November 17, 2008

Nov ’08 Research: Treatments, Causes, Risks

Posted in RESEARCH tagged , , , , , , , , , , , at 12:41 am by PCOSLady

New Studies Examine Treatments, Causes and Risks for
Women with PCOS

Toronto, Canada, June 21, 2000 – New research presented today on treatments, causes and risks
associated with Polycystic Ovary Syndrome(PCOS)
, a disease that effects between five and 10 percent of reproductive aged women, offers a glimmer of hope to the millions of women who suffer from the disease. The research was presented today in a panel at ENDO 2000, The Endocrine Society’s 82nd Annual Meeting, which is taking place in Toronto from June 21-24. The new studies examine several areas of PCOS, including a possible gene that triggers PCOS, new treatments for the disease, the relationship between diet and PCOS and the risk of heart disease in women with PCOS….
Two of the studies that were presented examined new treatments for women with PCOS. One study found that women with PCOS who reduced their dietary fat might improve some of their reproductive parameters. Another study of adolescent girls with PCOS found that treatment with metformin, a medicine that decreases the body’s requirement for insulin, improves irregular or absent periods, a symptom of PCOS in young girls; lessens body hair and acne; and promotes weight loss…. “We have shown that metformin, which is typically a diabetes treatment, is effective in treating young women with PCOS,” said Dr. Ken Lee Jones, an endocrinologist at the University of California, San Diego who presented the research on metformin. “The new information that is presented today will help improve the quality of life for the women throughout the world who suffer from this disease.” … Dr. Walter Futterweit and Dr. Yaron Tomer,
endocrinologists at Mount Sinai Medical Center in New York, presented a study that found an association between a marker near the insulin receptor gene and PCOS. Previous research has found that PCOS is hereditary. The new research discovered evidence that the insulin receptor gene, or a nearby gene, may cause the tendency for women to inherit PCOS…. “This type of research will ultimately lead to better diagnosis and treatment for women with PCOS,” said Dr. Tomer….
Additionally, the research suggests that the inheritance of PCOS is caused by subtle changes in the insulin receptor gene, which may alter its function in the ovaries…. “We hope that these findings will enable us to better understand the mechanisms leading to PCOS,” said Dr. Futterweit…. Two of the other studies examined risk factors for women with PCOS, including insulin resistance and heart disease. One
study, which was presented by Dr. David Ehrmann, an endocrinologist at the University of Chicago, found that women with PCOS function near their maximum ability to secrete insulin in response to glucose. According to this new research, any further reductions in insulin sensitivity would be met with inadequate compensation in insulin secretion…. Dr. Rose Christian, a clinical research fellow
at the Mayo Clinic, reported on additional research that points to an increased risk of coronary heart disease for women with PCOS. Researchers found that coronary artery calcium, a marker for atherosclerosis, is more common and extensive in women with PCOS than in ovulatory women of similar age,
weight and risk factors…. “Our research showed that women with PCOS are as likely to develop coronary calcium as men of the same age,” said Dr. Christian. “Normally, coronary calcium and heart disease are three to four times more common in young men than in women of the same age.” … “PCOS is a common yet, silent disease that affects thousands of women,” said Dr. Lisa Fish, an endocrinologist at Park
Nicollett Medical Center in Minneapolis, Minnesota. “These studies provide new options to women with PCOS in treating their illness and also offer new information on risks that are associated with the it, such as heart disease. In addition, this research looks into the genes that may cause PCOS and its relationship to diabetes.” … Based in Bethesda, Maryland, The Endocrine Society consists of over 9,000 scientists and physicians in more than 80 countries. Founded in 1916, The Endocrine Society is the world’s oldest, largest, and most active organization devoted to research on hormones, and the clinical practice of endocrinology. Together, these physicians, scientists, educators, nurses, and students who
make up the organization’s membership, represent all basic, applied, and clinical interests in endocrinology. To learn more about The Endocrine Society, and thefield of endocrinology, visit our web site at…. New Directions in the Treatment of Polycystic Ovarian Syndrome by Ellen
Friedman Bender … Polycystic Ovarian Syndrome (PCOS) is a hormonal disorder affecting between 5 percent and 10 percent of women of reproductive age. Although many people correctly associate PCOS with impaired fertility
– chronic anovulation and hyperandrogenism (elevated male hormones) are two of its cardinal symptoms, it is more than an infertility disorder. Increasingly, PCOS is being recognized as a major women’s health problem because of the havoc it wreaks on the endocrine system. Many women with PCOS suffer from endocrine abnormalities including insulin resistance which affects the bodies ability to metabolize
sugar and fat….Significantly, according to a research study, premenopausal women who have the disorder are seven times more likely to suffer from adult onset diabetes than women without PCOS. In addition, over time, many women with PCOS develop elevated levels of cholesterol and triglycerides so that here is a greater risk of heart attack and stroke for women in their forties and fifties. Moreover, because of their irregular menstrual cycles, women with PCOS are at greater risk for endometrial cancer. Women with PCOS also frequently encounter self- esteem and body-image issues arising from other frequent symptoms of the disorder including hirsutism (excess facial and body hair),obesity, acne and male-pattern baldness… Traditionally, treatment for PCOS has focused on individual symptoms instead of the syndrome as a whole. Thus, a woman with PCOS who was trying to get pregnant might be given fertility drugs such as clomid
or pergonal. A woman in her twenties might be given oral contraceptives to regulate her menstrual cycle or provera to periodically shed the lining of her uterus. Another woman might be given spironolactone to inhibit hair growth. But recent research suggests that there may be lifestyle changes and medications that by attacking the insulin resistance, actually treat the syndrome as a whole…. At the very least,
some doctors recommend that their PCOS patients follow a carbohydrate-restricted diet and increase their exercise level. But the cutting edge research in PCOS is in the area of insulin sensitizing drugs. Recent studies have found that insulin sensitizing drugs given to type 2 diabetics, such as metformin, may also benefit women with PCOS. In one study, recently reported in the New England Journal of Medicine, an insulin sensitizing drug called INS-1 not only induced ovulation in 86% of the PCOS patients in the study,
it also reduced their triglyceride and blood pressure levels, lowering their risk for cardiovascular disease. At the moment, however, none of these insulin sensitizing agents are FDA approved for the treatment of PCOS and some of them have unpleasant side effects…. Ellen Friedman Bender co-chaired
the American Infertility Association’s recent conference on PCOS, “Understanding Polycystic Ovarian Syndrome: A Reproductive and Metabolic Disorder.” A version of this article appeared in the November 1999 issue of the Women’s O.W.N. of NYU Medical Center newsletter….
Treatment Options For PCOS
This information is provided for informational purposes only and is in no way meant to replace advice from a qualified medical professional…. Until recently, only the symptoms of PCOS – hirsutism, acne, infertility – could be treated. In the past few years, however, there has been a great deal of research pointing to excess production of insulin and resulting insulin resistance as the root of the problem….
Treatment With Insulin-Sensitizing Medications – The Newest Option A number of recent studies have shown
that treating women with PCOS with insulin-lowering medications such as metformin (also known as
Glucophage), Avandia (rosiglitazone) and Actos (pioglitazone), used to treat adult-onset diabetes,
can not only reduce the risks of heart disease and diabetes in women with PCOS by treating the underlying
problems with insulin production and usage, but also relieve many of the bothersome symptoms and even
make weight loss possible.1, 2
(Please note that these are not weight-loss drugs; women whose weight problems stemmed from insulin resistance may lose weight when the problem is corrected.)
These drugs do not lower blood sugar and so are generally safe even for those with hypoglycemia3, but there may be side effects. Metformin often causes diarrhea and/or nausea, especially for the first few weeks and when the dosage is increased. This is most problematic if it’s taken without food; these problems may be minimized by taking it halfway through a meal. A rare side effect is lactic acidosis, which may be fatal if not detected. Rezulin (troglitazone) was also used for this purpose until recently, but has been taken off the market after reports of liver abnormalities and even a handful of
deaths in some people who were taking it. Avandia and Actos are chemically related to Rezulin, but the effective dosages are far lower (4-8 mg/day of Avandia or 45 mg/day of Actos vs. 200-400 mg/day of Rezulin), making liver complications less likely. In clinical trials involving over 4500 patients, there have been no reports of Avandia-related liver toxicity or related problems4, 5; there have also been no reports of such complications from Actos4, 6 Even so, the FDA has recommended that patients who already have elevated liver enzyme levels be monitored regularly. Some people who take Avandia or Actos experience
a slight weight gain. (This hasn’t been my experience, though – I’ve actually lost several pounds in the last few months.) It is important to be aware that all of these medications are currently only approved by the FDA (in the US – I’m not entirely sure of their approval status in other countries) for the treatment of diabetes. There is a lot of convincing research showing that most if not all cases of PCOS can be improved by treating insulin resistance, and these drugs treat diabetes by treating insulin resistance. So, they’re likely to be helpful to many women with PCOS, and doctors are allowed to prescribe an approved drug for any purpose they wish, but some (especially those who aren’t up to date on the new research) may not be willing to do this. I’m working on writing up some information about d-chiro-inositol, the first medication being studied specifically to treat PCOS-related insulin resistance, but I want to do more research before I post anything here. In the meantime, check out Ovulatory and Metabolic Effects of d-Chiro-Inositol in the Polycystic Ovary Syndrome. This is an abstract of an article that appeared last year in the New England Journal of Medicine summarizing the findings of a study of this drug in women with PCOS….
Birth Control Pills
Birth control pills treat a few of the symptoms of PCOS. They usually bring on a period each month (though some women with PCOS do not have regular periods even while taking birth control pills) which is important for women who do not have regular cycles because lack of menstruation puts a woman at higher risk for endometrial cancer. Some women find that hair problems either lessen or stop getting worse while on the pill, particularly with Diane-35 or Dianette (which contains cyproterone acetate, an anti-androgen), which is available in some countries in Europe and also in Ausralia and New Zealand but has not been approved in the United States. Acne may improve as well. Weight gain is highly variable –
for some women weight gain may stabilize while on the pill; for others it may get worse. Changing brands may help if you find yourself gaining weight or having other unpleasant side effects. The triphasic birth control pills, such as Ortho Tri-Cyclen, may be problematic in that the estrogen dose they provide in the early part of the cycle may be too low to prevent women with PCOS from developing follicles, possibly resulting in a greater number of cysts on the ovaries.1 …
Treating Hirsutism
Hirsutism can an extremely difficult and emotional issue in a society where women are expected to be smooth and hairless. Shaving, plucking, waxing, electrolysis and laser hair removal treatments may work in many cases but can be, depending on the method, time-consuming, messy, painful and/or very
expensive. Spironolactone (brand name Aldactone), if taken over a period of time, will stop new hair growth in many women with hirsutism and may possibly decrease existing growth for some. In countries where Diane-35 has been approved, it may be prescribed help with hair problems….
Provera or other forms of synthetic progesterone are often prescribed to women experiencing amenhorrea
(lack of periods). It’s common for a Provera-induced period to be more heavy or painful than usual, but it’s important that something be done to cause regular menstruation because prolonged amenhorrea may
increase a woman’s risk for endometrial cancer. This doesn’t mean that if you haven’t had a period
for a very long time that you are destined to get cancer, but it does introduce a higher than usual risk. Some women have had success using progesterone cream as an alternative to Provera….
1. Kidson, Warren. Polycystic ovary syndrome: a new direction in treatment. MJA 1998; 169: 537-540.
2. Hopkinson, Zoe E. C. et al. Polycystic ovarian syndrome: the metabolic syndrome comes to gynaecology, BMJ 1998;317:329-332
3. Perloe, Mark. Polycystic Ovarian Syndrome: Treatment With Insulin-Lowering Medications.
4. Fonseca, Vivian A. Overcoming Insulin Resistance and Preventing Cardiovascular Disease in Diabetes: The Contributions of the Thiazolidinediones.
5. Avandia Shows Promising Results in Combination Therapy
6. Actos Approved By FDA For Type II Diabetes
April 28, 1999
New Drug May Help Women With Infertility Syndrome An investigational drug that helps insulin to function more efficiently appears to combat infertility in women with polycystic ovary syndrome (PCOS), the most common cause of female infertility, according to a research team funded in part by the National Institute
of Child Health and Human Development (NICHD). The drug, D-chiro- inositol, occurs naturally in fruits and vegetables and appears to have no side effects in the comparatively small number of PCOS
patients who took part in this preliminary trial….
The study, conducted by researchers at Virginia Commonwealth University (VCU) in Richmond, appears in the April 29 issue of The New England Journal of Medicine….
“These early results show a lot of promise,” said Dr. Donna Vogel, Associate Chief for Clinical Research in NICHD’s Reproductive Sciences Branch and NICHD program officer for the study. “Dr. Nestler and his
colleagues have shown that a substance naturally produced by the body to assist in insulin action promotes ovulation in the majority of PCOS patients who take it.” …
PCOS affects from 5 to 10 percent of American women of reproductive age (as many as 5 million in all), explained the study’s principal investigator, John E. Nestler, M.D., chairman of endocrinology at
VCU’s Medical College of Virginia. The ovaries of women with PCOS appear to be filled with numerous small cysts. The cyst-like appearance results from an accumulation of immature ovarian follicles, the bubble-like structures which, upon maturation, rupture and give rise to the egg cell….
The features of PCOS may include failure to ovulate or menstruate, abnormally high levels of insulin, obesity, high blood pressure, hardening of the arteries, and high triglyceride levels. (Triglycerides are fatty substances used for energy storage, and high triglyceride levels may increase the risk for coronary artery disease.) PCOS patients also have high levels of the male hormone testosterone, which may cause them to grow excess facial or body hair….
* “PCOS is not just a reproductive disorder; it’s a major health concern for women who are affected,” Dr. Nestler said. “This is a promising new drug because not only does it dramatically improve ovulation, it improves a woman’s overall health.” …
Dr. Nestler added that, traditionally, physicians have been able to treat only the symptoms of PCOS, and not eliminate its cause. For example, antiandrogens were prescribed to block the action of testosterone and reduce excessive hair growth. Birth control pills were used to regulate the menstrual cycle, and when the women sought to have children, they were treated with fertility drugs–either alone or in combination with in vitro fertililzation….
Roughly two years ago, however, Dr. Nestler and his colleagues were successful in reducing the PCOS symptoms of a group patients by treating them with the drug metformin, used to treat insulin resistance in patients with adult onset (type II) diabetes. (Insulin resistance is the failure of cells to respond to insulin properly). Metformin increases the body’s sensitivity to insulin and allows the body to use insulin more efficiently. Troglitazone, another insulin- sensitizing agent, has similar effects in PCOS patients. * …
Although both drugs do restore ovulation, both have a number of side effects. Metformin, for example, may cause diarrhea, nausea, and loss of appetite, and Troglitazone may be toxic to the liver….
The current findings strongly suggest that PCOS results from a failure to use insulin properly. Presumably, Dr. Nestler said, this failure causes insulin levels to rise. The high insulin levels, in turn, cause a variety of other effects, such as high blood pressure, hardening of the arteries, and high triglyceride levels. Insulin also appears to have an effect on the ovaries, causing them to produce high levels of testosterone and similar compounds, which halt egg maturation and interfere with the menstrual cycle….
In the current study, the researchers followed 44 obese women with PCOS; half received D-chiro-inositol, and half received a placebo. Of the 22 women who received the study drug, 86 percent ovulated, compared with only 27 percent of the women in the placebo group. Women who received D-chiro-inositol also saw improvements in insulin, blood sugar, blood pressure, testosterone and triglyceride levels. No side
effects were reported….
Dr. Nestler explained that the body uses D-chiro-inositol to manufacture the D-chiro-inositol mediator, which allows the cell toprocess glucose after insulin binds to the cell’s surface. According
to Dr. Nestler, the research offers insight into the possible cause of insulin resistance in women with PCOS, which previously had been unknown. A PCOS patient’s insulin resistance could be due, in part, to
a D-chiro-inositol deficiency….
NICHD is currently funding a trial of D-chiro-inositol in a large number of patients to further ascertain its safety and effectiveness. The drug is also being tested in patients with type II diabetes.
The study drug is manufactured by INSMED Pharmaceuticals, Inc., which develops products to detect and treat insulin resistance. The research is funded by an NIH Small Business Innovation Research Grant. These
grants are given to independently owned and operated U.S. companies that have fewer than 500 employees….
Polycystic Ovarian Syndrome
New Thought on an Old Disease
Polycystic Ovarian Syndrome (PCOS) has been a subject of intense interest and research since it’s initial description by Drs. Stein and Levinthal in the 1930′s. However, it was not until the 1980′s that an
association between this syndrome and insulin resistance was discovered, and only in the last several years that the benefit of insulin sensitize therapy in treating this condition has become known. Hence, the recent flurry of articles appearing not only in scientific journals but also in the lay press….
Why all the fuss? Probably because virtually everyone has a friend, relative or acquaintance who is affected with this disease. It is seen in 5-9% of reproductive age women, making it arguably the most common endocrine abnormality in this age group….
In spite of decades of research and volumes of material written on PCOS, there is not a universally agreed upon definition. The reasons for this is that the condition is a syndrome rather than a single
specific disease intensity. In other words, there are many discreet abnormalities, which may cause women to develop this syndrome, and each has certain unique features. However, although most of the “classic” signs or symptoms of PCOS are present in little more than half of women with this disease, irregular cycles with absent of infrequent ovulation is a prerequisite for labeling a patient with this diagnosis. Hair growth, acne, obesity, and the various hormonal and biochemical abnormalities associated with this condition are usually absent in at least a third of patients diagnosed with this condition….
Traditional therapies for Polycystic Ovarian Syndrome include bilateral ovarian wedge resection (now largely replaced by medical therapy or laparoscopic ovarian diathermy) contraception if patient does not wish to conceive, and clomiphene citrate if the patient is desirous of conception….
For patients who desire cycle control or relief from acne or hirsutism, oral contraceptives are the first line of management. Clomiphene citrate, which is an antiestrogen, can induce ovulation in PCOS patients by altering the natural secretion of ovulation enhancing hormones. However, only 60-80% of women with Polycystic Ovarian Syndrome will achieve regular spontaneous ovulation with this drug, and only about half of that number will ultimately conceive. The reason for this discrepancy between ovulation and pregnancy rates is not fully understood….
More recently, the role of insulin resistance in this condition has become better understood. In some individuals, insulin resistance is probably responsible for the development of PCOS. In others, it is
merely an association, linked either to obesity or genetic factors. There is a tremendous amount of research presently being conducted in this arena….
Of most significance to our patients with this condition, the role of insulin sensitizer therapy has become well known. There are three such medicines in used today, the common names of which are Actos, Avandia, and Glucophage. These medications allow the cells to respond more normally to the body’s insulin secretion which leads to a decrease in insulin production by the pancreas. The resulting decline in insulin levels affect a number of other pathways, ultimately improving a woman’s overall hormone balance and helping her to achieve ovulation more readily. In some women, insulin sensitizer therapy alone will
allow women with PCOS to ovulate and conceive. In others, medicines such as clomiphene citrate are still necessary. However, we now can help such women to ovulate with lower doses of clomiphene, and some
women who could not previously ovulate even with high and prolonged doses of Clomiphene can now conceive without having to resort to expensive injectable medications. Therefore, the extreme usefulness of
these medications in the treatment of this condition have become recognized as the first major medical advance in many years….
Not all women with PCOS have insulin resistance, and many who do have only a mild problem, which would probably not benefit from use of insulin sensitizer therapy. Often, these women may achieve similar or
better results using other methods such as weight loss and exercise. Adjunctive medications such as Tamoxifen or Decadron, or injectable menotropins may also be used with excellent results. Finally, ovarian
diathermy, in which the ovaries are treated with electrical energy during an outpatient laparoscopic procedure, produces excellent ovulation and pregnancy rates. It is beyond the scope of this article
to delineate the situations which would favor one treatment modality over another….
We have also become increasingly aware that there are sufficient long-term complications of insulin resistance and polycystic ovarian syndrome. During pregnancy, these patients display a higher incidence
of gestational diabetes, a potentially serious condition for the mother and fetus. Further on down the road it appears that women with PCOS are at significantly increased risk for hypertension, Type II
diabetes, and cardiovascular disease. There is currently much interest and research in this area, but as yet little information on how these potential complications are best avoided….
If you have or think you may have polycystic ovarian syndrome or insulin resistance, see your physician, or your infertility specialist for testing. Further details may be found on our web site, or through
national organizations such as Resolve or American Society for Reproductive Medicine…..
Future Research
The role of insulin sensitizers in the long-term treatment of PCOS is still relatively new and hotly debated. More research is being conducted to determine the safety and efficacy of these treatments

It has also been found that PCOS is highly genetic. By studying families where PCOS is seen in several women, studies will hopefully be able to identify the gene(s) contributing to this disease. Dr.
Andrea Dunaif, Chief of the Division of Endocrinology, Metabolism, and Molecular Medicine at Northwestern University Medical School and a member of the Advisory Board for the Polycystic Ovary Syndrome Association, is the Principal Investigator of an ongoing National Institutes of Health-funded study examining the genetics of PCOS. She is recruiting women with PCOS (diagnosed or undiagnosed) and their
family members to study the genetics of this syndrome….


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