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Effectiveness of Gabapentin for Postherpetic Neuralgia
Postherpetic neuralgia is characterized by excruciating pain that affects up to 15 percent of patients who have had herpes zoster (shingles). Postherpetic neuralgia is most prevalent in persons over 60 years of age. Treatment with analgesics is generally ineffective, although symptom relief has been documented with tricyclic antidepressants alone, or with tricyclic antidepressants in combination with carbamazepine or opioids. Tricyclic antidepressants are most effective, but severe adverse effects and contraindication in many patients with cardiovascular disease may limit their use. Gabapentin may be promising in these patients, as it reportedly relieves intractable neuropathic pain and reflex sympathetic dystrophy. Rowbotham and colleagues of the Gabapentin Postherpetic Neuralgia Study Group evaluated the effectiveness of gabapentin in reducing the pain associated with postherpetic neuralgia.
Adult patients who had postherpetic neuralgia for at least three months after healing of a herpes zoster rash were eligible for this randomized controlled trial if they rated their pain at a score of at least 40 on a 100-point scale. Any medications that could interfere with their pain or their assessment of pain were discontinued at baseline, although stable dosages of narcotics or tricyclic antidepressants could be continued. Patients with serious or unstable medical conditions were excluded from the study. All patients kept a pain diary and, at each of four follow-up visits, patients completed a pain questionnaire. Patients who met the study criteria were randomized to receive either a placebo or gabapentin, beginning at 300 mg daily. The dosage was gradually increased over four weeks to a maximum of 3,600 mg daily in three divided doses. Patients who could not tolerate the maximum dosage were maintained on the highest tolerable dosage, with a minimum of 1,200 mg daily required for continuation in the study. The primary end point of the study was a change in average daily pain rating from baseline, although sleep parameters, mood and quality of life were also assessed.
Of the 229 patients enrolled in the study, 45 (15 percent) dropped out because of adverse effects associated with medication or placebo. Attrition was comparable between groups. By the end of the study, 33 percent of the treatment group reported significant improvement in average daily pain scores, compared with only 7.7 percent improvement in the placebo group. This reduction took place by the end of week 2. Sleep ratings, mood and overall quality of life also improved in the treatment group. Nearly one half of the patients receiving gabapentin reported moderate or much improvement overall, compared with only 12 percent of patients taking placebo. In fact, almost 60 percent of patients taking placebo reported no change in pain. Adverse effects reported by the treatment group included somnolence, dizziness, peripheral edema and ataxia.
The authors conclude that gabapentin appears to be a safe, effective first-line therapy for postherpetic neuralgia, although studies that directly compare its effectiveness with that of tricyclic antidepressants are needed.
GRACE BROOKE HUFFMAN, M.D.
Rowbotham M, et al. Gabapentin for the treatment of postherpetic neuralgia. A randomized controlled trial. JAMA December 2, 1998;280:1837-42.
Respiratory Syncytial Virus: A Cause of Acute Otitis Media
Acute otitis media is the most common reason for the use of antibiotics in the outpatient setting. The annual cost of this disease is estimated to be over $3.5 billion. Historically, antibiotics have been routinely prescribed for patients with otitis media with the intent of decreasing the complications of the infection. Several studies have shown that respiratory viruses frequently cause the infection. Heikkinen and colleagues performed a study to determine rates of middle ear invasion by common respiratory viruses in children with acute otitis media and concurrent virus infections in the upper respiratory tract.
Children between two months of age and seven years of age with a diagnosis of acute otitis media were included in the study. The diagnosis was based on the presence of one or more symptoms: earache, fever, irritability, an inflamed tympanic membrane and the presence of fluid in the middle ear on tympanocentesis. Children who had received antibiotics during the previous week were excluded. Fluid was obtained via tympanocentesis at the time of diagnosis for bacterial culture, viral culture and rapid antigen testing. A nasal wash specimen was also obtained for viral studies. At a follow-up visit two to five days later, tympanocentesis was repeated, and a second nasal wash specimen was obtained. Venous blood for viral antibody testing was drawn at the time of diagnosis and at the third follow-up visit (between days 9 and 12).
A total of 456 children were enrolled in the study, 186 of whom were diagnosed with viral respiratory tract infection. Compared with all the children in the study, those who had a viral illness did not differ in terms of age, race, sex or duration of respiratory symptoms--with the exception of children with influenzavirus infection, who were significantly older. Respiratory syncytial virus (RSV) was isolated from middle ear fluid in 74 percent of children with a viral illness. Other viruses found in these children were parainfluenzavirus, isolated in 52 percent; influenzavirus, isolated in 42 percent; enterovirus, in 11 percent; and adenovirus, in 4 percent.
The most common bacterial organism isolated from middle ear fluid was Streptococcus pneumoniae (25 percent), followed by Haemophilus influenzae (23 percent) and Moraxella catarrhalis (15 percent). In 10 percent of the children, two or all three of these pathogens were present at the same time. In 65 percent of ears from which a virus was isolated, a bacterial organism was also found.
The authors conclude that the rates of middle ear invasion vary significantly during acute otitis media. The most common of these invasions is RSV. This finding is consistent with data from several other published studies, which have indicated that RSV is the virus most likely to predispose a child to acute otitis media. The authors state that a vaccine effective against RSV could have a very significant impact on the incidence of acute otitis media.
JEFFREY T. KIRCHNER, D.O.
Heikkinen T, et al. Prevalence of various respiratory viruses in the middle ear during acute otitis media. N Engl J Med January 28, 1999;340:260-4.
Inhaler That Delivers Both Ipratropium and Albuterol
The American Thoracic Society standards for the treatment of chronic obstructive pulmonary disease (COPD) include both ipratropium and a selective beta2 agonist in patients with daily symptoms. A large multicenter trial, reported by the Combivent Inhalation Aerosol Study Group in 1994, found that use of a metered-dose inhaler (MDI) aerosol containing ipratropium bromide and the beta agonist albuterol sulfate was more effective than either agent alone. While albuterol base and albuterol sulfate are believed to be therapeutically equivalent, albuterol base is the only formulation used in MDI albuterol aerosols marketed in the United States. To further study the effectiveness of a combination aerosol in the treatment of COPD, Campbell and colleagues of the Combivent Inhalation Aerosol Study Group conducted a 29-day trial to directly compare the efficacy of an aerosol of ipratropium bromide and albuterol sulfate with that of the marketed albuterol base aerosol.
The double-blind, parallel-group study included 356 patients who were enrolled at 17 centers. Patients were randomly assigned to receive the combination aerosol (176 patients) or albuterol alone (180 patients). Efficacy was primarily evaluated by comparing the the forced expiratory volume in one second (FEV1) on the first day of treatment and at the end of the trial. Patients were instructed to not use their inhaled medication for at least 12 hours before pulmonary testing. On each day of testing, FEV1 was determined at baseline and 15, 30 and 60 minutes after treatment with study medication and then hourly for up to six hours. Patients could not use other bronchodilators during the study period, but they could receive theophylline for maintenance if the dosage had been stable for one month. The primary end point was improvement in the FEV1.
On each of the test days, patients in both treatment groups demonstrated a clinically significant response to therapy, with the mean improvement in the FEV1 being at least 15 percent over baseline. However, compared with albuterol alone, the ipratropium-albuterol aerosol produced a greater overall response to therapy, especially during the first four hours after administration. In addition, the mean peak response for the combination-therapy group was significantly greater than that for the albuterol-only group.
In the group receiving combination therapy, mean peak responses ranged from 26 to 28 percent greater than those in the group receiving albuterol alone. The median time to a peak response was one hour for combination therapy and 30 minutes for albuterol alone. The median duration of action for the combination aerosol ranged from three to four hours; for albuterol alone, it was two hours.
Physician evaluation of improvement in the patients' symptoms revealed that the scores were higher for combination therapy than for albuterol alone, although the difference between the two groups was not statistically significant. However, statistically significant differences in favor of combination therapy were found for improvements in wheezing and shortness of breath throughout the study and for tightness of the chest during the first two weeks of combination therapy. Adverse events were similar in the two groups.
The authors conclude that a fixed-dose combination of ipratropium bromide and albuterol sulfate is more effective than albuterol base alone in the treatment of COPD. The combination aerosol not only resulted in improved pulmonary function but also provided relief in times of increased symptoms, when patients used the combination aerosol for rescue therapy. The authors believe the combination aerosol would provide a useful addition to COPD therapy.
BARBARA APGAR, M.D., M.S.
Campbell S. For COPD a combination of ipratropium bromide and albuterol sulfate is more effective than albuterol base. Arch Intern Med January 25, 1999;159:156-60.
Uncommon Symptoms of Mild Primary Hyperparathyroidism
The diagnosis and treatment of primary hyperparathyroidism (HPT) present a problem for physicians because patients are often asymptomatic and show few signs of complications resulting from the disease. HPT is typically diagnosed after patients are found to have an elevated serum calcium level on routine biochemical screening. Because of this, conservative treatment is often recommended rather than surgery, despite the fact that parathyroid surgery sometimes corrects many of the consequences of primary HPT. Postmenopausal women comprise a risk group for this condition, with a recent population-based screening study reporting a 2.1 percent prevalence of HPT in this group. Lundgren and colleagues sought to identify some of the less common symptoms associated with primary HPT, including psychiatric complaints, evidence of bone loss and incidence of cardiovascular disease, in postmenopausal women who were diagnosed after initial screening for hypercalcemia.
Women between the ages of 55 and 75 years undergoing routine mammography were eligible for the study. Serum calcium levels were obtained at the time the mammography was performed to screen patients for inclusion in the study group. Of the 5,202 women screened, 109 had a serum calcium level greater than 10.2 mg per dL (2.55 mmol per L) and an elevated parathyroid hormone level. Other requirements for a diagnosis of HPT included a serum creatinine level less than 1.42 mg per dL (130 µmol per L), absence of low urinary calcium clearance and no family history of hypercalcemia. Patients in the control group had normal serum calcium and creatinine levels and were matched by age and time of screening with the HPT patients. All women underwent a physical examination and were questioned about their history of smoking, daily exercise, age of menarche and menopause, medication use and frequency of physician visits. Laboratory studies included a complete blood cell count, urinalysis, determination of uric acid and a complete lipid panel. In addition, all women were asked about a history of kidney stones, muscle weakness or pain, loss of energy during the day, fatigue, depression and memory loss. Patients also completed two survey instruments that evaluated their somatic and psychiatric symptoms. Finally, bone mass density studies of the total body, lumbar spine, cervical spine and greater trochanter were conducted for all patients.
A total of 102 women were in the HPT group, and 95 were in the control group. Mean patient age was 66.5 years, and the groups were similar in incidence of current diseases such as diabetes and hypertension, history of smoking and amount of daily exercise. Age at menarche and menopause was also similar between groups, but women in the HPT group had had more children. In addition, fewer women in the HPT group were taking estrogen replacement therapy for signs and symptoms of menopause. Fewer women in the HPT group reported predefined cardiovascular symptoms of HPT. However, data from the survey instruments indicated that women in the HPT group cited fatigue, daytime sleepiness, muscle weakness and lack of emotional and sexual interest more often than women in the control group. Finally, bone density studies revealed lower values in the HPT group, but no increased history of lumbar, forearm or hip fractures.
Total cholesterol levels were similar between groups, but women in the HPT group had lower high-density lipoprotein levels and higher very-low-density lipoprotein and triglyceride levels than women in the control group. Patients in the HPT group also reported more physician visits and sick leave days than women in the control group, although exact figures were not specified.
The authors conclude that women with mild "asymptomatic" primary HPT have significant psychiatric and somatic symptoms that, in most patients, either are unrecognized or are attributed to other causes. In addition, these women have significant bone loss and an increased risk of cardiovascular disease, based on changes in their lipid profiles, compared with women in the control group. The authors conclude that current treatment strategies for these patients should be reconsidered.
JEFFREY T. KIRCHNER, D.O.
Lundgren E, et al. Case-control study on symptoms and signs of "asymptomatic" primary hyperparathyroidism. Surgery December 1998;124:980-86.
EDITOR'S NOTE: The authors of this study are surgeons, which alone would suggest some inherent bias. However, as they point out, a significant number of "asymptomatic" patients are diagnosed with primary HPT based on the results of routine metabolic screening. Perhaps physicians are not asking patients the right questions. It may be an incorrect assumption that because the patients are elderly or have no history of kidney stones they can simply be observed. At the very least, physicians should have a low threshold for choosing to perform bone mineral density studies in all patients with HPT. However, more convincing studies and data on the natural history of this disease are needed before surgical removal of a parathyroid adenoma can be recommended for all patients.
J.T.K.
The Duration of Anticoagulation After Electrical Cardioversion
Current guidelines recommend four weeks of anticoagulation after electrical cardioversion of atrial fibrillation or flutter to reduce the risk of thromboembolic events. Berger and Schweitzer pooled the data from 32 studies (4,621 patients) to assess the timing of embolic complications following cardioversion and to examine whether four weeks of anticoagulation are warranted after electrical cardioversion to sinus rhythm.
Studies were included if they contained at least 10 patients who underwent electrical cardioversion of atrial fibrillation or flutter and if the interval between electrical cardioversion and the occurrence of embolic events was clearly stated. An embolic event occurred after cardioversion in 92 (2 percent) of the 4,621 patients. The underlying cardiovascular or systemic disorder that predisposed to atrial fibrillation or flutter included rheumatic heart disease (17 patients), hypertension (12 patients), coronary artery disease (12 patients), dilated cardiomyopathy (five patients), hypertrophic cardiomyopathy (five patients), chronic obstructive pulmonary disease (three patients), congestive heart failure (two patients), alcohol abuse (two patients), aortic stenosis (one patient), mitral valve prolapse (2 patients) and thyrotoxicosis (one patient). Seventeen patients had no underlying heart disease and were classified as having lone atrial fibrillation. The embolic event occurred in three patients who had atrial fibrillation for no longer than two days before cardioversion.
The interval between cardioversion and the thromboembolic event ranged from less than one day to 18 days. Of the 92 events, 75 (82 percent) occurred within three days of cardioversion, 88 (96 percent) within one week and 90 (98 percent) within 10 days of cardioversion. In the two remaining patients, embolic episodes occurred on the 15th day and the 18th day after cardioversion.
The authors conclude that since embolic episodes rarely occurred more than 10 days after electrical cardioversion, two weeks of anticoagulant therapy might be sufficient in patients undergoing electrical cardioversion of atrial fibrillation or flutter. They also suggest that even shorter periods of anticoagulation might be a consideration in patients at high risk of bleeding complications.
RICHARD SADOVSKY, M.D.
Berger M, Schweitzer P. Timing of thromboembolic events after electrical cardioversion of atrial fibrillation or flutter: a retrospective analysis. Am J Cardiol December 15, 1998;82:1545-7.
Changes in Uterine Volume from GnRH Agonist Therapy
Treatment with a gonadotropin-releasing hormone (GnRH) agonist reduces the total uterine volume, with the greatest change occurring in the first eight weeks of therapy. The uterine changes in response to GnRH agonist therapy have been attributed to uterine atrophy, vasoconstriction and myometrial activity. GnRH agonists have also been shown to affect the blood flow through the uterine artery. Weeks and associates assessed changes in uterine volume and in uterine artery pulsatility index in response to GnRH agonist therapy in 51 women scheduled to have a hysterectomy for uterine bleeding unrelated to fibroid tumors.
Patients in this double-blind, placebo-controlled study were randomized to receive either leuprolide or placebo for eight weeks. Vaginal ultrasonography was performed before and after treatment to evaluate changes in uterine size and uterine artery pulsatility. Color-flow Doppler imaging was used to quantify the blood flow to the uterus through the uterine artery. The pulsatility index and resistance index represent the ratios of maximum and minimum Doppler shift as the blood flows through the artery. Serum estrogen levels were also determined, at baseline and after eight weeks of treatment. Complete data were available in 43 of the 51 women.
The estradiol level dropped profoundly in response to GnRH agonist therapy; no change occurred in the placebo group. Following active drug treatment, uterine volume decreased a mean of 34 percent, a statistically significant change. The mean change in uterine volume in the placebo group was not significant. The degree of uterine shrinkage with GnRH agonist therapy was negatively correlated with initial uterine volume.
After leuprolide therapy, the pulsatility index value increased significantly by 20 percent; no significant change occurred in the placebo group. The fall in estradiol levels correlated with the increase in vascular bed resistance as indicated by the pulsatility index. A direct correlation between estradiol levels and pulsatility was seen: the greater the fall in the serum estradiol concentration, the greater the increase in the pulsatility index. The presence of adenomyosis had no effect on the uterine artery Doppler results.
The authors conclude that treatment with a GnRH agonist leads to uterine shrinkage and an increase in the uterine artery pulsatility index even in the absence of uterine fibroids. The ability to reduce the volume of the uterus in women who are candidates for hysterectomy may become increasingly important as physicians move to less invasive methods of performing a hysterectomy in order to improve postoperative outcome.
BARBARA APGAR, M.D., M.S.
Weeks AD, et al. Uterine ultrasonographic changes with gonadotropin-releasing hormone agonists. Am J Obstet Gynecol January 1999;180:8-13.
Using Sao2 Values as a Predictor of Fetal Acidosis
False-positive findings during electronic fetal heart rate monitoring may explain the increased rates of cesarean delivery without associated improvements in neonatal outcome. Because of the poor specificity of fetal heart rate monitoring in predicting fetal distress, methods of fetal blood gas monitoring are being investigated as a way to improve the accuracy of assessing the infant's condition during labor. Seelbach-Göbel and associates prospectively investigated the use of fetal arterial oxygen saturation (Sao2) as a predictor of acidosis caused by hypoxemia. The authors sought to identify the minimum duration of a low Sao2 value (i.e., 30 percent or less) that would serve as a predictor of a significant decline in fetal pH.
Fetal pulse oximetry was used to monitor fetal Sao2 during 400 deliveries of infants between 37 and 42 weeks' gestation. To identify the minimum duration of reduced Sao2 before the onset of acidosis, the authors determined the number of minutes in which Sao2 was low (30 percent or less), medium (31 to 60 percent) and high (more than 60 percent) during each delivery. Umbilical artery pH and base excess values after delivery, as well as Apgar scores, were then compared with the amount of time the infants spent in low, medium and high Sao2 during labor and delivery. Umbilical artery pH, base excess values and Apgar scores were categorized as follows: pH, less than 7.15 versus 7.15 or more; base excess, less than 12 mmol per L versus 12 mmol per L or more; and one-minute Apgar score, less than 7 versus 7 or more.
Umbilical artery pH immediately after delivery was less than 7.15 in 54 neonates and 7.15 or more in 346 neonates. Infants with a pH of less than 7.15 had a significantly longer duration of low fetal Sao2 values than did those with a pH of at least 7.15. In the group with lower pH values, the mean duration of Sao2 of 30 percent or less was 23.5 minutes, compared with a mean duration of 8.1 minutes in infants with a pH of at least 7.15. Neonates with an umbilical artery pH of 7.15 or more had high values of fetal Sao2 for a significantly longer time than did neonates with a lower pH.
Among the infants in whom fetal scalp blood sampling was performed during labor and delivery, the duration of a low Sao2 level proved to be the best predictor of a decline in the scalp pH between two samplings. The pH declined significantly with an increasing duration of low fetal Sao2. No decrease of more than 0.05 was observed unless the fetal Sao2 remained at less than 30 percent for more than 10 minutes.
The findings of this study confirm that a fetal Sao2 of 30 percent is the critical threshold value during labor. The pH was found to decrease by 0.02 per 10 minutes of a fetal Sao2 of 30 percent or less. Thus, when the fetal pH is 7.30 at the beginning of labor, an average of 60 minutes of a low fetal Sao2 level will reduce the fetal pH to 7.20. The findings suggest that fetal scalp sampling should be conducted at shorter intervals if the fetal Sao2 is continuously far below the 30 percent threshold.
The authors conclude that even in the presence of a nonreassuring fetal heart rate pattern, one should not expect a significant reduction in the fetal pH if the fetal Sao2 as measured by pulse oximetry does not drop to less than 30 percent for longer than 10 minutes. Because the specific acid-base status for a fetus would not be known without monitoring, the authors believe that monitoring should ideally begin with a fetal scalp sample to determine the actual fetal pH. Fetal blood sampling should then be repeated only if the fetal Sao2 is 30 percent or lower for a longer interval. The authors stipulate that the interval for repeat monitoring depends on the original pH, the severity of hypoxemia as determined by pulse oximetry and the quality and continuity of the fetal Sao2 signal. They suggest that the use of fetal pulse oximetry in practice may reduce the need for fetal blood sampling, an important consideration in hospitals in which fetal blood analysis is a routine part of labor and delivery.
BARBARA APGAR, M.D., M.S.
Seelbach-Göbel B, et al. The prediction of fetal acidosis by means of intrapartum fetal pulse oximetry. Am J Obstet Gynecol January 1999;180:73-81.
Home Exercise for Elderly Persons with Disabilities
Although the benefits of exercise have been well documented, only about 30 percent of adults exercise regularly. Among the elderly, barriers to regular exercise include physical disability and lack of accessibility and transportation. Jette and colleagues evaluated the effectiveness of a program called "Strong-for-Life," which was developed for use in sedentary older persons who also had some component of physical disability.
Patients were recruited for the randomized, controlled study through mailings and referrals from social service agencies, senior centers or housing sites. Study subjects were required to be at least 60 years old and to have some sort of functional limitation. Persons with significant medical problems, including current treatment for cancer, hemodialysis, blindness, recent fracture, uncontrolled diabetes or the need for daily use of a wheelchair, were excluded from participation. A physical therapist performed a baseline assessment and obtained informed consent during the initial screening of volunteers. The patients who met eligibility criteria were then randomized to an exercise group or a control group that was placed on a waiting list.
The Strong-for-Life program included viewing of a 35-minute videotape that demonstrated 11 resistance exercise routines. The videotape showed five minutes of warm-up exercises, 25 minutes of strengthening exercises and five minutes of cool-down exercises. The exercises could be performed in a seated or standing position. The subjects were instructed to increase the resistance levels (designated by different colored elastic bands) after a specific routine could be completed 10 times without significant fatigue. For follow-up the patients received two additional home visits from the physical therapist, who also provided telephone support to answer questions and encourage adherence. The participants were asked to complete and return a log that recorded compliance with the program. The goal was performance of the exercises three times a week for six months. Assessments of strength, mobility, functional status and emotional state were performed at baseline, three months and six months.
A total of 215 patients in the study were randomized into one of the two groups. The mean age of the subjects was approximately 75 years, three fourths were women and over 90 percent were white. Baseline differences in terms of disability or psychologic function were not significant. Members of the exercise group received an average of seven to eight telephone contacts from their physical therapist. The overall adherence rate was 89 percent over the six months of the study, and in 57 percent of the study subjects 100 percent compliance with the exercises was noted. Areas of definite improvement were hip and shoulder abduction, lower extremity strength and tandem gait steps. In addition, the exercise group had a net reduction of 15 to 18 percent in physical disability at three and six months, as well as an 18 percent reduction in overall disability at six months. No difference in psychologic mood states was apparent between the two groups.
The authors conclude that the home-based exercise program is effective in improving the functional status of elderly persons with varying degrees of disability. It is safe and inexpensive and may provide significant public health benefits in this patient population.
JEFFREY T. KIRCHNER, D.O.
Jette AM, et al. Exercise--it's never too late: the Strong-for-Life program. Am J Public Health January 1999;89:66-72.
Assessing the Risk of Rupture with Intracranial Aneurysms
Intracranial aneurysms are relatively common in the United States, with a reported incidence of 0.2 to 10 percent of the population, or 10 million to 15 million persons. Most intracranial aneurysms do not rupture; therefore, the need for surgical management is controversial, because little is known about the natural history of these lesions and the risks associated with their repair. Investigators for the International Study of Unruptured Intracranial Aneurysms evaluated the risks associated with repair of unruptured aneurysms and also explained the natural history of this condition.
The study consisted of retrospective and prospective components. The purpose of the retrospective component was to describe the natural history of unruptured intracranial aneurysms. Inclusion criteria for this group encompassed patients who had at least one intracranial aneurysm, regardless of symptoms. Patients were also eligible if they had had a previous aneurysm at another site that spontaneously ruptured or was treated surgically. Patients with a traumatic or mycotic aneurysm or one that measured less than 2 mm were excluded from the study.
The purpose of the prospective component was to assess treatment-related morbidity and mortality in patients with newly diagnosed unruptured intracranial aneurysm. Inclusion criteria for this group were similar to those of the retrospective group, except that investigators decided whether to include patients with or without planned surgical or endovascular intervention in this component of the study.
All patients underwent cerebral angiography to identify the size, presence and location of the aneurysms. Follow-up was conducted with a variety of methods, including annual questionnaires, telephone interviews and chart reviews. End points of the study included the incidence of intracranial hemorrhage, stroke and death. In addition, evidence of surgery-related complications, such as neurologic deficits and mortality, was recorded for patients in the prospective group.
A total of 1,449 patients from centers in the United States, Canada and Europe made up the retrospective group. Mean patient age was 52 years, and approximately 75 percent of the patients were women. In this group, 1,085 patients had single aneurysms, and 364 had multiple lesions. Signs and symptoms that led to the diagnosis were, in order of frequency, headaches, ischemic cerebrovascular disease, cranial nerve deficits, aneurysmal mass effect, ill-defined spells, seizures, and subdural or intracerebral hemorrhage. Principal risk factors in this group included a history of hypertension and its treatment, and smoking. Thirty-two patients experienced confirmed ruptures during the 10-year follow-up. The two significant predictors of rupture were a lesion size greater than 10 mm and a location at the basilar tip or in the posterior cerebral distribution. In addition, patients with a history of rupture were about 11 times more likely to experience subsequent rupture than patients who had not had a previous rupture.
A total of 1,172 patients were enrolled in the prospective group. The clinical presentations that resulted in the diagnosis of aneurysms in these patients were similar to those in the retrospective group, as were the principal risk factors. Intracranial surgery was performed on 996 of these patients. Overall surgical morbidity and mortality were approximately 16 percent at 30 days and 15 percent at one year after surgery. These figures included a total of 34 deaths, of which 30 were related to the surgery. Age was the only independent predictor of a poor surgical outcome, with patients over 64 years of age having the worst outcome.
The authors conclude that for patients with no history of subarachnoid hemorrhage, the likelihood of rupture of a cerebral aneurysm less than 10 mm in size is extremely small. Patients with a history of subarachnoid hemorrhage were 11 times more likely to experience a rupture. Moreover, the risks of morbidity and mortality from surgical intervention exceed the risk of rupture in patients with small aneurysms even 7.5 years after diagnosis, with or without planned surgical or endovascular intervention.
JEFFREY T. KIRCHNER, D.O.
The International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms--risk of rupture and risks of surgical intervention. N Engl J Med December 10, 1998;339:1725-33.
Maternal and Neonatal Injury with High Degrees of Forceps Rotation
Use of advanced degrees of forceps rotation compares favorably with cesarean delivery in terms of morbidity. The increased morbidity with forceps delivery has been found to stem principally from maternal injuries, such as vaginal and sphincter lacerations, urinary retention and vulvovaginal hematomas. However, there are reports of catastrophic neonatal injuries as a result of forceps rotation. It is not known whether these injuries are a result of mismanagement or a rare result of properly performed forceps rotation. To investigate this issue, Hankins and associates conducted a retrospective study of the occurrence of maternal and neonatal injury after forceps rotation of 90 degrees or more.
The authors reviewed the medical records of 113 deliveries in which forceps rotation of 90 degrees or more was performed. These cases were compared with 167 deliveries in which forceps rotation of 45 degrees or less was required. The two groups were matched for gestational age and parity. The 280 forceps deliveries were among 13,799 deliveries from July 1992 to September 1995 at a teaching hospital. Forceps rotation of 45 degrees or less was always accomplished with the use of classic forceps, whereas all rotations of 90 degrees or more were performed with Kielland's forceps.
In both groups, the primary indication for operative vaginal delivery was to conclude the second stage of labor because it was prolonged or because maternal fatigue and ineffective pushing or a medical indication necessitated shortening of the second stage. Fetal heart rate abnormalities were an indication for forceps rotation of 45 degrees or less in 24 percent of the cases, compared with 17 percent of the deliveries in which forceps rotation was 90 degrees or more. Birth weights were similar in both groups.
As far as maternal outcome was considered, the mean length of hospital stay was 2.2 days in the group that required forceps rotation of 90 degrees or more, compared with a mean hospitalization of 1.7 days in the group that required forceps rotation of 45 degrees or less. The mean drop in hematocrit was 1 percent greater in the group undergoing the more advanced degrees of forceps rotation. The occurrence of vaginal lacerations or a third- or fourth-degree episiotomy was independent of the degree of forceps rotation.
With regard to neonatal injury, major trauma occurred in 17 (10.2 percent) of the infants who required forceps rotation of 45 degrees or less and in 11 (9.7 percent) of the infants who required forceps rotation of 90 degrees or more. Major trauma was defined as cranial nerve or brachial plexus palsy, a skull fracture or intracranial hemorrhage. The only permanent injury was a brachial plexus palsy that occurred with a forceps rotation of 45 degrees and subsequent shoulder dystocia.
Most of the neonatal injuries were in the form of a cephalohematoma, bruising or forceps marks, or superficial lacerations not requiring repair. Cephalohematomas developed in nine (8.0 percent) of the infants who required forceps rotation of 90 degrees or more and in 16 (11.4 percent) of the infants who required forceps rotation of 45 degrees or less. Bruising or forceps marks were present in 23 (13.8 percent) of the infants in the 45-degrees-or-less rotation group; seven (6.2 percent) of the infants in the other group sustained these injuries.
Compared with forceps rotation of 45 degrees or less, forceps rotation of 90 degrees or more was not associated with an increased incidence of acidemia (umbilical arterial pH of below 7.0 or 7.1). No difference was noted between the two groups in the percentage of neonates with Apgar scores of less than 7 at five minutes.
The authors conclude that maternal morbidity is not significantly increased by advanced degrees of forceps rotation. Maternal outcome was excellent in this series of patients. Similarly, neonatal outcome was good, with no long-term sequelae among infants who required 90 degrees or more of forceps rotation for delivery. The authors state that a role for advanced forceps rotation exists. Although neonatal morbidity did occur, it was not increased in infants undergoing forceps rotation of 90 degrees or more.
BARBARA APGAR, M.D., M.S.
Hankins GD, et al. The role of forceps rotation in maternal and neonatal injury. Am J Obstet Gynecol January 1999;180:231-4.
Vitamin K Reduces Warfarin's Anticoagulation Effect
Patients who take long-term daily oral anticoagulation medications, such as warfarin, are at risk for excessive bleeding during minor surgical or dental procedures. However, the risk of a recurrent thromboembolic event is also possible if the patient stops taking anticoagulation medication, even for a short time. Patients at lower risk can be taken off anticoagulation medication for the procedure and resume therapy a few days later, while patients at higher risk must be hospitalized, taken off anticoagulation therapy and treated with intravenous heparin during surgery. Both starting and stopping anticoagulant therapy are considered complicated and dangerous. Wentzien and colleagues examined the safety and efficacy of partially reducing the anticoagulant effect of warfarin by giving patients a single small dose of oral vitamin K1.
Patients who were scheduled to undergo a minor surgical or dental procedure or those found to have an International Normalized Ratio (INR) of 5.0 and no current bleeding were eligible for the study. Exclusion criteria included clinical bleeding at the time of the screening or a history of a thromboembolic event after warfarin therapy was discontinued. The dosage of vitamin K was calculated by using the following formula: 16 – (17 × desired INR/initial INR), rounded to the nearest 1.25 mg.
Two groups of patients were studied: the first group was scheduled to undergo a dental or minor surgical procedure; the second group had an excessively high INR and no bleeding. Patients in the surgery group were given oral vitamin K1 36 hours before their scheduled procedure and were instructed to continue their same dosage of warfarin. Their target INR was 1.75; the INR was measured four hours before the procedure and again 32 hours after ingestion of the vitamin K1. After the procedure, their INR was tested every one to two days until it exceeded 1.9. For patients in the high-INR group, the goal of vitamin therapy was to return their INR levels to a therapeutic range of 2 to 3 (or 3 to 4 in patients with prosthetic heart valves). These patients did not take their warfarin dose on the first day of the study and were given a dose of oral vitamin K1, which was calculated by using the same formula used for the first group.
Fifty-one patients were enrolled in the study, with 30 in the surgery group and 21 in the high-INR group. Mean patient age was 55 years, and the distribution between men and women was almost equal. The average dose of vitamin K1 was 5 mg for the surgery group and 10 mg for the high-INR group. At baseline, the mean INR for patients in the surgery group was 2.6; the mean INR was 8.4 in the high-INR group. After ingestion of vitamin K1, patients' INRs corrected to a mean of 1.6 and 1.7, respectively. Fifty of 51 patients attained a desired INR after taking oral vitamin K1. Prothrombin times for patients in the surgery group returned to a therapeutic level within an average of six days, and no patient experienced a thromboembolic event.
The authors conclude that giving patients a single dose of oral vitamin K1 is a safe and effective method of reversing the anticoagulant effect of warfarin without decreasing the warfarin dosage or discontinuing the oral anticoagulant.
JEFFREY T. KIRCHNER, D.O.
Wentzien TH, et al. Prospective evaluation of anticoagulant reversal with oral vitamin K1 while continuing warfarin therapy unchanged. Chest December1998;114:1546-50.
Discontinuing Prophylaxis for PCP in HIV-Infected Patients
The most common opportunistic infection in patients with human immunodeficiency-1 (HIV-1) is Pneumocystis carinii pneumonia (PCP). Prophylaxis has been recommended since 1989; the current criteria for administration of primary PCP prophylaxis are a CD4 cell count of less than 200 per mm3 (200 × 106 per L), oral candidiasis, or unexplained fever that lasts more than two weeks. The introduction of highly active antiretroviral therapy (HAART) has resulted in many patients having fewer opportunistic infections and achieving increased CD4 counts--but it has not been known if these patients could safely discontinue PCP prophylaxis. Schneider and colleagues studied the withdrawal of PCP prophylactic therapy in selected patients whose CD4 counts had increased to above 200 cells per mm3 as a result of HAART.
Seventy-eight patients were recruited from a Dutch university clinic. All study patients were receiving PCP prophylaxis for documented HIV-1 infection and had achieved CD4 counts of 200 cells per mm3 on at least two occasions (with measurements taken at least one month apart) since beginning HAART protocols. After informed consent had been obtained, prophylaxis was withdrawn, and patients were assessed every three months. The mean time between start of HAART and discontinuation of PCP prophylaxis was 9.8 months. Prophylaxis was restarted if CD4 counts fell below 200 cells per mm3 during the study. If PCP was suspected, bronchoscopy was performed within 72 hours.
No patients developed PCP during the mean follow-up period of 12.7 months. Two patients underwent bronchoscopy for suspected PCP infection, but none was documented. In all but two patients, CD4 cell counts remained above 200 cells per mm3. Although the CD4 cell counts of these two patients fell as low as 14 and 27 per mm3 (14 and 27 × 106 per L), respectively, these two patients did not develop PCP.
The authors conclude that the reduction in viral load and the increase in CD4 cell counts induced by HAART enables PCP prophylaxis to be discontinued in certain patients; however, the safest criteria for discontinuation remain to be defined. In particular, it is not clear if the duration of HAART is critical or if the key issue is the magnitude and diversity of the CD4 cell count.
ANNE D. WALLING, M.D.
Schneider MM, et al. Discontinuation of prophylaxis for Pneumocystis carinii pneumonia in HIV-1 infected patients treated with highly active antiretroviral therapy. Lancet January 16, 1999;353:201-3.
EDITOR'S NOTE: Most family physicians are now treating HIV-infected patients. Even when these patients receive most of their care from specialized HIV clinics, family physicians need to be aware of developments in the field and are frequently called on by these patients for advice and support. This study illustrates the movement toward cautious reduction in prophylactic therapy. It must be stressed that these advances were only achieved in highly structured situations and in patients who successfully maintained HAART. One danger in publishing this study and others like it is that they are reported by the news media, with the result that HIV-infected patients may inappropriately stop prophylactic therapy, thereby possibly diminishing the public's impression of the seriousness of HIV infection. Family physicians play a key role in their patients' understanding of HIV infection and its consequences. We must ensure that good news is conveyed accurately and does not lead to either false hope or a reduction in vigilance against this terrible disease.
A.D.W.
Presentations of Some Common Types of Vertigo
Vertigo is a disorienting form of dizziness in which there is often an illusion of rotating movement. It can be caused by any disruption of the otolith organs, semicircular canals, inner ear and deep paravertebral stretch receptors of the neck, as well as various centers in the brain stem, cerebellum, thalamus and cortex, and the connections between them. Baloh reviews the causes and presentations of some common types of vertigo.
Associated nausea is generally more pronounced when the cause of vertigo is peripheral. Conversely, imbalance tends to be more severe in cases of vertigo of central origin. The best guide to the site of origin of vertigo is given by the associated clinical picture. Lesions of the labyrinth or eighth nerve are associated with ear pain, tinnitus, hearing loss and other auditory symptoms. More central lesions produce neurologic signs and symptoms determined by the site and size of the lesion. In vertigo of peripheral origin, nystagmus generally resolves on fixation within 24 to 48 hours, whereas nystagmus associated with central vertigo does not.
Common causes of prolonged spontaneous vertigo include otomastoiditis, vestibular neuritis, labyrinthine concussion, lateral medullary infarction and cerebellar infarction. Urgent magnetic resonance imaging should be considered if vertigo is of sudden onset or is accompanied by severe headache, direction-changing nystagmus or neurologic signs, or if the patient has risk factors for stroke or is unable to stand or walk.
Recurrent attacks of vertigo result from sudden, temporary and usually reversible impairment of one labyrinth or its central connections. If the attacks last for hours, the cause is likely to be an abnormality of the inner ear. Common causes of recurrent attacks of vertigo include Ménière's syndrome, autoimmune disease of the inner ear, perilymph fistula, migraine and vertebrobasilar insufficiency.
A careful history focusing on activities occurring immediately before the onset of symptoms distinguishes positional vertigo from spontaneous or recurrent attacks. Positional vertigo has been attributed to lesions of the semicircular canals, particularly their enclosed otoliths, and their central connections. Besides the relationship to movement or position, patients with positional vertigo may report a sensation of motion sickness that persists for hours.
The three strategies for management of vertigo are symptomatic, specific (or cause-directed) and rehabilitative. Symptoms of vertigo, nausea and vomiting can be suppressed with short courses of meclizine, dimenhydrinate, promethazine or diazepam. Stronger anti-emetics such as prochlorperazine or metoclopramide may be added if required. Sedation is a serious side effect of these agents.
Examples of specific therapies include salt restriction and diuretics for management of Ménière's disease, prophylactic therapy for migraine using beta-blocking drugs, and aspirin or anticoagulant therapy for vertebrobasilar insufficiency. Benign paroxysmal positional vertigo may respond to maneuvers designed to reposition calcium deposits in the semicircular canals. Vestibular rehabilitation consists of exercises to assist patients in compensating for permanent vestibular damage. Although these exercises initially induce dizziness, they should be started as soon as possible and performed at least twice daily.
ANNE D. WALLING, M.D.
Baloh RW. Vertigo. Lancet December 5, 1998;352: 1841-6.
Should Antibiotics Be Used to Treat Acute Bronchitis?
Most patients with acute bronchitis receive a prescription for antibiotics, even though these medications are indicated in the treatment of bronchitis only when the patient has chronic lung disease. Acute bronchitis is viewed as a self-limited viral illness for which the use of antibiotics is generally not supported. However, the studies on which these recommendations are based generally had small sample sizes. Smucny and associates conducted a meta-analysis of all relevant English-language, randomized, controlled, blinded trials from 1966 to 1998 to evaluate the effectiveness of antibiotics in the treatment of acute bronchitis and to assess whether the risks of side effects outweigh the benefits of treatment.
Studies of patients with chronic bronchitis or those that did not include a placebo group were excluded from the analysis. Nine studies with a total of 779 patients met the inclusion criteria. Each study compared the effectiveness of a single antibiotic (e.g., doxycycline, erythromycin or trimethoprim-sulfamethoxazole) with a placebo. All trials performed one or more subgroup analysis, including age, duration of illness and smoking status.
No one patient subgroup was found to consistently benefit from antibiotic therapy. However, patients who were over 55 years of age and those who had a frequent cough and felt ill at study entry experienced some benefit from antibiotics. In addition, patients who received antibiotics were less likely to have a cough on follow-up examination and were less likely to be rated as unimproved by their physician. However, these findings did not necessarily have clinical importance. The incidence of adverse effects to antibiotics was also insignificant.
The authors conclude that antibiotics are only moderately beneficial and should not be prescribed routinely for acute bronchitis, given the conflicting data presented in these nine studies. A small group of patients may benefit from such treatment, but further research is needed to define this population. Currently, large randomized trials are under way to further address the issue. The authors recommend that physicians report the relative risks and benefits of antibiotic treatment to patients and allow them to be involved in management decisions until more definitive results are available.
GRACE BROOKE HUFFMAN, M.D.
Smucny JJ, et al. Are antibiotics effective treatment for acute bronchitis? A meta-analysis. J Fam Pract December 1998;47:453-60.
Can Gabapentin Effectively Treat Diabetic Neuropathy?
Diabetes mellitus is the most common cause of peripheral neuropathy, with 45 percent of patients affected at some time during the course of their disease. Pain is typically localized to the feet and ankles but may affect other areas. Peripheral neuropathy is difficult to treat successfully; tricyclic antidepressants are effective at reducing pain, but intolerable side effects often limit their use. Inadequate treatment can affect mood and sleep patterns, as well as fail to provide pain relief. Gabapentin is a fairly new anticonvulsant agent that has successfully reduced pain syndromes in some studies. This effect may be due to its relationship to gamma-aminobutyric acid (GABA), a neurotransmitter that modulates pain. Backonja and associates evaluated the effectiveness of gabapentin in treating neuropathic pain in patients with diabetes mellitus.
Patients with diabetes mellitus and peripheral pain diagnosed as diabetic neuropathy were eligible for this randomized controlled trial if they rated their pain at a score of at least 40 on a 100-point scale. Other study criteria included a hemoglobin A1c level of no more than 0.11. Exclusion criteria included other types of severe pain that could interfere with the study assessment and a creatinine clearance of less than 60 mL per minute (1.00 mL per second), because impaired renal function necessitates adjusting the dosage of gabapentin. Acetaminophen and aspirin were the only medications allowed that might affect the symptoms of painful neuropathy.
During the screening phase of the study, a medical history and physical examination were obtained, as were blood studies to evaluate serum creatinine and hemoglobin A1c levels. Patients completed daily pain and sleep diaries during this phase of the study. Patients who met the inclusion criteria were then randomized to receive gabapentin or placebo for eight weeks. The starting dosage of gabapentin was 900 mg daily. This was gradually increased to a maximum of 3,600 mg daily over the course of the first four weeks, regardless of any efficacy achieved at a lower dosage. For the remaining four weeks, patients remained at the maximum dosage if they could tolerate it. If not, they could decrease the total daily dosage of gabapentin to a minimum of 900 mg daily. All patients kept daily pain and sleep diaries, and recorded information on overall quality of life. The primary end point of the study was a rating of pain severity. Secondary end points included disturbances in sleep patterns and changes in overall quality of life.
Of the 165 patients enrolled in the study, 84 were in the treatment group and 81 in the placebo group. Demographic and baseline characteristics, including pain scores and the extent of neuropathic pain, were similar between groups. In addition, the number of patients who completed the study and the number who withdrew because of adverse effects were also comparable. Mean pain scores and mean sleep interference scores were significantly improved in the treatment group compared with the placebo group. Quality of life was also improved in the treatment group. Hemoglobin levels did not appreciably change in either group, suggesting that gabapentin had no effect on glycemic control. Adverse effects of the drug were considered to be mild to moderate and included dizziness, somnolence, nausea and headache. Side effects associated with the placebo included dyspepsia, constipation and flatulence.
The authors conclude that gabapentin provides safe, effective pain relief in patients with diabetic neuropathy. The effects of gabapentin are similar to those found with tricyclic antidepressants but with a more rapid onset of action and fewer adverse effects. The adverse effects experienced with gabapentin were generally mild and are potentially avoidable with dosage adjustment.
GRACE BROOKE HUFFMAN, M.D.
Backonja M, et al. Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus. A randomized controlled trial. JAMA December 2, 1998;280:1831-6.
Laparoscopic Cholecystectomy vs. Open Surgery in the Elderly
The over-80 age group is a rapidly growing segment of the American population. The number of cholecystectomies, particularly those using laparoscopic techniques, is also increasing. Because the increase in laparoscopic cholecystectomies appears to be greatest among patients over 80 years of age, Maxwell and colleagues investigated the safety of laparoscopic cholecystectomy in these patients.
Surgical data for the years 1988 to 1992 from a database of hospitals in 11 states were examined. The database represented approximately 20 percent of U.S. community hospitals. Cholecystectomy was performed on 350,451 patients, of whom 18,500 were at least 80 years of age. Among these very elderly patients, 5,034 procedures were laparoscopic procedures, and 13,466 were open procedures. The number of cholecystectomies in patients 80 years or older increased each year of the study and almost doubled from 1988 to 1992. The proportion of cases performed laparoscopically in these patients rose dramatically, from 8 percent to 64 percent between 1990 and 1992.
In patients older than 80 years, the mortality related to laparoscopic cholecystectomy was significantly lower (1.8 percent) than mortality related to open procedures (4.4 percent). Laparoscopic procedures were found to have one half the mortality rate of open procedures in each age subset of this population. Men had a mortality rate of 2.1 percent with a laparoscopic procedure and 4.8 percent with open cholecystectomy. Women had slightly lower mortality rates: 1.6 percent with laparoscopy and 4.1 percent with open cholecystectomy. Lengths of hospital stay were lower for both male and female patients following laparoscopic cholecystectomy (7.9 days for men and 6.9 days for women, compared with 11.3 and 11.0 days for open cholecystectomy). Patients were significantly more likely to be discharged to skilled nursing facilities following open procedures (11 percent) compared with laparoscopic cholecystectomy (8 percent). Seventy-five percent of patients undergoing laparoscopic cholecystectomy were discharged home, compared with 68 percent of those treated with open procedures, but this difference was not statistically significant.
The authors conclude that laparoscopic cholecystectomy has low mortality and morbidity rates even in very elderly patients. The trends over time may reflect increasing surgical experience and a willingness to intervene earlier in the course of disease. They suggest that laparoscopic cholecystectomy could be offered early to elderly patients with symptomatic gall bladder disease.
ANNE D. WALLING, M.D.
Maxwell JG, et al. Cholecystectomy in patients aged 80 and older. Am J Surg December 1998;176:627-31.
Long-Term Effects of Oral Contraceptives on Mortality
Although oral contraceptives have been used by millions of women during the past 40 years, little is known about their long-term effects on health after their use is discontinued. Beral and colleagues have been monitoring the health of British women using oral contraceptives since 1968 and recently reported data from their study.
The study followed patients of 1,400 general practitioners in the United Kingdom. By monitoring health records and death certificates, the study covered 517,519 person-years of follow-up for women who had ever used oral contraceptives and 335,998 person-years for women who had never used them.
By 1993, the median age of study participants was 49 years, and the cohort had been followed for 25 years. During that time, 945 deaths occurred in the group of ever-users and 654 deaths occurred in the group of never-users. After adjustments for age, parity, social class and smoking, the relative risk of death for all causes was similar for users and nonusers of oral contraceptives.
For almost all causes of death, the relative risks of the two groups were similar. The exceptions were colorectal cancer and ovarian cancer, for which the relative risks of death were significantly reduced in ever-users, and cerebrovascular and violent or accidental deaths, for which the risks were significantly increased in ever-users. The risk of death within the first 10 years of oral contraceptive use was significantly increased for all causes, circulatory diseases and cerebrovascular disease but was significantly reduced for ovarian cancer. Women who used oral contraceptives for 10 years or more had excess mortality from lung and cervical cancer, but the excess deaths were related to smoking. No increase in mortality was found in women who had not used oral contraceptives for at least 10 years, including women reporting long durations of oral contraceptive use before discontinuation.
The authors conclude that the effects of oral contraceptive use on mortality are limited to current users and women who have used oral contraceptives within the previous 10 years. Although the women in this study predominantly used preparations with 50 mg of estrogen or more, no evidence was found of long-term increased mortality associated with prior oral contraceptive use. In particular, no evidence was found of a significantly increased risk of breast cancer or cancer of the reproductive tract in previous users of oral contraceptives.
ANNE D. WALLING, M.D.
Beral V, et al. Mortality associated with oral contraceptive use: 25 year follow up of cohort of 46,000 women from Royal College of General Practitioners' oral contraception study. BMJ January 9, 1999;318: 96-100.
Nicotine Spray and Patch Are Effective in Combination
Approximately one in five smokers who use nicotine replacement methods remains abstinent at one year. Although this is double the rate in smokers who do not use such aids, much remains to be learned about the optimal dosage and route of nicotine replacement therapy. Blondal and colleagues evaluated the short- and long-term abstinence rates in patients who used nicotine sprays in combination with patches in a placebo-controlled, double-blind trial.
In this Icelandic study, 237 smokers between 21 and 69 years of age were recruited through advertisements. To be included, they had to have a history of daily smoking for at least three years. Cardiac disease, alcohol abuse, pregnancy or lactation were grounds for exclusion. All participants attended an initial instructional meeting and four group meetings within the first three weeks of their quit dates.
Participants were randomly assigned by groups to receive either nicotine patch plus nicotine nasal spay or nicotine patch plus placebo spray. The patches provided 15 mg of nicotine for three months, followed by 10 mg for one month, then 5 mg for one month. The nicotine spray delivered 0.5 mg per dose and was packaged so that patients were unable to tell which therapy they had received.
Patients were assessed six weeks after stopping smoking and again at three, six, 12 and 72 months. Patients were finally checked after six years, and carbon monoxide levels were used to verify reported abstinence.
After six weeks, 51 percent of patients in the combined-therapy group had quit smoking, compared with 35 percent in the patch-only group. After six months, these figures were 31 and 16 percent, and after one year, 27 percent and 11 percent. After six years, one in six patients treated with combination therapy was abstinent, compared with one in 12 of those using only the patch.
The authors conclude that both short- and long-term abstinence rates are significantly improved by the use of combination therapy with a nicotine patch and spray compared with use of the patch alone. After the first year, few participants reported that they were still using the spray, indicating that the optimal time of spray use may not exceed one year.
ANNE D. WALLING, M.D.
Blondal T, et al. Nicotine nasal sray with nicotine patch for smoking cessation: randomised trial with six year follow up. BMJ January 30, 1999;318:285-9.
Do Antiseptic Catheters Reduce Risk of Bloodstream Infection?
Patients with central venous catheters are at increased risk for nosocomial bloodstream infections that often result in increased hospital stays, medical costs and, ultimately, mortality. Strategies to prevent infection include aseptic insertion technique, proper catheter care and, more recently, use of catheters impregnated with the antiseptic chlorhexidine-silver sulfadiazine. These catheters have been shown to decrease catheter colonization, but their effectiveness in reducing the number of catheter-related bloodstream infections (CR-BSI) is not as well documented. Veenstra and colleagues conducted a meta-analysis of randomized, controlled clinical trials from 1966 to 1998 to evaluate the effectiveness of catheters impregnated with chlorhexidine-silver sulfadiazine in preventing catheter colonization and CR-BSI.
To be included in the meta-analysis, studies had to compare the effectiveness of chlorhexidine-silver sulfadiazineimpregnated central venous catheters with nonimpregnated catheters in preventing colonization and CR-BSI. Twelve studies were available for analysis of catheter colonization, and 11 studies were available for evaluation of CR-BSI.
Most of the patients evaluated were at high risk for catheter infection, with approximately one third hospitalized in an intensive care unit and the rest in other hospital settings. The average duration of catheter placement was five to 11 days. The risk of catheter colonization and CR-BSI was decreased in patients with medication-impregnated catheters compared with patients using nonimpregnated catheters. However, the evidence for preventing colonization was much stronger than that for preventing CR-BSI.
The authors conclude that catheters impregnated with chlorhexidine-silver sulfadiazine reduce the risk of CR-BSI by about 40 percent in high-risk populations that require short-term, multilumen central venous catheters. Use of medication-impregnated catheters in these patients may decrease the overall incidence and ultimately the medical costs of catheter-related bloodstream infections. In rare instances, hypersensitivity reactions to chlorhexidine have been reported; these require further study.
GRACE BROOKE HUFFMAN, M.D.
Veenstra DL, et al Efficacy of antiseptic-impregnated central venous catheters in preventing catheter-related bloodstream infection. A meta-analysis. JAMA January 20, 1999;281:261-7.
Determining Need for Imaging in Young Children After a Fall
Head trauma in children results in 600,000 emergency department visits and 95,000 hospital admissions per year. It is likely that many more such children are evaluated in physicians' offices. Predicting which children require diagnostic imaging can be difficult, and no established guidelines are in place to direct physicians who care for pediatric patients with head trauma. Published guidelines are based on limited clinical data and are not followed uniformly in practice; in addition, they generally do not specify which imaging technique is preferred. Gruskin and Schutzman performed a retrospective study to determine the incidence of skull fracture and intracranial injury in children who presented to a pediatric emergency department. They also attempted to determine which historic features and physical findings predict complications of head injury and whether clinical criteria could aid in the selection of diagnostic imaging.
Medical records were reviewed for children younger than two years of age who were discharged from a Boston children's hospital with a diagnosis of head injury, skull fracture, intracranial injury, cerebral contusion or cerebral edema. Excluded from the study were children with a history of seizures, blood dyscrasias, neurologic disorders, ventricular shunts or suspected abuse. Historic information included the estimated height of the fall, level of consciousness and presence of scalp abnormalities, and whether the child was referred by another physician or came directly to the emergency department. When skull radiographs or cranial computed tomographic (CT) scans were obtained, these results were also noted. Children were diagnosed with a "minor head injury" if they had a normal neurologic examination and were alert at discharge, and if radiologic studies were normal.
A total of 291 patients were evaluated; medical records were available for 278 patients (96 percent). Most of these children had gone directly to the emergency department. Approximately 60 percent of the children were younger than 12 months of age; 40 percent were between 13 and 24 months of age. Eighty-two percent of all children were ultimately given a diagnosis of minor head injury, and 18 percent were diagnosed with a skull fracture or an intracranial injury. However, the incidence of skull fracture/intracranial injury was 29 percent in children younger than 12 months of age and 4 percent in those older than 12 months of age. An increase in the height of the fall was associated with a higher incidence of serious injury, although low height of fall did not rule out a diagnosis of skull fracture or intracranial injury.
The incidence of seizure, emesis, behavior changes and loss of consciousness did not differ significantly between children found to have a minor head injury and children diagnosed with skull fracture/intracranial injury. Of those determined to have a minor head injury, 29 percent exhibited a behavior change, and 11 percent had emesis. There was a very high incidence (94 percent) of skull fracture/ intracranial injury associated with scalp abnormality. Depressed level of consciousness and presence of skull fracture/intracranial injury were significantly correlated, but 92 percent of children with an isolated skull fracture and 75 percent with intracranial injury had a normal level of consciousness and a nonfocal neurologic examination.
The authors conclude from their data that the incidence of serious head injury from a fall is greatest in children younger than 12 months of age. Many children who apparently have minor falls may have sustained significant head injury, even in the absence of clinical signs and symptoms. Physicians should have a low threshold for ordering imaging studies in children who have fallen. A CT scan could appropriately be ordered, but a skull radiograph may be acceptable in some situations because it is easier to perform and does not require sedation. The authors report that children who fall 3 ft or less and have normal results on scalp examination and no history of neurologic symptoms do not need radiologic evaluation.
JEFFREY T. KIRCHNER, D.O.
Gruskin KD, Schutzman SA. Head trauma in children younger than 2 years. Are there predictors for complications? Arch Pediatr Adolesc Med January 1999;153:15-20.
EDITOR'S NOTE: This study seems to dispel the notion held by many physicians that if a child does not lose consciousness, the chance of a serious head injury is very small. In addition, many children with minor head injuries may exhibit behavior changes and vomiting. It appears that exercising clinical judgment and maintaining close follow-up is still prudent. In addition, there should be a very low threshold for ordering a cranial CT scan in a child under one year of age who has fallen. Obviously, more studies are needed to better define historic and clinical criteria for diagnostic imaging.
J.T.K.
Reducing the Risk of Stroke in Women with Migraine
Migraine headache has been suspected as both a risk factor and a precipitating event for stroke in premenopausal women, but the degree of association and the interplay between migraine and other factors, such as hypertension and use of oral contraceptives, has been unclear. The report of a large European study by Chang and colleagues clarifies the data and calls on physicians to actively intervene to reduce risk factors for stroke in young women who suffer from migraine.
The case-controlled study recruited women 20 to 44 years of age who had suffered stroke, acute myocardial infarction or venous thromboembolic disease; each case was matched with up to three control subjects. Patients were excluded from the study if they had a recent major illness, pregnancy or surgery; had died within 24 hours of admission to hospital; or had a history of stroke, deep venous thrombosis, pulmonary embolism, acute myocardial infarction or menopause. Case subjects and control subjects were interviewed using a standardized questionnaire to collect extensive demographic, medical and other types of information. Data were gathered on 291 women who had strokes and 736 matched control subjects. Most strokes were hemorrhagic (187); 86 ischemic strokes and 18 unclassified stroke were also reported. Within the hemorrhagic group, 150 patients (80 percent) had subarachnoid hemorrhages.
A history of migraine as defined by International Headache Society criteria was given by 74 of the stroke patients (25.4 percent) and 96 of the control patients (13.0 percent). Stroke patients were also more likely to report a history of hypertension, diabetes, heavy smoking, heavy alcohol intake, a family history of early stroke and migraine. Case subjects were also more likely to be current users of oral contraceptives. The overall risk of stroke (odds ratios) in women with a history of migraine was 1.78, but the risk was dramatically different for ischemic stroke (3.54) compared with hemorrhagic stroke (1.1).
The risk for ischemic stroke was multiplied by a history of hypertension (except during pregnancy), use of oral contraception and smoking, but the synergistic effect was significant only for smoking. The risk was lower for women who used low-dose oral contraceptives than for those who used contraceptives containing 50 mg or more of estrogen. More than 80 percent of women with migraine reported no change in their headache patterns in relation to oral contraceptive use. Up to 40 percent of strokes in women with migraine developed directly from a migrainous attack, and around 70 percent reported a headache within the three days before the stroke. Change in the type or pattern of migraine with use of oral contraceptives was not predictive of stroke. Women with classic migraine headaches and women with other migraine types had similar risks of stroke.
The authors stress that ischemic stroke is a rare event in premenopausal women but that the risk is increased in women who have a personal or family history of any type of migraine. This risk is significantly multiplied by smoking. The authors urge that women with migraine headaches be advised to stop smoking and to control blood pressure. The combination of smoking and oral contraceptive use in migrainous women was of considerable concern.
ANNE D. WALLING, M.D.
Chang CL, et al. Migraine and stroke in young women: case-control study. BMJ January 2, 1999;318:13-8.
Atovaquone and Dapsone for PCP Prophylaxis
Pneumocystis carinii pneumonia (PCP) is a significant cause of morbidity and mortality in patients infected with human immunodeficiency virus (HIV). Currently, the treatment of choice for PCP is trimethoprim- sulfamethoxazole; however, many patients cannot tolerate this drug. Common alternatives include dapsone and pentamidine, but these agents are less effective and are also associated with a high rate of intolerance. Atovaquone is a newer agent that has been shown to be effective in treating PCP. However, its role as a prophylactic agent has not been previously evaluated. El-Sadr and colleagues from the AIDS Clinical Trials Group and the Community Program for Clinical Research on AIDS compared the effectiveness of atovaquone with that of dapsone in preventing PCP in patients with HIV infection who were intolerant to trimethoprim-sulfamethoxazole.
Two groups of HIV-infected patients 13 years of age and older were eligible for this multicenter, open-label, randomized trial. The primary prophylaxis group included patients who had a CD4+ lymphocyte count of less than 200 per mm3 (200 × 106 per L) or less than 15 percent of the total lymphocyte count. The secondary prophylaxis group included patients who had a previous history of PCP. Patients were randomized to receive either 100 mg of dapsone daily or 1,500 mg of atovaquone suspension daily. Patients in the dapsone group who had CD4+ counts of less than 100 per mm3 (100 × 106 per L) and a positive serology for toxoplasma were also encouraged to take weekly pyrimethamine and leucovorin. If adverse events or PCP developed in any patient, he or she could be switched to the alternative study drug. The primary end point of the study was the development of PCP, as confirmed by histology or cytology of the organism in tissue or sputum specimens. Probable causes included clinical, radiographic and blood gas evidence consistent with PCP and the exclusion of other diagnoses. Secondary end points included drug intolerance necessitating its discontinuation, PCP pneumonia resulting in death, or confirmed or probable toxoplasmosis.
A total of 1,057 patients enrolled in the study. Most patients were men approximately 38 years of age with baseline median CD4+ counts of 60 per mm3 (60 × 106 per L). Approximately 20 percent of the patients were black, and 65 percent were white. Almost 50 percent of the patients had an established diagnosis of AIDS, and 28 percent had a prior history of PCP. At baseline, only 59 percent of the patients were receiving antiretroviral therapy; however, by the 24-month follow-up visit this number had increased to 93 percent.
At the end of the study, the mean follow-up time for all patients was 27 months and at this time, 617 of those originally enrolled were still alive. Of these, 289 were still taking the study-supplied dapsone or atovaquone, 214 were taking the originally prescribed drug and 75 had switched to a different treatment. A total of 257 patients had either confirmed or probable PCP, including 122 patients in the atovaquone group and 135 in the dapsone group. The cumulative percentages for PCP development over the two-year study period were 27 percent in the atovaquone group and 30 percent in the dapsone group. Toxoplasmosis developed in only seven patients, with essentially no difference between treatment groups. Of the 440 patients who died during the course of the study, 233 were in the atovaquone group and 208 in the dapsone group. The number of patients who had to stop taking medication because of intolerance was similar between groups. However, hypersensitivity reactions and anemia were more common in the dapsone group.
The authors conclude that atovaquone and dapsone are equally effective in preventing PCP in patients with HIV infection. Atovaquone appears to be better tolerated and may be the preferred drug in patients who cannot take trimethoprim-sulfamethoxazole.
JEFFREY T. KIRCHNER, D.O.
El-Sadr WM, et al. Atovaquone compared with dapsone for the prevention of Pneumocystis carinii pneumonia in patients with HIV infection who cannot tolerate trimethoprim, sulfonamides, or both. N Engl J Med December 24, 1998;339:1889-95.
EDITOR'S NOTE: This study supports a role for a fourth drug as prophylaxis against PCP in patients whose CD4+ counts are less than 200 per mm3 (200 × 106 per L) or in patients with a prior history of PCP. However, in the era of combination antiretroviral therapy, the best "prophylaxis" is a three-drug regimen directed against the virus.
J.T.K.
Treating H. pylori Does Not Affect Nonulcer Dyspepsia
Approximately one third or more of the adults in the industrialized world have recurrent dyspeptic symptoms, although most do not have peptic ulcer disease or gastroesophageal reflux. The term "nonulcer dyspepsia" is often used to describe this condition. The pathogenesis of nonulcer dyspepsia is unknown, but patients often are treated with antacids or histamine H2 blockers with mixed results. More recent data have implicated Helicobacter pylori as a contributing factor in patients with dyspeptic symptoms, similar to its established role in the pathogenesis of peptic ulcer disease. Blum and colleagues evaluated the effectiveness of a variety of antimicrobial agents that are commonly used to eradicate H. pylori in improving the symptoms associated with nonulcer dyspepsia.
Patients were eligible for this randomized double-blind study if they had had dyspeptic symptoms for at least six months but had no history of peptic ulcer disease or gastroesophageal reflux. Other inclusion criteria consisted of normal baseline endoscopic findings and positive results on biopsy, rapid urease testing or urea breath testing for H. pylori. During a one-week run-in period in which no treatment was given, patients were asked to rate and record their symptoms at bedtime, using a scale in which a score of zero indicated no symptoms and a score of 6 indicated very severe symptoms. Only patients who reported moderate to very severe symptoms were enrolled in the study. Exclusion criteria included a history of serious disease, use of H2-antagonists, prostaglandins or prokinetic agents within seven days of the study, or use of proton-pump inhibitors, antibiotics or bismuth compounds one month before the study began.
Patients were randomized to receive a one-week course of either 20 mg of omeprazole twice daily, 1,000 mg of amoxicillin and 500 mg of clarithromycin twice daily, or 20 mg of omeprazole twice daily, as well as placebo antibiotics. Patients were examined one week after treatment, then again one month later, followed by quarterly visits for one year. Upper endoscopy and biopsy, along with urea breath testing for H. pylori, were repeated at months 3 and 12. Abnormal histologic findings on gastric biopsy, a positive urea breath test, or both constituted responses positive for H. pylori. In addition to these studies, patient quality of life was assessed four times: at randomization, one week after treatment, and once every six months until the study was complete. Ratings were quantified with two survey instruments in which the severity of symptoms was assessed.
A total of 348 patients were enrolled, and 245 completed the study. Mean patient age was 47 years, approximately two thirds of the patients were women and 88 percent were white. Treatment success was the same in both groups, as was the percentage of patients with minimal or no symptoms at each follow-up visit. Mean symptom ratings were also similar at follow-up visits--1.73 and 1.74, respectively. Overall, patients' quality of life improved but not significantly, and two thirds of the patients reported an improvement in symptoms after treatment. H. pylori was eradicated in 79 percent of the patients who received multiple antibiotics, compared with only 3 percent of the patients in the omeprazole group. Symptom relief was reported in 31 percent of cured patients who received multiple medications, compared with 26 percent of patients who remained H. pylori-positive. No serious adverse events were reported in either group; however, 63 percent of the patients who received antibiotics reported having diarrhea.
The authors conclude that although the eradication of H. pylori with multiple antibiotics has been shown to prevent or cure peptic ulcer disease, it does not relieve symptoms in patients with nonulcer dyspepsia any better than treatment with omeprazole alone.
JEFFREY T. KIRCHNER, D.O.
Blum AL, et al. Lack of effect of treating Helicobacter pylori infection in patients with nonulcer dyspepsia. N Engl J Med December 24, 1998;339:1875-81.
5-mg vs. 10-mg Doses in the Initiation of Warfarin Therapy
To produce an adequate anticoagulant effect, warfarin therapy must be monitored carefully, with the dosage adjusted to maintain the prothrombin time (PT) in a safe and effective range, usually equivalent to an International Normalized Ratio (INR) of 2.0 to 3.0. Intensive monitoring of the patient's response during the initiation of warfarin therapy lasts a minimum of four to five days and is no longer required when the INR has remained in the therapeutic range for two consecutive days. A previous study by Crowther and associates suggested that a starting dose of 5 mg is as effective in producing an anticoagulant effect by the fourth or fifth day as a dose of 10 mg. To further investigate this observation, the authors prospectively studied the anticoagulant effects of 5-mg and 10-mg loading doses of warfarin to determine if the number of days required to achieve a therapeutic INR differed with these two starting doses.
The study consisted of 53 patients (28 women) who required anticoagulant therapy; 32 patients were randomly assigned to receive an initial warfarin dose of 5 mg, and 21 were assigned to receive an initial dose of 10 mg. The goal of therapy was a target INR of 2.0 to 3.0. The INR was measured daily for five days. The primary end point was therapeutic INR values on two consecutive days by the fourth or fifth day of therapy.
INR values of 2.0 to 3.0 were consistently more common at all time points in patients who received the 5-mg dose than in patients who received the 10-mg dose. The primary end point was achieved in five of the 21 patients (24 percent) in the 10-mg group, compared with 21 of the 32 patients (66 percent) in the 5-mg group. INR values on the fourth day were greater than 3.0 in five of the 21 patients (24 percent) who received a loading dose of 10 mg. In contrast, they were above 3.0 in two of 30 patients (7 percent) who received the 5-mg loading dose.
The authors conclude that an initial warfarin dose of 5 mg does not delay the attainment of an INR of 2.0 to 3.0 on day 3, 4 or 5 of therapy. The present study corroborates the authors' previous observation that a 5-mg starting dose of warfarin is as effective as a 10-mg loading dose.
BARBARA APGAR, M.D., M.S.
Crowther MA, et al. A randomized trial comparing 5-mg and 10-mg warfarin loading doses. Arch Intern Med January 1999;159:46-8.
Observation After Stopping Intravenous Antibiotics
Many patients on intravenous antibiotics often must wait 24 hours after their medications have been discontinued or until they are switched to oral antibiotics before being discharged from the hospital. This is done to protect patients from deteriorating after medications are discontinued, and to identify adverse events from oral antibiotics. However, the utility of this practice is in question, as modern antibiotics remain at therapeutic blood levels for several hours after the drug is discontinued. In addition, patients are often switched to the oral version of the same antibiotic. As a result, this practice increases costs for little or no clinical benefit. Dunn and colleagues conducted a retrospective study to evaluate whether an observation period after intravenous antibiotics are discontinued serves a clinically useful purpose.
Medical records of patients from an urban medical center who had diagnoses of cellulitis, pneumonia or urinary tract infection were reviewed over a six-month period. Patients had to be at least 18 years old and had to be admitted to one of the hospital's medical services or intensive care units. Exclusion criteria included a history of human immunodeficiency virus infection, abscess or empyema, nosocomial infection, drug-induced neutropenia and dialysis. Those included in the study had either been switched to oral antibiotics or had stopped taking antibiotics altogether.
Demographic information, admission data and comorbidities were recorded for all patients. Patients were divided into two groups: an observation group and a no-observation group. Those in the observation group were not discharged on the day their intravenous antibiotics were discontinued, while those in the no-observation group were discharged at that time. All available notes were reviewed to assess the rate of recurrence of infection or adverse reactions to oral antibiotics during the 24 hours after the intravenous antibiotics were discontinued. The two-week period after hospital discharge was also reviewed, when possible, to calculate the rate of hospital readmission for recurrent infection.
Of the 468 records reviewed, 371 were included in the analysis. A total of 308 (63 percent) were in the observation group and 63 (17 percent) were in the no-observation group. Patients in the latter group tended to be younger and less ill than those in the observation group. Three patients in the observation group experienced a recurrence, and three other patients in this group experienced adverse reactions to oral antibiotics. One patient in the no-observation group and 10 patients in the observation group were readmitted for recurrent infection.
The authors conclude that the often-used observation period after discontinuation of intravenous antibiotics is not warranted in patients with cellulitis, pneumonia or urinary tract infection. Eliminating this observation period decreases the length of hospital stay, the risk of iatrogenic illness and the risk of medication error.
GRACE BROOKE HUFFMAN, M.D.
Dunn AS, et al. The utility of an in-hospital observation period after discontinuing intravenous antibiotics. Am J Med January 1999;106:6-10.
Can Palpation Reliably Detect Abdominal Aortic Aneurysm?
Abdominal aortic aneurysms (AAA) cause thousands of deaths annually, many of which could be prevented with timely diagnosis and treatment. AAA can be asymptomatic for many years, but in the one third of patients whose aneurysms rupture, the mortality rate is 80 percent. In the past, palpation of the abdomen was the preferred method for identifying AAA; however, diagnostic imaging studies, such as computed tomographic scanning and ultrasonography, are more accurate and have become the methods of choice. Palpation is now limited to identification of patients who need imaging studies to confirm the diagnosis. Lederle and Simel searched the literature to evaluate the safety and accuracy of attempts to diagnose AAA through physical examination.
Relevant studies with more than 10 patients that were published after 1966 were included in the literature search. An AAA was defined as an aortic diameter of at least 3 cm (sometimes 4 cm). Two studies that provided results by age and gender indicated that abdominal palpation had the highest positive predictive value in asymptomatic men over 60 years of age, while examinations of women and younger men had lower predictive values. Several studies emphasized that routine abdominal palpation differs from that designed to identify AAA. In one study, use of routine abdominal palpation led to a missed diagnosis in all patients who were subsequently diagnosed with ultrasound examinations. Other studies indicate that the sensitivity of abdominal palpation increases as aortic diameter increases, ranging from 29 percent for diameters up to 3.9 cm to 76 percent for those greater than 5 cm. However, the lack of a widened aorta does not rule out AAA. Obesity appears to limit the effectiveness of abdominal palpation, as detecting AAA is more difficult in patients with greater abdominal girth.
The proper technique for detecting an AAA with abdominal palpation begins with placing the patient in a supine position with the knees raised and the abdominal muscles relaxed. The aortic pulse can be palpated just above and to the left of the umbilicus. The width of the aorta can then be measured by placing both hands palms down on the patient's abdomen, with one index finger on either side of the aorta. Each systole should move the fingers apart. Note that initially it is easier to palpate one side at a time. The width of the aorta is the key finding, not the intensity of the pulsation; intensity does not confirm or disprove the presence of an AAA. Patients with an aortic diameter of greater than 2.5 cm require additional diagnostic studies, usually ultrasonography. Abdominal palpation is not associated with an increased risk of rupture.
The authors conclude that physical palpation to detect AAA in asymptomatic patients under 50 years of age is not warranted. Abdominal palpation detects fewer than one half of the AAAs in high-risk patients and even fewer in low-risk patients, but those detected are likely be large enough to warrant surgery. In addition, palpation is not reliable enough to rule out the diagnosis; therefore, further diagnostic studies should be ordered in patients for whom there is a high index of suspicion.
GRACE BROOKE HUFFMAN, M.D.
Lederle FA, Simel DL. Does this patient have abdominal aortic aneurysm? JAMA January 6, 1999;281:77-82.
A Cost-Effective Evaluation of Gynecomastia in Men
Gynecomastia occurs in 40 to 65 percent of men but is asymptomatic in almost all cases. Patients may present for medical care because of tenderness in the breast mass, or they may be concerned about their body image. Since the role of endocrine testing in gynecomastia is controversial, Bowers and colleagues made a retrospective study to find the most cost-effective approach to patients with gynecomastia.
The medical records of all patients with gynecomastia presenting to an academic center between 1992 and 1997 were analyzed. The average age of the 87 men was 47 years (range 18 to 90 years); 73 had unilateral breast enlargement. Initial assessment identified hepatic or renal disease in 14 patients, medication-induced gynecomastia in 18 patients and hyperthyroidism in two patients. The remaining 53 patients (61 percent) were considered idiopathic cases.
Eight patients with idiopathic disease had fine needle aspiration followed by excision of the breast mass. All of these lesions were benign. The remaining 45 patients underwent some form of endocrine evaluation. One patient was found to have bilateral gynecomastia due to an occult Leydig cell testicular tumor. Endocrine testing was normal in the remaining patients, and all underwent simple excision.
The authors conclude that routine evaluation of idiopathic gynecomastia is rarely productive. Breast cancer should be apparent on initial physical examination followed, if necessary, by fine needle aspiration. If adrenal or testicular lesions are suspected of causing gynecomastia, ultrasound examination is less expensive and more accurate than endocrine evaluation.
ANNE D. WALLING, M.D.
Bowers SP, et al. Cost-effective management of gynecomastia. Am J Surg December 1998;176:638-41.
Active Training vs. Physical Therapy for Adductor Pain
Groin pain is common among athletes, with up to 18 percent of male soccer players reporting adductor-related pain every year. In theory, sports-related adductor pain should respond to active training programs designed to improve the coordination and strength of the muscles stabilizing the pelvis and hip joints. However, nonsurgical treatments have not been based on randomized clinical trials. Holmich and colleagues conducted a randomized clinical trial to compare an active training program with conventional physical therapy in 68 athletes with longstanding adductor pain.
Men 18 to 50 years of age who reported sports-related adductor pain of at least two months' duration and who wanted to return to active sports participation were eligible for the study if they met clinical criteria for adductor strain. Patients with alternative explanations for pain and those who missed more than one quarter of the treatment sessions were excluded from the study. One physician assessed the 68 patients using standardized techniques, a validated questionnaire to collect demographic and clinical data, and a standardized set of radiographs of the pelvis. Patients were then randomly assigned to treatment with either active training or physical therapy.
The active training program consisted of 90-minute training sessions three times weekly for up to 12 weeks. Patients were instructed to exercise on other days. The physical therapy group was treated by one physical therapist for 90 minutes twice weekly. Patients were asked to do stretching exercises on days between treatment sessions. Patients were banned from other therapies and from participation in any sports during the treatment period.
Patients were interviewed and examined one and four months after completion of treatment. The follow-up assessments were conducted by a single physician who was not informed of the treatment followed. The three principal outcome measures were a return to the same level of sports participation without groin pain; no pain on palpation of adductor tendons; and no pain on active adduction against resistance. Subjective global assessment of pain was also conducted before and after treatment.
In the active training group, 24 patients (79 percent) successfully returned to sports activity. The time to return to previous levels of activity ranged from 13 to 26 weeks (median: 18.5 weeks). Only four of the patients in the physical therapy group successfully returned to active sports participation. This difference, as well as improvement in adduction strength, showed the significant benefit derived from active training, compared with physical therapy. With regard to other outcome measures, trends in favor of active training did not reach statistical significance. In the subjective assessment, significantly more patients in the active training group than in the physical therapy group rated their condition as much better.
The authors conclude that the active training program was highly effective in returning athletes with longstanding adductor pain to full sports participation. A program aimed at improving muscle strength and coordination is more effective than the traditional physical therapy program and receives higher subjective ratings from patients.
ANNE D. WALLING, M.D.
Holmich P, et al. Effectiveness of active physical training as treatment for long-standing adductor-related groin pain in athletes: randomised trial. Lancet February 6, 1999; 353:439-43.
"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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