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PubMed1994

Intrapartum chemoprophylaxis of perinatal group B streptococcal infections: a critical review of randomized controlled trials.

The purpose of this overview was to critically appraise all published randomized, controlled trials evaluating the efficacy of intrapartum chemoprophylaxis in reducing perinatal group B streptococcal infections. The Oxford Database of Perinatal Trials, Medline, Excerpta Medica, and personal files were used for the literature search. By means of present inclusion criteria to select relevant articles, two independent researchers identified nine randomized, controlled trials. Three trials were excluded because of duplicate publication, one because the randomization process was violated, and one because the outcome data were collected retrospectively. The quality of the methods of the four accepted trials was poor, and because of basic flaws meta-analyses of trial results were not performed. Results of three studies showed a statistically significant reduction in neonatal group B streptococcal colonization rates with intrapartum chemoprophylaxis. Although a trend toward a reduction in proved neonatal infection was reported in three studies, each lacked the power to reach statistical significance. Intrapartum chemoprophylaxis to reduce perinatal group B streptococcal infections is not supported by conclusive evidence from well designed and conducted randomized, controlled trials.

Bacteremia↗
PubMed1990

Primary prevention of Pneumocystis carinii pneumonia by inhalation of pentamidine. Preliminary results from a placebo-controlled randomized trial. Swiss Group for Clinical Studies on AIDS.

Patients with AIDS but without pneumocystis carinii pneumonia, patients with advanced AIDS-related complex (ARC), and asymptomatic patients with less than 200 CD4-positive lymphocytes/mm3 were randomized to one of two groups: group I: Inhalation of 300 mg of pentamidine every 28 days; group II: Inhalation of placebo (300 mg of Na isethionate) every 28 days. From May to November 28, 1989, 160 patients have entered the trial. Inhalations were well tolerated, with only a 6% use of bronchodilators and a 15% incidence of cough. Until now five patients died, none of them drug related. So far, six patients have developed pneumocystis carinii pneumonia; four of these were on pentamidine, and two on placebo. Five of the six cases occurred before the second inhalation. Recruitment will continue until 250 patients are enrolled.

Administration, Inhalation↗
PubMed2002

Improving cardiovascular fitness by strength or endurance training in women aged 76-78 years. A population-based, randomized controlled trial.

BACKGROUND: there have been few population-based, randomized controlled trials on the effects of strength or endurance training on cardiovascular fitness in older women. OBJECTIVE: to study the effects of strength or endurance training on cardiovascular fitness in women aged 76-78 years. DESIGN: a population-based, randomized controlled trial. SETTING: exercise laboratory in a university faculty of sport and health sciences. SUBJECTS: we randomly assigned 42 medically-screened women aged 76-78 years, drawn from the population register to strength (n=16), endurance (n=15) or control (n=11) groups. METHODS: subjects in the two exercise groups performed a supervised, individually tailored 18-week strength or endurance training programme. Controls continued with physical activity at their normal level. RESULTS: the strength training group showed an increase in cycle ergometer peak power from 68.1 to 70.3 W (P=0.035 compared with controls). Their peak power per kg body weight increased from 1.02 to 1.05, while that of the endurance training group increased from 0.91 to 0.93 (P=0.027 and P=0.049 respectively). Peak oxygen uptake increased from 18.1 to 19.7 ml x kg(-1) x min(-1) in the strength and from 17.1 to 18.2 in the endurance group (non-significant). Six subjects (19%) in the exercise groups withdrew from the study because of health problems. CONCLUSIONS: even with its limitations, the study suggests that the effect of 18-week strength or endurance training on cardiovascular fitness among women aged >/=75 is relatively small. Furthermore, health problems can emerge during training programmes in medically-screened elderly women.

Aged↗
PubMed1998

Natural beta interferon in acute type-C hepatitis patients: a randomized controlled trial.

AIM OF THE STUDY: A multicentre randomized controlled trial to assess whether a short course of beta-interferon could reduce the rate of chronic evolution of acute hepatitis C, in line with recent observations, was started in Northern Italy in 1991. METHODS: Forty acute hepatitis C patients were randomized to receive natural beta interferon 3,000,000 international units intramuscularly three times a week for 4 weeks or symptomatic drugs, and were followed up for a median period of 22.5 months. RESULTS: The chronicity rate was 75% (15/20 patients) in the interferon-treated group, and 80% (16/20) in the untreated group. No difference in the duration of the acute phase of hepatitis was observed. Hepatitis C virus ribonucleic acid was determined in 21 cases and was positive in 19 cases at baseline and in 15/17 chronic and 1/4 non chronic cases at the end of follow-up. Side effects of therapy (flu-like syndrome in 40% of cases) were mild and short-lasting. No aminotransferase flare-ups were observed during treatment. CONCLUSIONS: Beta interferon at the suggested regimen is well tolerated but does not seem to significantly influence the natural course of acute hepatitis C.

Acute Disease↗
PubMed1995

The type and quality of randomized controlled trials (RCTs) published in UK public health journals.

BACKGROUND: Randomized controlled trials (RCTs) are increasingly being used to evaluate the effectiveness of health care interventions. Systematic reviews of RCTs form the basis of the Cochrane Collaboration, which aims to synthesize all RCTs concerned with the provision of health care. This paper reports the quantity and methodological quality of RCTs published in five UK public health journals, which were searched as part of a planned register of RCTs in public health. METHODS: Five journals were hand searched: The International Journal of Epidemiology, Health Trends, Journal of Public Health Medicine, Public Health and The Journal of Epidemiology and Community Health. All RCTs were identified and their methodological characteristics reviewed. RESULTS: Ninety-one trials were identified from the five journals. A wide variety of topics were covered, the most common being prevention strategies )46 percent of the trials). Although the actual number of reports of RCTs published increased over time, there was no detectable improvement in the quality of reports. The aspect of bias most well controlled was control of bias at entry (randomization), in 83 (91 per cent) of trials. However, even in these trials details about the process of randomization were poor. CONCLUSION: These trials will form the basis of a register of RCTs in public health. The diversity of topics covered illustrates the broad-based nature of public health. For this reason, many other RCTs relevant to the practice of public health are likely to be found in non-public health journals.

Humans↗
PubMed2000

Enhanced growth of preterm infants fed a new powdered human milk fortifier: A randomized, controlled trial.

OBJECTIVE: A prospective, double-blind, randomized, controlled trial was conducted to evaluate the growth and nutritional status of preterm infants receiving preterm human milk supplemented with a newly formulated powdered human milk fortifier (HMF), study fortifier (SF), or a powdered commercial HMF (CF). METHODS: Infants (n = 144) with a birth weight </=1600 g and gestational age at birth of </=33 weeks were enrolled and randomized before 21 days of life. Study day (SDAY) 1 was defined as the day full-strength fortification (4 packets/100 mL) began and the infant reached an intake of at least 100 mL/kg/day. Growth, biochemical indices of nutritional status, enteral intake, feeding tolerance, clinical histories, and morbidity were assessed serially. The primary outcome variable was weight gain (g/kg/day) from SDAYs 1 to 29 or hospital discharge, whichever came first. RESULTS: Infants fed human milk supplemented with SF consistently grew more rapidly from SDAYs 1 to 29 (or hospital discharge), regardless of whether the statistical analyses were performed on all subjects who were randomized into the study and reached SDAY 1 (intent-to-treat) or were limited to those able to adhere strictly to the feeding protocol of the study (subgroup). Using mean values adjusted for study site (least square [LS] means), the weight gain differences were 2.6 and 3.8 g/kg/day for the intent-to-treat and subgroup analyses, respectively. Likewise, the length-gain differences were.14 and.18 cm/week for the intent-to-treat and subgroup analyses, respectively. Infants in the SF group reached a weight of 1800 g at SDAY 18, and those in the CF group at SDAY 25. Mean alkaline phosphatase values among infants in the SF group were higher than for the CF infants (eg, LS means: 327 U/L vs 272 U/L, intent-to-treat analysis), likely reflecting the more rapid linear growth of the SF infants. Mean serum calcium values tended to be lower in the SF group in the intent-to-treat analysis and were significantly lower in the subgroup analysis (LS means: 10.3 mg/dL vs 11.2 mg/dL). Both fortifiers were generally well-tolerated, although an increased number of infants in the CF group exited the feeding protocol because of gastric residuals and abdominal distention. CONCLUSION: A new powdered HMF was shown to enhance the growth of preterm infants, compared with a commercially available powdered HMF in the United States.

Anthropometry↗
PubMed2001

Clarithromycin versus azithromycin in the treatment of Mediterranean spotted fever in children: a randomized controlled trial.

We conducted an open-label randomized controlled trial to compare the efficacy and safety of clarithromycin (15/mg/kg/day in 2 divided doses for 7 days) with those of azithromycin (10 mg/kg/day in 1 dose for 3 days) in the treatment of children with Mediterranean spotted fever. Until now, there has not been a gold-standard therapy for this rickettsial disease in children. Eighty-seven children were randomized to receive 1 of the 2 drugs. The mean time to defervescence (+/- standard deviation) was 46.2+/-36.4 h in the clarithromycin group and 39.3+/-31.3 h in the azithromycin group. These differences were not statistically significant and both drugs were equally well-tolerated. Clarithromycin and azithromycin could be acceptable therapeutic alternatives to chloramphenicol and tetracyclines for children aged < or =8 years with Mediterranean spotted fever. Azithromycin, because it has a long half-life, offers the advantages of administration in a single daily dose and a shorter duration of therapy, which could increase compliance in children.

Adolescent↗
PubMed1998

Palatoplasty for snoring: a randomized controlled trial of three surgical methods.

In a randomized, controlled trial, 62 patients (47 men and 15 women) with severe antisocial snoring, but no sleep apnea, were allocated to one of three surgical treatments. These were uvulopalatopharyngoplasty, laser palatoplasty, and diathermy palatoplasty. Postoperative morbidity was measured on a visual analogue scale of severity of pain, dysphagia, and nasal regurgitation at 1, 2, and 7 days after the operation. Efficacy of each procedure was measured by asking the sleeping partner to record the severity of snoring before and after the operation, again on a visual analogue scale. Measurements were taken at 1, 3, and 6 months. There were no significant differences in early postoperative morbidity among the treatment groups. Diathermy palatoplasty is a new technique for the relief of snoring that is associated with low morbidity and requires little in the way of expensive equipment.

Adult↗
PubMed2005

Early versus delayed cholecystectomy for acute cholecystitis: a meta-analysis of randomized controlled trials.

PURPOSE: We performed a meta-analysis of randomized controlled trials to determine the optimal timing of laparoscopic cholecystectomy and open cholecystectomy for acute cholecystitis. METHODS: We retrieved randomized controlled trials (RCTs) that compared early with delayed cholecystectomy for acute cholecystitis by systematically searching Medline and the Cochrane Library for studies published between 1966 and 2003. The outcomes of primary interest were mortality and morbidity. RESULTS: The ten trials we analyzed comprised 1 014 subjects; 534 were assigned to the early group and 480 assigned to the delayed group. The combined risk difference of mortality appeared to favor open cholecystectomy in the early period (risk difference, -0.02; 95% confidence interval, -0.44 to -0.00), but no differences were found among laparoscopic procedures or among all procedures. The combined risk difference of morbidity showed no differences between the open and laparoscopic procedures. The combined risk difference of the rate of conversion to open surgery showed no differences in the included laparoscopic studies; however, the combined total hospital stay was significantly shorter in the early group than in the delayed group. CONCLUSIONS: There is no advantage to delaying cholecystectomy for acute cholecystitis on the basis of outcomes in mortality, morbidity, rate of conversion to open surgery, and mean hospital stay. Thus, early cholecystectomy should be performed for patients with acute cholecystitis.

Cholecystectomy↗
PubMed1985

Intracoronary thrombolytic therapy in acute myocardial infarction: a prospective, randomized, controlled trial.

A prospective, randomized trial was designed to assess the efficacy of intracoronary thrombolytic therapy with streptokinase (STK) in acute myocardial infarction. Sixty-four patients with acute myocardial infarction were randomized within 6 hours of onset of symptoms to 1 of 3 groups. Sixteen patients were treated by conventional means (control group). Nineteen patients underwent coronary arteriography and received corticosteroids and intracoronary and intravenous nitroglycerin (NTG group). Twenty-nine patients received management identical to that of the NTG group, with the addition of intracoronary STK therapy (STK group). Recanalization was demonstrated in 21 of 29 patients (72%) in the STK group. Global and regional ejection fraction (EF) was determined by radionuclide ventriculography before any intervention and 7 to 10 days later. No significant improvement in global EF was achieved in the control and NTG groups. In STK patients as a group, global EF did not increase significantly; however, in patients recanalized with STK, EF improved from 42 +/- 17% to 49 +/- 16% (p = 0.023). All groups showed wide variability of response. Improvement in global EF of more than 5% was noted in 44% of patients recanalized with STK. When subgrouped on the basis of initial global EF of 45% or less or more than 45%, only patients recanalized with STK with an initial EF of 45% or less had an improved global EF (from 30 +/- 10% to 42 +/- 10%, p = 0.015).(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1999

Treating neurocysticercosis medically: a systematic review of randomized, controlled trials.

OBJECTIVE: To summarize the evidence from randomized controlled trials on the effects of cysticidal therapy used for treating human cysticercosis. METHODS: Published and unpublished studies in any language identified through MEDLINE (1966 - June 1999) specialized databases, abstracts, proceedings and contact with experts were analysed. Those which compared, using randomized or quasi-randomized methods, any cysticidal drug with placebo or symptomatic therapy were entered in the study. Data were extracted independently by two reviewers and trial quality assessed. Meta-analysis using fixed effects models calculated provided there was no significant heterogeneity, expressed as relative risk. RESULTS: Four trials met the inclusion criteria, treating intraparenchymatous neurocysticercosis with either albendazole or praziquantel compared to placebo or no treatment. In the two trials reporting clinical outcomes, treatment was not associated with a reduction in the risk of seizures, although numbers were small (RR 0.95, 95% CI 0.59-1.51). Four trials reported radiological outcomes, and cysticidal treatment was associated with a lower risk of cyst persistence of scans taken within six months of start of treatment (RR 0.83, 95% CI 0.70-0.99). Subsidiary analysis assuming different outcomes in patients lost to follow-up did not alter the findings of the main analysis. CONCLUSIONS: There is insufficient evidence to determine whether cysticidal therapy is of any clinical benefit to patients with neurocysticercosis. The review does not exclude the possibility that more patients remain seizure-free when treated with cysticidal drugs. Further testing through placebo-controlled trials is required.

Albendazole↗
PubMed2002

Patient-controlled sedation versus intravenous sedation for colonoscopy in elderly patients: a prospective randomized controlled trial.

BACKGROUND: A prospective randomized trial was conducted to compare the safety, effectiveness, and patient acceptance of patient-controlled sedation and intravenous sedation for colonoscopy in a group of elderly patients undergoing outpatient colonoscopy. METHODS: One hundred patients over 65 years of age were recruited and randomized to patient-controlled sedation (n = 50) or intravenous sedation (n = 50) groups by means of computer-generated numbers. In the patient-controlled sedation group, a mixture of propofol and alfentanil was delivered by means of a patient-controlled pump; each bolus delivered 4.8 mg propofol and 12 microg alfentanil. No loading dose was used and the lockout time was set at zero. In the intravenous sedation group, fixed doses of diazemuls (0.1 mg/kg) and meperidine (0.5 mg/kg) were given with further increases in dosages administered at the discretion of the endoscopist. Outcome measures assessed included cardiopulmonary complications, recovery time, pain score, and satisfaction score. RESULTS: The mean (SD) age of patients in the patient-controlled sedation and intravenous sedation groups were, respectively, 72.4 years (5.3) and 73.5 years (6.1). The mean dose of propofol consumed in the patient-controlled sedation group was 0.79 (0.46) mg/kg. The mean doses of diazemuls and meperidine consumed in intravenous sedation group were, respectively, 5.8 (1.3) mg and 30.1 (6.8) mg. Hypotension occurred in 2 (4%) patients in the patient-controlled sedation group and 14 (28%) in the intravenous sedation group (p < 0.01). Oxygen desaturation was recorded for 4 patients (8%) in the intravenous sedation group. The median (interquartile range [IQR]) recovery time was significantly shorter in the patient-controlled sedation group compared with the intravenous sedation group (respectively, 0 minutes [IQR 0-5] vs. 5 minutes [IQR 5-10]; p < 0.01). There were no statistically significant differences between groups for pain and satisfaction scores. CONCLUSIONS: Patient-controlled sedation appears to be safer than intravenous sedation, with comparable effectiveness and acceptance, in elderly patients undergoing elective outpatient colonoscopy.

Aged↗
PubMed1998

Aims, design and enrollment rate of the Cardiac Rehabilitation in Advanced Age (CR-AGE) randomized, controlled trial.

Data regarding the efficacy of cardiac rehabilitation after acute myocardial infarction in advanced age are limited, and are derived from either controlled but non randomized trials, or observational studies. Several aspects of cardiac rehabilitation after myocardial infarction in advanced age, including its effectiveness on exercise tolerance and health-related quality of life, as well as the feasibility of rehabilitation programs, need clarification. The objectives of this randomized, controlled trial, Cardiac Rehabilitation in Advanced Age (CR-AGE), are to examine the effects of an 8-week comprehensive cardiac rehabilitation intervention, comparing 1) supervised outpatient, hospital-based cardiac rehabilitation, 2) home-based cardiac rehabilitation, and 3) usual care in each of three groups of post-myocardial infarction patients, 45-65, 66-75, and 76-85 years of age. The primary objective of the trial is to evaluate the change in physical fitness in each age group assessed by total work capacity at the end of the intervention, and during follow-up over both the medium- (6 months) and the long-term (1 and 2 years). Secondary objectives of the trial include an examination of the feasibility of cardiac rehabilitation in older patients, as well as the determination of the following: exercise complication rates; changes in peak oxygen consumption; changes in other outcome measures, such as health-related quality of life, prevalence of anxiety and depressive symptoms, fluid intelligence, body composition and mass index; incidence of new cardiac and non-cardiac events; and utilization rates of health care services. Enrollment in the CR-AGE trial is expected to be completed within the first half of 1998.

Aged↗
PubMed2005

Telescopic-assisted radiofrequency adenoidectomy: a prospective randomized controlled trial.

OBJECTIVES/HYPOTHESIS: The objective was to conduct a prospective randomized controlled trial describing and investigating the efficacy and safety of transoral telescopic-assisted radiofrequency adenoidectomy in young children. STUDY DESIGN: Prospective randomized controlled trial. METHODS: One hundred twenty patients who were 36 months of age or less and planned to undergo adenoidectomy or adenoidectomy with insertion of tympanostomy tubes were included in the study. Children were prospectively and randomly assigned into two equal treatment groups: the telescopic-assisted adenoidectomy using radiofrequency curette and the conventional adenoid-curette adenoidectomy. The main parameters included visual analogue scale score for nasal breathing, amount of blood loss, operating time, completeness of adenoid resection, smoothness of postoperative recovery, and complications. RESULTS: Both groups had a significant improvement in the visual analogue scale score after surgery with no evidence for a significant difference between the conventional adenoid-curette and radiofrequency groups. The amount of blood lost during radiofrequency adenoidectomy was minimal, with a mean difference of 31 mL and a median difference of 26 mL. There was a tendency for shorter operative time in the radiofrequency group, but this did not reach a statistical significance. No evidence for a significant difference was noticed in the smoothness of postoperative recovery or complication rate. CONCLUSION: Telescopic-assisted radiofrequency-curette adenoidectomy allows removal of huge adenoids completely in a precise, easy, and cost-effective procedure, with minimal blood loss and short operating time. The use of transoral telescopes provides a clear visualization that helps complete removal of the adenoids, reduction of unnecessary trauma, and effective control of bleeding.

Adenoidectomy↗
PubMed2006

Evidence of improving quality of reporting of randomized controlled trials in subfertility.

BACKGROUND: The quality of randomized controlled trials (RCTs) in subfertility and their suitability for inclusion in meta-analyses have been assessed in the past and found to be insufficient. Our aim was to assess whether this quality has improved over time, particularly since the publication of the Consolidated Standards of Reporting Trials (CONSORT) statement, and to assess what proportion of trials could be included in the meta-analyses of pregnancy outcomes such as those included in Cochrane Reviews. METHODS: A selection of subfertility trials published in 1990, 1996 and 2002 was collected from the Cochrane Menstrual Disorder and Subfertility Group (MDSG) database. Only trials published in English as full journal articles, claiming to be randomized and reporting on pregnancy outcomes, were included. RESULTS: One hundred and sixty-four trials met our inclusion criteria. Twenty-four (15%) were found not to be randomized, despite claims, and only 10 trials (6%) provided adequate details on the methods of randomization and allocation concealment. Of these, only three had sufficient details extractable to allow for an intention-to-treat analysis of the outcome 'live birth'. CONCLUSIONS: Although an improvement in some subfertility-specific issues was observed, the quality of reporting of RCTs still needs to improve to make them suitable for inclusion in meta-analyses such as those in the Cochrane Library.

Female↗
PubMed2006

Improved compliance and self-care in patients with periodontitis--a randomized control trial.

UNLABELLED: The present study was a randomized control trial to test an intervention emanating from the Client Self-care Commitment Model (CSCCM), to encourage patients to increase their responsibility for their oral self-care. MATERIALS AND METHODS: A total of 75 individuals were re-examined 1-2 years after their initial therapy at the Department of Periodontology, Uppsala County Council, Sweden. Patients who exhibited insufficient compliance, 37 individuals, were included in a randomized single-blind control trial to test an intervention based on the CSCCM. Patients were examined at baseline and 3 months after hygiene treatment. RESULTS: The results demonstrated that patients in the intervention (IV) group increased their interdental cleaning and reduced their plaque index significantly compared with the control group. The former also reduced the number of periodontal pockets >4 mm significantly from baseline until after the hygiene treatment. The majority of the individuals in the IV group reported that the written commitment had influenced on their oral self-care habits in a positive direction. CONCLUSIONS: The CSCCM enhanced the client participation in the treatment process and improved the compliance and oral self-care behaviours. In addition, the model contributed to a reduction in periodontal pockets.

Adult↗
PubMed2002

Breastfeeding peer support: maternal and volunteer perceptions from a randomized controlled trial.

BACKGROUND: Several studies have demonstrated the positive effects of peer support on various breastfeeding outcomes, but no study has assessed women's and peer volunteers' views on, or the nature and intensity of, the supportive intervention. The objective of this study was to describe maternal and peer volunteer perceptions of their experience while participating in a breastfeeding peer support trial. METHODS: A randomized controlled trial was conducted to evaluate the effect of telephone-based peer (mother-to-mother) support on breastfeeding duration. Two hundred and fifty-six primiparous breastfeeding women were randomly allocated to receive either conventional care or conventional care plus peer support. Three primary outcome measures were peer volunteer activity logs, maternal perceptions of peer support, and evaluations of the peer volunteer experience. RESULTS: Questionnaires were completed by 98.5 percent (n=130) of the mothers in the peer support group. Mothers reported their peer volunteers were available when difficulties were experienced, increased their confidence, decreased their concerns, and assisted them in reaching their breastfeeding goals. These supportive interactions resulted in 81.5 percent of mothers (n=106) being satisfied with their peer support experience and suggesting that every new mother should be offered this intervention. Similarly, all the peer volunteers interviewed (n=30) viewed their experience positively. They suggested some intervention modifications as follows: ensure that mothers enrolled in the program want peer support; provide peer volunteers with ongoing educational sessions and opportunities to "socialize" with other volunteers; and disseminate the results of peer support efforts. CONCLUSIONS: Both mothers and peer volunteers perceived their intervention experiences positively. Whereas maternal satisfaction was related to the number and duration of peer volunteer contacts, peer volunteers enjoyed their training session and the opportunity to assist mothers for a variety of reasons. Specific intervention modifications should be implemented to enhance peer volunteer satisfaction and retention.

Adult↗