Understanding controlled trials. Randomising groups of patients.
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Effect of uterotonics on intra-operative blood loss during laparoscopy-assisted vaginal hysterectomy: a randomised controlled trial.
OBJECTIVE: To investigate the effectiveness of uterotonics misoprostol and oxytocin on reducing blood loss during laparoscopy-assisted vaginal hysterectomy (LAVH). DESIGN: Randomised, double-blind placebo-controlled trial. SETTING: University hospital. POPULATION: One hundred and seventy-three women underwent LAVH for symptomatic uterine myomas and were randomly allocated to uterotonics (n = 91) or placebo (n = 82). METHODS: Women underwent LAVH for symptomatic uterine myomas and were randomly assigned to receive either rectal misoprostol (400 microg) and intravenous oxytocin (10 IU/hour) or placebo during LAVH. Parameters related to surgical outcome were compared. MAIN OUTCOME MEASURES: The main outcome measure was intra-operative blood loss. RESULTS: Patient characteristics and indications for LAVH were similar in both groups. Mean [SD] for all continuous data estimated weight of blood loss (198.1 [123.2] vs 396 [337.6] g; P < 0.0001), mean operation time (106.2 [39.4] vs 116.6 [34.6] minutes; P = 0.02), mean change in haemoglobin (1.5 [1.0] vs 1.9 [1.2] g/dL; P = 0.02) and haematocrit levels (4.8 [2.9]% vs 5.8 [3.6]%; P = 0.04) and mean hospitalisation period (3.3 [0.8] vs 3.9 [1.1] days; P < 0.0001), which were significantly less in the group given rectal misoprostol and intravenous oxytocin than in the placebo group, respectively. There was no significant difference in complications and side effects between the two groups (P > 0.05). CONCLUSION: Combined rectal misoprostol and intravenous oxytocin is a feasible and effective method of reducing blood loss and operation time in LAVH.
Administration, Rectal↗
Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomised controlled trial. Galantamine International-1 Study Group.
OBJECTIVE: To evaluate the efficacy and safety of galantamine in the treatment of Alzheimer's disease. DESIGN: Randomised, double blind, parallel group, placebo controlled trial. SETTING: 86 outpatient clinics in Europe and Canada. PARTICIPANTS: 653 patients with mild to moderate Alzheimer's disease. INTERVENTION: Patients randomly assigned to galantamine had their daily dose escalated over three to four weeks to maintenance doses of 24 or 32 mg. MAIN OUTCOME MEASURES: Scores on the 11 item cognitive subscale of the Alzheimer's disease assessment scale, the clinician's interview based impression of change plus caregiver input, and the disability assessment for dementia scale. The effect of apolipoprotein E4 genotype on reponse to treatment was also assessed. RESULTS: At six months, patients who received galantamine had a significantly better outcome on the 11 item cognitive subscale of the Alzheimer's disease assessment scale than patients in the placebo group (mean treatment effect 2.9 points for lower dose and 3.1 for higher dose, intention to treat analysis, P<0.001 for both doses). Galantamine was more effective than placebo on the clinician's interview based impression of change plus caregiver input (P<0.05 for both doses v placebo). At six months, patients in the higher dose galantamine group had significantly better scores on the disability assessment for dementia scale than patients in the placebo group (mean treatment effect 3.4 points, P<0.05). Apolipoprotein E genotype had no effect on the efficacy of galantamine. 80% (525) of patients completed the study. CONCLUSION: Galantamine is effective and well tolerated in Alzheimer's disease. As galantamine slowed the decline of functional ability as well as cognition, its effects are likely to be clinically relevant.
Aged↗
Randomised controlled trial of general practitioner intervention in patients with excessive alcohol consumption.
OBJECTIVE: To determine effectiveness of advice from general practitioners to heavy drinkers to reduce their excessive alcohol consumption (35 U or more a week for men, 21 U or more for women). DESIGN: Randomised, controlled double blind trial over 12 months with interim assessment at six months. SETTING: Group practices (n = 47; list size averaging 10,000) recruited from Medical Research Council's general practice research framework, mostly in rural or small urban settings. PATIENTS: Patients recruited after questionnaire survey. Of total of 2571 (61.2%) of 4203 patients invited for interview who attended, 909 (35.4%) stated that in past seven days they had drunk above the limits set for study and had not received advice; they were randomised to control and treatment groups. INTERVENTIONS: Patients in treatment group were interviewed by general practitioner (who had had a training session) and received advice and information about how to reduce consumption and also given a drinking diary. END POINT: Study aimed at detecting a reduction in proportion of men with excessive alcohol consumption of 30% in treatment group and 20% in control group (for women 40% and 20%, respectively) with a power of 90% at 5% level of significance. In addition, corroborative measures such as estimation of gamma-glutamyltransferase activity were included. MEASUREMENTS AND MAIN RESULTS: At one year a mean reduction in consumption of alcohol of 18.2 (SE 1.5) U/week had occurred in treated men compared with a reduction of 8.1 (1.6) U/week in controls (p less than 0.001). The proportion of men with excessive consumption at interview had dropped by 43.7% in the treatment group compared with 25.5% in controls (p less than 0.001). A mean reduction in weekly consumption of 11.5 (1.6) U occurred in treated women compared with 6.3 (2.0) U in controls (p less than 0.05), with proportionate reductions of excessive drinkers in treatment and control groups of 47.7% and 29.2% respectively. Reduction in consumption increased significantly with number of general practitioner interventions. At one year the mean value for gamma-glutamyltransferase activity had dropped significantly more in treated men (-2.4 (0.9)IU/l) than in controls (+1.1(1.0)IU/l; t = 2.7, p less than 0.01). Reduction in gamma-glutamyltransferase activity tended to increase with number of intervention sessions in men. Changes in gamma-glutamyltransferase activity in women and changes in other indicators in both sexes did not differ significantly between treatment and control groups. CONCLUSIONS: If the results of this study were applied to the United Kingdom intervention by general practitioners could each year reduce to moderate levels the alcohol consumption of some 250000 men and 67500 women who currently drink to excess. General practitioners and other members of the primary health care team should therefore be encouraged to include counselling about alcohol consumption in their preventive activities.
Adolescent↗
Three day versus five day treatment with amoxicillin for non-severe pneumonia in young children: a multicentre randomised controlled trial.
OBJECTIVE: To assess the efficacy of three days versus five days of treatment with oral amoxicillin for curing non-severe pneumonia in children. DESIGN: Randomised, double blind, placebo controlled multicentre trial. SETTING: Outpatient departments of seven referral hospitals in India. PARTICIPANTS: 2188 children aged 2-59 months, 1095 given three days of treatment and 1093 given five days. INTERVENTION: Oral amoxicillin 31-54 mg/kg/day in three divided doses. MAIN OUTCOME MEASURES: Treatment failure: defined as development of chest indrawing, convulsions, drowsiness, or inability to drink at any time; respiratory rate above age specific cut points on day 3 or later; or oxygen saturation by pulse oximetry < 90% on day 3. RESULTS: The clinical cure rates with three days and five days of treatment were 89.5% and 89.9%, respectively (absolute difference 0.4 (95% confidence interval--2.1 to 3.0)). Adherence to treatment regimen was 94% and 85% for three day and five day treatments, respectively. Loss to follow up was 5.4% by day 5. There were no deaths, 41 hospitalisations, and 36 minor adverse reactions. There were 225 (10.3%) clinical failures and 106 (5.3%) relapses, and rates were similar in both treatments. At enrollment, 513 (23.4%) children tested positive for respiratory syncytial virus, and Streptococcus pneumoniae and Haemophilus influenzae were isolated from the nasopharynx in 878 (40.4%) and 496 (22.8%) children, respectively. Clinical failure was associated with isolation of respiratory syncytial virus (adjusted odds ratio 1.95 (95% confidence interval 1.0 to 3.8)), excess respiratory rate of > 10 breaths/minute (2.89 (1.83 to 4.55)), and non-adherence with treatment at day 5 (11.57 (7.4 to 18.0)). CONCLUSIONS: Treatment with oral amoxicillin for three days was as effective as for five days in children with non-severe pneumonia.
Amoxicillin↗
A randomised controlled trial of metronidazole for the prevention of preterm birth in women positive for cervicovaginal fetal fibronectin: the PREMET Study.
OBJECTIVE: To determine whether metronidazole reduces early preterm labour in asymptomatic women with positive vaginal fetal fibronectin (fFN) in the second trimester of pregnancy. DESIGN: Randomised placebo-controlled trial. SETTING: Fourteen UK hospitals (three teaching). POPULATION: Pregnancies with at least one previous risk factor, including mid-trimester loss or preterm delivery, uterine abnormality, cervical surgery or cerclage. METHODS: Nine hundred pregnancies were screened for fFN at 24 and 27 weeks of gestation. Positive cases were randomised to a week's course of oral metronidazole or placebo. MAIN OUTCOME MEASURES: Primary outcome was delivery before 30 weeks of gestation. Secondary outcomes included delivery before 37 weeks. RESULTS: The Trial Steering Committee (TSC) recommended the study be stopped early; 21% of women receiving metronidazole (11/53) delivered before 30 weeks compared with 11% (5/46) taking placebo [risk ratio 1.9, 95% confidence interval (CI) 0.72-5.09, P = 0.18]. There were significantly more preterm deliveries (before 37 weeks) in women treated with metronidazole 33/53 (62%) versus placebo 18/46 (39%), risk ratio 1.6, 95% CI 1.05-2.4. fFN was a good predictor of early preterm birth in these asymptomatic women; positive and negative predictive values (24 weeks of gestation) for delivery by 30 weeks were 26% and 99%, respectively (positive and negative likelihood ratios 15, 0.35). CONCLUSION: Metronidazole does not reduce early preterm birth in high risk pregnant women selected by history and a positive vaginal fFN test. Preterm delivery may be increased by metronidazole therapy.
Administration, Oral↗
A double blind, randomised, controlled trial of glutamine supplementation in parenteral nutrition.
BACKGROUND AND AIMS: To determine whether the inclusion of 20 g free glutamine as part of the nitrogen source of parenteral feeds reduces length of hospital stay or mortality. METHODS: In a randomised, double blind, controlled trial in 168 patients clinically accepted for parenteral nutrition, standard feeds were compared with feeds in which 3.8 g of the total nitrogen was replaced with the equivalent 20 g glutamine. A minimum of 11 g nitrogen/day was used in all patients. Daily intakes of energy and nitrogen were determined using a validated computer protocol and were similar for the two groups. All feeds included trace elements, vitamins, electrolytes, and minerals. RESULTS: A total of 85 patients received a median of eight (interquartile range 5-13) daily feeds containing glutamine while 83 received a median of eight (5-15) standard feeds. No difference between groups was detected for infective complications. Twenty control patients and 14 who had received glutamine died during their hospital stay (NS). Median length of stay was 32 (23-52) days on glutamine, which was not significantly different from the control value of 35 (25-55) days. Glutamine was associated with a significant (p<0.03) reduction in length of stay in surgical patients (45 days (range 29-81) versus 30 days (range 19-54)). CONCLUSION: The benefit from glutamine supplementation of parenteral feeds as used in this trial has not been proved. Supplementation may have advantages in surgical patients and in haematological malignancy. Further trials are required.
Adolescent↗
Mobile health apps improve Health-Related Quality of Life in Type 2 Diabetes Mellitus by enhancing medication adherence: A multicentre randomised controlled trial with mediation analysis.
AIMS: This study evaluated whether a gamified mHealth application (CareAide®) improves Health-Related Quality of Life (HRQoL) in Type 2 Diabetes Mellitus (T2DM) and whether this effect is mediated by medication adherence. METHODS: Prespecified secondary analysis of the T2DM cohort from a 6-month multicentre RCT (NCT06068309; N = 663; three Malaysian hospitals). Participants were randomised 1:1 to standard care or CareAide®. Adherence (MMAS-8), EQ-5D-5L utility (Malaysian value set), and AQoL-6D were assessed at baseline and 6 months. Simple mediation analysis (PROCESS Model 4; 5000 bootstraps) adjusted for baseline HRQoL. RESULTS: CareAide® significantly predicted higher MMAS-8 scores (mean difference +1.756; d = 1.638; p < 0.001). Higher MMAS-8 scores significantly predicted improved AQoL-6D utility (b = 0.024; p < 0.001). The direct effect on AQoL-6D was non-significant (p = 0.248). Bootstrapped indirect effect confirmed full mediation via AQoL-6D (0.042; 95% CI [0.024, 0.060]). A sensitivity analysis adjusting for baseline HbA1c confirmed full mediation (indirect = 0.034; 95% CI [0.015, 0.052]; n = 563). EQ-5D-5L utility showed a significant direct between-group difference at 6 months (p = 0.012) but did not operate as a mediation outcome. CONCLUSIONS: Medication adherence fully mediates the AQoL-6D HRQoL benefit of a gamified mHealth intervention in T2DM, as confirmed by both the primary and HbA1c-adjusted sensitivity analyses. These findings support integration of behaviourally informed digital adjuncts into routine primary diabetes care.
Humans↗
Randomised controlled trial of physiological and ventricular pacing.
Thirteen patients have completed a randomised double blind cross over study to compare the effects of chronic ventricular and atrial synchronous pacing on exercise capacity and symptoms. Maximal symptom limited exercise was significantly increased after one month of atrial synchronous pacing compared with ventricular pacing. Symptomatic assessment (by diary card and monthly symptom scores) of "shortness of breath", "palpitation", and "general well-being" was significantly improved during the physiological pacing mode. Atrial synchronous pacing has been shown to be superior to ventricular pacing.
Adult↗
Randomised controlled trial of cisapride in feed intolerance in preterm infants.
AIM: To assess the efficacy of cisapride in reducing the time required to establish enteral feeds in preterm infants. METHODS: A randomised, double blind, placebo controlled trial was conducted of 34 infants of < or = 32 weeks of gestation, assigned to receive either cisapride 0.2 mg/kg/dose four times daily (n = 18) or placebo (n = 16). RESULTS: The time taken by the babies to tolerate full enteral feeds was not significantly different between the groups (median 9.5 days vs 10 days). There was a significantly lower incidence of large gastric residuals and regurgitation in the treated group compared with the placebo group. The number of episodes of large gastric residuals per infant was also significantly less. No adverse effects were noted. CONCLUSION: The routine use of cisapride in preterm infants cannot be recommended to decrease the time to establish enteral feeds. Its use may be justified for clinically significant gastric stasis or regurgitation.
Cisapride↗
A randomised controlled trial of two methods of delivering nasal continuous positive airway pressure after extubation to infants weighing less than 1000 g: binasal (Hudson) versus single nasal prongs.
OBJECTIVES: Primary: to determine whether nasal continuous positive airway pressure (CPAP) delivered through binasal prongs results in a greater proportion of extremely low birthweight infants being successfully extubated, after a period of intermittent positive pressure ventilation, than nasal CPAP delivered by a single nasal prong. Secondary: to evaluate the effect of mode of delivery of nasal CPAP after extubation on the need for endotracheal reintubation, weight gain, rates of feeding intolerance, sepsis, suspected sepsis, cranial ultrasound abnormalities, retinopathy of prematurity, chronic lung disease, and the duration of assisted ventilation and care in the tertiary neonatal unit. DESIGN AND SETTING: Randomised, controlled, clinical trial conducted at the neonatal intensive care unit of the Royal Women's Hospital, Melbourne, Australia. PATIENTS: Infants of birth weight less than 1000 g, ventilated, requiring < 50% oxygen and ventilator rate less than or equal to 20/minute, and considered by the clinical management team to be ready for extubation. INTERVENTION: Infants were randomly allocated to receive nasal CPAP delivered through binasal (Hudson) prongs or a single nasal prong. PRIMARY OUTCOME MEASURE: Failure of extubation as defined by the following criteria: (a) apnoea (more than one episode/hour over a six hour period or one episode requiring bag and mask ventilation); (b) absolute increase in oxygen requirement greater than 15% above that required before extubation; (c) respiratory acidosis (pH < 7.25 with PCO(2) > 6.67 kPa). RESULTS: Ten of the 41 (24%) infants randomised to binasal prongs reached predetermined failure criteria compared with 26 of the 46 (57%) infants randomised to a single nasal prong (p = 0.005). Four of 17 (24%) infants of birth weight less than 800 g extubated to binasal prongs reached failure criteria compared with 14 of 16 (88%) extubated to a single nasal prong (p < 0.001). There were no significant differences in any of the secondary outcomes. CONCLUSIONS: For extremely low birthweight infants ventilated using an endotracheal tube, nasal CPAP delivered through binasal (Hudson) prongs is more effective in preventing failure of extubation than that delivered through a single nasal prong.
Device Removal↗
Single-dose ciprofloxacin versus 12-dose erythromycin for childhood cholera: a randomised controlled trial.
BACKGROUND: Single-dose ciprofloxacin is effective for the treatment of severe cholera in adults. We assessed whether single-dose ciprofloxacin would be as effective as 3-day, 12-dose erythromycin in achieving clinical cure in children with severe cholera. METHODS: We did a randomised, open label, controlled trial in children age 2-15 years with V cholerae O1 or O139 present in stool on dark-field microscopy. Children received either a single 20 mg/kg dose of ciprofloxacin (n=90) or 12.5 mg/kg of erythromycin (n=90) every 6 h for 3 days, and remained in hospital for 5 days. The primary outcome was clinical success of treatment, defined as cessation of watery stools within 48 h of start of drug treatment. Analysis was per protocol. This study is registered with the ClinicalTrials.gov Protocol Registration System at http://www.clinicaltrials.gov (registration number NCT 00142272) [corrected] FINDINGS: Of 180 children randomised 162 completed the study. Treatment was clinically successful in 60% (47/78) of children treated with ciprofloxacin and in 55% (46/84) of those treated with erythromycin (difference 5% [95% CI -10 to 21]). Children receiving ciprofloxacin vomited less often (58%vs 74%; difference 16% [2 to 30]), had fewer stools (15 vs 21; 6 [0 to 9]), and less stool volume (152 vs 196 mL/kg; 43 mL/kg [13 to 87]) than those receiving erythromycin. Bacteriological failure was more common in ciprofloxacin-treated patients (58%vs 30%; 28% [13 to 43]) than erythromycin-treated patients. INTERPRETATION: Single-dose ciprofloxacin achieves clinical outcomes similar to, or better than, those achieved with 12-dose erythromycin treatment in childhood cholera, but is less effective in eradicating V cholerae from stool.
Adolescent↗
Randomised controlled trial of zinc supplementation in malnourished Bangladeshi children with acute diarrhoea.
OBJECTIVE: To evaluate the impact of zinc supplementation on the clinical course, stool weight, duration of diarrhoea, changes in serum zinc, and body weight gain of children with acute diarrhoea. DESIGN: Randomised double blind controlled trial. Children were assigned to receive zinc (20 mg elemental zinc per day) containing multivitamins or control group (zinc-free multivitamins) daily in three divided doses for two weeks. SETTING: A diarrhoeal disease hospital in Dhaka, Bangladesh. PATIENTS: 111 children, 3 to 24 months old, below 76% median weight for age of the National Center for Health Statistics standard with acute diarrhoea. Children with severe infection and/or oedema were excluded. MAIN OUTCOME MEASURES: Total diarrhoeal stool output, duration of diarrhoea, rate of weight gain, and changes in serum zinc levels after supplementation. RESULTS: Stool output was 28% less and duration 14% shorter in the zinc supplemented group than placebo (p = 0.06). There were reductions in median total diarrhoeal stool output among zinc supplemented subjects who were shorter (less than 95% height for age), 239 v 326 g/kg (p < 0.04), and who had a lower initial serum zinc (< 14 mmol/l), 279 v 329 g/kg (p < 0.05); a shortening of mean time to recovery occurred (4.7 v 6.2 days, p < 0.04) in those with lower serum zinc. There was an increase in mean serum zinc in the zinc supplemented group (+2.4 v -0.3 mumol/l, p < 0.001) during two weeks of supplementation, and better mean weight gain (120 v 30 g, p < 0.03) at the time of discharge from hospital. CONCLUSIONS: Zinc supplementation is a simple, acceptable, and affordable strategy which should be considered in the management of acute diarrhoea and in prevention of growth faltering in children specially those who are malnourished.
Acute Disease↗
Randomised controlled trial of cardioprotective diet in patients with recent acute myocardial infarction: results of one year follow up.
OBJECTIVE: To test whether a fat reduced diet rich in soluble dietary fibre, antioxidant vitamins, and minerals reduces complications and mortality after acute myocardial infarction. DESIGN: Randomised, single blind, controlled trial. SETTING: Primary and secondary care research centre for patients with myocardial infarction. SUBJECTS: 505 patients with suspected acute myocardial infarction. Those with definite or possible acute myocardial infarction and unstable angina based on World Health Organisation criteria were assigned to diet A (n = 204) or diet B (n = 202) within 24-48 hours of infarction. INTERVENTIONS: Both groups were advised to follow a fat reduced diet. Group A was also advised to eat more fruit, vegetables, nuts, and grain products. MAIN OUTCOME MEASURES: Mortality from cardiac disease and other causes. Serum lipid concentrations and compliance with diet. RESULTS: Blood lipoprotein concentrations and body weight fell significantly in patients in group A compared with those in group B (cholesterol fell by 0.74 mmol/l in group A v 0.32 mmol/l in group B, 95% confidence interval of difference 0.14 to 0.70, and weight by 7.1 v 3.0 kg, 0.52 to 7.68). The incidence of cardiac events was significantly lower in group A than group B (50 v 82 patients, p less than 0.001). Group A also had lower total mortality (21 v 38 died, p less than 0.01) than group B. CONCLUSIONS: Comprehensive dietary changes in conjunction with weight loss immediately after acute myocardial infarction may modulate blood lipoproteins and significantly reduce complications and mortality after one year.
Adult↗
Randomised controlled trials relevant to aggressive and violent people, 1955-2000: a survey.
BACKGROUND: Randomised trials remain the gold standard for evaluating health interventions. This applies to the criminal justice system as well as to health. AIMS: To identify and survey randomised trials relevant to forensic mental health services. METHOD: We searched 29 electronic bibliographic databases and acquired randomised trials involving sex offenders, arsonists or people clearly and actively aggressive, or abusive of children or spouse. Two researchers reliably extracted data. RESULTS: Of 409 studies found, we able to acquire 300 for further inspection. They all involved particularly violent people (total n=28 669), mostly adult men; the mean study size was 197 (median 52, mode 60, range 1-1200).In these randomised trials over 700 interventions were evaluated and short-term outcomes were recorded on 345 different scales. CONCLUSIONS: Wider collaboration, rationalising treatments and simplifying outcomes could further strengthen the tradition of trialling in forensic psychiatry. Systematic reviews of these studies are overdue.
Adult↗
Health benefits of antiviral therapy for mild chronic hepatitis C: randomised controlled trial and economic evaluation.
OBJECTIVES: To determine whether combined therapy with interferon-alpha and ribavirin was more effective and cost-effective than no treatment for patients with mild chronic hepatitis C. DESIGN: A multicentre, randomised, controlled, non-blinded trial assessed the efficacy of combination therapy. A Markov model used these efficacy data combined with data on transition probabilities, costs and health-related quality of life (HRQoL) to assess the lifetime cost-effectiveness of the intervention. SETTING: A multicentre NHS setting. PARTICIPANTS: Treatment-naive, adult patients with histologically mild chronic hepatitis C (Ishak necroinflammatory scores <4 and fibrosis scores <3 on liver biopsy). INTERVENTIONS: Patients were randomised to receive interferon-alpha and ribavirin for 48 weeks or no treatment (control). MAIN OUTCOME MEASURES: The primary outcome measure was the proportion of patients having a sustained virological response (SVR), measured at 6 months after cessation of therapy. Secondary outcome measures were: the ability of early phase kinetics to predict the eventual outcome of treating mild disease; HRQoL measured using the Short Form 36 and EuroQol (5 Dimensions) questionnaires, and the cost per quality-adjusted life-year (QALY) of interferon-alpha and ribavirin for mild disease compared with no treatment. RESULTS: In the treatment group, 32 out of 98 patients (33%) achieved an SVR. Patients infected with genotype 1 had a lower SVR than those infected with genotype non-1 (18% versus 49%, p = 0.02). No patients who failed to achieve a 2-log drop in viral load at 12 weeks achieved an SVR. HRQoL fell during treatment and rose with treatment cessation. For patients having an SVR there were modest improvements in HRQoL at 6 months post-treatment. The mean cost per QALY gained was 4535 pounds sterling for 40-year-old patients with genotype non-1 and 25,188 pounds sterling for patients with genotype 1. For patients with genotype 1 aged 65, providing interferon-alpha and ribavirin for mild disease led to fewer QALYs gained, and a mean cost per QALY of 53,017 pounds sterling. The model using efficacy estimates from the literature, showed that the cost per QALY gained from providing pegylated interferon alpha-2b and ribavirin at a mild stage rather than a moderate stage was 7821 pounds sterling for patients with genotype non-1 and 28,409 pounds sterling for patients with genotype 1. CONCLUSIONS: Based on the evidence collected in this study, interferon-alpha and ribavirin treatment for mild chronic hepatitis C patients is in general cost-effective at the 30,000 pounds sterling per QALY threshold previously used by policy-makers in the NHS. For patients with chronic hepatitis C aged 65 or over with genotype 1, antiviral treatment at a mild stage does not appear cost-effective. Further research is required on the cost-effectiveness of pegylated interferon and ribavirin, in particular the intervention's long-term impact on HRQoL and health service costs requires further evaluation. Further research is also needed to develop predictive tests, based on pharmacogenomics, that can identify those cases most likely to respond to antiviral therapy. Liver biopsy before treatment no longer appears justified apart from for older patients (aged 65 or over) with genotype 1. However, further research should monitor the impact this strategy would have on costs and outcomes.
Adult↗
Oral corticosteroids in patients admitted to hospital with exacerbations of chronic obstructive pulmonary disease: a prospective randomised controlled trial.
BACKGROUND: The role of oral corticosteroids in treating patients with exacerbations of chronic obstructive pulmonary disease (COPD) remains contentious. We assessed in a prospective, randomised, double-blind, placebo-controlled trial the effects of oral corticosteroid therapy in patients with exacerbations of COPD requiring hospital admission. METHODS: We recruited patients with non-acidotic exacerbations of COPD who were randomly assigned oral prednisolone 30 mg once daily (n=29) or identical placebo (n=27) for 14 days, in addition to standard treatment with nebulised bronchodilators, antibiotics, and oxygen. We did spirometry and recorded symptom scores daily in inpatients. Time to discharge and withdrawals were noted in each group. We recalled patients at 6 weeks to repeat spirometry and collect data on subsequent exacerbations and treatment. Hospital stay was analysed by intention to treat and forced expiratory volume in 1 s (FEV1) according to protocol. FINDINGS: FEV1 after bronchodilation increased more rapidly and to a greater extent in the corticosteroid-treated group: percentage predicted FEV1 after bronchodilation rose from 25.7% (95% CI 21.0-30.4) to 32.2% (27.3-27.1) in the placebo group (p<0.0001) compared with 28.2% (23.5-32.9) to 41.5% (35.8-47.2) in the corticosteroid-treated group (p<0.0001). Up to day 5 of hospital stay, FEV1 after bronchodilation increased by 90 mL daily (50.8-129.2) and by 30 mL daily (10.4-49.6) in the placebo group (p=0.039). Hospital stays were shorter in the corticosteroid-treated group. Groups did not differ at 6-week follow-up. INTERPRETATION: These data provide evidence to support the current practice of prescribing low-dose oral corticosteroids to all patients with non-acidotic exacerbations of COPD requiring hospital admission.
Aged↗
Cognitive assessment of children at age 2(1/2) years after maternal fish oil supplementation in pregnancy: a randomised controlled trial.
OBJECTIVE: To assess the effects of antenatal omega 3 long-chain polyunsaturated fatty acid (n-3 LC PUFA) on cognitive development in a cohort of children whose mothers received high-dose fish oil in pregnancy. DESIGN: A double-blind randomised placebo-controlled trial. SETTING: Perth, Western Australia, Australia. PATIENTS: 98 pregnant women received the supplementation from 20 weeks' gestation until delivery. Their infants (n = 72) were assessed at age 2(1/2) years. INTERVENTIONS: Fish oil (2.2 g docosahexaenoic acid (DHA) and 1.1 g eicosapentaenoic acid (EPA)/day) or olive oil from 20 weeks' gestation until delivery. OUTCOME MEASURES: Effects on infant growth and developmental quotients (Griffiths Mental Development Scales), receptive language (Peabody Picture Vocabulary Test) and behaviour (Child Behaviour Checklist). RESULTS: Children in the fish oil-supplemented group (n = 33) attained a significantly higher score for eye and hand coordination (mean ((SD) score 114 (10.2)) than those in the placebo group (n = 39, mean score 108 (SD 11.3); p = 0.021, adjusted p = 0.008). Eye and hand coordination scores correlated with n-3 PUFA levels in cord blood erythrocytes (EPA: r = 0.320, p = 0.007; DHA: r = 0.308, p = 0.009) and inversely correlated with n-6 PUFA (arachidonic acid 20:4n-6: r = -0.331, p = 0.005). Growth measurements in the two groups were similar at age 2(1/2) years. CONCLUSION: Maternal fish oil supplementation during pregnancy is safe for the fetus and infant, and may have potentially beneficial effects on the child's eye and hand coordination. Further studies are needed to determine the significance of this finding.
Adult↗