Once daily fluticasone furoate nasal spray is effective in seasonal allergic rhinitis caused by grass pollen.

BACKGROUND: Fluticasone furoate is a new enhanced-affinity glucocorticoid with a unique combination of pharmacodynamic and physicochemical properties suitable for topical activity. METHODS: In this multicentre, randomized, double-blind, placebo-controlled, parallel-group study, patients [adults and adolescents >or=12 years of age with seasonal allergic rhinitis (SAR)] received once-daily (od) treatment for 2 weeks with either fluticasone furoate nasal spray 110 microg (n = 141) or placebo nasal spray (n = 144) administered in a unique, side-actuated device. Efficacy measures included total nasal symptom score (TNSS) and total ocular symptom score (TOSS). Patients also reported their overall response to therapy and rated their quality of life using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). RESULTS: Fluticasone furoate significantly improved the mean change from baseline in daily reflective TNSS compared with placebo (treatment difference of -1.757; P < 0.001). Fluticasone furoate was also significantly more effective in improving the morning predose instantaneous TNSS (treatment difference of -1.898; P < 0.001) and daily reflective TOSS (treatment difference of -0.741; P = 0.001). A significant treatment effect was observed as early as day 1. Compared with placebo-treated patients, fluticasone furoate-treated patients showed significantly greater improvements in overall evaluation of response to therapy (P < 0.001), as well as in overall RQLQ score (P < 0.001). Fluticasone furoate was well tolerated. CONCLUSION: Fluticasone furoate nasal spray 110 mug od was effective in improving the nasal symptoms of SAR. It also produced significant improvements in ocular symptoms.

Analgesia for colposcopy: double-masked, randomized comparison of ibuprofen and benzocaine gel.

OBJECTIVE: To evaluate pain relief effectiveness of oral ibuprofen and topical benzocaine gel during colposcopy. METHODS: In a double-masked, randomized controlled trial, women who attended a family medicine colposcopy clinic received one of four treatments, 800 mg of oral ibuprofen, 20% topical benzocaine, both, or placebos. Using visual analog scales, women recorded their pain after speculum placement, endocervical curettage (ECC), and cervical biopsy. Participants were 18-55 years old, spoke English, and were not taking other pain or psychotropic medications. Demographic and historical information was collected from each participant. RESULTS: Ninety-nine subjects participated. Twenty-five received oral ibuprofen and topical benzocaine (median pain scores on a 10-point scale for speculum placement, ECC, and biopsy were 0.75, 3.00, and 3.38, respectively), 24 received oral placebo and topical benzocaine (1.00, 3.75, and 2.63), 24 received oral ibuprofen and topical placebo (0.63, 3.75, and 2.25), and 26 received oral and topical placebos (0.75, 3.50, and 3.00). There were no statistically significant differences in patient visual analogue pain scale scores across the four groups (statistical power, ECC = 0.74, cervical biopsy = 0.62). Younger women and women who had pain with speculum placement were more likely to have increased pain during ECC. Increased pain during biopsy was associated with history of severe dysmenorrhea but no other demographic or historical factors. Women overall reported ECC and biopsy to be mildly painful, with median scores of 3.5 for ECC and 2.75 for biopsy on a 10-point scale. The range in pain scores was large, with some women reporting severe pain (for ECC minimum = 0.25, maximum = 10.0; biopsy: minimum = 0.0, maximum = 9.0). CONCLUSION: Colposcopy is perceived as somewhat painful, but oral ibuprofen and topical benzocaine gel, alone or together, provided no advantage over placebo in decreasing colposcopy pain.

Community patterns of transdermal nicotine use and provider counseling.

OBJECTIVES: To examine how transdermal nicotine is prescribed and used in the general population, and to identify variables associated with successful smoking cessation in patch users. DESIGN: Retrospective cohort survey. SETTING: A random sample of 70 pharmacies in King County, Washington, were asked to participate. Of those, 33 pharmacies ran computer searches of prescriptions for any nicotine patch dispensed between July 1 and December 31, 1992. A total of 1,087 individuals receiving patches were identified. PATIENTS: At least eight months after the nicotine patches were purchased, 972 subjects received questionnaires by mail from the participating pharmacies. The survey was completed by 433 (45.2%) subjects. MAIN RESULTS: Eighty percent of the respondents requested patches from a provider, 81% of whom were primary care physicians. Ninety-six percent used the patch, 45% smoked while using the patch, and 37% reported having quit smoking. Smoking cessation was associated with daily patch application (odds ratio [OR] 1.6, 95% confidence interval [CI] 1.2-2.2), abstinence during patch use (OR 7.7, 95% CI 4.8-12.5), and a longer duration of patch use (p = 0.001). A score reflecting counseling intensity by the provider was associated with abstinence while using patches and smoking cessation (chi 2 for tread = 0.01 and 0.04, respectively). CONCLUSIONS: Most nicotine patch users request treatment from a primary care physician, suggesting motivation to quit. Almost half continue to smoke while using the patch, a behavior that appears related to a lower level of counseling and an inability to quit. Increasing counseling may positively impact nicotine-patch-assisted smoking cessation in the general population.

Excessive thyroid hormone replacement therapy.

BACKGROUND: Excessive thyroid hormone replacement carries the potential for serious long-term metabolic complications (e.g., accelerated osteoporosis). The increased bioavailability of commercially available products, along with improved laboratory assays for measuring thyrotropin (TSH), has led to an increased chance of actual or detected iatrogenic hyperthyroxinemia. The purpose of this study was to determine the frequency of excessive prescribing and to examine the impact of changes in potency of replacement thyroid hormone formulations and sensitivity of thyroid function tests on its incidence. METHODS: A retrospective chart review was done of patients requiring thyroid hormone replacement therapy treated at a university-based, family medicine residency training program. The following information was extracted from each chart: specific thyroid medication (including dose and date of onset of therapy) and thyroid laboratory tests results (including serum thyroxine [T4] and TSH). This information from two different time periods (1975 to 1981 and 1982 to 1989) was compared using one-way analysis of variance. RESULTS: Serum T4 levels were not significantly different between the two time periods, 1975 to 1981 and 1982 to 1989 (8.06 +/- 2.93 micrograms/dl versus 9.0 +/- 03.69 micrograms/dl; NS), despite significant changes in TS serum levels (23.6 +/- 38.9 mIU/mL versus 7.44 +/- 18.7 mIU/ml; P = 0.009) and levothyroxine dosage (184 +/- 59.6 micrograms/d versus 145 +/- 64.1 micrograms/d; P = 0.002). Significantly more patients had low (supersuppressed) TSH levels between 1982 and 1990 than between 1975 and 1981 (33 percent versus 10 percent; P = 0.02.) CONCLUSIONS: Excessive thyroid hormone replacement with iatrogenic hyperthyroxinemia is a common occurrence. Clinicians need to be aware of this problem and implement measures (e.g., periodic monitoring of TSH) to minimize the occurrence of overdosing and the potential for long-term complications.

Smoking cessation counseling among hospitalized smokers.

The purposes of this study were (1) to describe how much smoking cessation counseling patients receive in a hospital with a nonsmoking policy and (2) to describe the attitudes of these smokers toward the nonsmoking policy. Forty-three (48%) of 89 eligible smokers hospitalized during a one-month period were surveyed by mail. Sixty-eight percent reported receiving, during hospitalization or at the time of discharge, at least one of nine counseling procedures related to smoking cessation. Forty-eight percent reported more than one counseling procedure. Less than 15% received information about symptoms of nicotine withdrawal, means of abstaining during hospitalization, means of permanently quitting, or medications for nicotine withdrawal symptoms during hospitalization. None of the patients had smoking cessation included in plans for future care upon hospital discharge. Only 24% strongly disagreed with the hospital's nonsmoking policy. We conclude that the mere institution of a nonsmoking hospital policy does not ensure that hospitalized smokers are adequately counseled regarding smoking cessation or that this counseling will be considered in discharge planning.

Randomized clinical trials in single patients during a 2-year period.

OBJECTIVE: To describe the feasibility of a single patient trial (SPT) service and study the influence of formal SPTs on therapeutic precision. DESIGN: Descriptive and evaluate study of SPTs. All planned trials were double-blind, randomized, multiple crossover trials. Other key features of individual trials were random assignment of order and assessment of predetermined explicit outcomes. Patients and physicians rated level of confidence in treatment before and after the SPT on visual analog scales. SETTING: Two-year experience (September 1988 to September 1990) of an SPT trial referral service available to physicians in an academic medical center. OUTCOME MEASURES: The number of planned and completed SPTs; proportion of completed trials yielding definitive answers; patient- and physician-rated levels of confidence in treatment pre- and post-SPT; time-motion studies to estimate resource consumption (costs) for selected SPTs. RESULTS: Of 34 completed trials, 17 were judged to give definitive results whereas 17 showed trends only. Results favored active treatment in 16 trials that led to treatment being continued (nine patients) or started (seven patients). Treatment was discontinued (seven patients) or not started (11 patients) based on 18 trial results that demonstrated active treatment was ineffective (seven), harmful (two), or apparently equivalent (nine). Most patients (65%) reported no change in their already high level of confidence in therapy as a result of trials, whereas physicians' confidence levels in therapy either increased or decreased post-SPT depending on the direction of trial results. Patients consistently rated the SPT service as extremely useful. Time-motion estimates indicate that 16.75 staff hours were spent per trial leading to a direct cost estimate of approximately $450 to $500 per trial. CONCLUSION: We conclude that an SPT service is feasible, trial costs compare favorably with other conventional services, and clinicians appear to gain confidence and precision from SPTs. When patients or clinicians are uncertain about the value (including the possibility of side effects) of treatment for symptomatic chronic diseases, we believe an SPT can be offered to a patient and will likely yield results that will effect subsequent treatment.

Amiodarone-clonazepam interaction.

OBJECTIVE: To describe a potential drug interaction between amiodarone and clonazepam. CASE SUMMARY: A 78-year-old man with a history of congestive heart failure and coronary artery disease began taking amiodarone to suppress sustained ventricular tachycardia. Following the development of restless leg syndrome, therapy with clonazepam 0.5 mg qhs was initiated. Subsequently, the patient demonstrated signs and symptoms of benzodiazepine toxicity, which cleared following the discontinuation of clonazepam. DISCUSSION: Amiodarone is a Class III antiarrhythmic with an adverse-effect profile involving many different organ systems. It also has been shown to inhibit the metabolism of drugs cleared by oxidative microsomal enzymes. Clonazepam undergoes extensive hepatic metabolism, primarily by reduction and acetylation, and is therefore susceptible to altered disposition during concomitant administration of agents that inhibit hepatic microsomal enzymes. Hypothyroidism, occurring in up to 11 percent of patients treated with amiodarone, can also alter drug metabolism and sensitize the central nervous system, thus increasing the potential for toxicity. It is likely that a combination of these factors was responsible for the symptoms described in this patient. CONCLUSIONS: The complex pharmacologic profile of amiodarone and its effects on multiple organ systems necessitates close patient monitoring during concurrent administration of medications such as clonazepam, which are cleared by oxidative metabolism.

A cardiovascular health education program for rural schools.

Public understanding of cardiovascular disease (CVD) risk factors and primary prevention has increased, due in part to community prevention efforts. However, many segments of society are difficult to reach. Such groups still need public education to acquire the knowledge that can lead to behavior change. Community intervention programs in rural areas face the challenge of disseminating health information to widely scattered populations isolated by difficult terrain and weather, and restricted by the sparsity of channels for mass communication. School health promotion programs, because of the special role schools play in rural communities, can help reach rural populations. During a five-year period, the Otsego-Schoharie Healthy Heart Program, a state-funded community intervention program, provided presentations to 18% of the combined total population of two rural counties through its school-based component. It also helped promote other program initiatives by establishing linkages in the community. Schools provide an effective channel for health promotion efforts to reach rural populations.

Treatment of atopic dermatitis with antihistamines: lessons from a single-patient, randomized clinical trial.

BACKGROUND: Single-patient randomized clinical trials (RCTs) can be utilized to maintain methodologic precision in the analysis of treatment effect in individual patients. We describe the results of a single-patient RCT in a patient with atopic dermatitis and review practical considerations regarding the use of antihistamines. METHODS: Using double-blind, crossover techniques, the patient was randomly allocated to four 2-week treatment periods with the following regimens: chlorpheniramine, 8 mg twice daily; chlorpheniramine, 12 mg twice daily; terfenadine, 120 mg twice daily; and placebo (phase 1). The drug that produced superior results from phase 1 (chlorpheniramine, 8 mg) was subsequently compared with astemizole, 10 mg/d, during phase 2, consisting of four 4-week, double-blind, crossover trial periods with random allocation of study drugs. Daily symptom scores, as well as end of treatment period summary impressions by patient and investigator, were analyzed. RESULTS: In both phases, chlorpheniramine produced the most noticeable positive therapeutic effect on the patient's mild but most disturbing symptoms (pruritus and eye irritation) associated with atopic dermatitis. Drowsiness was reported with chlorpheniramine. Tolerance to this side effect, however, developed quickly. CONCLUSIONS: A single-patient RCT with different antihistamines in a patient with chronic atopic dermatitis was a useful tool in achieving a favorable balance among efficacy, toxicity, and cost of therapy.

A system for drug utilization review in ambulatory care.

BACKGROUND: It is more difficult to conduct drug utilization reviews in ambulatory care settings than in inpatient care settings. This is true for several reasons: it is harder to identify outpatients who are receiving specific medications; often there is less evidence on which to base clinical standards for drug use; and it is more difficult to ensure patient compliance with drug therapy. METHODS: This article describes a drug utilization review system designed to operate in ambulatory care clinics. The system consists of (1) a computerized database for efficient identification of patients who receive prescriptions for a specific medication, (2) clinic-wide consensus guidelines, (3) reminders in the medical record, (4) regular chart audits, and (5) feedback to physicians. RESULTS: Experience in monitoring the use of serum theophylline assays illustrates how this system can be used in an ambulatory care clinic. According to guidelines adopted in our clinic, overuse of assays is not a problem. The system of physician reminders and chart audits can help prevent underuse. CONCLUSIONS: Despite the difficulties in conducting drug utilization reviews in the ambulatory setting, a system based on clinic-wide guidelines is feasible and should be an integral part of quality assurance programs.