NEWSLINE

CLINICAL INSIGHTS

Long-term alendronate is safe and effective

Alendronate, the drug most commonly used to treat osteoporosis, is safe and effective for the prevention of fractures and bone loss for as long as 10 years, according to results published by the Alendronate Phase III Osteoporosis Treatment Study Group involving 247 postmenopausal women.

Compared with baseline values, the study reported that 10 mg a day of alendronate given over 10 years produced mean increases in bone mineral density of 13.7% at the lumbar spine, 10.3% at the trochanter, 5.4% at the femoral neck, and 6.7% at the total proximal femur. Smaller gains occurred with 5 mg daily. The drug only gradually lost its effects when discontinued.

Critics of the current study say that it is still unclear whether women need to take alendronate for such a long period of time or when they should start. Some experts recommend a 1-, 2-, or 3-year break from the drug after 5 years of continuous use. And while previous shorter studies have reported that alendronate can halve the risk of fracture, the current study used bone density measurements, not fractures, as an endpoint. High bone density isn't a guarantee against fractures.

Bone HG, Hosking D, Devogelaer JP, et al. Ten years' experience with alendronate for osteoporosis in postmenopausal women. N Engl J Med. 2004;350:1189-1199.

Fetuses of vegetarians have more false-positive Down syndrome results

If your pregnant patient is a vegetarian, be aware of the fact that she may test false positive for Down syndrome. In fact, she is about three times more frequently than omnivores and reference pregnancy populations to have falsely elevated hCG readings, according to a study from Taiwan.

Researchers studied over 200 lactovegetarian and omnivore singleton pregnancies and found that midtrimester maternal serum free ß-human chorionic gonadotropin (ß-hCG) levels were elevated in the vegetarian pregnancies, which led to the higher false-positive rate in Down syndrome screening. The elevation in maternal serum free ß-hCG was especially pronounced in vegetarian women with low serum vitamin B₁₂ levels.

As a result, the authors emphasize the importance of adequate vitamin B₁₂ for all pregnant women, but especially those who are vegetarians. In addition, they posit that Down syndrome screening in vegetarian pregnancies be accomplished through ultrasound markers and nuchal translucency measurement to avoid invasive confirmation procedures, at least until reference biochemical marker levels for hCG are established for vegetarian pregnancies.

Cheng PJ, Chu DC, Chueh HY, et al. Elevated maternal midtrimester serum free ß-human chorionic gonadotropin levels in vegetarian pregnancies that cause increased false-positive Down syndrome screening results. Am J Obstet Gynecol. 2004;190:442-447.

Exemestane improves DFS in breast cancer patients

Substituting the aromatase inhibitor exemestane after 2 to 3 years on tamoxifen reduces the risk of breast cancer by about 32%, when compared to the standard 5-year tamoxifen course in postmenopausal women with primary, estrogen-receptor–positive breast cancer, according to a randomized trial involving almost 5,000 women from 37 countries.

After an average of about 30 months, 183 women in the exemestane group developed local or metastatic recurrence or contralateral breast cancer or died, versus 266 in the tamoxifen group. Overall survival, however, was not significantly different in the two groups: 93 deaths occurred in the exemestane group and 106 occurred in the tamoxifen group.

Severe toxic effects in the exemestane group were rare but the drug was linked with more arthralgia, diarrhea, and fractures than tamoxifen. Tamoxifen, on the other hand, was associated with more gynecologic symptoms, including vaginal bleeding and muscle cramps, with more thromboembolic events, and with a greater occurrence of a second non-breast cancer before a distant relapse.

Despite several positive reports on the benefits of aromatase inhibitors and given tamoxifen's long and successful track record, however, an accompanying NEJM editorial suggests that at present exemestane be limited to women at high risk of recurrence who understand the limitations of current data.

Coombes RC, Hall E, Gibson LJ, et al. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med. 2004;350:1081-1092.

MEETING HIGHLIGHTS

The Society of Gynecologic Oncologists (SGO) Annual Meeting

New optical system improves detection of precancerous cervical changes

A new optical detection system, used in conjunction with colposcopy, improves detection of precancerous changes of the cervix by more than 26% over colposcopy alone, according to a randomized, multicenter clinical trial of more than 2,000 women presented at the SGO meeting in San Diego, Calif.

The researchers found that the detection system with colposcopy identified 238 cases of biopsy-confirmed cervical intraepithelial neoplasia 2 and 3, whereas colposcopy alone identified 218. The authors calculated that this difference would translate into about 100,000 additional cases of precancer being identified each year. Not only would this help prevent unnecessary deaths, but it would also reduce the number of women requiring biopsy.

Gold MA, Walker JL, Huh WK, et al. Optical detection of cervical neoplasia: results from a randomized, dual-arm, multi-center clinical trial. Abstract 10.

ERT doesn't increase risk of endometrial cancer recurrence

In the largest randomized, controlled trial to date on the subject, researchers found that estrogen-only hormone replacement therapy (ERT) does not increase the risk of recurrence of endometrial cancer in women surgically treated for the condition.

Conducted over a 5-year period, the study included over 1,200 women who had hysterectomy and bilateral salpingo-oophorectomy for stage I or II endometrial cancer and who were experiencing symptoms of menopause; 618 women received ERT and 618 received placebo.

Both groups experienced few disease recurrences (1.9% on ERT, 1.6% on placebo) or endometrial cancer deaths (0.5% on ERT, 0.6% on placebo), and both groups had a low incidence of new cancer diagnoses of any type, including breast cancer. The survival rate for the study population was 96.6%.

Barakat RR, Bundy BN, Spirtos NM, et al. A prospective randomized double-blind trial of estrogen replacement therapy versus placebo in women with stage I or II endometrial cancer: a Gynecologic Oncology Group Study. Abstract 1.

PROFESSIONAL UPDATE

Ob/gyns see decrease in compensation

While primary care physicians generally saw little change in their compensation from 2002 to 2003, obstetricians/gynecologists saw a dip in their annual pay. According to a report in Managed Care (2/04) detailing the results of a physician compensation survey, ob/gyns saw a 7% decrease in compensation from 2002 to 2003. In contrast, family practice physicians, regardless of whether they provided obstetric services, gained a mere 1% in pay.

The survey found that salaries for physicians overall increased about 3% during this time frame. Invasive cardiologists saw the greatest increase in pay, gaining 24% from 2002 to 2003, whereas anatomic pathologists saw the greatest decrease in pay, losing 19%.

The 2003 Physician Compensation and Productivity Survey by Sullivan, Cotter & Associates is based on data collected from about 19,000 physicians in 180 hospitals, large multi-specialty medical groups, and other organizations.

JCAHO takes aim at reducing communication errors

To meet its goal of reducing errors in communication, the Joint Commission on Accreditation of Healthcare Organizations now requires each health-care facility to ban the use of certain abbreviations in written documentation and to follow specific guidelines when receiving verbal orders and reports. While the rules apply primarily to hospitals, it's common sense to implement them in office settings, as well.

As of April 2004, health-care organizations must develop and adhere to a "Do Not Use" list of abbreviations, acronyms, and symbols. According to Nursing 2004 (3/04), the list must include those banned by the Joint Commission, as well as three additional abbreviations, acronyms, or symbols added by the facility.

Among the abbreviations that have been banned by the Joint Commission in all clinical documentation are U, IU, q.d., and q.o.d.; instead, the terms unit, international unit, daily, and every other day, respectively, must be written out. The use of trailing zeros (such as 9.0 mg) and the absence of leading zeros (such as .9 mg) are also prohibited.

Moreover, the Joint Commission requires staff who receive orders or test results verbally to first write them down or enter them into the computer, and then read it back. The "read-back" rule applies to all spoken orders, not just medication orders. So be prepared to have a nurse or other staff member read your orders back to you, after they have written them down.

Web site tracking litigious patients shuts down

Just 4 months after going live, a Web site tracking litigious patients, plaintiffs' attorneys, and expert witnesses has shut down. Dallas-area radiologist John Shannon Jones, MD, created DoctorsKnow.Us to deter frivolous lawsuits, according to The Wall Street Journal (3/5/04). Physicians claim that the current litigious environment has contributed to the dramatic rise in medical malpractice premiums that have forced some physicians to abandon high-risk procedures or specialties.

While physicians claim that the Web site helped level the playing field, it came under fire from patients and plaintiffs' attorneys. They claim the site could be used to deny care to those who had filed lawsuits in the past or intimidate patients from filing legitimate claims.

DoctorsKnow.Us contained a database of patients who had filed medical malpractice, personal injury, and product liability lawsuits, as well as plaintiffs attorneys and expert witnesses, according to The Examiner (3/11-17/04), a newspaper covering Southeast Texas. The database did not provide the outcome of the claims, nor indicate whether the claims had merit or were frivolous. For a monthly fee, physicians, health-care workers, clinics, HMOs, hospitals, and risk managers could have searched the database and added names.

Due to the controversy, the site ceased operations on March 9.

Alaska case, reform bill sparks debate over informed consent standards

If a patient called you in the middle of the night complaining of abdominal pain and bloating and the inability to burp, what advice would you offer? One Alaska surgeon advised his patient to go to the emergency room, but she did not comply. Later, the patient went into shock due to intestinal blockage. She suffered brain damage and partial paralysis and sued.

The patient claimed that the surgeon did not provide enough information for her to make an informed choice. Specifically, she claimed that the surgeon did not inform her of the consequences of not going to the ER.

A jury found for the surgeon, but the Alaska Supreme Court has sent the case back to trial. The state's high court decided the case should not have been decided based on informed consent standards, but rather from the perspective of a "reasonable person," reported American Medical News (3/22-29/04). A re-trial was scheduled to begin in April.

The case has inspired legislation that would create an informed consent standard—thereby, eliminating the "reasonable patient" standard. Lawmakers are considering the bill, which would also provide immunity from liability to a physician who advises a patient via the phone or other electronic means to get further care or evaluation at a hospital or other facility, but the patient chooses not to comply. In addition, the bill would put a $250,000 cap on non-economic damage awards in medical malpractice suits.

Study reveals much about teens' sexual activity

Widely reported news about a study that looked at the sexual health and decision-making of teenagers hasn't gone far enough, according to The Medical Institute for Sexual Health. In March, news outlets nationwide reported on a study presented at the National STD Prevention Conference that found teens who pledge to maintain their virginity until marriage have the same rate of sexually transmitted diseases as those who don't pledge abstinence.

Critics of abstinence-only education saw the findings as evidence that such programs are ineffective, according to The Associated Press (3/9/04). However, the institute observed that abstinence-education programs provide other benefits, including character and relationship building and STD information.

The nonprofit institute also noted that the STD rates found for pledgers and nonpledge takers were for the relatively short period during which they were in the study. Given that nonpledge takers become sexually active at an earlier age and have a higher number of sexual partners, the institute speculates that these adolescents had more STDs in the past than those who pledged abstinence.

The institute also outlined other findings of the study, which were not widely reported by the press, including:

• Teens who took an abstinence pledge delayed having sex for an average of 18 months and, after becoming sexually active, had fewer sexual partners.

• Pledgers were 12 times more likely than nonpledge takers to be virgins at marriage, and twice as many pledgers were married by age 23 than nonpledgers.

 

NEWSLINE: Clinical Insights/Professional Update. Contemporary Ob/Gyn May 1, 2004;49:16-20.