Randomized controlled trial of Siberian ginseng for chronic fatigue.

BACKGROUND: Chronic fatigue greatly affects quality of life and is a common reason for consulting a physician. Since conventional therapy is often of limited help, fatigued patients may use herbal treatments. This randomized controlled trial evaluated the effectiveness of Siberian ginseng. METHOD: Subjects were recruited from advertisements in Iowa (82%) and members of chronic fatigue syndrome support groups (18%). Potential subjects were required to have substantial fatigue > or = 6 months with no identifiable cause. The mean change in a fatigue measure was compared for placebo and Siberian ginseng at 1 and 2 months. Comparisons were for all subjects and for subjects with characteristics previously identified in the literature as important for categorizing chronic fatigue. RESULTS: Ninety-six subjects were randomized to treatment groups, and 76 provided information at 2 months of follow-up. Fatigue among subjects assigned to either placebo or Siberian ginseng was substantially reduced during the study, but differences between treatment groups were not statistically significant in the full sample. Fatigue severity and duration had a statistically significant interaction with response to Siberian ginseng at the P < 0.05 level. Treatment was effective at 2 months for 45 subjects with less severe fatigue (P = 0.04 unadjusted for multiple comparisons) and for 41 subjects with fatigue for > or = 5 years (P = 0.09 unadjusted for multiple comparisons). CONCLUSION: Overall efficacy was not demonstrated. However, the findings of possible efficacy for patients with moderate fatigue suggests that further research may be of value.

Sudden cardiac death with clozapine and sertraline combination.

OBJECTIVE: To report a case of sudden cardiac death in a patient receiving combination therapy with clozapine and sertraline. CASE SUMMARY: A 26-year-old white man was discovered dead at his residence. His medical history included chronic paranoid schizophrenia, obsessive-compulsive disorder, major depressive disorder, obstructive sleep apnea, and akathisia. He had no prior history of cardiovascular disease. His medication regimen included clozapine 100 mg twice daily (started 4 y prior to his death), risperidone 3 mg twice daily, sertraline 200 mg once daily, atenolol 50 mg twice daily, and lorazepam 0.5 mg four times daily. Autopsy and toxicology studies revealed cardiomegaly suggestive of idiopathic cardiomyopathy, single-vessel coronary artery disease, sertraline and clozapine blood concentrations in the expected range, undetectable lorazepam and risperidone blood concentrations, obesity, and moderate fatty changes to the liver. The most likely cause of death was sudden cardiac death due to acute cardiac arrhythmia. DISCUSSION: Clozapine is structurally similar to the tricyclic antidepressants, which have type 1 A antiarrhythmic properties. Case reports have described electrocardiographic abnomalities, cardiomyopathy, and fatal myocarditis associated with its use. Unexplained death in patients on clozapine therapy has also been reported. Sertraline appears to have less cardiac effect; however, one report has observed clinically significant QT prolongation during sertraline therapy. CONCLUSIONS: Clozapine-induced cardiomyopathy and cardiac arrhythmia from clozapine and/or sertraline use may have contributed to this man's death.

Torsades de pointes associated with chlorpromazine: case report and review of associated ventricular arrhythmias.

PURPOSE: To present a case of chlorpromazine-associated torsades de pointes, review established cases of ventricular arrhythmias associated with chlorpromazine, and describe the proarrhythmic characteristics of this drug. DATA SOURCES: Articles identified through a search of MEDLINE and IDIS from January 1966-November 2000 and thorough review of the article bibliographies. Patient cases also were identified from a search of the Food and Drug Administration's Adverse Event Reporting System database (November 1997-March 2001). Cases involving intentional overdoses of chlorpromazine were excluded. RESULTS: In addition to the case reported herein, 12 cases of documented, chlorpromazine-associated ventricular arrhythmias were identified; five had characteristic features of torsades de pointes. Chlorpromazine delayed repolarization and produced electrocardiographic abnormalities; although, whether chlorpromazine induced torsades de pointes through a mechanism of early afterdepolarizations is unclear. Similar to other instances of drug-induced torsades de pointes, concurrent factors such as electrolyte deficiencies may place the patient at increased risk for arrhythmia. CONCLUSIONS: Chlorpromazine can delay repolarization and produce electrocardiographic abnormalities. These can result infrequently in ventricular arrhythmias and torsades de pointes, particularly in patients with confounding factors.

Diabetes management quality improvement in a family practice residency program.

BACKGROUND: Diabetes is a devastating chronic disease. Although optimal diabetes control reduces chronic complications, actual provision of diabetes care frequently falls short of accepted guidelines. We wanted to determine whether locally developed diabetes care initiatives can result in improvements in the provision of diabetes care. METHODS: This study was a retrospective cohort analysis using Medicare claims and chart abstraction data to ascertain diabetes care indicator utilization rates at the Northeast Iowa Family Practice Clinic (NEIFPC), which serves as the training site for the Northeast Iowa Family Practice Residency Program. Diabetic patients receiving care at the NEIFPC during 1996, 1997, and 1998 were included. Diabetes care rates are compared with those of other Iowa practices. Diabetes initiatives included chart audits, glycosylated hemoglobin (HbA1c) measurement reminder cards, educational symposia, an endocrinology outreach clinic, resident elective rotations, diabetes flow sheet utilization, pharmacist interface, and nursing foot-examination preparations. The primary outcome was the utilization rate of accepted diabetes care indicators. RESULTS: Diabetic patients at NEIFPC had greater utilization of diabetes care indicators than did patients of Iowa collaborators in 1997 and 1998. NEIFPC patients had HbA1c levels measured more frequently in 1997 and 1998 (84% and 88%, respectively) than did patients of Iowa collaborators (49% and 41%, respectively) (P < .001). The mean 1997 and 1998 HbA1c levels of 7.32% and 7.25%, respectively, are impressive compared with that of Iowa collaborators (8.83% and 8.36%) (P < .001) and other published data (8.5%-10%). The percentage of NEIFPC patients with good glycemic control (HbA1c < 8%) was 75%, compared with the reported 50% of all US patients. CONCLUSIONS: Our findings suggest that multimodal diabetes care quality improvement initiatives, applied longitudinally, can result in significant improvements in the provision and documentation of diabetes care.

Prescription medication costs: a study of physician familiarity.

BACKGROUND: Studies in the past 25 years have suggested that physicians are not familiar with the costs of common prescription medications. OBJECTIVES: To determine physician familiarity with the cost of common prescription medications and to determine the value physicians place on knowing information regarding the cost of medications. DESIGN: Survey. SETTING: Seven community-based family medicine residency teaching clinics in Iowa. PARTICIPANTS: Two hundred five practicing resident and faculty physicians. INTERVENTIONS: From a series of $10 price intervals (range, $0.01-$80.00), physicians were asked to select the interval containing the cash price of the medication to an uninsured patient for 50 medications commonly prescribed in outpatient family medicine clinics. Physicians were also questioned about the value of medication cost information to their practice. MAIN OUTCOME MEASURES: The percentage of correct responses and the mean pricing scores were calculated for each respondent and for all medications. RESULTS: One hundred seventy-eight physicians responded (86.8%). Only 22.9% of the responses correctly identified the cost of the medication. More than two thirds (68.3%) of the responses underestimated the correct price interval. Branded drugs were underestimated in 89.9% of responses, while generic drugs were overestimated in 90.2% of responses. Overall, 64.4% of physicians believed they did not receive sufficient information in their practices regarding prescription drug costs, and nearly all (93.6%) reported that regular information on prescription medication costs would help them prescribe more cost-effectively. CONCLUSIONS: Physicians are unfamiliar with the costs of medications they commonly prescribe, and they report that regular access to information on prescription medication costs would help them prescribe more cost-effectively. Arch Fam Med. 2000;9:1002-1007

Assessment of patients' perceptions and beliefs regarding herbal therapies.

We evaluated the demographics and beliefs regarding safety and efficacy of herbal therapy among individuals in Iowa and assessed the willingness to discuss the use of these products with health care providers. We distributed 1300 surveys to two random samples: patients attending eight clinics, and residents of the state (mailing). Data were categorized according to herb use and compared between users and nonusers. The response rate was 61% (794 people), with 41.6% of respondents reporting herb use. They were predominately white women and were likely to have had education beyond high school (p<0.05). Their use of prescription drugs was high (p<0.05). Although users rated safety and efficacy of herbs higher than nonusers (p<0.05), both groups believed that health care providers should be aware of use and would provide this information.

Thrombolytic-associated cholesterol emboli syndrome: case report and literature review.

Thrombolytics can cause cholesterol embolization syndrome (CES). This adverse effect has received less attention than other risks of thrombolytic therapy, such as systemic bleeding and hemorrhage, with only sporadic reports of CES in the literature. Risk factors have not been consistently identified and emphasized; therefore, occurrence of CES after thrombolysis remains difficult to predict, it results in substantial morbidity and mortality, and it lacks effective pharmacologic treatment. Heightened awareness of the disorder can aid in its correct identification and reporting.

Zolpidem: a nonbenzodiazepine hypnotic for treatment of insomnia.

The pharmacology, pharmacokinetics, and clinical efficacy of zolpidem tartrate, a new hypnotic agent, are described. Zolpidem belongs to the imidazopyridine class. It exhibits high-affinity binding at a benzodiazepine-receptor subtype that is located in the cerebellum and cerebral cortex but not in the spinal cord or peripheral tissues. It decreases sleep latency and increases total sleep time and sleep efficiency without affecting sleep architecture. Zolpidem tartrate is absorbed rapidly. Bioavailability is 67% after oral doses of 5-20 mg. Pharmacokinetics show age-related and sex-related variations. The disposition of zolpidem is reduced in hepatically and renally impaired patients. Clinical studies have shown effectiveness of zolpidem in increasing sleep time and decreasing sleep latency. It has demonstrated efficacy equal to that of benzodiazepines without causing rebound insomnia or withdrawal effects. Comparative trials have found zolpidem as effective as flunitrazepam, flurazepam, and triazolam. The optimum dose of zolpidem tartrate is 10 mg at bedtime; 5 mg for elderly patients. Adverse reactions to zolpidem are dose-related and have primarily CNS and gastro-intestinal manifestations. Zolpidem exhibits similar efficacy to the benzodiazepines in the treatment of insomnia. Zolpidem's advantages over benzodiazepines are that it does not lead to tolerance, withdrawal phenomena, or REM rebound; however, for short-term, as-needed use, these advantages are not relevant.