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PubMed2003

Group therapy for pathological gamblers: a cognitive approach.

This study evaluated the efficacy of a group cognitive treatment for pathological gambling. Gamblers, meeting DSM-IV criteria for pathological gambling, were randomly assigned to treatment (N=34) or wait-list control (N=24) conditions. Cognitive correction techniques were used first to target gamblers' erroneous perceptions about randomness, and then to address issues of relapse prevention. The dependent measures used were the DSM-IV criteria for pathological gambling, perceived self-efficacy, gamblers' perception of control, desire to gamble, and frequency of gambling. Post-treatment results indicated that 88% of the treated gamblers no longer met the DSM-IV criteria for pathological gambling compared to only 20% in the control group. Similar changes were observed on all outcome measures. Analysis of data from 6-, 12- and 24-month follow-ups revealed maintenance of therapeutic gains. Recommendations for group interventions are discussed, focusing on the cognitive correction of erroneous perceptions toward the notion of randomness.

Adult↗

PubMed2006

Telephone-based coping skills training for patients awaiting lung transplantation.

Impaired quality of life is associated with increased mortality in patients with advanced lung disease. Using a randomized controlled trial with allocation concealment and blinded outcome assessment at 2 tertiary care teaching hospitals, the authors randomly assigned 328 patients with end-stage lung disease awaiting lung transplantation to 12 weeks of telephone-based coping skills training (CST) or to usual medical care (UMC). Patients completed a battery of quality of life instruments and were followed for up to 3.4 years to assess all-cause mortality. Compared with UMC, CST produced lower scores on perceived stress, anxiety, depressive symptoms, and negative affect and improved scores on mental health functioning, optimism, vitality, and perceived social support. There were 29 deaths (9%) over a mean follow-up period of 1.1 year. Survival analyses revealed that there was no difference in survival between the 2 groups. The authors conclude that a telephone-based CST intervention can be effectively delivered to patients awaiting lung transplantation. Despite the severity of pulmonary disease in this patient population, significant improvements in quality of life, but not somatic measures or survival to transplant, were achieved.

Adaptation, Psychological↗

PubMed2002

Effectiveness of combined GnRH analogue plus raloxifene administration in the treatment of uterine leiomyomas: a prospective, randomized, single-blind, placebo-controlled clinical trial.

BACKGROUND: Raloxifene hydrochloride is a synthetic non-steroidal drug used for the prevention and treatment of post-menopausal osteoporosis. Pre-clinical and clinical data have shown that raloxifene may have a beneficial effect on leiomyomas. The aim of this prospective single-blind, randomized, placebo-controlled clinical trial was to evaluate the effectiveness of the addition of raloxifene to GnRH analogues on uterine, leiomyoma, and non-leiomyoma sizes, and on the occurrence of leiomyoma-related symptoms. METHODS: After randomization using a computer-generated list, 100 pre-menopausal women with symptomatic uterine leiomyomas received either leuprolide acetate depot plus raloxifene 60 mg daily (group A) or leuprolide plus placebo tablet (group B) for six cycles of 28 days. At baseline and after treatment, uterine, leiomyoma and non-leiomyoma sizes, and leiomyoma-related symptoms were evaluated for each woman. Analysis was by intention-to-treat method. RESULTS: After six cycles of treatment, a significant decrease in uterine, leiomyoma, and non-leiomyoma sizes was detected in both groups in comparison with baseline. At the same time, no significant difference in uterine and non-leiomyoma sizes was observed between the groups. Leiomyoma sizes were significantly (P < 0.05) lower in group A than in group B. No difference was observed in leiomyoma-related symptoms between groups throughout the study period. CONCLUSIONS: In women treated with GnRH analogue, the raloxifene administration induces a higher reduction of leiomyoma sizes.

Delayed-Action Preparations↗

PubMed2004

Ovarian function with the contraceptive vaginal ring or an oral contraceptive: a randomized study.

BACKGROUND: The effects on ovarian function of the combined contraceptive vaginal ring NuvaRing and a combined oral contraceptive (COC) were compared. METHODS: This randomized, open-label study was performed in 40 healthy female volunteers, who were randomized by a computer-generated list after stratification for the ovulation day in a pretreatment cycle. They received two cycles of NuvaRing (21 subjects) or a COC (30 microg ethinylestradiol and 150 microg levonorgestrel, 19 subjects). NuvaRing was started on cycle day 5, COC on cycle day 1. Follicular diameter, endometrial thickness and FSH, LH, 17beta-estradiol (E2) and progesterone concentrations were determined. RESULTS: The median maximum follicular diameter (maxFD) was < or =11 mm during treatment. In the first treatment cycle the maxFD was lower in the COC than in the NuvaRing group, due to the different starting procedures. MaxFD were not different in the second treatment cycle. In both groups, E2 and progesterone levels remained low during treatment. Ovulations did not occur. CONCLUSIONS: In both groups, ovarian activity was adequately suppressed. Due to the different starting procedures, lower ovarian activity was observed in the COC group in the first treatment cycle. In the second cycle, ovarian suppression was comparable with NuvaRing and COC treatment.

Adolescent↗

PubMed2004

[Clinical observation on effect of combination of zhuanyindan and hormone in treating male infertility with positive antisperm antibody].

OBJECTIVE: To explore the therapeutic effect of combination of Zhuanyindan (ZYD, a self-made Chinese herbal preparation) and hormone in treating male infertility with positive antisperm antibody and its influence on nitric oxide (NO) level. METHODS: Eighty-two patients were randomly divided (according to the digital list) into the WM group (n = 20, treated with prednisone), the TCM group (n = 28, treated with ZYD) and the ICWM group (n = 34, treated with prednisone plus ZYD). The clinical effect, negative converting rate of antisperm antibody, changes of NO level in semen and various parameters of sperm motion before and after treatment were observed. RESULTS: The total effective rate in the ICWM group was 88.2%, that in the TCM group 75.0% and in the WM group 65.0%. Significant difference was seen in the ICWM and TCM group before and after treatment in NO level, sperm motion parameters, including linear motion speed, linearity, propulsion, whip frequency, sperm vitality and mean moving angle, and quality of semen (P < 0.05 or P < 0.01). In the WM group, significant difference in comparison before and after treatment was seen in NO level, propulsion, whip frequency, mean moving angle and quality of semen, including vitality and survival rate (P < 0.01). CONCLUSION: Combination of Chinese herbs and hormone could lower the NO level in semen and improve the quality of sperm.

Adult↗

PubMed2004

Pediatric tonsillotomy with the radiofrequency technique: less morbidity and pain.

OBJECTIVE: To compare two techniques for pediatric tonsil surgery with respect to pain and postoperative morbidity. The two methods were the partial tonsil resection using radiofrequency (RF) technique (tonsillotomy [TT]) versus traditional tonsillectomy (TE). STUDY DESIGN: Prospective clinical randomized study in one tertiary care ENT clinic and two secondary care clinics. METHOD: One hundred fifty children, between 5 and 15 years of age, were randomized to either TT with RF using the Surgitron Ellman, 1.7 MHz, or regular TE. Randomization was performed from the waiting list, including children with both a history of obstructive problems and recurrent tonsillitis. The TT was performed with a specially made sling electrode using a cut/coagulation mode. RESULTS: Forty-nine children were operated on with TT and 43 with TE. There was significantly less bleeding in the TT group, although two cases of primary postoperative bleeding occurred among the TT children and one in the TE group. The pain recordings showed significantly less pain for the TT children from the second hour postoperatively onward, and the TT children were pain free and in school 3 days earlier than the TE group. The TT group had less need of the prescribed drugs (diclofenac and paracetamol). After 9 days, 73% of the TT children were completely healed, but only 31% of the TE children. By that time, the TE children had lost a mean of 660 g, and the TT children had gained 127 g. The effect on snoring was the same for both groups. CONCLUSION: RF appears to be a safe and reliable method for tonsil surgery with much less postoperative morbidity than regular TE.

Acetaminophen↗

PubMed2004

Vasectomy techniques for male sterilization: systematic Cochrane review of randomized controlled trials and controlled clinical trials.

BACKGROUND: The review aimed to compare the effectiveness, safety and acceptability of vasectomy techniques for male sterilization. METHODS: We searched five computerized databases and reference lists of relevant articles and book chapters for randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing vasectomy techniques. Two reviewers independently extracted data from eligible articles. RESULTS: Two poor-quality trials compared vas occlusion with clips versus a conventional technique, and four poor-quality trials examined vas irrigation with water versus no irrigation or irrigation with euflavine. No significant differences regarding the primary outcome of time to azoospermia were found. However, one trial reported fewer median number of ejaculations to azoospermia with euflavine rather than water irrigation. An interim report of a high-quality trial comparing vasectomy with and without fascial interposition found more azoospermia with fascial interposition but also more surgical difficulties. CONCLUSIONS: No conclusions can be reached regarding the effectiveness, safety and acceptability of vas occlusion techniques or vas irrigation since only low-quality, underpowered studies were available. Fascial interposition had improved vasectomy success but also increased surgical difficulty. High-quality, adequately reported RCTs are required. More work is also needed in the standardization of follow-up protocols, evaluation of vasectomy success and failure, recanalization and analytical methods.

Controlled Clinical Trials as Topic↗

PubMed1998

Neuro-otological and psychiatric abnormalities in a community sample of people with dizziness: a blind, controlled investigation.

OBJECTIVES: To determine neurootological and psychiatric abnormalities associated with complaints of dizziness in an epidemiological community sample of people of working age, and the extent of comorbidity between neuro-otological and psychiatric dysfunction. METHOD: A survey of 3884 people randomly selected from six general practice lists identified 262 people with significant dizziness, from which a subsample of 15 men and 22 women were recruited for testing. Dizzy subjects were evaluated by blind neuro-otological testing, computerised dynamic posturography, a computerised psychiatric assessment, neuro-otological and general medical examination, and diagnosis. An age matched control group of 18 men and 22 women underwent the same evaluation. RESULTS: Tests of auditory, vestibular, and oculo-motor function did not discriminate between dizzy subjects and controls, but dizzy subjects had significantly worse balance on posturographic testing, more diagnoses of medical disorder, and a higher prevalence of psychiatric morbidity. CONCLUSIONS: The findings suggest that dizziness in the community is typically characterised by mild physical disorder accompanied by some psychiatric disturbance. As the combination of minor physical and psychiatric disorder is known to be unusually persistent and handicapping, treatment programmes must be provided for this prevalent syndrome, perhaps by a partnership between primary care and neuro-otological and psychiatric hospital outpatient clinics with experience and expertise in the diagnosis and management of dizziness and psychiatric disturbance.

Adolescent↗

PubMed2004

Misoprostol versus curettage in women with early pregnancy failure after initial expectant management: a randomized trial.

BACKGROUND: Little is known about the effectiveness of misoprostol treatment in women with early pregnancy failure who have been managed expectantly. We therefore performed a randomized trial on this subject. METHODS: Women with early pregnancy failure, who had been managed expectantly for at least 1 week, were assigned randomly (using a computer-generated list) to receive either vaginal misoprostol 800 microg or curettage. If, after 24 h, there had not been complete evacuation, a further 800 microg of misoprostol was administered. In the absence of complete evacuation after > days, curettage was performed. The primary end-point was the complete evacuation of the products of conception, with secondary end-points being the occurrence of side effects, pain intensity, need for analgesics, and intensity and duration of bleeding. RESULTS: In the misoprostol group, 47% (37/79) required curettage due to incomplete evacuation. After 1 week, evacuation was complete in 85% (67 out of 79) of the misoprostol group and 93% (70 out of 75) of the curettage group. Severity of pain, bleeding and emergency evacuation was higher in the misoprostol group. The complication rate was 0% for misoprostol and 4% for curettage. CONCLUSIONS: Curettage is superior to misoprostol in the evacuation of early pregnancy failure after failed expectant management. However, misoprostol could be clinically useful since it reduces the need for curettage by half and has a lower complication rate, at the expense of increased pain, vaginal bleeding and emergency evacuation.

Abortifacient Agents, Nonsteroidal↗

PubMed2006

Worksite intervention effects on physical health: a randomized controlled trial.

Overweight and physical inactivity are risk factors for increased disease burden and health care expenditure. Well-designed studies are still needed to determine the treatment efficacy of worksite interventions targeting such risk factors. This randomized controlled trial was conducted at one of Australia's casinos in 2002-2003, to investigate the effects of a comprehensive exercise and lifestyle intervention on physical fitness. Only 6.4% of the workforce expressed interest in being study participants. Seventy-three employees (aged 32 +/- 8 years, 51% overweight/obese, 73% shift workers and 52% women) were recruited and randomized to treatment or wait-list control groups for 24 weeks, 44 of whom completed the intervention. Components of the intervention include supervised moderate-to-high intensity exercise including combined aerobic (at least 20 min duration 3 days/week) and weight-training (for an estimated 30 min completed 2-3 days/week), and dietary/health education (delivered via group seminars, one-on-one counselling and literature through the provision of a worksite manual). ANCOVA, by intention-to-treat and of study completers, found significant between-group differences in the mean waist circumference and predicted maximal oxygen uptake (VO2max), favouring the intervention, but effects were concentrated in one subject. For study completers, between-group differences in the mean waist circumference (82.3 +/- 9.2 versus 90.5 +/- 17.8 cm, p = 0.01) and predicted VO2max (47 versus 41 ml/kg/min, p < 0.001) remained significant without the outlier, favouring the intervention. Higher intervention compliance predicted greater improvements in physical fitness. No significant effects on body mass or body mass index were found. This worksite intervention significantly improved waist circumference and aerobic fitness in healthy but sedentary employees, most of whom were shift workers. Worksite interventions have the potential to counter the increasing burden of overweight and obesity, particularly visceral adiposity, as well as physical inactivity; however, substantial barriers to adoption/adherence need to be overcome for greater feasibility and impact on employee physical health.

Adult↗

PubMed2002

Splenectomy versus conservative management for acute sequestration crises in people with sickle cell disease.

BACKGROUND: Acute splenic sequestration crises are a complication of sickle cell disease, with high mortality rates and frequent recurrence in survivors of first attacks. Splenectomy and blood transfusion, with their consequences, are the mainstay of long term management used in different parts of the world. OBJECTIVES: To assess whether splenectomy (total or partial) to prevent acute splenic sequestration crises in people with sickle cell disease improved survival and decreased morbidity in patients with sickle cell disease, as compared with regular blood transfusion. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group specialist trials register which comprises references identified from comprehensive electronic database searches, hand searching relevant journals and hand searching abstract books of conference proceedings Additional randomized controlled trials were sought from the reference lists of the studies found and reviews identified by the search strategy. Date of the most recent search: December 2001 SELECTION CRITERIA: All randomized or quasi-randomized controlled trials comparing splenectomy (total or partial) to prevent recurrence of acute splenic sequestration crises to no treatment or blood transfusion in people with sickle cell disease. DATA COLLECTION AND ANALYSIS: No trials of splenectomy for acute splenic sequestration were found. MAIN RESULTS: No trials of splenectomy for acute splenic sequestration were found. REVIEWER'S CONCLUSIONS: Splenectomy, if full, will prevent further sequestration and if partial, may reduce the recurrence of acute splenic sequestration crises but there is lack of evidence from trials that it improves survival and decreases morbidity in sickle cell disease. There is a need for a well-designed, adequately powered randomised controlled trial to assess the benefits and risks of splenectomy compared to transfusion programmes as a means of improving survival and decreasing mortality from ASS in people with sickle cell disease.

Acute Disease↗

PubMed2004

Treatment for avascular necrosis of bone in people with sickle cell disease.

BACKGROUND: Avascular necrosis of bone is a frequent and severe complication of sickle cell disease and its treatment is not standardised. It is therefore important to gather evidence about the safety and effectiveness of different interventions. OBJECTIVES: To determine the impact of surgery compared to non-surgical management on both the short- and the long-term outcomes (efficacy, safety, and adverse events) for people with sickle cell disease-related avascular necrosis. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register, which comprises references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Additional randomized controlled trials were sought from the reference lists of the trials found and reviews identified by the search strategy. Date of the most recent search: April 2004. SELECTION CRITERIA: All randomized or quasi-randomized controlled trials (published or unpublished). DATA COLLECTION AND ANALYSIS: One ongoing clinical trial has been identified but no data are available for inclusion in the review. MAIN RESULTS: Five trials were identified by the searches. Four trials were not eligible for inclusion and one is an ongoing clinical trial. REVIEWERS' CONCLUSIONS: We were unable to find any evidence from completed randomized controlled trials assessing treatments for avascular necrosis in people with sickle cell disease. We await the results of an ongoing clinical trial to assess the benefits and risks of a surgical approach compared to a non-surgical approach as a means of improving survival and quality of life for people with sickle cell disease-related avascular necrosis of bone.

Anemia, Sickle Cell↗

PubMed2004

Meta-analysis of cephalosporin versus penicillin treatment of group A streptococcal tonsillopharyngitis in children.

OBJECTIVE: To conduct a meta-analysis of randomized, controlled trials of cephalosporin versus penicillin treatment of group A beta-hemolytic streptococcal (GABHS) tonsillopharyngitis in children. METHODOLOGY: Medline, Embase, reference lists, and abstract searches were conducted to identify randomized, controlled trials of cephalosporin versus penicillin treatment of GABHS tonsillopharyngitis in children. Trials were included if they met the following criteria: patients <18 years old, bacteriologic confirmation of GABHS tonsillopharyngitis, random assignment to antibiotic therapy of an orally administered cephalosporin or penicillin for 10 days of treatment, and assessment of bacteriologic outcome using a throat culture after therapy. Primary outcomes of interest were bacteriologic and clinical cure rates. Sensitivity analyses were performed to assess the impact of careful clinical illness descriptions, compliance monitoring, GABHS serotyping, exclusion of GABHS carriers, and timing of the test-of-cure visit. RESULTS: Thirty-five trials involving 7125 patients were included in the meta-analysis. The overall summary odds ratio (OR) for the bacteriologic cure rate significantly favored cephalosporins compared with penicillin (OR: 3.02; 95% confidence interval [CI]: 2.49-3.67, with the individual cephalosporins [cephalexin, cefadroxil, cefuroxime, cefpodoxime, cefprozil, cefixime, ceftibuten, and cefdinir] showing superior bacteriologic cure rates). The overall summary OR for clinical cure rate was 2.33 (95% CI: 1.84-2.97), significantly favoring the same individual cephalosporins. There was a trend for diminishing bacterial cure with penicillin over time, comparing the trials published in the 1970s, 1980s, and 1990s. Sensitivity analyses for bacterial cure significantly favored cephalosporin treatment over penicillin treatment when trials were grouped as double-blind (OR: 2.31; 95% CI: 1.39-3.85), high-quality (OR: 2.50; 95% CI: 1.85-3.36) trials with well-defined clinical status (OR: 2.12; 95% CI: 1.54-2.90), with detailed compliance monitoring (OR: 2.85; 95% CI: 2.33-3.47), with GABHS serotyping (OR: 3.10; 95% CI: 2.42-3.98), with carriers eliminated (OR: 2.51; 95% CI: 1.55-4.08), and with test of cure 3 to 14 days posttreatment (OR: 3.53; 95% CI: 2.75-4.54). Analysis of comparative bacteriologic cure rates for the 3 generations of cephalosporins did not show a difference. CONCLUSIONS: This meta-analysis indicates that the likelihood of bacteriologic and clinical failure of GABHS tonsillopharyngitis is significantly less if an oral cephalosporin is prescribed, compared with oral penicillin.

Anti-Bacterial Agents↗

PubMed2000

Consensus conferences must include a systematic search and categorization of the evidence.

BACKGROUND: Ideally, a consensus panel combines expert knowledge with external evidence derived from the literature. To date, many consensus conferences do not use a structured approach to search the literature, but simply compile an add-on reference list from all papers cited by the panelists. This study examined how well such panelists retrieved the relevant literature. METHODS: We used the reference lists of nine surgeons who took part in a consensus conference on common bile duct stones. We included all papers that were referred to as randomized controlled trials (RCTs). We then compared this list with a database search in order to calculate sensitivity and specificity. RESULTS: The nine experts cited between 35 and 518 papers, but only eight papers on average were RCTs. Of the 49 papers that the experts believed to be RCTs, only 23 actually were RCTs. The sensitivity resp. specificity for correctly identifying an RCT was 0.21 (95% Cl, 0.11-0.30) resp. 0.80 (95% Cl; 0.64-0.95). RCTs that included the word "randomized" in their title were significantly more likely to be identified (relative risk, 1.31; 95% Cl, 1.18-1.45). CONCLUSION: Our data indicate that consensus panelists usually do not perform systematic literature searches, but simply use their favorite papers to back up their arguments. Because this may lead to a biased selection of the evidence base on which the consensus statements are founded, a systematic search of all relevant articles should become a mandatory task in any consensus or guideline process.

Consensus Statements as Topic↗

PubMed2002

Ovarian stimulation in intrauterine insemination with donor sperm: a randomized study comparing clomiphene citrate in fixed protocol versus highly purified urinary FSH.

BACKGROUND: The study was conducted to compare the results of intrauterine donor insemination (DI) under ovarian stimulation with either clomiphene citrate (CC), in a fixed protocol, or FSH, with ovarian monitoring. METHODS: Forty-nine patients were randomized using a computer-generated list to receive highly purified urinary FSH (starting dose of 150 IU) and were subjected to periodic vaginal ultrasound and estradiol determinations. HCG was given when > or =2 follicles (> or =17 mm) were identified and estradiol reached >400 pg/ml. Intrauterine insemination (IUI) was performed 36 h later. The other 51 received CC on a fixed protocol (100 mg/day from the day 5-10 of the ovarian cycle) with HCG being administered on the day 12, and IUI performed 36 h later. Up to six IUI cycles were performed on all patients if pregnancy was not reached before. Women failing to conceive in the CC group underwent IUI with FSH. The main outcome measures were intrauterine gestational sac observed by transvaginal ultrasound, per cycle and per woman pregnancy rate (PR) and multiple PR. RESULTS: The per cycle PR was significantly higher in the FSH group, 14.4% (30/209) versus 6.1% (16/261), as well as the per woman PR, 61.2% (30/49) versus 31.4% (16/51). 12.5% (2/16) of pregnancies obtained in the CC group were multiple, compared with 20% (6/30) in the FSH group. There were no triplets or higher order pregnancies in CC versus two in FSH (6.7% of pregnancies). Patients failing to conceive with CC, who later underwent intrauterine DI with FSH, had similar results to the primary FSH group: 54.3% PR per patient (19/35) and 16.0% per cycle (19/118), with a multiple PR of 31.6% (6/19). The PR for women starting with CC cycles and, if pregnancy was not obtained, continuing with six FSH cycles, was 69.2%. CONCLUSIONS: The PR obtained with CC stimulation was approximately half that obtained with FSH. There was a trend to lower multiple PR with CC. It is recommended that each case should be considered on an individual basis and the treatment options discussed with patients. In our opinion, CC could be a reasonable approach for young women with good prognosis, whereas in the remaining cases FSH would be the preferable method.

Adult↗

PubMed2004

Intravenous immunoglobulin for preventing infection in preterm and/or low-birth-weight infants.

BACKGROUND: Nosocomial infections continue to be a significant cause of morbidity and mortality among preterm and/or low birth weight infants. Maternal transport of immunoglobulins to the fetus mainly occurs after 32 weeks gestation and endogenous synthesis does not begin until several months after birth. Administration of intravenous immunoglobulin provides IgG that can bind to cell surface receptors, provide opsonic activity, activate complement, promote antibody dependent cytotoxicity, and improve neutrophilic chemo luminescence. Intravenous immunoglobulin thus has the potential of preventing or altering the course of nosocomial infections. OBJECTIVES: To assess the effectiveness/safety of intravenous immunoglobulin (IVIG) administration (compared to placebo or no intervention) to preterm (< 37 weeks gestational age at birth) and/or low birth weight (LBW) (< 2500 g BW) infants in preventing nosocomial infections. SEARCH STRATEGY: MEDLINE, EMBASE, and The Cochrane Library Databases were searched in September 2003 using the keywords: immunoglobulin and infant-newborn and random allocation or controlled trial or randomized controlled trial (RCT). The reference lists of identified RCTs and personal files were searched. No language restrictions were applied. SELECTION CRITERIA: The criteria used to select studies for inclusion in this overview were: 1) DESIGN: RCTs in which administration of IVIG was compared to a control group that received a placebo or no intervention. 2) POPULATION: preterm (< 37 weeks gestational age) and/or LBW (<2500 g) infants. 3) INTERVENTION: IVIG for the prevention of bacterial/fungal infection during initial hospital stay (8 days or longer). (Studies that were primarily designed to assess the effect of IVIG on humoral immune markers were excluded as were studies in which the follow-up period was one week or less).4) At least one of the following outcomes was reported: sepsis, any serious infection, death from all causes, death from infection, length of hospital stay, intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD). DATA COLLECTION AND ANALYSIS: Two reviewers independently abstracted information for each outcome reported in each study, and one researcher (AO) checked for any discrepancies and pooled the results. Relative risk (RR) and Risk Difference (RD) with 95% confidence intervals (CI) using the fixed effects model are reported. When a statistically significant RD was found the number needed to treat (NNT) was also calculated with 95% CIs. The results include all accepted studies in which the outcome of interest was reported. Statistically significant between study heterogeneity was reported. The results of the inconsistency test (I squared) are also reported when statistically significant heterogeneity was found. MAIN RESULTS: No new trials were identified in September 2003. Nineteen studies met inclusion criteria. These included approximately 5,000 preterm and/or LBW infants and reported on at least one of the outcomes of interest for this systematic review. When all studies were combined there was a statistically significant reduction (p = 0.02) in sepsis, RR [0.85 (95% CI 0.74, 0.98)] and RD [-0.03 (95% CI 0.00, -0.05)], NNT 33. There was statistically significant between-study heterogeneity (p = 0.02); I squared 54%. A statistically significant reduction was found for any serious infection, one or more episodes, when all studies were combined [RR 0.82 (95% CI 0.74, 0.92); RD -0.04 (95% CI -0.02, -0.06,); NNT 25 (95% CI, 16.7, 50). There was statistically significant between-study heterogeneity (p = 0.0006); I squared 50%. There were no statistically significant differences for mortality from all causes, mortality from infection, incidence of NEC, BPD and IVH or length of hospital stay. No major adverse effects of IVIG were reported in any of the studies. REVIEWER'S CONCLUSIONS: IVIG administration results in a 3% reduction in sepsis and a 4% reduction in any serious infection, one or more episodes, but is not associated with reductions in other important outcomes: sepsis, NEC, IVH, or length of hospital stay. Most importantly, IVIG administration does not have any significant effect on mortality from any cause or from infections. Prophylactic use of IVIG is not associated with any short term serious side effects. From a clinical perspective a 3-4% reduction in nosocomial infections without a reduction in mortality or other important clinical outcomes is of marginal importance.The decision to use prophylactic IVIG will depend on the costs and the values assigned to the clinical outcomes. There is no justification for further RCTs testing the efficacy of previously studied IVIG preparations to reduce nosocomial infections in preterm and/or LBW infants. The results of these meta-analyses should encourage basic scientists and clinicians to pursue other avenues to prevent nosocomial infections.

Cross Infection↗

PubMed2005

Pharmacologic prophylaxis for postoperative atrial tachyarrhythmia in general thoracic surgery: evidence from randomized clinical trials.

BACKGROUND: Atrial tachyarrhythmia is the most common complication after general thoracic surgery and is associated with significant morbidity, longer hospital stay, and higher costs. We sought to determine whether the use of antiarrhythmic medications is associated with a reduced rate of postoperative atrial tachyarrhythmia. METHODS: MEDLINE, EMBASE, Cochrane Database of clinical trials (1980-2003), and reference lists of relevant articles were searched for randomized controlled trials with placebo control, general thoracic patients, and noncombined and prophylactic use of the medications. Search, data abstraction, and analyses were performed and confirmed by at least 2 authors. A fixed-effects model was used to perform meta-analyses. RESULTS: There were 11 unique trials (total n = 1294) that met the inclusion criteria. Calcium-channel blockers and beta-blockers reduced the risk of atrial tachyarrhythmia in 4 and 2 trials, respectively (relative risk of 0.50 and 95% confidence interval of 0.34-0.73; relative risk of 0.40 and 95% confidence interval of 0.17-0.95, respectively). However, beta-blockers tended to increase the risk of pulmonary edema (relative risk, 2.15; 95% confidence interval, 0.74-6.23). Magnesium tested in one unblinded trial also reduced the risk of atrial tachyarrhythmia (relative risk, 0.4; 95% confidence interval, 0.21-0.78). On the other hand, digitalis preparations were found to be harmful because they increased the risk of atrial tachyarrhythmia in 3 trials (relative risk, 1.51; 95% confidence interval, 1.00-2.28). Finally, 2 other medications, flecainide and amiodarone, were each tested in a single small trial, and their effects were associated with great uncertainty. CONCLUSIONS: Calcium-channel blockers and beta-blockers are effective in reducing postoperative atrial tachyarrhythmia. The use of these medications should be individualized, and possible adverse events of beta-blockers should be taken into account. Randomized clinical trials do not support the use of digitalis in general thoracic surgery. The value of magnesium as a supplement to a main prophylactic regimen should be explored.

Adrenergic beta-Antagonists↗

PubMed1996

Efficacy of bronchodilator therapy in bronchiolitis. A meta-analysis.

OBJECTIVE: To determine if bronchodilators are efficacious in treating bronchiolitis. DATA SOURCES: A search of bibliographic databases (MEDLINE, Excerpta Medica, and Reference Update) for bronchiolitis and albuterol or ipratropium bromide, or adrenergic agents or bronchodilator agents. Reference lists were also used. STUDY SELECTION: Randomized, placebo-controlled trials of bronchodilator treatment in bronchiolitis were selected by 2 investigators. Fifteen of 89 identified publications met the selection criteria. DATA EXTRACTION: Investigators independently abstracted data for 3 outcomes: clinical score, oxygen saturation, and hospitalization. Clinical score was measured as a dichotomous variable (score +/- improved) or continuous variable (average score). DATA SYNTHESIS: For primary analysis, data were pooled from 8 trials of children with first-time wheezing. The effect size for average score was -0.32 (95% confidence interval [CI], -0.54 to -0.11; P < .01), favoring treatment; the relative risk for score +/- improved was 0.76 (95% CI, 0.60 to 0.95; P = .02), favoring treatment. Bronchodilators had no effect on hospitalization (relative risk, 0.85; 95% CI, 0.47 to 1.53; P = .58), but co-interventions may have been administered prior to this outcome. The results for oxygen saturation were too varied to allow pooling of the results. Secondary analyses were performed on 4 outpatient trials of children with first-time wheezing, 7 trials in which only nebulized beta-agonists were used, and on all 15 trials identified. The results were similar, but the data varied more. CONCLUSION: Bronchodilators produce modest short-term improvement in clinical features of mild or moderately severe bronchiolitis.

Albuterol↗