ACOG Reports on Compounded Bioidentical Hormones

Compounded bioidentical hormones are plant-derived hormones, biologically similar or identical to those produced by the body, that can be custom prepared by a pharmacist based on physician specifications. These agents are controversial, however, because of concerns related to quality, purity, potency, and effectiveness. A committee of the American College of Obstetricians and Gynecologists (ACOG) has released a report on compounded bioidentical hormones, which was published in the November 2005 issue of Obstetrics & Gynecology.

No rigorous clinical trials have tested the safety or effectiveness of bioidentical hormone regimens. However, 10 out of 29 other compounded products failed one or more quality tests when analyzed by the U.S. Food and Drug Administration (FDA) compared with the 2 percent failure rate of FDA-approved agents. Because bioidentical hormones are not FDA approved, manufacturers are not required to provide official labeling that would list warnings or contraindications.

ACOG considers bioidentical hormones to have the same safety issues as the drugs that require approval by the FDA, along with possible additional risks associated with compounding. ACOG also concludes that there is no scientific evidence to support claims that these agents are safer or more effective than individualized estrogen or progesteronetherapy.

Failure to Thrive as a Manifestation of Child Neglect

Failure to thrive in infants and children may develop as a result of neglect, and in its extreme form it may result in death. The American Academy of Pediatrics has published a clinical report guiding the assessment, management, and support of children with failure to thrive as a manifestation of child neglect. The full report was published in the November 2005 issue of Pediatrics.

Clinical evaluation for failure to thrive should include a comprehensive family and medical history, a general physical examination, observation of feeding, and a home visit by an appropriate health care professional. Laboratory and radiologic testing usually is not necessary but may be used to rule out organic disease or to determine deficits of nutrition, or when the history or physical examination raises concerns.

There are several parental and family risk factors that should alert the physician to the possibility of child neglect, although they should be assessed in the context of family circumstances. These factors include depression or stress; marital strife or divorce; family history of child abuse; mental retardation or psychological abnormalities; inadequate adaptive or social skills; alcohol or drug abuse; young or single mother without social supports; excessive focus on career or activities outside the home; lack of knowledge about normal growth and development; failure to follow medication regimens; domestic violence; social isolation; and poverty.

Infants with failure to thrive often were born preterm or had a low birth weight, and they may have been separated from their caregivers in the perinatal period. Decrements in growth rates often are ignored in older children, but neglect is a possibility in children of any age.

Physicians should raise and monitor concerns of abuse or neglect during intervention for failure to thrive if it becomes clear that there has been intentional withholding of food, that a parent has a strong belief in a health or nutrition regimen that is detrimental to the child, or that the family is resistant to interventions.

Failure to thrive in infants who weigh less than 70 percent of the predicted weight for length is considered a medical emergency. Severe cases must be recognized and treated early to avoid detrimental effects on early brain development.

When urgent, life-threatening conditions have been resolved, the child should be monitored for several weeks or longer in a hospital, the home, or a foster home to determine the cause of the condition. Because hospitalization may improve outcomes, physicians should advocate for inpatient care when appropriate. Eager intake of food and above-average weight gain in the hospital setting support the diagnosis of failure to thrive secondary to neglect. Infants with failure to thrive may have caregiver attachment disturbances, and consultation with a mental health professional should be considered.

Institution of increased feeding may be difficult and may initiate metabolic problems (i.e., refeeding syndrome). A speech therapist can give guidance on effective feeding techniques. Parents should be involved throughout treatment in all aspects and should be supported and educated to carry out the care plan. If a child with failure to thrive does not respond to treatment, a multidisciplinary approach must be taken involving nursing staff, social services, and dietitians.

Physicians should recognize child neglect as a possible cause of failure to thrive and should report cases of failure to thrive that do not resolve on treatment to the appropriate child protective services. Documentation should be made of attempted interventions, instructions to parents, evidence of parental understanding of instructions and adverse consequences, and evidence of parental failure to carry out recommendations. If aggressive interdisciplinary intervention does not correct and maintain the weight to above 80 percent of expected levels, foster care may be required. The physician must be involved in all phases of the protective services intervention.

Few Americans with Diabetes Receive Multiple Preventive-Care Services

Preventive-care services such as annual foot and dilated eye examinations and biannual A1C tests can prevent or delay amputation and blindness from diabetes. The Centers for Disease Control and Prevention analyzed data from the Behavioral Risk Factor Surveillance System surveys to determine the percentage of Americans with diabetes who receive these services. The report, “Prevalence of Receiving Multiple Preventive-Care Services Among Adults with Diabetes–United States, 2002–2004,” was published in the November 11, 2005, issue of Morbidity and Mortality Weekly Report and is available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5444a5.htm.

The study showed that although the percentage of patients with diabetes who received individual preventive-care services was close to or above national targets (75 percent for foot and eye examinations and 50 percent for A1C tests), less than one half of patients reported receiving all three services. Several factors were associated with a greater likelihood of receiving these services: age 75 years or older, non-Hispanic black race, higher education, diabetes duration of 10 to 19 years, insulin use, diabetes management education, and health insurance coverage. Smoking had a negative association. Possible barriers to receiving these services may include lack of awareness, inadequate health insurance coverage, and the inability to make co-payments or visit specialists.