Despite Recent Report, You Still Need an Annual Pelvic Exam

Recently, the U.S. Preventive Services Task Force (USPSTF) concluded that, “the current evidence is ‘insufficient’ to determine the balance of benefits and harms of the pelvic exam.” The USPSTF then made the recommendation to discontinue routine pelvic exams for women who are healthy and not pregnant. The broader media jumped on this as if it were fact, and an accepted change in practice. But does this lack of evidence mean there is no benefit to routine pelvic exams? Absolutely not.

The absence of evidence does not indicate the evidence of absence- If there is an absence of or limited evidence for the benefits of routine pelvic exams that does NOT mean there is adequate evidence to recommend against them.

The conclusion to discontinue the routine pelvic exam runs counter to the goals of improving women’s health through preventive care- Being asymptomatic is not the same as being healthy or not having a problem. The recommendation to perform pelvic exams only if women complain of problems will lead to missed opportunities to diagnose potentially fatal pelvic conditions. I understand that women do not like pelvic exams as they are intrusive, invasive and sometimes painful, but here is a fact I think most people are forgetting: they save lives. If you never check a temperature you’ll never find a fever.

Many others are also refuting the elimination of routine pelvic exams. As Dr. Maureen Phipps told the New York Times,This is not a recommendation against doing the exam. This is a recommendation to call for more research to figure out the benefits and harms associated with screening pelvic exams. That’s the big message here.” She is the chairwoman of obstetrics and gynecology at Brown University’s Warren Alpert Medical School and was on the USPSTF task force. The American College of Obstetrics and Gynecology (ACOG) and other organizations are still recommending yearly pelvic exams for women over the age of 21.

So, at the risk of being redundant, I strongly disagree with the conclusion of the USPSTF draft evidence review, but particularly as it applies to postmenopausal women. There is a lot more that goes into the routine gynecological visit, including the pelvic exam. Women 18 years and older or anyone with risk factors like multiple partners, history of HPV, chronic infection or fertility issues should be seeking routine pelvic exams and pap smears. Contact our office to see if you should come in for a screening.

Sincerely,

Dr. James A. Simon, MD, CCD, NCMP, IF, FACOG

USPTF Rebuttal: Why Women Still Need Pelvic Exams

Recently, the U.S. Preventive Services Task Force (USPSTF) concluded that there is limited evidence to support doing routine pelvic exams for women who are healthy and not pregnant. They say: “There is limited evidence regarding the diagnostic accuracy and harms of the routine screening pelvic examination to guide practice.”

An Absence of Evidence
Does this lack of evidence mean there is no benefit to routine pelvic exams? Absolutely not. The absence of evidence does not indicate the evidence of absence. In other words, if there is absence of or limited evidence for the benefits of routine pelvic exams that does NOT mean there is adequate evidence to recommend against them. In fact, these most recent draft guidelines don’t make much sense to me at all. Here are just a few reasons why:

  • Possibility of bias- The authors are all women from the West Coast of the US, and there isn’t a single gynecologist among them, so there is a significant absence of diversity (by gender, by geography, and by specialty) which could be a source of bias. In fact, most of the authors are not physicians, nor have they ever performed a routine pelvic exam.
  • “Insufficient” evidence- The authors note that “the current evidence is ‘insufficient’ to determine the balance of benefits and harms of the pelvic exam,” however, this didn’t deter them in drafting recommendations in favor of stopping routine pelvic exams.
  • The authors judged the effectiveness of the pelvic examination in reducing all-cause mortality, cancer- and disease-specific morbidity and mortality, and improving quality of life. These are all very “blunt instruments” (aka insensitive assessments) which are particularly obtuse in younger women where death and cancer related morbidity are rarely relevant, and almost never proximate in time.
  • The authors found only eight studies looking at the diagnostic accuracy of pelvic exams, and for only four medical conditions: ovarian cancer, bacterial vaginosis, trichomoniasis, and genital herpes. So in the studies evaluated, the only endpoint that would lead to mortality, cancer- and disease-specific morbidity and mortality, is ovarian cancer, and everyone knows that the pelvic exam is notoriously bad for detecting ovarian cancer. Furthermore, no one dies from bacterial vaginosis, genital herpes and vaginal trichomoniasis, all of which are treatable (and don’t cause death).
  • Finally, the authors did not recommend changes to current cervical cancer screening guidelines (aka pap smears with or without human papilloma virus (HPV) testing). Since these guidelines DO recommend routine cervical cancer screening, which does require–at a minimum–a vaginal speculum exam (not exactly the same as a pelvic exam), how is one to do this without a routine screening pelvic examination?

So, at the risk of being redundant, I strongly disagree with the conclusion of the USPSTF draft evidence review, but particularly as it applies to postmenopausal women. There is a lot more that goes into the routine gynecological visit, including the pelvic exam. The pelvic exam is needed to screen for conditions such as the genitourinary syndrome of menopause (vaginal atrophy, that affects more than 50% of postmenopausal women), fibroid tumors, abnormal or heavy menstrual bleeding, pelvic floor conditions, and cancers and precancers of the vulva, vagina, cervix and uterus, etc. Not to mention: gonorrhea, chlamydia, syphilis, hepatitis, HIV; spousal, alcohol and drug abuse; menopausal hot flashes and night sweats, sexual dysfunction, among many other conditions.

Missed Opportunities
Broadly, the conclusion to discontinue the routine pelvic exam runs counter to the goals of improving women’s health through preventive care. If pelvic exams are performed only when women complain of problems or have symptoms, we will miss opportunities to diagnose potentially fatal pelvic cancers and other conditions. Being asymptomatic is not the same as being healthy or not having a problem.
Sincerely,

Dr. James A. Simon, MD, CCD, NCMP, IF, FACOG

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Released July 1, 2016

Under the editorship of NAMS Executive Director JoAnn V. Pinkerton MD, NCMP, First to Know presents commentary on the latest, breaking scientific articles as suggested by members of The North American Menopause Society (NAMS), the leading nonprofit scientific organization dedicated to improving women’s health and quality of life through an understanding of menopause and healthy aging. Opinions expressed in the commentary are not necessarily endorsed by NAMS or by Dr. Pinkerton.


USPSTF looks for public comment on routine pelvic exams draft evidence review

“There is limited evidence regarding the diagnostic accuracy and harms of the routine screening pelvic examination to guide practice.”

Guirguis-Blake JM, Henderson JT, Perdue LA,
Whitlock EP. Screening for Gynecologic Conditions With Pelvic Examination: A Systematic Review for the US Preventive Services Task Force. Evidence Synthesis
No. 147. AHRQ Publication No. 15-05220-EF-1. June 2016.

Summary. The US Preventive Services Task Force (USPSTF) has opened for public comment a draft evidence review on the necessity of annual well-woman pelvic examinations. The final evidence review will be used to inform the first-ever USPSTF recom- mendation statement on pelvic exams.

The USPSTF has pointed out that although some 60 million pelvic exams are done each year, the practice has not been very well studied and said that the current evidence is “insufficient” to determine the balance of benefits and harms of the pelvic exam.

The systematic review was written to support the USPSTF in creating its recommendation on the periodic screening pelvic examination. The authors sought to discover direct evidence for the effectiveness of the pelvic examination in reducing all-cause mortality, cancer- and disease-specific morbidity and mortality, and improving quality of life.

The authors performed a search of the medical literature published over the past 60 years. They located just eight studies looking at the diagnostic accuracy of pelvic exams for only four medical conditions: ovarian cancer, bacterial vaginosis, trichomoniasis, and genital herpes.

In the four ovarian cancer screening studies, with more than 26,000 women screened, more than 96% of the positive test results were false positives, and many patients had unnecessary follow-up procedures. Surgery rates resulting from an abnormal pelvic examination ranged from 5% to 36% at 1 year, with the largest study reporting an 11% surgery rate and 1% complication rate within 1 year.

In the end, the authors found no studies that assessed how effective the exams are for reducing death and disease or improving quality of life.

The draft recommendation does not apply to women who are pregnant or those with existing conditions that need to be evaluated and does not recommend changes to current guidelines for cervical cancer screening.

The American College of Obstetricians and Gynecologists (ACOG) said in a June 28, 2016, statement on the draft recommendations that it continues to recommend an annual pelvic examination for women aged 21 years and older but acknowledges that there is a lack of data. Its Well-Woman Task Force in 2015 recommended annual external exams but said that internal speculum and bimanual exams for women without specific complaints or symptoms should be “a shared, informed decision between the patient and provider.” ACOG is reviewing the draft recommendation to decide whether it needs to update its own pelvic-exam guidelines.

The opportunity for public comment on the draft review evidence expires on July 25, 2016, at 8:00 PM EST. To comment, go to USPSTF draft evidence review.

Commentary. The Executive Committee of The North American Menopause Society (NAMS) strongly disagrees with the conclusion of the USPSTF draft evidence review, particularly as it applies to postmenopausal women. The only four outcome measures available for inclusion in the review—ovarian cancer (for which there is NO good method of detection), bacterial vaginosis, genital herpes and vaginal trichomoniasis—represent a narrow fraction of the key medical conditions screened during the pelvic exam and disregards the many

benefits of the pelvic exam. Although it is perhaps reasonable to recommend against the pelvic exam for diagnosing those four conditions, there is no scientific basis for extrapolating beyond those four specific conditions to the myriad conditions that affect women.

The pelvic exam is needed to screen for conditions such as the genitourinary syndrome of menopause that affects more than 50% of postmenopausal women, neoplasias, fibroids, pelvic floor conditions, and dermatologic conditions associated with elevated disease risks (eg, lichen sclerosis). Broadly, the conclusion to discontinue the exam runs counter to the goals of improving women’s health through preventive care. The recommendation to perform pelvic exams only if women complain of problems will lead to missed opportunities to diagnose pelvic issues. Being asymptomatic is not the same as being healthy or not having a problem. The recommendation to discontinue routine pelvic exams runs the risk of further marginalizing postmenopausal women.

We strongly encourage a call to action to comment on this draft recommendation and to have your voices heard BEFORE women lose their right to routine screening pelvic exams.

The NAMS 2016 Executive Board

JoAnn V. Pinkerton, MD, NCMP, NAMS Executive Director
Peter F. Schnatz, DO, NCMP, NAMS President
Marla Shapiro, MD, NCMP, NAMS President-elect
Pauline M. Maki, PhD, NAMS Past-President
James Liu, MD, NCMP, NAMS Treasurer
Gloria Richard-Davis, MD, FACOG, NAMS Secretary
Sheryl Kingsberg, PhD, NAMS Board Member


First to Know® is a registered trademark of The North American Menopause Society Copyright © 2016 The North American Menopause Society
All rights reserved
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fda approved addyi todayDear Patient, Supporters and Friends,

Today the FDA made #HERstory for women with the approval of a first-ever medical treatment option for women’s most common sexual dysfunction, known as Hypoactive Sexual Desire Disorder, or HSDD. You can think of this disorder (HSDD) as: distressing low desire that can affect a woman, her partner or both and that lasts and lasts and lasts for more than 6 months regardless of circumstances, mood, vacation, health, etc. After enjoying normal sexual function, and then totally losing one’s interest in or desire for sex for longer than 6 months gives you some idea of the scope and impact of HSDD.

I know all of you have been closely monitoring the national conversation over the “little pink pill” or the “female Viagra” during the last year as the drumbeat has built among organizations such as ours – and among hundreds of thousands of people across the country – for treatment options for a condition that the FDA itself has recognized as a key unmet medical need. We at James A. Simon, MD, PC have been actively involved in the development of Flibanserin, or its new trade name ADDYI, for many years and have conducted several of the clinical trials used for FDA approval right here in the Washington, DC, office. For those of you who participated in those clinical studies, we want to personally thank you. Whether you received the active treatment in those trials or the matching placebo, soon you will be able to take “the real thing.”

James A. Simon, MD, PC is proud to be a part of such a thrilling moment in women’s sexual health and for the 16 million American women currently living without a single FDA-approved medical treatment option for HSDD.

With the FDA’s action today, The Agency not only approved a first-ever medical treatment option for HSDD, it also demonstrated that there IS a viable regulatory pathway forward toward approval of additional therapies for this and other female sexual health indications. Further, Flibanserin’s (ADDYI’s) approval today, opens the pipeline for other future options yet to come for women’s sexual health. In that vein, we are currently conducting additional studies on other medications for female sexual dysfunction right here at James A. Simon, MD, PC, and we are always looking for qualified study subjects/volunteers.

Women with HSDD deserve the safety and peace of mind that comes with access to FDA-approved medical treatment options, and today we write a new chapter in the fight for equity in sexual health.

Sincerely,
The entire James A. Simon, MD, PC family

 

Interested in women’s sexual health? Contact us for an appointment.

Electronic Medical Records (EMR) –A Balanced View

screenshot_5148_432x324One of the cornerstones of The New Government Health Plan is the use of the electronic medical record (EMR), sometimes called Electronic Health Records (EHR).  Proponents offer these as some of the advantages of those systems:

  • Universal coding of medical diagnoses and procedures so that insurers can better understand the public’s health and properly allocate resources
  • Avoidance of problems interpreting various handwriting styles
  • Ability to incorporate automated reminders and alerts (i.e. patient due for colonoscopy or bone density test, or vaccination) as part of the system.

Most hospitals and large practice administrators support the EMR concept. In addition to having the staff and resources to make the system  function, the system is effective in capturing more charges and assists in better collections.  And the federal government subsidizes the initial purchase an implementation of the system.

Practitioners are a little less enthusiastic.

Enormous amounts of time are required to fill out electronic templates, complete countless electronic forms and respond to automated questions not impacting patient care, while often negotiating frustrating electronic roadblocks. The time required for the process occupies the staff and diverts the practitioner’s focus from the patient to a computer process. As a result, practitioners are spending less time interacting with their patients and more time looking at the computer screen. Overall, patient’s best interests seem to have largely been lost in this conversation.

Our practitioners – James A. Simon, MD; Lucy D. Treene, MSHS, PA-C; Carol J. Mack, MSHS, PA-C, MPH – are not Luddites (people just down on technology). Quite the contrary!  We use many facets of the EMR systems, such as e-prescribing, e-scheduling, electronic billing to Medicare, all of which improve patient care, reduce medical errors, or, in the case of Medicare billing, are required by the government. But we are selective because we are, particularly in our field, first and foremost concerned with the privacy of our patients.

Consider the recent cyber attacks at the Department of Health and Human Services (DHS) and the successful electronic security breach at the Office of Personnel Management (OPM) affecting 22.1 million people (“Hackers stole vast amount of sensitive data” according to The Washington Post), which resulted in the resignation of OPM Director Katherine Archuleta. The Carefirst® BlueCross BlueShield family of companies was also recently and successfully hacked for personal information (including that of James A. Simon, MD, PC employees).

Being one of the foremost specialty medical practices in women’s sexual health in the world, the risk of our patients’ private records becoming public is simply not worth taking.  Our patients’ sexual problems, predilections and peccadillos are private and, unlike your FICO “credit” score which can be restored if your credit card is lost or stolen, once the details of your private sexual life are “out there,” that information can live forever on Google, Facebook or Twitter. And in case you should think, even for a minute, “who cares about MY sexual life,” don’t forget our offices are convenient to many in the public eye, five blocks from The White House, 2 ½ miles from The Capitol, and 3 miles from The Supreme Court.  Patients, many of them quite prominent, come to see us from all over the world as well.  No matter who you are, your health information is private at James A. Simon, MD, PC, and no one’s business but yours!

In our world of internet immediacy and electronic everything we agree with author Lisa Gardner’s comment, “There are things that once done can’t be undone, things that once said can’t be unsaid.”

 

Interested in women’s sexual health? Contact us for an appointment.

Vulvovaginal Atrophy

th_100candidiasis_vaginal_vulvovaginalThe symptoms of vaginal atrophy in postmenopausal women most commonly include dryness (the sensation of dryness unrelated to sexual activity), and dyspareunia (difficult or painful sexual intercourse). The relative proportion of these two symptoms appears to vary. Reported differences in the relative prevalence of dryness vs. dyspareunia may have more to do with the frequency and type of sexual activity in the women surveyed than the prevalence of the symptom per se.

Other symptoms include vaginal itching, discharge, pain unrelated to sexual activity, bleeding, and increased susceptibility to both vaginal and urinary tract infections. Severe narrowing, shortening and ultimately the complete obliteration of the vaginal vault can occur. When such anatomic changes result sexual intercourse becomes impossible.  Even in milder cases, dyspareunia and reduced vaginal lubrication during sexual arousal commonly result in deterioration of a patient’s sexual quality of life, with aggravation and intensification of preexisting disorders of female sexual response.

Collectively, these physiologic changes and associated symptoms can impact all stages of the sexual response cycle, including desire, arousal, and/or orgasm. Overall sexual satisfaction is diminished. It is well documented that such effects not only impact the postmenopausal woman, but also interfere with her intimate partner relationships.  And unlike other menopausal symptoms which are usually temporary an eventually cease even without treatment, the problems associated with VVA usually increase with age in the absence of treatment.

Despite the prevalence of vulvovaginal atrophy and its associated symptoms, few women suffering from them report their problem/symptoms to their physicians or other healthcare professionals. Only 20 – 25% of affected women seek treatment. Despite the adverse impact of the vulvar, vaginal, and urinary tract symptoms on their quality of life, postmenopausal woman appear to silently and stoically accept their symptoms and the associated health problems as a natural and unavoidable part of the aging process. Unfortunately, many healthcare professionals are often complicit in this, as they do not sufficiently query patients about their symptoms or inform them about the nature of the disease state.

The good news is that there exist many therapeutic options for the treatment of these symptoms, and not all of them hormonal. If your current healthcare professional seems disinterested in improving the quality of your life in this area, seek out one who does. There simply is no need to suffer in silence.

Vulvovaginal Atrophy – Are You Suffering in Silence?

 

Interested in women’s sexual health? Contact us for an appointment.

Vulvovaginal Atrophy

vulvovaginalVulvovaginal atrophy (VVA) is a common condition associated with the decreased estrogenization of the vaginal tissues. It occurs most often after menopause, but it can also develop during breast-feeding or at any other time your body’s estrogen production declines.

The inevitable estrogen deficiency that accompanies reproductive aging and menopause results in universal changes in the vaginal ecosystem associated with a variety of vulvovaginal and urogenital complaints. At some point in their lives, the majority of women will experience these symptoms, collectively termed the genitourinary syndrome of menopause (GSM), a term which has recently replaced vulvovaginal atrophy (VVA) in the accepted nomenclature. VVA or GSM symptoms usually develop gradually and become most bothersome as women transition to the mid-to-late 50’s. These symptoms typically follow the vasomotor symptoms of menopause, such as hot flashes and night sweats. Unlike VMS, which usually subside after several years, the symptoms of GSM (see below) persist and increase in both frequency and intensity as women age.

With estrogen deficiency, the epithelium (aka the surface cells) of the vagina and vulva thins and loses its rugal folds. Those folds are really important. Think of the difference between a pair of pants with elastic, or a skirt with pleats vs one without. Imagine how you would feel trying to put them on if you’ve gained 20 pounds. Which pants would you like to squeeze into? With menopause and increasing VVA or GSM, the elasticity provided by those rugal folds diminishes, and susceptibility to injury, even with minor trauma, can ensue. Estrogen deficiency also leads to diminished vaginal glycogen and decreased acidity of the vaginal secretions (increased pH), thereby reducing the vagina’s natural defense against local pathogens (i.e. yeast and coliforms [the most common bacteria of fecal material]). The close proximity of the lower urinary tract to fecal contamination is associated with an increased risk for acute and recurrent urethritis and cystitis (bladder infections).

When a woman doesn’t have intercourse or other vaginal sexual activity on a regular basis following menopause, her vagina may also become shorter and narrower. Continuing to have regular vaginal sexual activity through menopause helps keep the vaginal tissues thick and moist and maintains the vagina’s length and width. This can help keep sexual activity pleasurable. This has euphemistically been referred to as “use it or lose it”.

If you do experience vulvovaginal symptoms (dryness, irritation, burning, itchiness, pain) do not automatically assume that reduced estrogen levels are the reason for these symptoms. Because vaginal discomfort can arise from many different sources, persistent symptoms should be brought to the attention of your healthcare provider for evaluation.

 

Interested in women’s sexual health? Contact us for an appointment.

Is the FDA Approval of the “Pink Pill” a Probable Outcome?

18jdwo1qlvkujjpgA failure to approve flibanserin would set a dangerous precedent. Why? Because the pharmaceutical company did everything the FDA asked it to do, and the results came out statistically significantly better than placebo—which was the desired endpoint. If the FDA were to deny approval of the drug, it would be saying, in effect, that it can change its mind in the middle of the argument.

In reality, the FDA is likely to say yes to approval, but with restrictions, as that is what its advisory committee recommended. What those restrictions will be remains to be determined, but they are likely to resemble those of other drugs in the class, such as selective serotonin reuptake inhibitors (SSRIs), including a warning to be careful using flibanserin with alcohol until the drug’s effects are clear.

 

Interested in women’s sexual health? Contact us for an appointment.

Menopause PhysiciansThese days, it seems like hormone “treatment centers” are popping up all over the place, and online “pharmacies” are constantly pushing the latest and greatest hormones for menopausal and postmenopausal women. But what about the woman who is looking for individualized evidence-based counsel and care to help guide her through the menopause transition? Why is it so hard to find a physician who specializes in menopausal medicine?

Part of the reason dates back to the Women’s Health Initiative, a first-of-its-kind, 15-year study that included a trial on the effects of combined (estrogen-progestogen) hormone replacement therapy. Before the trial’s abrupt end in 2002, menopause care was a developing area of medicine, with a growing number of continuing education classes being offered to healthcare professionals, and the use of hormone therapy among postmenopausal women on the rise. But then the combined hormone therapy arm of the study was cut short—four years ahead of schedule—and news quickly spread of its controversial results.

Results showed that women taking the estrogen-progestogen combination had a greater incidence of breast cancer, heart disease, stroke and blood clots—risks that far outweighed the benefits of hormone therapy. With this news, everything stopped. Patients were advised to discontinue treatment. Physicians were afraid to prescribe anything.

Unfortunately, the publicity surrounding the combined therapy results overshadowed the positive results of the estrogen-only therapy, which did not show an increased risk of heart disease or breast cancer. But the damage was done. The topic didn’t get much attention after that. And the impact on physician education was significant.

Ten years later, views on hormone therapy continue to evolve. For instance, recently released guidelines from the North American Menopause Society (NAMS) indicate that many women can safely take hormone therapy. (To view the latest NAMS recommendations, click here. But I suppose some physicians are still a bit gun-shy about what remains a controversial topic in the media and even the medical community—despite the rapidly growing number of women seeking menopause care.

The fact remains, however, that the alternative treatment options—the online pharmacies and “hormone houses”—are no substitute for evidence-based medical care by a certified menopause practitioner. Menopause treatment is highly individualized and requires a patient-focused approach to care.

So do yourself a favor, and seek out a healthcare professional specially trained in the care of women during menopause. If you live in or around DC, I’d love the opportunity to partner with you in your care. And if you’re not local to DC, simply visit the NAMS website to find a certified menopause practitioner near you.

 

Interested in women’s sexual health? Contact us for an appointment.

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