Now, know your cellular age and manage it too: measuring telomere length by Teloyears

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How well we are aging? That question is often pondered upon but, till now there was no readily available tests to measure our cellular age and compare it with the chronological age. Telomere Diagnostics(TDx), a molecular testing company based in Silicon Valley, California has launched Teloyears. It is home based, easy to use test that requires just a drop of blood sent to the lab, where the telomers in White Blood Cells (WBC) are analyzed and the results are mailed back in 6 weeks. The results show that how well or bad you are aging as compared to others of your age and gender, along with insights into improving it. 

One of the TDx founder, Dr. Elizabeth Blackburn, was recipient of 2009 Nobel Prize in Medicine and a trailblazer in molecular biology. It’s been more than two decades that numerous research papers have well established the importance of measuring Average Telomere Length (ATL) as a predictor of overall health.

The New York Times bestselling book is coauthored by the Dr. Elizabeth Blackburn who discovered telomerase and telomeres' role in the aging process and the health psychologist who has done original research into how specific lifestyle and psychological habits can protect telomeres, slowing disease and improving life. Get the bestseller by Dr Elizabeth Blackburn

Teloyears 

Unlike other genetic test which just tells you about traits or risk for a particular disease, knowing telomere length is much more dynamic because personal lifestyle interventions can slow down or even reverse the aging. In fact, it is known that stress, serious illness or infection can accelerate the telomere shortening and during period of good health the shortening is slowed down.  Along with your results, you also receive expert guidance from ‘Telocoach’ to establish your own custom lifestyle improvement plan based on telomere science. It’s way beyond the routine cholesterol test or tracking ordinary vital signs.

Studies have shown that it’s possible to slow down aging by managing diet, exercise, stress and sleep.

Telomeres are protective caps at the end of our DNA stands. If we imagine that the DNA strand is a big ladder with millions of rungs, telomeres are few thousand rungs at the end of each strand that keep it from ‘unzipping’ and protect the genes which are in the middle of the ladder. Remember the stopper like thing at the end of ordinary zipper, telomeres are just like that.

https://beautyblackbook.com

As we age, the telomere shorten because of repeated division and a stage comes when they can no longer replicate and become “senescent” which is the cellular equivalent of aging. There is growing evidence (nearly 20,000 peer reviewed publications) that shortened telomeres are related to many chronic diseases, particularly cardiovascular diseases. Average telomere length is associated with risk of cardiovascular disease independent of other vascular risk factors.

The company wants to increase awareness among consumers and physician about the Teloyears test, so that it is integrated in annual physical exams, as the information it provides can help change the life style.

It will also help physician in managing individual patients as the Telomere blueprint is different for each one of us.

It is worth noting that Teloyears test does not replace age appropriate medical tests recommended by physicians based on your risk profile or age, nor does the results should be used in making any treatment decisions for existing  medical conditions.

Telomere Diagnostics has successfully resolved the lawsuit it brought to prevent Titanovo from using the patented technology behind the TeloYears™ genetic test for cellular age. In response to the lawsuit, Titanovo has taken down its website and ceased all sales and distribution of all of its products and services.

Teloyears has not been cleared or approved by the U.S. Food and Drug Administration.

Here is a video about Telomere length by Teloyears.

Teloyears.

Related link:  23 and Me receives FDA clearance for at home risk testing for 10 genetic diseases 

MAP healthwatch: Watch that monitors, analyze and predict your health status

Since the first wave of wearables hit the market, everyone is excited about the impact these devices have on improving the healthcare industry. We have seen Fitbits, Jawbones and others in the market but, these were not medical device and clinicians knew that a break is yet to come.

Well, MAP healthwatch is about to hit the market soon. MAP watch is a medical sensor that is CE and FDA certified that continuously analyze 7 vital parameters that can most commonly predict life threatening diseases. The watch has 5 separate sensors that measures blood pressure, ECG, Heart rate variability, blood oxygen levels, skin temperature, stress and galvanic skin response.

The sensors include PPG sensor with 2 different color LED, 4 contact ECG (Einthoven I lead), Skin conductivity, Skin temperature and 3-axis accelerometer.

MAP was designed, invented and tested by a group of dedicated doctors, engineers and designers from all across the globe.

Each watch is personalized to individual needs. The medical team records the personal medical history, risk factors and inputs the data to customize the watch. Your vital data is continuously recorded on a secure server and evaluated based on medical algorithms. A team of doctors will analyze the data and the person gets regular advice about medical and lifestyle management to lead a healthier life.

This is giant leap of technology on the “life alert” and “cardiac sensors” wearables that are in the market currently.

The watch has a panic button to deal with any kind of medical emergency, if the wearer presses the button he gets assisted by a medical team 24/7.

There is a mobile app for MAP and is compatible with Android and iOS platform.

Being a medical device has not compromised the look of the MAP watch. It’s very aesthetically designed and can be worn every day as a regular watch. It comes is several different colors and available in man and woman size. Its battery lasts for 24 hours without recharging in between.

It can also be worn during any of the fitness activity and will track and monitor the necessary data.

MAP is currently available on preorder and it will hit the regular market in a week.

http://maphealthwatch.com/

Prophylactic negative pressure wound therapy may help cut down surgical wound infections after cesarean

Prophylactic negative pressure wound therapy (NPWT) at cesarean delivery may reduce the surgical site infections (SSI) and overall wound complications says the results of a systematic review and meta-analysis published ahead of print in American journal of obstetrics and gynecology.

Morbidly obese women have a very high rate of SSIs and readmission to hospitals.

The researchers conducted a literature review and included RCTs and observational studies comparing surgical outcome between prophylactic negative pressure wound closure and standard cesarean wound closure.  

The investigators were mainly looking at difference in SSI because of NPWT besides other minor outcomes like composite wound complications, wound gaping, hematoma, endometritis and readmission to the hospital.

Six RCTs and three cohort study met the inclusion criteria. It was seen that women with NPWT faced a 55% lower risk of SSI as compared to women with standard dressing (pooled RR 0.45; 95% CI 0.31- 0.66). The Number Need to Treat (NNT) was 17.

Women with NPWT also had a 22 lower risk of composite wound complications, while the other minor outcomes were comparable in both the groups.

The authors concluded that although the studies were heterogenous, use of NPWT decreases the SSIs after  cesarean, larger clinical trials are awaited to fully understand the impact of the intervention.

Abstract

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USPSTF issues draft recommendations on low-dose vitamin D and calcium for fracture prevention

http://www.huffingtonpost.com/ellen-sarver-dolgen/vitamin-d-calcium-supplements_b_3543283.html

The USPSTF today issued draft recommendations for effectiveness and potential harm of prescribing Vitamin D and Calcium in community dwelling men and pre-and post-menopausal women for the primary prevention of fractures.

Aging population, low bone mass and falls all contribute to a substantial health burden of fractures. Nearly 1 in 2 women older than 50 years of age will experience a fracture during her life time.

Currently, Vitamin D and Calcium supplementation are often advised for postmenopausal women to prevent fractures.

USPSTF recommendations on efficacy of Calcium and Vitamin D in preventing fractures are based on data from a total of 41,772 women across eight 8 RCTs with mean age between 53 to 80 years while for assessing the harm it reviewed the evidence from 9 RCTs with a total of 39,659 subjects, which also included 5,991 men.

The review of evidence concluded:

USPSTF found sufficient evidence to recommend against daily supplementation of 400 IU or less of vitamin D combined with 1,000 mg or less of calcium in prevention of fractures in postmenopausal women.

Evidence is also insufficient to make recommendations for greater than 400 IU of vitamin D and greater than 1000 mg of calcium supplementation in postmenopausal women.

At this time, there is insufficient evidence to determine the balance of benefits and harms of prescribing vitamin D and calcium supplementation, alone or combined, for the primary prevention of fractures in men and premenopausal women.

USPSTF found sufficient evidence that supplementation with vitamin D and calcium increases the incidence of kidney stones, although the magnitude of this harm was small.

This recommendation does not apply to persons living in institutional or nursing home care or with a history of osteoporotic fractures or those who are at increased risk for falls. It also does not apply to persons with a diagnosis of osteoporosis or vitamin D deficiency.

USPSTF recommends screening for osteoporosis in women aged 65 or older and in younger women if they have a high fracture risk. Evidence is insufficient to recommend for or against screening for vitamin D deficiency in asymptomatic adults.

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ACOG updates recommendations for diagnostic imaging during pregnancy and lactation

http://www.infantrisk.com/content/radiological-procedures-pregnancy

ACOG has issued recommendations addressing the concerns surrounding the use of X-ray, sonography, nuclear medicine, CT and MRI in pregnancy and lactation. The committee opinion was published in October issue of Journal Obstetrics and Gynecology.

These investigative modalities have become an integral part of our diagnostic armamentarium for evaluating acute and chronic conditions. However, there is confusion and fear surrounding these tests among physician and patients alike that many times they are delayed or totally avoided. Many a times breast feeding is stopped while patient undergo these investigations.

The ACOG’s committee on obstetric practice make the following recommendations:

Ultrasonography and MRI are safe and are the imaging modalities of choice in pregnancy and lactation, although they should be availed only when they are expected to answer a relevant clinical dilemma or are provide health benefit to the patient.

Routine radiography, computed tomography (CT) scan, or nuclear medicine imaging techniques exposes the pregnant women to a dose that is much lower than what is associated with fetal harm and so these techniques should be used if deemed necessary in addition to USG or MRI or alone if they answer the relevant clinical question.

The use of gadolinium contrast with MRI is not advised in routine practice and should only be used as contrast if it significantly improve the diagnosis and maternal and fetal outcome during pregnancy.

Breastfeeding need not be interrupted after gadolinium administration.

Nuclear Medicine imaging should be limited to the use of technetium 99m at 5 mGy when indicated during pregnancy. 

Radioactive iodine (iodine 131) readily crosses placenta and is absolutely contraindicated in pregnancy.

Full Text 

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Hologic’s SmartCurve Device makes mammography comfortable and less painful for women

Hologic today commercially launched its SmartCurve breast stabilization system, that makes mammography experience less painful for women without compromising on image quality and diagnostic accuracy.

SmartCurve breast stabilization system is compatible with FDA approved Hologic's Genius™ 3D Mammography™ exam, which detects cancers at early stage, reduces false positive results in normal and dense breast.

Women are afraid of getting a mammogram because of pain and discomfort associated with the procedure as the breast are compressed during the procedure. A recent survey of 10,000 women reported that fear of physical discomfort was the number one reason cited for avoiding the annual examination. 

Pain felt during the procedure depends upon the time spent undergoing compression and distribution of the pressure applied. While, time spent is not modifiable, the pressure distribution can be modified. 

The team of engineers at Hologic precisely worked upon distributing the pressure in a smart way to lessen the pain.

The SmartCurve system features a proprietary curved surface that mirrors the shape of a woman's breast to reduce pinching and allow better distribution of force over the entire breast. The system is equipped with image processing algorithms that ensures that quality of image is not compromised.

In a clinical study, 93% women reported that using the new system lessened the pain and discomfort as compared to the traditional flat paddle compression. The system can accommodate a variety of breast sizes can be paired with Hologic's MammoPad® breast cushion for even greater comfort. 

Ninety-five percent of women in the same study said they would recommend it to others.

The new system is also radiologist and technologist friendly and does not affect the workflow and ensures that efficacy is maintained in busy environment.

Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions said, "Hologic is the world leader in breast cancer screening technology, and with that leadership comes a responsibility to develop products that provide optimal patient satisfaction without sacrificing clinical performance. We are thrilled to introduce the new SmartCurve system which, when used with the Genius exam, is the first and only 3D mammography system that is clinically proven to deliver a more comfortable and more accurate mammogram, compared to 2D mammography alone. This game-changing product is yet another example of our dedication to innovation designed to meet the needs of our customers and their patients."

The SmartCurve system is available standard on Hologic's new 3Dimensions™ mammography system and as an enhancement option to existing Hologic Selenia® Dimensions® systems.

Here’s is singer Sheryl Crow speaking about her experience with SmartCurve system and just how she thinks SmartCurve can help women.

Hologic News Release.

On World Contraceptive day: Review of contraception during perimenopausal years.

September 26^th is World Contraceptive day, it is annual worldwide campaign to improve global awareness about contraception, with the dream that every pregnancy is intentional.

RCOG has released a review paper about contraceptive methods around menopause, published today in RCOG journal The Obstetrician and Gynecologists. The WHO defines the menopause as permanent cessation of menstruation caused by the loss of ovarian follicular activity, which is essentially a retrospective diagnosis.

There exists no accurate biological marker that defines the moment when the woman ceases to be fertile.  During the perimenopausal years menstrual irregularities are very common with irregular scanty or heavy blood loss.

Although after 30’s natural fertility is on decline, effective contraception should still be used till menopause to avoid unintended pregnancies.

Some important key contents of this review paper on perimenopausal contraception are:

No method of contraception is contraindicated based on age alone, up to the age of 50 years, HRT does not provide adequate contraception as it inhibits ovulation in only 40% of women.

Some hormonal contraceptive also helps in relieving common perimenopausal gynecological problem.  Contraception must be used alongside HRT to avoid unplanned conception. Progestogen-only methods and intrauterine contraception (IUC) are suitable.

During the perimenopausal years, in women over the age of 50 years not using hormonal methods, contraception can be stopped after 1 year of amenorrhea as fertility is unlikely to return, while in women under 50 years of age, contraception should be continued for 2 years, as the return of fertile ovulation is more likely to occur.

The Faculty of Sexual and Reproductive Healthcare (FSRH) recommends that contraception should be continued for 1 year after recording two FSH levels at >30 IU/l, taken at least 6 weeks apart.

Alternatively, women can consider stopping their method of contraception at the age of 55 years when most will have reached natural infertility.

Women must be advised on all available methods of contraception, including long-acting reversible methods (LARC), so they can make an informed choice.

Combined oral contraception have the advantage of regular bleeding pattern and relief in hot flushes, but increased risk of thrombosis, and breast and cervical cancer. Some women prefer progesterone only pills because it is contraindicated in few medical conditions but irregular bleeding is a problem.

Progesterone only injectables are long acting but they often mask menopause, causes loss of BMD and once injected cannot be removed.

Copper intrauterine device and Levonorgestrel-releasing device are unsuitable if women have irregular uterine cavity.

Barrier methods are best, without any side effects and can be safely used till menopause.

Women can also avail emergency contraception in the perimenopausal age group. Levonorgestrel an oral progestogen; ulipristalacetate (UPA) an oral selective progestogen receptor modulator; and the copper IUD can be used in emergency.

Contraceptives of future: Frameless IUDs and Intrauterine ball has recently been licensed in Austria and will likely be marketed elsewhere in Europe and North America. It is a frameless IUD consisting of a shaped memory alloy (Nitinol^®) thread that holds 20 tiny copper spheres. The device becomes spherical once delivered into the uterus and might have greater potential for use in non-uniform endometrial cavities. As a hormone-free method, there will be no contraindications to its use in perimenopausal women.

http://newatlas.com/intra-uterine-ball-iub/23534/

Microchip drug-release technology is currently under development and will allow a progestogen-releasing microchip to be implanted for up to 16 years of use, which can be switched on and off with a remote control.

http://news.mit.edu/2015/implantable-drug-delivery-microchip-device-0629

Researchers are working on vaginal ring releasing UPA, a selective progesterone receptor modulator that will provide estrogen free contraception.

Not much progress has been made in areas of male contraception and condoms and sterilization are only current methods available.

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First automated pumping bra that massages the breast and relieve clogged ducts to produce more milk.

Breast pumps technology has evolved a long way from the awkward manual tools of yesteryear's. But, most modern breast pumps only provide good suction without any massaging action and also keep mother’s hands engaged while pumping the milk.

Now a startup company has designed Lilu, first automated, pumping bra that also massages the breast in circular manner to open up the clogged ducts, thereby increasing the quantity and quality of breast milk. It closely mimics the hand motion mothers use to express the breast milk.

It was developed by  Sujay Suresh and Adriana Vazquez who wanted to design a smart product keeping in mind the needs of busy nursing mothers.The bra technology helps nursing mother keep their hands free, so that you can just relax or do some other necessary task.

The product was showcased at Tech Crunch Disrupt San Francisco, which helps and supports promising start-up companies.

The lilu bra looks like a large sports bra and comes in seamless pouch and strap design that can easily fit over a woman’s nursing bra. The mother does not need to undress to put on the bra. Whenever the mother is ready to pump, she just has to pull the  flaps of her nursing bra, wear the lilu bra over it and attach the breast pump that is connected with a bottle. She than presses the button in the middle, which starts the massaging action in a compression manner that bring forward all the milk.

The amount of compression applied is adjustable. The compressor can be detached from the bra and charged via a microUSB cable. The bra is soft and molds to the changing shape during lactation period.

Evi Triantafyllides, a Lilu spokesperson, quotes that, “The automated compressor helps produce 50 percent more milk than with just a normal pump.” The bra also opens the clogged ducts, thereby bringing down the incidence of postpartum mastitis.

The patent pending massaging cups use pneumatic technology just like a BP cuff.

The lilu automated bra is currently prized at $249 USD and can be preordered by clicking this link.

Here is a video about lilu

ACOG issues clinical practice guidelines for Gestational Diabetes Mellitus

Courtesy: YouTube.

The American College of Obstetricians and Gynecologists (ACOG) has issued clinical practice guidelines for the diagnosis and treatment of gestational diabetes mellitus (GDM).

Although prevalence of GDM is directly proportional to prevalence of type 2 DM in a given population, it is estimated that GDM accounts for 90% of cases diabetes in pregnancy. The prevalence of DM in pregnancy is around 6-9%.

The prevalence of GDM globally is on the rise because of increasing obesity, delayed childbearing and sedentary lifestyle.

The document provides a brief overview of GDM, one of the most common complication of pregnancy, identifies the disease process, its diagnosis and management based on current research and identifies the lacunae for future research.

Screening for GDM is done by various methods and there is still no standardized method. ACOG supports the two-step process most commonly used in USA. It involves first screening with the administration of a 50-g oral glucose solution followed by a 1-hour venous glucose determination. 

Women whose glucose levels meet or exceed an institution’s screening threshold then undergo a 100-g, 3-hour diagnostic OGTT. Gestational diabetes mellitus is most often diagnosed in women who have two or more abnormal values on the 3-hour OGTT.

Other institutions and private practitioners use International Association of Diabetes and Pregnancy Study Group (IADPSG) recommended one step, universal 75-g, 2-hour OGTT to diagnose GDM.

The summary of recommendations by ACOG:

Recommendations based on good scientific evidence (Level A):

All women diagnosed with GDM should first be treated with adequate nutritional and exercise counselling, before starting any pharmacological treatment.

If lifestyle modifications fail to control glucose levels, Insulin is the first line of drug for controlling blood sugar in pregnancy.

Recommendations based on limited or inconsistent scientific evidence (Level B):

All pregnant women should be screened for GDM with a laboratory based blood glucose level testing.

Women who refuse to take insulin, or who are unable to safely administer insulin, metformin is a reasonable second-line choice.

Glyburide is not be recommended as a first-line pharmacologic treatment because, in most studies, it does not yield equivalent outcomes to insulin.

All women should be counselled about limitations of safety data regarding oral hypoglycemic agents.

Women should also receive counselling regarding the risks and benefits of a scheduled cesarean delivery when the estimated fetal weight is 4,500 g or more.

Recommendations based primarily on consensus and expert opinion (Level C):

In the absence of clear evidence and comparative trials, no single value of blood glucose can be taken as cutoff over another for 1-hour glucose test nor one set of diagnostic criteria for the 3-hour OGTT can be clearly recommended over the other. Practitioners should select a single set of criteria and use it consistently with their patients.

Women should be advised dietary guidance and 30 minutes of moderate physical activity, 5 days a week or 150 minute/week.  

In women, whose GDM is well controlled by diet and exercise, delivery is not indicated before 39 weeks of gestation, in absence of other obstetric indication. She can be safely managed expectantly up to 40 6/7 weeks of gestation, with antepartum fetal surveillance.

In women, whose GDM is well controlled by medications, delivery is recommended at 39 0/7 to 39 6/7 weeks of gestation.

All women with GDM should be screened at 4–12 weeks postpartum to identify women with diabetes, impaired fasting glucose levels, or impaired glucose tolerance, with an appropriate referral to medical practitioner.

The American Diabetic Association (ADA) and ACOG recommend repeat testing every 1–3 years for women who had a pregnancy affected by GDM and normal postpartum screening test results.

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Today is World Cancer Research Day: A call to action by ASCO- Don’t Stand Still. We Won’t

September 24th is  World Cancer Research Day. American Society of Clinical Oncology (ASCO)calls upon to continue and heighten research in areas of cancer prevention and treatment, along with discovering new drugs. World Cancer Research Day is a global initiative that aims to raise awareness about the critical importance of cancer research.

It is estimated that by 2030 cancer will be the leading cause of death worldwide with new cases expected to increase to 21.6 million each year. According to the GLOBOCAN report, in 2012 there were 14 million new cases diagnosed and 8.2 million cancer-related deaths worldwide.

Life years and productivity loss, together with disabilities resulting from cancer account for the largest economic cost on a global scale, compared to other causes of death including infectious diseases.

One of the most important areas is to support and promote research on the causes, prevention and early detection of cancer as a key element in controlling the disease. This will lead us towards the discovery of a cure for cancer or transforming the disease into a chronic illness, both approaches translating into higher survival rates.

Some of the important research paper on Obstetrics and Gynecological cancer published recently are:

USPSTF simplifies cervical cancer screening recommendations: Dual testing no longer advised

The US Preventive Services Task Force (USPSTF) has issued new draft recommendations for cervical cancer screening with a major change that it recommends either cervical cytology (CC) or high-risk HPV (hrHPV) test as a screening procedure every 3 years for women aged 30-65 years, and not both ( Grade A)  

https://obgynupdated.blogspot.com/2017/09/uspstf-simplifies-cervical-cancer.html

Magseed, a minimally invasive breast marker for cancer localization during surgery receives clearance in Europe

Endomag, a surgical guidance company received CE clearance for Sentimag+Magseed breast cancer diagnostic system, that guides surgeon for precise location of impalpable tumor during breast lumpectomy. It improves outcome and reduces the amount of radioactive exposure for patients.

https://obgynupdated.blogspot.com/2017/09/magseed-minimally-invasive-breast.html

FDA clears first 2D digital mammography system that allows patients to control the compression

GE Healthcare announced today FDA 510(k) clearance of an industry-first, patient-assisted mammography system, Senographe Pristina Duetathat makes mammography experience more comfortable by putting the control in patients’ own hands.

https://obgynupdated.blogspot.com/2017/09/fda-clears-first-2d-digital-mammography.html

FDA approves world’s first pioneering gene therapy for cancer

The U.S.Food and Drug Administration in its landmark and historic action today approved the world’s first gene therapy, Novartis' Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).

This opens a new frontier in treatment of cancer and other serious and life-threatening diseases.

https://obgynupdated.blogspot.com/2017/09/fda-approves-worlds-first-pioneering.html

Are you dense? What every woman and her healthcare provider needs to know.

Nearly 20 plus years of research have provided sufficient evidence to link dense breast tissue and increased risk of missing cancer diagnosis by screening mammography. As the breast density increases, the reliability of mammogram as a screening tool for picking up breast malignancy decreases.

What is meant by “being dense”? Breast density does not correlate with physically palpated firmness of breast, it is a radiologic finding and cannot be predicted without obtaining a mammogram. 

https://obgynupdated.blogspot.com/2017/08/are-you-dense-what-every-woman-and-her.html

Now Ovarian Tissue paper to support normal hormonal production: Breakthrough in Regenerative Medicine

An accidental Spill has sparked a breakthrough in the field of regenerative medidicne. Scientists and engineers at the Northwestern Medicine have invented a range of bioactive “tissue papers” made from organs combined with a polymer to make them so pliable.

These new “tissue papers” are so thin and pliable that they can be folded into an origami bird. Their clinical application is for wound healing and aid in natural hormone production in young cancer patients.

https://obgynupdated.blogspot.com/2017/08/now-ovarian-tissue-paper-to-support.html

Adjunct Metformin helps reversal of atypical endometrial hyperplasia

Adjunct metformin treatment help reversal of atypical endometrial hyperplasia (AEH) and improves overall survival in endometrial cancer reports the result of a systematic review and meta-analysis published ahead of print in Journal of Gynecologic Oncology.

https://obgynupdated.blogspot.com/2017/08/adjunct-metformin-helps-reversal-of.html

FDA Approves PARP inhibitor Zejula for treatment of recurrent ovarian cancer.

The U.S.Food and Drug Administration today approved Zejula (niraparib) for the maintenance treatment of epithelial ovarian, fallopian tube or primary peritoneal cancer in adult patients who have already responded well to platinum-based chemotherapy.

https://obgynupdated.blogspot.com/2017/03/fda-approves-parp-inhibitor-zejula-for.html

Here is an interesting video about importance of research on World Cancer Research Day 2017

FDA approves first single dose oral secnidazole (Solosec) for Bacterial Vaginosis

The US Food and Drug Administration (FDA) approved first and only single dose oral therapy, secnidazole 2 gms (Solosec, Symbiomix Therapeutics) for treatment of women with bacterial vaginosis (BV), the most common U.S. gynecologic infection in women aged 14 to 49 years, according to the Centers for Disease Control and Prevention.

The antibiotic is manufactured by Symbiomix Therapeutics, Newark, NJ.

The single dose 2 gm secnidazole comes in the form of packaged granules, the entire contents of the packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. It cannot be consumed by dissolving it in any liquid.

The current treatment regimen is prescribed for at least twice a day for 7 days, which has resulted in only 50% of the patient taking the full course of antibiotics. Incomplete treatment of BV leads put the patient at high risk of contracting other sexually transmitted diseases like chlamydia, gonorrhea, herpes, trichomaniasis and HIV. It also results in preterm births and low birth weight.

David L. Stern, CEO of Symbiomix, “The FDA’s approval of this first-of-its-kind treatment is an important milestone for Symbiomix and most importantly, millions of women suffering from BV. The approval of Solosec™ represents a critical moment in our efforts to bring innovative medicines to the women’s health market. Solosec is the first new oral antibiotic to treat BV in more than a decade and will provide women with a new treatment option. We look forward to making this treatment available to patients in the first quarter of 2018.”

The FDA’s approval comes in wake of successful results of two pivotal clinical trials involving a total of 333 nonpregnant women up to age 54. The patients were assessed based on 3 endpoints namely: clinical responder, therapeutic responder and Nugent score cure (Nugent score < 3).

In both the trials significant more number of patients attained clinical and therapeutic cure as compared to placebo. Adverse effects were mild or moderate and includes Vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, abdominal pain and diarrhea. The drug label warns that Vulvovaginal candidiasis may require antifungal treatment.

The FDA designated Solosec as a Qualified Infectious Disease Product (QIDP) for the treatment of BV and granted it Fast Track designation, which made Solosec eligible for priority review and at least 10 years of U.S. market exclusivity.

The label also warns against chronic use, animal studies have demonstrated its carcinogenic potential after long use. It is also contraindicated in pregnancy and lactation.

The FDA Drug label.

New release by Symbiomix Therapeutics

Nearly 10% of young women worldwide prefer Cesarean section to vaginal birth as delivery option

One in ten young women prefers cesarean section to vaginal birth as her choice of delivery in a seemingly healthy pregnancy, because of fear of uncontrollable labor pains and physical damage says the result of large study published in Journal of Reproductive Health.

All attempts to bring down cesarean section rates in middle income and developed countries have mostly focused on educating the physicians and midwives, changing hospital policies and environment and less on patient education and knowledge about benefits of vaginal births.

It is estimated that 6.2 million unnecessary cesarean sections (CS) are performed worldwide each year and most countries that participated in this study exceeds the optimal limit between 10-19%.

Recently, psychological indication of Cesarean Section has emerged as an important contributing in increasing the global cesarean rate. A survey of 6000 European found that 16.7% of primiparas and 31.7% of multiparas had a CS without medical indications because of severe fear of childbirth.

The current study recruited student from Universities and Schools across 8 OECD countries (Australia, Canada, Chile, England, Germany, Iceland, New Zealand, United States.

Childless young men and women who plan to have one child in near future were sent online questionnaire, of which 6571 completed the survey.

During the final analysis, overall 10.8% of women wanted to have a CS in a healthy future pregnancy, with the highest rate of 16.0% in Australia.

The most common reason cited was fear of labor pains and maintain vaginal integrity, the other being CS is well planned and good for mother’s health.

Regression analysis showed that students who studied health science had significant less fear and lower odds of preferring CS.

Epidural analgesia might theoretically appear a lucrative solution, but it increased the rates of instrumental delivery and created a lasting negative impression in long term.

All women expressed a significant interest in knowing more about anatomy and process of childbirth.

The authors concluded, “Education sessions delivered online, through social media, and face-to-face using drama and stories told by peers (young women who have recently had babies) or celebrities could be designed to maximize young women’s capacity to understand the physiology of labor and birth, and the range of methods available to support them in coping with labor pain and to minimize invasive procedures, therefore reducing fear of pain, bodily damage, and loss of control. The most efficacious designs and content for such education for young women and girls remains to be tested in future studies.”

Abstract, Full Text.