Clinical Briefs



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Am Fam Physician. 2001 Mar 15;63(6):1237-1240.

Role of Isoflavones in Menopausal Health Conditions

The North American Menopause Society (NAMS) has released a formal consensus opinion on the role of isoflavones for acute or chronic health conditions associated with menopause and aging.

Isoflavones are a major type of plant-derived estrogen. The main sources of isoflavones are whole soy foods, isoflavone supplements and isoflavone-fortified foods. According to NAMS, these products are being used by women in an effort to improve well-being and prevent disease.

According to the panel of experts who developed the NAMS consensus opinion, many studies have been performed to evaluate the effects of isoflavones on short-term menopausal symptoms and on various diseases in women. The review showed that scientific data are inconclusive about whether the observed health effects are attributable to isoflavones alone or to isoflavones plus other components in whole foods. The panel concludes that more studies documenting benefits and safety should be conducted.

The NAMS consensus opinion recommended that women consume whole foods containing isoflavones, especially for potential cardiovascular benefits. Data supporting the use of isoflavones for hot flushes are conflicting, and inadequate data exist to evaluate their effect on female cancers, bone mass and vaginal dryness.

Isoflavones have a significant effect on lipid levels. Studies have found that isoflavones significantly reduce low-density lipoprotein levels and triglyceride levels, as well as increase high-density lipoprotein levels. In 1999, these data led the U.S. Food and Drug Administration to approve the health claim that 25 g per day of soy protein, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.

The NAMS consensus opinion appears in the July/August 2000 issue of Menopause and is also available on the NAMS Web site at http://www.menopause.org.

New Asthma Medication for Infants and Children

The U.S. Food and Drug Administration has approved a new asthma medication for infants and young children. Budesonide inhalation suspension (Pulmicort Respules) is the only asthma treatment approved for use in children as young as 12 months, and is the first corticosteroid to be available in a nebulized formulation for the management of pediatric asthma.

Asthma is the most common chronic pediatric disease, affecting nearly 5 million children in the United States. As many as 80 percent of these children have symptoms of asthma before the age of five. According to David Skoner, M.D., chief of allergy and immunology at Children's Hospital of Pittsburgh, before the approval of budesonide inhalation suspension, “…the anti-inflammatory treatment options for a young asthmatic child or infant were quite limited or non-existent.”

Budesonide inhalation suspension is indicated for maintenance and prophylactic therapy in children 12 months to eight years of age. Improvement in asthma control can occur within two to eight days, but maximal benefit may not be achieved for four to six weeks. Also, budesonide inhalation suspension can increase wheezing and induce bronchospasm after dosing. It should not be used for the relief of acute bronchospasm or as the primary treatment for status asthmaticus or other acute episodes of asthma. If bronchospasm occurs, a fast-acting inhaled bronchodilator should be used.

Budesonide inhalation suspension should be taken by jet nebulizer connected to an air compressor in dosages of 0.5 to 1.0 mg once or twice daily. It should be administered separately from other nebulizable medications. The mouth should be rinsed and the face wiped after the treatment to avoid localized corticosteroid effects. Patients on maintenance corticosteroids should start budesonide inhalation suspension concurrently with the usual doses of systemic corticosteroid. Slow incremental reductions in the amount of systemic corticosteroid can be made in stable patients at a rate of no more than 25 percent of the prednisone dose every one to two weeks.

In clinical trials, budesonide inhalation suspension reduced the need for bronchodilators and improved the control of nighttime and daytime asthma symptoms. Adverse effects of budesonide inhalation suspension in clinical trials included respiratory infection, runny nose, coughing, earache, viral infection, stomachache and ear infection, although these were not necessarily related to drug treatment. The incidence of side effects was similar to that seen with placebo.

To obtain full prescribing information for budesonide inhalation suspension, call the manufacturer at 800-942-0424, ext. 1974.

Call for Medical Informatics Papers

A call for medical informatics papers has been issued by the American Academy of Family Physicians (AAFP) for possible presentation at the 2001 Scientific Assembly October 3–7, 2001, in Atlanta. Applications must be submitted by April 2, 2001. Membership in the AAFP is not a prerequisite for submission.

Applications may be submitted in various categories to be determined. Each category has seven author classifications: family physicians and fellows primarily in academic medicine, family physicians primarily in clinical practice, family practice residents, medical students, international attendees, professionals primarily engaged in medical informatics and others.

The author of the winning paper in each category will receive a cash award. All awards are given at the discretion of the Medical Informatics Advisory Council. Application forms may be obtained from Vicky Binder, Scientific Program Department, AAFP, 11400 Tomahawk Creek Pkwy., Leawood, KS 66211; telephone: 800-274-2237, ext. 6564.

Delayed-Release Drug for Juvenile Rheumatoid Arthritis

Sulfasalazine delayed-release tablets (Azulfidine EN-tabs) have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of children six through 16 years of age with juvenile rheumatoid arthritis involving five or more diseased joints who have not responded adequately to salicylates or other non-steroidal anti-inflammatory drugs. The tablets are the only formulation of sulfasalazine approved by the FDA for the treatment of juvenile and adult rheumatoid arthritis.

According to the manufacturer of sulfasalazine, rheumatoid arthritis is a debilitating disease that affects 50,000 children in the United States. The disease causes joint pain, stiffness and swelling in or around joints, and joint destruction.

In clinical trials, sulfasalazine significantly reduced the number and severity of swollen joints, the number of active joints and overall joint severity score. There was also a significant reduction in disease activity scored by physicians, parents and patients.

Sulfasalazine delayed-release tablets are enteric coated to reduce the likelihood of nausea and stomach upset. The most common side effects of sulfasalazine are nausea, dyspepsia, rash, immunoglobulin suppression, headache, abdominal pain, vomiting and fever. Patients who have intestinal or urinary obstructions, porphyria or hypersensitivity to sulfasalazine, sulfonamides or salicylates should not use sulfasalazine delayed-release tablets.

AAP Statement on the Use of Inhaled Nitric Oxide

The Committee on Fetus and Newborn of the American Academy of Pediatrics (AAP) has issued an official statement on the use of inhaled nitric oxide in newborns. The AAP statement discusses the conditions under which inhaled nitric oxide should be administered to the neonate with hypoxic respiratory failure. The statement appears in the August 2000 issue of Pediatrics.

Inhaled nitric oxide is a selective pulmonary vasodilator. According to the AAP, the mechanism of action involves guanylyl cyclase activation that leads to the production of cyclic guanosine monophosphate and subsequent smooth muscle relaxation.

The U.S. Food and Drug Administration (FDA) evaluated two large, randomized, controlled trials of term and near-term neonates with hypoxic respiratory failure that demonstrated improved outcome with inhaled nitric oxide therapy. In one trial, inhaled nitric oxide reduced the need for extracorporeal membrane oxygenation (ECMO) in neonates without increasing neurodevelopmental, behavioral or medical abnormalities at two years of age. The second trial also found that inhaled nitric oxide reduced the need for ECMO and the incidence of chronic lung disease. However, the treatment was not effective in infants with congenital diaphragmatic hernia.

Currently, the limited data on hypoxic preterm neonates suggest that low-dose inhaled nitric oxide improves oxygenation but does not improve survival. The AAP stresses that additional large, randomized trials in premature neonates are needed because these infants may experience more toxic effects than term and near-term infants.

According to the AAP committee, infants with hypoxic respiratory failure in whom conventional ventilator therapy fails or is predicted to fail must be cared for in institutions that have immediate availability of personnel who are qualified to use multiple modes of ventilation and rescue therapies. Radiologic support and laboratory support are also essential.

The AAP committee also states that FDA-approved devices should be used to administer the inhaled nitric oxide in constant concentration ranges in parts per million or less throughout the respiratory cycle. Infants who receive this therapy should be monitored according to institutionally derived protocols designed to avoid potential toxic effects.

The indication for use of inhaled nitric oxide has been failure of ventilatory therapy. If this therapy fails, ECMO should be initiated. Therefore, institutions that offer therapy with inhaled nitric oxide should also have ECMO capability.

Women's Health Report on Irritable Bowel Syndrome

The National Women's Health Resource Center (NWHRC) has published a health report on irritable bowel syndrome, a chronic disorder characterized by abdominal pain associated with abnormal bowel function, including diarrhea, constipation or alternating bouts of each. The June 2000 issue of “National Women's Health Report” offers readers information on irritable bowel syndrome.

According to the health report, 20 percent of people in the United States suffer from irritable bowel syndrome, and 70 percent are women. Irritable bowel syndrome can affect a woman's family life and her ability to work.

The NWHRC report discusses the classic symptoms of irritable bowel syndrome; suggestions on finding a physician who can diagnose and treat the condition; the effects of diet, exercise and alternative therapies; treatment options; and tips on living with irritable bowel syndrome. The report also features case studies of women who saw several physicians over a period of years while trying to find a diagnosis for their symptoms and a discussion of the obstacles they had to overcome to get help.

To obtain a copy of “National Women's Health Report” free of charge, call the NWHRC at 877-986-9472; write to the NWHRC, 120 Albany St., Ste. 820, New Brunswick, NJ 08901; or send an e-mail request to info@healthywomen.org.

Medical Concerns of the Young Female Athlete

The Committee on Sports Medicine and Fitness of the American Academy of Pediatrics (AAP) has issued a position statement on medical concerns of the female athlete. The statement appears in the September 2000 issue of Pediatrics.

According to the AAP committee, young female athletes who are regular participants in sports may develop certain medical conditions, such as eating disorders, menstrual dysfunction and decreased bone mineral density. This revision of a previous AAP statement provides updated and expanded information for physicians on health concerns of the young female athlete. The statement discusses disordered eating, menstrual dysfunction, decreased bone mineral density, clinical evaluation and treatment. The AAP committee also makes the following recommendations:

  • Exercise and participation in sports should be encouraged among girls and female adolescents for health benefits and enjoyment.

  • Dietary practices; exercise intensity, duration and frequency; and menstrual history should be reviewed during evaluations that precede participation in sports or other medical encounters in which related problems may present.

  • Amenorrhea should not be considered a normal response to exercise. A complete medical evaluation is required for any adolescent with primary or secondary amenorrhea or persistent oligomenorrhea.

  • Disordered eating should be considered in adolescents with amenorrhea. Treatment often requires a team of health care professionals, including a physician, nutritionist and mental health professional, in addition to the cooperation of coaches, parents and teammates.

  • Athletes, parents and coaches should receive education and counseling on eating disorders, menstrual dysfunction, decreased bone mineralization, and adequate calorie and nutrient intake to meet energy expenditure and maintain normal growth and development.

  • When athletes and coaches want to know what weight and amount of body fat are best for a given athlete, it is preferable to establish a range of values rather than specific values. Defining a specific ideal weight or body fat level is difficult and potentially dangerous.

  • An adolescent with menstrual dysfunction attributed to exercise should be encouraged to increase her caloric intake and modify excessive exercise. If an athlete's weight is low, she may be required to gain weight before resuming athletic activity.

  • Estrogen-progesterone supplementation may be considered in the mature amenorrheic athlete.

  • Measurement of bone mineral density may be considered as a tool when making treatment decisions for the amenorrheic athlete.



Copyright © 2001 by the American Academy of Family Physicians.
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