Validating the EMG(FT) from a single incremental cycling test.

The purposes of this study were to (1) identify the EMG(FT) from a single incremental cycle ergometry test and (2) validate this fatigue threshold by having participants perform constant workload rides at 70, 100 and 130% of the estimated EMG(FT). 11 healthy college-age participants performed incremental cycle ergometry on the initial visit. The EMG amplitude was recorded from the vastus lateralis muscle for each power output and fitted with linear regression which provided the estimated EMG(FT). In subsequent visits, participants exercised at 3 percentages of their EMG(FT) with the EMG amplitude recorded for each condition. The results indicated no significant (p>0.05) increases in EMG amplitude vs. time for the 70% and 100% workloads, respectively. In addition, the participants were able to maintain these exercise intensities for over 40 min. For the 130% workload, however, EMG amplitude vs. time increased significantly (p<0.001) and the participants were able to maintain the exercise condition for less than 12 min. These findings indicate that the EMG(FT) estimated from a single incremental cycle ergometry test is a valid measure of neuromuscular fatigue and may potentially be useful in assessing the efficacy of rehabilitative interventions.

The effect of corn distiller's dried grains with solubles, ractopamine, and conjugated linoleic acid on the carcass performance, meat quality, and shelf-life characteristics of fresh pork following three different storage methods.

The objective of this study was to evaluate dietary corn distiller's dried grains with solubles (DDGS), ractopamine hydrochloride (RAC), and conjugated linoleic acid (CLA) on growth performance, carcass and fat quality, and shelf-life of fresh pork from finishing pigs. Barrows (n=72) were fed one of eight treatments consisting of two diet sources (corn-soy and corn-soy+20% DDGS), two levels of RAC (0 and 7.4ppm), and two levels of CLA (0 and 0.6%) for 28days. Loins were portioned (n=3) into one of three storage conditions (fresh, cold, frozen); each followed with seven days of retail display. Feeding RAC improved ADG and G:F (P<0.05), whereas DDGS decreased belly fat firmness (P<0.05). Dietary DDGS increased total polyunsaturated fatty acids in jowl and belly samples and increased Iodine Value (IV) (P<0.05), but addition of CLA decreased IV. Dietary DDGS, RAC, or CLA had minimal impact on pork quality following varied storage methods.

Favorable effects of lacrimal plugs in patients with an anophthalmic socket.

BACKGROUND: The use of punctal plugs in the treatment of dry eyes is well established. Anophthalmic patients have less tears in the anophthalmic socket in comparison to their normal side, due to an absent corneal reflex (Lee & Elsie, 1981a,b). Many of those patients complain of dry eye symptoms, even when they are treated with tear replacement therapy. The authors wished to examine whether they could improve their dry socket complaints with punctal plugs. PURPOSE: To evaluate the clinical efficacy and tolerability of punctal plug (Smart Plugs) insertion in anophthalmic patients with symptoms of dry eye. PATIENTS AND METHODS: Interventional case series. Fifteen anophthalmic patients with dry eye symptoms, a Schirmer test of less than 3 mm and an open lacrimal passage were examined before and after insertion of punctal plugs. The patients were asked for their subjective evaluation of the treatment and were examined to evaluate the change. Schirmer tests were compared. Bacterial cultures were taken at both visits. RESULTS: Schirmer results of less than 3 mm in the anophthalmic socket were obtained in 75% of patients with dry eyes symptoms; 87% of patients in whom punctal plugs were inserted reported an improvement in dry eye sensation. More than half of the patients demonstrated less discharge (p < or = 0.05). Schirmer tests improved from 1.4 mm to 1.9 mm (p < or = 0.05). Patients with a Schirmer outcome of 2 mm or more tended to have less pathogenic bacterial cultures (p = 0.11). CONCLUSION: Punctal plugs improve the symptoms and signs of dry socket. Punctal plugs seem to reduce the pathogenic bacterial growth in the anophthalmic socket.

Comparative clinical efficacy, onset and duration of action of levocetirizine and desloratadine for symptoms of seasonal allergic rhinitis in subjects evaluated in the Environmental Exposure Unit (EEU).

The Environmental Exposure Unit, an indoor pollen challenge system to test anti-allergic medications, was used to compare the onset and duration of action and the efficacy of levocetirizine and desloratadine, two recently developed H1-antagonists. In this double-blind, placebo-controlled, parallel-group study, qualified subjects were randomised to once-daily levocetirizine 5 mg (n = 141), desloratadine 5 mg (n = 140) or placebo (n = 92) and exposed to ragweed pollen on two consecutive days (7 h and 6 h). Symptoms were self-rated every 30 min. On both days, levocetirizine produced a greater improvement in the major symptom complex score (primary efficacy variable) than desloratadine (p = 0.015); both were better than placebo (p < 0.001). Levocetirizine acted earlier (1 h vs. 3 h) and produced greater symptom relief at 24 h than desloratadine (p = 0.003). Levocetirizine also alleviated nasal obstruction better than desloratadine (p = 0.007) on day 1; and better than placebo (p = 0.014) after the second dose on day 2, which was not observed with desloratadine. Levocetirizine and desloratadine were safe and well tolerated.

Comparative onset of action and symptom relief with cetirizine, loratadine, or placebo in an environmental exposure unit in subjects with seasonal allergic rhinitis: confirmation of a test system.

BACKGROUND: The environmental exposure unit (EEU) is an instrument designed to determine onset of action of antiallergic treatment. Confirmation of test results would be useful in defining its role. OBJECTIVE: This study was intended to confirm a previous study comparing cetirizine, loratadine, and placebo in the EEU using an identical protocol design (randomized, double-blind, parallel-group comparison having the same symptom scoring system, endpoints, and statistical analyses), thus demonstrating reproducibility of studies conducted in the EEU. METHODS: Onset of action and symptom relief with once-daily cetirizine 10 mg, loratadine 10 mg, and placebo (n = 120 each group) were evaluated replicating a previous study design. Subjects meeting inclusion and exclusion criteria and qualifying symptom scores were randomized to 2 days' exposure (6 to 7 hours daily) with treatment. Changes in total and major symptom complex (TSC, MSC) scores based on 14 symptoms evaluated at 30-minute intervals served as primary efficacy variables. RESULTS: Onset of action again was earlier with cetirizine (at 1 hour, P < or = 0.001) versus loratadine (at 3 hours, P < or = 0.01). Cetirizine produced a 25.4% least-square mean reduction in TSC scores overall versus an 11.2% decrease with loratadine (P = 0.006) and a 4.8% increase with placebo (P < 0.001); loratadine and placebo were also significantly different (P = 0.002). Similar changes were also noted in MSC scores. Cetirizine consistently reduced TSC and MSC scores after the first dose versus placebo (P < or = 0.001) and at most time points versus loratadine (P < or = 0.05). Adverse events were reported in 1.7% of patients in each active-treatment group and in 2.5% on placebo. CONCLUSIONS: Cetirizine acted earlier and was more effective than loratadine or placebo in reducing symptoms of seasonal allergic rhinitis in subjects undergoing a controlled pollen challenge, replicating results from an earlier, identically designed study, demonstrating reproducibility of these assessments by the EEU.

Backscatter of high-frequency (200kHz) acoustic wavefields from ocean turbulence.

Near space and time coincident 200-kHz acoustic backscatter and CTD measurements were taken during an interdisciplinary study of the internal wave packets that propagate through Massachusetts Bay. The data strongly support the contention that acoustic wavefields can be backscattered from turbulent mixing events (microstructure) associated with the internal wave packets.

Suicide in the farming community: methods used and contact with health services.

Farmers have a high rate of suicide (1% of suicides in England and Wales). This study sought to test whether farmers would be less likely to have been in contact with primary or mental health services before death due to their reluctance to seek help. The study also sought to identify other characteristics that differentiated suicide among male farmers from other professional groups. A retrospective case-control design was used comparing male farmers with an age and sex matched control group. Cases were all members of the farming community within the Exeter Health District on whom suicide or open verdict had been recorded between 1979 and 1994. 63 Cases were identified and entered into the study. Controls were non-farmers with the same verdict who were matched for age (5 year age bands) sex and social class. Farmers were significantly more likely to use firearms to kill themselves (42% of farmers v 11% controls). They were less likely to use a car exhaust or to die by poisoning (9% farmers v 50% controls). Farmers were significantly less likely to leave a suicide note (21% farmers v 41% controls). There was no significant difference between farmers and controls for numbers in contact with their general practitioner or mental health services in the 3 months before death. There may be some differences in help seeking behaviour between farmers and the general population as over 30% of farmers presented with exclusively physical symptoms. General practitioners should consider depressive and suicidal intention in farmers presenting with physical problems. When depression is diagnosed consideration should be given to the temporary removal of firearms as the high rate of suicide in the farming community may be strongly influenced by access to means.

Onset of action of intranasal budesonide (Rhinocort aqua) in seasonal allergic rhinitis studied in a controlled exposure model.

BACKGROUND: Intranasal budesonide aqueous nasal spray (BANS) is recognized as an efficacious treatment for seasonal allergic rhinitis (SAR), but the time to onset of action is not known. OBJECTIVE: The primary objective was to evaluate the time at which the onset of action of BANS in the symptomatic relief of seasonal allergic rhinitis becomes evident within 12 hours after a single dose in a controlled ragweed pollen exposure setting. METHODS: The study was of a double-blind, randomized, parallel-group design, testing BANS (64 microgram and 256 microgram) and placebo on ragweed-sensitive subjects with symptoms for at least 1 year by using a controlled pollen challenge system (Environmental Exposure Unit). The efficacy variables were the combined nasal score (the sum of blocked nose, runny nose, and sneezing-itchy nose), individual nasal symptoms, overall evaluation of treatment efficacy reported by participants on diaries, and peak nasal inspiratory flow (PNIF). RESULTS: A total of 217 participants were treated with BANS or placebo. At 7 to 12 hours, BANS was better than placebo in reducing combined nasal and blocked nose symptoms. For PNIF, the time to onset of action was shortest for 256 microgram of BANS relative to placebo (3 hours, P =.003). BANS 64 microgram was better than placebo in reducing the individual scores of blocked nose, runny nose, and sneezing-itchy nose from 3 to 5 hours after administration. Treatment efficacy was higher for those receiving BANS compared with placebo starting at 5 hours. All treatments were well tolerated, and no specific adverse events occurred. CONCLUSIONS: The onset of action of intranasal BANS was 7 hours according to combined nasal and blocked nose symptom scores. Evidence of earlier response was observed at 3 hours for runny nose and PNIF.

Environmental exposure unit: a system to test anti-allergic treatment.

LEARNING OBJECTIVES: Reading this article will enable readers to recognize the Environmental Exposure Unit (EEU), its historic development and its current role as a system to test anti-allergic treatment; to recognize clinical relevance of this test system and its relationship with other pollen challenge methods of evaluation of anti-allergic medication; and, to recognize variables associated with standard clinical studies of anti-allergic medication. Readers will review four studies of antihistamines tested in the Environmental Exposure Unit, three studies on nasal corticosteroids, one on topical eye drops and one on immunotherapy conducted in the EEU. DATA SOURCES: The EEU has been in operation since 1985 preceded by a prototype challenge system to assess respiratory effects of urea formaldehyde foam insulation. A number of studies on the onset of action and efficacy of different antihistamines and nasal corticosteroids as well as other treatments have been completed producing accurate and consistent results influenced to some extent by study designs. STUDY SELECTION: Studies of commonly used antihistamines and nasal corticosteroids are discussed in detail and represent several of the studies undertaken to date in the EEU. RESULTS: Controlled ragweed pollen exposure using the EEU has shown that some antihistamines demonstrate an onset of action within 30 minutes while others have taken up to 3 hours to produce significant effect. Nasal corticosteroids evidenced the onset of clinical improvement at 5 to 6 hours with significance over placebo between 6 and 12 hours depending on dose. CONCLUSION: The EEU is an effective pollen delivery system that accurately and consistently determines the onset of action and efficacy of anti-allergic treatment in large groups of subjects. It eliminates variables associated with various other methods of evaluation of these medications but does not supplant the need for such evaluations.

Identification of nearly fatal suicide attempts: Self-Inflicted Injury Severity Form.

The Self-Inflicted Injury Severity Form (SIISF) was developed as an epidemiological research tool for identifying individuals in hospital emergency departments who have life-threatening self-inflicted injuries. Data were collected from 715 patients with self-inflicted injuries in two large hospitals. In 295 of these cases, a second set of data was independently collected for assessment of interrater reliability. Validity was assessed by comparing the SIISF results with simultaneously collected Risk-Rescue Ratings. Assessment of interrater reliability found that only 2.4% of physicians disagreed on the suicide method used. The kappa statistic for method used was .94, indicating excellent agreement. The SIISF was found to distinguish between severe and less severe injuries. Thus, it appears to provide a simple method to distinguish patients who have life-threatening self-inflicted injuries.

Cetirizine, loratadine, or placebo in subjects with seasonal allergic rhinitis: effects after controlled ragweed pollen challenge in an environmental exposure unit.

BACKGROUND: Allergic rhinitis affects nearly one in 10 Americans. Cetirizine is a newer once-daily selective H1-antagonist. In traditional clinical trials, cetirizine has been shown to be safe and effective for the treatment of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria. OBJECTIVE: To better characterize the efficacy and onset of action of cetirizine in a more controlled but clinically relevant setting, this agent was compared with loratadine and placebo in patients with symptomatic seasonal allergic rhinitis undergoing controlled pollen challenge in an environmental exposure unit (EEU). METHODS: This was a double-blind, randomized, parallel-group study. After screening, patients were exposed to ragweed pollen (primed) in the EEU (up to six exposures), and those with qualifying symptom scores were randomized to controlled pollen exposure (two periods of 5.5 to 6.5 hours over 2 days) and once-daily treatment with 10 mg cetirizine (n = 67), 10 mg loratadine (n = 67), or placebo (n = 68). The mean ragweed pollen level was 3480 +/- 350 grains/m3 (standard deviation). The primary efficacy variables were the total symptom complex (TSC) and the major symptom complex (MSC) scores. Symptoms were evaluated every half hour in the EEU throughout the study. RESULTS: Cetirizine produced a 36.7% mean reduction in TSC scores overall versus 15.4% with loratadine and 12.0% with placebo (p < or = 0.01). Cetirizine also produced a 37.4% mean reduction in MSC scores overall versus 14.7% with loratadine and 6.7% with placebo (p < or = 0.01). Onset of action as assessed by reductions in TSC and MSC scores versus placebo was evident within 1 hour with cetirizine (p < or = 0.02) and 3 hours with loratadine (p < or = 0.03). The incidence of treatment-related side effects was similar among groups, with headache reported most commonly in each group. CONCLUSION: Cetirizine is well tolerated and effective in reducing symptoms of seasonal allergic rhinitis in patients undergoing controlled pollen challenge.

A comparison of triamcinolone acetonide nasal aerosol spray and fluticasone propionate aqueous solution spray in the treatment of spring allergic rhinitis.

BACKGROUND: Many nasal corticosteroids with different potencies and formulations are available, but they have all been proven safe and effective. The clinical relevance, if any, of these differences is not yet completely established. OBJECTIVE: We sought to compare the efficacy, safety, and patients' acceptance of triamcinolone acetonide aerosol spray and fluticasone propionate aqueous solution in the treatment of spring allergic rhinitis. METHODS: After a drug-free baseline evaluation, patients with rhinitis were randomized to receive either a triamcinolone aerosol spray of 110 microg in each nostril once daily (n = 117) or a fluticasone solution spray of 100 microg in each nostril once daily (n = 116) in a single-blind, parallel-group study. The Rhinitis Index Score (sum of scores of symptoms on a scale from 0 to 3) was evaluated daily, in the morning before drug administration, for 21 days. The efficacy of each treatment was assessed by the mean reduction from baseline in the Rhinitis Index Score and in individual symptom scores. Patients' acceptance of the study drugs was also monitored by a daily questionnaire. RESULTS: Reductions of the Rhinitis Index Score (mean +/- SEM) were 4.20 +/- 0.21 and 4.60 +/- 0.21 for triamcinolone and fluticasone, respectively (p = 0.23). There were no statistically significant differences between the drugs in the reduction of any of the individual symptoms. Patients expressed statistically significant differences between the drugs regarding acceptance; different properties of the aerosol and the solution were appreciated differently. CONCLUSIONS: This study shows that triamcinolone acetonide aerosol and fluticasone propionate solution sprays are both clinically equally effective, safe, and well tolerated for the treatment of spring pollen allergic rhinitis.

Onset of action and efficacy of terfenadine, astemizole, cetirizine, and loratadine for the relief of symptoms of allergic rhinitis.

BACKGROUND: Terfenadine, astemizole, cetirizine, and loratadine are compared in their abilities to produce relief of symptoms of allergic rhinitis. OBJECTIVE: The aim of this study was to compare the onset of action and efficacy of the study medications. METHODS: 111 ragweed-sensitive subjects were primed with pollen in the Environmental Exposure Unit. Study entry required adequate symptoms over a 3 hour exposure to 5000 +/- 300 grains/m3 of ragweed pollen. On the test day, subjects were given a single dose of either terfenadine 60 mg (22), astemizole 10 mg (22), cetirizine 10 mg (23), loratadine 10 mg (22), or placebo (22) when sufficiently symptomatic after a 60-minute exposure. Allergen levels were maintained and symptoms recorded every 30 minutes. RESULTS: Proportions of subjects with clinically important relief were cetirizine, 69.6%; terfenadine, 54.5%; loratadine, 50.0%; astemizole, 40.9%; and placebo, 31.8% but differences weren't significant between treatment groups (P = .119). Survival curves for times to onset of clinically important relief for the four treatment groups were not different (P = .119). Subjects realizing definitive relief were cetirizine, 65.2%; terfenadine, 45.5%; loratadine, 31.8%; placebo, 27.3%; and astemizole, 22.7% (P = .023). Survival analysis of onset time for definitive relief found significant differences (P = .010). The ranking was cetirizine --> terfenadine --> loratadine --> astemizole (quickest to slowest). Global evaluation based on subject willingness to take the medication again yielded percentages: cetirizine, 82.6%; terfenadine, 66.7%; astemizole, 63.6%; loratadine, 40.9%; and placebo, 36.4% (P = .036). CONCLUSION: Cetirizine and terfenadine continuously ranked higher in terms of onset of action and efficacy, while loratadine and astemizole ranked lower. Significance was detected in definitive relief and relative efficacy.

Onset of action, efficacy, and safety of a single dose of fexofenadine hydrochloride for ragweed allergy using an environmental exposure unit.

BACKGROUND: Fexofenadine hydrochloride is the active acid metabolite of terfenadine. Fexofenadine's anti-allergic properties require confirmation in a clinical setting. OBJECTIVE: The purpose of this study was to characterize the time to onset of clinically important relief of symptoms of allergic rhinitis in subjects taking single doses of either 60 mg or 120 mg fexofenadine HCl, or placebo, after exposure to ragweed pollen in a controlled environment. Other objectives were to assess the efficacy and safety of single doses of fexofenadine HCl. METHODS: One hundred forty-six ragweed-sensitive subjects were primed in the off-season with ragweed pollen in the environmental exposure unit. One hundred thirty-six subjects who adequately responded to priming entered a single-dose placebo phase. Placebo-responders were disqualified from the study, leaving 99 subjects with adequate symptoms to be randomized and given a single dose of either fexofenadine HCl 120 mg (33), 60 mg (33) or placebo (33), after 60 minutes of allergen exposure. Exposure continued over five hours and subjects recorded symptoms every 20 minutes. This study was of a randomized, placebo-controlled, double-blind, parallel design. RESULTS: Median time to onset for relaxed criteria clinically important relief was 60 minutes for both fexofenadine treatment groups, and 100 minutes for placebo (P = .018). The proportion with relief was 82% at 60 mg, 85% at 120 mg, and 64% for placebo. Treated groups had reductions in symptom scores double that of placebo. CONCLUSIONS: Fexofenadine is safe and efficacious at single doses of 60 mg and 120 mg. Average time to onset was 60 minutes using controlled pollen exposure in an environmental exposure unit.

Efficacy of immunotherapy to ragweed antigen tested by controlled antigen exposure.

BACKGROUND: Immunotherapy is a recognized component in the management of allergic rhinitis. Its efficacy has been evaluated in a number of clinical field trials. These methods of evaluation are limited by control of antigen exposure. OBJECTIVE: A study was designed to evaluate the efficacy of immunotherapy in ragweed-induced rhinoconjunctivitis using an environmental exposure unit. METHODS: Forty-three subjects were grouped into (1) immunotherapy group: ragweed-allergic subjects on maintenance ragweed immunotherapy for at least 2 years (N = 16), (2) positive control group: ragweed-allergic subjects who had never received immunotherapy (n = 16), and (3) negative control group: ragweed-nonallergic subjects (N = 11). Ragweed specific skin tests and ragweed IgE levels were obtained prior to exposure. The study was done in a room where levels of 2,500 to 3,000 grains m3 of ragweed were maintained over three hours. Symptoms were recorded every 15 minutes. RESULTS: Nasal symptoms in the immunotherapy group were significantly less than in the positive control group after 45 minutes (P = .025). Significant differences were not observed for ocular symptoms. Combined nasal and ocular scores were 50% less in the immunotherapy group than in the positive control group by 75 minutes (P = .039). Ragweed-specific skin tests and IgE were significantly less in the immunotherapy group than in the positive control group. Rhinoconjunctivitis symptoms in the negative control group were absent throughout. CONCLUSIONS: Controlled ragweed pollen exposure in this setting demonstrated that ragweed immunotherapy significantly reduced symptoms of ragweed-allergic rhinitis but had no significant effect on ocular symptoms. This system presents opportunities for additional studies on immunotherapy for allergic respiratory conditions.

A randomized, double-blind, placebo-controlled, controlled antigen delivery study of the onset of action of aerosolized triamcinolone acetonide nasal spray in subjects with ragweed-induced allergic rhinitis.

BACKGROUND: Clinically apparent relief of nasal symptoms of allergic rhinitis is generally recognized to occur within 3 days to 1 week when intranasal corticosteroids are used. OBJECTIVE: A study was designed to evaluate the onset of action of triamcinolone acetonide (TA) in patients with ragweed-induced allergic rhinitis with an environmental exposure unit (EEU). METHODS: Eighty-five adults with ragweed-induced allergic rhinitis were primed with ragweed allergen in the EEU. Symptoms were recorded during a baseline exposure in the EEU, and subjects were randomized with a 5:1 ratio to receive either TA 400 micrograms (n = 71) or its propellant (n = 14). Subjects received study medication for 7 days under supervision in the morning and returned to the EEU in the evening for ragweed allergen challenge and symptom assessment. Clinically apparent onset of action was defined as a 25% decrease in symptom scores from baseline. RESULTS: A mean reduction in nasal congestion from baseline of greater than 25% (onset of action) was observed in the TA group, but not in the placebo group, by 10 hours. This was also observed for itching of the nose or palate and a combined measure of symptoms. In addition, the proportion of subjects with less nasal congestion after 1 day of treatment was greater in the TA group (41%) than in the placebo group (7%) (p less than 0.05). CONCLUSION: The unexpected early relief of symptoms observed in the TA group and, to a lesser extent in the placebo group, has important clinical implications in the treatment of allergic rhinitis.

Intranasal fluticasone propionate versus loratadine in the treatment of adolescent patients with seasonal allergic rhinitis.

Fluticasone propionate (FP) is a topical corticosteroid with minimal systemic activity. We examined safety and compared the efficacy of FP aqueous nasal spray, 200 micrograms every day with loratadine tablets, 10 mg by mouth every day in 240 adolescents with ragweed pollen-induced seasonal allergic rhinitis for 4 weeks in a randomized, double-blind, parallel-group study. Nasal and eye symptoms were recorded daily on a 4-point (0 to 3) scale. A higher percentage of symptom-free days was observed for nasal blockage on waking during treatment with FP (p < 0.0001). Significant results were also obtained for all other nasal symptoms when analyzed for both symptom-free days and symptom scores. No differences were found for eye irritation symptoms (p = 0.14). Morning and evening nasal peak inspiratory flow (PIF) was recorded daily by 57 subjects. FP treatment was associated wit significantly higher PIF values than loratadine both morning (p = 0.0051) and evening (p = 0.0036). A greater improvement over 4 weeks was observed for PIF morning values in the FP group (p = 0.008) but not for evening values (p = 0.358). Statistically significant correlations were found for nasal blockage and PIF in the morning (r = -0.54, p = 0.0001) and in the evening (r = -0.46, p = 0.008).