The Safety of Soy Supplements

For a number of years now, women have recognized that soy supplements, which contain phytoestrogens, or plant derived estrogens, may help to control their menopausal symptoms related to lowered estrogen levels. Despite their widespread use, few studies have demonstrated the safety of long term soy supplement use. As soy contains plant derived estrogenic compounds, safety concerns include the risk of estrogen related cancers such as breast and uterine cancers. A recently published study in American Journal of Clinical Nutrition demonstrated that daily supplementation for 2 years with up to 120 mg of soy hypocotyl isoflavones carried minimal risk in healthy postmenopausal women. Although this information is encouraging, it only applies to the safety of the specific isoflavone supplement utilized. The studied supplement is manufactured in the Netherlands (Frutarom, Belgium www.frutarom.com) and contains only the hypocotyl portion of the soy bean. The contents of this supplement may be very different than those of over the counter supplements sold in the United Sates.

Posted: December 29th, 2010 | Author: | Filed under: estrogen, general health, great health at every age, gynecology, menopause, nutrition & diet | Tags: , | No Comments »


Menopause News Update November 2010

Hormone Replacement Therapy Is Linked to More Aggressive Breast Cancer

It was demonstrated in the initial analysis of the Women’s Health Initiative Study that women who were treated with estrogen and progestin had an elevated risk to develop breast cancer. This recent analysis has further demonstrated that these cancers are also more likely to be more advanced at the time of diagnosis.

Estrogen Therapy Accelerates Ovarian Cancer Growth

Researchers from the University of Colorado have demonstrated that estrogen can cause some types of ovarian cancer to grow faster in mouse models. About 60% of ovarian cancers will have estrogen receptors, and estrogen can cause these cancers to grow faster in these animal models.

Soy based Supplement, Natural S-equol, Can Reduce Hot Flashes, and Muscle and Joint Pain in First Study of US Women

This information was recently presented in poster form at the North American Menopause Society. S-equol is a whole soy germ –based supplement. It was recently shown to decrease the frequency of moderate to severe hot flashes and reduces menopausal associated muscle and joint pain. S-equol [7-hydroxy-3-(4'-hydroxyphenyl)-chroman] is a compound resulting — when certain bacteria are present in the digestive tract — from the natural metabolism, or conversion, of daidzein, an isoflavone found in whole soybeans. However, not everyone who consumes soy can produce s-equol. S-equol selectively binds to the estrogen receptor, most strongly to the receptor beta. Additional clinical evidence has also demonstrated that S-equol can help preserve bone.

Manufacturing Plan for Hot Flash Drug Candidate Menerba Approved by the FDA

Menerba is an oral, botanically derived drug candidate designed to treat hot flashes associated with menopause. Its action is through the estrogen receptor beta. The designs for the definitive studies are currently being planned with the FDA and the drug’s manufacturer, Bionovo.

The National Institute of Health is Increasing Funding to Study the Health Effects of Botanical Estrogens

The Botanical Research Center based at the University of Illinois, will receive a large portion of the funding, as well as University of Mississippi, Oregon State University and the FDA’s National Center for Toxicological Research. The research will utilize the expertise of a multidisciplinary team of researchers to address the many unknowns associated with use of botanical estrogens. Examples of naturally derived phyto estrogens are from soy, licorice root, wild yam and dong quai, Prior research related to the efficacy of the naturally derived estrogens has lead to mixed results. Some research has even demonstrated that some of these agents may interfere with breast cancer treatment and induce cognitive problems.

Non-Hormone Treatments of Hot Flashes

A new Cochrane review finds that a variety of non-hormonal treatments (mostly non-hormonal drugs) can offer women who have had breast cancer some relief from hot flashes. Relaxation therapy, the anti hypertensive Clonidine, the anti convulsant gabapentin and the anti depressants that inhibit serotonin reuptake were found in review to have a mild to moderate effect.

Menopause Associated Depression Can be Treated with an Antidepressant

Pristiq was recently demonstrated to be effective in treating menopause associated depression in the Journal of Clinical Psychiatry. . This data was recently published study generated from Virginia Commonwealth University. This is the first study to demonstrate the effectiveness of an antidepressant specifically related to perimenopause and post menopause.

Progestin Type May Alter Breast Cancer Risk in Hormone Replacement Therapy

In animal studies recently published in Cancer Prevention Research from the University of Missouri, researches compared synthetic progestins (medroxyprogesterone acetate – MPA), norgesterel, norethindrone, and megesterol acetate. Animal studies have demonstrated that MPA is a tumor promoter, however norgesterel and norethindrone are tumor inhibitors.

Posted: November 1st, 2010 | Author: | Filed under: estrogen, general health, gynecology, menopause | Tags: , | No Comments »


My Pap Smear has HPV: What does this mean?

HPV stands for human papilloma virus and is the most common sexually transmitted infection; it is also the virus that causes cervical cancer. If you have HPV on your Pap smear it does not mean that you have cervical cancer, but may be more likely to develop pre cancerous and cancerous changes in the genital and oral areas. For some women, your health care provider may suggest that you have more frequent Pap smears or a test called a colposcopy, a more detailed examination of the genital area. Most women who are infected with HPV do not know it, because most of the time there will be no symptoms.

Approximately 20 million Americans are infected with HPV and 6 million will be newly infected each year. Indeed, approximately 50% of sexually active women will be infected. About 1% of sexually active adults in the U.S. have genital warts at any one time.

There are more than 40 HPV types that can infect the genital areas of males and females. These HPV types can also infect the anal region, mouth and throat. HPV is passed on through genital contact, anal sex, oral sex and genital-to-genital contact.

A person can have HPV even if years have passed since he or she had sexual contact with an infected person. Most infected persons do not realize they are infected or that they are passing the virus on to a sex partner. It is also possible to get more than one type of HPV.

Most women do not develop serious problems from an HPV infection, and the vast majority of the time a woman’s immune system will clear the virus. However, HPV infections may lead to warts in the genital or oral areas (throat), precancerous and cancerous changes in the cervix, vulva and vagina, and head and neck (tongue, tonsils and throat).

The over 40 HPV types that can infect a woman are generally categorized as high-risk (linked to cancers and significant, high-grade precancerous changes) and low-risk (linked to warts and low grade precancerous changes). HPV infections can cause the cells of the genital and oral areas to turn abnormal. Genital warts can appear weeks to months after infection, cancer most often takes years to develop. If the immune system if effective at clearing the HPV infection, abnormal cells may also go back to normal. Women who have weakened immune systems due to conditions such as HIV or are on immunosuppressant drugs are at higher risk for some HPV-related problems.

HPV can be prevented though vaccines, condoms, and limiting the number of sexual partners. There are currently two HPV vaccines available, Gardasil and Cervarix. These vaccines do not protect against all types of HPV types and are targeted to the most common types. Gardasil protects against the two most common low risk types 6 and 11, as well as the two most common high-risk types 16 and 18. Cervarix protects against HPV types 16 and 18. To be most effective the vaccines should be given before first sexual contact. They are FDA approved for use up to the age of 26 years.

Condoms may lower the risk of transmission of HPV. To be most effective, they should be used with every sex act, from start to finish. They are, however, not 100% effective as the virus can still be transmitted through skin-to-skin contact.

If you do have the presence of an HPV infection, review management with your health care provider. Make sure that you get your Pap smears on a regular basis and recommended more intense screening for precancerous changes of the genital areas, such as colposcopy. If you are having anal intercourse, review this with your health care provider. Currently, there are no screening recommendations for the anal areas, however an anal Pap smear may be recommended. The HPV tests on the market are only used to help screen for cervical cancer. There is no HPV test approved for the mouth or throat. There are no formal recommendations concering head and neck screening for people with HPV. However, symptoms of a persistent sore throat; persistent hoarse voice, neck lump  or mouth lesions may be present. These should be reported to your health care provider. You should see a dentist on a regular basis and talk to your health care provider concerning seeing a head and neck physician for screening.

There is no proven effective treatment for the virus itself, but there are treatments for the diseases that HPV can cause. Eat a healthy diet rich in antioxidant nutrients with a variety of fruits and vegetables.

In summary, HPV usually goes away on its own, without causing major health problems. However, infection can lead to precancerous and cancerous changes of the genital, anal and head and neck areas. Review prevention and screening strategies with your healthcare provider.

Posted: October 23rd, 2010 | Author: | Filed under: cancer diagnosis & treatment, cancer prevention, general health, gynecology | Tags: | No Comments »


What is Endometriosis and how is it Treated?

Endometriosis is a condition which usually affects women in their childbearing years and can lead to pelvic pain and infertility. Endometriosis consists of clusters of endometrial cells (the cells which form the lining of the uterus and are shed each month with menstruation) growing outside the uterus. These clusters of endometrial cells, or implants, can be found most commonly in the pelvis including the ovaries, fallopian tubes, and the surface of the uterus. They can also be found on the intestine, upper abdomen or in other parts of the body such as the lung. Because endometriosis cells are subject to the same monthly hormonal changes that normal endometrial cells are, but cannot be shed, this can lead to scar tissue, cysts, and pain. Women who have  endometriosis may have a higher risk of developing ovarian cancer. This risk has been difficult to quantify and the mechanism of this elevated risk is unknown.

It is estimated that endometriosis affects over one million women in the United States, and most cases are diagnosed in women between 25 and 35 years of age. However, because many women have no symptoms, the exact prevalence is unknown. The condition is uncommon in postmenopausal women. Other risk factors for endometriosis include being Caucasian (compared to African American and Asian), being tall and thin with a low body mass index, being infertile and delaying pregnancy until older ages.

We do not know the exact causes of endometriosis, but there are several theories. It is thought that estrogens contribute to the formation of endometriosis. Other possible causes of endometriosis include: retrograde menstruation – when endometrial tissue is deposited in strange locations because of menstrual flow that backs up into the fallopian tubes and abdominal cavity, immune system problems – causing the body to not recognize and destroy cells or tissue that is growing where it should not be, and cellular metaplasia – the cells of the areas lining the pelvic organs have certain cells that can grow into other forms of tissue such as endometrial cells.

Many women will have no symptoms of endometriosis, and the amount of the endometriosis does not correlate with the degree of symptoms. The predominant symptom of endometriosis is pain. Endometriosis associated pain may be located in the pelvis, lower abdomen, rectum, vagina, or lower back. It may vary with different points in the menstrual cycle. It may also occur during sex, bowel movements, ovulation, or all the time.  Abnormal bleeding is also a symptom of endometriosis. Heavy periods, spotting or bleeding between periods, bleeding after sex, or blood in the urine or stool can occur as a result of the condition. Infertility can also be caused by endometriosis. Disrupted bowel habits such as constipation or diarrhea can also occur.

In order to diagnose endometriosis, a thorough medical history and physical examination will be taken in order to ascertain for the symptoms of the condition. Some health care practitioners will prescribe medical treatments for endometriosis; an improvement in symptoms after medication usually indicates that the problem was endometriosis.  Imaging tests, such as ultrasounds, magnetic resonance image (MRI) tests, and CT scans also may be employed  However, endometrial implants will many times not show up on even the most sensitive of imaging tests. The only way to truly diagnose endometriosis is through directly evaluating the abdominal and pelvic cavity.  This most commonly accomplished through the use of laparoscopy, which is minimally invasive or “belly button” surgery. Biopsies are usually taken in order to rule out other conditions such as ovarian cancer.

Treatment options consist of medical treatments and surgical treatments. The route of treatment will depend on the goal of the woman and can differ if the woman wants to get pregnant or is focused on treating pain. Medical treatments include pain medicines such as NSAIDs (non steroidal anti inflammatory), birth control pills, hormone therapy such as GNRH (gonadotropin-releasing hormone analogs) such as Lupron, Danazol and progestins, and aromatase inhibitors. Many of the medical treatments provide only temporary relief while they are being utilized and can have side effects. Some, like Lupron, can only be used for a limited period of time due to their side effects of bone loss. Surgery may be an option chosen for some women who are attempting to get pregnant or in which medical management has failed. This may consist of ablation techniques or accomplished by excision techniques. This form of surgery, when conducted properly, is quite complex and a gynecologic surgical sub-specialist is encouraged to be consulted. The ovaries and uterus may also be recommended to be removed for some women. This type of surgery, while may be successful in the short run for relieving the symptoms of endometriosis, may not provide long-term pain control for all women,

Take home message:

Endometriosis may be a cause of unexplained pelvic pain, abnormal bleeding, or infertility.

Endometriosis is not an uncommon problem in women.

Diagnosis is usually made on the basis of symptoms and laparoscopy may be used.

Treatments may be either medical or surgical.

If surgery is being entertained as a treatment option, in order to assure that you have the best outcome, consult and expert gynecologic surgeon.

Posted: August 8th, 2010 | Author: | Filed under: endometriosis, general health, gynecology | Tags: | No Comments »


Balanced Women’s Health Update: Week of June 21, 2010 Source: Medical News Today

Pain Management Of Endometriosis: Conservative Approach Is First-Line Treatment

Source: Medical News Today June 23, 2010

Ob-gyns recommend conservative nonsurgical treatment approaches for treating women with endometriosis-associated pain followed by more invasive procedures if these fail to alleviate pain, according to a newly updated Practice Bulletin published in the July issue of The American College of Obstetricians and Gynecologists’ journal, Obstetrics & Gynecology. The Practice Bulletin “Management of Endometriosis” includes the latest recommendations on the incidence, diagnosis, and treatment of this common gynecologic health condition.

Endometriosis is a chronic condition in which endometrial tissue that lines the inside of the uterus migrates outside of the uterus and attaches to the lining of the abdominal cavity and to internal organs inside the pelvis, including the ovaries, fallopian tubes, bladder, and bowel. The condition occurs in 6-10% of reproductive-age women. Endometriosis is a leading cause of chronic pelvic pain and a common cause of infertility, the two main symptoms. Some women with endometriosis have no symptoms, but for those that do, pain can range from mild to severe.

“We recommend starting with conservative approaches to treating women with endometriosis-associated pain,” says Tommaso Falcone, MD, who led the document update. “For instance, continuous oral contraceptives and nonsteroidal anti-inflammatory drugs are effective. If these fail and further medical management is needed, then gonadotropin-releasing hormone agonists or progestins can help by suppressing the disease.” Medical therapy, however, will not improve fertility for women trying to get pregnant since most of these drugs suppress ovulation. Medical therapy is effective while using it, but recurrence of pain symptoms is common after discontinuing the drugs. Surgery to remove endometriosis tissue helps improve pregnancy rates among infertile women, but it is difficult to predict by how much, said Dr. Falcone.

According to the College vaginal ultrasound is the best way to investigate the presence of endometriosis. The only definitive way to diagnose endometriosis is with laparoscopic surgery. Laparoscopy also can remove visible endometriosis lesions, but it is not 100% effective in helping pain. As with medical therapy, there is a high recurrence of symptoms in patients after laparoscopic surgery. Both laparoscopic surgery and long-term hormone suppression-typically with an oral contraceptive-will likely be needed to control pain.

The treatment of last resort for women with severe endometriosis is hysterectomy. “If a woman has completed having children and all other conservative treatments haven’t worked to stop the pain, she may consider having her uterus removed,” said Dr. Falcone. “If both ovaries are normal and all of the visible endometriosis is removed, then consideration should be given to conserving them.” This way, Dr. Falcone noted, women won’t suffer the consequences of a surgical menopause.

Even when both ovaries are removed, endometriosis symptoms can recur in some women, likely due to lesions that remain attached to the bowel. The Practice Bulletin notes that estrogen therapy after ovary removal does not appear to affect the risk of recurrence of endometriosis and can be safely considered to avoid an immediate surgical menopause.

Practice Bulletin #114, “Management of Endometriosis,” is published in the July 2010 issue of Obstetrics & Gynecology.

American College of Obstetricians and Gynecologists

Abbott And Neurocrine Announce Global Agreement To Develop And Commercialize Elagolix For The Treatment Of Endometriosis

Source: Medical News Today June 17, 2010

Abbott and Neurocrine Biosciences, Inc. announced they have entered into a collaboration agreement to develop and commercialize elagolix for the treatment of endometriosis-related pain. Elagolix is a novel, first-in-class oral gonadotropin-releasing hormone (GnRH) antagonist, which has recently completed a phase IIb study in endometriosis. In addition to endometriosis, elagolix will be evaluated for the treatment of uterine fibroids.

“Extensive preclinical and clinical experience with elagolix suggests this drug could be an important advance for women with endometriosis and uterine fibroids, highly prevalent conditions where there is a need for new treatments,” said John Leonard, M.D., senior vice president, pharmaceuticals, research and development, Abbott. “This agreement enhances Abbott’s late stage pipeline, with the potential for additional compounds in earlier stage development.”

Under the terms of the agreement, Abbott will receive worldwide exclusive rights to develop and commercialize elagolix and all next-generation GnRH antagonists for women’s and men’s health. Abbott will make an upfront payment of $75 million and will fund all ongoing development activities. Neurocrine is eligible to receive additional milestone payments of approximately $500 million from Abbott for the achievement of certain development, regulatory and commercial milestones; funding for certain internal collaboration expenses; plus royalty payments on any future product sales.

“We are pleased to have one of the world’s most admired companies as our partner in developing our entire GnRH portfolio for both women’s and men’s health indications,” said Kevin Gorman, president and chief executive officer, Neurocrine Biosciences. “Abbott shares our long-term vision for elagolix, and, together, we look forward to bringing this important new treatment option to endometriosis and uterine fibroid sufferers.”

About GnRH and Elagolix

Elagolix inhibits gonadatropin releasing hormone (GnRH) receptors in the pituitary gland and ultimately reduces circulating sex hormone levels. Elagolix has a unique profile that allows partial estrogen suppression. It maintains estradiol in the low-normal range, providing symptom reduction while avoiding significant bone loss or other adverse effects that can sometimes be associated with excessive suppression of estrogen. In Phase II studies, elagolix has been found to be effective in reducing the pain associated with endometriosis. To date, elagolix has been studied in 18 clinical trials totaling more than 1,000 subjects.

About Endometriosis and Uterine Fibroids

Endometriosis is associated with a multitude of symptoms, some of the most common of which include pain related both to menstruation (dysmenorrhea) as well as chronic pelvic pain throughout the menstrual cycle, and infertility. The World Endometriosis Research Foundation estimates that there are approximately 100 million women worldwide who suffer from endometriosis. With annual healthcare costs and endometriosis-related productivity losses of approximately $4,000 per patient, the annual direct and indirect costs of endometriosis are estimated to exceed $20 billion in the United States alone.

Uterine fibroids are benign tumors that form on the wall of the uterus. They are the most common type of growth found in a woman’s pelvis and are most common in women aged 30-40 years. While many women do not have symptoms, depending on the size, location and number, uterine fibroids can cause heavy menstrual bleeding, can put pressure on the bladder and rectum, and can cause pain and nausea. Symptoms can also include miscarriages and infertility. Depending on the symptoms, treatment sometimes requires surgery.

Source: Abbott LaboratoriesNeurocrine Biosciences

BioSante Pharmaceuticals Reports Positive LibiGel(R) Safety Data In Phase III Clinical Program

Source: Medical News Today June 23, 2010

BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), announced that the independent Data Monitoring Committee (DMC) of the ongoing LibiGel® Cardiovascular (CV) and Breast Cancer Safety Study unanimously recommended study continuation without modifications, after its third review of the study’s unblinded safety data. The review was based on data from almost 1,500 women-years of exposure. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is currently no FDA approved product. BioSante anticipates the submission of a new drug application (NDA) for LibiGel in 2011.

“To date, there have been only seven adjudicated CV events and only four diagnoses of breast cancer reported in the study population,” said Michael Snabes, M.D., Ph.D., BioSante’s vice president of clinical development. “If testosterone increased CV disease, the CV event rate would be expected to be higher in the women enrolled since as per the protocol, the study subjects are at the higher end of cardiovascular risk for the intended treatment population. With this favorable DMC recommendation, we believe that LibiGel will be the first product approved by the FDA to treat HSDD in menopausal women, also referred to as FSD.”

The LibiGel Phase III Cardiovascular and Breast Cancer Safety Study is a randomized, double-blind, placebo-controlled, multi-center, CV events and breast cancer study that will enroll between 2,500 and 4,000 women, exposed to LibiGel or placebo for 12 months. After NDA submission and potential approval of LibiGel, BioSante will continue to follow the women enrolled in the study for an additional four years. The first decision point as to whether enrollment is complete or needs to continue will occur early in the fourth quarter 2010.

The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke, in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also will be tracked over the course of the study.

About LibiGel

LibiGel® is a testosterone gel Phase III in clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after a once-daily pea-sized application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner.

In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.

Source: BioSante Pharmaceuticals, Inc

Advisory Panel Says FDA Should Not Approve Drug To Address Female Sexual Dysfunction

Source: Medical News Today June 22, 2101

On Friday, an FDA advisory panel voted 11-0 against recommending FDA approval of a proposed treatment for hypoactive sexual-desire disorder, which decreases women’s sex drive, the Wall Street Journal reports.

The Reproductive Health Drugs Advisory Committee reviewed an application seeking FDA approval of the drug flibanserin, also known as the “pink pill” or “female Viagra.” Although the agency is not required to follow the panel’s recommendation, it typically does (Corbett Dooren, Wall Street Journal, 6/18).

The drug’s effects on women’s sexual drive was “not robust enough to justify the risks,” which included dizziness, fatigue and nausea, particularly with long-term daily use, according to Julia Johnson, chair of the advisory panel and head of the department of obstetrics and gynecology at the University of Massachusetts Medical School. She added that the drugmaker — Germany-based Boehringer Ingelheim — should continue to pursue research on the drug (Wilson, New York Times, 6/18).

According to the Journal, the panel’s recommendation “wasn’t surprising” because FDA released a background document last week with a “fairly negative review” of the drug. The company submitted data involving about 2,400 women for about six months treated with either flibanserin or a placebo months. FDA scientists said the drug did not show an increase in the women’s libido, although some women reported an increase in their number of sexually satisfying events. The document noted that it was “not clear whether the safety and efficacy data from these trials are generalizable to the target population for this drug.”

Boehringer said that women with HSDD have “extremely limited” treatment options and that flibanserin provided “clinically relevant” data for the drug’s efficacy (Wall Street Journal, 6/18). Christopher Corsico, the company’s U.S. medical director, said in a statement that the company is “disappointed with the advisory committee’s recommendation and will work with the FDA to address questions raised” (New York Times, 6/18).

Drug Marketing ‘Bigger Issue’ in Flibanserin Review, Los Angeles Times Editorial Say

Early Menopause Linked To Higher Risk Of Future Cardiovascular Disease

Source: Medical News Today June 22, 2010

Women who experience early menopause appear to have more than twice the risk of having a heart attack, stroke or other cardiovascular disease event later in life than do women who do not go through early menopause, a new study indicates. The results will be presented Saturday at The Endocrine Society’s 92nd Annual Meeting in San Diego.

Early menopause was defined as going through menopause before age 46, either naturally or surgically through removal of both ovaries.

“It is important for women to know that early menopause is a potential risk factor for cardiovascular disease the number one killer of American women. They can then work harder to improve their modifiable risk factors, such as high cholesterol and blood pressure, by exercising and following a healthy diet,” said the study’s principal author, Melissa Wellons, MD. She is a fellow at the University of Alabama, Birmingham.

Previous research found a link between early menopause and cardiovascular disease in mostly white and European populations, according to Wellons, but the new study had a multiethnic representation of women. Of the more than 2,500 participants, about 40 percent were white, 25 percent were black, 22 percent were Hispanic and 13 percent were Chinese-American.

At the beginning of the study in July 2000, women were ages 45 to 84. Nearly 28 percent of the women reported early menopause; 446 women had natural menopause and 247 had surgical menopause. Women not yet past menopause were included in the group that did not have early menopause. Follow-up tracked whether participants had a cardiovascular disease event, which included a heart attack, nonfatal cardiac arrest (a suddenly stopped heart), angina (chest pain due to narrowed or blocked arteries), probable angina followed by angioplasty or bypass surgery, a stroke or death due to stroke, heart attack or other cardiovascular disease.

No one had any such event before age 55. After that, women who had early menopause were more likely to have had a cardiovascular disease event than women who had not gone through menopause before age 46.

Even when the researchers’ statistical analysis controlled for current or previous use of hormone replacement therapy or for major cardiovascular risk factors, it did not change the results. Early menopause remained a risk factor on its own, although it is unclear why, Wellons reported.

“Our study is observational; therefore, we cannot conclude that early menopause somehow causes future cardiovascular disease,” Wellons said. “However, our findings do support the possible use of age at menopause as a marker of future heart and vascular disease risk.”

The women in this study were part of the Multi-Ethnic Study of Atherosclerosis (MESA), an observational research study funded by the National Institutes of Health and involving more than 6,000 men and women from six U.S. communities. Also contributing to the current study were researchers from Johns Hopkins Medicine, Baltimore; Wake Forest University, Winston-Salem, N.C.; and the University of Minnesota, Minneapolis.

Source: Endocrine Society

Progesterone Is Effective For Hot Flash Treatment And Provides An Alternative To Estrogen

Source: Medical News Today June 22, 2010

Postmenopausal women who experience bothersome hot flashes or night sweats may have an alternative treatment to estrogen. According to a new study, oral micronized progesterone relieves those symptoms. The results will be presented Saturday at The Endocrine Society’s 92nd Annual Meeting in San Diego.

“This is the first evidence that oral micronized progesterone, which is molecularly identical to the natural hormone, is effective for women with symptomatic hot flashes,” said the presenting author, Jerilynn Prior, MD, professor, University of British Columbia, Vancouver, Canada.

Available only by prescription and sold under the brand name Prometrium in the United States and Canada, this form of progesterone is manufactured from a steroid in yams.

“Vasomotor symptoms” hot flashes (sometimes called hot flushes) and night sweats are experienced by most women during the years around the final menstrual period. In the most symptomatic women (at least 5-10%) these symptoms disturb sleep, energy and quality of life, Prior said.

The researchers recruited 114 healthy postmenopausal women seeking hormonal therapy for hot flashes and night sweats and randomly assigned them to take either oral micronized progesterone or an inactive substance (placebo), both as three round capsules at bedtime. Neither the women nor the study team members were aware which treatment the study participants received during the three months of therapy. The time since their last menstrual flow was one to 10 years, with an average of four years. To be eligible to participate in the study, women could not have taken ovarian hormone therapy within the past six months.

Prior and Christine Hitchcock, PhD, of the University of British Columbia, calculated the average daily vasomotor symptom score, or VMSScore, from the data that subjects recorded in a daily diary. This score reflects both intensity and number for hot flashes and night sweats each day.

Progesterone, in a 300-milligram dose, was more effective than placebo at decreasing the intensity and number of symptoms, the authors reported, and the difference was both statistically significant and clinically important. The 68 women taking progesterone showed a 56% improvement from baseline in VMSScore, and a 48% reduction in the number of VMS; the 46 women taking placebo had 28% lower VMSScores and a 22% reduction in number.

“Women improve very quickly on oral micronized progesterone. The improvement is apparent within the first 4 weeks,” Prior said.

Micronized progesterone did not cause any serious side effects, she said. The drug may be an option for postmenopausal women who do not want to or should not take estrogen “currently the only effective therapy for decreasing severe vasomotor symptoms,” Prior said.

Besins Healthcare and Schering Canada donated the progesterone and placebo for this study.

Source: Endocrine Society

For Insulin-Resistant Women, Cutting Carbs Is More Effective Than Low-Fat Diet

Source: Medical News Today June 21, 2010

Obese women with insulin resistance lose more weight after three months on a lower-carbohydrate diet than on a traditional low-fat diet with the same number of calories, according to a new study. The results were presented at The Endocrine Society’s 92nd Annual Meeting in San Diego.

“The typical diet that physicians recommend for weight loss is a low-fat diet,” said the study’s lead author, Raymond Plodkowski, MD, chief of endocrinology, nutrition and metabolism at the University of Nevada School of Medicine, Reno. “However, as this study shows, not all people have the same response to diets.”

People with insulin resistance, a common precursor for Type 2 diabetes, metabolize carbohydrates, or “carbs,” abnormally, which may affect their rate of weight loss. For them, Plodkowski said, “the lower-carb diet is more effective, at least in the short term.”

At 12-weeks, the study funded by Jenny Craig and using prepared calorie-controlled meals as part of a behavioral weight loss program, found that the insulin resistant women on a lower-carb diet lost 3.4 pounds more than those on a low-fat diet.

Forty-five obese women between the ages of 18 and 65 years participated in the study, and all had insulin resistance, as found by fasting blood levels of insulin. The researchers randomly assigned the women to either a low-fat or lower-carb diet. The groups did not differ significantly in average body weight, the authors reported. On average, women in the low-fat diet group weighed 213 pounds, while women in the other group weighed 223 pounds.

The composition of the low-fat diet was 60 percent of calories from carbs, 20 percent from fat and 20 percent from protein. Although the lower-carb diet also had 20 percent of calories from protein, it had 45 percent from carbs and 35 percent from primarily unsaturated fats, such as nuts. Menus included a minimum of 2 fruits and 3 vegetable servings a day.

Use of prepared meals helped make the structured diets easier and more palatable for the dieters, according to Plodkowski. “We wanted to make this study real-world – anyone could follow this plan by making moderate changes as part of a healthy menu,” he said.

Both groups lost weight at each monthly weigh-in, but by 12 weeks, the insulin resistant group receiving the lower-carb diet lost significantly more weight, 19.6 pounds versus 16.2 pounds in the low-fat diet group – approximately 21 percent more on average.

“These data have potential widespread applications for clinicians when counseling people with insulin resistance to help improve weight loss as part of a calorie-restricted diet,” Plodkowski said. “They should at least initially lower their carbohydrate intake.”

Source: The Endocrine Society

Posted: June 25th, 2010 | Author: | Filed under: endometriosis, gynecology, menopause, nutrition & diet, sex, weight loss | Tags: , , , , , , , , | 3 Comments »


My Pap Smear is Abnormal: What does this mean?

First, take a deep breath and realize that if your Pap smear is abnormal it does not mean that you have cancer and that you are not alone. About 55 million Pap tests are performed each year in the United States. Of these, approximately 3.5 million (6 percent) are abnormal and require medical follow-up.. The Pap smear samples cells which are on the surface of the cervix and these cells are looked at underneath the microscope. The procedure is named after the doctor who first discovered that cervical cells changed before cancer of the cervix develops, Dr. George Papanicolaou. Cells on the surface of the cervix sometimes appear abnormal but are very rarely cancerous. The Pap smear was designed to pick up abnormal cells before they have a chance to become cancerous and having regular Pap smear tests and appropriate treatment and follow-up of abnormal results, significantly reduces the chance that cervical cancer will ever develop. Prior to the introduction of the Pap test, cervical cancer was a leading cause of cancer death in women, and still is in some parts of the world.  Since the introduction of the Pap test, deaths caused by carcinoma of the cervix have been reduced by up to 99% in some populations where women are screened regularly.  A healthcare provider may simply describe Pap test results to a patient as “abnormal.” It is important to remember that abnormal conditions do not always become cancerous, and some conditions are more likely to lead to cancer than others.

The cells of the cervix may be abnormal due to infection, lack of estrogen in older women, or precancerous changes. Although the Pap smear is not designed to reliably pick up abnormal cells from sources other than the cervix, some abnormal Pap smears may be due to vaginal, endometrial, fallopian tube, ovarian, or rectal abnormalities. Breast cancer cells have even been found in Pap smears, although quite rarely. The vast majority of precancerous changes in the cervix are due changes in the cells that cover the outer surface of the cervix, the squamous cells. Some precancerous changes will be due to the cells lining the inner portion of the cervix, called glandular cells. If any unusual cells are detected, further tests are done to determine if treatment is needed. This is the best way to find out if cancerous or precancerous cells are present.

Precancerous changes in the squamous cells of the cervix are referred to as cervical dysplasia or cervical intraepithelial neoplasia (CIN). If these type of changes are detected on your Pap test, they will be graded as mild (CIN 1), moderate (CIN 2), or severe (CIN 3). CIN 1 is also referred to as a low-grade squamous intraepithelial lesion (LGSIL) and CIN 2 and CIN 3 are referred to as a high-grade squamous intraepithelial lesions (HGSIL). Any of these changes require further discussion and evaluation with your health care professional.

We know understand that virtually all precancerous and cancerous changes in the cervix are due to the human papilloma virus (HPV), a very common, sexually transmitted virus. HPV infection is the primary risk factor for cervical cancer, however only a very small percentage of women with untreated HPV infections develop cervical cancer.  Approximately 80% of women will become infected with the HPV virus in their lifetime and many times there are no associated signs or symptoms other than an abnormal Pap smear. About 6 million new genital HPV infections occur each year in the United States. HPV may also cause vulvar, vaginal and rectal cancers. In most cases of HPV infection, the immune system quickly attacks the virus, and it is cleared from a woman’s system. For other women, the immune system does not rid the body of the virus, and a small number of these women will develop CIN. The development of CIN is more likely to occur in older women who have had HPV for a long time. Women who smoke and have HPV face twice the risk of developing CIN than women who do not smoke. The good news is that if you have regular Pap smear tests and appropriate, regular follow-up, it’s unlikely that cervical cancer will develop.

The most common system for describing Pap smear test results is the Bethesda System. The Bethesda System uses a number of terms to relate the results. Squamous intraepithelial lesion (SIL) describes precancerous changes in cervical cells. Using this system, your Pap smear test results may be:

  • Normal
  • Atypical squamous cells of undetermined significance (ASCUS) This is the most common abnormal Pap smear test result indicating the presence of cervical cell changes. This term simply means that the squamous cells of the cervix appear unusual and cannot be further categorized. These changes may be due to infections, thinning of the cervix and vagina in women who have low estrogen levels, or precancerous or cancerous changes.
  • Squamous intraepithelial lesion (SIL) This term describes abnormal cervical cell changes that may be a sign of precancer. SIL is either low grade (LGSIL) or high grade (HGSIL). LGSIL or HGSIL refers to the grade of dysplasia and CIN. LGSIL is indicative of either the presence of HPV or mild precancerous changes; this is a common type of abnormal Pap smear result. HGSIL, on the other hand, indicates more serious cervical cell changes.
  • Atypical squamous cells, cannot exclude HGSIL (ASCH) This Pap smear test result means there is uncertainty about whether HSIL is present.
  • Atypical glandular cells (AGC) This term implies precancerous changes to the upper cervix or uterus.
  • Cancer Hopefully, you will never get this result from your Pap smear. Having regular Pap smear tests can almost guarantee that you will never get a result of cancer
  • Endocervical and endometrial abnormalities can also be detected, as well as a number of infectious processes, including yeast, herpes simplex virus, and trichomonas.

What next?

Make sure that you review results with your health care professional. Many times, this will mean a trip to the office to review the meaning of an abnormal Pap smear and review recommendations for treatment.

Not all abnormal Pap smear test results require other tests and sometimes observation and closer surveillance will be recommended. The important thing is that you follow recommendations after having any type of abnormal Pap smear test result. In some instances, further investigation of the cervix with colposcopy will be recommended.

If the Pap test shows an ambiguous or minor abnormality, the healthcare provider may repeat the test to determine whether further follow-up is needed. Many times, cell changes in the cervix go away without treatment. In some cases, healthcare providers may prescribe estrogen cream for women who have ASC–US and are near or past menopause as these cell changes are often caused by low hormone levels. Applying an estrogen cream to the cervix for a few weeks can usually help to clarify the cause of the cell changes.

If the Pap test shows a finding of ASCUS, ASC–H, LGSIL, or HGSIL, the healthcare provider may perform a colpsocopy. A colposcope is a microscope that provides a closer view of the cervix. The colposcopic exam is similar to a regular pelvic exam and should only take a few minutes to perform. Anesthesia is not required.

Dilute acetic acid (vinegar solution) is placed in the vagina to help determine of there are any abnormal areas, they turn white and may be refereed to as aceto-white lesions. The colposcopy itself is painless, however if abnormal areas are seen, then very small (2-3mm) pieces of tissue may be removed in the form of a colposcopically directed biopsy. This may lead to a small about of pain, cramping and bleeding which usually rapidly resolves. This cervical tissue is then sent for laboratory evaluation. These biopsies cause no long-term damage to your cervix. Endocervical sampling may also be performed, which is a scraping from the inside of the cervix. This may also lead to cramping and spotting.

If the testing shows abnormal cells that have a high chance of becoming cancer, further treatment is needed. Treatment options include the following: LEEP (loop electrosurgical excision procedure) is surgery that uses an electrical current which is passed through a thin wire loop to act as a knife and is a larger cervical biopsy, CO2 laser which uses a narrow beam of intense light to destroy or remove abnormal cells, or conization which removes a cone-shaped piece of tissue using a knife, a laser, or the LEEP technique.

Summary:

Take a deep breath, the vast majority of abnormal Pap smears do not indicate the presence of cancer.

Follow your healthcare providers recommendations for treatment and follow-up.

Treatment of abnormal Pap smear test results depend on the type of cervical changes seen, the age of the women, and other individual circumstances.

With appropriate treatment, cervical cancer can be prevented in the vast majority of the time.

Resources:

http://www.cancer.gov/cancertopics/factsheet/Detection/Pap-tes

http://www.cancer.gov/cancertopics/factsheet/Risk/HPV

http://www.cancer.gov/cancertopics/understandingcervicalchanges

Posted: June 19th, 2010 | Author: | Filed under: cancer diagnosis & treatment, cancer prevention, general health, gynecology | Tags: , , , | 3 Comments »


North American Menopause Society Releases New Position Statement on Hormone Therapy in Postmenopausal Women

The use of estrogen in the treatment of women has radically changed over the past fifteen years. Fifteen years ago virtually all women were encouraged to take estrogen soon after menopause in order to prevent cardiac disease. At this point in time we knew that there may be an elevated risk to develop breast cancer with estrogen therapy, but we counseled our patients that estrogen helped to prevent the leading killer of women, cardiac disease. Then in 2002, the Women’s Health Initiative (WHI) Study changed the landscape of hormone therapy for women.
This very large scale study determined that the risks of hormone therapy outweighed any perceived benefits, and women throughout the country were told to stop taking their estrogen. Unfortunately, this study was flawed from the beginning and did not yield results that were generally applicable to the recently menopausal woman who was considering hormone therapy to control symptoms of this life transition. We have now realized the problems with the WHI study and have swung back to a more reasonable, individualized approach to hormone therapy in women, and have also realized that estrogen therapy may indeed prevent cardiac disease when initiated soon after menopause. Our larger questions which now need to be addressed include the safety and efficacy profiles of various preparations. While prolonged estrogen and progestin use may increase a woman’s risk to develop breast cancer or thromboembolic disease (problems from blood clots) the benefits for some women may outweigh this risk.
The North American Menopause Society (NAMS) has released today an updated position statement on the use of estrogen and progestogen in postmenopausal women. NAMS is a non-profit organization which has previously released position statements from advisory panels consisting of clinicians and researchers who are experts in the field of women’s health. This is an updated version from their 2008 release. Their goal is to clarify the risk benefit ratio of hormone therapy with estrogen and progestin in the treatment of menopause symptoms and disease prevention. They have concluded that the use of hormone therapy should be consistent with treatment goals, benefits and risk for the individual woman. They note that the benefit and risk ratio will change for each woman with her age and her menopausal symptoms as she ages.

The below summarizes and highlights their recent position statement.

Benefits of the use of hormone therapy include:

Relief of vasomotor symptoms (hot flashes and night sweats)Treatment of vaginal atrophy (dryness).

Improvement of sexual function through relief of dryness and increase sexual satisfaction due to increased blood flow and sensation in the genital tissues.

Improvement in urge incontinence (a form of urinary incontinence).

Decreased risk of recurrent urinary tract infections.

Prevention of osteoporosis.

Early initiation of hormone replacement therapy does not increase cardiac disease and may reduce cardiac disease.

May lead to improved mood (data is mixed).

Risks:

Elevated risk of uterine cancer when estrogen is used without a progestin (five times elevated risk after three years of estrogen alone use).

Breast cancer is elevated in women treated with combined estrogen and progestin therapy after 3-5 years of use; however women treated with estrogen alone having a lower risk of developing breast cancer but may increase after 10-15 years of use.

May increase dementia when hormone therapy is initiated in older women (over 65 years).

There is currently no data to determine if one type of estrogen or progestin has a better safety profile, however there are likely to be differences of different regimens Transdermal estrogens (patches and gels or mists) do not increase triglycerides, lead to no change in C reactive protein and have little effect on blood pressure. They may also be associated with a lower incidence of deep venous thrombosis.

Usage recommendations:

A progestin is generally not recommended to be used in conjunction with ultra low dose vaginal and transdermal estrogens; however the addition of progestins may improve vasomotor symptoms.

The lowest effective dose of estrogen consistent with treatment goals, benefits and risks for the individual woman should be the therapeutic goal, with the addition of a progestin added if the woman has her uterus in place.

There is emerging data that the timing of initiation of hormone therapy is important, and that early initiation of therapy may reduce total mortality and heart disease risk. Therapy should not be initiated in women over the age of 60 years without a compelling indication.

The length of use is not well established and extending the use of hormone therapy for an extended period of time if the symptom benefit outweighs the risk and for the woman who is on estrogen replacement therapy for her bones when other treatments are not appropriate.

Bioidentical hormone therapy:

The term “bioidentical hormone therapy” generally refers to estrogens and progestin naturally produced in women. However the term is many times used to describe custom made preparations that are compounded for an individual according to a healthcare provider’s prescription. These are generally made in compounding pharmacies. These compounds have not been tested for safety or efficacy by the FDA and they are not FDA approved. NAMS recommends that filled prescriptions for bioidentical hormone therapy should include a package insert identical to those that have regulatory approval. The FDA has stated that there is no scientific basis for using saliva testing to adjust hormone levels.

Summary:

Therapy should be individualized.

There is a growing body of evidence that each type of estrogen and progestin, route of administration, and timing of therapy has distinct beneficial and adverse effects.
Further research remains essential.

Posted: February 16th, 2010 | Author: | Filed under: estrogen, gynecology, menopause, science | Tags: , , , , | 1 Comment »