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|Jump to:||Choose article section...New progestin controls flushing, preserves bone, with acceptable bleeding profile The overmedicalization of female sexuality How safe is assisted reproductive technology? Increased exercise decreases breast cancer risk in postmenopausal women New tubal microinserts prove safe, well-tolerated, and effective as permanent contraception Fibroid embolization or myomectomy? It depends on the patient A new approach to SUI is in the wings Prenatal NSAIDs increase risk of miscarriage Testosterone improves libido in postmenopausal women There is a reason to continue glucose tolerance testing during pregnancy Far less estrogen still protects against osteoporosis Sentinel node biopsy: viable alternative to axillary dissection PROFESSIONAL UPDATE Many ob/gyns are disenchanted with their careers Survey reveals ob/gyns are the highest paid PCPs More and more med students let lifestyle dictate choice of specialties Benefits and barriers to large group practices New tax law could mean bigger breaks for some practices|
A large, randomized multicenter study shows that combined sequential estrogen (CE) and trimegestone (TMG)a novel progestinhold promise in treating postmenopausal vasomotor symptoms and vaginal atrophy and increasing bone mineral density (BMD). Reporting at the 59th Annual Meeting of the American Society for Reproductive Medicine in San Antonio, researchers said the therapy offers endometrial protection with an acceptable bleeding profile.
The study assigned more than 1,600 healthy women aged 40 to 65 (mean 51.8) with intact uteruses to placebo or one of four regimens of oral CE/TMG: continuous combined CE 0.625 mg with TMG 0.0625 or 0.125 mg; or sequential CE 0.625 mg on days 1 to 28 plus TMG 0.125 or 0.250 mg on days 17 to 28. The treatment's metabolic and endometrial impact was analyzed after 13 28-day cycles or 1 year, and the impact on bone was examined after 2 years.
Diaries were used to track vasomotor symptoms and adverse events, and vaginal atrophy was assessed using the vaginal maturation index (VMI). Lipid, carbohydrate, and hemostasis profiles were assessed at baseline and cycles 6 and 13; several lipid measures also were collected at cycles 19 and 26. Endometrial biopsies were done at baseline and cycles 6, 13, and 26 and read by two pathologists. Dual-energy x-ray absorptiometry (DXA) was used to measure lumbar spine and proximal femur BMD at baseline and cycles 6, 13, and 26.
By the end of cycle 3, women receiving CE/TMG were experiencing more than 90% fewer hot flushes, versus a 30% decrease in the placebo group. By cycle 6, they also had a significant increase in percentage of vaginal superficial cells (P<0.001). Differences in dosage did not have a clinical impact on these results. The CE/TMG regimens also increased high-density lipoprotein cholesterol by 7% to 21% and decreased low-density lipoprotein cholesterol by 8% to 17%.
By the end of cycle 13, women receiving CE/TMG had significantly lower rates of endometrial hyperplasia (<0.5%) than those on CE 0.625 mg alone in previous studies (8% to 20%; P<0.001). Amenorrhea patterns by cycle and cumulative amenorrhea rates at cycle 13 were similar for the two continuous combined regimens: 85% and 86%. In the sequential group at cycle 8, 78% and 75% of women had withdrawal bleeding after discontinuation of cyclic progestin and 5% to 10% of the women had irregular bleeding (mean 24 days/cycle). As presenter James H. Pickar, MD, noted, "bleeding with CE/TMG is comparable to standard-dose PremPro but PremPro has a higher rate of amenorrhea."
When the investigators looked at the impact of 2 years' treatment on bone, they found a significant increase (P<0.001) in BMD at the lumbar spine (4.7% to 5.1%), femoral neck (3.0% to 4.0%), and femoral trochanter (4.2% to 5.5%) compared with placebo. BMD measurements increased significantly from baseline in all treatment groups except for femoral neck BMD in women on sequential CE/TMG. As presenter, Robert Lindsay, MD, noted, "the doses of trimegestone and estrogen studied would likely produce an antifracture response."
Lobo RA, Dorin MH, Lewis V, et al. Safety and efficacy of conjugated estrogens (CE/) trimegestone (TMG) on vasomotor symptoms, vaginal atrophy, and metabolic profiles in a double-blind, randomized, placebo-controlled study. Presented October 13, 2003 at the 59th Annual Meeting of the American Society for Reproductive Medicine, San Antonio, Tex. Fertil Steril. 2003;80(suppl 3):O-42.
Lindsay R, Gallagher JC, Harrison DD, et al. Effect of conjugated estrogens (CE)/trimegestone (TMG) on bone mineral density (BMD) in early postmenopausal women in a double-blind, randomized, placebo-controlled study. Presented October 13, 2003 at the 59th Annual Meeting of the American Society for Reproductive Medicine, San Antonio, Tex. Fertil Steril. 2003;80(suppl 3):O-45.
Pickar JH, Yeh IT, Cunnane MF, et al. Impact of conjugated estrogens (CE)/trimegestone (TMG) on endometrial hyperplasia and bleeding profiles in a double-blind, randomized, placebo-controlled study. Presented October 13, 2003 at the 59th Annual Meeting of the American Society for Reproductive Medicine, San Antonio, Tex. Fertil Steril. 2003;80(suppl 3):O-47.
Leonore Tiefer, PhD, an associate clinical professor at New York University Medical Center, gave one of the more provocative presentations at this year's ASRM meeting, asserting that we have been conditioned by the entertainment industry, drug companies, and the mass media to develop a somewhat warped sense of human sexuality. They've convinced the American public to expect life-long ecstatic sexual experiences. And they have also persuaded us to see sex as "nothing more than a medical function like breathing or digestion. Women are all supposed to experience sex in the same way and those who don't are diagnosed with 'female sexual dysfunction (FSD).' " One of the consequences of this overmedicalized view is that it encourages clinicians to seek "magic bullet" pharmaceutical solutions to "correct" what has come to be perceived as a physiological defect.
Dr. Tiefer proposes a far more complexand realisticapproach to managing female sexual problems. Among the underlying causes of FSD that need to be addressed are:
In a call to action to clinicians, she concluded that you "have tremendous leverage in the eyes of the public and the media because of your technical expertise. But if you just are technocrats, you're not going to understand sexuality or be helpful." For more details on her research, see http://www.fsd-alert.org .
Last year, an Australian study made headline news when it reported that "Infants conceived with the use of intracytoplasmic sperm injection (ICSI) or in vitro fertilization have twice as high a risk of a major birth defect as naturally conceived infants."1 To look more closely at the possible link between infertility treatments and fetal/obstetrical complications, several investigators gathered at this year's ASRM meeting to present their findings.
When University of Iowa researchers compared children who had been conceived with the help of traditional IVF, ICSI, and ZIFT (zygote intrafallopian transfer) to those conceived by means of intrauterine insemination (IUI), and to those conceived without unusual medical interventions (normal controls), they found birth defects in 6.61% of the 1,500+ children conceived by ART, 7.49% in the IUI group (300 children), and 4.87% in the control populations (n=8,280). In other words, the risk of developing birth defects was about 34% greater after any form of ART, when compared to normal controls. Their retrospective analysis also suggested that the threat of birth defects was about 40% greater among women who had undergone IUIwhen compared to the general publicbut the results did not reach statistical significance, perhaps because of the relatively small number of patients in the sample. The researchers theorize that since there wasn't much difference between the IUI and ART groups, ART itself was probably not to blame for complications; it was more likely some factor within the infertile population. (Abstract P-159)2
In a separate ASRM presentation, University of Washington clinicians compared ICSI (n=474) to traditional IVF (n=321) over a 2-year period. They weren't able to find any significant difference in the frequency of obstetric complications and fetal abnormalities in their retrospective analysis, even after taking into account varying sperm quality from couple to couple. They were quick to point out, however, that the children were not tested for micro-deletions among the severe male factor cases. Nor did they compare either of their groups to children conceived by noninvasive techniques like IUI. And of course they didn't match their patients to a control group from the general population. (Abstract P-171)
And finally, when Japanese researchers compared naturally conceived children to those brought into the world with the help of traditional IVF, ICSI, or FET (frozen embryo transfer), they noticed that those in all three IVF groups were less physically developed (height and weight were lower at birth, when compared to naturally conceived infants). Those disadvantages disappeared, however, by the time the children reached 6 months of age. More specifically, IVF infants weighed on average 2,440 g at birth and were 46 cm long, while naturally conceived infants weighed 3,040 g and were 49 cm long. The differences started to even out by the third month. (Abstract P-129)
Because both the public and the profession remain concerned about the potential adverse effects of ART, the American Infertility Association just recently announced that it will start the first US database to track the health and welfare of children conceived through IVF. It will collect basic information like birthweight, birth defects, surgical procedures, and developmental milestones, tracking IVF children from pregnancy through at least 3 years of age. The registry should come online in the spring of 2004. For more details, visit http://www.americaninfertility.org .
1. Hansen M, Kurinczuk JJ, Bower C, et al. The risk of major birth defects after intracytoplasmic sperm injection and in vitro fertilization. N Engl J Med. 2003; 346:725-730.
Exercising longernot necessarily harderdecreases the risk of breast cancer in postmenopausal women, according to the results of a prospective cohort study.
The 5-year study involved more than 74,000 women aged 50 to 79 at 40 centers across the United States. Compared with less active women, women who engaged in regular physical activity at age 35 reduced their risk of breast cancer by 14%. Similar findings emerged for women aged 18 and 50.
Those who engaged in activity equivalent to 1.25 to 2.5 hours per week of brisk walking decreased their risk by 18%. Slightly greater benefit was afforded to those engaging in the equivalent of 10 or more hours per week of brisk walking. The effects were most pronounced in the women weighing the least.
Women can now achieve permanent sterilization without surgery and in about 80 minutes of outpatient time, according to a prospective, Phase III, international, multicenter trial of the Essure Permanent Birth Control System (Conceptus Inc., San Carlos, CA).
Under hysteroscopic guidance, researchers successfully transcervically delivered the bilateral tubal occlusion microinserts into the proximal fallopian tube lumens of 464 women. The women ranged in age from 21 to 40 years and ranged in body weight from 90 to 300 lb. All were required to have regular menses for 2 months prior to placement, to have given birth to at least one live child, and to have a minimum of four to eight acts of intercourse per cycle.
Ninety-three percent of the women received local anesthesia with or without IV sedation. One woman received general anesthesia, and 7% received nothing other than the oral nonsteroidal anti-inflammatory drug given to all the women. More than half the women rated pain during the procedure and after the procedure as mild or nonexistent, 88% rated tolerance as good to excellent, and virtually all of the women (99%) rated comfort as good to excellent. Only 12% of the women received narcotic-containing analgesics after the procedure.
Average time to discharge was 1 hour and 20 minutes. Sixty percent of the women returned to normal activity within 1 day. Ninety-two percent missed 1 day or less of work. Correct placement of the microinserts and tubal occlusion were maintained 90 days after initial placement in 96% and 92% of the women, respectively. And after 9,620 woman-months of exposure to intercourse, no pregnancies were reported.
Uterine fibroid embolization is more effective at treating menorrhagia, causes fewer complications, and requires less of a hospital stay, less narcotic use, and less convalescence than abdominal myomectomy, according to a retrospective study. But it's no better at treating pain, is less effective at treating mass effect, and may not reduce tumor size adequately or quickly enough in those seeking cosmetic effect.
Researchers reviewed the experiences of 111 women who underwent either of the procedures during a 30-month period. They found that women whose dominant symptom was menorrhagia faired better with embolization, perhaps because the culprit tumor is not always removed with surgery. Bleeding resolved in 92% of the embolization group versus 64% of the myomectomy group (P< 0.05). But patients who complained primarily of abdominal distention or urinary tract symptoms (the mass effect) did better with surgery (91% success) than embolization (76%) (P< 0.05), perhaps because the fibroids are not removed with embolization and may not reduce in size for some time. Relief of pain was similar in both groups at 54% for the myomectomy group versus 74% for the embolization group (P> 0.05).
On a related note, women who underwent myomectomy required on average 2.9 days in the hospital versus 0 for those who were embolized, 8.7 days of narcotics for pain versus 5.1 in the embolization group, and 36 days until resuming all normal activities versus 8 in the embolization group.
Duloxetine may become the first drug approved by the FDA to specifically treat stress urinary incontinence (SUI), which affects one in three American women over the age of 18. A recently published Phase III study found that the serotonin and norepinephrine reuptake inhibitor significantly reduced the number of weekly incontinent episodes among women with the bothersome condition and measurably improved their quality of life.
The 12-week, double-blind, placebo-controlled study involved 683 North American women between the ages of 22 and 84 who had a mean baseline weekly incontinent episode frequency (IEF) of 18. Duloxetine, 40 mg twice daily, significantly decreased IEF compared with placebo (50% vs. 27%, P< 0.001). Slightly more than half (51%) the women taking duloxetine experienced a 50% to 100% decrease in incontinent episodes, compared to 34% of those taking placebo (P< 0.001); 10.5% of those taking duloxetine experienced no incontinent episodes at all. Unfortunately, almost one fourth (24%) of the duloxetine group discontinued treatment due to side effects, of which nausea was the most common, followed by fatigue and insomnia.
Since the average voiding interval of those taking duloxetine actually increased 20 minutes, researchers concluded that efficacy was not due to more frequent voiding. Instead, researchers believe the agent works by blocking the reuptake of serotonin and norepinephrine in the spinal cord. The increase in neurotransmitters increases activity of the nerve that stimulates the urethral sphincter, thus increasing contraction of the urethral sphincter at the opening of the bladder.
Prenatal use of nonsteroidal anti-inflammatory drugs (NSAIDs) increases the risk of miscarriage by 80%, according to this population-based cohort study, and the risk is even higher if NSAIDs are taken around the time of conception or for more than a week. Researchers from Kaiser Permanente also found a weak association with prenatal aspirin use, but no increased risk of miscarriage with prenatal use of paracetamol (acetaminophen).
In-person interviews with more than 1,000 women immediately after a positive pregnancy test formed the basis of the study, which looked at prenatal use of NSAIDs, aspirin, and paracetamol. Prenatal use was defined as use after the last menstrual period. The drugs studied were ibuprofen or naproxen or preparations containing them, aspirin or drugs containing it, and acetaminophen or drugs containing it. Seven women who had taken NSAIDs or aspirin for crampingwhich could have been an early sign of miscarriagewere excluded.
The women were also asked about their reproductive history, known or potential risk factors for miscarriage, and sociodemographic characteristics. Mean gestational age at entry was 40 days and information on pregnancy outcome was obtained for every participant up to 20 weeks' gestation.
After adjustment for previous miscarriage, education, maternal age, gravidity, race, use of a Jacuzzi or hot tub, multivitamin use, and smoking since last menstruation, the use of NSAIDs during pregnancy increased the risk of miscarriage by 80% (adjusted hazard ratio 1.8 [95% CI 1.03.2]). The risk of miscarriage was much higher when women took NSAIDs around conception (adjusted hazard ratio 5.6 [2.313.7]) or used them for more than a week (8.1 [2.823.4]). Adjusting for prenatal alcohol or coffee intake did not change the results. Prenatal use of aspirin also increased the risk of miscarriage, but the association was weaker and the estimates were unstable because of the small number of aspirin users. Using acetaminophen during pregnancy did not increase the risk of miscarriage, regardless of when or for how long a woman took it.
While estrogen can relieve hot flashes, it also suppresses testosterone by enhancing sex-hormonebinding globulins, leaving many older women with less interest in sex. Replacing this testosterone, according to a recent randomized, double-blind study, provided women with a more than twofold improvement in sexual drive and interest, compared to patients who received estrogen alone.
Researchers in New York and New Jersey looked at 221 healthy, postmenopausal women between the ages of 40 and 65 who were taking estrogen and experiencing diminished sexual desire. Half the women were given 0.625 mg esterified estrogen alone, while the other half received 1.25 mg methyltestosterone along with the estrogen.
Improvement was noted 8 weeks into the study and continued through the end of the 16-week study. Testosterone was well-tolerated with no reports of acne or excessive hair growth.
Lobo RA, Rosen RC, Yang HM, et al. Comparative effects of oral esterified estrogens with and without methyltestosterone on endocrine profiles and dimensions of sexual function in postmenopausal women with hypoactive sexual desire. Fertil Steril. 2003;79:1341-1352.
Pregnant women with untreated impaired glucose tolerance (IGT) have more cesarean sections, more premature babies, more large-for-gestational age (LGA) infants, and increased admission to a neonatal intensive care unit (NICU) for 2 days or longer, according to a recent prospective study of 213 Swedish women.
According to the study results, patients with untreated IGT were about twice as likely as controls to have C/S, about twice as likely to give birth prematurely, and about seven times as likely to have LGA babies. In addition, their babies were about twice as likely as those of controls to require NICU stays of 2 days or longer.
The good news is that most of the children were healthy: 71.3% of the children of the IGT group had no neonatal complications, as did 87.3% of the control subjects.
One quarter of the usual dose of estrogen may be enough to prevent osteoporosis in postmenopausal women, according to a randomized, double-blind, placebo-controlled trial.
Researchers gave 167 community-dwelling women older than age 65 either 0.25 mg/d micronized 17ß-estradiol or placebo over a 4-year period. Women who had not had a hysterectomy also received 100 mg/d oral micronized progesterone for 2 weeks every 6 months.
Compared with the women receiving placebo, those given low-dose estradiol had mean increases in bone mineral density at the femoral neck of 2.6%, at the hip of 3.6%, at the spine of 2.8%, and total body of 1.2%. In addition, markers of bone turnover, N-telopeptides of type 1 collagen, and bone alkaline phosphatase decreased significantly in the low-dose estradiol group compared with those taking placebo.
In terms of adverse effects, there were no significant differences between the two groups in breast tenderness, changes in endometrial thickness or pathology, or annual mammographic results, and no reports of breast cancer emerged during the study.
While numerous studies have reported that sentinel node biopsy accurately predicts the status of other axillary nodes in women with small breast tumors, efficacy and safety remain unresolved issues.
But a recent study confirms that sentinel node biopsy is effective at identifying women with one or more axillary nodes that are positive for metastasis, that it does spare a number of women from unnecessary axillary dissection, and that it causes less pain and less impairment of arm mobility than full axillary dissection.
Researchers randomly assigned 516 women with a breast tumor of 2 cm or less in diameter to receive either sentinel node biopsy and total axillary dissection (group 1) or sentinel node biopsy followed by axillary dissection only if the sentinel node revealed metastases (group 2).
Of 259 patients in group 2, 35.5% were found to have a positive sentinel node and underwent total axillary dissection, a percentage almost identical to that found to have axillary metastasis in group 1 (35.4%). Accuracy of the second protocol was 96.9%, sensitivity was 91.2%, and specificity was 100%. Among the women who did not undergo axillary dissection as a result of sentinel node biopsy findings, no cases of overt axillary metastases appeared during 46 months of follow-up.
Nearly one quarter of obstetricians/gynecologists are experiencing dissatisfaction with their chosen specialty, according to a study in Obstetrics & Gynecology (9/03). While the majority of ob/gyns are indeed satisfied, the minority's disenchantment with their professioncaused by various sources of professional distressmay adversely affect the health-care delivery system, say the study's authors.
The authors, who are researchers at the University of California-Davis Medical Center, found that ob/gyns had significantly lower career satisfaction than other primary care physicians such as internists or family physicians, and were ranked 30th among 31 specialties in career satisfaction.
What is the cause of this dissatisfaction? One reason could be an inability to maintain continuing, long-term relationships with patientsthe kind that promote high-quality care. According to the study, in 19961997, only 55% agreed that they could maintain such relationships.
The authors also note that career satisfaction was strongly linked to whether the doctors could obtain the services necessary for patient care. Among the top concerns of ob/gyns: Arranging for nonemergency hospital admissions (only 54% of ob/gyns said they could always or almost always obtain this service), and getting an adequate number of bed days for their patients (just 42% could get this service).
The study also found that ob/gyns who were 65 years or older and practiced in medical schools, small communities, or within a subspecialty of obstetrics and gynecology were significantly more satisfied with their careers. Physicians who worked in health maintenance organizations were less likely to be satisfied with their careers.
Among primary care specialists, obstetricians/gynecologists led the pack with the highest practice revenue and total compensation in 2002, according to a survey published in Medical Economics (9/19/03), a sister publication of Contemporary Ob/Gyn. The survey found that ob/gyns earned $500,000 from practice revenue and $220,000 in total compensation.
In comparison to ob/gyns' practice revenues, family practitioners and pediatricians held the second highest earnings at $350,000 in 2002. Internists and general practitioners earned $318,600 and $249,000, respectively.
When it comes to total compensation in 2002, internists and family practice physicians earned $150,000 in total compensation, placing them second behind ob/gyns. Pediatricians followed with $130,000. General practitioners rounded out the group with $116,000.
Taking into consideration all practice specialties, the survey of 1,994 physicians also found that large practices with 10 to 24 doctors earned the highest revenueat $700,000and physicians in these groups earned the highest total compensationat $300,000. In addition, the total compensation for those in single-specialty groups was 16% higher than those in multispecialty groups.
An increasing number of US medical students are choosing specialties that seem to offer a "controllable lifestyle"one that allows for time to spend with family or on activities unrelated to work, according to a study in the Journal of the American Medical Association (9/3/03). The study's researchers suggest that this trend could alter the distribution of physiciansby creating shortages in specialties, such as obstetrics and gynecology or family practice, which require doctors to be on call during off-hours.
The findings show, for example, that the proportion of US senior medical students ranking anesthesiologyconsidered a specialty with a controllable lifestyleas their first choice of specialty increased from 1.6% in 1997 to 6.4% in 2002. In contrast, the proportion of seniors whose first choice of specialty was obstetrics and gynecologyconsidered a specialty with an uncontrollable lifestyledecreased from 7.8% in 1997 to 6% in 2002.
The study's researchers suggest that the increasing number of women entering medicine and decreasing professional autonomy will exacerbate the trend.
The study was based on an analysis of results from the National Resident Matching Program, the San Francisco Matching Program, and the American Urological Association Matching Program from 1996 to 2002.
It's long been argued that group medical practices can improve the quality of health care, decrease costs, and create a desirable professional working environment for physicians. But what do leaders of physician groups, hospitals, and health plans truly think are the benefits and barriers to group practice? That's what researchers from the Department of Health Studies at the University of Chicago, the Center for Studying Health System Change, Mathematica Poly Research Inc., and MedImmune Inc. sought to find out.
The researchers' findings, published in the Archives of Internal Medicine (9/8/03), found that the benefit most frequently cited by leaders of physician groups, hospitals, and plans was gaining leverage with health plans. Gaining economies of scale was another benefit, followed in order by gaining leverage with hospitals, potential to profit, and a better lifestyle. Improving quality of care was cited least frequently, at eight times less than the most frequently cited benefit of gaining leverage with health plans.
The top three most frequently cited barriers to group practices were a lack of physician cooperation, investment, and leadership. The researchers note that physicians' desire for autonomy and the lack of physicians with management skills as contributing factors. Other barriers include the failure of groups to manage the costs for capitated patients and the added costs of abiding by regulatory mandates, including laws defining minimum lengths of stay for obstetric patients.
For those medical practices that have been holding off on making major capital purchases, now may be the time to reconsider. The new tax cuts, signed into law in May, now allow for greater off-the-top deductions and depreciation for purchases such as new computers, office furniture, and medical equipment, according to American Medical News (6/23/03).
The new law provides an eligible practice with a $100,000 deduction on equipment and computer purchases up to $400,000. Under the old rule, practices could take a one-time $25,000 deduction in the first year that the purchases were made.
Moreover, under the new law, 50% of the value of certain assetssuch as computerscan be deducted immediately, with the remaining value deducted on a sliding scale over 3, 5, or 7 years. Under the previous rule, the initial deduction was 30%.
"Financial experts say the new rules provide strong incentive for doctors to invest in their practices by giving them more deductions in the first year that the assets were purchased," according to AMNews.
However, not all practices are eligible for these write-offs. A practice's corporate structure, for instance, or whether the practice posted a loss are among the factors that will determine what kinds of deductions can be taken.
Clinical Insights/Professional Update. Contemporary Ob/Gyn Nov. 1, 2003;48:16-35.