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Biomedical subjects

J E Berg

Publications and source records attributed to J E Berg.

At least 19 recordsLinked to original sources
PubMed2004

Treatment of pseudobulbar affect in ALS with dextromethorphan/quinidine: a randomized trial.

BACKGROUND: Patients with ALS commonly exhibit pseudobulbar affect. METHODS: The authors conducted a multicenter, randomized, double-blind, controlled, parallel, three-arm study to test a defined combination of dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) (AVP-923) for the treatment of pseudobulbar affect in ALS. Q inhibits the rapid first-pass metabolism of DM. The effects of AVP-923 (30 mg of DM plus 30 mg of Q) given twice daily for 28 days were compared with those of its components. Patients were evaluated on days 1, 15, and 29. The primary efficacy variable was the change from baseline in the Center for Neurologic Study Lability Scale (CNS-LS) score. Secondary efficacy variables were laughing/crying episode rates and changes in Visual Analog Scales for Quality of Life (QOL) and Relationships (QOR). Efficacy was evaluated in intention-to-treat subjects who were not poor metabolizers of DM (n = 65 for AVP-923, n = 30 for DM, and n = 34 for Q). Safety was assessed in all randomized subjects (n = 140). RESULTS: AVP-923 patients experienced 3.3-point greater improvements in CNS-LS than DM patients (p = 0.001) and 3.7-point greater improvements than Q patients (p < 0.001). AVP-923 patients exhibited lower overall episode rates, improved QOL scores, and improved QOR scores (p < 0.01 for all endpoints). Adverse effects were mostly mild or moderate; treatment-related discontinuation was 24% for AVP-923, 6% for DM, and 8% for Q. CONCLUSIONS: AVP-923 palliates pseudobulbar affect in ALS. Overall benefits of treatment are reflected in fewer episodes of crying and laughing and improvements in overall quality of life and quality of relationships.

Adult↗
PubMed2004

Influence of concomitant quinidine administration on dextromethorphan disposition in rats.

High doses of dextromethorphan (DM) have been clinically investigated for the treatment of multiple neuronal disorders including neuropathic pain. Several authors have suggested the concomitant administration of DM and a CYP2D6 reversible inhibitor in order to enhance the exposure of DM and limit the exposure to total dextrorphan (DX). The present study proposes to determine whether or not a single dose of quinidine is sufficient to enhance the plasma concentrations of DM in rats and keep those of DX at a minimal level. Oral doses of DM (50 mg/kg) were administered with increasing dose levels of quinidine (0, 2, 20, and 50 mg/kg) to male Sprague-Dawley rats and blood samples were collected over 24 h. Plasma concentrations of DM and total DX were determined using ESI-LC/MS/MS. Quinidine coadministration resulted in a more than twofold increase in the area under the curve of DM with an ED(50) of approximately 2 mg/kg whereas those of total DX were only increased by 21%. These results support the working hypothesis that a single dose of quinidine may enhance the plasma concentrations of DM relative to those of total DX and may therefore improve the treatment of neuropathic pain.

Animals↗
PubMed2001

The antiviral drug docosanol as a treatment for Kaposi's sarcoma lesions in HIV type 1-infected patients: a pilot clinical study.

Docosanol inhibits a broad spectrum of lipid-enveloped viruses in vitro including HSV-1, HSV-2, VZV, CMV, HHV-6, and HIV-1. These observations led us to conduct a pilot clinical study with docosanol 10% cream as a topical treatment for Kaposi's sarcoma (KS) in HIV-1-infected patients. In this open-label study 28 cutaneous KS lesions in 10 HIV-1-infected patients were treated topically five times daily for 4 weeks with evaluation of lesion characteristics of area, edema, and color. All patients elected to enroll in an extended treatment protocol and continued to treat for up to 35 weeks. Within 28 days, 2 of 10 patients exhibited a partial response based on standardized criteria exhibiting 74 to 83% reductions in total target lesion areas. With extended treatment, a partial response was exhibited in two additional patients where total target lesion area was reduced by 52% in one patient and target lesions in another patient that had been large, swollen, and painful at study initiation were no longer visible. No patient experienced disease progression or signs of visceral disease. The average percent decrease in lesion area for all target lesions was 20% (p < 0.01). A patient's response to therapy appeared to be independent of anti-HIV regimen, HIV viral load, or previous KS treatments. These results suggest that docosanol merits further investigation as a potential topical therapy in the treatment of AIDS-associated Kaposi's sarcoma lesions.

AIDS-Related Opportunistic Infections↗
PubMed2001

Clinical efficacy of topical docosanol 10% cream for herpes simplex labialis: A multicenter, randomized, placebo-controlled trial.

BACKGROUND: Recurrent herpes simplex labialis (HSL) occurs in 20% to 40% of the US population. Although the disease is self-limiting in persons with a healthy immune response, patients seek treatment because of the discomfort and visibility of a recurrent lesion. OBJECTIVE: Our purpose was to determine whether docosanol 10% cream (docosanol) is efficacious compared with placebo for the topical treatment of episodes of acute HSL. METHODS: Two identical double-blind, placebo-controlled studies were conducted at a total of 21 sites. Otherwise healthy adults, with documented histories of HSL, were randomized to receive either docosanol or polyethylene glycol placebo and initiated therapy in the prodrome or erythema stage of an episode. Treatment was administered 5 times daily until healing occurred (ie, the crust fell off spontaneously or there was no longer evidence of an active lesion) with twice-daily visits. RESULTS: The median time to healing in the 370 docosanol-treated patients was 4.1 days, 18 hours shorter than observed in the 367 placebo-treated patients (P =.008; 95% confidence interval [CI]: 2, 22). The docosanol group also exhibited reduced times from treatment initiation to (1) cessation of pain and all other symptoms (itching, burning, and/or tingling; P =.002; 95% CI: 3, 16.5); (2) complete healing of classic lesions (P =.023; 95% CI: 1, 24.5); and (3) cessation of the ulcer or soft crust stage of classic lesions (P <.001; 95% CI: 8, 25). Aborted episodes were experienced by 40% of the docosanol recipients versus 34% of placebo recipients (P =.109; 95% CI for odds ratio: 0.95, 1.73). Adverse experiences with docosanol were mild and similar to those with placebo. CONCLUSION: Docosanol applied 5 times daily is safe and effective in the treatment of recurrent HSL. Differences in healing time compared favorably with those reported for the only treatment of HSL that has been approved by the Food and Drug Administration.

Acute Disease↗
PubMed1998

Functional diagnosis as a tool in rehabilitation: a comparison of teachers and other employees.

Work-related stress and burnout has been observed in primary school teachers in many countries. Functional deficits have been related to certain psychosomatic diagnoses and the work environment. We have compared 100 teachers with a matched group of non-teachers according to diagnostic differences, all attending a 4 week resident stay at a vocational rehabilitation centre in 1993-5. Seventy-five percent were women. The use of ICD-9 diagnoses and a five-dimensional functional diagnostic tool were compared. The five dimensions were defined along the following axes: work environment, family relations, health, personal economy and leisure time activity. There were no significant differences between ICD-9 diagnostic groups between teachers and non-teachers. Indefinite diagnostic entities (fatigue, chronic myalgia, fibromyalgia, etc.) were used in more than half of residents in both groups. Definite musculo-skeletal disorders were the second most prominent diagnosis. On the five-dimensional functional diagnostic tool teachers scored significantly worse than non-teachers on the family relations axis, and on a sum score of all axes. The difference was mainly present in women. The study suggests that work-related stress and signs of burnout in teachers may be higher than in other employees, but the factors contributing to this may be found outside the work environment.

Adult↗
PubMed1996

[Mortality among Norwegian addicts after admission to different types of institutions. A 10-year follow-up study 1985-94].

Ten years after enrollment in six different treatment and rehabilitation facilities in 1984-85, 482 drug addicts (158 women) were followed-up by means of official death records. 97 drug addicts (20%) had died, i.e. an incidence rate of 2.3 per 100 observation years. The incidence rate among those enrolled in psychiatry-oriented institutions was 2.8 for men and 2.0 for women. Among those enrolled in rehabilitation-oriented institutions the corresponding incidence rate was 2.0 and 0.6. The ratio between the incidence rates for the two types of institutions was 1.6 (95% CI 1.0-2.6). Excluding those who were 21 to 25 years of age in 1984-85, the death rate was significantly higher among the drug addicts in psychiatry-oriented institutions than among the addicts at institutions focusing on rehabilitation(relative risk 2.1, 95% CI 1.1-4.1).

Adult↗
PubMed1996

Cardiovascular risk factors in young drug addicts.

Since the type of life-style often encountered in drug addicts is purported to influence their risk of cardiovascular disease, it seemed of interest to carry out a descriptive study on risk factors in young addicts. Twenty-four young intravenous drug addicts, mean age 29 years and mean body mass index (BMI) 22.5 (kg/m(-2)), were compared with 24 healthy people matched for age, gender and BMI. Both groups responded to a questionnaire on life-style risk factors. In addition, fasting blood samples were investigated for several coronary risk factors. Drug addicts had smoked more cigarettes (17 vs. 3 cigarettes/day) for a longer time period (15 vs. 5 years) than control subjects. They also had higher serum activities of liver enzymes related to alcohol abuse than controls. Level of physical activity and indicators of dietary intake of fruit, vegetables and salt were not significantly different between the groups. Blood lipid values, total cholesterol (5.1 vs. 5.6 mmol/l), and HDL-cholesterol (1.2 mmol/l), apolipoproteins, and an atherogenic index reflecting the balance between the atherogenic low density lipoproteins (LDL) and the antiatherogenic fraction (HDL), as well as the smoking-related factors fibrinogen and TBARS, were all similar in both groups. The study indicates that the prevalence of many known cardiovascular risk factors was similar in drug addicts and matched controls.

Journal Article↗
PubMed1996

Normal cholesterol measurements in white collar workers still at cardiovascular risk?

Low serum total cholesterol (TC) in workers has been taken to indicate absence of cardiovascular (CV) risk. In angiographically confirmed coronary artery disease TC has been shown to be less poignant than compound indices of cardiovascular risk in separating patients from controls. The implications for prevention in an industrial medical setting of relying on TC measurements are discussed. Employees (n = 229) tested by an occupational health service in a non-manufacturing firm were dichotomized as low and high cardiovascular risk subjects either by the level of total cholesterol, or by two compound indices of blood lipid components. The compound indices were: the TC/HDLc-ratio, and an 'atherogenic index' (ATH-index) defined as ([TC-HDLc] x [apo B]) + ([HDLc] x [apo A]). (apo A = apolipoprotein A-I, apo B = apolipoprotein B). Cut-off values to separate between low- and high-risk subjects were defined as TC = 6.0 mmol/l, HDLc = 0.9 mmol/l, apo A = 1.8 milligrams and apo B = 1.3 milligrams, based on clinical guidelines in Norway. These individual cut-off values gave TC/HDLc and ATH-index cut-off values of 6.7 and 4.1, respectively. Assuming a more correct discrimination between persons at low- and high-risk, using compound lipid indices, both the number of persons given unnecessary advice on lifestyle changes or urged to take TC reducing medication, and the number of persons not treated on the basis of normal TC levels, would be reduced. Percentages of persons classified as TC-level-low risk, were adjusted using empirical data on sensitivity and specificity of the compound indices. Among employees with TC < 6.0mmol/l, 15% and 23% of women, and 12% and 19% of men would be classified as high-risk persons using the TC/HDLc-ratio or the ATH-index, respectively. Lack of prospective data on compound indices suggests cautious interpretation. TC values in spurious testing, as often applied in occupational health service without due regard to other lipid fractions, would increase the probability of unnecessarily treating persons not at CV risk and withholding people at probable CV risk from treatment. Although prospective studies are needed to confirm findings, the changes observed suggest avoiding measurements of some single lipid factors.

Adult↗
PubMed1996

A comparison of cardiovascular risk as measured by compound blood lipid indices and two indices including lifestyle factors in occupational health service.

Healthy employees in a non-manufacturing firm (n = 252) were divided into low and high cardiovascular risk subjects in order to compare different indices of cardiovascular risk for use in occupational health service. The levels of total cholesterol (TC), a compound index of blood lipid components, the 'atherogenic index' (ATH-index) defined as ([TC-HDLc] x [apoB])/([HDLc] x [apoA]), and two other compound indices, one Norwegian (Westlund) and one Scottish (Dundee score) were compared. Information on smoking habits and blood pressure were part of the two last indices. Cut-off values to separate between low and high risk subjects were defined with TC = 6.5 mmol/l, HDLc = 0.9 mmol/l, apoA = 1.8 g/l and apoB = 1.3 g/l, all values based on clinical guidelines in Norway. No smoking and a systolic blood pressure < 150 mmHg was included as cut-off of the combined indices. According to the three indices (ATH, Westlund and Dundee) 102, 25 and 116 employees were allocated to the increased risk group. Persons allocated to the increased risk group by the combined indices and not by the compound index were practically all smokers. Systolic blood pressure differed between indices only for persons with extreme pressures. A compound blood lipid index of CV risk, which may be drawn easily in an occupational health setting in an unfasting state and sent by post to a laboratory, mimics the allocation of persons to an increased risk group using combined indices. Smokers with normal lipid values would be allocated to increased risk by the combined indices, but not necessarily by the compound index. The use of the compound index together with advice to stop smoking is suggested as a time-saving strategy.

Adult↗
PubMed1995

[Alcohol--no universal drug against heart disease].

Alcohol is part of the normal culture for a majority of the population in western countries. Few investigators or clinicians disagree with the contention that there is a positive relationship between cardiovascular disease and mortality in the upper part of the alcohol consumption curve. No such general agreement exists when infrequent users and non-users are studied. Epidemiological evidence of the relationship between cardiovascular mortality and levels of alcohol consumption is scrutinized, with emphasis on how alcohol anamnestic data are collected, the characterization of non-users, and the authors' definition of moderate consumers. The results indicate that there is hardly any evidence to advocate moderate consumption of alcohol as a health-promoting activity. On the other hand there seems to be a positive relationship between moderation in many aspects of lifestyle and some health gain.

Alcohol Drinking↗
PubMed1995

Screening for cardiovascular risk: cost-benefit considerations in a comparison of total cholesterol measurements and two compound blood lipid indices.

BACKGROUND: Serum total cholesterol measurements have been shown to differentiate between patients with angiographically confirmed coronary artery disease and controls less well than compound indices of cardiovascular risk. Details of employees (n = 229) nominated by an occupational health service in a non-manufacturing firm were used as a starting point for calculations to compare the costs and benefits of using compound indices of cardiovascular risk with those of total cholesterol measurements alone. METHODS: Healthy employees were defined as having a low or a high risk of cardiovascular disease according to either total cholesterol level or two compound indices of blood lipid components. The compound indices were the ratio of total to high-density lipoprotein (HDL) cholesterol (the TC: HDLC ratio) and an 'atherogenic index' defined as ([total cholesterol-HDL cholesterol] x [apolipoprotein B])/([HDL cholesterol] x [apolipoprotein A]). If compound indices discriminate better between people at low and high risk, both the number of people given unnecessary advice on lifestyle changes or urged to take cholesterol-reducing medication and the number of people not treated because of their 'normal' cholesterol levels would be reduced. In our calculations, we assumed as 'gains' that (1) the disclosure that a total cholesterol test result is false-positive is equal to treatment costs, consultation fee and consumption foregone (i.e. resources already used on medication, services etc.) (8909 Nkr [US $1 = 7 Nkr]), and (2) the disclosure that a test result is false-negative is equal to consultation fee plus loss of 2 h wages (288 Nkr). RESULTS: The screening of 100,000 men and 100,000 women would incur a cost of 99 and 710 Nkr, respectively, per person assumed to benefit from extended screening using two different compound indices. Net gain would be 438 and 192 million Nkr, respectively, for the two compound indices. However, the lack of prospective data on compound indices suggests the need for cautious interpretation. CONCLUSION: Although prospective studies are needed to confirm our findings, the changes in number of false-positive and false-negative values achievable using different indices suggests a need for greater caution when using single lipid measurements as predictors of risk. The calculations of this non-prospective study indicated an increased benefit-cost ratio in assessing cardiovascular risk by using compound indices of cardiovascular risk compared with total cholesterol measurements alone.

Adult↗
PubMed1994

Workload and cardiovascular risk factors in executives and non-executives of the same company.

The lifestyle of executives purportedly differs from that of their employees who are not in an executive position, with respect to workload, amount of travelling, and eating habits. These aspects of lifestyle and cardiovascular (CV) risk factors in blood were compared in 22 executives and a matched sample of non-executives in an insurance company in Norway. The mean age was 42.8 years in both groups and the mean body mass index was 25.5 and 24.8 kg/m2 in executives and non-executives, respectively. Executives travelled more and worked more hours than non-executives, but smoking habits, levels of physical activity, diet habits and blood pressure were comparable in the two groups. The blood lipoprotein estimates of total cholesterol, high density lipoprotein cholesterol, apolipoproteins and two compound lipoprotein indices of CV risk, as well as liver enzymes, were also of the same magnitude in both groups. The executive lifestyle as such, compared to that of non-executives, does not imply an elevated CV risk in this study, as judged from CV risk factors in blood. The efforts of the occupational health service to improve health, including the opportunity for executives to choose their workload, may have contributed to this 'negative' finding. This may indicate that preventive health programmes in the company could have been acting as intended for all groups of employees. However, somewhat high mean levels of total cholesterol (> 6.0 mmol/l) and of a compound atherogenic index in both groups suggest that continued action by the occupational health service is required.

Adult↗
PubMed1994

Cardiovascular risk determination: discrepancy between total cholesterol evaluation and two compound laboratory indices in Norway.

OBJECTIVE: To compare group classification of cardiovascular risk by two compound laboratory indices with classification according to the serum total cholesterol concentration alone. DESIGN: Healthy employees were defined as low and high cardiovascular risk subjects according to their total cholesterol concentration or two compound indices of blood lipid components-the total cholesterol: high density lipoprotein (HDL) cholesterol ratio and an atherogenic index defined as ([total cholesterol-HDL cholesterol]*[apolipoprotein B])/([HDL cholesterol]*[apolipoprotein A-I]). Cut off values to distinguish between low and high risk subjects were as follows: total cholesterol 6.5 mmol/l, HDL cholesterol 0.9 mmol/l, apolipoprotein A = 1.8 g/l, and apolipoprotein B = 1.3 g/l. These gave total: HDL cholesterol ratio and atherogenic index cut off values of 7.2 and 4.5 respectively. SETTING: An occupational health service in a non-manufacturing company in Norway. PARTICIPANTS: A total of 112 male and 117 female employees. The mean body mass index values were 25.6 and 23.6 kg/m2 and the mean ages 39.8 and 40.1 years in men and women respectively. Those with cardiovascular, diabetic, or renal diseases were excluded. MEAN OUTCOME MEASURES: Serum total cholesterol, HDL cholesterol, apolipoproteins A-I and B, lipid peroxidation, blood pressure, smoking, physical activity, and fruit, vegetables, and salt in the diet were determined. RESULTS: The cut off values allocated 19%, 7%, and 40% as high risk subjects according to total cholesterol, total: HDL cholesterol, and the atherogenic index respectively. The mean age was two to four years higher in the high risk groups. Cardiovascular risk in siblings and no reported physical activity were more prevalent in those high risk groups defined by the compound indices than by total cholesterol alone, as was a high body mass index and a measure of lipid peroxidation. Grouping according to total cholesterol failed to allocate heavy smokers mainly to the high risk group. Diet variables did not demarcate clearly between indices. CONCLUSIONS: There is considerable variability in classification into high and low risk subjects when using the total cholesterol concentration alone compared with compound risk indices. Smoking was more prevalent in the high risk groups defined by the compound indices than by total cholesterol. These findings call for caution when total cholesterol is used to estimate cardiovascular risk in epidemiological studies, and even more so at individual counselling in occupational or primary health care settings.

Adult↗