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PubMed1999

Three-year maintenance of improved diet and physical activity: the CATCH cohort. Child and Adolescent Trial for Cardiovascular Health.

OBJECTIVE: To assess differences through grade 8 in diet, physical activity, and related health indicators of students who participated in the Child and Adolescent Trial for Cardiovascular Health (CATCH) school and family intervention from grades 3 through 5. DESIGN: Follow-up of the 4-center, randomized, controlled field trial with 56 intervention and 40 control elementary schools. PARTICIPANTS: We studied 3714 (73%) of the initial CATCH cohort of 5106 students from ethnically diverse backgrounds in California, Louisiana, Minnesota, and Texas at grades 6, 7, and 8. RESULTS: Self-reported daily energy intake from fat at baseline was virtually identical in the control (32.7%) and intervention (32.6%) groups. At grade 5, the intake for controls remained at 32.2%, while the intake for the intervention group declined to 30.3% (P<.001). At grade 8, the between-group differential was maintained (31.6% vs 30.6%, P = .01). Intervention students maintained significantly higher self-reported daily vigorous activity than control students (P = .001), although the difference declined from 13.6 minutes in grade 5 to 11.2, 10.8, and 8.8 minutes in grades 6, 7, and 8, respectively. Significant differences in favor of the intervention students also persisted at grade 8 for dietary knowledge and dietary intentions, but not for social support for physical activity. No impact on smoking behavior or stages of contemplating smoking was detected at grade 8. No significant differences were noted among physiologic indicators of body mass index, blood pressure, or serum lipid and cholesterol levels. CONCLUSION: The original CATCH results demonstrated that school-level interventions could modify school lunch and school physical education programs as well as influence student behaviors. This 3-year follow-up without further intervention suggests that the behavioral changes initiated during the elementary school years persisted to early adolescence for self-reported dietary and physical activity behaviors.

Adolescent↗
PubMed1990

A randomized trial to improve self-management practices of adults with asthma.

The prevalence and impact of adult asthma are substantial, and poor self-management practices, especially failures to adhere to treatment regimens, appear to be a significant problem. Desirable characteristics of an intervention program to improve self-management were identified through needs assessment and review of existing patient education resources. A comprehensive program was developed that integrated a workbook with one-to-one counseling and adherence-enhancing strategies. A longitudinal 1-year study compared patients receiving this self-management program with "usual care" patients receiving standard asthma pamphlets. Patients were randomly assigned to conditions. Baseline score and asthma severity were statistically controlled. Self-management patients had substantially better adherence than usual care patients, as well as improved functional status, at follow-up. Hospital and emergency department visits decreased in both groups but did not differ between groups.

Adult↗
PubMed1990

Acebutolol effects on lipid profile.

The relation between lipid profile and the incidence of coronary artery disease has been confirmed by the results of epidemiologic and intervention studies. Among antihypertensive agents, beta blockers, particularly those without intrinsic sympathomimetic activity (ISA), are generally reported to have negative effects on lipids, which may increase the risk of coronary artery disease. The ongoing Treatment of Mild Hypertension Study, now in its third year, has evaluated 847 patients to date with regard to lipid profile. Additional end points measured in this multicenter, randomized, controlled, double-blind study include blood pressure reduction and target organ deterioration. During the trial, all patients received nutritional and behavioral counselling to modify their diet, exercise habits and alcohol and sodium consumption to control their hypertension by nonpharmacologic means. In addition, some patients were randomized to receive low doses of 1 of the 5 classes of antihypertensive medication: acebutolol, a beta blocker with ISA (n = 124); amlodipine, a calcium channel blocker (n = 122); chlorthalidone, a diuretic (n = 125); doxazosin, an alpha blocker (n = 128); enalapril, an angiotensin-converting enzyme inhibitor (n = 127) or placebo (n = 221). At 1 year, acebutolol showed a statistically significant (p less than 0.001) decrease in total cholesterol (-12.7 mg/dl) compared with placebo (-5.2 mg/dl) and with chlorthalidone (1.0 mg/dl); a significant (p less than 0.001) decrease in low-density lipoprotein cholesterol (-6.0 mg/dl) compared with placebo (+0.7 mg/dl) and with chlorthalidone (+8.0 mg/dl) and no change in high-density lipoprotein cholesterol (-0.4 mg/dl).

Acebutolol↗
PubMed1995

Intensified diabetes management: lessons from the diabetes control and complications trial.

The results of the multicenter diabetes control and complications trial are examined and methods for the implementation of the findings for individuals with type I and type II diabetes are discussed. More than a decade ago the question was raised of whether tight glycemic control would prevent or slow the progression of microvascular complications. In 1993, having studied 1441 individuals with type I diabetes randomized to either intensive glycemic control (HbA1c < 7%) or conventional glycemic control (HbA1c > 9%), it was concluded that a reduction in risk of retinopathy, neuropathy and nephropathy could be realized if near normal glycemic control were achieved. Some questions remained, however. For example, could intensive treatment be achieved in routine practice under the auspices of primary care physicians? Are the findings in this study applicable to individuals with type II diabetes? These questions are addressed through the introduction of staged diabetes management (SDM), an innovative approach to the treatment of diabetes and the prevention of its complications. SDM is designed as a data-based systematic approach to diabetes treatment that targets blood glucose control. Studied in 40 clinical sites throughout the United States and evaluated in 30 sites worldwide, SDM promises to provide appropriate clinical guidance to both primary care and specialist physicians seeking to alter current practice patterns by adopting a systematic approach to diabetes management.

Chromatography, High Pressure Liquid↗
PubMed1990

[Insuject-X for children. A clinical trial of the NPH insulin pen].

The use of Insuject-X for NPH insulin was tested by 21 children, age less than or equal to 10 years with insulin dependent diabetes mellitus less than or equal to 1 year, on conventional treatment with NPH insulin once or twice daily. After a preliminary period of one month the syringe injection regimen was changed to injections by Insuject-X for a four-month "pen" period. We observed no significant changes in metabolic control. The mean potency of NPH insulin in partly used cartridges was 103.6 +/- 5.6 IU/ml (range 91.0-118.1, n = 39) with no correlation to the residual volume or days of use. Measurements over 110 IU/ml were seen at the end of the study indicating the need of repeated instruction in use of the pen by children. No microbial contamination of the cartridges, nor any local reactions at injection sites were found. We observed more technical problems than in adult studies indicating that children handle the pen more roughly. The accept of Insuject-X was good as a more convenient means of injecting. All of the children preferred to continue using it.

Adolescent↗
PubMed1989

Mitoxantrone use in breast cancer patients with elevated bilirubin.

To determine the safety and efficacy of mitoxantrone use in hyperbilirubinemic breast cancer patients, a prospectively determined dosage schedule was evaluated in a multi-center trial. Pretreatment bilirubin prospectively defined three groups: Controls (with normal bilirubin) and two Study groups (with either moderate or severe bilirubin increase). Bilirubin determined initial mitoxantrone dose as well: bilirubin less than 3.5 mg/dl, 14 mg/m2; and bilirubin greater than or equal to 3.5 mg/dl, 8 mg/m2. Mitoxantrone at 14 mg/m2 was well tolerated in patients with moderate hepatic dysfunction. Patients with severe hepatic dysfunction demonstrated a mixed toxicity picture, with performance status (ECOG level 3) defining a population with limiting myelosuppression and/or early death. The survival of Study patients with severe hepatic dysfunction (median 17 days) was significantly worse than both Control (p less than 0.01) and Study (p less than 0.05) patients with lower bilirubin. Entry performance status (ECOG level 0-2 versus level 3) profoundly influenced survival (median survival 222 days versus 25 days, respectively, p less than 0.0001). Objective responses were seen in patients with both normal and elevated bilirubin. Bilirubin reduction following mitoxantrone commonly occurred, representing at least an indicator of favorable prognosis. Recommendations for mitoxantrone use include: 1. Patients with moderate bilirubinemia tolerate 14 mg/m2 mitoxantrone with reasonable chance for benefit. 2. Patients with severe hepatic dysfunction and poor performance status should not be given mitoxantrone. A definitive recommendation regarding use of reduced 8 mg/m2 mitoxantrone in patients with severe hyperbilirubinemia and favorable performance status requires further study.

Adenocarcinoma↗
PubMed2004

Dietary intake in the diabetes prevention program cohort: baseline and 1-year post randomization.

PURPOSE: To describe usual dietary intake assessment at baseline and 1-year post-randomization in the ethnically diverse Diabetes Prevention Program cohort. METHODS: Participants were randomized to Lifestyle Modification, Metformin, or Placebo. Usual diet was assessed by a modified, previously validated food frequency interview. RESULTS: Complete data were available for 2934 subjects (90.7% of those randomized). Baseline median estimated energy intake was 7676 kJ/d (1828 kcal/d) and 8585 kJ/d (2044 kcal/d) for women and men, respectively. The median percent of energy from fat ranged from 30.6% for Asian American men to 37.5% for American Indian men and women. After 1 year among the Lifestyle group, the median change in total energy and percent energy from fat was -1897 kJ/d (-452 kcal/d) and -6.6%, respectively. For the Metformin and Placebo groups, change in median total energy was -1235 kJ/d (-294 kcal/d) and-1051 kJ/d (-250 kcal/d), respectively, and change in median percent energy from fat was -0.8% and-0.8%, respectively (p < 0.001 for differences between groups, adjusted for gender and ethnicity). CONCLUSIONS: One-year post-randomization, significant differences in dietary intake were observed in the Lifestyle compared with the Metformin or Placebo group, and these were consistent with the general intent of the DPP lifestyle modification intervention.

Aged↗
PubMed1996

Fluconazole therapy for histoplasmosis. The National Institute of Allergy and Infectious Diseases Mycoses Study Group.

We assessed the efficacy of oral fluconazole (200-800 mg daily) in the treatment of non-life-threatening acute pulmonary histoplasmosis, chronic pulmonary histoplasmosis, or disseminated histoplasmosis in patients without human immunodeficiency virus infection. Of 27 evaluable patients, two had progressive acute pulmonary histoplasmosis, 11 had chronic pulmonary histoplasmosis, and 14 had disseminated histoplasmosis. Median durations of treatment in each of the three groups were 6 months, 7 months, and 11 months, respectively. Nineteen patients were treated with 400 mg of fluconazole daily (two of these patients received 800 mg daily for a portion of their treatment courses), seven were treated with 200 mg daily, and one was treated with 800 mg daily. Treatment was successful in 17 (63%) of 27 cases. Both of the patients with acute pulmonary infection responded to therapy, as did five (46%) of 11 patients with chronic pulmonary infection and 10 (71%) of 14 patients with disseminated infection. No substantial toxicity was observed. We conclude that fluconazole therapy for histoplasmosis is only moderately effective and should be reserved for patients who cannot take itraconazole.

Female↗
PubMed1990

Clinical evaluation of the rocker bottom crutch.

One hundred fifty hospitalized patients referred to a physical therapy department for crutch walking instruction were evaluated in a randomized, controlled crossover study with "rocker bottom" and conventional axillary crutches. A large training effect was observed with each crutch, but no significant differences (all P greater than .05) of gait speed, stride length, heart rate, stability, or feeling of security were noted between the groups. Thus, rocker bottom crutches, despite potential stability and energy conservation benefits, were found to be no more effective than conventional axillary crutches in this hospital setting.

Aged↗
PubMed2002

Clinical results with bisoprolol 2.5 mg/hydrochlorothiazide 6.25 mg combination in systolic hypertension in the elderly.

Hypertension in the elderly, especially systolic hypertension, has been recognized as a major cardiovascular risk factor. Several international studies, using primarily diuretics and/or beta-blockers, have shown the benefits of antihypertensive treatment in elderly patients in terms of cardiovascular morbidity and mortality reduction. However, because the risk of side-effects is a major concern when treating the elderly, the use of low-dose combination treatments may be of particular interest. A randomized, multicentre, double-blind, parallel group study was conducted to compare the efficacy and safety of bisoprolol 2.5 mg/hydrochlorothiazide 6.25 mg (biso 2.5/HCTZ 6.25) (n = 84) versus amlodipine 5 mg (n = 80) in subjects over 60years of age with isolated systolic hypertension. The effects of these two treatment strategies on patients' quality of life were also assessed. After a two- to four-week placebo washout period, both drugs were administered once daily and taken for 12 weeks. Blood pressure was measured 24 h after treatment administration. Systolic blood pressure/diastolic blood pressure changes from baseline to week 12 were similar for both biso 2.5/HCTZ6.25 and amlodipine (-20.0/-4.5 mmHg and -19.6/-2.4 mmHg, respectively). Overall adverse events for biso 2.5/HCTZ 6.25 and amlodipine were 39% and 40%, respectively. Both treatments improved quality of life scores in the same way. This study demonstrates comparable efficacy and tolerability of biso 2.5/HCTZ 6.25 and amlodipine. Low-dose combination of bisoprolol and hydrochlorothiazide may be an appropriate alternative for elderly patients with systolic hypertension.

Aged↗
PubMed1990

Effect of cyclic estrone sulfate treatment on lipid profiles of postmenopausal women with elevated cholesterol levels.

The effects of two doses of cyclic unopposed estrone sulfate therapy on the lipid profiles of 153 healthy postmenopausal women with baseline total cholesterol levels above 219 mg/dL were compared in a multicenter, double-blind, placebo-controlled study. Patients were assigned randomly to one of three treatment groups: estrone sulfate 0.625 mg (N = 59) or 1.25 mg (N = 43), or placebo (N = 51). The median baseline total cholesterol levels of the three treatment groups were 262, 269, and 262 mg/dL, respectively. Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), and the HDL/LDL ratio were assessed after 6, 9, and 12 months of treatment. There was a significant monotonic dose-response relationship of estrone sulfate in raising HDL levels, lowering LDL levels, and raising the HDL/LDL ratio at all intervals measured. These results indicate that estrone sulfate is effective in creating a beneficial change in the lipid profile of postmenopausal women with elevated baseline total cholesterol.

Cholesterol, HDL↗
PubMed1989

Converting enzyme inhibitors in the treatment of elderly hypertensives.

Angiotensin-converting enzyme inhibitors are gaining acceptance as safe and effective agents for treatment of hypertension. Addressed in this review of the available literature are the questions whether they are effective in lowering blood pressure in the elderly, whether their effects are age-related, and what effects, if any, do they have on morbidity and mortality in geriatric hypertension.

Aged↗
PubMed1989

The relationship between knowledge and reported behavior in childhood asthma.

Numerous educational interventions have been developed and tested to improve management of childhood asthma. Most programs assume that knowledge about asthma is related to initiating and/or maintaining recommended management behaviors. Although this assumption is widely accepted, some available evidence casts doubt upon its validity. We investigated the relationship between asthma management behaviors and (1) knowledge about asthma, (2) behavioral adjustment, (3) anxiety, and (4) health locus of control. Data were collected on 91 children 7 to 12 years of age with moderately severe asthma. After adjusting for covariates, reported asthma management behavior was significantly related only to knowledge about asthma (p less than .05). The relationship between knowledge and behavior is nonlinear: accurate knowledge is related to engaging in more of the recommended behaviors, but only up to a moderate level of knowledge. Also, the relationship between knowledge and asthma management behavior was especially strong for children who scored lower on behavioral adjustment. These results suggest that children's knowledge about asthma can influence behavior, but only under certain conditions. Educational interventions for children whose knowledge is already adequate may not increase adherence to recommended practices.

Anxiety↗