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Results for “Randomised Controlled Trial”

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PubMed2003

A prospective randomised controlled trial of capnography vs. bronchoscopy for Blue Rhino percutaneous tracheostomy.

A crucial step for successful percutaneous tracheostomy is the introduction of the needle and guide wire into the trachea. Capnography has recently been proposed as one way to confirm tracheal needle placement. In this randomised controlled study, we used capnography in 26 patients and bronchoscopy in 29 patients to confirm needle placement for percutaneous tracheostomy using Blue Rhino kit. The operating times and the incidence of peri-operative complications were similar for both groups. Capnography proved to be as effective as bronchoscopy in confirming correct needle placement.

Adolescent↗

PubMed1998

Effect of educational leaflets and questions on knowledge of contraception in women taking the combined contraceptive pill: randomised controlled trial.

OBJECTIVE: To assess whether provision of educational leaflets or questions on contraception improves knowledge of contraception in women taking the combined contraceptive pill. DESIGN: Randomisation of women into three groups according to type of educational leaflet on contraceptive information. These groups were subdivided into two on the basis of questions on contraception asked by the doctor or practice nurse. The women were followed up by postal questionnaire 3 months later. SETTING: 15 general practices in South and West region. SUBJECTS: 636 women attending check up appointment for repeat prescription of the combined contraceptive pill. MAIN OUTCOME MEASURES: Knowledge of: factors causing pill failure, subsequent action, emergency contraception, and all the rules (pill rules) that apply to the contraceptive pill. RESULTS: 523 women returned completed questionnaires (response rate 82%). Knowledge of contraception with no intervention was low with only 10 (12%) women knowing all the pill rules. Educational intervention had a highly significant effect on knowledge of: factors causing pill failure (likelihood ratio chi2=22); subsequent action (21); emergency contraception (24); and all the pill rules (22) (P<0.01 in all cases). Improvement in knowledge of all the pill rules occurred with provision of the summary leaflet (28% knew all the rules, adjusted odds ratio 4.04, 95% confidence interval 1.68 to 9.75), the Family Planning Association's leaflet (27%, 3.43, 1.45 to 8.09), and asking questions (26%, 3.03, 1.30 to 7.00). Asking questions in addition to provision of leaflets improved knowledge of contraception further for the summary leaflet (39%, 6.81, 2.85 to 16.27) but not for the Family Planning Association leaflet (21%, 2.58, 1.07 to 6.18). CONCLUSION: Women attending check ups for repeat prescriptions of the contraceptive pill should be provided with educational leaflets on contraception or asked relevant questions to help improve their knowledge of contraception. Asking questions in addition to providing a summary leaflet is time consuming, but results in the most knowledge gained.

Adolescent↗

PubMed2005

The NK1-receptor antagonist TKA731 in painful diabetic neuropathy: a randomised, controlled trial.

Substance P is one of the neurotransmitters released by primary nociceptive neurons in the dorsal horn of the spinal cord and it binds postsynaptically to NK(1)-receptors. This receptor is therefore an obvious target for analgesic drugs. The aim of this multicenter, randomised, double-blind, placebo-controlled and parallel-group study was to test if the non-peptide NK(1)-receptor antagonist TKA731 would relieve painful diabetic polyneuropathy. Eighty-seven patients completed a treatment period of 2 weeks' duration with TKA731 (150 mg daily) or placebo preceded by one week for baseline observations. There was no significant difference between TKA731 and placebo in change in pain rating from baseline to study end neither for rating of total pain (mean -13.4 mm vs. -11.6 mm, p = 0.664) nor for change in ratings of different pain symptoms (touch- or pressure-evoked pain, pain paroxysms, steady burning or deep aching pain) (p = 0.169-0.834).

Administration, Oral↗

PubMed1989

Randomised controlled trial of subcutaneous calcium-heparin in acute myocardial infarction. The SCATI (Studio sulla Calciparina nell'Angina e nella Trombosi Ventricolare nell'Infarto) Group.

In a multicentre study 711 patients were randomised to a group receiving calcium-heparin, 12,500 U, subcutaneously (360), or to a group receiving no heparin (351), beginning within 24 h of the onset of symptoms. 433 of these patients, admitted within 6 h, were given intravenous streptokinase (SK). Results were analysed for the in-hospital period. Calcium-heparin had no significant effects on the frequency of electrocardiographically documented ischaemic episodes or non-fatal reinfarction in the whole series; in the subgroup receiving SK, transient ischaemic episodes recurred in 14.2% of those treated with heparin vs 19.6% of the controls (p = 0.08). Mortality was significantly lower in the calcium-heparin treated patients, both in the overall groups (21/360 vs 35/351, p = 0.03) and in the SK subgroups (10/218 vs 19/215, p = 0.05). In 200 patients with first anterior myocardial infarction, it was possible to assess the effect of heparin on left ventricular mural thrombosis. On predischarge two-dimensional echocardiography, the prevalence of thrombus was significantly lower in the heparin group than in the control group (19/107 vs 34/93). Heparin also greatly reduced the incidence of thrombus formation in those who were thrombus-free on admission. Complications of heparin treatment were few.

Aged↗

PubMed2005

Randomised controlled trial of mammographic screening in women from age 40: predicted mortality based on surrogate outcome measures.

A trial in the UK to study the effect on mortality from breast cancer of invitation for annual mammography from the age of 40-41, has randomised a total of 160 921 women in the ratio 1 : 2 to the intervention and control arms. All breast cancers diagnosed in the two arms have been identified, and the histology reviewed. This paper presents the results of an interim analysis using surrogate outcome measures to compare predicted breast cancer mortality in the two arms based on 1287 cases diagnosed to 31.12.1999. Due to earlier diagnosis, there is currently an 8% excess of invasive breast cancers in the intervention arm. The ratio of predicted deaths at 10 years in the intervention arm relative to the control arm, adjusted for this excess diagnosis, ranges from 0.89 (95% confidence interval (CI) 0.78-1.01) to 0.90 (95% CI 0.80-1.01). Screening from age 40 may result in a lower reduction in breast cancer mortality than that observed in other trials including women below age 50. This analysis based on surrogate outcome measures suggests that a reduction in breast cancer mortality may be observed in this trial. However, a number of assumptions have been necessary and firm conclusions must await the analysis of observed mortality from breast cancer.

Adult↗

PubMed2006

Intravenous immunoglobulin for post-polio syndrome: a randomised controlled trial.

BACKGROUND: Survivors of poliomyelitis often develop increased or new symptoms decades after the acute infection, known as post-polio syndrome. Production of proinflammatory cytokines within the CNS indicates an underlying inflammatory process, accessible for immunomodulatory treatment. We did a multicentre, randomised, double-blind, placebo-controlled study of intravenous immunoglobulin in post-polio syndrome. METHODS: 142 patients at four university clinics were randomly assigned infusion of either 90 g in total of intravenous immunoglobulin (n=73) or placebo (n=69) during 3 consecutive days, repeated after 3 months. Seven patients were withdrawn from the study. Thus, 135 patients were assessed per protocol. Primary endpoints were muscle strength in a selected study muscle and quality of life as measured with the SF-36 questionnaire (SF-36 PCS). Secondary endpoints were 6-minute walk test (6MWT), timed up and go (TUG), muscle strength in muscles not chosen as the study muscle, physical activity scale of the elderly (PASE), visual analogue scale (VAS) for pain, multidimensional fatigue inventory (MFI-20), balance, and sleep quality. Outcome tests were done immediately before the first infusion and 3 months after the second infusion. This study is registered with , number NCT00160082. FINDINGS: Compared with baseline, median muscle strength differed by 8.3% between patients receiving intravenous immunoglobulin and placebo, in favour of the treatment group (p=0.029). SF-36 PCS did not differ significantly between the groups after treatment (p=0.321). Differences in the subscale vitality score (p=0.042) and PASE (p=0.018) favoured the active treatment group. MFI-20, TUG, muscle strength in the muscles not chosen as the study muscle, 6MWT, balance, and sleep quality did not differ between groups. For the whole study population there was no significant change in pain, as determined by VAS. Nevertheless, patients who reported pain at the study start improved in the intervention group but not in the placebo group (p=0.037). Intravenous immunoglobulin was well tolerated. INTERPRETATION: Intravenous immunoglobulin could be a supportive treatment option for subgroups of patients with post-polio syndrome. Further studies on responding subgroups, long-term effects, and dosing schedules are needed.

Aged↗

PubMed2000

Comparison of St John's wort and imipramine for treating depression: randomised controlled trial.

OBJECTIVES: To compare the efficacy and tolerability of Hypericum perforatum (St John's wort extract) with imipramine in patients with mild to moderate depression. DESIGN: Randomised, multicentre, double blind, parallel group trial. SETTING: 40 outpatient clinics in Germany. PARTICIPANTS: 324 outpatients with mild to moderate depression. INTERVENTION: 75 mg imipramine twice daily or 250 mg hypericum extract ZE 117 twice daily for 6 weeks. MAIN OUTCOME MEASURES: Hamilton depression rating scale, clinical global impression scale, and patient's global impression scale. RESULTS: Among the 157 participants taking hypericum mean scores on the Hamilton depression scale decreased from 22.4 at baseline to 12.00 at end point; among the 167 participants taking imipramine they fell from 22.1 to 12.75. Mean clinical global impression scores at end point were 2.22 out of 7 for the hypericum group and 2.42 for the imipramine group. On the 7 point self assessments of global improvement completed by participants (score of 1 indicating "very much improved" and 7 indicating "very much deteriorated") mean scores were 2.44 in the hypericum group and 2.60 in the imipramine group. None of the differences between treatment groups were significant. However, the mean score on the anxiety-somatisation subscale of the Hamilton scale (3.79 in the hypericum group and 4.26 in the imipramine group) indicated a significant advantage for hypericum relative to imipramine. Mean scores on the 5 point scale used by participants to assess tolerability (score of 1 indicating excellent tolerability and 5 indicating very poor tolerability) were better for hypericum (1.67) than imipramine (2.35). Adverse events occurred in 62/157 (39%) participants taking hypericum and in 105/167 (63%) taking imipramine. 4 (3%) participants taking hypericum withdrew because of adverse events compared with 26 (16%) taking imipramine. CONCLUSIONS: This Hypericum perforatum extract is therapeutically equivalent to imipramine in treating mild to moderate depression, but patients tolerate hypericum better.

Adult↗

PubMed2006

A randomised controlled trial of the effect of outreach placement on treatment planning by dental students.

UNLABELLED: Undergraduate dental students' curricula are being supplemented with primary care placements. OBJECTIVE: To compare the effect of outreach placement and traditional hospital-based training alone on students' treatment planning ability. DESIGN: Randomised controlled trial.Setting Four existing primary care placements in England during 2004. SUBJECTS AND METHODS: At follow-up the fourth-year students took a history from a standard 'patient' then recorded a treatment plan. Interview skill was scored. The history and plan were assessed by clinicians blind to the intervention. INTERVENTION: Five-week block outreach placements for 25 of 49 students. MAIN OUTCOME MEASURES: Interviewing skill, quality of dental and social histories, the appropriateness of planned treatments and the consideration of wider issues. RESULTS: The two groups were similar in the scores for interviewing and taking a dental history. The outreach group scored higher for capturing a social history (outreach mean 4.4, SD = 2.1, n = 22 and hospital 2.8, SD = 1.9, n = 23; p = 0.01) and for developing an appropriate treatment plan (5.6 [SD = 2.1] and 3.9 [SD = 2.3]; p = 0.01). There were no differences in scores relating to the wider issues. CONCLUSION: Dental outreach training was significantly more effective than traditional training alone in improving students' ability to capture relevant points of social history from a patient and to consider them when planning treatment.

Clinical Clerkship↗

PubMed1999

Family intervention for intellectually disabled children. Randomised controlled trial.

BACKGROUND: Resources to address the needs of parents of intellectually disabled children in developing countries are limited. AIMS: The efficacy of interactive group psychoeducation on measures of parental attitude towards intellectual disability was assessed in southern India. METHOD: Fifty-seven parents randomised to 10 weeks of experimental and control therapy were assessed using the Parental Attitude Scale towards the Management of Intellectual Disability. The pre- and post-intervention measurements were done by a single-blinded rater and compared. RESULTS: The intervention group had a statistically significant increase in the outcome scores and clinical improvement in the total parental attitude score, orientation towards child-rearing knowledge towards intellectual disability and attitude towards management of intellectual disability, but no change in attitude towards the intellectual disability subscale. CONCLUSIONS: Interactive group psychoeducation is effective for changing the attitude of parents with intellectually disabled children, and is a viable option to be developed in situations where resources are limited.

Adult↗

PubMed2005

A randomised-controlled trial in England of a postnatal midwifery intervention on breast-feeding duration.

OBJECTIVE: To determine whether postnatal 'hands off' care by midwives on positioning and attachment of the newborn baby improves breast-feeding duration. DESIGN: Mothers were randomised at the first postnatal feed to receive either care by a midwife trained in the experimental protocol or by a control midwife undertaking routine care. SETTING: Eight wards in four English Midlands hospitals. PARTICIPANTS: 370 primiparous mothers with term babies who intended to breast feed, and could sit out of bed to do so. INTERVENTIONS: Experimental protocol of verbal-only advice on positioning and attachment, delivered at the first postnatal ward feed compared with routine care by a qualified midwife. MAIN OUTCOME MEASURES: Duration of breast feeding up to 17 weeks as assessed by diaries and interviews with mothers and protocol adherence from self-completed checklist by the midwife. The mothers' self-reported experience of care and support before, during and after delivery were assessed at 6 weeks, and feeding outcomes and employment status at 17 weeks. FINDINGS: Experimental group mothers more often held the baby across their lap and received 'hands off advice', but fewer babies in the experimental than control groups attached and fed: 59% (106/180) vs. 67% (118/175), p=0.1. No significant differences were found in the numbers of mothers breast feeding at 6 or 17 weeks in the experimental and control groups (stopped exclusive breast feeding: 76% (130/172) vs. 77% (126/163) at 6 weeks; 96% (167/174) vs. 96% (161/168) at 17 weeks; odds ratio 1.02, 95% CI 0.77 to 1.22; p=0.8; stopped any breast feeding: 35% (61/172) vs. 32% (53/167) at 6 weeks; 63% (109/173) vs. 60% (101/167) at 17 weeks; odds ratio 1.10, 0.84 to 1.45; p=0.5). There were no significant differences in the incidence of problems with breast feeding and care experienced by mothers before or during hospitalisation (other than at the first postnatal ward feed), nor after discharge home. CONCLUSIONS: No significant beneficial effect was found on breast-feeding duration of the verbal- only advice on positioning and attachment, perhaps because aspects of the intervention are already within routine UK practice. Other care practices at subsequent feeds may negate benefits of care at earlier feeds. 'Hands off' care at the first feed may be less important to subsequent feeding than achieving a first feed under supervision in the postnatal ward. IMPLICATIONS FOR PRACTICE: Midwives can be trained in a 4-hr workshop to achieve improved knowledge of 'hands off' positioning and attachment care, and these can be translated into clinical practice. Future studies should differentiate the elements of the care that are effective in achieving postnatal feeds, and apply this advice consistently at successive feeds.

Adult↗

PubMed2006

Medical outcome after immediate computed tomography or admission for observation in patients with mild head injury: randomised controlled trial.

OBJECTIVE: To compare immediate computed tomography during triage for admission with observation in hospital in patients with mild head injury. DESIGN: Multicentre, pragmatic, non-inferiority randomised trial. SETTING: 39 acute hospitals in Sweden. PARTICIPANTS: 2602 patients (aged > or = 6) with mild head injury. INTERVENTIONS: Immediate computed tomography or admission for observation. MAIN OUTCOME MEASURE: Dichotomised extended Glasgow outcome scale (1-7 v 8). The non-inferiority margin was 5 percentage points. RESULTS: At three months, 275 patients (21.4%) in the computed tomography group had not recovered completely compared with 300 (24.2%) admitted for observation. The difference was - 2.8 percentage points, non-significantly in favour of computed tomography (95% confidence interval - 6.1% to 0.6%). The worst outcomes (mortality and more severe loss of function) were similar between the groups. In the patients admitted for observation, there was a considerable delay in time to treatment in those who required surgery. None of the patients with normal findings on immediate computed tomography had complications later. Patients' satisfaction with the two strategies was similar. CONCLUSIONS: The use of computed tomography in the management of patients with mild head injury is feasible and leads to similar clinical outcomes compared with observation in hospital. TRIAL REGISTRATION: ISRCTN81464462.

Adolescent↗

PubMed1989

A randomised controlled trial of propranolol for the prevention of initial bleeding in cirrhotic patients with portal hypertension. Preliminary results. The Italian Multicenter Project for Propranolol in the Prevention of Bleeding.

The preliminary analysis of a multicentre, randomised, single-blind trial of propranolol for prophylaxis of first bleeding in cirrhosis is reported. 174 consecutively-chosen patients with large oesophageal varices were randomly assigned to either propranolol, in doses which reduced the resting heart rate by 25% (85 patients), or to vitamin K (89 patients). 25 patients had to be withdrawn from treatment with propranolol because of poor tolerance. The 30-month cumulative proportion of patients free of bleeding was 74% in the propranolol group and 63% in the vitamin K group; corresponding survival figures were 59% and 74%, respectively. These differences were not statistically significant. A retrospective analysis, according to the presence of ascites at randomisation showed that a significantly higher proportion of patients without ascites in the propranolol group were free of bleeding compared with those in the control group (87% vs 64%; p = 0.023). No significant differences were found in patients with ascites at randomisation. Length of survival was not significantly affected by treatment in any subgroup, although it was shorter in ascitic patients given propranolol than in controls (33% vs 63%; p = 0.07). If confirmed on a longer follow-up, these results suggest that propranolol could prevent primary variceal haemorrhage in patients with well-compensated cirrhosis.

Aged↗

PubMed2001

Effectiveness of the direct observation component of DOTS for tuberculosis: a randomised controlled trial in Pakistan.

BACKGROUND: DOTS is the control strategy for tuberculosis promoted by WHO. Pakistan is currently developing its National Tuberculosis Programme, and requires guidance on types of direct observation of treatment appropriate for the local conditions. We did a randomised trial to assess the effectiveness of different packages for tuberculosis treatment under operational conditions in Pakistan. METHODS: We enrolled 497 adults with new sputum-positive tuberculosis. 170 were assigned DOTS with direct observation of treatment by health workers; 165 were assigned DOTS with direct observation of treatment by family members; and 162 were assigned self-administered treatment. The trial was done at three sites that provide tuberculosis services strengthened according to WHO guidelines for the purposes of the research, with a standard daily short-course drugs regimen (2 months of isoniazid, rifampicin, pyrazinamide, and ethambutol, followed by 6 months of isoniazid and ethambutol). The main outcome measures were cure, and cure or treatment completion. Analysis was by intention to treat. FINDINGS: Within the strengthened tuberculosis services, the health-worker DOTS, family-member DOTS, and self-administered treatment strategies gave very similar outcomes, with cure rates of 64%, 55%, and 62%, respectively, and cure or treatment-completed rates of 67%, 62%, and 65%, respectively. INTERPRETATION: None of the three strategies tested was shown to be superior to the others, and direct observation of treatment did not give any additional improvement in cure rates. The effectiveness of direct observation of treatment remains unclear, and further operational research is needed.

Adolescent↗

PubMed1999

Twice daily versus four times daily insulin dose regimens for diabetes in pregnancy: randomised controlled trial.

OBJECTIVE: To compare perinatal outcome and glycaemic control in two groups of pregnant diabetic patients receiving two insulin regimens. DESIGN: Randomised controlled open label study. SETTING: University affiliated hospital, Israel. PARTICIPANTS: 138 patients with gestational diabetes mellitus and 58 patients with pregestational diabetes mellitus received insulin four times daily, and 136 patients with gestational diabetes and 60 patients with pregestational diabetes received insulin twice daily. INTERVENTION: Three doses of regular insulin before meals and an intermediate insulin dose before bedtime (four times daily regimen), and a combination of regular and intermediate insulin in the morning and evening (twice daily regimen). MAIN OUTCOME MEASURES: Maternal glycaemic control and perinatal outcome. RESULTS: Mean daily insulin concentration before birth was higher in the women receiving insulin four times daily compared with twice daily: by 22 units (95% confidence interval 12 to 32) in patients with gestational diabetes and by 28 units (15 to 41) in patients with pregestational diabetes. Glycaemic control was better with the four times daily regimen than with the twice daily regimen: in patients with gestational diabetes mean blood glucose concentrations decreased by 0.19 mmol/l (0.13 to 0.25), HbA(1c) by 0.3% (0.2% to 0.4%), and fructosamine by 41 micromol/l (37 to 45), and adequate glycaemic control (mean blood glucose concentration <5.8 mmol/l) was achieved in 17% (8% to 26%) more women; in patients with pregestational diabetes mean blood glucose concentration decreased by 0.44 mmol/l (0.28 to 0.60), HbA(1c) by 0.5% (0.2% to 0.8%), and fructosamine by 51 micromol/l (45 to 57), and adequate glycaemic control was achieved in 31% (15% to 47%) more women. Maternal severe hypoglycaemic events, caesarean section, preterm birth, macrosomia, and low Apgar scores were similar in both dose groups. In women with gestational diabetes the four times daily regimen resulted in a lower rate of overall neonatal morbidity than the twice daily regimen (relative risk 0.59, 0.38 to 0.92), and the relative risk for hyperbilirubinaemia and hypoglycaemia was lower (0.51, 0.29 to 0.91 and 0.12, 0.02 to 0.97 respectively). The relative risk of hypoglycaemia in newborn infants to mothers with pregestational diabetes was 0.17 (0.04 to 0.74). CONCLUSIONS: Giving insulin four times rather than twice daily in pregnancy improved glycaemic control and perinatal outcome without further risking the mother.

Adult↗

PubMed1983

Randomised, controlled trial of the comparative efficacy, auditory toxicity, and nephrotoxicity of tobramycin and netilmicin.

254 patients with serious gram-negative bacillary infections were enrolled into a multicentre, randomised, blind clinical trial and treated with tobramycin-ticarcillin or netilmicin-ticarcillin. The two treatment groups were similar as to sex, age, and weight. The mean daily dose of netilmicin (237 mg) was higher than that of tobramycin (211 mg), p less than 0.01, but the mean duration of therapy was longer with tobramycin (9.4 days versus 8.7 days), p less than 0.01. The netilmicin cohort also had more serious underlying diseases, p less than 0.028. Clinical (tobramycin, 93% and netilmicin, 91%) and bacteriological responses (tobramycin, 87% and netilmicin, 89%) were similar. 84 tobramycin and 73 netilmicin patients had serial audiograms. Eighth nerve deficits developed in 10 (12%) tobramycin and two (3%) netilmicin patients, p = 0.037. Drug-related renal dysfunction developed in 5 (4%) of 114 tobramycin patients whose renal function was monitored and in 1 (1%) of 116 netilmicin patients, p = 0.12.

Anti-Bacterial Agents↗

PubMed2005

Glycaemic control in type II diabetic tube-fed patients with a new enteral formula low in carbohydrates and high in monounsaturated fatty acids: a randomised controlled trial.

OBJECTIVES: To investigate the effects of long-term treatment with a new enteral formula low in carbohydrates and high in monounsaturated fatty acids (MUFAs), in comparison with a standard formula, on glycaemic control in tube-fed type II diabetic patients. DESIGN: Randomised, double-blind, controlled, multi-centre trial. SETTING: Early rehabilitation centres, primary care and nursing facilities. SUBJECTS: A total of 78 patients with insulin-treated type II diabetes with HbA(1C) > or =7.0% and/or fasting blood glucose >6.66 mmol/l, who required enteral tube feeding due to neurological dysphagia. INTERVENTIONS: Patients received 113 kJ (27 kcal)/kg of body weight of either test feed or an isoenergetic, isonitrogenous enteral formula (control) for 12 weeks. Glycaemic control (total daily insulin dosage (IU), fasting blood glucose, and HbA(1C)) and gastrointestinal tolerance were monitored daily. RESULTS: After 12 weeks, median values for changes from baseline were as follows (test group vs control group, 'data as available' analysis): total daily IUs -6.0 vs 0.0 (P=0.0024), fasting blood glucose (mmol/l) -1.59 vs -0.08 (P=0.0068); HbA(1C) (%) -0.8 vs 0.0 (P=0.0016). Both formulas were tolerated comparably. CONCLUSIONS: This study indicates that in tube-fed insulin-treated type II diabetic patients, the new low-carbohydrate, high MUFA formula results in a more effective glycaemic control than the standard diet, while being comparable in safety.

Adult↗

PubMedDate not supplied

Effectiveness of an educational intervention delivered through the health services to improve nutrition in young children: a cluster-randomised controlled trial.

BACKGROUND: Malnutrition is the underlying cause of half of child mortality. Many programmes attempt to remedy this issue but there is a lack of evidence on effective ways to decrease child malnutrition. METHODS: We did a cluster-randomised trial of an educational intervention in a poor periurban area (ie, shanty town) of Peru. Guided by formative research, the intervention aimed to enhance the quality and coverage of existing nutrition education and to introduce an accreditation system in six government health facilities compared with six control facilities. The primary outcome measure was growth that was measured by weight, length, and Z scores for weight-for-age and length-for-age at age 18 months. Main secondary outcomes were the percentage of children receiving recommended feeding practices and the 24-h dietary intake of energy, iron, and zinc from complementary food at ages 6, 9, 12, and 18 months. Analysis was by intention to treat. FINDINGS: We enrolled a birth cohort of 187 infants from the catchment areas of intervention centres and 190 from control areas. Caregivers in intervention areas were more likely to report receiving nutrition advice from the health service than were caregivers in control health facilities (16 [52%] of 31 vs 9 [24%] of 37, p=0.02). At 6 months more babies in intervention areas were fed nutrient-dense thick foods at lunch (a recommended complementary feeding practice) than were controls (48 [31%] of 157 vs 29 [20%] of 147; difference between groups 19 [11%], p=0.03). Fewer children in intervention areas failed to meet dietary requirements for energy (8 months: 30 [18%] of 170 vs 45 [27%] of 167, p=0.04; 12 months: 64 [38%] of 168 vs 82 [49%] of 167, p=0.043), iron (8 months: 155 [91%] of 170 vs 161 [96%] of 167, 9 months: 152 [93%] of 163 vs 165 [99%] of 166, p=0.047), and zinc (9 months: 125 [77%] of 163 vs 145 [87%] of 166, p=0.012) than did controls. Children in control areas were more likely to have stunted growth (ie, length for age less than 2 SD below the reference population median) at 18 months than children in intervention groups (26 [16%] of 165 vs 8 [5%] of 171; adjusted odds ratio 3.04 [95% CI 1.21-7.64]). Adjusted mean changes in weight gain, length gain, and Z scores were all significantly better in the intervention area than in the control area. INTERPRETATION: Improvement of nutrition education delivered through health services can decrease the prevalence of stunted growth in childhood in areas where access to food is not a limiting factor.

Caregivers↗

PubMed2006

Once versus twice daily formoterol via Novolizer for patients with moderate to severe COPD--a double-blind, randomised, controlled trial.

STUDY OBJECTIVES: To evaluate in patients with moderate to severe COPD whether a single morning dose of 24 microg formoterol from the Novolizer is not inferior to two divided doses of 12 microg formoterol inhaled in the morning and in the evening. DESIGN: Randomised, double blind, active-controlled, parallel-group, multi-centre study with a 2-week run-in period and a 12-week treatment phase. SETTING: Forty-seven outpatient centres in Germany, including private practices. PARTICIPANTS: N=321 symptomatic patients with moderate to severe COPD aged 40-70 years with an FEV1 of 30-80% predicted and the requirement of 3-12 actuations of salbutamol per day on 5 days during the run-in period. TREATMENT: Eligible patients were randomised to inhale formoterol either (a) as a single 24 microg dose in the morning (OD) or (b) in two divided 12 microg doses in the morning and in the evening (b.i.d.). MEASUREMENTS AND RESULTS: The mean age was 60.3 (SD 7.3) years, and mean baseline pre-dose FEV1 was 1.5l (0.5l) or 50% (12%) of predicted, respectively. After 12 weeks of treatment, pre-dose FEV(1) improved in both groups (mean: OD, +104 ml, b.i.d., +135 ml, mean difference between groups: 31 ml). The 95% CI exceeded the pre-determined margin of 100ml by 2 ml, so that the statistical hypothesis of non-inferiority of once daily dosing was not confirmed. No statistically significant differences were seen for improvements in PEF, MEF75, MEF50, and MEF25. COPD symptoms, percentage of symptom-free days and quality of life (SGRQ) improved in both groups to a similar degree. There were no relevant differences in the incidence of adverse events. CONCLUSIONS: Based on a comparable efficacy and tolerability, the dosing schedule with formoterol via Novolizer as once daily in the morning seems to be an alternative compared to twice daily treatment. The primary endpoint suggests the equivalence of both treatment schedules from a clinical perspective. This regimen can be considered as an alternative therapeutic approach for a subgroup of COPD patients and may help to improve patient compliance.

Adult↗