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Vaginal Use of Estriol

Vaginal Use of Estriol

Pharmacy Staff – Women’s International Pharmacy

woman with tulipsEstriol is one of the three main estrogens made in a woman’s body. The other estrogens are estrone and estradiol. Estriol levels are highest in a woman’s body during pregnancy. Normal ranges for non-pregnant, non-menopausal and menopausal women are not usually noted, making it difficult to determine what would be considered “normal levels” in the body. Estriol is the weakest estrogen of the three. It may be used alone or in combination with the other estrogens in a number of different dosage forms, and has been shown in studies to have good activity in the vaginal area. In 1993, a landmark study published by Raul Raz et al. in the New England Journal of Medicine sparked great interest in using estriol vaginally, not only for improving the condition of the urinary tract, but vaginal tissue as well.[i]

In 2016, Salvatore Caruso et al. published a study in Menopause reaffirming the effectiveness of vaginally-used estriol.[ii] This study included monitoring the acidity of the vaginal tissue. Healthy vaginal tissue is in the slightly acidic range and favors the growth of friendly lactobacillus acidophilus bacteria. When this tissue becomes thinner and more alkaline as estrogen declines in menopause, the protection of the friendly bacteria declines, which may lead to infections by other less desirable organisms. Even the small amount of estriol used in this study, 50 microgram doses, caused an improvement in cell structure, acidity of the vaginal tissue, better urine control, and increases in sexual function and in quality of life. The study concluded that estriol should be a first choice in managing menopausal symptoms in the genital and urinary tracts in menopausal women.

Also in 2016, Filippo Murina et al. studied the application of a 25 microgram dose of estriol (applied daily with a finger or cotton swab) to the vulvar vestibule. After the study period of 12 weeks over 80% of the participants experienced relief from pain on intercourse. The authors maintain that direct application of estriol to the vestibule, rather than applying it vaginally, is necessary for pain relief.[iii]

Estrogen receptors

Although in reality, the process is much more complex, a simplified description of estrogen’s interaction with its receptors begins with an estrogen hormone binding to an estrogen receptor protein. When bound, the estrogen hormone-estrogen receptor complex is shuttled to the cell nucleus, where it gives specific DNA instructions and produces proteins to create an estrogen effect. This description is complicated by discoveries that there is more than one type of estrogen receptor (alpha and beta). The beta type tends to predominate in the mucosal areas, such as the vagina. The higher affinity of estriol to beta receptors over other estrogens such as estradiol predicts that estriol might be more effective in those tissues. (For more on this topic, see our article, How Hormones Interact With Receptor Sites.)

Labial Adhesions

Estrogens are sometimes used to treat labial adhesions in babies and young girls. Estriol may be the preferred choice because of its strong affinity to mucosal estrogen receptors. A study published in 2016 by Stefanie Bussen et al. demonstrated a favorable outcome in comparison to manual or surgical separation. A 1 milligram estriol dose was applied in this study nightly for four weeks at the fusion site. In most of the cases, further treatment was not needed.[iv]

Commercially Available Abroad

Estriol has been in use both as an oral and a topical estrogen supplement for many years in other countries. A product named Ovestrin, which contains a half milligram of estriol per dose, is government-approved for use in many countries.[v] The recommended dosing of estriol for the genital tract and urinary tract atrophy is one dose nightly for some weeks, then decreasing to a maintenance dose of twice weekly applications as symptoms improve. As the cells normalize and normal bacteria and acidity is re-established, issues such as infection, inflammation, pain on intercourse, dryness, itching, urinary complaints, and mild incontinence may resolve.

Estriol in the United States

Estriol has had a tumultuous time in the United States. Since there was no commercial product available, compounding pharmacists came to the rescue by preparing estriol containing creams or other dosage forms in varying strengths for individual use. The drug company Wyeth (the makers of Premarin and Prempro until purchased by Pfizer in 2009) sought to have the FDA ban its use in the United States, even while selling a commercial product containing estriol in Europe.[vi] To this date, there is no human drug product containing estriol in the United States which has been approved by the FDA. At this time, it is solely available through compounding pharmacies.

Ironically, there is an estriol product for animals approved by the FDA for use in spayed (the surgical removal of the ovaries and uterus) female dogs with estrogen-responsive urinary incontinence. Urinary incontinence is a common problem in spayed female dogs because the removal of the ovaries depletes hormones, including estrogens. This drug, Incurin, contains 1 mg of estriol in tablets.[vii]

Conclusion

The use of estriol vaginally is a clear illustration that our current medical system, based on government approvals and a one-size-fits-all model, leaves large therapy gaps. As of the time of this writing, no drug company in the United States has succeeded in bringing an estriol-containing product to market for human use. In the meantime, compounding pharmacists have made estriol available in a wide array of dosage forms and doses to address each woman’s individual needs.

  • [i] Raz R, et al. A controlled trial of intravaginal estriol in postmenopausal women with recurrent urinary tract infections. N Engl J Med. 1993 Sep 9;329(11):753-6.
  • [ii] Caruso S, et al. Quality of life and sexual function of naturally postmenopausal women on an ultralow-concentration estriol vaginal gel. 2016 Jan;23(1):47-54. doi: 10.1097/GME.0000000000000485.
  • [iii] Murina F, et al. Coital Pain in the elderly: could a low dose estriol gel thrill the vulva vestibule? Eur J Obstet Gynecol Reprod Bio 2016 Dec;207:121-124. doi: 10.1016/j.ejogrb.2016.10.016. Epub 2016 Nov 2.
  • [iv] Bussen, S et al, Comparison of Conservation and Surgical Therapy Concepts for Synechia of the Labia in Pre-Pubertal Girls. Geburtshilfe Frauenheilkd. 2016 Apr; 76(4): 390–395. doi:1055/s-0035-1558101.
  • [v] Ovestin cream (estriol). http://www.netdoctor.co.uk/medicines/a7950/ovestin-cream-estriol/. Accessed February 9, 2018.
  • [vi] Alliance for Natural Health USA. Access to Estriol. http://www.anh-usa.org/access-to-estriol-2/. Accessed February 9, 2018.
  • [vii] MSD Animal Health. Incurin product details. http://www.msd-animal-health.co.nz/Products/Incurin_/020_Product_Details.aspx. Last accessed: April 2018.
Vaginal Use of Estriol 2018-05-01T14:54:42+00:00

Book Review – The LDN Book edited by Linda Elsegood

Book Review – The LDN Book, edited by Linda Elsegood

Written by Carol Petersen, RPh, CNP – Women’s International Pharmacy

Linda Elsegood’s personal success story tells how using low-dose naltrexone (LDN) to treat her multiple sclerosis restored her quality of life and gave her hope for the future. Now she is a woman on a mission to help others learn about LDN and to promote further research into how it may be used to treat a variety of diseases. In The LDN Book: How a Little-Known Generic Drug—Low Dose Naltrexone—Could Revolutionize Treatment for Autoimmune Diseases, Cancer, Autism, Depression, and More, Elsegood has compiled chapters written by practitioners who have become experts in the use of LDN.

History

Pharmacist Stephen Dickson provides a comprehensive history of the opium poppy and the subsequent creation of synthetic drug compounds called opiates, which are all active at the opioid receptor sites. Opioid receptors are meant to be activated by hormones produced in the body called endorphins and enkephalins, which can relieve pain and contribute to wellbeing. However, these receptors can also be stimulated by opiates. Naltrexone was originally developed to block these receptor sites in order to assist people addicted to opiates. The developers of naltrexone reasoned that when opioid receptors were blocked, there would be no need to use or abuse opiate drugs. While a logical theory, in actual practice they had little success.

However, in low doses, naltrexone acts to temporarily block opioid receptors. The body responds by producing increased amounts of endorphins and enkephalins. The opioid receptors also increase in sensitivity and number.

Multiple Sclerosis and Lupus

Dr. Deanna Windham begins with a thorough explanation of multiple sclerosis and lupus. While she recognizes that we do not currently have drugs that treat the complexity of these diseases, LDN has been shown in a number of studies to stabilize and stop their progression. The use of LDN is a pillar in Dr. Windham’s treatment plans, though she maintains that each patient must be treated individually for their toxic load, hormone imbalances, nutrient deficiencies, and sleep issues.

Inflammatory Bowel Diseases

Dr. Jill Smith was the first to publish a study on LDN and inflammatory bowel diseases. There are opioid receptors in the gut and on immune system cells. There are a number of different types of opioid receptors and naltrexone may target different opioid receptors depending on the dose.

Dr. Smith provides case studies of remissions of inflammatory bowel diseases, Crohn’s disease and ulcerative colitis with the use of LDN, both alone and with other commonly-used drugs. LDN blocks opioid receptors for about six hours, during which the body increases its endorphin and encephalin production. After about six hours, the LDN is removed from the opioid receptors by the body and the elevated endorphins and enkephalins can act at the receptor to block cell proliferation or reverse inflammation. LDN also sensitizes and increases the number of receptors. Remission may be confirmed with radiology showing healing of the intestinal tract.

Few of Dr. Smith’s patients have experienced side effects, however, one possible side effect is sleep disturbances, which can be alleviated by changing to a morning dose or using a lower strength.

Thyroid

Dr. Kent Holtorf, president of the National Academy of Hypothyroidism, explores LDN treatment with thyroid disorders. He explains how LDN can be used effectively in both Grave’s Disease (hyperthyroidism) and Hashimoto’s Disease (hypothyroidism). He believes LDN can potentially improve abnormal inflammation and immune dysfunction seen with thyroid disorders, and thus, improve the reduced tissue T3 (active thyroid hormone) levels inside the cells that these conditions can cause. Normal thyroid tests cannot predict the activity of thyroid inside the cell, and so this can go unidentified and untreated.

Chronic Fatigue and Fibromyalgia

Dr. Holtorf also addresses chronic fatigue and fibromyalgia.  He writes about phases of treatment with LDN:

  1. Stabilize the patient. This stage is where pain and sleep disturbances are addressed.
  2. Enhance mitochondrial energy production with nutrients.
  3. Balance hormones as these patients typically have deficiencies.
  4. Enhance the immune system function and treat the infectious components. LDN is often part of this stage of treatment.
  5. Address issues like heavy metals, leaky gut, mold toxicity, and coagulation problems.
  6. Maintain health and balance.

An integrative approach has shown success, with treatment plans adjusted to the individual needs of each patient.

Restless Leg Syndrome

Dr. Leonard Weinstock is a gastroenterologist and internist, with a special interest in restless legs syndrome (RLS) and has identified an association between RLS and small intestine bacterial overgrowth (SIBO) and other inflammatory conditions in the gut. He used LDN to treat patients with and without antibiotics for infection. In each case he found some positive results, and has used LDN for long-term remission.

Depression

Endorphins are very psychoactive, and account for the warm feelings of falling in love, coping with stress, and bringing joy and contentment. Dr. Mark Shukhman describes the symptoms of endorphin deficiency as including:

  • Discomfort with disturbances such as changes in sound, light, temperature, or touch
  • Immune system problems such as frequent infections, allergies, and autoimmune disease
  • Crying easily, and have difficulty with painful situations
  • Craving chocolate, wine, marijuana, and alcohol

LDN helps in these conditions by increasing the levels of endorphins. Many people who have turned to opiates describe that it is the first time that they have felt normal. Although his chapter focuses on depression, psychiatrist Dr. Shukhman has also used LDN in his practice for treatment of autism, post-traumatic stress disorder, multiple personality disorder, anxiety, obsessive compulsive disorder, psychosis, and even sexual dysfunctions.

Autism

Dr. Brian Udell has a special needs pediatric practice and has found a common theme with autism to be inflammation and gut disturbances. He cites Dr. Jacquelyn McCandless’ work with children using LDN as a cream, rather than tablets, because of its bitter taste. He has seen LDN increase speech and communication, decrease aggression, and improve social development. Beta endorphin levels can be measured to confirm LDN activity.

Cancer

Dr. Angus Dalgleish, an oncology practitioner in the UK, writes that, while there is very little in the published literature, LDN seems to be universally useful across all tumor types. He writes of his personal experience treating patients with metastases, achieving stability and long–term, disease-free status. He finds that LDN affects more receptor sites than just the opioid receptors. Naltrexone in large doses actually promotes tumor growth in the laboratory, so the best effects occur when it is used in low doses and used intermittently rather than continuously. Its anti-inflammatory action can be helpful in cancer. Dr. Dalgleish reports that the use of LDN also increases the production of natural killer cells. Finally, LDN can produce positive effects on mood that help in combatting the disease. He writes that failure with LDN may be linked to low vitamin D levels.

Conclusion

The LDN Book is just a part of Linda Elsegood’s work. Under her direction, the LDN Research Trust has an incredible number of accomplishments, including organized conferences, LDN radio, and crowdfunded documentaries. This outreach has stimulated investigation into endocrine and immune system activity that was hardly known before. This book is a window into the large body of knowledge we have gained in the last ten years.

Book Review – The LDN Book edited by Linda Elsegood 2018-02-26T12:09:00+00:00

MS, Lupus, LDN, and the Hormone Connection

Multiple Sclerosis, Lupus, Low-Dose Naltrexone, and the Hormone Connection

Written by Carol Petersen, RPh, CNP – Women’s International Pharmacy

Nerve cells are affected by autoimmune diseases such as MS.

According to the American Autoimmune Related Diseases Association (AARDA) about 50 million Americans have an autoimmune disease and 75% of Americans with autoimmune disease are women. Multiple sclerosis (MS) and lupus are the most common of the more than 100 different autoimmune diseases.[i] Research suggests that low-dose naltrexone (LDN)—and its potential effects on hormone imbalance—may prove a positive treatment option for these diseases.

Multiple Sclerosis and Lupus

Multiple sclerosis is an autoimmune disease that affects the central nervous system. The immune system attacks the myelin sheath, the insulating layer of cells that surround and protect the nerve cells. A healthy myelin sheath allows electrical impulses to transmit quickly and efficiently along the nerve cells. When the myelin sheath is damaged, the nerve cells are left exposed and inflamed and plaques begin to form along the central nervous system. The inflammation and plaques can slow or disrupt the electrical impulses moving between the brain and the rest of the body which may cause symptoms such as numbness, weakness, tingling, dizziness, fatigue, pain, vision disturbances, difficulty walking, slurred speech and difficulties with bladder and bowel function.[ii]

Lupus is an autoimmune disease that targets the body’s tissues and organ systems including the skin, joints, cardiovascular system, brain, and kidneys. There are several types of lupus and one type may be induced by medications such as blood pressure medications, antibiotics and anticonvulsants.[iii] Because tissue damage can occur anywhere in the body, lupus can be difficult to diagnose.

While the causes for MS and lupus are unknown, environmental factors may be an instigator in susceptible people. Environmental factors that may instigate MS or lupus include:

  • Nutritional deficiencies (possibly caused by poor food quality)
  • Pathogens and distortion of the gut microbiome
  • Disturbed sleep or sleep deprivation
  • Chemical exposures
  • Hormone imbalances
  • Gluten sensitivity
  • Emotional or physical stress.
  • Vitamin D deficiency (MS)
  • Smoking (MS)
  • Epstein Barr infection (MS)

 

Low-Dose Naltrexone

Low-dose naltrexone (LDN) has emerged as particularly effective in treating autoimmune diseases that involve impaired gastrointestinal function. Crohn’s disease, irritable bowel syndrome, and ulcerative colitis have responded, sometimes dramatically, to LDN treatment.[iv] Autoimmune disorders such as MS and lupus may also be associated with gut disturbances. Recent research on MS has found a connection with the gut microbiome, providing a reason to consider low-dose naltrexone as part of a treatment plan.[v]

Naltrexone was originally developed as a drug to block opioid receptors. These receptors are meant to be activated by hormones produced by the body called endorphins and enkephalins, which can relieve pain and contribute to wellbeing. However, these receptors can also be stimulated by opium-derived drugs called opioids. The developers of naltrexone reasoned that when opioid receptors were blocked, there would be no need to use or abuse opioid drugs. While a logical theory, in actual practice they had little success.

Low doses of naltrexone act by temporarily blocking opioid receptors. The body responds by producing increased amounts of endorphins and enkephalins. The opioid receptors also increase in sensitivity and in number.

Naltrexone is commercially available in a 380mg injection and 50mg tablets to be used as part of a treatment program for alcohol or opioid dependence. It is also added as an abuse deterrent to opioid medications and available in combination with an antidepressant for weight loss. LDN, however, is currently only available from compounding pharmacies.

The use of very small doses of naltrexone was pioneered by Dr. Bernard Bihari. He first demonstrated the effectiveness of LDN in the treatment of patients with AIDS. He established that endorphin levels were low in patients with AIDS and LDN treatment provided substantial increases in these levels. LDN treatment not only improved these patients’ quality of life, but also reduced the rate at which they died.

LDN has since been shown in studies to have multiple health benefits. LDN appears to improve the body’s response to infection with an immunomodulatory effect, resulting in patients having fewer and less frequent infections. LDN also can help the body eliminate and manage toxic exposures by improving glutathione levels, which aids in detoxification and decreases oxidative damage, making it easier to clear the body of toxins. Oxidative stress has been implicated as a triggering factor of both MS and lupus due to loss of antioxidant/oxidant balance.[iv] LDN may help to repair the linings of the gut and brain barriers that prevent absorption of foreign substances, thus healing issues caused by a damaged microbiome. Additionally, LDN may balance stress hormones and also relieve anxiety and depression by improving brain neurotransmitter function.

Treatment

Dr. Deanna Windham, a contributor to The LDN Book,[iv] explored treating patients with MS and lupus with LDN. While it is not the only treatment option she uses for MS and lupus, Dr. Windham does not hesitate to use LDN because of the many benefits she has seen it provide. She cautions that full benefit may not be achieved for 12 to 18 months, so patience and commitment is essential. Dr. Windham individualizes treatment to each patient’s needs by taking a holistic approach.

  • Address diet by eliminating gluten, sugar, saturated fats, and non-foods, and add nutrient supplements
  • Help patients with detoxification of metals and solvents
  • Assist patients in smoking cessation
  • Help patients with sleep problems
  • Test hormone levels, and treat deficiencies with bioidentical hormones
The Hormone Connection

So, how are MS, lupus, and LDN connected to hormones?

High levels of estrogen relative to progesterone, or exposures to estrogen-like chemicals, may be linked to the development of autoimmune disease. In addition, high estrogen levels in men with MS correlate with more brain damage.iv However, research has shown that one specific estrogen, estriol, can have an anti-inflammatory effect in MS. Women’s International Pharmacy provided the estriol capsules used in this landmark study.[v]

Adrenal and thyroid function may also play a role in autoimmune disease. Individuals with autoimmune disease commonly experience low levels of adrenal hormones, specifically cortisol and DHEA. In fact, DHEA has reached clinical trials for FDA-approval for the treatment of lupus. Treating even subclinical thyroid deficiencies can help fatigue, brain fog, memory and sleep. Additionally, increased endorphins stimulated by LDN may even help with hormone balance.[iv]

Conclusion

Seeing the benefits of using LDN has directed research into studying previously unknown connections between the immune and endocrine systems. According to Dr. Windham’s experience, the key to treating MS and lupus may be using LDN in conjunction with diet, addressing other health concerns, and a healthy balance of hormones.

MS, Lupus, LDN, and the Hormone Connection 2018-04-09T13:55:26+00:00

Progesterone for Mental Health

Progesterone for Mental Health

Written by Carol Petersen, RPh, CNP – Women’s International Pharmacy

The Diagnostic and Statistical Manual of Mental Disorders (DSM) outlines the symptoms of schizophrenia and bipolar disorders to include scattered thinking, memory problems, confusion, behavioral changes, depression, anxiety disorders, unstable emotions, uncontrollable anger, low motivation, and changes in appetite. Many psychiatrists rely on the DSM’s description of symptoms as a way to diagnose mental disorders. They attempt to describe and categorize aberrant behaviors before applying an assortment of treatments that may include antipsychotic drugs, behavior modifications, counseling, or institutionalization. Often, the goals of treatment are to return patients to society, but may not include a “cure.”

Recent studies suggest hormones–specifically, progesterone—may offer some solutions not found in standard treatments. According to Doris King, each of the DSM’s symptoms for schizophrenia and bipolar disorder can be traced back to a deficiency of progesterone. In her book, Curing Bipolar Disorder and Schizophrenia, King claims that she was able to turn around her diagnoses of both these disorders.[i] She bases many of her arguments on writings by the late Dr. John Lee, which stress the importance of maintaining normal progesterone levels.

Could Progesterone Be the Key?

Dr. Lee recommended supplementing progesterone in doses that reflect the amount of hormone the body should normally produce.[ii] However, King maintains that people who have a long history of progesterone depletion—as in the case of patients with schizophrenia or bipolar disorder—need much more progesterone, stating simply, “When you have bipolar disorder or schizophrenia, your brain doesn’t have the progesterone it needs to function properly.” She introduces the idea of a loading dose, using progesterone in doses 3-4 times higher than Dr. Lee’s recommendation, until the body’s deficit is restored. During King’s recovery from bipolar disorder she used high doses of progesterone for four months.

Niacin and Schizophrenia

Another progesterone-related angle to schizophrenia is through treatment with niacin. Niacin aids in the synthesis of the sex hormones estrogen, testosterone, and progesterone. Dr. Abram Hoffer spent his career successfully treating patients with schizophrenia with high doses of niacin, a B vitamin.[iii] Niacin taken in high doses may normalize adrenaline metabolism. Dr. Hoffer identified an oxidized metabolite of adrenaline, which he named adrenalchrome, as being responsible for the hallucinogenic effects present in schizophrenia.

Progesterone and Adrenaline Imbalance

In his book, Adrenaline Dominance, Dr. Michael Platt writes that the medical field often ignores the effects of excessive production of adrenaline by the adrenal glands.[iv] Adrenaline is part of our “fight or flight” response, which may make us shaky, hyperactive, superhumanly strong, and intensely aware. A problem occurs when adrenaline is consistently overproduced, leading to symptoms associated with ADHD, anger, depression, PTSD, bipolar disease, addictions, and more. According to Dr. Platt, progesterone, produced in both the adrenal glands and sex organs, is the natural balancing hormone for excess adrenaline.

Nerve Damage Research and Other Breakthroughs

The myelin sheath wraps itself around nervous system tissue as a protective shield. If the myelin sheath is damaged, nerve conductivity is lost. Led by Natalya Uranova, Russian scientists have published research linking damaged myelin sheaths to both schizophrenia and bipolar disorder.[v] They examined the nervous system tissue of deceased patients who had these disorders, identifying myelin damage in these patients. In another study, Michael Schumaker et al. concluded that progesterone can be independently produced by myelin tissue and can be used in myelin repair strategies.[vi]

Conclusion

Mental health has become a large focus of today’s healthcare, as researchers strive to identify the genetic and environmental influences on mental health. While sex hormones have long been associated with changes in mood—such as anxiety and depression found in PMS or menopause—we can now turn our attention to the hormonal influences on other psychiatric disorders such as schizophrenia, bipolar disorders, and more. As research continues, progesterone may emerge as a key factor in developing treatments to recover and optimize mental health.

Additional Resources:

For more information on mental health and hormones visit our Mental Health Resources page.

Progesterone for Mental Health 2018-04-09T13:58:51+00:00

Book Review – The 6-Week Cure for the Middle-Aged Middle by Mary Dan Eades, MD, & Michael R. Eades, MD

Book Review – The 6-Week Cure for the Middle-Aged Middle by Mary Dan Eades, MD, & Michael R. Eades, MD

Written by Carol Petersen, RPh, CNP – Women’s International Pharmacy

 

scale and measuring tapeHow many middle-aged adults experience weight gain in their midsection?  Even with no changes in diet or exercise, weight gain is commonplace, particularly around the middle. Worse, this area of weight gain is the very abdominal obesity associated with heart disease. Drs. Michael and Mary Dan Eades address ways to eliminate unhealthy fat that accumulates around the organs in their book, The 6-Week Cure for the Middle-Aged Middle.

Drs. Michael Eades and Mary Dan Eades gained fame in the 70s for their weight loss success and their bestselling book, Protein Power. Both physicians lost a considerable amount of weight by incorporating principles they learned as they researched their weight problem. In turn, they successfully helped many others lose weight.

After decades of success, however, a problem arose. As the Eadeses prepared for a televised show, although they continued to follow their own prescription for success, the cameras zeroed in on a problem: a middle-aged spread around the middle. They wondered how they could promote the success of their program with this weight concern.

The Eadeses went back to what had worked for them the first time: research. They set out to find what had sabotaged their program for successful weight loss.

The answer? Hormones.

 

Cortisol and Estrogen

During middle age, the adrenal glands may increase their production of cortisol. This may be provoked by a number of factors including stress or sleep disturbances. The increased cortisol levels send signals to store fat, particularly in the abdominal area.

Weight can be affected by both high and low estrogen levels. With aging, estrogen (the hormone associated with curviness in women) decreases, and may contribute to midlife weight gain. The Eadeses recommend using only bioidentical estrogens, estradiol or estradiol with some estriol, as non-bioidentical therapies may not help with weight and may even worsen it.

The Liver and Hormone Deficiencies

6 week cure for the middle aged middle bookIn middle age, the pancreatic hormone insulin rises, signaling the liver to store more fat. Additionally, as we age, the liver creates more sex hormone binding globulin (SHBG), a protein carrier for hormones. When the hormones are bound to this protein, they are not available for use by the body.  While SHBG levels increase with age, the sex hormones carried by SHBG such as testosterone, DHEA, and estrogens decline with age. Hormone deficiencies can occur as lower levels of hormones are produced overall and more SHBG binds the hormones that are produced, making them unavailable for use by the body. These hormone deficiencies can lead to loss of muscle and bone mass and an increase in body fat percentage.

According to the Eadeses, what happens in middle age is a combination of a number of factors: loss of sleep, increased stress, a diet lacking in fat (due to concerns with cholesterol levels), hormones imbalances, introduction of new medications, and difficulties with nutritional intake. Their book is not a weight loss plan, but a path to “body-rehabilitation,” as fat stores leave the middle and the body becomes leaner and stronger.

A dietary plan to address abdominal weight gain is spelled out in The 6-Week Cure for the Middle-Aged Middle. The Eadeses report great success for themselves and their patients. For those that are struggling with middle aged weight gain, this book may hold the resources needed to help combat it.

Book Review – The 6-Week Cure for the Middle-Aged Middle by Mary Dan Eades, MD, & Michael R. Eades, MD 2018-01-22T10:50:12+00:00

Green Tea for Oral Health

Green Tea for Oral Health

Written by Carol Petersen, RPh, CNP – Women’s International Pharmacy

green teaTea is one of the most popular beverages consumed worldwide, second only to water.[i] A review by Sabu Chacko et al. discusses the studies and observations of green tea in particular as an antibacterial, antiviral, anti-inflammatory, anti-carcinogenic, and antioxidant.[ii] Here we will explore the role of green tea in promoting oral health.

 

Green Tea and HPV

In 2006 the FDA approved a green tea ointment called Veregen.  As the first botanical ever approved by the FDA, this product demonstrates evidence of green tea’s antiviral properties. Veregen is indicated for the treatment of genital and perianal warts caused by human papilloma virus (HPV).[iii] HPV can also cause lesions to form in the mouth.

Evidence suggests such HPV lesions could be precursors to oral cancers.[iv] In the Journal of Natural Science, Biology and Medicine, Vijayalakshimi Ramshankir et al. explored the use of green tea to prevent oral cancers, identifying many biomarkers that indicate cancer development. Drinking green tea or using green tea extracts may positively impact these biomarkers.[v]

 

Whole Green Tea Extracts

Whole plant extracts, or preparations containing all parts of the plant as opposed to one isolated compound, may have an additional benefit of synergy between multiple complex substances enhancing the effectiveness of each other. One of the most useful substances found in green tea is epigallocatechin-3-gallate (EGCG), a very potent antioxidant. EGCG is not typically extracted from green tea to use alone as it not a stable single molecule. When whole green tea extracts are used in supplements, the percentage of ECGC is often specified on the label. Green tea extracts are available as supplements in various strengths of ECGC.

Compounded Green Tea Lozenges

Some might find a drawback to green tea consumption to be its caffeine content.  Larger amounts of green tea or green tea extract that might achieve the best results may be too stimulating for regular use. Compounded lozenges of decaffeinated green tea extract could be a solution for oral health issues without the stimulatory effects of caffeinated green tea or green tea extract. Lozenges are designed to slowly dissolve in the mouth. The tissue in the mouth may benefit by prolonged exposure to the green tea before swallowing. Because green tea, black tea, and coffee are known for staining the teeth, rinse your mouth with water to minimize staining after drinking these beverages or using lozenges.

Like many plants, green tea contains a wealth of substances that scientists are discovering to be beneficial to our health. While drinking tea is an ancient practice, modern science confirms that green tea is a powerful supplement and oral health is just one of its benefits.

  • [i] Tea Association of the U.S.A. Inc. Tea Fact Sheet. http://www.teausa.com/14655/tea-fact-sheet. Last accessed: April 2018.
  • [ii] Chacko S, et al. Beneficial effects of green tea: A literature review. Chinese Medicine. 2010;5:13.
  • [iii] Fougera Pharmaceuticals Inc. Veregen information. PharmaDerm. www.veregen.com.
  • [iv] National Institute of Dental and Craniofacial Research. Oral Cancer. https://www.nidcr.nih.gov/OralHealth/Topics/OralCancer/DetectingOralCancer.htm. Reviewed February 2018. Last accessed: April 2018.
  • [v] Ramshankar V, et al. Chemoprevention of oral cancer: Green tea experience. J Nat Sci Biol Med. 2014;5(1):3-7.
  • [vi] American Academy of Periodontology. Go Green for Healthy Teeth and Gums. https://www.perio.org/consumer/green-tea. Last accessed: April 2018.
  • [vii] Deshpande N, et al. Evaluation of intake of green tea on gingival and periodontal status: An experimental study. J Interdiscip Dentistry. 2012;2(2):108-112.
Green Tea for Oral Health 2018-04-09T13:11:48+00:00

Book Review – Bursting With Energy by Frank Shallenberger

Book Review – Bursting with Energy by Frank Shallenberger, MD, HMD

Written by Carol Petersen, RPh, CNP – Women’s International Pharmacy

 

Bursting with Energy Book CoverDo you have an energy crisis? Dr. Frank Shallenberger poses this question on the back of his book, Bursting with Energy.[i] How many people tell their practitioners that they feel fatigued or lack energy? How many illnesses, such as multiple sclerosis, involve debilitating fatigue? How many teenagers are unable to keep up with their peers because of fatigue? How many individuals notice a lack of energy as they age? Studies show that 15% percent of women and 10% of men often feel very tired or exhausted.[ii]

Dr. Shallenberger argues that diminished energy production is the primary cause of many diseases, including allergies, obesity, diabetes, heart disease, infections, and even aging. “Chronic fatigue syndrome (CFS)” and other fatigue-related illnesses exist, yet are difficult to diagnose and understand.[iii]

Energy production occurs in specialized structures called mitochondria in all cells in the body. It is inside the mitochondria that the molecule, adenosine triphosphate (ATP), is produced to store the energy created. Energy levels are affected by how well the mitochondria function, as well as how many and how efficiently ATP molecules are produced.

The sun is required to begin producing energy in the body. The plant world picks up the sun’s energy and uses it to convert carbon dioxide into oxygen. Once oxygen is inhaled, the lungs help deliver it to the blood stream. The heart and circulatory system distribute the oxygen to the cells, where the mitochondria busily produce energy and the ATP needed to store the energy for the body. Energy production also depends upon our nutrient intake of carbohydrates, fats, and proteins.

What exactly is interfering with this cycle of energy production? Conventional practitioners may have a difficult time evaluating a patient’s symptoms when they complain of fatigue and low energy. They will likely test to determine the level of fatigue, the causes, and what may help alleviate the lack of energy.

Dr. Shallenberger has pioneered a testing procedure called “Bio-Energy Testing,” which can measure how much oxygen the body uses and how much carbon dioxide the body produces. From these values, mitochondrial function is determined. His book thoroughly outlines how this new method allows for the assessment of energy production and identification of issues that can affect fatigue. The success (or lack of success) with treatments can be measured with repetitive testing.

Bursting with Energy presents eight secrets to achieve optimal mitochondrial activity. Of particular interest is Secret #8, which is restoring depleted hormones with bioidentical hormone therapies. Throughout the book Dr. Shallenberger explains how the energy production process is directed by hormones. Cortisol, growth hormone, insulin, progesterone, testosterone, and thyroid all contribute to this process. Hormones are intimately intertwined in the energy production in every part of the body.

For example, the adrenal glands function to control the blood sugar, glucose, which feeds energy production in the mitochondria. Stress depletes the adrenal glands. Adrenal hormones, such as cortisol and DHEA, assist in managing stress.  Patients may not seek professional help for fatigue until the functioning of the adrenal glands is exhausted. Dr. Shallenberger writes that a clue to early adrenal exhaustion is the presence of normal energy at rest but a decline in energy when challenged with exercise. Restoring depleted hormones can be an essential part of recovery.

Dr. Shallenberger has condensed decades of his clinical work and research into Bursting with Energy. A primer for the successful operation of your body, this book contains many secrets that anyone can start to apply. The best secret of all is that you can turn back the decline in energy and bring back life’s exuberance.

Book Review – Bursting With Energy by Frank Shallenberger 2018-04-07T11:11:17+00:00

Hormones and Reproductive Health

Hormones and Reproductive Health

Written by Michelle Violi, Pharm.D. – Women’s International Pharmacy

 

Couple expecting babyWhat would we do without the human reproductive system? True, we might have fewer hormonal ups and downs, but it wouldn’t be long before humans would no longer populate the earth. Let’s take a closer look at how this very important system works in both women and men.

The Female Reproductive System

A woman’s reproductive system is delicate and complex. In order for conception to occur, it is important for a woman’s hormones to be balanced and her organs and tissues healthy. Hormones such as estrogen and progesterone play leading roles; however, there are many other hormones that are important players in the intricate process that is the female reproductive system.

Immediately following menstruation, estrogen levels begin to rise, causing the lining of the uterus to thicken. At ovulation an egg is expelled from the ovary into the fallopian tube where it travels to the uterus. After ovulation occurs, progesterone is produced from the corpus luteum, which forms in the ovary from which the egg was released.

Progesterone causes the uterine lining to become secretory and ready for the egg to implant should fertilization occur. If fertilization occurs, the fertilized egg implants in the uterine lining. The corpus luteum continues to produce progesterone until the placenta takes over its production in the second trimester of pregnancy. If fertilization does not occur, the corpus luteum breaks down, estrogen and progesterone levels fall, menstruation occurs, and the cycle begins anew.

The Male Reproductive System

A man’s reproductive system is no less complex. The primary hormones involved in the functioning of the male reproductive system are follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone.

FSH and LH are produced by the pituitary gland located at the base of the brain. FSH is necessary for sperm production (spermatogenesis), and LH stimulates the production of testosterone, which is necessary to continue the process of spermatogenesis. Testosterone also is important in the development of male characteristics, including muscle mass and strength, fat distribution, bone mass, and sex drive.

Hormonal Effects on Fertility

Infertility issues are very complicated and have many possible causes, including hormone imbalances or deficiencies. The following are just a few ways hormones play a role in fertility.

Hypothyroidism, or low thyroid function, can affect fertility due to menstrual cycles without ovulation, insufficient progesterone levels following ovulation, increased prolactin levels, and sex hormone imbalances. In a study involving 394 infertile women, 23.9% had hypothyroidism. After treatment for hypothyroidism, 76.6% of infertile women conceived within 6 weeks to 1 year.

Luteal phase deficiency (LPD) is a condition of insufficient progesterone exposure to maintain a normal secretory endometrium and allow for normal embryo implantation and growth. Progesterone is used in patients who experience recurrent miscarriages due to LPD. In addition, studies have shown progesterone can reduce the rate of preterm birth in certain individuals.

Conclusion

The human reproductive system is delicate, complex, and affects the overall health of women and men. Hormones serve an important role in maintaining harmony and promoting fertility in this intricate system. Because of this, achieving hormonal balance is a crucial component to supporting reproductive and overall health.

  • Lessey BA, Young SL. Yen & Jaffe’s Reproductive Endocrinology. 7th ed. Amsterdam, The Netherlands: Elsevier; 2014. https://www-clinicalkey-com.ezproxy.library.wisc.edu/#!/content/book/3-s2.0-B978145572758200010X?scrollTo=%23hl0000927 Accessed July 3, 2017
  • https://my.clevelandclinic.org/health/articles/the-male-reproductive-system Accessed July 3, 2017
  • Liedman R, Hansson SR, Howe D, et al. Reproductive hormones in plasma over the menstrual cycle in primary dysmenorrhea compared with healthy subjects. Gynecol Endocrinol. 2008;24:508-513. Accessed April 11, 2017.
  • Hassan SS, Romero R, Vidyadhari D, et al. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011;38:18-31.
  • Barda G, Ben-Haroush A, Barkat J, et al. Effect of vaginal progesterone, administered to prevent preterm birth, on impedance to blood flow in fetal and uterine circulation. Ultrasound Obstet Gynecol. 2010;36:743-748.
  • Mesen TB, Young SL. Progesterone and the luteal phase. Obstet Gynecol Clin North Am. 2015;42(1):135-151.
  • Verma I, Sood R, Juneja S, et al. Prevalence of hypothyroidism in infertile women and evaluation of response of treatment for hypothyroidism on infertility. Int J Appl Basic Med Res. 2012 Jan-Jun; 2(1):17-19.
Hormones and Reproductive Health 2017-12-05T12:33:07+00:00

Listen Up!

Listen Up!

Women’s International Pharmacy

 

We need your help!megaphone

Your freedom of choice and ability to receive compounded prescription medications from the pharmacy of your choice is at risk!

In a move that exceeds what federal law allows, FDA is trying to limit the number of compounded medications a pharmacy is able to ship over state lines. If this action is finalized, Women’s International would be unnecessarily and severely restricted in the compounded medications that could be delivered to our patients!

We may not be able to ship your compounded medication to you!

You can help, however! You can do something to prevent this from happening! Please read the information and follow the link to let your congressperson know you need your compounded medication.

There is a new proposed legislation in Congress (H.R. 2871, The Preserving Patient Access to Compounded Medications Act of 2017) that clarifies that FDA does not have the authority to limit the ability of pharmacies to fill prescriptions for compounded medications across state lines.

Key points of H.R. 2871 include:
  • Clarifying that FDA does not have the authority to limit patient specific prescriptions for compounded medications that can be filled across state lines.
  • Allowing practitioners to use compounded medications in their offices, if allowed by their state.

TO VIEW H.R. 2871 IN ITS ENTIRETY, PLEASE DOWNLOAD THE PDF BELOW.

BILLS-115hr2871ih.pdf

PLEASE CLICK ON THE LINK BELOW TO CONTACT YOUR HOUSE REPRESENTATIVE AND ASK THEY SUPPORT H.R. 2871!

http://www.house.gov/representatives/find/

It is vitally important that you let your House representative know that you support H.R. 2871, and that you would like your Congressman or Congresswoman to cosponsor and support this bill. Please tell them your story, and how not getting your compounded medications would personally impact you!  There is a suggested message below that you can feel free to use or modify. After you explain to them how important your compounded medication is to you and that you are able to receive it from a pharmacy of your choice, please ask them to co-sponsor H.R. 2871.

Thank you for your support!

Sample Message: “I use compounded medications, and ask that you cosponsor and support H.R.2871, a bill that would preserve my right to get compounded medications from the pharmacy of my choice. FDA, without legitimate authority, is trying to severely limit the availability of compounded medications.

This bipartisan bill, called Preserving Patient Access to Compounded Medications Act of 2017, protects my rights to choose my pharmacy and to get my compounded medications from the pharmacy of my choice, even if it is in another state.

Please let me know your position on H.R. 2871, and please let me know if you will sign on as a cosponsor. Thank you.”

Listen Up! 2017-07-28T17:12:45+00:00

Choosing a Dosage Form for Compounded BHRT

Choosing a Dosage Form

for Compounded Bioidentical Hormone Replacement Therapy

Written by Carol Petersen, RPh, CNP – Women’s International Pharmacy

row of doorsOne of the truly wonderful things about using compounded bioidentical hormone therapy is the opportunity to choose from a wide array of dosage forms. A “dosage form” is the manner used to deliver a medication into the body, such as capsules, creams, lozenges, gels, suppositories, and drops. Women’s International Pharmacy offers many choices of dosage forms in order to help meet each individual’s specific needs.

Oral Dosage Forms

Capsules are convenient to use. They are quick and easy to take, and multiple hormones can be combined into one capsule, allowing for increased individualization and ease of use. Women’s International Pharmacy pioneered compounding hormones mixed with an edible oil inside a capsule. These oil-based capsules were based on original research with progesterone done by Drs. Hargrove and Maxon. They demonstrated that micronization, or reducing the particle size of the hormone powders, and mixing the powders in oil inside the capsule allowed for good absorption of hormones like progesterone.

Sex and adrenal hormones mixed with oil are absorbed into the body from the intestinal tract and transported via chylomicrons (particles that transport fats throughout the body) through the lymphatic system. This allows the hormones to avoid extensive destruction by the liver on their first pass through the body, and may increase the amount of drug available for use by the body. Some criticize using capsules with hormones orally, citing that the hormones are broken down by stomach acids. This is true of hormones that are protein-based, but not those that are related to cholesterol like most sex and adrenal hormones.

Progesterone taken orally in a capsule may cause drowsiness for some individuals. This occurs when progesterone is broken down by the body into other substances called metabolites. Some of these metabolites may have a sedative effect for some. Practitioners may deliberately prescribe progesterone at bedtime for patients having trouble falling asleep hoping the patient experiences the drowsy effect.

Capsules might not be a first choice for individuals who have problems with their digestive tract. However, because the hormones are dispersed in oil inside the capsule, a practitioner may direct their patients to open the capsule and use the hormones and oil directly on the skin.

Transdermal Dosage Forms

Hormones may be applied to the skin in creams, gels, ointments, lotions, sprays, and drops. Patches are also available commercially from drug manufacturers. Most transdermal dosage forms allow for multiple hormones to be combined together for ease of application. Transdermal dosage forms also allow the flexibility to use varying amounts of the medication to adjust the dose based on a practitioner’s directions.

The skin usually acts as a barrier that prevents substances from entering the body, but cholesterol-based hormones can travel through hair follicles and make it past the outer skin layer into the blood and tissues. A common misconception when dosing hormones transdermally is that the amount of hormone applied is the amount absorbed. It has been estimated that only 10-80% of the hormone applied in a cream is actually absorbed. With such a large range, it is easy to see why doses may vary for individual patients. Additionally, absorption through the skin may be compromised for people who have impaired blood flow to the skin, such as those diagnosed with hypothyroidism, or low thyroid function.

It can also make a difference where on the skin the hormones are applied. Hormones can easily get through hair follicles but very hairy areas could interfere with the dosage form coming into contact with the skin. The part of the body where the hormones are applied may have a higher temporary level of hormones available to the hormone receptors in that area. This can be important if treating a specific area such as the eyes or vaginal area.

When using transdermal dosage forms, it is important to take steps to ensure the hormones aren’t transferred to other individuals through direct (touch) or indirect (laundry, door handles, bedding) contact. Wash hands with soap and water after applying the medication and avoid person-to-person and person-to-pet contact with application sites.

Sublingual Dosage Forms

Sublingual dosage forms are placed under the tongue or between the cheek and gum to allow the hormones to be absorbed through the tissue of the mouth into the body. However, part of the dose should be considered to be an oral dose as it would be very difficult not to swallow any of the dose.

Sublingual use tends to raise the blood levels of the hormones quickly and to a higher level than the hormones delivered in oral capsules. Sometimes these enhanced levels are useful. Sublingual estradiol is sometimes used to rapidly relieve headaches triggered by low estrogen levels, and lozenges have been used 4-8 times daily to mimic the surges in testosterone that young men naturally experience throughout the day.

Lozenges and drops are examples of sublingual dosage forms. Lozenges are prepared by placing hormones in a tablet like form that dissolves easily in the mouth. Drops are made by suspending or dissolving the hormone powder in an edible oil or other liquid. Drops can be used under the tongue or on the skin. It is important to shake the drops vigorously before use so the hormones are evenly distributed.

The drop dosage form is ideal for very sensitive patients because the hormones can be suspended in an edible oil with no other ingredients added. One can determine if the hormone itself is presenting an issue or if it is the presence of other ingredients. Taste can be an issue when using sublingual dosage forms; however, compounding pharmacies can help by adding flavors and/or sweeteners if desired.

Vaginal or Rectal Dosage Forms

Hormones may be inserted vaginally or rectally in suppositories, capsules, creams and gels. The vaginal and rectal routes can be used to distribute the hormones throughout the entire body, but may also be used when a direct effect is desired at the site of application. For example, the rectal route may be used to relieve hemorrhoid symptoms and the vaginal route may be used to relieve symptoms of vaginal atrophy and dryness.

Conclusion

For many people, any one of the dosage forms described above will work well, and the deciding factor is purely preference. Others—whether due to sensitivities, absorption issues, or something else—may need to try a number of dosage forms before finding the one that works best for them. Women’s International Pharmacy is here to help patients and practitioners sort through the options and make the best choice for each individual.

  • Arafat ES, et al. Sedative and hypnotic effects of oral administration of micronized progesterone may be mediated through its metabolites. Am J Obstet Gynecol. 1988 Nov;159(5):1203-9.
  • Maxson WS, Hargrove JT. Bioavailability of oral micronized progesterone. Fertil Steril. 1985 Nov;44(5):622-6.
  • Järvinen A, et al. Steady-state pharmacokinetics of oestradiol gel in post-menopausal women: effects of application area and washing. Br J Obstet Gynaecol. 1997 Nov;104 Suppl 16:14-8.
  • Hargrove JT, Maxson WS, Wentz AC. Absorption of oral progesterone is influenced by vehicle and particle size. Am J Obstet Gynecol. 1989 Oct;161:948-51.
  • McCormick K. Hormone Testing. Women’s International Pharmacy. http://www.womensinternational.com/connections/hormone-testing/.
Choosing a Dosage Form for Compounded BHRT 2017-12-12T15:31:40+00:00