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Hormone Replacement Therapy for Women
Structural differences exist between human, and synthetic and animal hormones. In order for a replacement hormone to fully replicate the function of hormones which were originally naturally produced and present in the human body, the chemical structure must exactly match the original. There are significant differences between hormones that are natural to humans and synthetic or horse preparations. Side chains can be added to a naturally-occurring hormone to create a synthetic drug that can be patented by a manufacturer. A patented drug can be profitable to mass produce, and therefore a drug company can afford to fund research as to the medication’s use and effectiveness. However, naturally-occurring substances can not be patented, so scientific studies are less numerous on natural hormones, because medical research is usually funded by drug companies.
Natural hormones include estrone (E1), estradiol (E2), progesterone, testosterone, dehydroepiandrosterone (DHEA), and pregnenolone. Our compounding specialists work together with patients and prescribers to provide customized hormone replacement therapy that provides the needed hormones in the most appropriate strength and dosage form to meet each woman’s specific needs. Hormone replacement therapy should be initiated carefully after a woman’s medical and family history has been reviewed. Every woman is unique and will respond to therapy in her own way. Close monitoring and medication adjustments are essential.
The findings of numerous studies on hormone replacement therapy (HRT) conflict and, as a result, have raised serious questions regarding the appropriateness of HRT. Hormone replacement is an approved therapy for relief from moderate to severe hot flashes and symptoms of vulvar and vaginal atrophy. Numerous studies have confirmed that estrogen replacement decreases the risk of colon cancer, estrogen and progesterone decrease fracture risk, and various hormones increase energy levels and enhance libido. Reputable sources offer conflicting reports regarding issues such as memory, Alzheimer’s disease, and stroke.
With the exception of the Postmenopausal Estrogen/Progestin Interventio n (PEPI) study, major studies have either failed to distinguish among types and dosages of HRT used in the study, or examined only the use of synthetic HRT preparations (as in the case of the Women’s Health Initiative). The Women’s Health Initiative (WHI) study was designed to identify the potential risks and benefits of HRT. The estrogen-progestin portion of the clinical trial was stopped in 2002 after results showed that a synthetic hormone combination containing conjugated equine estrogens (CEE) plus medroxyprogesterone acetate (MPA) increased the women’s risks of developing invasive breast cancer, heart disease, stroke, and pulmonary embolism. The data and safety monitoring board concluded that the risks outweighed the evidence of benefit for fractures and colon cancer. Utilizing data from the WHI, researchers later concluded that synthetic CEE plus MPA does not improve mental functioning and may increase the risk of dementia in women over age 65. They suggest these hormones increase the risk of stroke, which is known to increase the risk of dementia. With regard to the risk of dementia, typical HRT users are in their 50s and the WHI study focused on women aged 65 and over, who have a higher risk for dementia. The “estrogen-only” portion of the WHI study was halted in March 2004 after analysis of data suggested that synthetic CEE alone had no impact either way on heart disease (the main focus of the study), but may increase the risk of stroke.
Many patients and medical professionals are unaware of the availability of alternatives. In reality, women’s experiences and clinical outcomes of HRT differ vastly depending on the dose, dosage form, and route of administration, and also the type of hormone that is used. As a result of concerns and doubts generated by studies that use synthetic hormones, many women who could substantially benefit from customized hormone replacement may never have the opportunity.
Published research delineating the differences between natural and synthetic HRT is now more abundant, but studies of natural HRT will probably never be as plentiful as those dealing with patented synthetic hormones. Our pharmacy welcomes your questions.
Estrogens actually refers to a group of related hormones, each with a unique profile of activity. Under normal circumstances, a woman’s circulating estrogen levels fluctuate based on her menstrual cycle. For Hormone Replacement Therapy, these hormones are often prescribed in combination to re-establish a normal physiologic balance. The three main estrogens produced in female humans are:
- E1 (Estrone; 10-20% of circulating estrogens) is the primary estrogen produced after menopause.
- E2 (Estradiol; 10-30% of circulating estrogens) is the most potent and major secretory product of the ovary, and the predominant estrogen produced before menopause.
- E3 (60-80% of circulating estrogens)
Progesterone is a term that is incorrectly used interchangeably to describe both progesterone which is “chemically identical” to what the body naturally produces, and synthetic derivatives. Synthetic progestins are analogues of progesterone, and have been developed because they are patentable, more potent, and have a longer duration. Medroxyprogesterone acetate, the most commonly used synthetic progestin, was shown in a large study to cause significant lowering of HDL “good” cholesterol, thereby decreasing the cardioprotective benefit of estrogen therapy. Side effects are a frequent cause for discontinuation of HRT. Only about 20% of women who start synthetic HRT remain on it two years later.
- is commonly prescribed for perimenopausal women to counteract “estrogen dominance” which occurs when a woman produces
- smaller amounts of progesterone than normal relative to estrogen levels.
- alone, or combined with estrogen, may improve Bone Mineral Density.
- minimizes the risk of endometrial cancer in women who are receiving estrogen.
- is preferred by women who had previously taken synthetic progestins.
The benefits of progesterone are not limited to prevention of endometrial cancer in women who are receiving estrogen replacement. Progesterone therapy is not only needed by women who have an “intact uterus”, but is also valuable for women who have had a hysterectomy. Vasomotor flushing is the most bothersome complaint of menopause, and is the most common reason women seek HRT and remain compliant. For over 40 years, estrogens have been the mainstay of treatment of hot flashes, but progesterone may be effective as well.
Androgens are hormones that are important to the integrity of skin, muscle, and bone in both males and females, and have an important role in maintaining libido. Declines in serum testosterone are associated with hysterectomy, menopause, and age-related gender-independent decreases in DHEA and DHEA-sulfate. DHEA (dehydroepiandrosterone) is an androgen precursor from which the body can derive testosterone. After menopause, a woman’s ovaries continue to produce androgens; however, the majority of the androgens produced in the female body, even before menopause, come from peripheral conversion of DHEA. As the body ages, production of DHEA declines so that by the time a woman goes through menopause, the production of DHEA is often inadequate. Additionally, ERT may cause relative ovarian and adrenal androgen deficiency, creating a rationale for concurrent physiologic androgen replacement. Recently, attention has turned to the addition of the androgens to a woman’s HRT regimen in order to alleviate recalcitrant menopausal symptoms and further protect against osteoporosis, loss of immune function, obesity, and diabetes.
Androgens, such as testosterone and DHEA:
- enhance libido.
- enhance bone building (increase calcium retention).
- provide cardiovascular protection (lower cholesterol).
- improve energy level and mental alertness.
Treatment for Vulvodynia
In 2002 and again in 2006, the National Institutes of Health characterized vulvodynia (defined as chronic, unexplained vulvar pain or discomfort, characterized by burning, stinging, irritation, or rawness) as a poorly understood and underresearched focal pain syndrome for which optimal treatment remained unclear. Nearly 14 million U.S. women may at some point in their lives experience the symptoms of chronic vulvar burning and pain, and a localized form of vulvodynia involving the vulvar vestibule is thought to be the leading cause of dyspareunia in premenopausal women. Treatment recommendations range from topical therapies to oral medications, physical therapy and biofeedback, and surgical excision, although the latter is reserved for women with localized pain only. Although many of these modalities demonstrate efficacy, many are also associated with adverse effects, require numerous visits to physicians, or are invasive.
A 47% complete response to oral tricyclic antidepressants for the treatment of vulvodynia (both generalized and localized) was reported in 33 women attending a vulvar pain clinic. Amitriptyline is often used as a first line agent, started at an oral dose of 5 mg to 25 mg nightly and increased by 10 to 25 mg weekly, generally not to exceed 150 mg daily.
Gabapentin appears to be very effective in the treatment of unprovoked generalized vulvodynia, and has a very low side effect profile. To evaluate the clinical efficacy and tolerability of topical gabapentin in the treatment of women with vulvodynia, between January 2001 and December 2006, fifty-one women with vulvodynia were treated with 2% to 6% gabapentin prepared by local compounding pharmacists. Patients were instructed to apply a small amount of cream (approximately 0.5 mL, equivalent to the size of a pea) three times daily. After a minimum of 8 weeks of therapy, the mean pain score among the 35 evaluable women was significantly reduced. Sexual function improved. Common adverse effects of oral gabapentin, including dizziness, somnolence, and peripheral edema, were not reported by any of the 50 patients studied. The conclusion: “Topical gabapentin seems to be well-tolerated and associated with significant pain relief in women with vulvodynia.”
- Journal of Lower Genital Tract Disease 2005;9(1):40–51 The Vulvodynia Guideline.
- J Reprod Med 2007 Feb;52(2):103-6 Evaluation of gabapentin in the treatment of generalized vulvodynia, unprovoked.
- National Vulvodynia Association News, Winter 2005 (accessed 06/09) Obstet Gynecol. 2008 Sep;112(3):579-85 Topical gabapentin in the treatment of localized and generalized vulvodynia.
Boric Acid Therapy for Chronic Vaginitis
Recalcitrant vaginal trichomoniasis is extremely distressing for patients and frustrating for physicians. Numerous studies have shown that an increase in vaginal pH creates a better environment for the growth of Trichomonas vaginalis. Vaginal acidification using boric acid has resulted in resolution of recalcitrant Trichomonas vaginalis.1
Patients with diabetes mellitus (DM) are at increased risk of vulvovaginal candidiasis (VVC) due to Candida glabrata. Observational studies indicate that diabetic patients with C. glabrata VVC respond poorly to azole drugs. Women with DM and VVC showed an overall superior mycological cure rate (74% versus 51%) at day 15 with boric acid suppositories given daily for 14 days as compared to fluconazole as a single oral dose of 150 mg. 2, 3
A study done at New York Hospital-Cornell University Medical Center reported the “ineffectiveness of conventional antifungal agents appeared to be the main reason for chronic mycotic infections. In contrast, boric acid was effective in curing 98% of the patients who had previously failed to respond to the most commonly used antifungal agents and was clearly indicated as the treatment of choice for prophylaxis.”4 “A double-blind comparison was made of the use of 14 daily intravaginal gelatin capsules containing 600 mg of boric acid powder versus the use of identical capsules containing 100,000 U nystatin… for the treatment of VVC… Cure rates for boric acid were 92% at 7 to 10 days after treatment and 72% at 30 days, whereas the nystatin cure rates were 64% at 7 to 10 days and 50% at 30 days.”5 Torulopsis glabrata is second only to Candida albicans in frequency of isolation from the vagina in both asymptomatic women and those with yeast vaginitis. In sixty patients with T. glabrata vaginitis, for whom repeated courses of antimycotic therapy with azoles had previously failed, boric acid emerged as a promising modality.”6 Another study concluded “in non-Candida albicans infections, boric acid suppositories achieved the best mycologic cure rate (85%).”7
- J Obstet Gynaecol Can. 2008 Jan;30(1):55-8 Recalcitrant Trichomonas vaginalis infections successfully treated with vaginal acidification.
- J Infect. 2007 Oct;55(4):374-7 Prolonged (3-month) mycological cure rate after boric acid suppositories in diabetic women with vulvovaginal candidiasis.
- Diabetes Care. 2007 Feb;30(2):312-7 Prevalence of Candida glabrata and its response to boric acid vaginal suppositories in comparison with oral fluconazole in patients with diabetes and vulvovaginal candidiasis.
- J Reprod Med. 1991 Aug;36(8):593-597 Antifungal agents vs. boric acid for treating chronic mycotic vulvovaginitis.
- Am J Ob Gyn. 1981 Sep 15;141(2):145-148 Treatment of vulvovaginal candidiasis with boric acid powder.
- Clin Infect Dis. 1997 Apr;24(4): 649-652 Treatment of Torulopsis glabrata vaginitis: retrospective review of boric acid therapy.
- Am J Ob Gyn. 1995 Sep;173(3 Pt 1):820-823 Chronic fungal vaginitis: the value of cultures.
We welcome your questions and the opportunity to help you. Call our compounding professionals to discuss individualized treatments that meet your needs and preferences.
Key Compounding Pharmacy
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