PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “list randomization”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,099 records · Page 61Linked to original sources

The effect of early education on patient anxiety while waiting for elective cardiac catheterization.

BACKGROUND: A supply-demand mismatch with respect to cardiac catheterization (CATH) often results in patients experiencing waiting times that vary from a few weeks to several months. Long delays can impose both physical and psychological distress for patients. PURPOSE: The purpose of this study was to examine the effect of a psychoeducational nursing intervention at the beginning of the waiting period on patient anxiety during the waiting time for elective CATH. METHODS: This was a 2-group randomized controlled trial. Intervention patients received a nurse-delivered, detailed information/education session within 2 weeks of being placed on the waiting list for elective CATH. Control group patients received usual care. RESULTS: The mean waiting time for CATH was 13.4+/-7.2 weeks, which did not differ between groups (P=0.509). Anxiety increased in both groups over the waiting time (P=0.028). Health-related quality of life deteriorated over the waiting time in both groups (P<0.05). On a visual analogue scale, there was a significant difference (P=0.002) between the intervention (4.0+/-2.7) and control (5.2+/-3.0) groups in self-reported anxiety 2 weeks prior to CATH. CONCLUSIONS: The waiting period prior to elective CATH has a negative impact on patients' perceived anxiety and quality of life and a simple intervention, provided at the beginning of the waiting period, may positively affect the experience of waiting.

Aged↗

Aerobic exercise and lipids and lipoproteins in women: a meta-analysis of randomized controlled trials.

BACKGROUND: Cardiovascular disease (CVD) in women is the leading cause of mortality in the United States, and less than optimal lipid and lipoprotein levels are major risk factors for CVD. The purpose of this study was to use the meta-analytic approach to examine the effects of aerobic exercise on lipids and lipoproteins in women. METHODS: Studies were retrieved via computerized literature searches, review of reference lists, hand searching selected journals, and expert review of our reference list. The inclusion of studies was limited to randomized controlled trials published in the English language literature between January 1955 and January 2003 in which aerobic exercise was used as the primary intervention in adult women aged > or =18 years. One or more of the following lipids and lipoproteins were assessed: total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides (TG). RESULTS: Using a random effects model, statistically significant improvements were observed for all lipids and lipoproteins (TC, +/- SEM, -4.3 +/- 1.3 mg/dl, 95% CI -6.9 to -1.7 mg/dl; HDL-C, +/- SEM, 1.8 +/- 0.9 mg/dl, 95% CI 0.1 to 3.5 mg/dl; LDL-C, +/- SEM, -4.4 +/- 1.1 mg/dl, 95% CI -6.5 to -2.2 mg/dl; TG, +/- SEM, -4.2 +/- 2.1 mg/dl, 95% CI -8.4 to -0.1 mg/dl). Reductions of approximately 2%, 3%, and 5%, respectively, were observed for TC, LDL-C, and TG, whereas an increase of 3% was observed for HDL-C. CONCLUSIONS: Aerobic exercise is efficacious for increasing HDL-C and decreasing TC, LDL-C, and TG in women.

Cardiovascular Diseases↗

Association of malocclusion and functional occlusion with temporomandibular disorders (TMD) in adults: a systematic review of population-based studies.

The aim of this systematic review of population-based studies was to establish whether or not associations exist between different types of malocclusions, as well as factors of functional occlusion (eg, occlusal interferences, nonworking-side occlusal contacts) and temporomandibular disorders (TMD) in adults 20 years or older. Defined criteria were employed in the search of MEDLINE and EMBASE databases, as well as in a manual search. Finally, using inclusion criteria (eg, random sampling from residents' registration office files or census lists, adequate response rates), out of 22 preselected studies, four relevant population-based studies on this subject were found. Eighteen studies were excluded because of insufficient description of material and methods (eg, lack or unclear description of sample method, randomization, age distribution), mixed under- and over-20-year-old study population, or different outcome of interest (eg, tooth loss, dentures). The methodologic quality of the selected studies was established with a quality assessment list. The average total methodologic score achieved was 43 out of a possible 100 points. Few associations were reported between malocclusion and parameters of functional occlusion and clinical as well as subjective TMD, and these associations were not uniform. No particular morphologic or functional occlusal factor became apparent. Additionally, the occlusal factors found were partly protective for TMD, ie, subjects with these occlusal parameters showed fewer signs and symptoms of TMD (angle Class II malocclusion, deep bite, anterior crossbite). A positive relationship was only described in two cases-between the number of rotated lateral teeth and subjective symptoms of dysfunction, and between excessive abrasions and clinical dysfunction. In neither case, however, was the strength of the correlation given. In summary, few associations were established between malocclusion or functional occlusion and signs and symptoms of TMD. In view of the small number of randomized studies and their methodologic quality, these results should be verified through further valid representative studies.

Adult↗

Blood glucose distribution and prevalence of diabetes in Hanoi (Vietnam).

Few epidemiologic surveys have been performed to assess the prevalence of diabetes in representative samples, and few data are available on the epidemiologic features of diabetes in Southeast Asia. We report the results of a 1990 study performed in the Hanoi area (Vietnam) on 4,912 subjects (95.0% of the eligible population), aged 15 years or over, selected by a stratified random cluster procedure using the 1989 census list. A two-step design was used: 1) screening for diabetes by measuring capillary blood glucose (CBG) before dinner with a Glucometer II device; and 2) for subjects with a CBG measurement of > or = 105 mg/dl, a diagnostic test on the following morning, using a 75-g oral glucose tolerance test and World Health Organization criteria (93.9% of the positive screenees took this test). CBG values before dinner were unimodally distributed and skewed to the right, increasing with age in both sexes. Women had a significantly higher level of age-adjusted CBG than did men before dinner (p < 0.0001) as well as when fasting (p < 0.0001) and 2 hours after the oral glucose tolerance test (p = 0.013). The prevalence of diabetes was 1.2% (95% confidence interval (CI) 0.9-1.5) and of impaired glucose tolerance, 1.6% (95% CI 1.3-2.0). Women had a significantly higher age-adjusted prevalence of diabetes than did men (relative risk = 2.3; 95% CI 1.3-4.1). Of the 63 diabetic subjects, nine (14.3%) had been diagnosed before the study, only one was obviously insulin dependent, and only one was obese with a body mass index of > or = 27 kg/m2. The subjects living in the urban areas had higher levels of fasting and 2-hour CBG and a higher diabetes prevalence than did the rural inhabitants (relative risk = 1.3; 95% CI 1.04-3.23). Diabetes appears to be a rare disease in the Hanoi area (1.4% for subjects aged 30-64 years, after age standardization using the Segi distribution), affecting women two times as often as men. Typical insulin-dependent (type I) or obese non-insulin-dependent (type II) diabetes mellitus patients are uncommon.

Adolescent↗

What benefit do patients expect from adding second and third antihypertensive drugs?

AIMS: To discover whether patients have the same expectations of benefit from taking the first and any additional drugs for the treatment of hypertension and to investigate any patient characteristics which predict willingness to take treatment. METHODS: This was an anonymous questionnaire survey carried out in a single primary care group. A random sample of patients from the practice list stratified by age and gender were surveyed to determine what benefit they required before deciding to receive first and subsequent drugs to treat hypertension. They were asked to indicate the largest number needing treatment for 5 years (NNT5) to prevent myocardial infarction in 1 (smallest benefit) that would persuade them of the need for treatment. Demographic information which might explain variability in enthusiasm for treatment was also collected. RESULTS PARTICIPANTS: required far higher benefit to consider drug treatment than expected with a mean NNT5 for the first treatment of 15.0 (95% CI 12.3, 17.8). Marginal benefit demanded for the addition of second and third treatments was at least as great with an NNT5 of 13.2 (95% CI 10.8, 15.7) and NNT5 of 11.0 (95% CI 8.6, 13.4). Additional factors influencing willingness to take treatment were gender with a difference in NNT5 between men and women of 7.1 (95% CI 1.7, 12.5), difficulty in making the decision (very easy vs very difficult) of 14.9 (95% CI 6.0, 23.8), and years in full time education 2.0 (95% CI 0.9, 3.0) for each additional year of education. Any slope of NNT5 with increasing number of tablets disappeared when gender, years in education, and difficulty in reaching a decision were taken into account simultaneously. CONCLUSIONS: People may have greater expectation of benefit from antihypertensive drug treatment than it provides. They certainly do not view the addition of subsequent drugs as any lesser step than starting the first in terms of the benefit expected. Full understanding of both the risks and benefits may be of critical importance with those spending longer in full time education and those expending more effort in making the decision accepting more treatment. The discrepancy between benefit expected and that available demands further research into methods of determining patients' expectations and informing individual patient decisions.

Adult↗

Risk of adverse effects of intensified treatment in insulin-dependent diabetes mellitus: a meta-analysis.

While the benefits of intensified insulin treatment in insulin-dependent (Type 1) diabetes mellitus (IDDM) are well recognized, the risks have not been comprehensively characterized. We examined the risk of severe hypoglycaemia, ketoacidosis, and death in a meta-analysis of randomized controlled trials. The MEDLINE database, reference lists, and specialist journals were searched electronically or by hand to identify relevant studies with at least 6 months of follow-up and the monitoring of glycaemia by glycosylated haemoglobin measurements. Logistic regression was used for calculation of combined odds ratios and 95% confidence intervals (95% CI). The influence of covariates was examined by including covariate-by-treatment interaction terms. Methodological study quality was assessed and sensitivity analyses were performed. Fourteen trials were identified. These contributed 16 comparisons with 1028 patients allocated to intensified and 1039 allocated to conventional treatment. A total of 846 patients suffered at least one episode of severe hypoglycaemia, 175 patients experienced ketoacidosis and 26 patients died. The combined odds ratio (95% CI) for hypoglycaemia was 2.99 (2.45-3.64), for ketoacidosis 1.74 (1.27-2.38) and for death from all causes 1.40 (0.65-3.01). The risk of severe hypoglycaemia was determined by the degree of normalization of glycaemia achieved (p=0.005 for interaction term), with the results from the Diabetes Control and Complications Trial (DCCT) in line with the other trials. Ketoacidosis risk depended on the type of intensified treatment used. Odds ratios (95% CI) were 7.20 (2.95-17.58) for exclusive use of pumps, 1.13 (0.15-8.35) for multiple daily injections and 1.28 (0.90-1.83) for trials offering a choice between the two (p = 0.004 for interaction). Mortality was significantly (p = 0.007) increased for causes potentially associated with acute complications (7 vs 0 deaths, 5 deaths attributed to ketoacidosis, and 2 sudden deaths), and non-significantly (p = 0.16) decreased for macrovascular causes (3 vs 8 deaths). We conclude that there is a substantial risk of severe adverse effects associated with intensified insulin treatment. Mortality from acute metabolic causes is increased; however, this is largely counterbalanced by a reduction in cardiovascular mortality. The excess of severe hypoglycemia in the DCCT is not exceptional. Multiple daily injection schemes may be safer than treatment with insulin pumps.

Blood Glucose↗

Active rehabilitation for chronic low back pain: cognitive-behavioral, physical, or both? First direct post-treatment results from a randomized controlled trial [ISRCTN22714229].

BACKGROUND: The treatment of non-specific chronic low back pain is often based on three different models regarding the development and maintenance of pain and especially functional limitations: the deconditioning model, the cognitive behavioral model and the biopsychosocial model. There is evidence that rehabilitation of patients with chronic low back pain is more effective than no treatment, but information is lacking about the differential effectiveness of different kinds of rehabilitation. A direct comparison of a physical, a cognitive-behavioral treatment and a combination of both has never been carried out so far. METHODS: The effectiveness of active physical, cognitive-behavioral and combined treatment for chronic non-specific low back pain compared with a waiting list control group was determined by performing a randomized controlled trial in three rehabilitation centers. Two hundred and twenty three patients were randomized, using concealed block randomization to one of the following treatments, which they attended three times a week for 10 weeks: Active Physical Treatment (APT), Cognitive-Behavioral Treatment (CBT), Combined Treatment of APT and CBT (CT), or Waiting List (WL). The outcome variables were self-reported functional limitations, patient's main complaints, pain, mood, self-rated treatment effectiveness, treatment satisfaction and physical performance including walking, standing up, reaching forward, stair climbing and lifting. Assessments were carried out by blinded research assistants at baseline and immediately post-treatment. The data were analyzed using the intention-to-treat principle. RESULTS: For 212 patients, data were available for analysis. After treatment, significant reductions were observed in functional limitations, patient's main complaints and pain intensity for all three active treatments compared to the WL. Also, the self-rated treatment effectiveness and satisfaction appeared to be higher in the three active treatments. Several physical performance tasks improved in APT and CT but not in CBT. No clinically relevant differences were found between the CT and APT, or between CT and CBT. CONCLUSION: All three active treatments were effective in comparison to no treatment, but no clinically relevant differences between the combined and the single component treatments were found.

Adult↗

Hearing aids and tinnitus--an experimental group study.

From a waiting list consisting of hearing-impaired patients waiting for hearing aids to be fitted, 39 subjects who at interview also stated that they had tinnitus took part in an experimental group study with the aim of investigating the effect of a hearing aid on tinnitus. No subject had any previous experience of hearing aids. The subjects were randomly allocated to a treatment and a waiting list control group. After an initial interview, the routine programme for the fitting of hearing aids started in the treatment group, while the waiting list control group had to wait for 6 weeks before starting the same hearing aid rehabilitation programme. The hearing aids were fitted exclusively for hearing purposes. As expected, the hearing aids improved the hearing capacity, but they did not reduce tinnitus as recorded on a visual analogue scale. According to information obtained at the final interview, there were significant differences in tinnitus between subjects who used their aid for more than 2 hours daily and those who used it for less than 2 hours. However, the results of scaling (pre- and post-fitting) did not support this finding. The discrepancy between the scaling and interview data is probably due to demand characteristics.

Aged↗

Attrition prevention with individuals awaiting publicly funded drug treatment.

AIMS: To evaluate the effectiveness of a motivational intervention to reduce attrition from a waiting list for substance abusers seeking publicly funded treatment. DESIGN: Randomized clinical trial comparing an "attrition prevention" condition to standard care while awaiting treatment admission. SETTING: A centralized substance abuse assessment and referral center in Seattle, Washington. PARTICIPANTS: Substance abusers (n = 654) eligible for publicly funded drug abuse treatment. MEASUREMENTS: Alcohol and drug use, substance-related negative consequences, areas in need of help, perceived need for help, emotional status, readiness to change, reasons for seeking and perceived barriers to entering treatment. FINDINGS: Overall, approximately 70% of clients entered treatment, and of these approximately 70% completed their assigned treatment. Those who entered treatment showed significant reductions in substance use and improved psychosocial function at a short-term 3-month follow-up. However, the attrition prevention intervention had no differential effect on treatment entry, completion or outcome compared to the standard waiting list. Further, there were no differences across therapists on these outcome measures. CONCLUSIONS: A motivational attrition prevention intervention did not enhance treatment entry, completion or outcome among treatment-seeking substance abusers. It is suggested that alternative strategies, such as contingency management and case management, may help facilitate treatment entry for individuals seeking publicly funded treatment.

Adolescent↗

Physician fee indices in California and the U.S. through June 1971.

California physicians' fees increased 2.2 percent in the first half of 1971, according to figures compiled by the Bureau of Research and Planning. Nationally, physicians' fees increased at a faster rate of 3.4 percent during the same period. This was the slowest semi-annual increase in the California Index since the final six months of 1968 when fees increased only 2.0 percent. A decline was also recorded in the rate of price increase for other goods and services in the first half of 1971. Nationally, the "all items" increase amounted to 2.0 percent, and the service component rose 2.1 percent. Also included in this Report is special information on the charging patterns of physicians for office and hospital visits and data on physicians' fees in the Los Angeles and San Francisco Metropolitan Areas. The California Physician Fee Index is a continuing survey conducted by the CMA Bureau of Research and Planning since 1962. The survey questionnaire which lists 26 medical, surgical, radiological, and laboratory procedures, elicits fee information from approximately 1,000 randomly selected physicians. Since June 1970, the procedures on the questionnaire have been listed according to the coding nomenclature used in the 1969 edition of the Relative Value Studies, published by the California Medical Association. Prior to that, the 1964 edition was used to delineate the procedure being surveyed.

California↗

Effect of a preoperative intervention on preoperative and postoperative outcomes in low-risk patients awaiting elective coronary artery bypass graft surgery. A randomized, controlled trial.

BACKGROUND: In publicly funded health care systems, a waiting period for such services as coronary artery bypass graft surgery (CABG) is common. The possibility of using the waiting period to improve patient outcomes should be investigated. OBJECTIVE: To examine the effect of a multidimensional preoperative intervention on presurgery and postsurgery outcomes in low-risk patients awaiting elective CABG. DESIGN: Randomized, controlled trial. SETTING: A regional cardiovascular surgery center in a tertiary care hospital, southwestern Ontario, Canada. PATIENTS: 249 patients on a waiting list for elective CABG whose surgeries were scheduled for a minimum of 10 weeks from the time of study recruitment. INTERVENTION: During the waiting period, the treatment group received exercise training twice per week, education and reinforcement, and monthly nurse-initiated telephone calls. After surgery, participation in a cardiac rehabilitation program was offered to all patients. MEASUREMENTS: Postoperative length of stay was the primary outcome. Secondary outcomes were exercise performance, general health-related quality of life, social support, anxiety, and utilization of health care services. RESULTS: Length of stay differed significantly between groups. Patients who received the preoperative intervention spent 1 less day [95% CI, 0.0 to 1.0 day] in the hospital overall (P = 0.002) and less time in the intensive care unit (median, 2.1 hours [CI, -1.2 to 16 hours]; P = 0.001). During the waiting period, patients in the intervention group had a better quality of life than controls. Improved quality of life continued up to 6 months after surgery. Mortality rates did not differ. CONCLUSION: The waiting period for elective procedures, such as CABG, may be used to enhance in-hospital and early-phase recovery, improving patients' functional abilities and quality of life while reducing their hospital stay.

Anxiety↗

An office-based instrument for exercise counseling and prescription in primary care. The Step Test Exercise Prescription (STEP).

BACKGROUND: Available evidence suggests that despite physicians' positive attitudes toward exercise as an important part of promoting a healthy lifestyle, few physicians actually prescribe exercise for their patients. One barrier may be lack of a standard office instrument. OBJECTIVES: To determine the (1) exercise counseling habits among a large group of Canadian family physicians and (2) acceptance and utilization of an exercise counseling instrument geared to primary care practice. DESIGN: Randomized control trial. SETTING: Primary care practice. PARTICIPANTS: Family physicians (N = 400) from 3 regions of Canada, representing both rural and urban practice (ratio of 1:3). Patients (10 per practice) were healthy community dwellers older than 65 years obtained as a convenience sample in their family practice. INTERVENTIONS: In phase 1, 400 physicians listed as being in general or family practice by their provincial registries were randomly selected from a larger group listed by these registries and contacted by telephone. A total of 362 completed a 10-minute questionnaire that detailed practice demographics, preventive practice, and exercise counseling habits. In phase 2, 293 agreed to further participate in the administration of an exercise prescription randomly assigned to them by the study team. Two methods of exercise prescription were compared: counseling using the American College of Sports Medicine guidelines (control) and counseling using guidelines and an office-based step test (Step Test Exercise Prescription [STEP]) to determine fitness level and prescribe an exercise training heart rate. Physicians were asked to deliver their assigned exercise prescription to a convenience sample of the next 10 healthy patients older than 65 years who presented to the office. MAIN OUTCOME MEASURES: Primary outcome measures were physician exercise counseling confidence and knowledge before and after the study. Secondary outcomes included details of the exercise counseling sessions (e.g., time required). RESULTS: In phase 1, more than 90% of the 362 physicians claimed to practice preventive health counseling, and 70% claimed to include exercise counseling. Only 67.4% felt confident regarding their exercise prescribing, and most (93.8%) were interested in improving their exercise prescribing skills. The leading barriers to exercise prescription were described in order as inadequate time, lack of necessary skills and tools, and lack of reimbursement. In phase 2, no difference in physician profile, patient profile, or indications for exercise counseling were observed between control (n = 145) and STEP (n = 148) groups. STEP was significantly longer (16.4 vs 12.9 min; P = .001) to administer; however, improvement in physician confidence (P = .01) and knowledge (P = .009) were significantly greater compared with controls. CONCLUSIONS: Most family physicians practiced preventive exercise counseling but reported lack of time and skills as barriers to this practice. Physicians randomized to the STEP group took longer to deliver exercise advice but felt more confident and knowledgeable compared with controls.

Aged↗

Risedronate: a clinical review.

BACKGROUND: Risedronate sodium has recently been approved for the prevention and treatment of postmenopausal and corticosteroid-induced osteoporosis. METHODS: Studies of risedronate were obtained from the MEDLINE database (1966 to the present) of references using risedronate, risedronic acid, osteoporosis, and human subject as keywords. Additional references were sought from the reference lists of the articles obtained. RESULTS: Nine randomized controlled trials and 7 other clinical trials were obtained. In postmenopausal women with normal bone density, risedronate increases lumbar spine bone density and preserves femoral neck density. In postmenopausal women with prior vertebral fracture, risedronate decreases new vertebral and nonvertebral fracture incidence. In patients who experienced breast cancer and who have chemotherapy-induced menopause, risedronate preserves bone. Risedronate prevents vertebral bone loss in patients beginning long-term corticosteroid therapy. Risedronate decreases pagetic bone pain and induces radiological improvement in pagetic lesions. Risedronate induces normalization of biochemical abnormalities and may be more effective than etidronate disodium for Paget disease. Only one study, a trial in patients with postmenopausal osteoporosis using a low dose (2.5 mg) of risedronate, did not have a positive result. Adverse effects in patients with postmenopausal osteoporosis, breast cancer, and Paget disease and in those taking corticosteroids are similar to those of patients taking placebo, and do not include notable upper gastrointestinal tract adverse event rates or serious adverse events. CONCLUSIONS: Risedronate prevents postmenopausal bone loss, decreases fracture in those with established postmenopausal osteoporosis, effectively treats Paget disease, and prevents corticosteroid-induced bone loss. Long-term toxic effects and efficacy, particularly fracture end point data, are unknown. Also undefined are optimal duration of therapy, potential for use in combination with other agents, and direct comparison with other bisphosphonates used for osteoporosis.

Animals↗

Effects of sodium restriction on blood pressure, renin, aldosterone, catecholamines, cholesterols, and triglyceride: a meta-analysis.

CONTEXT: One of the controversies in preventive medicine is whether a general reduction in sodium intake can decrease the blood pressure of a population and thereby reduce the number of strokes and myocardial infarctions. In recent years the debate has been extended by studies indicating that reduced sodium intake has adverse effects. OBJECTIVE: To estimate the effects of reduced sodium intake on systolic and diastolic blood pressure (SBP and DBP), body weight, and plasma or serum levels of renin, aldosterone, catecholamines, cholesterols, and triglyceride, and to evaluate the stability of the blood pressure effect in relation to additional trials. DATA SOURCES: MEDLINE search from 1966 through December 1997 and reference lists of relevant articles. STUDY SELECTION: Studies randomizing persons to high-sodium and low-sodium diets were included if they evaluated at least one of the effect parameters. DATA EXTRACTION: Two authors independently recorded data. DATA SYNTHESIS: In 58 trials of hypertensive persons, the effect of reduced sodium intake as measured by urinary sodium excretion (mean, 118 mmol/24 h) on SBP was 3.9 mm Hg (95% confidence interval [CI], 3.0-4.8 mm Hg) (P<.001) and on DBP was 1.9 mm Hg (95% CI, 1.3-2.5 mm Hg) (P<.001). In 56 trials of normotensive persons, the effect of reduced sodium intake (mean, 160 mmol/24 h) on SBP was 1.2 mm Hg (95% CI, 0.6-1.8 mm Hg) (P<.001) and on DBP was 0.26 mm Hg (95% CI, -0.3-0.9 mm Hg) (P=.12). The cumulative analysis showed that this effect size has been stable since 1985. In plasma, the renin level increased 3.6-fold (P<.001), and the aldosterone level increased 3.2-fold (P<.001); the increases were proportional to the degree of sodium reduction for both renin (r=0.66; P<.001) and aldosterone (r=0.64; P<.001). Body weight decreased significantly, and noradrenaline, cholesterol, and low-density lipoprotein cholesterol levels increased. There was no effect on adrenaline, triglyceride, and high-density lipoprotein cholesterol. CONCLUSION: These results do not support a general recommendation to reduce sodium intake. Reduced sodium intake may be used as a supplementary treatment in hypertension. Further long-term studies of the effects of high reduction of sodium intake on blood pressure and metabolic variables may clarify the disagreements as to the role of reduced sodium intake, but ideally trials with hard end points such as morbidity and survival should end the controversy.

Aldosterone↗

Educational interventions for asthma in children.

BACKGROUND: Self-management education programs have been developed for children with asthma, but it is unclear whether such programs improve outcomes. OBJECTIVES: To determine the efficacy of asthma self-management education on health outcomes in children. SEARCH STRATEGY: Systematic search of the Cochrane Airways Group's and Cochrane Schizophrenia Group's Special Registers of Controlled Trials and hand searches of the reference lists of relevant review articles. SELECTION CRITERIA: Randomized and controlled clinical trials of asthma self-management education programs in children and adolescents aged 2 -18 years. DATA COLLECTION AND ANALYSIS: All studies were assessed independently by two reviewers. Disagreements were settled by consensus. Study authors were contacted for missing data or to verify methods. Subgroup analyses examined the impact of type and intensity of educational intervention, self-management strategy, trial type, asthma severity, adequacy of follow-up, and study quality. MAIN RESULTS: Of 45 trials identified, 32 studies involving 3706 patients were eligible. Asthma education programs were associated with moderate improvement in measures of airflow (standardized mean difference [SMD] 0.50, 95% confidence interval [CI] 0.25 to 0.75) and self-efficacy scales (SMD 0.36, 95% CI 0.15 to 0.57). Education programs were associated with modest reductions in days of school absence (SMD -0.14, 95% CI -0.23 to -0.04), days of restricted activity (SMD -0.29, 95% CI -0.49 to -0.08), and emergency room visits (SMD -0.21, 95% CI -0.33 to -0.09). There was a reduction in nights disturbed by asthma when pooled using a fixed-effects but not a random-effects model. Effects of education were greater for most outcomes in moderate-severe, compared with mild-moderate asthma, and among studies employing peak flow versus symptom-based strategies. Effects were evident within the first 6 months, but for measures of morbidity and health care utilization, were more evident by 12 months. REVIEWER'S CONCLUSIONS: Asthma self-management education programs in children improve a wide range of measures of outcome. Self-management education directed to prevention and management of attacks should be be incorporated into routine asthma care. Conclusions about the relative effectiveness of the various components are limited by the lack of direct comparisons. Future trials of asthma education programs should focus on morbidity and functional status outcomes, including quality of life, and involve direct comparisons of the various components of interventions.

Adolescent↗

Calcium and vitamin D for corticosteroid-induced osteoporosis.

OBJECTIVES: To assess the effects of calcium and vitamin D compared to calcium alone or placebo in the prevention of bone loss in patients taking systemic corticosteroids. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal trials register, Cochrane Controlled Trials Register, EMBASE and Medline up to 1996. We also conducted a hand search of abstracts from various scientific meetings and reference lists of selected trials. SELECTION CRITERIA: All randomized trials comparing calcium and vitamin D to calcium alone or placebo in patients taking systemic corticosteroids. DATA COLLECTION AND ANALYSIS: Data was abstracted from trials by two investigators. Methodological quality was assessed in a similar manner. Analysis was performed using fixed effects models. MAIN RESULTS: Five trials were included, with 274 patients. The analysis was performed at two years after starting calcium and vitamin D. There was a significant weighted mean difference (WMD) between treatment and control groups in lumbar (WMD 2.6 (95% CI 0.7, 4.5), and radial bone mineral density (WMD 2.5 (95% CI 0.6, 4.4). The other outcome measures (femoral neck bone mass, fracture incidence, biochemical markers of bone resorption) were not significantly different. REVIEWER'S CONCLUSIONS: This meta-analysis demonstrated a clinically and statistically significant prevention of bone loss at the lumbar spine and forearm with vitamin D and calcium in corticosteroid treated patients. Because of low toxicity and cost all patients being started on corticosteroids should receive prophylactic therapy with calcium and vitamin D.

Calcium↗

Antiplatelet therapy for preventing stroke in patients with non-valvular atrial fibrillation and no previous history of stroke or transient ischemic attacks.

BACKGROUND: Atrial fibrillation (AF) carries an increased risk of stroke; antiplatelet agents are proven effective for stroke prevention in other settings. OBJECTIVES: The objective of this review was to determine the efficacy and safety of antiplatelet therapy for prevention of stroke in patients with chronic non-valvular AF. SEARCH STRATEGY: We searched the Cochrane Stroke Group Specialised Register of Trials, MEDLINE database (June 1999), and the database of the Antithrombotic Trialists Collaboration, as well as reference lists of relevant articles. SELECTION CRITERIA: All randomized trials comparing antiplatelet therapies to placebo in patients with non-valvular AF and no history of transient ischemic attack (TIA) or stroke. DATA COLLECTION AND ANALYSIS: Trials for inclusion were independently selected by two reviewers who also extracted each outcome and double-checked the data. The Peto method was used for combining odds ratios. All analysis were, as far as possible, "intention-to-treat". Since the published results of two trials included 3-8% of participants with prior stroke or TIA, unpublished results excluding these participants were obtained from the Atrial Fibrillation Investigators. MAIN RESULTS: Among 1680 participants without prior stroke/TIA, randomized to aspirin (N = 838) or placebo in two trials, aspirin was associated with nonsignificantly lower risks of ischemic stroke (OR = 0.71, CI 95% 0. 46 - 1.10), all stroke (OR = 0.70, CI 95% 0.45 - 1.08) all disabling/fatal stroke (OR =0.88, CI 95% 0.48 - 1.58) and the constellation of stroke, MI or vascular death (OR = 0.76, CI 95% 0. 54 - 1.05 ). Considering all randomized participants including those with prior stroke or TIA, reductions in these events by aspirin were consistently smaller and marginally statistically significant: ischemic stroke (OR = 0.77, CI 95% 0.60-1.00), all stroke (OR = 0.76, CI 95% 0.61 - 0.93), all disabling/fatal stroke (OR = 0.87, CI 95% 0.64 - 1.19) and the combined outcome (OR = 0.79, CI 95% 0.64 - 0. 99). No increase in major hemorrhage was seen, but the number of hemorrhagic events was small. REVIEWER'S CONCLUSIONS: Considering all randomized data, aspirin modestly (by about 20%) reduces stroke and major vascular events in nonvalvular AF. For primary prevention among AF patients with an average stroke rate of 4.5%/year, about 10 strokes would be prevented yearly for every 1000 given aspirin.

Atrial Fibrillation↗

Oral anticoagulants for preventing stroke in patients with non-valvular atrial fibrillation and no previous history of stroke or transient ischemic attacks.

BACKGROUND: Non-valvular atrial fibrillation (AF) is associated with an increased risk of stroke. OBJECTIVES: The objective of this review was to characterize the efficacy and safety of oral anticoagulation (OAC) with vitamin K antagonists for the primary prevention of stroke in patients with chronic AF. SEARCH STRATEGY: We searched the Cochrane Stroke Group Specialised Register of Trials (June 1999), MEDLINE database, and the database of the Antithrombotic Trialists Collaboration, as well as reference lists of relevant articles. SELECTION CRITERIA: All randomized controlled trials comparing the value of OAC versus control in patients with non-valvular chronic atrial fibrillation and no history of transient ischemic attack (TIA) or stroke. DATA COLLECTION AND ANALYSIS: Trials for inclusion were independently selected by two reviewers who also extracted each outcome and double-checked the data. The Peto method was used for combining odds ratios. All analysis were, as far as possible, "intention-to-treat". Since the published results of four trials included 3-8% of participants with prior stroke or TIA, unpublished results excluding these participants were obtained from the Atrial Fibrillation Investigators. MAIN RESULTS: Of 2313 participants without prior cerebral ischemia from five trials, about half (n = 1154) were randomized to adjusted-dose OAC with an estimated mean INRs ranging between 2.0-2.6 during 1.5 years/participant average follow-up. Participant features and study quality were similar between trials. OAC was associated with large, highly statistically significant reductions in ischemic stroke (OR = 0.34, 95% CI 0.23 - 0.52), all stroke (OR = 0.39, 95% CI 0.26 - 0. 59), all disabling or fatal stroke (OR = 0.47, 95% CI 0.28 - 0.80), and the combined endpoint of all stroke, MI or vascular death (OR = 0.56, 95% CI 0.42 - 0.76). The observed rates of intracranial and extracranial hemorrhage not significantly increased by OAC therapy, but confidence intervals were wide. REVIEWER'S CONCLUSIONS: Adjusted-dose OAC (achieved INRs between 2-3) reduces stroke as well as disabling/fatal stroke for patients with nonvalvular AF, and these benefits were not substantially offset by increased bleeding among participants in randomized clinical trials. Limitations include relatively short follow-up and imprecise estimates of bleeding risks from these selected participants. For primary prevention in AF patients who have an average stroke rate of 4%/year, about 25 strokes and about 12 disabling fatal strokes would be prevented yearly for every 1000 given OAC.

Anticoagulants↗