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Tips from Other Journals
Use of Bupropion as an Aid in Smoking Cessation
Bupropion hydrochloride, currently marketed as an antidepressant, is now being reintroduced in a sustained-release formulation to be used as a smoking cessation aid. Bupropion potentiates the effects of norepinephrine and dopamine. Dopamine has been associated with the rewarding effects of addictive substances. It is postulated that inhibition of norepinephrine reuptake might lead to a decrease in withdrawal symptoms. Consultants from The Medical Letter on Drugs and Therapeutics reviewed bupropion as an aid in smoking cessation.
No complete studies have been published to date documenting the effectiveness of bupropion as an aid in smoking cessation. Two studies have been summarized in the manufacturer's prescribing information. One study compared the effects of a seven-week course of 100 mg, 150 mg and 300 mg of sustained-release bupropion with placebo. At the end of treatment, smoking cessation rates with placebo were 17 percent compared with 22 percent, 27 percent and 36 percent with increasing dosages of bupropion. The difference between bupropion in dosages of 150 mg and 300 mg and placebo was statistically significant.
The other study compared the use of transdermal nicotine, sustained-release bupropion, a combination of the two, and placebo. After 10 weeks of treatment, smoking cessation rates were 20 percent with placebo, 32 percent with transdermal nicotine alone, 46 percent with bupropion alone, and 51 percent with transdermal nicotine combined with bupropion. All three active treatments led to a statistically significant difference in smoking cessation rates compared with placebo.
Bupropion is excreted primarily in the urine. With chronic use, plasma concentrations of metabolites of bupropion may increase. Although there has been a concern about seizures with dosages up to 300 mg per day, the incidence has been only about 0.1 percent. The risk might be higher in patients with conditions predisposing to seizures such as alcohol withdrawal, use of cocaine, or anorexia nervosa or bulimia.
Bupropion does not have a sedating effect, although agitation and insomnia have been commonly reported in patients taking the drug for depression. It is not frequently associated with sexual dysfunction, weight gain or anticholinergic effects. Tremor, rash and a few anaphylactoid reactions have been reported. Panic symptoms and psychotic reactions have been reported in patients taking bupropion and fluoxetine concurrently. Bupropion is contraindicated in patients taking monoamine oxidase inhibitors or ritonavir. Carbamazepine increases the metabolism and decreases the antidepressant effect of bupropion.
The recommended dosage in patients attempting smoking cessation is 150 mg once daily for three days and then twice daily for seven to 12 weeks or longer. This regimen may be accompanied by nicotine replacement therapy. Patients are advised to stop smoking during the second week of treatment. The manufacturer offers a counseling and support service. The wholesale cost of a 10-week supply of bupropion is $186.32.
Consultants from the Medical Letter conclude that a two- or three-month course of bupropion, with or without transdermal nicotine replacement therapy, may help to alleviate some of the withdrawal effects from smoking cessation. However, conclusive data have not been published. Long-term relapse rates have been high with use of all smoking cessation agents.
BARBARAR APGAR, M.D., M.S.
Medical Letter consultants. Bupropion (Zyban) for smoking cessation. Med Lett Drugs Ther 1997 August;39 (1007);77-8.
EDITOR'S NOTE: A mass marketing blitz is in effect to alert patients to the availability of this drug, and patients are asking their physicians for prescriptions. Until further data are published, the drug should be prescribed with caution and with the understanding that side effects are similar to those occurring with antidepressant dosages.
--B.A.
Urease Breath Test for Helicobacter pylori Infection
Helicobacter pylori is well-established as the causative agent in most cases of gastric and duodenal ulcers. H. pylori produces high concentrations of urease, which hydrolyzes urea into ammonium and bicarbonate. The bicarbonate enters the blood stream, is transported to the lungs and is rapidly exhaled as carbon dioxide. Diagnosis of H. pylori infection is typically confirmed by endoscopy with biopsy--a test that is both invasive and expensive. Felz and colleagues evaluated the effectiveness of the carbon 14 urea breath test as a noninvasive and less expensive way of diagnosing H. pylori infection in patients with symptoms of chronic gastritis.
Twenty-six patients with symptoms of gastritis were included in the nonblinded study. All patients underwent upper gastrointestinal endoscopy and biopsy, a CLO (Campylobacter-like organism) test of gastric antral tissue and a 14C-urea breath test. In the breath test, patients first swallowed a 14C-labeled gelatin capsule, and breath samples were obtained 10, 15 and 20 minutes after ingestion of the capsule. Patients exhaled through a straw into a 1.5-L aluminized balloon, and carbon radioactivity was counted in a liquid scintillation counter. Samples were considered positive if they contained more than 100 disintegrations per minute (dpm), indeterminate if they contained 50 to 99 dpm and negative if they contained less than 49 dpm.
Seventeen patients (65 percent) had endoscopic evidence of gastric or duodenal ulceration. Three patients (12 percent) had no visible ulcers but had histologic evidence of H. pylori infection on biopsy, microorganisms on Giemsa stain and positive results on a CLO test. Of these 20 patients, all had strongly positive 14C-urea breath tests, with an average 15-minute reading of 1,868 dpm. The other six patients (23 percent) had no positive findings for ulceration based on the testing parameters of the study. Results of the 14C-urea breath test were negative in five of these patients and indeterminate in one. These results correlate with a sensitivity of 100 percent (20 of 20 positive) and a specificity of 100 percent (six of six negative). Since no diagnostic errors occurred with the breath test, the positive and negative predictive values for this study were also 100 percent.
The authors concluded that the 14C-urea breath test is a noninvasive and very reliable method for diagnosing H. pylori infection in patients with symptoms of duodenal or gastric ulceration or active chronic gastritis. This test is quick, easy and well tolerated by patients. The amount of radiation exposure associated with this test is far less than that received in mammography, an intravenous pyelogram or an upper gastrointestinal series. The estimated cost of the test is about $200.
JEFFREY T. KIRCHNER, D.O.
Felz MW, et al. Breath test diagnosis of Helicobacter pylori in peptic ulcer disease: a noninvasive primary care option. J Am Board Fam Pract 1997 November;10:385-9.
Falls from Low Heights and Pediatric Cervical Spine Injury
Falls from low heights, such as from a counter top or a shopping cart, are common in childhood. Caregivers are often concerned about the possibility of a head or neck injury and seek medical evaluation. Advanced Trauma Life Support guidelines for adults instruct that the cervical spine is "cleared clinically" if there is no pain on palpation, no limitation in range of motion and neurologic findings are normal in a patient without distracting injuries. Cervical spine injuries in children are uncommon. There are no guidelines for evaluating children with potential cervical injury. Yet physicians routinely obtain radiographs even though they are technically difficult and costly. Schwartz and associates conducted a retrospective review of the medical records of children with a diagnosis of cervical vertebral or cord injury to determine if historical and physical examination data adequately identify cervical spine injuries in young children after falls from low heights.
Study participants included children under the age of six years who had a documented fall of five feet or less. Only eight children were identified at the four participating institutions in chart reviews spanning six to 20 years. Seven of the children were boys. The most common diagnoses were rotary subluxation of C1 (three patients) and subluxation of C1-C2 (three patients). All eight children had neck pain or limited range of neck motion. No child presented with permanent neurologic deficit.
Cervical spine injuries in children are most often associated with a significant impact such as a high-speed motor vehicle crash. These children usually have multiple associated injuries. Falls from low heights are a much less frequent cause of cervical spine injuries. Radiographs are difficult to obtain in young children, and proper imaging of the upper cervical spine is particularly difficult because of lack of cooperation. Special expertise is needed to read radiographs in young children. Computed tomography may be more accurate but is more expensive and may require the use of sedation, thus prolonging evaluation time.
The authors conclude that cervical spine injuries sustained from falls of less than five feet are extremely rare. When injuries did occur, the child presented with clinical evidence of injury, including neck pain or limited cervical range of motion. Radiographic evaluation of the cervical spine in asymptomatic children who present after a fall from a low height may not be necessary.
RICHARD SADOVSKY, M.D.
Schwartz GR, et al. Pediatric cervical spine injury sustained in falls from low heights. Ann Emerg Med 1997 September; 30:249-52.
Incidence of Bicycle-Related Injuries in Preschool Children
Injury prevention efforts related to bicycle riding are often aimed at school-age children. Preschool children also ride bicycles, and information about injuries in this age group is lacking. Powell and associates reviewed information from the National Pediatric Trauma Registry (NPTR) regarding bicycle injuries to compare injuries in children less than five years of age with injuries among children five to 14 years of age.
Because the NPTR data deal mainly with children admitted to hospitals, the study includes a high proportion of children with severe injuries. Tricycle-related injuries are not designated separately in this registry. Five percent of the bicycle-associated injuries occurred in children younger than five years. Few of these children were wearing helmets. A motor vehicle was involved in 31 percent of injuries to young children. Sixty-eight percent of young children were injured in falls from bicycles. The proportion of accidents occurring in nonstreet locations such as a driveway, garage, sidewalk or yard was significantly higher among children younger than five years. Almost one half of these younger children sustained head trauma.
Young children appeared to have an anatomic injury pattern similar to that of older children, with head injury being the most common severe injury. Hospitalized preschool cyclists had trauma scores and rates of operating room use similar to those of older children. The value of helmets in limiting bicycling injuries has been clearly established.
The authors conclude that young children sustained severe injuries, frequently involving the head, at a rate similar to that of older children. Accidents often occurred in nonstreet locations. Helmets are indicated for use by all children who ride bicycles and probably by children who ride tricycles. Establishing the "helmet habit" at a young age is a good idea; however, further study is needed to evaluate the efficacy of helmets in preventing serious head injury in young cyclists and to determine whether helmet use at a young age will result in continued use during adolescence and adulthood.
RICHARD SADOVSKY, M.D.
Powell EC, et al. Bicycle-related injuries among preschool children. Ann Emerg Med 1997 September;30:260-5.
Diagnostic Proficiency and Use of Cardiac Auscultation
Because of the recent shift toward managed care and the accompanying pressures to contain costs of diagnosis, physical examination skills are under increased scrutiny. Mangione and Nieman conducted a cross-sectional assessment of internal medicine and family practice residents to determine their proficiency in using cardiac auscultation to identify various cardiac events.
Auscultatory skills were evaluated in 198 internal medicine and 255 family practice residents. Study participants listened to 12 different cardiac events (such as mitral regurgitation or S3 gallops) and then answered a multiple-choice questionnaire regarding the presence or absence of the sound and its characteristics. The resident's cumulative score reflected accuracy in recognizing six extra sounds, six murmurs and 12 auscultatory events. Participants also completed a one-page questionnaire assessing their motivation to learn cardiac auscultation and their level of confidence in their skills. A smaller group of third- and fourth-year medical students was also assessed for comparison.
The internal medicine residents were significantly more proficient than the family practice residents at identifying the 12 cardiac events and the six extra sounds. However, the residents' scores were never significantly better than those of the medical students. Overall, internal medicine and family practice residents correctly identified about 20 percent of the cardiac sounds. Family practice residents were never more accurate than the medical students and were significantly less accurate than the medical students in identifying some sounds (specifically, early systolic clicks and aortic stenosis murmurs). Although some residents had had more training and felt more confidence in their auscultatory skills, this confidence did not actually manifest itself as improved accuracy. Those who listened to teaching audiotapes and those who could play a musical instrument were more proficient at cardiac auscultation.
The authors conclude that training in cardiac auscultation is lacking and that there were no significant improvements as residents progressed to higher levels of training. They recommend that the boards of internal medicine and family practice consider adding the evaluation of cardiac auscultation skills to their certifying examinations.
GRACE BROOKE HUFFMAN, M.D.
Mangione S, Nieman LZ. Cardiac auscultatory skills of internal medicine and family practice trainees. A comparison of diagnostic proficiency. JAMA 1997 September; 278:717-22.
Low-Dose Steroids and Theophylline in Moderate Asthma
Inhaled steroids are the preferred treatment for chronic asthma because, in many patients, their anti-inflammatory effects greatly reduce the need for adjunctive therapies. Unfortunately, their long-term effects are still unknown, and the medications currently available are quite expensive. In the past, theophylline was widely used to treat asthma, but it is now less popular because of its side effects and apparent lack of anti-inflammatory activity. However, recent short-term studies have shown that, when used in combination with oral or inhaled steroids, theophylline improves pulmonary function. Evans and associates compared the effects of a regimen of inhaled steroids and low-dose theophylline with that of an increased dosage of steroids in patients who were already using budesonide on a daily basis.
Patients eligible for the study had the classic signs of asthma and fulfilled the criteria of the American Thoracic Society for a diagnosis of asthma. At the beginning of the study, all patients had to have a persistent cough, wheeze or breathlessness during the day or night, despite their current therapy of 800 to 1,000 mg of budesonide or an equivalent dosage of beclomethasone or fluticasone. During the initial screening, three measurements of peak expiratory flow (PEF), forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) were obtained. The greatest value obtained for each was used as the patient's baseline value. In addition, baseline theophylline levels and a morning cortisol level were measured in all patients.
A total of 62 patients were randomly assigned to one of two groups. The groups were similar in age, demographics and severity of asthma. The first group received 400 mg of budesonide plus 250 mg of theophylline or 375 mg of slow-release theophylline. The second group was given 800 mg of budesonide plus placebo. All medications were given twice a day. Patients were seen every three weeks during the 12-week treatment period and one week after the study ended. At each visit, PEF, FVC, FEV1 and theophylline levels were measured; a morning serum cortisol level was obtained at week 12. In addition, all patients kept a diary in which they recorded their own peak flow measurements, their use of albuterol and the severity of their symptoms using a four-point scale. The diaries were also used to record the number of exacerbations of asthma, which were subsequently classified as mild or severe based on the patient's symptom scores.
The therapies were well tolerated by both groups. Mean serum theophylline levels throughout the study were 8.7 mg per mL, which is lower than the usual therapeutic levels. Both groups showed improvements from baseline in FEV1, FVC and PEF that were sustained throughout the study. However, the patients who took theophylline showed greater improvements in both FEV1 and FVC. Both groups also decreased their daytime use of beta2 agonists, but patients in the theophylline group decreased their nighttime use of these drugs as well. Both groups recorded a decrease in the severity of symptoms. The number of exacerbations was small in both groups, with fewer reported in the theophylline group. Serum cortisol levels were much lower in patients in the high-dose steroid group but unchanged in the other group.
The authors concluded that therapy combining theophylline with low-dose inhaled steroids is as effective as therapy using high-dose inhaled steroids alone for treating asthma. Maintaining theophylline levels below 10 mg per mL appears to be beneficial and avoids the adverse side effects that occur at the usual therapeutic level of 10 to 20 mg per mL. Another advantage to this combination therapy is that the cost of theophylline and 800 mg of budesonide is about $60 per month, compared with about $100 per month for 1,600 mg of budesonide.
JEFFREY T. KIRCHNER, D.O.
Evans DJ, et al. A comparison of low-dose inhaled budesonide plus theophylline and high-dose inhaled budesonide for moderate asthma. N Engl J Med 1997 November;337:1412-8.
Implantable Defibrillators for Ventricular Arrhythmias
Patients who survive ventricular fibrillation or sustained ventricular tachycardia are at high risk for experiencing recurrent, and often fatal, episodes of these arrhythmias. Most of these patients are treated with antiarrhythmic medications, although some have been treated with implantable cardioverter-defibrillators. Neither therapy has been proved to reduce mortality. The Antiarrhythmics versus Implantable Defibrillators Trial compared initial therapy using either an implantable cardioverter-defibrillator or antiarrhythmic drug therapy with amiodarone or sotalol to determine whether either had an effect on overall survival rates.
Patients were eligible for inclusion in the study if they had been resuscitated from near-fatal ventricular fibrillation or had sustained ventricular tachycardia and hemodynamic compromise. After screening over 6,000 patients, 1,016 were randomized to treatment with antiarrhythmic drugs or an implantable cardioverter-defibrillator. Baseline characteristics of the two groups were almost identical: mean patient age was 65 years, and 79 percent of the patients were men. Of the study subjects, 561 had documented ventricular tachycardia and 455 had ventricular fibrillation. An implantable defibrillator was placed in 507 patients, and 509 were assigned to drug therapy. The drug group was further divided--356 patients were given amiodarone alone because they were not candidates for sotalol therapy, and the remaining 153 were given amiodarone alone or both drugs. Mean ejection fraction was 0.31 in the drug group and 0.32 in the defibrillator group.
After a mean follow-up period of approximately 18 months, crude death rates were 15.8 percent in the defibrillator group and 24.0 percent in the drug groups. After three years, 75.4 percent of the patients in the defibrillator group were still alive, compared with 64.1 percent of the patients in the drug group. In fact, survival rates were better in the defibrillator group throughout the entire course of the study. More specifically, these patients experienced a decrease in death rates of approximately 39 percent at one year, 27 percent at two years and 31 percent at three years after enrollment in the study. The rate of medical or surgical complications in all patients was not significantly different.
The authors conclude that therapy with the implantable cardioverter-defibrillator is superior to drug therapy in improving survival in patients who have been resuscitated from ventricular fibrillation or who have sustained symptomatic ventricular tachycardia. They believe that the implantable cardioverter-
defibrillator should be offered as first-line therapy for patients with potentially fatal ventricular arrhythmias.JEFFREY T. KIRCHNER, D.O.
The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med 1997 November;337:1576-83.
Effect of Environmental Tobacco Smoke in Nonsmokers
Some studies have found a surprisingly large risk of ischemic heart disease in nonsmokers who live with smokers. This risk appears to be out of proportion to the environmental exposure to tobacco products in smoke. Law and colleagues reviewed all available research to verify this apparently disproportionate risk and to offer explanations.
Their meta-analysis of 19 studies that met the study criteria covered 6,600 episodes of ischemic heart disease in never-smoking spouses of smokers. The relative risk of ischemic heart disease in these never-smoking spouses was 1.30. Because these families share dietary and other habits that increase the risk of heart disease, the study corrected for diet. The net effect of living with a smoker was a 23 percent increase in risk of ischemic heart disease. The authors conclude that the most plausible explanation is platelet aggregation; it is possible that the effect could be neutralized by aspirin therapy.
In a related paper, Hackshaw and colleagues reviewed evidence from 37 studies of the risk of lung cancer in nonsmoking female spouses of smokers. They calculated the excess risk of lung cancer for these women to be 24 percent, which rose to 26 percent after adjustment for bias and dietary factors. A definite dose-response effect was observed based on duration and intensity of tobacco smoke exposure. In several studies, tobacco-specific carcinogens had been identified in the blood and urine of nonsmokers who were married to smokers.
Both articles and a related editorial stress the size and consistency of the evidence that environmental tobacco exposure is a major public health problem. One estimate for the United States implicates environmental smoke in 3,000 deaths from lung cancer, up to 62,000 deaths from ischemic heart disease, up to 300,000 cases and 212 deaths from pulmonary disease in young children, and up to 2,700 sudden infant deaths every year. Health advocates are encouraged to use all available strategies to eliminate this hazard.
ANNE D. WALLING, M.D.
Law MR, et al. Environmental tobacco smoke exposure and ischaemic heart disease: an evaluation of the evidence. BMJ 1997 October;315:973-80, and Hackshaw AK, et al. The accumulated evidence on lung cancer and environmental tobacco smoke. BMJ 1997 October;315: 980-8, and Davis RM. Passive smoking: history repeats itself [Editorial]. BMJ 1997 October;315:961-2.
Precepting Medical Students: Effect on Patient Satisfaction
Some studies have shown that precepting medical students decreases physician productivity (ranging from 0.65 fewer patients seen per day to 0.6 fewer patients seen per hour) and causes an increase in the length of the physician's work day (up to 50 minutes per day). Frank and associates conducted a cross-sectional study to determine how the presence of a medical student affects physician productivity and patient satisfaction during an office visit.
Sixteen physicians were observed during 369 visits with patients without students present and during 83 patient visits with students present. A research nurse was present during the office visit to make observations regarding physician behavior, services delivered and length of time the physician spent with the patient. An exit questionnaire was also completed by the patient to determine the patient's level of satisfaction with the office visit.
Students were significantly more likely to see minority patients and those who were on Medicaid. Physician behavior was significantly different when a student was present in four out of 10 areas observed. When students were present, history taking was shorter, feedback to the patient was shorter, fewer patient questions were answered and more time was taken setting up the structure of the office visit (i.e., setting expectations for the visit). There was no significant difference in all other physician behaviors observed, including physicial examination and health education. The amount of time the physician spent with the patient was not significantly different when a student was present: with-student encounters averaged 9.9 minutes and without-student encounters averaged 10.3 minutes. Total patient satisfaction did not decrease when a student was present.
The authors conclude that although a physician's work day may be longer and his or her productivity may be decreased (according to other studies), patient care does not suffer when medical students are present during a patient examination. Patients remain satisfied, and their expectations continue to be met, even when the physician serves as a community preceptor.
GRACE BROOKE HUFFMAN, M.D.
Frank SH, et al. Direct observation of community-based ambulatory encounters involving medical students. JAMA 1997 September;278:712-6.
Home-Based Therapy After Hip Fracture in the Elderly
Most of the approximately 300,000 persons who sustain hip fractures each year are over 65 years of age. Rehabilitation, which takes place primarily at home, usually fails to restore patients to their prefracture level of function. Tinetti and colleagues evaluated the effectiveness of home-based therapy in elderly patients recovering from hip fractures and assessed whether a home exercise program could be used without injuries to the patients.
Patients were eligible for inclusion in the study if they were at least 65 years of age, had undergone previous surgery for hip fracture, were cognitively intact and lived at home. Of the 148 patients who began the study, 104 completed the six-month program. The physical therapy protocol evaluated and treated balance difficulties, strength, gait, transfers and stair climbing. A physical therapist evaluated patients at home within 48 hours of discharge and then on a regular schedule. The functional therapy protocol focused on identifying and improving unsafe or inefficient performance of activities of daily living (ADLs). A rehabilitation nurse evaluated patients at home within one week of discharge and then on a regular basis, as long as they continued making progress.
Patients using the physical therapy protocol experienced significant improvements in upper and lower extremity strength, higher levels of balance, better categories of transfer performance and excellent progression of stair climbing and gait. Seventy-seven percent of the patients could perform these home exercise programs, and no injuries were reported as a result of this activity. In addition, ADL functioning scores improved with the functional therapy program, and patients were better able to carry out basic functions such as bathing, dressing, preparing meals and toileting at home.
The authors conclude that systematic assessment and intervention protocols provide the basis for a successful home-based therapy program in elderly patients after hip fracture. Protocols that target impairments and ADL function are feasible, safe and effective in improving the functional status of these patients and can help them approach their prefracture abilities.
JEFFREY T. KIRCHNER, D.O.
Tinetti ME, et al. Systematic home-based physical and functional therapy for older persons after hip fracture. Arch Phys Med Rehabil 1997 November;78:1237-47.
Asthma Education for Inner-City Children
Asthma has a high prevalence among economically disadvantaged urban children, since they often do not have regular access to medical care and, when they do, the care is often fragmented or substandard. This lack of care is believed to account for the higher degree of asthma-related morbidity and mortality in this population. Christiansen and colleagues developed and implemented a school-based asthma education program to assess the effectiveness of such a program for inner-city children with asthma.
Fourth-grade students from four schools in San Diego, Calif., were eligible for the study. Children with asthma symptoms were identified through a parent survey, a student questionnaire or a physical examination. Each participant was categorized with mild, moderate or severe asthma on the basis of frequency of specific symptoms, including nocturnal awakening, effect on physical activity, type and frequency of medication use and need for emergency medical care. Participants were assigned to either the educational program or a control nonintervention group. The educational program was based on the asthma guidelines of the National Heart, Lung, and Blood Institute and consisted of 20-minute teaching segments conducted over a five-week period during school hours. All lessons had bilingual (English and Spanish) interaction that was intended to be at the students' level of comprehension.
Outcomes measured at the beginning and the end of the study included the children's knowledge about asthma, their skills in using a peak flow meter and a metered-dose inhaler, and the effect of the educational intervention on asthma severity. In addition, participants were interviewed at school on a monthly basis to assess their level of functional asthma severity. Questions focused on the frequency and duration of symptoms, the use of medication, the need for medical care (including emergency department visits and hospitalizations), absences from school and restriction of physical activities. Monthly symptom scores were generated on the basis of the children's responses to several of these questions.
Following the study, children in the education group knew more about asthma (scores improved from 9.9 to 13.7) and had improved their skills in using both the peak flow meter (3.9 to 6.4) and the metered-dose inhaler (2.3 to 4.3). Those in the control group showed no improvement in asthma knowledge (11.3 to 10.9) or in use of the inhaler (2.5 to 2.2). Peak flow meter scores increased slightly from 2.6 to 3.1. Neither group experienced any improvement in asthma severity or frequency of wheezing, nor were there any differences in school absences, emergency department visits or hospitalizations. However, symptom scores for asthma severity after 180 days were significantly lower in the education group (2.87) than in the control group (4.36). Children in the education group also tended to use less medication over time. The authors concluded that a school-based asthma education program can be successful, as it can increase asthma knowledge, improve peak flow meter and metered-dose inhaler skills, and may reduce the severity of asthma symptoms.
JEFFREY T. KIRCHNER, D.O.
Christiansen SC, et al. Evaluation of a school-based asthma education program for inner-city children. J Allergy Clin Immunol 1997 November;100:613-7
Drug Treatment Used as a Diagnostic Tool in GERD
A diagnosis of gastroesophageal reflux disease (GERD) may be established by using various modalities, including upper gastrointestinal endoscopy, esophageal pH monitoring, radiologic studies and acid infusion tests. However, no one method is 100 percent accurate in confirming the diagnosis, and each has limitations that decrease the probability of an accurate overall diagnosis. Endoscopy alone lacks sensitivity, and pH monitoring is not always available. The classic symptoms of GERD are heartburn and acid regurgitation, both of which are relieved with a two- to four-week course of therapy with omeprazole. Schenk and colleagues studied whether treatment with omeprazole also could be used as an easy, noninvasive, safe and reliable test for diagnosing GERD.
Patients eligible for the study had a history of signs and symptoms of GERD, including heartburn, acid regurgitation and dysphagia. A total of 98 patients were evaluated on the basis of results of an upper gastrointestinal endoscopy. If results of endoscopy appeared normal or showed only mild abnormalities, the patient was enrolled in the study. Patients then underwent 24-hour esophageal pH monitoring in which a pH level below 4 was considered abnormal. In addition, patients completed a survey that asked them to rate their GERD symptoms during the previous week. Patients were then randomized into one of two groups--a treatment group that received 40 mg of omeprazole or a placebo group. Each group completed another survey after weeks one and two of the study.
The effectiveness of treatment was based on patient report of heartburn relief, since more than 92 percent of the patients reported this symptom. More than one half of the patients (54 percent) in the treatment group reported improved symptoms. Treatment response was as accurate in confirming the diagnosis as was pH monitoring.
The authors conclude that relief of symptoms following a two-week course of omeprazole therapy can be diagnostic for GERD. However, patients who did not respond to treatment would require further diagnostic testing. Use of a treatment-based approach provides physicians with a simple, inexpensive diagnostic test for GERD that is as effective as esophageal pH monitoring.
KARL MILLER, M.D.
Schenk BE, et al. Omeprazole as a diagnostic tool in gastroesophageal reflux disease. Am J Gastroenterol 1997 November; 92:1997-2000.
Efficacy of Dong Quai for Symptoms of Menopause
Dong quai is an herb present in at least one popular health remedy. This herb has been used in traditional Chinese medicine for over 2,000 years, but its efficacy has not been evaluated. Hirata and colleagues assessed the estrogenic effects of dong quai and its effect on menopausal symptoms. They also measured dong quai's effect on estradiol and estrone levels.
The double-blind, placebo-controlled study included 71 women who were postmenopausal for at least six months and had a significant problem with hot flushes or night sweats. The initial assessment included a Papanicolaou smear to determine the maturation values of vaginal cells, ultrasonography to measure the thickness of the endometrial lining, and measurement of serum estradiol, estrone and sex hormonebinding globulin (SHBG) levels.
Serum estrogen levels and vaginal cell maturation were checked again after 12 weeks, and endometrial ultrasonography was performed in the sixth, 12th and 24th weeks of the study. Women who were found to have an endometrial thickness of more than 5 mm at the final visit underwent endometrial biopsy to exclude endometrial abnormalities. Patients also kept a diary of the number of vasomotor episodes they experienced each day. At each visit, the Kupperman index was used to assess each patient's degree of symptoms. Patients were randomized to receive placebo or dong quai, in a dosage of three capsules three times daily, which is equivalent to 4.5 g of dong quai root daily. At the end of the study, no statistically significant difference in endometrial thickness was found between the dong quai group and the placebo group. The average maturation value of vaginal cells in both groups was less than 40 at 12 weeks, which is consistent with a menopausal, nonestrogenic pattern. No statistically significant changes occurred in the serum estradiol, estrone and SHBG levels. While the Kupperman index and the number of vasomotor episodes in both groups were reduced by 25 to 30 percent from initial values, no statistically significant differences were noted between the two groups.
The authors conclude that dong quai alone is no more useful than placebo in the treatment of menopausal symptoms, and they state that women should be discouraged from using this herb as a remedy for these symptoms.
KARL E. MILLER, M.D.
Hirata JD, et al. Does dong quai have estrogenic effects in postmenopausal women? A double-blind, placebo-controlled trial. Fertil Steril 1997 December;68:981-6.
Fluoxetine for Depression in Children and Adolescents
Depression is a significant cause of injury and death in children and adolescents. Many children with depression have difficulties in school and sometimes drop out of school altogether. Suicide continues to be a leading cause of death among adolescents. Many adults with depression, especially women, experienced their first episode during the teenage years. Studies to date have shown little, if any, real benefit from prescribed antidepressant medications in patients between six and 18 years of age. Use of selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, has been studied on a rather limited basis. Emslie and colleagues compared the efficacy of treatment with fluoxetine with use of a placebo in children and adolescents with nonpsychotic major depressive disorder.
Children and adolescents between the ages of seven and 17 years who met criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM-III-R) for nonpsychotic major depressive disorder were enrolled in the study. Patients with histories of bipolar disorder, psychotic depression, alcohol or other substance abuse (within the past year), anorexia nervosa or bulimia, or previous treatment with fluoxetine for more than three weeks were excluded.
A total of 583 patients underwent initial screening, 256 were interviewed, and 106 patients were enrolled in the study. After a one-week placebo run-in period, 96 patients were randomized to the placebo group or the fluoxetine group. Demographic and clinical characteristics were similar in both groups. In each group, 24 patients were younger than 12 years of age, and 24 patients were 13 years of age or older. The treatment group received 20 mg daily of fluoxetine for eight weeks. Outcomes were measured weekly, and a Clinical Global Impressions (CGI) scale improvement rating and a Children's Depression Rating Scale-Revised (CDRS-R) were obtained at each visit.
After eight weeks of treatment, 25 patients (74 percent) in the fluoxetine group showed a clinical response, compared with only 15 (58 percent) in the placebo group. Improvement in the fluoxetine group was first found to be statistically significant after week five of medication. Based on CGI ratings after eight weeks of treatment, 27 patients (56 percent) in the fluoxetine group and 16 patients (33 percent) in the placebo group were rated as "much" or "very much" improved. Age and sex had no effect on patient responsiveness. However, complete remission of depressive symptoms was uncommon in all patients. Side effects from the drug were minimal, with four patients in the fluoxetine group and one patient in the placebo group discontinuing the study because of medication intolerance.
The authors conclude that treatment with 20 mg of fluoxetine daily is superior to placebo in treating nonpsychotic major depressive disorder in children and adolescents. However, they add that the effectiveness of long-term treatment requires more study.
JEFFREY T. KIRCHNER, D.O.
Emslie GJ, et al. A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression. Arch Gen Psych 1997 November; 54:1031-7.
Prophylaxis Following Occupational Exposure to HIV
The risk of infection following percutaneous exposure to human immunodeficiency virus (HIV) infection is believed to be approximately three in 1,000 (0.3 percent). Unfortunately, specific factors that influence this risk have not been fully identified. In addition, while it is believed that postexposure prophylaxis with zidovudine decreases the risk of infection, this has not been proved. Cardo and associates conducted a case-control study to identify possible risk factors for the transmission of HIV infection to health care workers after percutaneous exposure to HIV-infected blood.
Study subjects were identified through reports from state and local health departments in the United States, France, Italy and the United Kingdom and reported to national surveillance systems for occupationally acquired HIV infection run by the U.S. Centers for Disease Control and Prevention (CDC). Study subjects were health care workers with a documented percutaneous exposure to HIV-infected blood by a needle stick injury or a cut with a sharp object and HIV seroconversion that was temporally associated with this exposure. Patients could not have any other reported concurrent exposure to HIV. Control subjects were health care workers exposed to HIV-infected blood through percutaneous exposure and were identified through the CDC Needlestick Study. The control subjects were all HIV-negative at the time of exposure and at repeat testing at least six months later. Personal information (age, sex, occupation, work location), information about the route of exposure (type of needle, type of procedure, severity of the injury) and information about the source patient (stage of HIV disease, symptomatic or asymptomatic, terminal illness at two months after exposure) were collected for all patients in the study.
A total of 712 patients were included in the study, with 33 study subjects and 679 control subjects. Thirty of the study subjects (91 percent) were exposed by a needle stick with a hollow-bore needle. Three patients (9 percent) were injured with other sharp objects. In the control group, 620 patients (91 percent) were exposed by needle stick injuries, with 59 patients (9 percent) injured by another sharp object.
Data analysis revealed the following factors to be associated with an increased risk of HIV transmission: deep injury, injury with a device that is visibly contaminated with blood, procedures that involve inserting a needle into the source patient's artery or vein, and terminal illness in the source patient (defined as a disease leading to death from acquired immunodeficiency syndrome within two months after the health care worker's exposure). After controlling for these four factors, no difference was apparent in the rates at which study subjects or control patients were offered prophylactic zidovudine after HIV exposure. However, it was determined that the study subjects were significantly less likely to have taken prophylactic zidovudine than the control subjects.
The authors conclude that the risk of HIV transmission after percutaneous exposure is influenced by the four factors noted above. The increased risk from a terminally ill source patient is likely related to the higher viral loads occurring in these patients but could also be related to the presence of the more virulent syncytium-inducing strains of HIV. Use of prophylactic zidovudine after exposure reduces the risk of infection by 81 percent. Results from this study should be used as a basis for counseling and educating health care workers and also for encouraging prophylaxis for most patients after accidental HIV exposure.
JEFFREY T. KIRCHNER, D.O.
Cardo DM, et al. A case-control study of HIV seroconversion in health care workers after percutaneous exposure. N Engl J Med 1997 November;337:1485-90.
EDITOR'S NOTE: The U.S. Public Health Service and the International AIDS Society issued treatment guidelines concerning postexposure prophylaxis based, in part, on the findings of this study. The available data are scant, but the nature of this problem makes conducting a prospective randomized placebo-controlled study virtually impossible. Knowing the risk factors that increase the potential for accidental transmission of HIV should help physicians and other health care workers decide whether to begin prompt prophylaxis with antiviral medication. Treatment recommendations include taking not only zidovudine but also lamivudine and indinavir for a total of four weeks after percutaneous exposure to HIV.
--J.K.
Cancer Screening in Women with Physical Disabilities
Anecdotal evidence suggests that women with physical disabilities face barriers to preventive health care measures such as breast and cervical cancer screening. Nosek and Howland evaluated the rate of mammography and cervical cancer screening among women with physical disabilities in a case-comparison study that was part of the National Study of Women with Physical Disabilities.
A total of 946 women completed a 311-item questionnaire eliciting information about reproductive health. Of this group, 504 women had physical disabilities and 442 women did not. The women without disabilities were used as the comparison group. Of 450 women with disabilities who were questioned about the frequency of pelvic examinations, 67.1 percent reported receiving a pelvic examination regularly. In comparison, 72.8 percent of the women without disabilities reported having regular pelvic examinations. The reasons the physically disabled women gave for not having regular pelvic examinations included difficulty getting onto an examination table (37.2 percent), lack of time (31.1 percent) and inability to find a doctor who suits them (29.1 percent).
The question about mammography was answered by 320 women (210 with disabilities and 110 without disabilities). No significant difference between the two groups was noted in the rate of screening mammography within the previous two years; 55.2 percent of the women with disabilities had had a mammographic examination, compared with 50.0 percent of those without disabilities. The most common reasons given by the women with physical disabilities who had not had mammograms were inability to get into the position required for mammography (34.1 percent), not being informed by their physician of the need for mammography (25.0 percent) and the belief that they were at very low risk of breast cancer (23.5 percent).
The authors conclude that women with physical disabilities, especially those with more severe functional limitations, are less likely than women without disabilities to receive regular pelvic examinations. Data from the study suggest that women with mild or moderate functional impairment are not unlike women in general with regard to cervical cancer screening. The authors note that the results of the survey must be interpreted cautiously. The women who participated in the study had a relatively high level of education and moderate income and lived in an urban area. In addition, the eligibility criteria excluded women over age 65, a group that may be more noncompliant with pelvic examinations.
KARL E. MILLER, M.D.
Nosek MA, Howland CA. Breast and cervical cancer screening among women with physical disabilities. Arch Phys Med Rehabil 1997 December ;78:S39-S44.
Evaluation of Patients Who Resume Driving After a Stroke
Little is known about the extent to which patients resume driving after a stroke, what advice they receive concerning driving and what assessment, if any, is performed to evaluate their driving capability. Fisk and colleagues conducted a survey of patients to answer these questions.
The 290 patients participating in the survey had been seen in the psychology service of a university rehabilitation center. The survey was conducted in Alabama, a state where no laws restrict driving after a stroke or require an evaluation before a person who has had a stroke can resume driving.
Patients were interviewed three months to six years after the stroke. To assess functional ability, a functional independence score for each patient was obtained from the rehabilitation center's database. While patients who resumed driving generally had higher scores than those who did not resume driving, there was considerable overlap in the scores of these two groups.
Thirty percent of the 290 patients reported that they had resumed driving after the stroke. Forty-eight percent of the survey participants stated that they had not received any advice concerning driving after the stroke, and 87 percent did not receive any evaluation of their ability to drive after the stroke. When a driving assessment was performed, the test most commonly given was a vision test. Five percent of the patients received an evaluation of their driving capabilities in an on-road driving situation. For those patients who reported receiving advice about driving, physicians were mentioned as the source by 33 percent, and family members were mentioned by 27 percent.
The survey results revealed two distinct groups of drivers. Some patients reported driving no more than three days per week and fewer than 25 miles each week, whereas others (one fourth to one third of those who resumed driving) reported driving six to seven days per week and between 100 to 200 miles each week. Information about urban versus rural driving was not obtained in the survey, so the relationship between driving environment and amount of driving is not clear.
The authors conclude that stroke survivors often make decisions about their ability to drive without professional input. Physicians must address this issue to decrease the risk for motor vehicle accidents in patients who have had a stroke.
KARL E. MILLER, M.D.
Fisk GD, et al. Driving after stroke: driving exposure, advice, and evaluations. Arch Phys Med Rehabil 1997 December;78:1338-45.
Histologic Examination of Seborrheic Keratotic Lesions
The cost effectiveness of routine histologic examination of excised seborrheic keratotic lesions has been debated. Eads and associates retrospectively studied the diagnostic yield of histologic examination of seborrheic keratoses.
The authors reviewed 577 pathology reports on lesions believed to be seborrheic keratosis. For comparison, 1,592 pathology reports on lesions diagnosed clinically as melanocytic nevi were also reviewed. The specimens had been submitted by community-based dermatologists and other specialists in four midwestern states.
Of the 577 specimens submitted as seborrheic keratoses, 37 (6.4 percent) were histologically interpreted as malignant tumors. Of the 379 lesions with a primary diagnosis of seborrheic keratosis and a differential diagnosis that included only benign tumors, 12 (3.2 percent) were histologically malignant tumors. In contrast, 16 (19.3 percent) of the 84 lesions submitted with a differential diagnosis of malignant tumor were found to be cancer on histologic examination. The physicians who were not dermatologists were three times more likely than dermatologists to mistake a basal cell or squamous cell carcinoma for seborrheic keratosis on the basis of clinical findings.
Seborrheic keratotic lesions with a clinical appearance of irritation or inflammation were more likely to be malignant tumors than were lesions not exhibiting inflammation. Nine (7.8 percent) of the 84 lesions that were described as inflamed or irritated were found to be malignant on histologic examination.
In contrast to the 6.4 percent rate of malignancy in the seborrheic keratotic lesions, 32 (2.0 percent) of the 1,592 lesions thought to be melanocytic nevi were histologically malignant. The rate of malignancy varied and depended on the clinician's concern that the lesion was atypical.
The authors conclude that data from this study indicate that 16 seborrheic keratoses would need to be excised to detect one malignant tumor, and 289 lesions would need to be removed to detect one melanoma. However, if the lesion is inflamed or atypical, then the ratio of benign-to-malignant lesions decreases significantly, to 8:1 for a malignant tumor and 99:1 for a melanoma. The authors note that it was surprising to find that lesions submitted as seborrheic keratoses were more likely to be melanomas than were lesions clinically identified as nevi. The authors believe that their findings support a policy in favor of histologic examination of lesions believed to clinically represent seborrheic keratoses.
BARBARAR APGAR, M.D., M.S.
Eads TJ, et al. The diagnostic yield of histologic examination of seborrheic keratoses. Arch Dermatol 1997 November;133:1417-20. *
"Tips from Other Journals" are written by the medical editors of American Family Physician.
Copyright © 1999 by the American Academy of Family Physicians.
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