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PubMed2000

Aerosolized diuretics for preterm infants with (or developing) chronic lung disease.

BACKGROUND: Lung disease in preterm infants is often complicated with lung edema. OBJECTIVES: The aim of this review is to assess the risks and benefits of aerosolized diuretic administration in preterm infants with or developing chronic lung disease (CLD). Primary objectives are to assess effects on short term outcome (changes in need for oxygen or ventilatory support) and effects on long-term outcome. Secondary objectives are to assess changes in pulmonary mechanics and potential complications of therapy. SEARCH STRATEGY: We used the standard search method of the Cochrane Neonatal Review Group. We used the following keywords: ¿ or ¿ and , limited to and limited to or . We searched Medline (1966-1998), Embase (1974-1998) and the Cochrane Controlled Trials Register (CCTR) from the Cochrane Library (1998, Issue 4). In addition, we hand searched several abstract books of national and international American and European Societies. SELECTION CRITERIA: We included in this analysis trials in which preterm infants with or developing chronic lung disease and at least five days of age were all randomly allocated to receive an aerosolized loop diuretic. Eligible studies needed to assess at least one of the outcome variables defined a priori for this systematic review. Primary outcome variables included important clinical outcomes, and secondary outcome variables included pulmonary mechanics and potential complications of therapy. DATA COLLECTION AND ANALYSIS: We used the standard method for the Cochrane Collaboration which is described in the Cochrane Collaboration Handbook. Two investigators extracted, assessed and coded separately all data for each study, using a form that was designed specifically for this review. Any disagreement was resolved by discussion. We combined parallel and cross-over trials and, whenever possible, transformed baseline and final outcome data measured on a continuous scale into change scores using Follmann's formula. MAIN RESULTS: We identified eight studies which met selection criteria. Most studies focused on pathophysiological parameters and did not assess effects on important clinical outcomes defined in this review or the potential complications of diuretic therapy. No study assessed the amount of diuretic effectively delivered to the patient. Furosemide was the only diuretic used in the eight studies included in this review. Among preterm infants < 3 weeks of age developing CLD, not enough information is available to assess the effect of aerosolized furosemide on outcome or lung function. Among infants > 3 weeks with CLD, a single aerosolized dose of 1 mg/kg of furosemide may transiently improve pulmonary mechanics. Not enough information is available to assess the effect of chronic administration of aerosolized furosemide on oxygenation and pulmonary mechanics. REVIEWER'S CONCLUSIONS: In preterm infants > 3 weeks with CLD administration of a single dose of aerosolized furosemide improves pulmonary mechanics. In view of the lack of data from randomized trials concerning effects on important clinical outcomes, routine or sustained use of aerosolized loop diuretics in infants with (or developing) CLD cannot be recommended based on current evidence. More double-blinded randomized trials are needed (1) to analyze factors likely to affect the response to aerosolized furosemide, e.g. , washout period and delivery of furosemide to distal airways, and (2) to assess the effects of chronic administration of aerosolized furosemide on mortality, O2 dependency, ventilator dependency, length of hospital stay and long-term outcome.

Aerosols↗
PubMed1990

Double blind comparative study of omeprazole and ranitidine in patients with duodenal or gastric ulcer: a multicentre trial. Cooperative study group.

We studied omeprazole and ranitidine in promoting duodenal ulcer healing in a multicentre trial by comparing the proportion of healed ulcers after two, four, and eight weeks of treatment. Altogether, 194 patients (143 men) were randomly allocated according to a prearranged treatment schedule to either drug and were treated double blind. Each received 40 mg omeprazole in the morning and a ranitidine placebo morning and evening or 150 mg ranitidine morning and evening with an omeprazole placebo in the morning. A total of 188 patients (94 taking omeprazole, 94 taking ranitidine) completed the trial. Sixty four (68%) omeprazole treated and 45 (48%) ranitidine treated patients had healed ulcers at two weeks, 91 (99%) omeprazole treated and 79 (88%) ranitidine treated had healed ulcers by four weeks, and 91 (100%) omeprazole treated and 86 (97%) ranitidine treated patients had healed ulcers by eight weeks. The overall difference in healing rates was significant (p = 0.0008, Mantel-Haenszel test). The differences were significant also at two weeks (20%, 95% confidence interval 5.6 to 34.4, p less than 0.01) and at four weeks (11%, 95% CI 3.7 to 17.3, p less than 0.01), but not at eight weeks (3%, 95% CI -0.5 to + 7.3, p = 0.25), using the chi 2 statistic, the study having a power to detect a 20% difference on 90% of occasions. After two weeks of treatment complete symptom relief was observed in 70 (74%) patients receiving omeprazole and in 58 (62%) receiving ranitidine. Diary cards showed a significantly lower percentage of days with pain in the omeprazole treated group (7.4% v 21.4%, p < 0.02) when assessed over either the first two weeks or over weeks three and four treatment. A total of 144 patients with healed duodenal ulcer were followed up, with no treatment, for six months. At the end of this period 19 (26%) of 74 patients healed with omeprazole and 17 (24%) of 70 patients healed with ranitidine were still in remission. A similar protocol was used for 46 patients (25 men) with gastric ulcer who were randomly allocated to treatment with omeprazole or ranitidine as described above. Forty patients (16 omeprazole, 24 ranitidine) completed trial. Thirteen (81%) omeprazole treated and 14 (58%) ranitidine treated patients had healed ulcers at four weeks; at eight weeks 14 (93%) omeprazole treated and 20 (87%) ranitidine treated patients had healed ulcers. These differences were not significant at four weeks (p = 0.25) or eight weeks (p = 0.96). Twenty seven gastric ulcer patients were followed up for six months and seven (58%) of the 12 omeprazole healed and five (33%) of the 15 ranitidine healed patients were in remission at six months. Unwanted adverse events were trivial except for one fatality in a 67 year old women, who died from bronchopneumonia and myocardial ischaemia while receiving treatment with omeprazole, which was judged to be unrelated to her death.

Aged↗
PubMed1995

Effects of bull exposure on the cyclic activity of beef cows.

In Experiment I, 38 crossbred suckled beef cows grazing fescue pastures and 34 crossbred beef cows grazing bluestem pastures were randomly allocated at the time of calving into a group with 4 teaser bulls or no bulls. Two blood samples were collected 7 d apart from the cows to determine cyclic activity 67 and 76 d after calving in the fescue and bluestem pastures, respectively. Progesterone greater than 1.0 ng/ml in one or both samples indicated cyclic activity. There was no difference in the percentage of cows cyclic among the different groups. The number of cyclic cows in the fescue pasture with bulls was 16/19 (84%); in the fescue pasture with no bulls, 14/19 (74%); in the bluestem pasture with bulls, 17/17 (100%); and in the bluestem pasture with no bulls, 16/17 (94%). Overall cyclic activity among all cows for teaser bull-exposed and no bull was similar, 33/36 (91%) and 30/36 (83%). Overall cyclic activity was greater (P < 0.05) in cows grazing bluestem (33/34), 97% than fescue pastures (30/38), 80%. Measurements of cyclic activity were initiated too late in the postcalving period to quantify differences in estrous activity between the bull and no bull treatment groups. Another trial was planned for the following year with a modified protocol. In Experiment II, blood samples were collected for progesterone concentrations soon after calving and were repeated at intervals to characterize both the occurrence and duration of estrous cycles. In this experiment, 29 crossbred suckled beef cows grazing fescue pastures were randomly allocated 12 d after calving (Day 0) into 1 of 2 groups with teaser bulls or without bulls. Nineteen crossbred beef cows grazing bluestem pastures were allocated similarly 10 d after calving (Day 0). Bulls were added to the groups with bulls in fescue and bluestem pastures on day 6 after the initial allocations. Blood samples were collected from all cows on Day 0 and every 3 d until Day 46. Means (+/- SEM) of the cumulative progesterone concentrations (ng/ml) per cow for the 16 samples from cows grazing fescue were 12.5 +/- 3.5 for cows exposed to bulls, 2.5 +/- 0.16 for cows not exposed to bulls, 27.6 +/- 4.42 for cows grazing bluestem pastures and exposed to bulls, and 16.0 +/- 2.75 for cows without exposure to bulls. Progesterone concentrations were higher in cows exposed to bulls (P < 0.01). The percentages of both short and normal cycles increased (P < 0.01) in groups exposed to bulls (88%, 21/24 and 63%, 15/24) when compared with the no bull groups (29%, 7/24 and 21%, 5/24), respectively. Cows exposed to bulls also showed increased cyclic activity.

Journal Article↗
PubMed2000

Vitamin E for neuroleptic-induced tardive dyskinesia.

BACKGROUND: Neuroleptic (antipsychotic) medication is used extensively to treat people with chronic mental illnesses. However, it is associated with a wide range of adverse effects, including movement disorders such as tardive dyskinesia (TD). Vitamin E has been proposed as a treatment to prevent or decrease the severity of TD. OBJECTIVES: To determine the clinical effects of vitamin E for people with schizophrenia or other chronic mental illnesses who also developed neuroleptic-induced tardive dyskinesia. SEARCH STRATEGY: Electronic searches of Biological Abstracts (1982-1998), The Cochrane Schizophrenia Group's Register (September 1998), EMBASE (1980-98), LILACS (1982-96), MEDLINE (1966-98), PsycLIT (1974-98), SCISEARCH, handsearching the references of all identified studies and contacting the first author of each included trial. SELECTION CRITERIA: Reports identified in the search were included if they were controlled trials dealing with people with neuroleptic-induced TD and schizophrenia or other chronic mental illness who had been randomly allocated to either vitamin E or to a placebo or no intervention. DATA COLLECTION AND ANALYSIS: Data were independently extracted from these trials by each reviewer and Peto odds ratios (OR) or average differences, with the 95% confidence intervals (CI) were estimated. The reviewers assumed that people who dropped out had no improvement. MAIN RESULTS: Eight studies were included, and another three are currently awaiting further data from authors. The overall results for both, 'clinically relevant improvement' and 'any improvement' of TD symptoms, were in favour of vitamin E (OR 0.16, CI 0.04-0.7, NNT 5 CI 2.-32 and OR 0.23, CI 0.10-0.55, NNT 4 CI 2. 5-12 respectively). People who had not used vitamin E showed more deterioration of their symptoms (OR 0.20, CI 0.04-0.93). No difference could be found regarding the presence of adverse effects or leaving the study early before the end of study. There is no trial-based information regarding the effect of vitamin E for those with early onset of TD. REVIEWER'S CONCLUSIONS: Small trials with uncertain quality of randomisation, tend to suggest that vitamin E improves the symptoms of TD. Methodological problems such as small sample size, short term interventions, and inappropriate use of crossover design need to be dealt with in any future studies. The results of a recently completed trial involving 158 participants are eagerly awaited.

Antipsychotic Agents↗
PubMed2000

Diuretics for respiratory distress syndrome in preterm infants.

BACKGROUND: Lung edema may complicate respiratory distress syndrome (RDS) in preterm infants. OBJECTIVES: The aim of this review was to assess the risks and benefits of diuretic administration in preterm infants with RDS. SEARCH STRATEGY: We used the standard search method of the Cochrane Neonatal Review Group. We searched Medline, Embase and the Cochrane Controlled Trials Register from the Cochrane Library, using the following keywords: and . In addition, we searched the abstract books of the American Thoracic Society and Pediatric Research Societies. SELECTION CRITERIA: We only included trials in which preterm infants with RDS and less than 5 days of age were randomly allocated to diuretic administration. Of those trials, we only included studies in which at least one of the following outcomes measures was evaluated: mortality, patent ductus arteriosus, hypovolemic shock, intraventricular hemorrhage, renal failure, duration of oxygen supplementation, duration of mechanical ventilation, need for oxygen supplementation at 28 days of life, oxygen supplementation at 36 weeks of postconceptional age (gestational age + postnatal age), length of stay, number of rehospitalizations during the first year of life, and neurodevelopmental outcome. DATA COLLECTION AND ANALYSIS: We used the standard method for the Cochrane Collaboration which is described in the Cochrane Collaboration Handbook. Two investigators extracted, assessed and coded separately all data for each study. Any disagreement was resolved by discussion. MAIN RESULTS: Six studies met inclusion criteria. Studies available for this systematic review were all done before the current era of prenatal steroids, surfactant, indomethacin and fluid restriction. Furosemide administration had no long-term benefits. Furosemide-induced transient improvement in pulmonary function did not outweigh an increased risk for patent ductus arteriosus and for hemodynamic instability. REVIEWER'S CONCLUSIONS: There are no current data to support routine diuretic administration in preterm infants with RDS. Elective administration of furosemide or any diuretic to any patient with RDS should be carefully weighed against the risk of precipitating hypovolemia. In addition, elective administration of furosemide should be weighed against the risk of developing a symptomatic patent ductus arteriosus.

Diuretics↗
PubMed2000

Cholinergic medication for neuroleptic-induced tardive dyskinesia.

BACKGROUND: Since the 1950's neuroleptic medication has been extensively used to treat people with chronic mental illnesses, such as schizophrenia. These may cause tardive dyskinesia (TD), abnormal, repetitive and involuntary movements, in up to 20% of those using the medication for longer than three months. One theory of causation supports the use of cholinergic drugs for the management of TD. OBJECTIVES: To determine whether the use of cholinergic agents (arecoline, choline, deanol, lecithin, meclofenoxate, physostigmine, RS 86) were associated with clinical improvement in neuroleptic-induced TD in people with schizophrenia or other chronic mental illnesses. SEARCH STRATEGY: Electronic searches of Biological Abstracts (1982-1995), Cochrane Schizophrenia Group's Register of trials (1995), EMBASE (1980-1995), LILACS (1982-1996), MEDLINE (1966-1995), PsycLIT (1974-1995), and SCISEARCH (1995) were undertaken. References of all identified studies were searched for further trial citations. Principal authors of trials were contacted. SELECTION CRITERIA: Reports identified in the search were included if they were controlled trials dealing with people with neuroleptic-induced TD and schizophrenia or other chronic mental illnesses who had been randomly allocated to either a cholinergic agent or to a placebo (or no intervention). DATA COLLECTION AND ANALYSIS: Seven different studies (8 references) were included in this review, and another ten trials are currently awaiting further data from authors. Data were independently extracted from these trials by each reviewer and odds ratios (OR) or average differences, with the 95% confidence intervals (95% CI) were estimated. The reviewers assumed that people who dropped out had no improvement. MAIN RESULTS: The studies failed to detect any significant advantage of deanol or lecithin when compared to placebo. Data from two deanol trials demonstrated an excess of side effects in the active treatment group. People on cholinergic compounds report a range of gastrointestinal adverse effects (anorexia, nausea, vomiting, diarrhea, abdominal pain), sedation, and undesirable body odour. One person died of acute aspiration in a deanol versus placebo cross-over study. REVIEWER'S CONCLUSIONS: This review provides no strong evidence for the use of cholinergic agents in the treatment of neuroleptic-induced tardive dyskinesia. While people receiving cholinergic treatment had a marginal benefit compared to placebo, because of the small sample size, the cumulative data must be interpreted as inconclusive. Clinicians and trialists considering using cholinergic agents to treat TD should balance the lack of evidence for the efficacy against the excess of side effects associated with these compounds.

Antipsychotic Agents↗
PubMed2000

Kinesthetic stimulation for preventing apnea in preterm infants.

BACKGROUND: Recurrent apnea is common in preterm infants, particularly at very early gestational ages. These episodes of loss of effective breathing can lead to hypoxemia and bradycardia, which may be severe enough to require resuscitation including use of positive pressure ventilation or other treatments. Physical stimulation is often used to restart breathing and it is possible that repeated stimulation, such as with an oscillating mattress (kinesthetic stimulation), might prevent apnea and its consequences. OBJECTIVES: In preterm infants at risk for apnea, does prophylactic use of kinesthetic stimulation lead to a clinically important reduction in apnea and bradycardia, and use of intemittent positive preswsure ventilation (IPPV). SEARCH STRATEGY: The standard search strategy of the Neonatal Review Group was used. This included searches of the Oxford Database of Perinatal trials, Cochrane Controlled Trials Register, MEDLINE, previous reviews including cross references, abstracts, conferences and symposia proceedings, expert informants, journal handsearching mainly in the English language. SELECTION CRITERIA: All trials in preterm infants at risk of developing clinical apnea which utilised random or quasi-random allocation to treatment with an oscillating mattress or control, were eligible. DATA COLLECTION AND ANALYSIS: Standard methods of the Cochrane Collaboration and its Neonatal Review Group were used with separate evaluation of trial quality and data extraction by each author and synthesis of the data using relative risk. MAIN RESULTS: There were no differences in short term effects (apnea /bradycardia, IVH, use of IPPV, sleep/wake cycles and neurological status at discharge) or longterm effects (in one trial - growth and development to one year). REVIEWER'S CONCLUSIONS: Implications for practice. Prophylactic use of kinesthetic stimulation cannot be recommended to reduce apnea/bradycardia in preterm infants. Implications for research. There are currently no clear research questions regarding prophylactic use of kinesthetic stimulation to prevent apnea in preterm infants.

Apnea↗
PubMed2000

Community interventions for preventing smoking in young people.

BACKGROUND: Decisions to smoke are made within a broad social context. Community interventions use co-ordinated, widespread, multi-component programmes to try and influence behaviour. OBJECTIVES: To determine the effectiveness of community interventions in preventing the uptake of smoking in young people. SEARCH STRATEGY: The Tobacco Addiction group specialised register, Medline and 21 other health, psychology and public policy electronic databases were searched, the bibliographies of identified studies were checked and contact was made with content area specialists. SELECTION CRITERIA: Randomised and non randomised controlled trials that assessed the effectiveness of multi-component community interventions compared to no intervention or to single component or school-based programmes only. Reported outcomes had to include smoking behaviour in young people under the age of 25 years. DATA COLLECTION AND ANALYSIS: Information relating to the characteristics and the content of community interventions, participants, outcomes and methods of the study was extracted by one reviewer and checked by a second. Studies were combined using qualitative narrative synthesis. MAIN RESULTS: Thirteen studies were included in the review, 44 studies did not meet all of the inclusion criteria. All studies used a controlled trial design, with four using random allocation of schools or communities. Of nine studies which compared community interventions to no intervention controls, two, which were part of cardiovascular disease prevention programmes, reported lower smoking prevalence. Of three studies comparing community interventions to school-based programmes only, one found differences in reported smoking prevalence. One study reported a lower rate of increase in prevalence in a community receiving a multi-component intervention compared to a community exposed to a mass media campaign alone. One study reported a significant difference in smoking prevalence between a group receiving a media, school and homework intervention compared to a group receiving the media component only REVIEWER'S CONCLUSIONS: There is some limited support for the effectiveness of community interventions in helping prevent the uptake of smoking in young people.

Adolescent↗
PubMed2004

When should the doctor order a spine X-ray? Identifying vertebral fractures for osteoporosis care: results from the European Prospective Osteoporosis Study (EPOS).

UNLABELLED: Vertebral fractures are common but usually remain unrecognized in primary care. Data from 2908 women and 2653 men in the EPOS study were used to derive algorithms to indicate the need for a spine X-ray to identify a fracture using easily elicited determinants. At a sensitivity of 50% for identifying cases, the specificity was increased from 50% to 78% in women and from 50% to 72% in men compared with a random allocation of X-rays. Use of X-rays can be optimized by selecting patients at high risk using a short screening procedure. INTRODUCTION: Previous osteoporotic fracture is an independent risk factor for further fractures and an indication for treatment. Vertebral fractures are the most common osteoporotic fractures before age 75, accounting for 48% of all fractures in men and 39% in women over 50. They usually remain unrecognized, so many patients requiring treatment are denied it, doubling their risk of a further fracture. Our objective was to develop an efficient algorithm indicating the need for an X-ray. MATERIALS AND METHODS: Data from 2908 women and 2653 men >or=50 years of age in the European Prospective Osteoporosis Study (EPOS) were analyzed. Lateral thoracic and lumbar spine radiographs were taken at baseline and at an average of 3.8 years later. Prevalent fractures were qualitatively diagnosed by an experienced radiologist. Fracture risk was modeled as a function of age, statural height loss since age 25, gender, and fracture history including limb fractures in the last 3 years using negative binomial regression. Receiver operating characteristic (ROC) curves were used to summarize a model's predictive ability, and a prediction algorithm was devised to identify those most likely to have a fracture. RESULTS: In a multivariate model for women, the risk of prevalent vertebral fracture significantly increased with age (RR, 1.67 [95% CI, 1.46, 1.93] per decade), statural height loss (1.06, [1.03, 1.10] per centimeter decrease), self-reported history of spine fracture (7.52 [5.52, 10.23]), and history of other major fracture (1.83 [1.46, 2.28]). Higher body weight reduced risk (0.86 [0.79, 0.95] per 10-kg increase). In men, the respective RR estimates were as follows: age (1.32 [1.18, 1.49]); height loss (1.06 [1.04, 1.09]); self-reported spine fracture (5.05 [3.69, 6.90]); other major fracture (1.42 [1.12, 1.81]); and weight (0.86 [0.79, 0.94]). Using algorithms based on these easily elicited determinants, specificity was increased from 50% to 78% in women and from 50% to 72% in men at a sensitivity of 50% compared with a random allocation of X-rays. At a sensitivity of 75%, the specificity was 50% in women and 40% in men. Inclusion of hip BMD (femoral neck or trochanter), measured in 1360 women and 1046 men, significantly improved the area under the ROC curves by 4% in women (p < 0.002) but not in men (p > 0.350). Spine BMD, measured in 982 women and 847 men, produced a significant 5% AUC improvement in women (p = 0.007) but not in men (p = 0.554). CONCLUSION: A woman 65 years of age with one vertebral fracture has a one in four chance of another fracture over 5 years, which can be reduced to one in eight by treatment. Positive treatment decisions are often contingent on identifying a vertebral fracture. Selective use of lateral vertebral X-rays can be optimized using a 2-minute screening procedure administered by a nurse.

Age Factors↗
PubMed2000

Parent-training programmes for improving maternal psychosocial health.

BACKGROUND: The prevalence of mental health problems in women is 1:3 and such problems tend to be persistent. There is evidence from a range of studies to suggest that a number of factors relating to maternal psychosocial health can have a significant effect on the mother-infant relationship, and that this can have consequences for the psychological health of the child. It is now thought that parenting programmes may have an important role to play in the improvement of maternal psychosocial health. OBJECTIVES: The objective of this review is to address whether group-based parenting programmes are effective in improving maternal psychosocial health including anxiety, depression and self-esteem. SEARCH STRATEGY: A range of biomedical, social science, educational and general reference electronic databases were searched including MEDLINE, EMBASE CINAHL, PsychLIT, ERIC, ASSIA, Sociofile and the Social Science Citation Index. Other sources of information included the Cochrane Library (SPECTR, CENTRAL), and the National Research Register (NRR). SELECTION CRITERIA: Only randomised controlled trials were included in which participants had been randomly allocated to an experimental and a control group, the latter being either a waiting-list, no-treatment or a placebo control group. Studies had to include at least one group-based parenting programme, and one standardised instrument measuring maternal psychosocial health. DATA COLLECTION AND ANALYSIS: A systematic critical appraisal of all included studies was undertaken using the Journal of the American Medical Association (JAMA) published criteria. The data were summarised using effect sizes but were not combined in a meta-analysis due to the small number of studies within each group and the presence of significant heterogeneity. MAIN RESULTS: A total of 22 studies were included in the review but only 17 provided sufficient data to calculate effect sizes. These 17 studies reported on a total of 59 outcomes including depression, anxiety, stress, self-esteem, social competence, social support, guilt, mood, automatic thoughts, dyadic adjustment, psychiatric morbidity, irrationality, anger and aggression, mood, attitude, personality, and beliefs. Approximately 22% of the outcomes measured suggested significant differences favouring the intervention group. A further 40% showed differences favouring the intervention group but which failed to achieve conventional levels of statistical significance, in some cases due to the small numbers that were used. Approximately 38% of outcomes suggested no evidence of effectiveness. REVIEWER'S CONCLUSIONS: It is suggested that parenting programmes can make a significant contribution to the improvement of psychosocial health in mothers. While the critical appraisal suggests some variability in the quality of the included studies, it is concluded that there is sufficient evidence to support their use with diverse groups of parents. However, it is also suggested that some caution should be exercised before the results are generalised to parents irrespective of the level of pathology present, and that further research is still required.

Anxiety↗
PubMed2000

Furosemide for symptomatic patent ductus arteriosus in indomethacin-treated infants.

BACKGROUND: Inhibition of prostaglandin synthesis mediates closure of the ductus arteriosus and renal side effects after indomethacin administration. Because furosemide increases prostaglandin production, it could potentially help prevent indomethacin-related toxicity but also decrease ductal response to indomethacin. OBJECTIVES: The primary objectives of this review were to assess (1) whether furosemide affects the incidence of failure of ductal closure after indomethacin and that of indomethacin-related toxicity and (2) the effect of furosemide on mid-term and long-term outcome. The secondary objective was to determine whether the effect of furosemide on renal function and water balance depends on prior extracellular volume (assessed by blood urea nitrogen [BUN]/creatinine ratio). SEARCH STRATEGY: We searched electronic databases (Medline, Embase and Cochrane) and selected abstract books, without language restriction. SELECTION CRITERIA: We selected studies with (1) random allocation to either indomethacin alone or indomethacin and furosemide and (2) analysis of either short-term risk-benefit ratio of furosemide, mid- or long-term outcome, or the relationship between extracellular volume at study entry and changes in renal function. DATA COLLECTION AND ANALYSIS: We assessed studies for possible bias and for quality of assessment of ductal patency. We assessed categorical variables using relative risk and absolute risk reduction. We assessed the effects of furosemide on renal function and fluid balance by comparing changes from baseline in the treatment group with those in controls. Subsets were determined a priori based on BUN/creatinine ratio at study entry. MAIN RESULTS: All 3 studies fulfilling the entry criteria had limitations, including possible or definite bias. There was substantial heterogeneity among studies. Furosemide administration did not significantly increase the risk of failure of ductal closure; however, sample size was insufficient to rule out even a 31% increase. In the subset with initial BUN/creatinine ratio > 20 mg/mg, 2 of 18 patients receiving furosemide could not complete a 3-dose course of indomethacin because of toxicity. Minimal or no information was available about any of the other main outcome variables. Furosemide increased urine output regardless of the initial BUN/creatinine ratio, leading to a 5% weight loss during a 3-dose course, an undesired effect in patients with initial BUN/creatinine ratio > 20 mg/mg. Furosemide increased creatinine clearance only in patients with initial BUN/creatinine ratio <20 mg/mg. REVIEWER'S CONCLUSIONS: There is not enough evidence to support the administration of furosemide to premature infants treated with indomethacin for symptomatic patent ductus arteriosus. Furosemide appears to be contraindicated in the presence of dehydration in those infants.

Cyclooxygenase Inhibitors↗
PubMed2000

Continuous positive airway pressure versus theophylline for apnea in preterm infants.

BACKGROUND: Recurrent apnea is common in preterm infants, particularly at very early gestational ages. These episodes of loss of effective breathing can lead to hypoxemia and bradycardia which may be severe enough to require resuscitation including use of positive pressure ventilation. Theophylline stimulation of breathing and continuous positive airways pressure have been used to prevent apnea and its consequences. OBJECTIVES: The main objective was to determine in preterm infants with recurrent apnea, if treatment with CPAP compared with treatment with theophylline leads to a clinically important reduction in apnea or use of mechanical ventilation, without clinically important side effects. SEARCH STRATEGY: The standard search strategy of the Neonatal Review Group was used. This includes searches of the Oxford Database of Perinatal Trials, Cochrane Controlled Trials Register, MEDLINE, previous reviews including cross references, abstracts, conferences, symposia proceedings, expert informants and journal hand searching mainly in the English language. SELECTION CRITERIA: All trials using random or quasi-random allocation to CPAP or theophylline in preterm infants with clinical recurrent apnea/bradycardia were eligible. DATA COLLECTION AND ANALYSIS: Data were extracted using standard methods of the Cochrane Collaboration and its Neonatal Review Group, with separate evaluation of trial quality and data extraction by each author and synthesis of data using relative risk. MAIN RESULTS: The use of mask CPAP is associated with a higher treatment failure rate as measured by less than a 50% reduction in apnea or use of the alternative treatment [RR 2.89 (95% CI 1.12,7.47); RD 0.42 (95% CI 0. 11, 0.74)]. For every 2.4 infants (95% CI 1.4, 9.5) treated with mask CPAP rather than theophylline, there results one treatment failure. In the mask CPAP group there is more use of IPPV [RR 3.09 (1.42,6.70; RD 0.58 (95% CI 0.30, 0.86). For every 1.7 infants (95% CI 1.2, 3.3) treated with mask CPAP rather than theophylline, one infant is intubated for IPPV. In the mask CPAP group, there are trends towards more deaths in the first year, and in death or major disability in survivors at follow up, which do not reach significance. There are no differences in rates of necrotizing enterocolitis or major disability in survivors at follow up. REVIEWER'S CONCLUSIONS: Theophylline is more effective than mask CPAP for preterm infants with apnea. Since CPAP is no longer administered by mask, the results of this review have limited importance for current clinical practice. Further evaluation of the benefits and harms of CPAP vs theophylline for preterm infants with apnea requires further trials in which CPAP is administered by current methods.

Apnea↗
PubMed2002

Randomised trials in the South African Medical Journal, 1948-1997.

OBJECTIVE: To describe randomised controlled trials (RCTs) published in the South African Medical Journal (SAMJ) over a 50-year period from 1948 to 1997 with regard to number, topic and quality. METHODS: We hand searched all issues of the SAMJ published during the study period to identify all published RCTs. OUTCOME MEASURES: Number, topic and quality of RCTs published from 1948 to 1997. RESULTS: Eight hundred and fifty-eight clinical trials were published during the period reviewed. Eighty-four per cent of RCTs were published as full articles. During the 1980s the number of RCTs published increased rapidly, with a peak of 35 in 1985, but then declined to only 5 in 1997. The majority (92%) of RCTs were conducted in a hospital setting. A varied range of subjects was covered, with gastroenterology taking the lead and no trials in public health. The sample size in more than 50% of RCTs was smaller than 50 patients. Fifty-one per cent (435 trials) used random allocation and 49% (423) quasi-random methods of allocation. Concealment of treatment allocation was judged to be adequate in 46% of studies (N = 200), blinding of observers assessing outcomes was adequate in 28% (123), and all the allocated test subjects were included in the primary analysis in 28% (123). The follow-up period was more than 1 year in 4% (17) and less than 6 days in 16% (71). CONCLUSIONS: Compared with other international journals the SAMJ is highly regarded in terms of the number of trials published. There are, however, a number of deficiencies in the quality of the trials.

Clinical Protocols↗
PubMed2004

Effective treatment and control of biting lice, Felicola subrostratus (Nitzsch in Burmeister, 1838), on cats using fipronil formulations.

The efficacy of 0.25% fipronil spray (Frontline Spray, Merial), 10% fipronil spot-on (Frontline Spot-on for Cats, Merial) and 10% fipronil/12% (S)-methoprene (Frontline Plus for Cats, Merial) against the biting louse Felicola subrostratus on cats was assessed and confirmed under laboratory conditions. A field study evaluated the efficacy of a single topical application of Frontline Spray, and spot-on against the parasite on cats. In the laboratory studies, animals were allocated based on pre-treatment louse counts to the treatment groups: (1) untreated control and (2) 10% fipronil spot-on in the exploratory study or (1) untreated control, (2) 0.25% fipronil spray, at 6 ml/kg; (3) 10% fipronil spot-on as per label and (4) 10% fipronil/12% (S)-methoprene as per label in the confirmation study. Cats in treatment groups 2-4 were treated twice topically on Days 0 and 28. No live F. subrostratus were found on cats treated with fipronil formulations at any post-treatment examination. The difference from controls was significant (P < 0.01) for each product at each examination. Based on whole body counts at Day 42, the efficacy of each product was determined to be 100%. In the field study, cats were allocated in strict order of presentation. Cats were randomly allocated to one of the three treatment groups: (1) propoxur collar (Bolfo, Bayer); (2) 0.25% fipronil spray, at 6 ml/kg and (3) 10% fipronil spot-on as per label. Cats were treated once topically on Day 0. Louse counts of cats treated with fipronil formulations were not different than those of cats receiving the propoxur collar. The efficacy was determined to be > 98% on Day 2 and 100% on Days 28 and 42 in all treatment groups. The results of these studies demonstrate that fipronil in topical formulations is effective for treatment and control of biting lice (F. subrostratus) infestations on cats.

Administration, Topical↗
PubMed2004

Tocolytic therapy in conservative management of symptomatic placenta previa.

OBJECTIVES: To study the effect of ritodrine therapy on maternal and perinatal outcome in cases of symptomatic placenta previa being managed conservatively. METHODS: A prospective, randomized controlled clinical trial was made of a total of 60 women whose pregnancies ranged from 28 through 34 menstrual weeks who were randomly allocated to the two study groups using Tippet's random number table. Of these women, 30 were included in the study group where tocolysis with ritodrine was given whereas the other 30 in the control group did not receive tocolysis. Prolongation of pregnancy and birth weight of the newborn were evaluated. The unpaired t-test and chi-square test were used for statistical analysis. RESULTS: Use of tocolysis in symptomatic placenta previa was associated with significant prolongation of pregnancy (25.33 vs. 14.47 days, P<0.05) and difference in birth weight (2270 g vs. 1950 g, P<0.05). There was no observed statistical difference between the two groups with regard to number of episodes of hemorrhage after admission, total amount of blood loss during stay in hospital, number of blood transfusions and maternal complications due to tocolysis in the study group. CONCLUSIONS: The present prospective study suggests that ritodrine hydrochloride in patients with symptomatic placenta previa tends to prolong the pregnancy and result in an increase in birth weight of the babies without causing any adverse effect on the mother and fetus.

Adult↗
PubMed2002

Allocation concealment in randomised trials: defending against deciphering.

Proper randomisation rests on adequate allocation concealment. An allocation concealment process keeps clinicians and participants unaware of upcoming assignments. Without it, even properly developed random allocation sequences can be subverted. Within this concealment process, the crucial unbiased nature of randomised controlled trials collides with their most vexing implementation problems. Proper allocation concealment frequently frustrates clinical inclinations, which annoys those who do the trials. Randomised controlled trials are anathema to clinicians. Many involved with trials will be tempted to decipher assignments, which subverts randomisation. For some implementing a trial, deciphering the allocation scheme might frequently become too great an intellectual challenge to resist. Whether their motives indicate innocent or pernicious intents, such tampering undermines the validity of a trial. Indeed, inadequate allocation concealment leads to exaggerated estimates of treatment effect, on average, but with scope for bias in either direction. Trial investigators will be crafty in any potential efforts to decipher the allocation sequence, so trial designers must be just as clever in their design efforts to prevent deciphering. Investigators must effectively immunise trials against selection and confounding biases with proper allocation concealment. Furthermore, investigators should report baseline comparisons on important prognostic variables. Hypothesis tests of baseline characteristics, however, are superfluous and could be harmful if they lead investigators to suppress reporting any baseline imbalances.

Adult↗
PubMed2005

[The CONSORT statement for cluster randomised trials].

With the publication of the CONSORT statement there is now increased awareness of the need to adequately report the findings of randomised controlled trials. The CONSORT statement includes a checklist of items that should be addressed in the trial report. The original CONSORT statement was developed to ensure the appropriate reporting of parallel group randomised controlled trials in which individual participants are allocated to different intervention groups. In cluster randomised trials, however, groups of participants, rather than individuals, are randomly allocated to study groups. The process of allocating groups of participants raises additional reporting considerations and led to the publication of an extension to the CONSORT statement specifically for cluster randomised trials. In this paper we review the CONSORT extension to cluster randomised trials, outlining the special features of the cluster randomised trial which must be considered.

Authorship↗