Zinc supplementation in children with cholera in Bangladesh: randomised controlled trial

Objective To investigate the impact of zinc supplementation in children with cholera.Design Double blind, randomised, placebo controlled trial.Setting Dhaka Hospital, Bangladesh.Participants 179 children aged 3-14 years with watery diarrhoea and stool dark field examination positive for Vibrio cholerae and confirmed by stool culture.Intervention Children were randomised to receive 30 mg elemental zinc per day (n=90) or placebo (n=89) until recovery. All children received erythromycin suspension orally in a dose of 12.5 mg/kg every six hours for three days.Main outcome measures Duration of diarrhoea and stool output.Results 82 children in each group completed the study. More patients in the zinc group than in the control group recovered by two days (49% v 32%, P=0.032) and by three days (81% v 68%, P=0.03). Zinc supplemented patients had 12% shorter duration of diarrhoea than control patients (64.1 v 72.8 h, P=0.028) and 11% less stool output (1.6 v 1.8 kg/day, P=0.039).Conclusion Zinc supplementation significantly reduced the duration of diarrhoea and stool output in children with cholera. Children with cholera should be supplemented with zinc to reduce its duration and severity.Trial registration Clinical trials {"type":"clinical-trial","attrs":{"text":"NCT00226616","term_id":"NCT00226616"}}NCT00226616.     

Cognitive effects of polyunsaturated fatty acids in children with attention deficit hyperactivity disorder symptoms: a randomised controlled trial

This study investigated effects of PUFA and micronutrient supplementation on cognition in children with ADHD symptoms. In a randomised controlled trial, 7-12-year-old children with symptoms 2 S.D. on Conners' ADHD Index were given PUFA, PUFA+multivitamins/minerals (MVM), or placebo for 15 weeks, and then all children were given PUFA+MVM for an additional 15 weeks. After 15 weeks there were improvements in a test of the ability to switch and control attention (Creature Counting) in the PUFA groups compared to placebo (N=129, p=0.002). This improvement was also observed in the placebo group after taking PUFA from weeks 16 to 30 (N=104). There were no significant improvements in other cognitive measures, or with additional micronutrient supplementation. However, improvements in cognitive performance mediated previous parent-reported improvements in inattention, hyperactivity and impulsivity [N. Sinn, J. Bryan, Effect of supplementation with polyunsaturated fatty acids and micronutrients on ADHD-related problems with attention and behaviour, J. Dev. Behav. Pediatr. 28 (2) (2007) 82-91], suggestive of a common neurological mechanism for these symptoms.     

Effectiveness of out-of-home day care for disadvantaged families: randomised controlled trial

Objective To assess the effects of providing daycare facilities for young children on the health and welfare of disadvantaged families.Design Randomised controlled trial. Eligible children from the application list to a daycare facility were randomly allocated to receive a daycare place or not.Setting Early Years daycare centre in Borough of Hackney, London.Participants 120 mothers and 143 eligible children (aged between 6 months and 3.5 years).Intervention A place at the centre, which provided high quality day care. Control families used other child care that they secured for themselves.Main outcome measures Maternal paid employment, household income, child health and development.Results At 18 months'' follow up, 67% of intervention group mothers and 60% of control group mothers were in paid employment (adjusted risk ratio 1.23 (95% confidence interval 0.99 to 1.52)), but were no more likely to have a weekly household income of above £200 (risk ratio 0.88 (0.70 to 1.09)). Intervention group children had more otitis media with effusion (risk ratio 1.74 (1.02 to 2.96)) and used more health services (1.58 (1.05 to 2.38)), but both estimates were imprecise.Conclusion The provision of child day care may have increased maternal employment, but it did not seem to increase household income. The results suggest that providing day care may be insufficient as a strategy to reduce poverty. The study shows how random allocation can be used to ration and evaluate interventions where demand exceeds supply.     

Preventing injuries in children: cluster randomised controlled trial in primary care

ObjectiveTo assess the effectiveness of safety advice at child health surveillance consultations, provision of low cost safety equipment to families receiving means tested state benefits, home safety checks, and first aid training on frequency and severity of unintentional injuries in children at home.DesignCluster randomised controlled trial.Setting36 general practices in Nottingham.SubjectsAll children aged 3-12 months registered with participating practices.InterventionsA package of safety advice at child health surveillance consultations at 6-9, 12-15, and 18-24 months; provision of low cost safety equipment to families on means tested state benefits; and home safety checks and first aid training by health visitors.ResultsAt baseline, both groups had similar risk factors for injury, sociodemographic characteristics, safety practices, possession and use of safety equipment, knowledge and confidence in dealing with first aid, and perceptions of risk. No significant difference was found in frequency of at least one medically attended injury (odds ratio 0.97, 95% confidence interval 0.72 to 1.30), at least one attendance at an accident and emergency department for injury (1.02, 0.76 to 1.37), at least one primary care attendance for injury (0.75, 0.48 to 1.17), or at least one hospital admission for injury (0.69, 0.42 to 1.12). No significant difference in the secondary outcome measures was found between the intervention and control groups. ConclusionsThe intervention package was not effective in reducing the frequency of minor unintentional injuries in children at home, and larger trials are required to assess the effect on more severe injuries.

Key messages

• A package of activities for preventing injuries, as suggested by the Health of the Nation, delivered to families with children aged under 3 in primary care did not reduce the frequency of minor injuries
• The findings were consistent with a reduction in the frequency of more severe injuries, and larger primary care based studies are required to test this hypothesis
• The effectiveness of each of the interventions, delivered singly, is not known

     

Transurethral microwave treatment for benign prostatic hypertrophy: a randomised controlled clinical trial.

OBJECTIVES--To determine whether transurethral microwave treatment for patients with benign prostatic hypertrophy provides significant symptomatic relief, a reduction in residual urine volumes, and improvements in flow rates compared with sham treatment. DESIGN--Prospective double blind randomised study with follow up at three months. SETTING--Department of Urology in a London teaching hospital. PATIENTS--40 men completed the study: 22 received microwave treatment and 18 received sham treatment. Entry criteria were symptoms of prostatism of at least six months'' duration, a total symptom score > 14, and a peak urine flow rate < 15 ml/s or a residual urine volume > 50 ml. Exclusion criteria were prostatic cancer, a residual urine volume > 200 ml, a very large prostate, an obstructing middle lobe, acute urinary retention, impaired renal function, coexisting urinary tract disease, and previous prostatic surgery. INTERVENTIONS--A single 90 minute transurethral microwave treatment or sham treatment. OUTCOME MEASURES--Patients'' symptoms (including daytime frequency and nocturia) recorded in a self assessment symptom score questionnaire, peak urinary flow rates, and residual urine volumes. RESULTS--The mean total symptom scores of the patients who received microwave treatment fell from 30 to 11 compared with a fall from 31 to 26 for patients who received sham treatment (p < 0.001). Among patients who received microwave treatment daytime frequency fell from 9.4 to 5.5 voids a day and night time frequency from 3.5 to 1.6 voids a night; residual urine volumes fell from 104 ml to 52 ml; and peak urine flow rates increased by 2.3 ml/s. In the control group there was no improvement in any of these features. Treatment preserved sexual function and antegrade ejaculation. CONCLUSIONS--For selected patients with prostatism microwave treatment is effective and has few side effects.     

Effectiveness of appropriately trained nurses in preoperative assessment: randomised controlled equivalence/non-inferiority trial

ObjectiveTo determine whether preoperative assessments carried out by appropriately trained nurses are inferior in quality to those carried out by preregistration house officers.DesignRandomised controlled equivalence/non-inferiority trial.SettingFour NHS hospitals in three trusts. Three of the four were teaching hospitals.ParticipantsAll patients attending for assessment before general anaesthesia for general, vascular, urological, or breast surgery between April 1998 and March 1999.InterventionAssessment by one of three appropriately trained nurses or by one of several preregistration house officers.Results1907 patients were randomised, and 1874 completed the study; 926 were assessed by house officers and 948 by nurses. Overall 121/948 (13%) assessments carried out by nurses were judged to have possibly affected management compared with 138/926 (15%) of those performed by house officers. Nurses were judged to be non-inferior to house officers in assessment, although there was variation among them in terms of the quality of history taking. The house officers ordered considerably more unnecessary tests than the nurses (218/926 (24%) v 129/948 (14%).ConclusionsThere is no reason to inhibit the development of nurse led preoperative assessment provided that the nurses involved receive adequate training. However, house officers will continue to require experience in preoperative assessment.     

Ready-to-use therapeutic food for catch-up growth in children after an episode of Plasmodium falciparum malaria: an open randomised controlled trial

Background

Catch-up growth after an infection is essential for children to maintain good nutritional status. To prevent malnutrition, WHO recommends that children are given one additional healthy meal per day during the 2 weeks after onset of illness. We investigated to what extent ready-to-use therapeutic food (RUTF) promotes catch-up growth in children after an acute, uncomplicated episode of Plasmodium falciparum malaria.

Methods

We did an open randomised trial of children aged 6–59 months with confirmed malaria who attended a Médecins Sans Frontières-supported outpatient clinic in Katanga Province, Democratic Republic of Congo. All children received a clinical examination and malaria treatment. Patients were then randomly assigned to either an RUTF group, who received daily supplemental RUTF (a high-protein peanut-based paste) for 14 days, or to a control group, who received no supplemental food. Children were weighed at baseline and on days 14 and 28. The primary outcome was mean weight change after 14 days'' RUTF. Analysis was by intention-to-treat.

Results

93 children received RUTF and 87 received no food supplementation. At day 14, the RUTF group had a mean weight gain of 353 g compared with 189 g in the control group (difference 164 [95%CI 52–277], p = 0.005). However, at day 28 there was no statistically significant difference between the groups (539 g versus 414 g, respectively [p = 0.053]). Similarly, rate of weight gain per kg bodyweight per day was significantly higher at day 14 in the RUTF group (2.4 g/kg per day versus 1.3 g/kg per day, p = 0.005) but at day 28 was 1.9 g/kg per day in the RUTF group versus 1.5 g/kg per day in the control group (p = 0.076).

Conclusions

Children receiving RUTF for 14 days after effective treatment of an uncomplicated malaria episode had a faster weight gain than children not given supplementation, reducing the period that children were at risk of malnutrition.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00819858","term_id":"NCT00819858"}}NCT00819858     

Befriending carers of people with dementia: randomised controlled trial

Objective To evaluate the effectiveness of a voluntary sector based befriending scheme in improving psychological wellbeing and quality of life for family carers of people with dementia.Design Single blind randomised controlled trial.Setting Community settings in East Anglia and London.Participants 236 family carers of people with primary progressive dementia.Intervention Contact with a befriender facilitator and offer of match with a trained lay volunteer befriender compared with no befriender facilitator contact; all participants continued to receive “usual care.”Main outcome measures Carers’ mood (hospital anxiety and depression scale—depression) and health related quality of life (EuroQoL) at 15 months post-randomisation.Results The intention to treat analysis showed no benefit for the intervention “access to a befriender facilitator” on the primary outcome measure or on any of the secondary outcome measures.Conclusions In common with many carers’ services, befriending schemes are not taken up by all carers, and providing access to a befriending scheme is not effective in improving wellbeing.Trial registration Current Controlled Trials ISRCTN08130075.     

Effectiveness of cognitive behaviour therapy for the treatment of catastrophisation in patients with fibromyalgia: a randomised controlled trial

Introduction  

No randomised, controlled trials have been conducted to date on the efficacy of psychological and pharmacological treatments of pain catastrophising (PC) in patients with fibromyalgia. Our aim in this study was to assess the effectiveness of cognitive-behaviour therapy (CBT) and the recommended pharmacological treatment (RPT) compared with treatment as usual (TAU) at the primary care level for the treatment of PC in fibromyalgia patients.     

Combined oral and nasal beclomethasone diproprionate in children with atopic eczema: a randomised controlled trial.

In a double blind, placebo controlled, crossover trial in 26 children with severe atopic eczema those receiving four weeks'' treatment with combined oral plus nasal beclomethasone diproprionate improved significantly more than those receiving placebo. No adverse effects were observed, but 24 hour urinary cortisol excretion was slightly reduced. This combination may provide effective treatment in refractory atopic eczema with relatively little of the danger associated with systemic administration of prednisolone and other traditional corticosteroids.     

Effectiveness of teaching general practitioners skills in brief cognitive behaviour therapy to treat patients with depression: randomised controlled trial

ObjectiveTo assess the effectiveness of teaching general practitioners skills in brief cognitive behaviour therapy.DesignParallel group, cluster randomised, controlled trial of an educational package on cognitive behaviour therapy.SettingGeneral practices in north London.Participants84 general practitioner principals and 272 patients attending their practices who scored above the threshold for psychological distress on the hospital anxiety and depression scale.InterventionA training package of four half days on brief cognitive behaviour therapy.ResultsDoctors'' knowledge of depression and attitudes towards its treatment showed no major difference between intervention and control groups after 6 months. The training had no discernible impact on patients'' outcomes.ConclusionGeneral practitioners may require more training and support than a basic educational package on brief cognitive behaviour therapy to acquire skills to help patients with depression.

What is already known on this topic

Trained professionals can deliver effective cognitive behaviour therapy to depressed patients presenting to general practitionersLimited evidence shows that cognitive behaviour therapy is effective when delivered by general practitioners who have received extensive instructionMost doctors do not have the time or inclination to carry out such comprehensive training

What this study adds

Basic training in brief cognitive behaviour therapy has little effect on general practitioners'' attitudes to the identification and treatment of depression or the outcome of their patients with emotional problemsGeneral practitioners may require more extensive training and support if they are to acquire skills in brief cognitive behaviour therapy that will have a positive impact on their patients     

Effectiveness of steam inhalation and nasal irrigation for chronic or recurrent sinus symptoms in primary care: a pragmatic randomized controlled trial

Background:Systematic reviews support nasal saline irrigation for chronic or recurrent sinus symptoms, but trials have been small and few in primary care settings. Steam inhalation has also been proposed, but supporting evidence is lacking. We investigated whether brief pragmatic interventions to encourage use of nasal irrigation or steam inhalation would be effective in relieving sinus symptoms.Methods:We conducted a pragmatic randomized controlled trial involving adults (age 18–65 yr) from 72 primary care practices in the United Kingdom who had a history of chronic or recurrent sinusitis and reported a “moderate to severe” impact of sinus symptoms on their quality of life. Participants were recruited between Feb. 11, 2009, and June 30, 2014, and randomly assigned to 1 of 4 advice strategies: usual care, daily nasal saline irrigation supported by a demonstration video, daily steam inhalation, or combined treatment with both interventions. The primary outcome measure was the Rhinosinusitis Disability Index (RSDI). Patients were followed up at 3 and 6 months. We imputed missing data using multiple imputation methods.Results:Of the 961 patients who consented, 871 returned baseline questionnaires (210 usual care, 219 nasal irrigation, 232 steam inhalation and 210 combined treatment). A total of 671 (77.0%) of the 871 participants reported RSDI scores at 3 months. Patients’ RSDI scores improved more with nasal irrigation than without nasal irrigation by 3 months (crude change −7.42 v. −5.23; estimated adjusted mean difference between groups −2.51, 95% confidence interval −4.65 to −0.37). By 6 months, significantly more patients maintained a 10-point clinically important improvement in the RSDI score with nasal irrigation (44.1% v. 36.6%); fewer used over-the-counter medications (59.4% v. 68.0%) or intended to consult a doctor in future episodes. Steam inhalation reduced headache but had no significant effect on other outcomes. The proportion of participants who had adverse effects was the same in both intervention groups.Interpretation:Advice to use steam inhalation for chronic or recurrent sinus symptoms in primary care was not effective. A similar strategy to use nasal irrigation was less effective than prior evidence suggested, but it provided some symptomatic benefit. Trial registration: ISRCTN, no. 88204146.Rhinosinusitis probably affects more than 25 million Americans and 2.5 million Canadians.¹ Quality of life of patients with chronic or recurrent sinusitis has been reported to be similar to congestive heart disease and chronic pulmonary disease.² Antibiotics are prescribed for nearly all patients with sinusitis,³ but the evidence is modest⁴ and an international priority is to contain antibiotic resistance.⁵ Steam inhalation is widely advocated in rhinosinusitis, but a Cochrane review of steam for the “common cold” found equivocal evidence,⁶ and a recent primary care trial found no benefit and some harm (mild thermal injury) for pragmatic advice to inhale steam twice daily for a range of respiratory tract infections.⁷ The Cochrane review of nasal saline irrigation reported benefit.⁸ However, most of the trials were small, mainly from secondary care settings, and the review documented symptom data from only 129 participants, with high heterogeneity. Two small randomized controlled trials included some participants from primary care settings.^9,10 One of the studies compared a gravity-based nasal irrigation device with routine care among 76 participants mainly from primary care settings; it found that symptoms improved very little in the control group (by 1 point on the Rhinosinusitis Disability Index [RSDI] converted to a 100-point scale), as compared with a 14-point improvement in the irrigation group.⁹ The other (published since the Cochrane review) compared a positive-pressure squeeze bottle with saline nasal spray among 121 volunteers from various sources and found an 8.5-point improvement in the control group, as compared with a 15-point improvement in the irrigation group.¹⁰We conducted a large pragmatic randomized controlled trial of the effectiveness of brief advice to use nasal irrigation or steam inhalation in routine primary care for chronic or recurrent sinus symptoms.     

Bezafibrate in men with lower extremity arterial disease: randomised controlled trial

ObjectiveTo assess the effect of bezafibrate on the risk of coronary heart disease and stroke in men with lower extremity arterial disease.DesignDouble blind placebo controlled randomised trial.Setting85 general practices and nine hospital vascular clinics.Participants1568 men, mean age 68.2 years (range 35 to 92) at recruitment.InterventionsBezafibrate 400 mg daily (783 men) or placebo (785 men).ResultsBezafibrate did not reduce the incidence of coronary heart disease and stroke. There were 150 and 160 events in the active and placebo groups respectively (relative risk 0.96, 95% confidence interval 0.76 to 1.21). There were 90 and 111 major coronary events in the active and placebo groups respectively (0.81, 0.60 to 1.08), of which 64 and 65 were fatal (0.95, 0.66 to 1.37) and 26 and 46 non-fatal (0.60, 0.36 to 0.99). Beneficial effects on non-fatal events were greatest in men aged <65 years at entry, in whom benefit was also seen for all coronary events (0.38, 0.20 to 0.72). There were no significant effects in older men. There were 60 strokes in those on active treatment and 49 in those on placebo (1.34, 0.80 to 2.01). There were 204 and 195 deaths from all causes in the two groups respectively (1.03, 0.83 to 1.26). Bezafibrate reduced the severity of intermittent claudication for up to three years.ConclusionsBezafibrate has no effect on the incidence of coronary heart disease and of stroke combined but may reduce the incidence of non-fatal coronary events, particularly in those aged <65 years at entry, in whom all coronary events may also be reduced.

What is already known on this topic

The beneficial effects of bezafibrate on blood lipids and fibrinogen concentrations should reduce the incidence of heart attacks and strokesSo far, however, there is only limited evidence on clinical outcomes from randomised controlled trials

What this study adds

Treatment with bezafibrate was not associated with a reduction in the combined incidence of heart attacks and strokes, though there were substantially fewer non-fatal heart attacks in those taking bezafibrateBezafibrate was associated with a reduction in the incidence of all heart attacks, especially non-fatal, in men aged <65 yearsBezafibrate seems to reduce the severity of intermittent claudication for two or three years     

Hemiarthroplasty or internal fixation for intracapsular displaced femoral neck fractures: randomised controlled trial

Objective To compare the functional results after displaced fractures of the femoral neck treated with internal fixation or hemiarthroplasty.Design Randomised trial with blinding of assessments of functional results.Setting University hospital.Participants 222 patients; 165 (74%) women, mean age 83 years. Inclusion criteria were age above 60, ability to walk before the fracture, and no major hip pathology, regardless of cognitive function.Interventions Closed reduction and two parallel screws (112 patients) and bipolar cemented hemiarthroplasty (110 patients). Follow-up at 4, 12, and 24 months.Main outcome measures Hip function (Harris hip score), health related quality of life (Eq-5d), activities of daily living (Barthel index). In all cases high scores indicate better function.Results Mean Harris hip score in the hemiarthroplasty group was 8.2 points higher (95% confidence interval 2.8 to 13.5 points, P=0.003) at four months and 6.7 points (1.5 to 11.9 points, P=0.01) higher at 12 months. Mean Eq-5d index score at 24 months was 0.13 higher in the hemiarthroplasty group (0.01 to 0.25, P=0.03). The Eq-5d visual analogue scale was 8.7 points higher in the hemiarthroplasty group after 4 months (1.9 to 15.6, P=0.01). After 12 and 24 months the percentage scoring 95 or 100 on the Barthel index was higher in the hemiarthroplasty group (relative risk 0.67, 0.47 to 0.95, P=0.02. and 0.63, 0.42 to 0.94, P=0.02, respectively). Complications occurred in 56 (50%) patients in the internal fixation group and 16 (15%) in the hemiarthroplasty group (3.44, 2.11 to 5.60, P<0.001). In each group 39 patients (35%) died within 24 months (0.98, 0.69 to 1.40, P=0.92)Conclusions Hemiarthroplasty is associated with better functional outcome than internal fixation in treatment of displaced fractures of the femoral neck in elderly patients.Trial registration {"type":"clinical-trial","attrs":{"text":"NCT00464230","term_id":"NCT00464230"}}NCT00464230.     

Cimetidine for recurrent ulcer after vagotomy or gastrectomy: a randomised controlled trial.

In a randomised controlled trial cimetidine 1 g daily for six weeks was compared with placebo in the treatment of recurrent ulcers after gastrectomy or vagotomy for duodenal ulcer. Healing, assessed endoscopically, was seen in seven out of 12 patients given cimetidine and in five out of 12 controls. Four of the controls whose ulcers did not heal were subsequently treated with cimetidine, and in two the ulcers healed after six weeks. Pain recorded by the patient and consumption of alkalis were each slightly but not significantly less in the cimetidine-treated patients. When cimetidine is to be used for recurrent ulceration probably the dosage and duration of treatment should be increased.