Diagnosis of polycystic ovary syndrome (PCOS) is challenging, and there should be no rush to label an adolescent as having the condition before a thorough evaluation of symptoms, according to a leading endocrinologist who was speaking at the RCOG World Congress 2018 in Singapore.
“Common features of PCOS such as hirsutism, acne, and obesity are often present in otherwise ‘normal’ adolescents,” said Dr Veronique Celine Viardot-Foucault from the KK Women’s and Children’s Hospital, Singapore, adding that these features may not necessarily be indicative of PCOS.
Appropriate diagnosis of PCOS in adolescents should involve careful evaluation of symptoms such as menstrual irregularities, hyperandrogenism, and polycystic ovarian morphology, she said. Menstrual irregularities—including secondary amenorrhoea and oligomenorrhoea in girls beyond 2 years after menarche, or primary amenorrhoea in those who have completed puberty—may be indicative of androgen excess. [Horm Res Paediatr 2017;88:371-395]
As symptom such as acne is common in adolescence and usually transient, it may not be indicative of hyperandrogenism, said Viardot-Foucault. Also, isolated cases of acne and/or alopecia should not be considered as diagnostic criteria for PCOS in adolescence, but moderate or severe inflammatory acne that is unresponsive to topical therapy may require investigation of androgen excess. [Horm Res Paediatr 2017;88:371-395]
Another feature commonly seen with PCOS is hirsutism, which can be evaluated using the modified Ferriman–Gallwey (FG) scoring system. “However, the FG scoring system is not applicable to younger, perimenarchal patients [younger than 15 years old],” she advised, pointing out that biochemical evidence of hyperandrogenism is preferred in this group.
As there is no clear cut-off of testosterone levels for adolescents, biochemical hyperandrogenism should be defined based on the methodology used, informed Viardot-Foucault. “Ideally, to establish the existence of androgen excess, assaying for free testosterone levels is the gold standard as it is more sensitive than measuring the total testosterone levels,” she said. “But a downside of this is that it requires equilibrium dialysis techniques which are costly and not widely available.”
However, most commercial laboratories use direct analogue radio-immunoassay, which is notoriously inaccurate for measuring free testosterone, cautioned Viardot-Foucault. “If uncertain regarding the quality of the free testosterone assay, it is preferable to rely on calculated free testosterone, which has a good concordance and correlation with free testosterone levels measured by equilibrium dialysis methods,” she suggested. [J Clin Endocrinol Metab 1999;84:3666-3672]
Also, the value of measuring other androgens besides free testosterone in patients with PCOS is relatively low, although increased levels of dehydroepiandrosterone sulphate (DHEAS) have been observed in 30–35 percent of PCOS patients. [Ann N Y Acad Sci 2006;1092:130-137]
“Transabdominal pelvic ultrasound has a lower diagnostic accuracy,” said Viardot-Foucault. “The presence of polycystic ovarian morphology [on ultrasound] in an adolescent who does not have hyperandrogenism or oligo-anovulation does not indicate a diagnosis of PCOS.”
When menstrual irregularities are concerned, the first-line treatment should be cyclical progestogens when contraception is not required and there are no signs of hyperandrogenism, according to Viardot-Foucault. If there is clinical hyperandrogenism or a need for contraception in those sexually active, third-generation oral contraceptives such as ethinyl estradiol 30 µg can be considered.
“There is room for local treatment of hirsutism such as laser [hair removal, but only for patients beyond] 16 years old and [who are] at least 2 years post-menarche,” she said. “If there are metabolic complications, [patients should be referred] to the endocrinologist.”
Two treatments and a placebo yield similar relief for postmenopausal vaginal discomfort
A clinical trial comparing two common treatments for postmenopausal vaginal discomfort to placebo treatment found that both low-dose vaginal estrogen and a vaginal moisturizer produced symptom improvements similar to those associated with placebo after 12 weeks of treatment.
The authors note that better understanding of the causes of postmenopausal symptoms could lead to more effective treatment options for this bothersome problem.
“The fact that all three treatments—vaginal estradiol tablets, a vaginal moisturizer and the lubricating gel we used as a placebo—were able to reduce symptoms is great news for women, since it means that regular use of any of these treatments is likely to have benefit, whether the cost is $20 or $200,” said corresponding author Caroline Mitchell, HMS assistant professor of obstetrics, gynecology and reproductive biology at Massachusetts General Hospital.
“The significant impact of vaginal discomfort on the lives of women is reflected by how quickly we were able to enroll more than 300 participants in less than a year. Women are desperate for some kind of intervention for these symptoms,” Mitchell said.
The authors, from seven research centers across the country, note that symptoms such as vaginal dryness, itching and pain during sexual intercourse affect around half of postmenopausal women and can have negative quality-of-life effects similar to those of chronic conditions like arthritis or irritable bowel syndrome.
But more than half of affected women use no medical treatments. Available nonprescription products, such as vaginal lubricants and moisturizers, can be messy; and prescription hormonal treatments in the form of creams, vaginal tablets and oral pills can be expensive and may raise concerns about safety.
The current trial was designed to assess the effectiveness of the two most commonly recommended treatments—low-dose estrogen vaginal tablets and a nonhormonal vaginal moisturizer.
The study enrolled 302 women, most between the ages of 55 and 64, who reported moderate to severe symptoms of vaginal itching, dryness, irritation or pain with sexual activity.
Participants were randomly divided into three groups, one receiving a low-dose vaginal estrogen tablet and a placebo vaginal gel, one receiving a placebo vaginal tablet and a nonprescription vaginal moisturizer and one receiving both placebo tablets and placebo gel.
Participants were instructed to administer the vaginal tablet once a day for 2 weeks and then twice a week for the remaining 10 weeks of the study period. The moisturizing gels were to be applied every three days throughout the study period. Neither participants nor study staff knew to which group individual participants were assigned.
At the end of the study period all three groups had similar decreases in the severity of their most bothersome symptom. A similar proportion of women in each group had at least a 50 percent decrease in overall symptom severity.
Improvement in sexual function and overall treatment satisfaction were also similar across all three groups. There was a significantly higher positive response to the question, “Did you have a meaningful benefit from the treatment?” among those receiving the vaginal estrogen tablet than among those receiving placebos.
Mitchell notes that, while most studies of treatments for vaginal discomfort show a significant placebo effect, the size of the response to placebo treatments in this trial was surprising.
“It’s hard to say whether the properties of the placebo gel itself, which is an excellent lubricant, are responsible, but our results suggest that regular use of any one of these products may be helpful,” she said.
“During the 12 weeks of the trial, more than 90 percent of women used the medication regularly, but prior studies suggest that many women do not continue use of this type of treatment beyond six months. A remaining question is whether women find the benefits of the treatment worthwhile enough to continue regular use,” Mitchell said.
Co-author Susan Reed, of the University of Washington, added, “It was notable that the overwhelming majority of women in our study were bothered by pain with sexual activity and earnestly wanted to help find a treatment for the many women bothered by this problem. More couples are remaining sexually intimate despite aging, and better therapies for vaginal discomfort need to be developed.”
A high Menopause Rating Scale (MRS) score supports the decision to treat bothersome climacteric symptoms, researchers from Chile report.
“There was no previous study that objectively indicated the need for treatment of climacteric symptoms,” Dr. Juan Enrique Blumel of Universidad de Chile, in Santiago, told Reuters Health by email. “Our study indicates that a score of 14 or more on the MRS questionnaire marks the need for treatment.”
The MRS has been validated in several languages and is the most commonly used instrument for evaluating the severity of symptoms associated with menopause. A total score of 17 indicates “severe symptomatology,” but no cutoff score has been determined to be an objective indication of the need for treatment.
Dr. Blumel and colleagues used MRS data from 500 healthy women aged 40 to 59 years to establish a cutoff score that would allow better decisions regarding the need to start treatment of menopausal symptoms.
The percentage of women who felt they required treatment increased along with their MRS scores and reached 90% in those who considered at least one of their symptoms to be very severe, the researchers report in Maturitas, online February 15.
Symptoms most commonly deemed to require treatment when rated very severe included physical and mental exhaustion, muscle and joint discomfort, and bladder problems, whereas sexual problems, anxiety, and heart discomfort were least frequently considered to require treatment.
ROC curve analysis identified an MRS total score of 14 or more as the optimal cutoff score for defining the need for treatment. This cutoff had a sensitivity of 76.5% and a specificity of 83.6%; 97.1% of women who consider that they require treatment for at least one of their symptoms would be treated on the basis of this cutoff score.
“The presence of a single climacteric symptom with a very severe intensity is associated in almost all women with a score of 14 or more points in the MRS questionnaire, a score that indicates the need for treatment,” Dr. Blumel said.
“Physicians should ask women not only for the classic vasomotor symptoms, but also for the other symptoms that are included in the MRS scale,” he said. “Hot flushes are not the most frequent symptoms in climacteric women; we and other researchers have shown that musculoskeletal discomfort and fatigability are much more frequent and are rarely considered climacteric symptoms.”
Dr. Stephanie S. Faubion from Mayo Clinic’s Office of Women’s Health in Rochester, Minnesota, told Reuters Health by email, “Midlife women in the community have bothersome menopause-related symptoms that are not being addressed. It is also clear that women will say they need treatment when symptoms are severe if we ask them. Asking about these symptoms (hot flashes, night sweats, sleep and mood disturbances, sexual symptoms, vaginal dryness) should be routine for clinicians caring for midlife women.”
“These questions aren’t validated individually (only the total score), so if this is used, the total score should be used,” she said. “It’s interesting that the mood-related scores are more highly correlated with total MRS scores over 14. We have also noted that mood seems to be a strong driver of perceptions about menopause.”
Dr. Faubion added, “We do actually use the MRS in our clinical practice, though I’m in a tertiary care setting in a specialty menopause practice. I do find it useful, but women will tell you when they need treatment if you ask them, which was demonstrated clearly in this study. I don’t think the MRS will make or break decision making for the clinician who is in front of a patient. For research purposes, the MRS is useful for assessing bothersome (clinically meaningful as demonstrated in this study) menopause-related symptoms and for monitoring response to therapies.”
Plus, the lowdown on when it’s normal to miss a cycle.
You’d think that after getting your period month after month for a decade or two, you’d know it intimately well. And yet, there are still things about our own menstrual cycles that elude us. Part of the problem is that no one ever really talks about periods, which makes it harder to know what’s normal and what’s not. So we often cobble together information from our friends and some Google searches, but that can still leave some gaps in our knowledge about our own bodies.
Considering that, on average, women have about 450 periods in their lifetime, according to the Association of Reproductive Health Professionals, it’s worth getting to know your cycle and how it works. So we tapped top experts to address some common period myths and misconceptions.
Let’s clear up some confusion, shall we?
1. Figuring out the first day of your cycle isn’t as complicated as you might think.
For some reason, there’s a lot of confusion surrounding what exactly counts as the first day of a woman’s menstrual cycle. The good news: Pinpointing when your cycle officially starts is simple: “The first day of your cycle is the first day you start bleeding,” Leah Millheiser, M.D., clinical assistant professor of obstetrics and gynecology and director of the Female Sexual Medicine Program at Stanford University Medical Center, tells SELF. “That is cycle day one.” (This video shows your entire menstrual cycle in two minutes.)
2. Ovulation, on the other hand, is a bit trickier to nail down.
In general, women with regular cycles who are not on hormonal contraceptives (since you don’t ovulate while on most types of oral contraceptives) ovulate between day 10 and day 14 of their cycle. As we’ve already established, day one is the first day that you bleed, so you can do the easy math from there.
That said, “women are not machines, so it can vary,” Fahimeh Sasan, D.O., an assistant professor of obstetrics, gynecology, and reproductive science at Icahn School of Medicine at Mount Sinai, tells SELF. “You may not ovulate exactly on the 10th day every single month. That’s why when women are trying to conceive we don’t tell them to only have sex on days 10 through 14. Instead, have sex three to four times per week [around the ovulation period] because sometimes it can vary.”
3. Your cycle doesn’t have to be exactly 28 days long.
That’s the number that’s often touted as “normal” because a 28-day cycle is the average—meaning, 28 days from the first day of your period to the first day of your next period. But there’s actually a range when it comes to what’s considered a normal, healthy menstrual cycle: anywhere from 21 days to 35 days in adults (and 21 to 45 days in teens), per the U.S. Department of Health and Human Services. So anything that falls within that span is A-OK.
Also, most periods last three to five days, notes Millheiser, but as little as two days and up to seven days is also considered normal. If your periods are consistently longer than seven days, though, you should get checked out by a gynecologist. Longer bleeding days can be a sign of fibroids, uterine polyps, or adenomyosis, which is when endometrial tissue grows into the muscular wall of the uterus and can cause painful, heavy periods, according to the Mayo Clinic. “That’s certainly something we want to treat,” says Sasan.
4. And even if your cycle is 28 days, it may not always stay that way.
Yes, it can be a little disconcerting if your period tends to show up like clockwork and then there’s a slight delay, but your cycle isn’t set in stone. “Everyone assumes that if their period is exactly 28 days for the last 10 years and now it’s every 30 days that something is wrong,” says Millheiser. But you’re probably fine: “Period cycles fluctuate, depending on the environment, diet, stressors, and hormonal changes,” she explains.
5. It’s not unusual to skip a month once in a while—but get it checked out anyway.
Although pregnancy is the most likely reason why a period is MIA if you’re sexually active, high levels of stress—such as a big breakup, getting laid off, or moving—can also suppress reproductive hormones, causing secondary amenorrhea. In fact, a 2014 study of more than 370 couples that was published in the journal Human Reproduction found that psychological stress makes it harder to get pregnant.
In addition, low body weight, because of major weight loss, anorexia, or exercising rigorously (think: marathon running), can affect the hypothalamus, which helps regulate a woman’s menstrual cycle, leading to skipped periods, notes Millheiser.
While one missed period followed by your cycle going back on track is nothing to worry about, if you’re missing more than one period in a row, see your doctor. (The exception: If you’re adjusting your contraception to purposefully miss your period—more on that below.) missed periods signal that there’s likely a health issue at play, such as polycystic ovarian syndrome (PCOS), which is a hormonal imbalance—namely, high levels of androgens, a male hormone—that causes irregular cycles, such as only getting your period three or four times a year, or no periods at all. PCOS affects one in 10 women of childbearing age, according to the U.S. Department of Health and Human Services. Here’s some information on how to know if you have PCOS, endometriosis, or both that may be helpful.
If you’re over 40 and you’re skipping two to three periods in a row followed by a heavy period (thanks to a uterine lining that’s been building up for months)—especially if that’s joined by mood swings, night sweats or hot flashes—you’re experiencing the telltale signs of perimenopause, notes Millheiser.
But don’t panic thinking you’re going into full-blown menopause right away. “Perimenopause can go on for one to five years—you’re not going to go into menopause tomorrow,” Millheiser notes. “Menopause is one full year without a period.”
6. Once and for all, it’s usually perfectly safe to use the Pill to skip your period.
And more young women are doing just that. A 2013 study published in the journal Conception found that many college-age women are choosing to skip their periods by taking the hormonal pills in the pack back-to-back (and skipping the sugar pills) or using other hormonal contraceptives like the vaginal ring continuously. Of the more than 1,300 women in the study using combined hormonal contraception currently or recently, about 17 percent deviated from package instructions to alter their scheduled periods. Half of these women said they delayed or skipped their period for convenience’s sake.
“Is it safe for you to not have your period [by choice]? Absolutely,” says Millheiser. “The progesterone in your birth control pills is keeping the uterine lining thin. Often women will choose to have their periods two to three times per year.” If you have a health condition that affects your reproductive system, such as PCOS or endometriosis, check with your ob/gyn before you decide to skip periods.
Keep in mind that if you do continuous birth control pills, except some breakthrough bleeding eventually. The spotting is caused by hormonal fluctuations that cause some of the uterine lining to slough off, notes Millheiser.
7. And yes, you can get pregnant while on your period.
One of the most persistent period myths is that it’s impossible to get pregnant while you’re menstruating. It’s not common, but getting pregnant while on your period can definitely happen. Sperm can last in the cervical mucous and uterus for up to five days. If a woman has a short menstrual cycle, such as 24 days, and has unprotected sex on the last day of her period and ovulates three days later, it’s possible for the egg and sperm to meet, resulting in a pregnancy. The chances are slim, notes Millheiser, but is a possibility. This is especially true if a woman’s cycle is short and her period lasts six or seven days. Adds Sasan: “It’s very unlikely for a woman who is actively menstruating to get pregnant. However, with every rule there’s an exception, and women should not use their period as a form of contraception.”
Another risk is thinking you’re on your period while you’re actually ovulating. Here’s why: In some cases, when a woman is spotting during her cycle, that can be mistaken for a period when it can actually be a sign of ovulation. “It’s very common for a woman to spot during ovulation,” notes Millheiser. “One day—typically mid-cycle—a woman might notice a couple of drops of light red or dark brown spotting, not usually bleeding. It’s just hormonal changes during ovulation—it causes this little shedding. It’s nothing concerning. In fact, for women trying to get pregnant, it’s a really good sign that you can get pregnant now.” So some women might mistake the spotting for their actual period and, thinking they can’t get pregnant during their period, have unprotected sex when they’re actually at their most fertile. The misconception can lead to a pregnancy outcome.
8. Painful cramping isn’t something you have to put up with.
When you’re having your period, hormones called prostaglandins cause the uterus to contract to help shed the uterine lining. As almost anyone with a period knows, those contractions can be uncomfortable and even downright painful. Over-the-counter pain relievers, as well as birth control pills, can help. “For some women, being on birth control pills can help make periods less painful,” says Sasan, because birth control pills reduce the amount of prostaglandins produced by the body. “Even in someone who is not using it for contraception purposes, we often prescribe it since it can be used specially for dysmenorrhea, which is painful periods.”
If your periods are predictable and your doctor gives you the green light, Sasan recommends taking an anti-inflammatory prophylactically the day before you expect your period. That way, the medication is already in your system. “Unless there are contraindications, start taking Advil or Motrin the day before every six hours,” she says. “Most people report painful periods for the first day or two, so continue to take the medication every six hours or for however many painful days you typically experience.” Sasan recommends Advil and Motrin since they’re anti-inflammatory and suggests taking the meds with food so they don’t upset your stomach.
But if your periods are very painful and nothing seems to help (or they weren’t painful and now are), don’t dismiss it, says Sasan. “No one should put up with pain,” she says. “If you’re in pain, you should definitely talk to your doctor and have a thorough exam.” In some cases, painful periods can be a sign of a cyst, fibroids, or endometriosis that should be evaluated and treated by a doctor.
There are three sources of variability in fertility – genetics, the family environment and the individual environment.
Genetic profiling could help determine whether an embryo created through in-vitro fertilisation (IVF) is likely to successfully transfer to the womb, increasing the success rate of the procedure.
It’s part of a field of work looking at the role of genetics in fertility.
‘Understanding why some people do not have children, and developing treatments for them is extremely important,’ said Joris Vermeesch, professor of molecular cytogenetics and genome research at KU Leuven in Belgium. ‘People sometimes spend years of their life trying to get pregnant, and it doesn’t work.’
Despite advances in IVF, its success for each cycle – counted via the so-called baby take-home rate – is only 30%. But a project called SARM, led by Prof. Vermeesch, aimed to improve that figure by looking at ways to identify which embryos were unlikely to survive in the womb.
Already, in 2009, scientists at KU Leuven had discovered that most early IVF embryos were unstable — at high risk of having the wrong number of chromosomes or loss or gain of chromosomal fragments. This made them much less likely to develop properly, leading to failed embryo transfers — and frustration for prospective parents.
Prof. Vermeesch led that initial research. As part of SARM he and his team wanted to find a better a way to detect those imbalances, a method they could apply in IVF to boost its chances of success.
Experiments in human fertility are constrained by ethical boundaries. The scientists worked with cow embryos because bovine reproductive systems mirror those of humans at this stage of embryonic development.
Using a technique called haplotyping, which determines which gene sets come from which parents, the researchers succeeded in analysing the genetic make-up of an embryo’s cells. This new technique allowed them to determine which embryos are chromosomally unstable and which are more likely to thrive.
The same technology can identify whether an embryo is affected by genetic disease. To reduce the risk of transmission, clinics can simply decide not to transfer those embryos.
‘If we can do these tests on all IVF embryos it’s possible and likely that the success rate of IVF will increase,’ Prof. Vermeesch said. ‘You eliminate those embryos with chromosomal abnormalities and you only transfer those with fewer or no abnormalities.’
Infertility affects 10% of couples in the world, a growing demographic challenge with a human cost. Embarking on having a family later in life is one clear cause, poor lifestyles another, but reproductive health isn’t just about age or wellbeing — some of it is also in our genes.
Scientists exploring the role of genetics in these trends have found that heritability plays a significant part, which is not yet well understood.
‘If we can do these tests on all IVF embryos it’s possible and likely that the success rate of IVF will increase.’
Joris Vermeesch, KU Leuven, Belgium
If there are few environmental constraints and a population cohort follows certain social norms — taking the pill and living through the era of sexual liberation, or postponing childbearing because of pressures in the job or housing market — then genetic factors become more of a factor in the differences in reproductive fertility.
Some problems, like endometriosis, polycystic ovary syndrome or premature menopause, are highly genetic, says Dr Nicola Barban from the Institute for Social and Economic Research at the University of Essex, UK.
Dr Barban is a scientific collaborator on Sociogenome, a project run by Professor Melinda Mills at the University of Oxford, UK, that looks at how infertility is influenced by genetics and environment. It’s the first study to look at these two factors together.
‘What we know is that some women can conceive when they’re in their 40s or late 40s, and some women have problems much earlier in time,’ he explained. ‘We are (investigating) the end of the reproductive window where there’s more variability due to genetics.’
One strand of the project looked at the role of genetics compared with environment and individual choice and studied differences between identical twins, who share 100% of their genome, and fraternal twins, who share 50% of their genomes. The research found that genes make up 15-45% of the factors that determine the number of children a person ends up having, depending on the sample.
Dr Barban stresses that the methods could not be used to predict when an individual might have children because other factors are also involved. ‘Think of three possible sources of variability,’ he said. ‘Genetics, the family environment, the individual environment.’
Next, the Sociogenome researchers wanted to analyse the genome itself. To create their bank of data, the team persuaded 250 other scientists to share their records and formed a massive data pool — roughly 251,000 participants of European ancestry for age at first birth and 343,000 for number of children ever born.
They focused on demographic traits that both men and women share. While fertility research has traditionally focused on the female patient, researchers on Sociogenome wanted to look at both men and women.
‘Much of the research on infertility is on women only but we think that both men and women should be studied,’ Dr Barban said.
This strand of the project probed which parts of individual genes affect child-bearing. It identified 12 genetic loci, or parts of the gene, that can explain around 1% of variation in the age at which a person has their first baby — which may not seem like a lot. But although the results don’t say much about individual fertility at a population level they’re significant, Dr Barban says, because understanding 1% of the genetic predisposition of thousands of people builds a picture of a population’s fertility.
The next phase, with 800,000 participants, aims to show which parts of the gene are expressed in hormones, brain activity and other biological processes — shedding further light on why some people are more fertile than others.
All this doesn’t yet answer the tricky questions of why a particular individual is infertile but it lays the ground for a more sophisticated understanding of the causes of infertility.
‘I think finding the genes that are connected with some of these biological mechanisms could be a very first step towards drug development,’ Dr Barban said.
The causes of suicide attempts and suicide are hard to investigate, but there is strong evidence for the importance of depression, which in itself has been linked with a wide range of possible hormonal abnormalities across many studies. Now a team of investigators from the University of Copenhagen, Denmark, have undertaken a study to assess the relative risk of suicide attempt and suicide in users of hormonal contraception. Using national Danish registers, the investigators followed nearly half a million women with a mean age of 21 years on average for 8.3 years (3.9 million person-years). They identified 6999 first suicide attempts and 71 suicides and found that, compared with women who never used hormonal contraceptives, the relative risk among current and recent users was 1.97 for suicide attempt and 3.08 for suicide. They concluded that use of hormonal contraception was positively associated with subsequent suicide attempt and suicide, that adolescents had the highest relative risk, and that the association between hormonal contraceptive use and a first suicide attempt peaked after 2 months of use.
So, what is the clinical significance of these associations? First, there is no evidence from this study of a causative link between hormonal contraception and suicidal behavior, but it does seem that we should be screening for suicidal ideation in any woman, especially adolescents, who are starting hormonal contraceptives for the first time. Not surprisingly, this may be a stressful developmental time for such individuals, in terms of new relationships and sexual activities, and is potentially a time of increased risk for victimization and abuse, which may be the drivers of suicidal behavior, with the need for contraceptives being the potential identifying marker. More studies to examine this link between hormonal contraception and suicide are certainly needed.
Despite having the highest health care expenditures in the world, U.S. rates of premature births have risen two years in a row, hitting 9.8 percent in 2016 — a 2 percent increase from 2015
Underweight births in the U.S. have also increased since 2014, and increases a child’s risk of infections and brain bleeds during infancy, and chronic health problems such as obesity, diabetes and heart disease later in life
Racial disparities are pronounced. African-Americans have a 13 percent low birth weight rate compared to 8 percent for Asian and Native Americans and 7 percent for Hispanics and Caucasians
Research shows vitamin D optimization could prevent 60 percent of premature births. Among African-Americans, up to 75 percent of all preterm births could be prevented by raising vitamin D levels to 40 ng/mL by the third trimester
The Organic & Natural Health Association will be submitting a health claim petition for vitamin D’s ability to lower premature birth to the FDA
By Dr. Mercola
Despite having the highest health care expenditures in the world, U.S. rates of premature births are on the rise, especially among African-Americans. Preterm birth (which is responsible for 28 percent of newborn deaths during the first month of life) is defined as a baby being born before 37 weeks of gestation,1 and preterm birth rates have risen two years in a row, hitting 9.8 percent in 2016 — a 2 percent increase from the year prior.2
That means nearly 1 in 10 babies is now born prematurely in the U.S. Prevalence of low birth weight is also rising. Any newborn weighing less than 5 pounds, 8 ounces is considered underweight. While the most common reason for low birth weight is premature birth, poor maternal nutrition also plays a role.
African-American Women Are Disproportionately Affected
According to the “2018 County Health Rankings Key Findings Report”3 produced by the University of Wisconsin Population Health Institute in collaboration with the Robert Wood Johnson Foundation, underweight births in the U.S. have increased since 2014, and as noted in Mother Jones,4 “Low birth weight is associated with a range of health problems, from infections and brain bleeds in infancy to a higher risk of obesity, diabetes and heart disease later in life.”
Because of its health implications for both mother and child, birth weight is a good indicator of public health in general. Interestingly, Southeast and Southwest states are disproportionately affected by low birth weight rates. Racial disparities are also pronounced, with African-Americans having a 13 percent low birth weight rate compared to 8 percent for Asian and Native Americans and 7 percent for Hispanics and Caucasians. African-American women are also four times more likely to die during childbirth.
Vitamin D Optimization Can Prevent 60 Percent of Premature Births
Research shows vitamin D optimization could prevent 60 percent of premature births. Among African-American and Hispanic populations, as much as 70 to 75 percent of all preterm births might be prevented. Many other benefits could also be achieved by making vitamin D testing and optimization part of standard prenatal care. For example:
Women with a vitamin D level of above 40 nanograms per milliliter (ng/mL) have a 25 percent lower risk of infections, including respiratory and vaginal infections,5 which in turn lowers their risk of pregnancy complications
Comorbidities of pregnancy are 30 percent lower in women who achieve a vitamin D level of at least 40 ng/mL, including diabetes, high blood pressure and pre-eclampsia — a potentially deadly increase in blood pressure and fluid accompanied by low platelets
A mother’s vitamin D status during pregnancy can have lifelong ramifications for her child. Vitamin D deficiency in pregnancy has been linked to higher rates of childhood allergies, asthma,6,7 colds and flu, dental cavities, diabetes, and even strokes and cardiovascular disease later in life8,9
According to Julie A. Willems Van Dijk, a public health scientist at the University of Wisconsin and a lead researcher on the featured report, “the right kind of action” will be necessary to close the racial gap, and this includes not just medical care but also societal issues such as reducing segregation and improving access to healthy food and employment.10 What she failed to mention was vitamin D optimization — one of the least expensive and quickest acting remedial actions available!
Organic Trade Association to Submit Petition for Vitamin D Health Claim
It’s quite remarkable that at a time when there’s so much research data supporting the use of vitamin D to dramatically improve pregnancy outcomes, lower preterm birth rates and improve the long-term health of both mother and child, health authorities still make no mention of it whatsoever.
In an effort to break the silence, the Organic & Natural Health Association, which is committed to “empowering conscious consumer choice,”11 will be submitting a health claim petition for vitamin D to the U.S. Food and Drug Administration.
In a press release, executive director and CEO Karen Howard noted “The petition will assert there is a well-established body of research, including that of GrassrootsHealth and its results12 at the Medical University of South Carolina, documenting vitamin D levels of 40 ng/ml or higher reduces the rate of preterm birth by 60 percent.”
The petition is being prepared for submission during a planned April 12 meeting at Capitol Hill, where the association will be sharing the message with key legislators and staff. The key message is that vitamin D supplementation “directly impacts health outcomes and is changing the standards of care, in this case, for pregnant women and a generation of children.”
40 ng/mL Is the ‘Magic’ Minimum Number for Reducing Preterm Birth Rates
According to findings by Grassrootshealth, there’s a clear and definitive correlation between vitamin D levels and time of gestation — up to 40 ng/mL, where the impact plateaus.13 Overall, evidence shows pregnant women with a vitamin D level between 40 and 60 ng/mL have 46 percent lower preterm birth rate than the general population, while those with a vitamin D level at or above 40 ng/mL by their third trimester have a 59 percent lower risk for premature birth compared to those with levels below 20 ng/mL.14
Among non-Caucasian women (among whom vitamin D deficiency is far more common) the reduction in risk is even more significant. In this group, those who achieved a vitamin D level of 40 ng/mL by their second vitamin D test had a 78 percent lower preterm birth rate — reducing the preterm birth rate from 18 percent to 4 percent! To ignore this astounding improvement in preterm birth rate among African-American would be foolhardy in the extreme.
As noted in a 2015 press release announcing the findings:15“The March of Dimes estimates that the annual cost of preterm births in the United States as $12 billion (for 455,918 children). If approximately 50 percent of preterm births could be prevented in the general population, as this analysis suggests is possible, there could be $6 billion available for other services, and more than 225,000 children and families spared this trauma.”
Researchers Call for Vitamin D Testing as Part of Standard of Prenatal Care
As a result of these findings, the Medical University of South Carolina (MUSC) updated its standard of care for prenatal patients to include vitamin D testing and, if necessary, vitamin D3 supplementation. Pregnant women are typically given 4,000 IU of vitamin D3 per day to start. Regular testing then helps determine whether this dose is sufficient, or how much more might be needed to reach a serum level of at least 40 ng/mL by the third trimester.
MUSC is clearly a frontrunner in this regard, and it’s a great start, but it’s quite clear vitamin D testing and optimization needs to be expanded across the nation, and there’s absolutely no reason not to. It’s simple, inexpensive and profoundly effective.
To speed up this change, physicians across the U.S. are encouraged to enroll their pregnant patients in the Protect Our Children NOW! project, which seeks to resolve vitamin D deficiency among pregnant women and children, and raise global awareness about the health risks associated with vitamin D deficiency.
The project was initiated by Carole Baggerly of GrassrootsHealth16 in 2015, and has a panel of 42 vitamin D researchers that provide scientific advice. If you are 12 to 17 weeks pregnant, at least 18 years of age, and currently reside in the U.S., this fully sponsored study is available at no cost to you. Participation in the program includes:
Free vitamin D blood tests, which you can do from the comfort of your own home
Your and your newborn’s new questionnaire entries
Reporting of results directly to you
Free vitamin D supplements
If you are planning a pregnancy, or are more than 17 weeks pregnant, you can still take control of your and your child’s health by using the D*Action test kit. It’s one of the most cost-effective ways to monitor your vitamin D status. Again, the minimum vitamin D level you’re aiming for is 40 ng/mL, while additional research suggests a level between 60 and 80 ng/mL provides the greatest health benefits and widest protection against chronic disease.
Vitamin D Status Is Strongly Correlated With Cancer Risk
For example, mounting evidence suggests that optimizing your vitamin D level may significantly reduce your risk of cancer, including breast cancer. Most recently, a Japanese study17 published in The BMJ concluded higher vitamin D levels do in fact provide cancer protection, as indicated by many other studies. As reported by Technology Networks:18
“As vitamin D concentrations and metabolism can vary by ethnicity, it is important to find out whether similar effects would be seen in non-Caucasian populations. So an international research team, based in Japan, set out to assess whether vitamin D was associated with the risk of total and site specific cancer. They analyzed data from the Japan Public Health Center-based Prospective Study, involving 33,736 male and female participants aged between 40 to 69 years …
After accounting for … seasonal variation, samples were split into four groups, ranging from the lowest to highest levels of vitamin D. Participants were then monitored for an average of 16 years …
After adjusting for several known cancer risk factors … the researchers found that a higher level of vitamin D was associated with a lower (around 20 percent) relative risk of overall cancer in both men and women … [N]one of the cancers examined showed an increased risk associated with higher vitamin D levels.”
As mentioned, the link between vitamin D status and cancer risk has been assessed in many studies, including the following, which found that:
Having a serum vitamin D level of at least 40 ng/mL reduces your risk for cancer by 67 percent, compared to having a level of 20 ng/ml or less.19,20 Most cancers occur in people with a vitamin D blood level between 10 and 40 ng/mL, and the optimal level for cancer protection was identified as being between 40 and 60 ng/mL
Women with vitamin D concentrations of at least 30 ng/mL have a 55 percent lower risk of colorectal cancer than those who had a blood level below 18 ng/mL21
Women with vitamin D levels above 60 ng/mL have an 83 percent lower risk of breast cancer than those with levels below 20 ng/mL22
Women over 55 who raised their average serum level to 38 ng/mL lowered their risk of all invasive cancers, including breast cancer, by 77 percent23
Vitamin D also increases your chances of surviving cancer if you do get it,24,25 and this includes melanoma26,27 and breast cancer. In the case of the latter, breast cancer patients with high vitamin D levels are twice as likely to survive than those with low levels.28 Higher vitamin D levels are also associated with a lower risk of severe peripheral neuropathy in cancer patients29
Additional studies can be found on GrassrootHealth’s vitamin D*Action breast cancer page,30 where you can also enroll in the D*Action Breast Cancer Prevention project, which now includes both vitamin D and omega-3 testing. Besides cancer protection, vitamin D sufficiency also lowers your mortality risk from all causes.31,32
It even lowers your risk of Type 2 diabetes by about 60 percent, as evidenced by a GrassrootsHealth analysis.33 Here, those with a median vitamin D level of 41 ng/mL had a diabetes rate of 3.7 per 1,000, compared to a rate of 9.3 per 1,000 among those with a median serum level of 22 ng/mL.
Be Mindful of the Interplay of Vitamins D and K2, Calcium and Magnesium
The best way to optimize your vitamin D level is through sensible sun exposure, but for many, oral supplementation will be necessary to achieve an optimal level, especially if you’re pregnant during the winter. Remember, the only way to accurately assess your need for supplementation is to measure your vitamin D level. It’s a simple, relatively inexpensive blood test. Considering the extreme cost of pregnancy complications and preterm birth, the cost of vitamin D testing and supplementation is negligible.
Just keep in mind that if you take high-dose vitamin D, you may also need to increase your intake of calcium, magnesium and vitamin K2 as well, as these four nutrients work in tandem and rely on sufficient amounts of each to work properly. Importantly, excessive vitamin D in combination with lack of vitamin K2 may cause overabsorption of calcium, which in turn may result in calcium deposits in your heart and kidneys.
Maintaining an appropriate calcium-to-magnesium ratio34 is also important, as magnesium helps keep calcium in your cells so they can function better. A ratio of 1-to-1 appears to be ideal. Magnesium is also required for the activation of vitamin D. Without sufficient magnesium, taking a vitamin D supplement may be ineffective, essentially making it appear you need unnecessarily high amounts. Magnesium and vitamin K2 also complement each other.
Preterm Birth Rate Can Be Significantly and Immediately Slashed
At this point, there’s simply no doubt that maintaining a vitamin D level of 40 to 60 ng/mL during pregnancy is one of the most important strategies you can implement, both for your own health and for the health of your child. The science is done and the results are in. It just needs to be put into practice. I cannot think of any other measure that can reduce pregnancy complications, deaths, and future health problems for less money, and be as safe and risk free.35
If you’re planning a pregnancy or are already pregnant, please, get your vitamin D tested, and if you’re below 40 ng/mL, take a vitamin D3 supplement (and make sure you’re getting sufficient amounts of vitamin K2, magnesium and calcium as well). One in 10 children is born prematurely in the U.S., and there’s simply no reason for this tragedy to continue. This rate can be cut by at least 60 percent simply by making vitamin D optimization a standard part of prenatal care.
Again, if you’re between 12 and 17 weeks pregnant, you can enroll for free in the Protect Our Children NOW! study. If you’re planning a pregnancy, or have passed the 17-week mark, enrolling in the D*Action study is a cost-effective way to get regular testing done. The D*Action study is also open to non-pregnant women, as well as men and children.
An 89% drop in opioid use with restrictive prescribing protocol
The amount of opioids prescribed after gynecologic surgery declined by almost 90% with few complaints from patients after implementation of a restrictive prescription protocol, as reported here at the Society of Gynecologic Oncology (SGO) meeting.
Over a 6-month period, the total opioid pill count declined by 89% as compared with historical prescribing practices. The total included a 73% reduction the number of pills dispensed after open surgery and 97% after minimally invasive procedures.
Patients undergoing ambulatory/minimally invasive procedures and with no history of chronic pain received only prescription-strength ibuprofen or acetaminophen at discharge. Those with a history of opioid exposure or chronic pain, received a 3-day supply (12 pills) of hydrocodone-acetaminophen (Norco) or oxycodone-acetaminophen (Percocet).
Patients undergoing open surgery received either nonopioid pain medication or a 3-day opioid prescription at discharge. If a patient used an opioid for pain in the previous 24 hours, then a 3-day supply consisting of 24 pills (two every 6 hours) was prescribed.
More than 90% of patients went home without an opioid prescription after minimally invasive procedures, and fewer than 5% of patients expressed dissatisfaction with their doctors’ prescribing practices under the restrictive prescribing protocol, said Jaron D. Mark, MD, of the Roswell Park Comprehensive Cancer Center in Buffalo, New York.
“We were quite surprised by how few inquiries and requests for medication we got from our patients,” said Mark. “We expected that we would be able to reduce use of opioids without detrimental consequences, but the extent to which our hypothesis was supported by these results was really striking.”
Principal investigator Emese Zsiros, MD, PhD, also of Roswell Park, said the key factor in reducing opioid use after gynecologic surgery was setting appropriate expectations about pain management in advance of surgery — for clinicians and patients.
A second study reported at SGO documented overprescribing of opioids for minimally invasive hysterectomy. Patients routinely went home with an opioid prescription, but almost a third used none of the pills. The vast majority of patients used only a portion of the prescription, reported Erica Weston, MD, of Johns Hopkins Hospital in Baltimore.
Data, Planning, Caution
Taken together, the two studies showed that most patients undergoing gynecologic surgery — open or minimally invasive — require little or no opioid medication, said invited discussant Sean C. Dowdy, MD, of the Mayo Clinic in Rochester, Minnesota. Availability and use of nonopioid alternatives and preoperative education of patients are critical elements in a strategy to reduce opioid use.
Dowdy called for the development of procedure-specific guidelines for opioid use, which he helped develop at Mayo and will describe in detail at an upcoming meeting. Noting the lack of guidance in the medical literature, Dowdy and colleagues reviewed historical data encompassing 2,500 patients, 25 procedures, and 10 subspecialties. They then performed a survey of outpatient opioid prescribing practices covering a similar number of patients, procedures, and subspecialties.
After reviewing the data, surgeons at Mayo implemented a restrictive prescribing protocol similar to the one described by Mark. Dowdy said they expect to cut opioid use by 1.5 million pills a year.
However, he cautioned against allowing the prescription pendulum to swing too far in the direction of restrictive practices.
“There is no question that our current state is overprescribing, but we need to be very careful not to overcompensate and move to a state of underprescribing,” said Dowdy. “These guidelines apply to acute, postsurgical pain. They do not apply to management of chronic pain and certainly not apply to patients in the palliative-care setting.
Prior to implementing the restrictive protocol, Mark and colleagues surveyed U.S. gynecologic surgeons about their opioid prescribing practices. For patients undergoing minimally invasive procedures, half the surgeons prescribed 15-20 opioid tablets at discharge, and another 28% wrote prescriptions for 21 to 40 pills. For patients undergoing open surgery, two thirds of surgeons prescribed 21-40 opioid tablets and discharge, and 13% prescribed more than 40 tablets.
The restrictive protocol was evaluated from June 2017 through January 2018 and included 337 patients. Investigators compared the results with a control group of 626 patients who underwent similar procedures in prior years.
Overall, the average number of opioid tablets prescribed at discharge declined from 31.7 to 3.5, an 89% reduction. The total reduction included a 73% decline in average pill count for patients who had open surgery (43.6 vs 11.6, P<0.001) and a 97% decrease among patients undergoing minimally invasive procedures (28.1 vs 0.9, P<0.001). The proportion of patients discharged with no opioid prescription after minimally invasive procedures increased from 19.6% to 92.6% (P<0.001).
The average number of opioid tablets prescribed for patients with no prior opioid use declined from 31.7 to 3.1 (P<0.001) and from 31.6 to 6.2 among opioid-dependent patients (P<0.001).
The proportion of patients requesting refills within 30 days after surgery did not change significantly. Mean postoperative pain scores were virtually identical before and after implementation of the restrictive prescribing protocol (P=0.34).
Weston reported findings from a prospective cohort study involving 114 women who underwent minimally invasive hysterectomy. The patients received an average of 3 opioid doses while in the hospital, and all were discharged with opioid prescriptions, averaging 30 pills per prescription. Weston said 25 patients used no opioid medication during hospitalization.
The women were surveyed regarding opioid use at follow-up visits 1-2 weeks after surgery and again at 4-6 weeks. At the first follow-up, 45 patients (36.9%) reported no opioid use since discharge, and the median number of pills used across the entire cohort was nine. At the end of follow-up, 37 patients (32.5%) had used no opioids, and the median number of pills since discharge was 11 for all 114 patients.
“We found that 90% of the patients used 30 or fewer opioid tablets,” said Weston. “The strongest predictor of opioid use after discharge was opioid use during the inpatient stay.”
Injectable contraceptives are popular in sub-Saharan Africa but have high discontinuation rates due partly to the need for provider-administered re-injection. We compared continuation rates of women who self-injected subcutaneous depot medroxyprogesterone acetate (DMPA-SC) and women who received DMPA-SC from a health-care provider, including community health workers (CHWs).
We did an open-label randomised controlled trial based at six Ministry of Health clinics in rural Mangochi District, Malawi. Health-care providers recruited adult women who presented at the six clinics or to CHWs in rural communities in the clinic catchment areas. Participants received DMPA-SC and were randomised (1:1) to receive provider-administered injections or training in how to self-inject DMPA-SC. Randomisation was done via a computer-generated block randomisation schedule with block sizes of four, six, and eight and stratified by study site, generated by an independent statistician. Self-injectors administered the first injection under observation and were sent home with three doses, written instructions, and a calendar. The provider-administered group received a DMPA-SC injection and a calendar, and were asked to return for subsequent injections. Data collectors contacted participants after the 14-week re-injection window at 3, 6, and 9 months to collect continuation data. At 12 months after enrolment or early discontinuation, women had their final interview, which included pregnancy testing. The primary outcome was discontinuation of DMPA-SC, as assessed in the intention-to-treat population. We used Kaplan-Meier methods to estimate the probabilities of continuation and a log-rank test to compare groups. Safety was assessed in the as-treated population, which consisted only of participants who successfully received at least one DMPA-SC injection after randomisation. This trial is registered with ClinicalTrials.gov, number NCT02293694.
This study lasted from Sept 17, 2015, to Feb 21, 2017. 731 women underwent randomisation, with 364 assigned to the self-administered group and 367 to the provider-administered group. One woman in the self-injection group withdrew at month 0. Treatment was discontinued by 99 women in the self-administered group and 199 women in the provider-administered group. The 12 month continuation rate was 73% in the self-injection group and 45% in the provider-administered group, giving an incidence rate ratio of 0·40 (95% CI 0·31–0·51; p<0·0001). Adverse events deemed to potentially be treatment-related were reported by ten women (20 events) in the self-administered group and 17 women (28 events) in the provider-administered group. Five serious adverse events were reported during the trial by four women; two events related to DMPA-SC (menorrhagia and anaemia requiring hospital admission) were reported by the same woman in the provider-administered group and resolved without sequelae. The other serious adverse events, including one death, were deemed to be unrelated to DMPA-SC.
Women who self-injected DMPA-SC had significantly higher rates of continuation than those receiving provider-injected DMPA-SC. Community-based provision of injectable contraception for self-injection in low-resource settings seems to be safe and feasible. Self-administration of DMPA-SC should be made widely available.
Contraceptive implant use is rising rapidly, substantially, and equitably in many sub-Saharan African countries, across almost all sociodemographic categories. Gains in implant use have exceeded combined gains for IUDs, pills, and injectables. Key contributing factors include sizeable reductions in commodity cost, much-increased commodity supply, greater government commitment to expanded method choice, and wider adoption of high-impact service delivery practices that broaden access and better reach underserved populations. Continued progress in meeting women’s reproductive intentions with implants calls for further investment in quality services for both insertion and removal, and for addressing issues of financing and sustainability.
This article draws from national surveys of every sub-Saharan African country with at least 1 recent survey published between 2015 and 2017 and 2 prior surveys from 2003 to 2014. Twelve countries comprising over 60% of the region’s population met these inclusion criteria. The analysis considers recent and longer-term changes in 3 key variables: modern contraceptive prevalence rate (mCPR), method-specific prevalence, and a method’s share of the current modern method mix. As recently as 2011, implant CPR in sub-Saharan Africa was only 1.1%. Since then, sizeable price reductions, much-increased commodity supply, greater government commitment to rights-based family planning, broader WHO eligibility guidance, and wider adoption of high-impact service delivery practices have resulted in expanded client access and marked increases in implant prevalence and share of the method mix. Ten of the 12 countries now have an implant CPR around 6% or higher, with 3 countries above 11%. Increased implant use has been the main driver of the increased mCPR attained by 11 countries, with gains in implant use alone exceeding combined gains in use of injectables, pills, and intrauterine devices. In countries as diverse as Burkina Faso and Ethiopia, Democratic Republic of the Congo and Ghana, Kenya and Senegal, implant use now accounts for one-fourth to one-half of all modern method use. Implants have become the first or second most widely used method in 10 countries. In the 7 countries with multiple surveys conducted over a 2- to 3-year span between 2013–14 and 2016–17, average annual gains in implant prevalence range from 0.97 to 4.15 percentage points; this contrasts to historical annual gains in use of all modern methods of 0.70 percentage points in 42 sub-Saharan African countries from 1986 to 2008. Implant use has risen substantially and fairly equitably across almost all sociodemographic categories, including unmarried women, women of lower and higher parity, women in all 5 wealth quintiles, younger and older women, and women residing in rural areas. A notable exception is the category of nulliparous married women, whose implant use is mostly below 1%. These attainments represent a major success story not often seen in family planning programming. With continued program commitment and donor support, these trends in implant uptake and popularity are likely to continue for the next few years. This implies even greater need for the international family planning community to maintain its focus on rights-based programming, ensuring reliable access to implant removal as well as insertion services, and addressing issues of financing and sustainability.