.
Bioidentical progesterone is micronized progesterone, oral forms of which are used in conventional medicine. Transdermal progesterone cream, however, remains an alternative treatment in the United States. Although all oral hormonal preparations require a prescription, topical hormone preparations are generally regulated as cosmetics, not drugs, 3 and so are readily available without a prescription. Health food stores sell progesterone and DHEA creams, and estrogen creams may be purchased on the internet.
Natural hormone proponents, however, claim that bioidentical hormones are different than conventional hormone regimens and will prevent disease.
Transdermal progesterone cream has also been tested for hot flashes; one study found a positive effect 8 and another found no effect.
However, no clinical trials support the use of progesterone cream for either of these claims. The perception that progesterone cream is a panacea can be traced to the late John M.
Popular books have contributed to misconceptions about hormones. Several physicians promote these hormones. Steven F. The terms bioidentical and natural may imply safety to consumers. A survey of 82 women interviewed at a compounding pharmacy found that 74 had heard about natural hormones and 37 used them.
Bioidentical hormones are identical to hormones used in some commercial pharmaceutical preparations. The WHI tested conjugated equine estrogens with and without medroxyprogesterone acetate , but no RCT to date has shown a benefit for any estrogen on cardiovascular events. Two RCTs have shown that estradiol, a natural hormone, prevents neither heart attack 22 , 23 nor stroke.
Estriol, specifically, is believed by bioidentical hormone proponents to decrease breast cancer risk. This belief is based on several articles written in the s by a researcher who remained enthusiastic about estriol even after his only published clinical study failed. Six of the 24 subjects with breast cancer who took estriol developed metastases; two developed endometrial hyperplasia. Other evidence refutes the purported benignity of bioidentical estrogens on the breast. High levels of endogenous estradiol and estrone are associated with increased breast cancer risk; 32 — 37 estriol has also been implicated in increased risk.
Little information is available about long-term effects of micronized progesterone. This study by no means constitutes proof of a differential effect.
Women with intact uteri are prescribed estrogen with a progestogen to oppose estrogen-induced endometrial hyperplasia and cancer. Bioidentical hormone proponents sometimes recommend topical progesterone cream instead of oral progestin for this purpose. However, it is unclear whether topical progesterone can effectively mitigate estrogen-induced endometrial stimulation. Three studies have examined the ability of progesterone to oppose estrogenic stimulation. Although oral estriol preparations are an alternative treatment for menopausal symptoms in the United States, estriol is a commonly prescribed conventional drug in other countries 51 and was often prescribed without a progestin.
Vaginal estriol did not significantly increase risk. Saliva testing for hormones has been promoted to individualize the dosing of bioidentical hormone treatment. It is not clear how best to correlate progesterone levels with endometrial effects, but it is clear that salivary progesterone levels are unreliable. Correlations between serum and salivary levels of reproductive hormones vary by hormone tested, time of day, diet, and type of assay.
Hormone tests are not indicated for menopausal symptoms because there is no correlation between hormone levels and symptoms. Salivary tests may be used to persuade asymptomatic women to use hormones, and may encourage symptomatic women to use higher doses than are necessary to treat symptoms. This would be expected to result in an unfavorable risk—benefit ratio. As Boothby et al. Bioidentical hormones are an unusual form of alternative medicine. No reliable data support the claim that bioidentical hormones are safer than other hormones, and natural, bioidentical, and compounded preparations must be assumed to have the same risks as commercial hormone preparations.
Commercial or compounded estrogen preparations should be effective for treating hot flashes or vaginal dryness, and oral micronized progesterone is acceptable as the progestogen portion of menopausal hormone therapy. Any estrogen, including estriol, should be opposed with an oral progestogen in nonhysterectomized women.
Whereas some progesterone creams may provide some endometrial protection in some women, studies to date are not reassuring. Progesterone creams should not be relied upon to protect uterine endometrium from estrogen-induced stimulation. Oral progestogens with known effects are preferred. Any menopausal hormone therapy should be reserved for women with bothersome symptoms, and used in the lowest effective dose for as brief a period as possible.
Whereas compounded preparations may be useful for creating lower-dose preparations of hormones, these preparations lack the consistency and regulatory oversight required of commercial hormonal drugs.
Adverse effects of hormones must be assumed to be drug class effects until reliable clinical evidence proves otherwise. Claims that the hormones present in compounded prescriptions are safer than commercial pharmaceuticals can only be made by those unfamiliar with or unwilling to accept scientific data.
Women who wish to use compounded hormones to treat menopausal symptoms should be counseled that bioidentical hormones have the same risks as conventional hormones. Because hormones are readily absorbed through the skin, the FDA should regulate transdermal hormone preparations as drugs.
In addition, the FDA should require compounding pharmacies to provide patients with the same written information required of commercial drugs with any compounded prescriptions made with those drugs. To do otherwise risks the health of consumers. The authors received no funding for this report. Conflict of Interest Dr. Bythrow is currently employed as a pharmaceutical sales representative with Eli Lilly. National Center for Biotechnology Information , U.
J Gen Intern Med. Published online Mar 7. Author information Article notes Copyright and License information Disclaimer. Corresponding author. This article has been cited by other articles in PMC. SAFETY Natural hormones, including estradiol, estriol, estrone, and progesterone, can be expected to have the same adverse event profile as conventional menopausal hormone regimens. KEY WORDS: natural hormones, bioidentical hormones, menopausal hormone therapy, topical progesterone cream, estriol, compounding pharmacies, Triest, salivary hormone testing.
Placebo cream, each applied topically twice daily All subjects received conjugatedestrogens 0. Serum progesterone levels rose to 0. Median plasma progesterone levels increased from 1. No significant difference between groups; median AUC area under the curve was Salivary progesterone levels were high, variable, and did not correlate with serum levels. No difference between single and divided dose.
Salivary progesterone rose significantly in both groups within an hour. Burry et al. Transdermal estradiol patch 0. Open in a separate window. References 1. Hogg JA. Steroids, the steroid community, and Upjohn in perspective: a profile of innovation.
Investigation of product quality between extemporaneously compounded progesterone vaginal suppositories and an approved progesterone vaginal gel. Drug Dev Ind Pharm. Food and Drug Administration. Accessed 19 Sep Especially Designed for Women. Youngtown, Ariz, and Madison, Wisc.
In this case, when switching someone to a Biest, you need to start with a higher dose. Nat Med Mar;3 3 Medroxyprogesterone interferes with ovarian steroid protection against coronary vasospasm. Or would effect be slightly slower or faster? For static dosing, taking progesterone all month is a good idea. For many clinicians, the preferred progesterone formulation has been Prometrium Abbott Laboratories, Abbott Park, IL , the FDA-approved, micronized formulation of oral progesterone, because it is identical to endogenous progesterone and has improved bioavailability.
Bi est troche. Sign Up Our FREE Monthly E-Journal
Effectiveness of Compounded Bioidentical Hormone Replacement Therapy: An Observational Cohort Study
Bioidentical Hormone Replacement Therapy BHRT is believed it to be a safer and equally effective alternative to Conventional Hormone Therapy for the relief of menopausal symptoms; however, data are needed to support these claims.
The objective of this study is to evaluate the effectiveness of compounded BHRT provided in six community pharmacies. This was an observational cohort study of women between the ages of who received a compounded BHRT product from January 1, to April 30, in six community pharmacies. Data included patient demographics, comorbidities, therapeutic outcomes, and hormone therapies. Women self-rated menopausal symptoms as absent, mild, moderate, or severe. Descriptive statistics were used to characterize the patient population, BHRT use, and adverse events.
Patient symptom severity was compared at baseline and 3 to 6 months follow-up using the Wilcoxon signed-rank test. Compounded BHRT regimens were generally initiated at low doses regardless of route. This study demonstrates that compounded BHRT improves mood symptoms. Larger studies are needed to examine the impact on vasomotor symptoms, myocardial infarction and breast cancer.
Bioidentical Hormone Replacement Therapy BHRT describes supplementation of hormones that are molecularly identical to those hormones produced in the human body. Compounded BHRT is a form of personalized medicine whereby the dose, regimen, and dosage forms are customized based on the patient's symptoms, hormone levels, and preferences. The idea is that these individualized preparations containing bioidentical hormones may improve the safety and effectiveness of treating menopausal symptoms.
This study first describes the characteristics and prescribing patterns of compounded BHRT in six community pharmacies. This was an observational cohort study of female patients age treated for menopause-related hormone imbalances from January 1, to April 30, in six community pharmacies.
Oakdell Pharmacy, Inc. Patient charts are maintained locally at the pharmacy. At these seminars, credentialed medical professionals e. Patients are referred to the Oakdell Wellness Center through physicians, family members, and friends. BHRT consultation services consist of an extensive initial evaluation, hormone replacement education, and follow-up visits.
Patients complete a new patient evaluation form and a laboratory hormone panel prior to their initial visit. This hormone panel, determined through serum or salivary testing, aids in identification of sex hormone deficiencies, adrenal function deficiencies, and thyroid dysfunction. During the initial evaluation, patients are questioned regarding medical history, menopausal symptoms, and treatment goals. They are educated on several components of hormone therapy including: hormonal changes of menopause, causative factors associated with menopausal symptoms, risks and benefits of hormone therapy both conventional and bioidentical therapies , and different BHRT dosage forms.
During initial evaluation and follow-up visits, pharmacists use a standardized form to monitor symptom resolution and adverse effects. This form lists several symptoms associated with menopause. Patients are asked to indicate whether their symptoms are "absent," "mild," "moderate," or "severe. BHRT compounds vary by active ingredients, dose, and dosage form.
Once the physician's approval is received, the individualized BHRT compound is prepared. Patients are instructed to complete monthly evaluation forms for the first few months and every six months thereafter to monitor menopausal symptoms and side effects. Upon review of a patient's evaluation form, the pharmacist decides if further laboratory work, telephone, or face-to-face follow-up is needed. The pharmacist then makes changes to the patient's therapy in consultation with the patient and their physician.
Patients were also excluded if they did not complete a follow-up hormone evaluation form. All data were collected at Oakdell Pharmacy from the existing medical records. The instrument was designed to mimic the appearance of the initial patient intake and follow-up forms used during pharmacist consultations at Oakdell Pharmacy. All research personnel were trained on the tool prior to collection of any patient data. Data included patient demographics, comorbidities, laboratory values, medications, and adverse effects of hormone therapy.
If patient data were available at 6 months, those data were used. That is, if patient data were available at 3 months, but not 6 months, then the data from 3 months were used. The dependent variables utilized in this study were vasomotor symptoms, mood symptoms, myocardial infarction, and breast cancer.
A decrease in symptom intensity was defined as a decrease in symptom ratings from baseline to follow-up three to six months. Myocardial infarction and breast cancer adverse event rates were reported as events and cases per 10, person years. This number was then multiplied by 10, to give AE rates per 10, person years.
The term "estrogen" was used to describe the use of any of the estrogen combinations [i. Patient's length of therapy LOT was obtained from the pharmacy records and patient charts. The patient's treatment timeframe was obtained from pharmacy records and was calculated as the date of follow-up minus the date of baseline assessment. All statistical analyses were performed using JMP 8. Statistical significance was defined as an alpha less than 0.
Descriptive statistics e. Patient demographics, baseline characteristics, comorbid conditions, baseline menopausal symptoms, dosing regimens, symptom improvement, and adverse effects were compared between groups.
Categorical variables were compared using chi-square and Fisher's exact tests. Continuous variables were tested for normality using the Shapiro Wilk-W Test. Normally distributed variables were reported as means standard deviations , while non-normally distributed variables were reported as medians 25th and 75th percentiles. Paired data were compared using the Wilcoxon signed-rank test. All tests were two-sided. Of charts reviewed, women met study criteria. The mean standard deviation age was 52 9 years and the mean weight was 32 lbs.
One-third of the women had a hysterectomy and one-quarter had an oophorectomy. Women initiated on P4 monotherapy were younger 50 vs. Some women received multiple dosage forms simultaneously. These estrogen combination therapies were also frequently initiated at low doses. Women receiving compounded BHRT also experienced non-significant reductions in vasomotor symptoms within 3 to 6 months of therapy. These 62 women had an average follow-up of 1.
This study confirms that compounded BHRT is effective for improving mood symptoms. We were unable to draw firm conclusions regarding the utility of compounded BHRT for vasomotor symptoms, but the observed trends are encouraging. Similar trends were seen in the subgroup analysis of women between the ages of 40 and 70 years. This is the first time "compounded" BHRT therapy has been evaluated, but there are several studies that confirm the effectiveness of "manufactured" BHRT.
Trials have shown estrone E1 and estradiol E2 to be effective for reducing menopausal symptoms as monotherapy or combination therapy, but trials have not been conducted to evaluate the effectiveness of estriol E3.
The effectiveness of E1 for reducing the severity of menopausal symptoms has been observed. Takahashi [ 7 ] conducted an open label trial in 53 women receiving 2 mg E1 for 12 months.
Menopausal relief was evaluated using the Kupperman index KI for severity. The KI is a numerical conversion index of 11 menopausal symptoms including vasomotor and mood symptoms designed to measure total menopausal relief. Although individual symptoms were not evaluated, E1 was shown to be effective for relief of composite menopausal symptoms.
Large randomized controlled trials RCTs have documented E2's effectiveness for relieving menopausal symptoms [ 8 , 9 ]. Simon and colleagues [ 8 ] conducted a RCT in women randomized to receive 0.
Additionally, the 1. Similar to our method of evaluating severity, women reported hot flashes as severity ratings, yet limited numerical data were available to evaluate the extent of vasomotor symptom reduction.
This may be one reason our study did not find a significant reduction in vasomotor symptoms with these compounded BHRT products. Additionally, E1 and E3 combination therapy has been shown to be effective for reducing menopausal symptoms.
This study evaluated menopausal symptom relief using graphic rating scales. Despite use of a different method to evaluate symptom relief, this study provides additional data that supports the use of combination estrogens for reducing vasomotor and mood symptoms.
Although estrogens are generally regarded as the therapeutic hormones in hormone replacement therapy [ 11 ], P4 monotherapy has also been shown to be effective in treating menopausal symptoms [ 12 - 14 ]. Leonetti and colleagues [ 12 ] conducted a single-center RCT of women within 5 years of menopause who were randomized to receive P4 monotherapy 20 mg or placebo.
Two other RCTs have documented non-significant improvements in menopausal symptoms [ 13 , 14 ]. Wren and colleagues [ 13 ] evaluated 80 women randomized to receive topical P4 monotherapy 32 mg or placebo.
A reduction in vasomotor Another RCT conducted by Benster and colleagues [ 14 ] randomized women to receive P4 monotherapy 5 mg, 20 mg, 40 mg, and 60 mg or placebo. The investigators observed a reduction in vasomotor symptoms for P4 5 mg These trials utilized the Greene Climacteric Scale, in which patients self-rated their symptom severity i.
This approach is similar to our study. Vashisht and colleagues [ 15 ] conducted an open label week study in 41 women with the secondary objective of determining improvements in menopausal symptoms. Similar to P4 monotherapy trials, the Greene Climacteric Scale was utilized to evaluate mood and vasomotor symptom improvement. Collectively, these findings support the effectiveness of BHRT in reducing menopausal symptoms. The WHI also demonstrated a 1. This study only had person-years of follow-up and none of these women experienced an MI or breast cancer; however, the study lacks a sufficient sample size to make firm statements about the safety of compounded BHRT.
Based on the favorable effects on cardiovascular surrogate markers, BHRT may eventually prove to be cardio-neutral or even cardioprotective. These studies support the belief that P4 may prevent breast epithelial hyperplasia. This study has strengths and limitations. First, these six pharmacies were located in one geographical region; therefore, these findings may not be generalized to all settings.