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PubMed2004

Tai chi and self-rated quality of sleep and daytime sleepiness in older adults: a randomized controlled trial.

OBJECTIVES: To determine the effectiveness of tai chi on self-rated sleep quality and daytime sleepiness in older adults reporting moderate sleep complaints. DESIGN: Randomized, controlled trial with allocation to tai chi or exercise control. SETTING: General community. PARTICIPANTS: One hundred eighteen women and men aged 60 to 92. INTERVENTION: Participants were randomized into tai chi or low-impact exercise and participated in a 60-minute session, three times per week, for 24 consecutive weeks. MEASUREMENTS: Primary outcome measures were the seven subscales of the Pittsburgh Sleep Quality Index (PSQI), PSQI global score, and Epworth Sleepiness Scale (ESS). Secondary outcome measures were physical performance (single leg stand, timed chair rise, 50-foot speed walk) and 12-item short form (SF-12) physical and mental summary scores. RESULTS: Tai chi participants reported significant improvements in five of the PSQI subscale scores (sleep quality, sleep-onset latency, sleep duration, sleep efficiency, sleep disturbances) (P<.01), PSQI global score (P=.001), and ESS scores (P=.002) in comparison with the low-impact exercise participants. Tai chi participants reported sleep-onset latency of about 18 minutes less per night (95% confidence interval (CI)=-28.64 to -7.12) and sleep duration of about 48 minutes more per night (95% CI=14.71-82.41) than low-impact exercise participants. Tai chi participants also showed better scores in secondary outcome measures than low-impact exercise participants. Both groups reported improvements in SF-12 mental summary scores. CONCLUSION: Older adults with moderate sleep complaints can improve self-rated sleep quality through a 6-month, low- to moderate-intensity tai chi program. Tai chi appears to be effective as a nonpharmacological approach to sleep enhancement for sleep-disturbed elderly individuals.

Aged↗

PubMed2006

[Clinical efficacy and safety of akatinol memantine in treatment of mild to moderate Alzheimer disease: a donepezil-controlled, randomized trial].

OBJECTIVE: To evaluate the clinical efficacy and safety of akatinol memantine in the treatment of patients with mild to moderate Alzheimer disease (AD). METHODS: One hundred patients with diagnosis of possible or probable AD and Mini Mental State Examination total scores between 10 and 26 from 6 centers in two cities of China were randomly divided into two groups: akatinol memantine group (n = 50, given akatinol memantine 5 mg/d in first week, 10 mg/d in second week, 15 mg/d in third week and 20 mg/d from fourth to sixteenth week); donepezil group (n = 50, donepezil 5 mg/d). Different scales were used to evaluated cognitive function (MMSE), activity of daily life and behavior and mood (Blessed-Roth scale) as well as the severity of dementia (GDS). Safety evaluation was conducted every 4 weeks. RESULTS: In comparison with the baseline data, there were significant improvements in cognition assessed with MMSE on 16th week in akatinol memantine group (P = 0.000) and donepezil group (P = 0.000) respectively; There also were significant improvements in activity of daily life, behavior and mood assessed by Blessed-Roth scale in akatinol memantine group (P = 0.000) and donepezil group (P = 0.000) on 8th week and 16th week. However there was no improvements in the change of the basic habit of life assessed with the Part II of Blessed-Roth scale (P > 0.05), and nor an improvements in the serious level of dementia assessed with GDS (P > 0.05). In comparison with the data in donepezil group, there were no improvement in the change of MMSE score, Blessed-Roth scale score and GDS score in akatinol memantine group on 16th week (P > 0.05). Mild and transient adverse events were observed in 6% of akatinol memantine group. CONCLUSION: As a safe and effective medicine, akatinol memantine, which has a similar effect as donepezil for AD, can remarkably improve the cognition, behavior, and mood of AD patients.

Aged↗

PubMed2004

An ontology of randomized controlled trials for evidence-based practice: content specification and evaluation using the competency decomposition method.

Randomized controlled trials (RCTs) are one of the least biased sources of clinical research evidence, and are therefore a critical resource for the practice of evidence-based medicine. With over 10,000 new RCTs indexed in Medline each year, knowledge systems are needed to help clinicians translate evidence into practice. Common ontologies for RCTs and other domains would facilitate the development of these knowledge systems. However, no standard method exists for developing domain ontologies. In this paper, we describe a new systematic approach to specifying and evaluating the conceptual content of ontologies. In this method, called competency decomposition, the target task for an ontology is hierarchically decomposed into subtasks and methods, and the ontology content is specified by identifying the domain information required to complete each of the subtasks. We illustrate the use of this competency decomposition approach for the content specification and evaluation of an RCT ontology for evidence-based practice.

Database Management Systems↗

PubMed2001

Randomized controlled trial of intrasphincteric botulinum toxin A injection versus balloon dilatation in treatment of achalasia cardia.

As the few randomized controlled trials available in the literature comparing botulinum toxin (BT) injection with established endoscopic treatment of achalasia cardia, i.e. pneumatic dilatation, showed conflicting results, we conducted a prospective randomized trial. Seventeen consecutive patients with achalasia cardia diagnosed during a period between December 1997 and February 2000 were randomized into two treatment groups [pneumatic dilatation by Rigiflex dilator (n=10), BT injection by sclerotherapy needle into four quadrants of lower esophageal sphincter (LES) (n=7) 80 units in five cases, 60 units in two cases] after dysphagia grading, endoscopy, barium esophagogram, and manometry, all of which were repeated 1 week after treatment. Patients were followed up clinically for 35.2+/-14 weeks. Chi-squares, Wilcoxon rank-sum test, Kaplan-Meier method and log-rank tests were used for statistical analysis. After 1 week, 6/7 (86%) BT-treated vs. 8/10 (80%) dilatation-treated patients improved (P=NS). There was no difference in LES pressure and maximum esophageal diameter in the barium esophagogram in the two groups before therapy. Both therapies resulted in significant reduction in LES pressure. The cumulative dysphagia-free state using the Kaplan-Meier method decreased progressively in BT-treated compared with dilatation-treated patients (P=0.027). Two patients with tortuous megaesophagus, one of whom had failed dilatation complicated by perforation previously, improved after BT. One other patient in whom pneumatic dilatation had previously failed improved in a similar manner. BT is as good as pneumatic dilatation in achieving an initial improvement in dysphagia of achalasia cardia. It is also effective in patients with tortuous megaesophagus and previous failed pneumatic dilatation. However, dysphagia often recurs during 1-year follow up.

Adult↗

PubMed2026

Nurse-led attribution remodeling training based on the Neuman systems model to enhance resilience, adaptive coping, and attributional style in women newly diagnosed with breast cancer: A randomized controlled trial.

BACKGROUND: Psychological interventions for patients with breast cancer often overlook the critical role of maladaptive attributional style in shaping their adjustment. Therefore, the need for theory-driven, scalable interventions that target cognitive restructuring, particularly during the vulnerable post-diagnosis period, is clear. OBJECTIVE: To evaluate the effectiveness of a nurse-led attribution remodeling training intervention grounded in the Neuman systems model for improving resilience, adaptive coping, and attributional style among women newly diagnosed with breast cancer. DESIGN: A randomized controlled trial. SETTING: A tertiary general hospital. PARTICIPANTS: A total of 130 eligible women newly diagnosed with breast cancer were recruited between March and November 2024. METHODS: A two-arm parallel-group randomized controlled trial was conducted. Participants were randomly assigned to receive either attribution remodeling training plus routine nursing (n = 65) or routine nursing only (n = 65). The nurse-led attribution remodeling training intervention, delivered via a blended model of in-person sessions and continued support through the WeChat mobile platform, was designed to systematically reshape maladaptive attributions into more adaptive ones. Resilience (primary indicator), coping strategy (i.e., confrontation, avoidance, resignation), and attributional style (secondary indicators) were assessed at baseline and at 1, 3, and 6 months post-baseline. A linear mixed model was used to analyze the effects of group, time, and group-by-time interactions. Effect sizes (Cohen's D) were calculated based on the means and standard deviations. RESULTS: At the 6-month follow-up, the intervention group had better outcomes than the control group in terms of resilience (mean difference: 1.49, 95% confidence interval: 0.37, 2.61), confrontation coping (3.35 [2.33, 4.37]), and adaptive attributional style (4.16 [3.87, 4.45]). Avoidance coping showed a small increase (0.82 [0.22, 1.42]), whereas resignation coping decreased (-1.66 [-2.49, -0.83]). Group effects and group-by-time interactions were statistically significant for all outcomes. Effect sizes at 6 months ranged from small for resilience (D = 0.28) and avoidance coping (D = 0.26) to moderate for confrontation coping (D = 0.60) and resignation coping reduction (D = -0.51), and large for attributional style (D = 0.94). CONCLUSIONS: Attribution remodeling training is a promising and effective theory-based intervention that can enhance psychological adaptation in women newly diagnosed with breast cancer. By strengthening key defense mechanisms, as conceptualized by the Neuman systems model, the program is effective, scalable, and nurse-deliverable for psycho-oncology care, bridging a critical gap in supportive cancer care and empowering nurses as primary psychological support providers. REGISTRATION: ChiCTR2000031827, registered prospectively on April 11, 2020, www.Chictr.or.cn.

Humans↗

PubMed2026

Effectiveness of a blended care intervention in physiotherapy with exercise and education for patients with hip or knee osteoarthritis (SmArt-E): A multicentre pragmatic randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness of a twelve-month smartphone-assisted physiotherapy (SmArt-E) intervention versus usual care in hip and/or knee osteoarthritis (OA), and to assess usability and patient satisfaction with the digital support. METHOD: We conducted a multicentre, pragmatic, parallel-group randomized controlled trial in 27 physiotherapy practices in Germany. Patients with physician-diagnosed hip and/or knee OA aged ≥50 (hip) or ≥38 years (knee) were randomly allocated to SmArt-E (IG; n=166) or usual care (CG; n=164). The twelve-month intervention combined supervised and smartphone-assisted training and education (blended care). Primary outcomes were pain (NRS, 0-10) and physical function (HOOS/KOOS-ADL, 0-100) at twelve months. Secondary outcomes followed OARSI domains; usability and patient satisfaction were also assessed. RESULTS: Among 330 participants (mean age 64±8 years), baseline NRS was 3.2±2.3 in the CG and 3.5±2.4 in the IG; HOOS/KOOS-ADL was 71.6±17.7 and 69.4±17.5, respectively. No significant between-group differences were found for pain (-0.36; 95% CI: -0.84 to 0.12; p=0.14) or physical function (2.66; 95% CI: -0.46 to 5.77; p=0.09). Among 13 secondary outcomes, significant differences favouring the IG emerged at three and twelve months for several domains; however, effect sizes were small and unlikely to be clinically meaningful. CONCLUSION: SmArt-E did not demonstrate superior effectiveness over usual care in mild hip and/or knee OA. Both groups improved over time, with slightly more favourable but clinically inconclusive outcomes in the IG. Findings highlight the need to refine the intervention, better identify eligible patients, and optimize digital and in-person components.

Humans↗

PubMed2001

Vaginal application of the nitric oxide donor isosorbide mononitrate for preinduction cervical ripening: a randomized controlled trial to determine effects on maternal and fetal hemodynamics.

OBJECTIVE: Our aim was to assess the effects of vaginally administered isosorbide mononitrate (a nitric oxide donor) on maternal and fetal hemodynamics in pregnant women at term. STUDY DESIGN: We conducted a randomized controlled trial. Women were randomly selected to receive vaginally administered isosorbide mononitrate, 20 mg (n = 13) or 40 mg (n = 11), or to undergo a vaginal examination only (n = 12). Maternal pulse, blood pressure, and fetal heart rate were recorded at baseline and then every 30 minutes until 360 minutes. Umbilical artery resistance index and pulsatility index measurements were performed at 0, 180, and 330 minutes. RESULTS: Maternal pulse rate was greater after the administration of isosorbide mononitrate, 20 or 40 mg, compared with the pulse rate in the vaginal examination-only group (greatest difference in means, 21 beats/min; P <.01). Maternal systolic and diastolic blood pressures were greater in the 20-mg and 40-mg isosorbide mononitrate groups than in the vaginal examination-only group (greatest difference in mean systolic and diastolic blood pressure, 15 and 16 mm Hg, respectively; P <.02 and P <.001, respectively). Fetal heart rate was greater in the 40-mg isosorbide mononitrate group than in either the 20-mg isosorbide mononitrate group or the vaginal examination-only group (difference in mean, 15 beats/min; P <.05). No woman required treatment for maternal or fetal tachycardia or maternal hypotension. Neither dose of isosorbide mononitrate had a significant effect on umbilical artery resistance or pulsatility index. CONCLUSIONS: Vaginal administration of 20 or 40 mg isosorbide mononitrate to pregnant women at term has an effect on both maternal and fetal hemodynamics, but this effect is not clinically significant.

Adolescent↗

PubMed1991

External cephalic version at term. A randomized controlled trial using tocolysis.

OBJECTIVE: To assess the role of external cephalic version (ECV) at term, using tocolysis. DESIGN: A randomized controlled trial over a 12 month period. SETTING: Harare Maternity Hospital, Harare, Zimbabwe. SUBJECTS: 208 women with breech presentation at term were recruited after satisfying eligibility criteria. There were 103 women in the study group and 105 in the control group. At the end of the study a further 104 women were recruited for ECV. INTERVENTION: ECV attempted after intravenous injection of 10 micrograms of hexaprenaline, using either forward or backward somersault over a maximum period of 5 min. MAIN OUTCOME MEASURES: Success rate in terms of presentation during labour, need for caesarean section, and various variables related to fetal outcome. RESULTS: ECV reduced the frequency of breech presentation during labour from 83% to 17% and that of caesarean section from 33% to 13%. There were no troublesome complications from the procedure. CONCLUSION: In carefully selected women with breech presentation, ECV at term using tocolysis, safely reduced the rate of breech presentation in labour and also the caesarean section rate. Further research is needed to determine the role of ECV in early labour.

Adolescent↗

PubMed2003

Randomized controlled trials in interventional spine: perils and pitfalls.

It is the responsibility of clinician investigators to advance clinical knowledge and specifically its application to patient care. Randomized controlled trials remain near the top of the hierarchy of evidence based medicine. The acquisition of evidence based medicine by means of randomized controlled trials presents general difficulties and additional pitfalls specific to interventional treatments. The nature of interventional procedures makes the performance of these studies more difficult to plan and execute. To generate clinically useful research results requires an understanding of the mechanics of performing studies and the reporting of methodologies to ensure appropriate interpretation. Placebo arms and sham interventions present serious ethical issues, which must be analyzed on a case by case basis. The conscientious researcher must always abide by the principles of ethical research and the tenets of human subject protection.

Journal Article↗

PubMed1993

Treatment of septic shock with a protease inhibitor in a canine model: a prospective, randomized, controlled trial.

OBJECTIVES: To evaluate the efficacy and mechanism of action of a protease inhibitor (ulinastatin) in septic shock. DESIGN: Prospective, randomized, controlled trial. SETTING: A university laboratory. SUBJECTS: Twelve mongrel dogs. INTERVENTIONS: One of the protease inhibitors, ulinastatin, a glycoprotein (molecular weight 67,000 daltons) detected in human urine was estimated. We used Escherichia coli to obtain a model of septic shock in dogs in vivo study. Human neutrophils were used as an activating target in vitro. MEASUREMENTS AND MAIN RESULTS: The final concentration of E. coli was 1.9 x 10(6) colony-forming units/mL. There was no significant difference in E. coli concentration between ulinastatin-treated and control groups. Human neutrophils treated with 100 U/mL of ulinastatin showed 70.5% to 78.7% of the superoxide production or untreated neutrophils. Phagocytic activity was enhanced in a dose-dependently manner by ulinastatin. At a ulinastatin concentration of 100 U/mL, an approximate two-fold increase in activation was found. In the ulinastatin-treated group, cardiac index, blood pressure, lactic acid, blood glucose, and blood base values significantly improved 60 mins after ulinastatin administration, and the bacterial count was significantly decreased, while the endotoxin concentration in the control group showed a continuous increase of endotoxin concentration. The improvement in the monitored factors observed 60 mins after initiation of treatment persisted after the end of treatment. The survival rate after 1 wk in the ulinastatin-treated group was 84% (five of six dogs survived), while it was 16% (one of six dogs survived) in the control group (p = .04). CONCLUSIONS: Ulinastatin does not have antimicrobial activity, and it does not sufficiently activate phagocytes. It is suggested that the efficacy of this agent in experimental septic shock is due to a mechanism that activates the reticuloendothelial system and septic reactions.

Adult↗

PubMedDate not supplied

Prevention of atherosclerosis progression using atorvastatin in normolipidemic coronary artery disease patients--a controlled randomized trial.

BACKGROUND: Statins have been known to reduce progression of atherosclerosis when used in high dosage in patients with elevated cholesterol. A large majority of Indian patients, however, develop coronary artery disease with average or below average cholesterol level. There is insufficient data on effect of low-dose statins on progression of atherosclerosis in such patients with normal/average lipid levels. METHODS AND RESULTS: In this prospective study, 150 patients with angiographically proven coronary artery disease and baseline total cholesterol <200 mg/dl and low-density lipoprotein cholesterol <130 mg/dl were randomized to treatment with low-dose atorvastatin (10 mg) or placebo. Both groups were comparable in demographic characteristics. Progression of atherosclerosis was assessed using carotid intima media thickness as surrogate marker using standard protocol on B-mode ultrasound including common carotid artery, common carotid bifurcation and internal carotid artery measurements. Follow-up study for carotid intima media thickness was done at end of one year. A decrease in mean maximum carotid intima media thickness was recorded for all the three carotid segments individually from basal to end of one year in atorvastatin group [common carotid artery -0.008 mm (p = 0.01), common carotid bifurcation-0.022 mm (p = 0.001), internal carotid artery -0.009 mm (p = 0.01)] while the same showed an increase in placebo group [common carotid artery +0.011 mm (p = NS), common carotid bifurcation +0.013 mm (p=NS), internal carotid artery +0.007 mm (p=NS)]. The average mean carotid intima media thickness (all three segments included) decreased from 0.739 +/- 0.114 mm to 0.726 +/- 0.115 mm (difference -0.013 mm) in statin group and increased from 0.733 +/- 0.124 mm to 0.742 +/- 0.117 mm (difference + 0.009 mm) in placebo group (p < 0.001). Along side, there was a reduction in the total cholesterol from 144 +/- 26 mg/dl to 130 +/- 18 mg/dl (decreased arrow 9.7%, p = 0.05) and in low-density lipoprotein cholesterol from 86 +/- 24 mg/dl to 74 +/- 19 mg (decreased arrow 13.9%, p = 0.05) in study group and an increase in total cholesterol from 148 +/- 32 mg/dl to 154 +/- 8 mg/dl (increased arrow 4.05%, p=NS) and in low-density lipoprotein cholesterol from 84 +/- 19 mg/dl to 87 +/- 16 mg/dl (increased arrow 3.57%, p=NS) in placebo group at end of one year (p=NS). No adverse effects of statins were reported in the treatment arm. CONCLUSIONS: We conclude that low-dose statins reduce progression of atherosclerosis as observed by carotid intima media thickness in Indian patients with known coronary heart disease and normal lipid values independent of lipid lowering. The study favors use of this therapy in patients with normal/below average cholesterol levels.

Anticholesteremic Agents↗

PubMed2006

An absence of pediatric randomized controlled trials in general medical journals, 1985-2004.

OBJECTIVE: There are numerous potential barriers to conducting randomized controlled trials (RCTs) in children. The purpose of this study was to compare the quantity, trends over time, characteristics, and quality of pediatric RCTs published in general medical journals (GMJs) with adult RCTs. STUDY DESIGN AND SETTING: We conducted an electronic search of adult and pediatric RCTs from 1985-2004 and a manual search of published RCTs in the year 2000 in five high-impact GMJs (New England Journal of Medicine, Journal of the American Medical Association [JAMA], the Lancet, British Medical Journal [BMJ], Canadian Medical Association Journal [CMAJ]). Linear trends were identified and the 1-year sample was analyzed for publication characteristics (location of recruitment, sample size, number of centers, funding sources, and results) and quality scoring (Jadad score, intention-to-treat analysis, and citation frequency since publication). RESULTS: Adult RCTs increased by 4.71 RCTs/year (95% confidence interval (CI) 3.62-5.80; P<0.001), which was significantly higher (P<0.0001) than pediatric RCTs, which increased by 0.4 RCTs/year (95% CI -0.02 to 0.9; P=0.06). Adult RCTs were more likely to be hospital-based (P=.001) and to involve more centers in multicenter studies (P=0.02). Quality scores were similar, although adult RCTs were cited more frequently (P=0.003). CONCLUSION: There may be significant barriers to the publication of high-quality pediatric RCTs in GMJs.

Child↗

PubMed2001

Re-evaluation of a randomized controlled trial of antibiotics for minor respiratory illness in general practice.

BACKGROUND: A systematic review examining the efficacy of antibiotics in acute respiratory illness concluded that antibiotics are of little benefit. However, that review was based on analysis of only six randomized controlled trials, one of which was excluded because its analysis included patients with multiple episodes of illness; treatment group, either antibiotic or placebo, might have confounded the likelihood of suffering a subsequent episode of illness. METHODS: This previously excluded randomized controlled trial of 301 patients with symptoms of minor respiratory illness was re-analysed to examine the efficacy of antibiotic versus placebo in terms of resolution of symptoms, most particularly cough. RESULTS: Antibiotic had no impact on the resolution of symptoms of cough at 1 and 2 weeks, respectively; adjusted odds ratio 1.2 [95% confidence interval (CI) 0.7--2.1] and 0.8 (95% CI 0.4--1.6). In those 220 (73%) individuals who suffered a cough, 48 (44%) and 19 (17%) of patients taking placebo were still coughing after 1 and 2 weeks, respectively. CONCLUSION: It appears that an antibiotic is likely to have, at best, a marginal impact on resolution of symptoms for most patients with minor respiratory illness in the community.

Adult↗

PubMed1999

Mailed reminders for area-wide influenza immunization: a randomized controlled trial.

OBJECTIVE: To determine if mailed reminders would increase area-wide influenza immunization for persons aged 65 and older. DESIGN: A randomized, controlled trial. SETTING: Ten counties in Indiana. PARTICIPANTS: Using a Medicare database, 10,000 subjects were selected randomly from 10 counties in Indiana and randomized for the study. Using pre-established criteria, 4503 persons in the control group and 4508 in the intervention group were eligible for study. INTERVENTION: Intervention subjects received mailed reminders during the immunization season of 1995. MEASUREMENTS: Data from mailed surveys, Medicare claims, and phone calls were used to determine immunization rates. RESULTS: Of those surveyed who received immunization, only 63.4% filed a Medicare claim. Immunization rates were high in both groups but higher in the intervention group, 69.0% versus 64.2%. Age, presence of lung disease, assignment to the intervention group, presence of heart disease, and an age-sex interaction term were significantly and independently related to immunization. CONCLUSIONS: The Healthy People Year 2000 goal (60% immunization for persons 65 and older) was exceeded in this population. Medicare claims data do not reflect immunization rates accurately. Mailed reminders, an inexpensive intervention, increased immunization rates area-wide and have potential for cost savings.

Age Factors↗

PubMed1990

Efficacy and safety of quinidine therapy for maintenance of sinus rhythm after cardioversion. A meta-analysis of randomized control trials.

Because individual studies evaluating the role of quinidine in the maintenance of sinus rhythm after cardioversion from chronic atrial fibrillation have involved relatively few patients, a meta-analysis of randomized control trials was performed. Six trials published between 1970 and 1984 were selected by two blinded reviewers based on study design and statistical analysis. Data from these six trials involving 808 patients were pooled after testing for homogeneity of treatment effects across trials. Life table estimates of the percent of patients still in sinus rhythm at 3, 6, and 12 months after cardioversion were constructed for quinidine and control groups. The proportion of patients remaining in sinus rhythm in the quinidine group was 69%, 58%, and 50% at 3, 6, and 12 months postcardioversion respectively. The proportion of patients remaining in sinus rhythm in the control group was 45%, 33%, and 25% at the same time intervals. The pooled rate difference, or difference in proportion of patients in sinus rhythm between quinidine and control groups, was 24%, 23%, and 24% at 3, 6, and 12 months of follow-up (p less than 0.001 at all time intervals). The unadjusted total mortality rate in the quinidine-treated patients was 2.9% and in the control group was 0.8%. The odds of dying in the quinidine-treated group were approximately three times that of the control group ("typical" odds ratio = 2.98, p less than 0.05). Thus, quinidine treatment is more effective than no antiarrhythmic therapy in suppressing recurrences of atrial fibrillation but appears to be associated with increased total mortality.

Adolescent↗

PubMed1989

Encouraging primary care physicians to help smokers quit. A randomized, controlled trial.

STUDY OBJECTIVE: To increase the effect that primary care physicians have on their patients who smoke. DESIGN: Randomized, controlled trial with 112 general internists and their patients who smoke. PATIENTS: Sample of 1420 patients from a general medicine clinic of a city-county teaching hospital, who smoke at least one cigarette a day and were recruited regardless of their interest in quitting smoking. INTERVENTIONS: Physicians were randomly assigned to one of four groups: participants who received a protocol for smoking management and a lecture on the consequences and management of smoking (control); in addition, had nicotine gum freely available to patients (gum); had stickers attached to their smokers' charts (reminder); or had both gum and reminders (both). MEASUREMENTS AND MAIN RESULTS: The percentage of patients with a return visit at 6 months who quit smoking (alveolar carbon monoxide of less than nine parts per million) was 1.3% (control), 7.7% (gum), 7.0% (reminders), and 6.3% (both). At 1 year the percentages were 2.7%, 8.8%, 15.0%, and 9.6%, respectively. Subsequent pairwise comparisons showed that the three intervention groups were not significantly different, but that each was significantly different from the control group (P less than 0.05). Physicians in all three intervention groups spent significantly more time than did the physicians in the control group counseling their patients about smoking. CONCLUSIONS: The availability of nicotine gum or labeling the charts of smokers can help primary care physicians increase their success rates two- to six-fold in helping patients quit smoking. If all primary care physicians used these procedures, they could help an additional 2 million smokers quit.

Adult↗

PubMed2001

Antibiotics for the prevention of urinary tract infection in children: A systematic review of randomized controlled trials.

OBJECTIVE: The objective was to evaluate the effectiveness of low-dose, long-term antibiotics for the prevention of symptomatic urinary tract infection (UTI) in children. DESIGN: This was a systematic review of randomized controlled trials with a random effects model meta-analysis. PARTICIPANTS: Five trials involving 463 children were performed. RESULTS: Three trials (n = 392) evaluated the effectiveness of long treatment courses of antibiotics (2 to 6 months) for children with acute UTI to prevent subsequent, off-treatment infection. Only 2 trials (n = 71) evaluated the effectiveness of long-term, low-dose antibiotics to prevent on-treatment UTI. Very few of the children enrolled in the trials were boys, had abnormal renal tracts, or were infants. The trial quality was poor, with a lack of blinding, and unstated UTI definitions were almost universal. Long-term antibiotic administration reduced the risk of UTI with treatment (relative risk 0.31, 95% confidence limits 0.10 to 1.00), but there was significant heterogeneity (Q = 13.45, P <.01), and there was no sustained benefit once antibiotics had ceased (relative risk 0.79, 0.61 to 1.02). CONCLUSIONS: Methodologic and applicability problems with published trials mean that there is considerable uncertainty about whether long-term, low-dose antibiotic administration prevents UTI in children. Well-designed, randomized, placebo-controlled trials are still required to evaluate this commonly used intervention.

Anti-Bacterial Agents↗

PubMed2006

Aerobic exercise and HDL2-C: a meta-analysis of randomized controlled trials.

PURPOSE: Use the meta-analytic approach to examine the effects of aerobic exercise on high-density lipoprotein two cholesterol (HDL2-C) in adults. STUDY SOURCES: (1) Computerized literature searches; (2) cross-referencing from retrieved articles; (3) hand-searching; and (4) expert review of our reference list. STUDY SELECTION: (1) Randomized controlled trials; (2) aerobic exercise > or = 8 weeks; (3) adults > or = 18 years of age; (4) studies published in journal, dissertation, or master's thesis format; (5) studies published in the English-language between January 1, 1955 and January 1, 2003; and (6) assessment of HDL2-C in the fasting state. DATA ABSTRACTION: All coding conducted by both authors, independent of each other. Discrepancies were resolved by consensus. RESULTS: Nineteen randomized controlled trials representing 20 HDL2-C outcomes from 984 males and females (516 exercise, 468 control) were pooled for analysis. Using random-effects modeling and bootstrap confidence intervals (BCI), a statistically significant increase of approximately 11% was observed for HDL2-C (X +/- S.E.M., 2.6 +/- 0.9 mg/dl, 95% BCI, 1.0-4.4 mg/dl). With each study deleted from the model once, results remained statistically significant. Increases in HDL2-C were independent of decreases in body weight, body mass index (kg/m2), and percent body fat. CONCLUSION: Aerobic exercise increases HDL2-C in adults.

Adult↗