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Results for “Randomised Controlled Trial”

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PubMed2000

Inhaled salbutamol for wheezy infants: a randomised controlled trial.

BACKGROUND: Salbutamol is frequently used as a bronchodilator for infants who wheeze. Many single dose studies have questioned its effectiveness. AIMS: To investigate the response of wheezy infants to salbutamol over an extended time period in order to elucidate either symptomatic relief or a protective effect. METHODS: Eighty infants under 1 year, with persistent or recurrent wheeze and a personal or family history of atopy, were recruited to a randomised, double blind, cross over, placebo controlled trial. Salbutamol (200 microg three times daily) or placebo were administered regularly over two consecutive treatment periods of four weeks via a spacer and mask. Symptoms of wheeze and cough were recorded in a diary. At the end of the study pulmonary function tests were performed before and after salbutamol (400 microg). RESULTS: Forty eight infants completed the diary study; 40 infants underwent pulmonary function testing. No difference in mean daily symptom score was observed between the salbutamol and placebo periods. There was no difference in the number of symptom free days. Compliance and forced expiratory flows remained unchanged and resistance increased following salbutamol. There was no relation between the response measured by symptom score or pulmonary function in individual patients. CONCLUSION: In wheezy infants with an atopic background, there was no significant beneficial effect of salbutamol on either clinical symptoms or pulmonary function. Clinical effects could not be predicted from pulmonary function tests. Salbutamol cannot be recommended as the bronchodilator of choice in this age group.

Administration, Inhalation↗

PubMed2001

Comparison of elderly people's technique in using two dry powder inhalers to deliver zanamivir: randomised controlled trial.

OBJECTIVE: To determine whether elderly people can learn to use the inhaler used to deliver zanamivir (Relenza Diskhaler) as effectively as the Turbohaler and to identify which aspects of inhaler technique are most problematic. DESIGN: Randomised, controlled, intervention study. SETTING: Wards for acute elderly care in a large district general hospital. PARTICIPANTS: 73 patients who were unfamiliar with the use of an inhaler, aged 71 to 99 (mean 83) years. MAIN OUTCOME MEASURES: Initial scores and changes in scores 24 hours later using a 10 point scoring system of five aspects of inhaler technique. RESULTS: 38 patients were allocated the Relenza Diskhaler and 35 the Turbohaler. The mean total score was significantly greater in the Turbohaler than Diskhaler groups both initially (8.74 v 7.05) and after 24 hours (8.28 v 5.43). The major difference between inhalers was in loading and priming. After tuition 50% (19 of 38) of patients allocated the Diskhaler were unable to load and prime the device and 65% (24 of 37) were unable to do so 24 hours later. Of those allocated the Turbohaler, two patients were unable to load and prime the device after initial review and one after 24 hours. CONCLUSION: Most elderly people cannot use the inhaler device used to deliver the anti-influenza drug zanamivir. Treatment with this drug is unlikely to be effective in elderly people unless the delivery system is improved.

Administration, Inhalation↗

PubMed2003

The effect of conducting a lottery on questionnaire response rates: a randomised controlled trial.

AIM: To study the effect of a lottery incentive on questionnaire response rate. MATERIAL AND METHODS: In Copenhagen County, Denmark, a random sample of 2543 men and women between the ages of 19 and 60 were randomised into a control group and an intervention group. Both groups were contacted by mail and asked to complete a questionnaire on sociodemografic characteristics, self-rated health and self-reported physical activity level. The intervention group was offered participation in a small lottery for returning the questionnaire. No incentive was offered to the control group. MAIN RESULTS: The final response rate for the control group was 60.4 and 63.4% for the intervention group. Although the response rate was significantly higher in the intervention group after 2 and 3 weeks, the difference in the final response rate between groups was not statistically significant (p = 0.12). There was no statistically significant difference between groups in sociodemografic characteristics, self-rated health or self-reported physical activity level. CONCLUSION: A lottery incentive had no significant effect on the overall response rate, but may have contributed to a quicker response. Furthermore a lottery incentive did not seem to alter the selection of respondents.

Adolescent↗

PubMed2004

Efficacy and satisfaction rate comparing endometrial ablation by rollerball electrocoagulation to uterine balloon thermal ablation in a randomised controlled trial.

OBJECTIVE: To compare two methods of endometrial ablation, hysteroscopic rollerball electrocoagulation (RBE) and non-hysteroscopic uterine balloon thermal ablation (Thermachoice trade mark ), regarding efficacy for reducing dysfunctional uterine bleeding and patients satisfaction rate. METHODS: A randomised controlled study was performed in a teaching hospital at the department of gynaecology. One hundred and thirty-seven premenopausal women with dysfunctional uterine bleeding proved by validated menstrual score list were included. Endometrial ablation by a hysteroscopic or non-hysteroscopic method was performed by one gynaecologist. RESULTS: Reduction of menstrual blood loss was significantly more successful at 24 months for thermal ablation with uterine balloon. Success rate measured by menstrual score < 185 for rollerball and thermal balloon ablation are equivalent at 12 and 24 months post-operatively. Satisfaction of the patients for both methods at 24 months post-operatively is not significantly different (respective 75% for rollerball and 80% for uterine balloon). CONCLUSIONS: Endometrial ablation by uterine balloon thermal ablation (Thermachoice trade mark ) is equally effective as hysteroscopic RBE of the endometrium.

Adult↗

PubMed2004

Does additional feeding support provided by health care assistants improve nutritional status and outcome in acutely ill older in-patients?--a randomised control trial.

BACKGROUND & AIMS: Malnutrition is common in the elderly and increases morbidity and mortality. Most attempts to reverse malnutrition have used liquid supplements, but the findings are inconsistent. This study tests a new approach using a randomised-controlled design. The aim was to examine whether health care assistants, trained to provide additional support with feeding, can improve acutely ill elderly in-patients' clinical outcomes. METHODS: The study was carried out on three acute medicine for the elderly wards at Hammersmith Hospitals NHS Trust, London. In all, 592 patients, all over 65 years old, were recruited. RESULTS: The results showed that the median time patients received feeding support was 16 days, and the assisted group was given less intravenous antibiotics (P=0.007). However, the groups did not differ in markers of nutritional status, Barthel score, grip strength, length of stay or mortality. CONCLUSION: It was concluded that the use of health care assistants in this specialised role, in an acute setting, without change to the food provision or without targeting higher risk patients, reduced the need for intravenous antibiotics. However, the intervention did not improve nutritional status or have an effect on length of stay in the time span studied. The results highlight the difficulties of improving the intake of acutely ill elderly patients during a hospital stay.

Acute Disease↗

PubMedDate not supplied

Reduction in hospital readmission stay of elderly patients by a community based hospital discharge scheme: a randomised controlled trial.

STUDY OBJECTIVE: To compare a community support scheme using care attendants with standard aftercare for their effects on independence and morale of elderly patients discharged from hospital and on their use of health and social services. DESIGN: Randomised controlled study of cohort of patients over 75 discharged to their own homes. SETTING: District general hospital and community. PATIENTS: Total of 903 patients (mean age 82, 25% over 85). INTERVENTIONS: Total of 464 patients received support from care attendants on first day at home and for up to 12 hours a week for two weeks. Support comprised practical care, help with rehabilitation, and organising social help. The remaining 439 patients received standard aftercare. END POINT: Difference between two groups of 7% in hospital readmission rates or one point on activities of daily living scale (power 80%, significance level 5%). MEASUREMENTS AND MAIN RESULTS: Three months after the initial discharge 763 patients were interviewed (84%). There were no significant differences between the two groups in physical independence (activities of daily living scale), in measures of morale (Philadelphia scale), or in death rates. Hospital readmission rates within 18 months of discharge, however, were significantly higher in the control group and they spent more days in hospital (mean; control group 30.6 days, support group 17.1 days; p = 0.014). Of the patients living alone who were followed up for 18 months 21 (15%) receiving standard aftercare were readmitted more than twice compared with 6 (5%) supported by care attendants (p less than 0.01). CONCLUSIONS: If the findings are confirmed, and the policy extended to all patients over the age of 75 living alone, an average health district might expect either to save about 23 hospital beds at a net annual saving of about pounds 220,000 in the short term or to increase available beds by this number.

Activities of Daily Living↗

PubMed1987

Randomised controlled trial of lymphoblastoid interferon for chronic active hepatitis B.

Thirty male patients (27 homosexual) with biopsy proven chronic active hepatitis B were randomised to receive lymphoblastoid interferon (Wellferon) or no treatment. All patients were HBeAg positive and had continuing viral replication. Patients receiving treatment were given a single daily intramuscular injection of interferon for 28 days at a starting dose of 2.5 MU/m2 increasing to a maximum of 7.5 MU/m2/day. Transient side effects of malaise and influenza like symptoms occurred in all patients and resolved rapidly after treatment. Hepatitis B viral replication was suppressed during interferon treatment in all patients but the effect was limited to the period of therapy. After one year there was no appreciable difference in viral markers between the two groups of patients and this treatment schedule appears less effective than the thrice weekly, three month regimes recently reported from other centres.

Adult↗

PubMed2005

The silver-releasing foam dressing, Contreet Foam, promotes faster healing of critically colonised venous leg ulcers: a randomised, controlled trial.

The study compared the effect of a sustained silver-release foam dressing (Contreet Foam) with a foam dressing (Allevyn Hydrocellular) without added silver in critically colonised venous leg ulcers with delayed healing. The study was a multicentre, open, randomised, controlled study lasting for 4 weeks. Ulcer area and healing were assessed weekly. Odour, maceration, absorption capacity and leakage were evaluated at dressing changes. All adverse events were recorded. One hundred and twenty-nine patients were included (Contreet Foam: 65, Allevyn Hydrocellular: 64). The two groups were comparable in all respects. After 4 weeks, there was a significantly greater reduction in ulcer area in the Contreet Foam group (45%) than in the Allevyn Hydrocellular group (25%). After 1 and 4 weeks, odour was present in significantly less of the ulcers in the Contreet Foam group (17% and 19%, respectively) compared with the Allevyn Hydrocellular group (47% and 39%, respectively) and at the final visit there were significantly fewer leakages in the Contreet Foam group (19%) compared with the Allevyn Hydrocellular group (49%). Also, less maceration was observed after 1 and 4 weeks in the Contreet Foam group (34% and 37%, respectively) compared with the Allevyn Hydrocellular group (55% and 48%, respectively). The occurrence and cause of adverse events were equally distributed between the study groups. The present study provides evidence of the superior performance of the silver-releasing dressing, Contreet Foam, compared with a traditional moist foam wound healing dressing in the treatment of critically colonised, chronic venous leg ulcers. The results of this randomised, controlled study suggest an important role of sustained silver-releasing dressings in the treatment of critically colonised chronic wounds.

Adult↗

PubMed2005

Efficacy of fluticasone on cough: a randomised controlled trial.

Cough may be the consequence of bronchial hyperresponsiveness (BHR) and inflammation. This study was designed to investigate the short-term effects of an inhaled steroid (fluticasone propionate (FP)) on cough, and to determine the effects of smoking, BHR, allergy and forced expiratory volume in one second (FEV1) on the efficacy of FP. In a community-based primary healthcare centre, 135 previously healthy adults suffering from cough for > or =2 weeks were enrolled in a randomised, double-blind, placebo-controlled trial of inhaled FP 500 microg b.i.d. for 2 weeks. Participants completed daily diary cards of lower respiratory tract symptoms. The primary outcome measure was the decrease in mean total daily cough score (0-6) during the second week of treatment. In the FP group, the cough score decreased from 3.8 at baseline to mean+/-SEM 1.4+/-0.2 during the second week. In the placebo group, this decrease was from 3.8 to 1.9+/-0.1 and was statistically significantly less. A favourable effect of FP was only detectable in nonsmokers, in whom the score was 0.9 points lower compared with placebo. The clinical relevance of this finding has to be established further. Allergy, FEV1 and BHR at baseline did not affect the efficacy of FP. In conclusion, anti-inflammatory treatment with the inhaled steroid fluticasone propionate reduces cough in otherwise healthy adults who do not smoke.

Administration, Inhalation↗

PubMed1998

Randomised controlled trial of novel, simple, and well supervised weight reducing diets in outpatients.

OBJECTIVES: To investigate the contribution of novelty and simplicity to compliance with a low energy diet among obese outpatients. DESIGN: Three arm randomised trial for 16 weeks. SETTING: NHS hospital obesity clinic. SUBJECTS: 45 patients aged over 17 years with a body mass index >27 who were not diabetic, pregnant, or lactating. INTERVENTIONS: Conventional 3.4 MJ diet (control), isoenergetic novel diet of milk only, or milk plus one designated food daily. Follow up visit every 4 weeks. MAIN OUTCOME MEASURE: Weight loss. RESULTS: Mean weight loss (kg) after 16 weeks on control, milk only, and milk plus diets was 1.7 (95% confidence interval 0.3 to 3.7), 9.4 (5.9 to 12.9), and 7.0 (2.7 to 11.3) respectively. Weight loss on the novel diets was significantly greater than on the control diet. CONCLUSIONS: Dietary treatment can achieve as much weight loss in obese outpatients over 16 weeks as has been reported for the most successful drug treatment, but compliance with the prescribed diet is poor unless the diet is novel and simple.

Adolescent↗

PubMed1983

A prospective randomised controlled trial of diazepam (valium) vs emulsified diazepam (diazemuls) as a premedication for upper gastrointestinal endoscopy.

Two hundred and forty four patients were randomised to receive either diazepam or emulsified diazepam (diazemuls) intravenously prior to routine upper gastrointestinal endoscopy. The groups were comparable with regard to age, sex, medical condition, vein size, and amount of drug administered. A quantitative assessment of symptoms at the injection site during the ensuing week was made by analysing questionnaires on pain and tenderness, which the patients graded each day, on a scale 0-3. Twenty-one out of 82 patients who received diazepam (25.6%) and 22 out of 84 who received diazemuls (26.2%) had local symptoms. Although the mean symptom scores over 7 days for the two groups were not different (5.95 +/- 5.19 and 7.27 +/- 6.30 respectively), more patients who received diazepam reported induration (P = 0.033). In 112 patients, signs of thrombosis in the injected veins were looked for 3-7 weeks later without knowledge of the preparation given. Thrombosis was present in 13 (25%) patients who had received diazepam and two (3.6%) who had received diazemuls (P less than 0.002). Only eight (53%) patients with thrombosed veins had symptoms. Thrombosis after intravenous injection of diazepam or diazemuls may be symptomless, and is significantly less likely following diazemuls.

Adult↗

PubMed2005

Randomised controlled trial of mammographic screening in women from age 40: results of screening in the first 10 years.

Debate continues over the effectiveness of screening by mammography in women below age 50. We report here on results of screening in the first 10 years of a randomised trial to study the effect on breast cancer mortality of invitation to annual mammography from age 40 to 41 compared to first invitation to the 3-yearly UK national programme at age 50-52. The trial is taking place in 23 NHS breast screening centres. Between 1991 and 1997, 160 921 women were randomised in the ratio 1 : 2 to intervention and control arms. Screening is by two views at first screen and single view subsequently; data on screening up to and including round five are now complete. Uptake of invitation to screening is between 68 and 70% at all but the latest screening rounds. Rates of referral for assessment are 4.6% at first screen and 3.4% at subsequent screens. Invasive cancer detection rates are 0.09% at first screen, and similar at rescreens until the sixth and later screens. There is little evidence of regular mammography in the trial control arm. The setting of this trial within the NHS breast screening programme should ensure applicability of results to a national programme.

Adult↗

PubMed2002

A randomised controlled trial of micronised purified flavonoid fraction vs placebo in patients with chronic venous disease.

OBJECTIVE: to evaluate the efficacy of a micronised purified flavonoid fraction (MPFF) in the treatment of chronic venous disease (CVD). DESIGN: prospective double blind, randomised, control study. PATIENTS AND METHODS: one hundred and one patients with symptomatic CVD were randomly allocated to treatment for 60 days with either MPFF (51 patients) or placebo (50 patients) 500 mg twice daily. There were 28 men and 73 women, aged 22-65 years (mean age 48 years). No difference regarding age, gender, clinical class or duration of symptoms was recorded between the treatment and placebo groups. A global score for evaluation of symptoms was used. Patients were investigated with plethysmography (foot-volumetry) and duplex-ultrasonography before and after the treatment period. For statistical comparison Cochran-Mantel-Haenszel test, two-sided Student t-test and covariance analysis were used and p<0.05 was regarded significant. RESULTS: improvement of the global score of symptoms was reported by 21 patients in the MPFF group and by 16 in the placebo group (N.S.). For the whole groups, no significant differences were recorded before and after treatment regarding foot-volumetric or ultrasonographic parameters. On the other hand, in patients with edema (20 in the MPFF group, 23 in the placebo group) ultrasonographic reflux time was significantly reduced for those in the treatment group (p=0.03). This finding did not correlate to clinical symptoms. CONCLUSION: in this study, MPFF did not change the symptoms of CVD, except night cramps. A secondary finding was reduced reflux times in patients with oedema, although no ultrasonographic or foot-volumetric parameters changed significantly for the whole group. The role of MPFF in treatment of patients with CVD needs to be further analysed in a large population.

Adult↗

PubMed2006

Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial.

BACKGROUND: Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist--such as the uterotonic drug oxytocin--most are not feasible in resource-poor settings where many births occur at home. We aimed to investigate whether oral misoprostol, a potential alternative to oxytocin, could prevent postpartum haemorrhage in a community home-birth setting. METHODS: In a placebo-controlled trial undertaken between September, 2002, and December, 2005, 1620 women in rural India were randomised to receive oral misoprostol (n=812) or placebo (n=808) after delivery. 25 auxiliary nurse midwives undertook the deliveries, administered the study drug, and measured blood loss. The primary outcome was the incidence of acute postpartum haemorrhage (defined as > or =500 mL bleeding) within 2 h of delivery. Analysis was by intention-to-treat. The trial was registered with the US clinical trials database (http://www. clinicaltrials.gov) as number NCT00097123. FINDINGS: Oral misoprostol was associated with a significant reduction in the rate of acute postpartum haemorrhage (12.0% to 6.4%, p<0.0001; relative risk 0.53 [95% CI 0.39-0.74]) and acute severe postpartum haemorrhage (1.2% to 0.2%, p<0.0001; 0.20 [0.04-0.91]. One case of postpartum haemorrhage was prevented for every 18 women treated. Misoprostol was also associated with a decrease in mean postpartum blood loss (262.3 mL to 214.3 mL, p<0.0001). Postpartum haemorrhage rates fell over time in both groups but remained significantly higher in the placebo group. Women taking misoprostol had a higher rate of transitory symptoms of chills and fever than the control. INTERPRETATION: Oral misoprostol was associated with significant decreases in the rate of acute postpartum haemorrhage and mean blood loss. The drug's low cost, ease of administration, stability, and a positive safety profile make it a good option in resource-poor settings.

Administration, Oral↗

PubMed2004

Frontotemporal dementia: a randomised, controlled trial with trazodone.

Behavioural troubles due to frontotemporal dementia (FTD) are difficult to treat. The serotonergic system is associated with frontal lobes, the degeneration of which contributes to FTD. Trazodone increases the extracellular 5-HT levels in the frontal cortex. In a randomised, double-blind, placebo-controlled cross-over study, we investigated the effect of trazodone. There was a significant decrease in the Neuropsychiatry Inventory (NPI) total score with trazodone (p = 0.028) in the 26 evaluable patients. A decrease of more than 50% in the NPI score was observed in 10 patients with trazodone. This improvement was mainly based on the improvement of 4 items of the scale (irritability, agitation, depressive symptoms and eating disorders). The Mini-Mental State Examination was not modified and trazodone was well tolerated. Results of this first placebo-controlled trial suggest that trazodone is an effective treatment for the behavioural symptoms of FTD.

Adult↗

PubMed1992

Randomised controlled trial of nasal nicotine spray in smoking cessation.

Studies with nicotine chewing gum and nicotine skin patches indicate that nicotine replacement can help people to give up smoking. The rapidity with which nicotine is absorbed when given as a nasal spray suggests that it might be effective for those for whom the other means of replacement are too slow. The efficacy and safety of a nasal nicotine spray as an adjunct to group treatment for stopping smoking were assessed in a randomised, double-blind, placebo-controlled trial in which 227 cigarette smokers attending the Maudsley Hospital Smokers Clinic received 4 weeks of supportive group treatment plus active nicotine (0.5 mg per shot) or placebo nasal spray. The main end-point was biochemically validated complete abstinence from smoking from the third week of group treatment until the 12-month follow-up. Side-effects were assessed by self-reports and, where necessary, by physical examination. Of subjects assigned to active treatment 26% (n = 30) were validated abstinent throughout the year, compared with 10% (n = 11) of those assigned to placebo (relative abstinence rate 2.6, 95% CI 1.5-4.5, p less than 0.001). The advantage of the active spray was greatest in the heaviest smokers. Plasma nicotine concentrations from the spray were typically between one-half and three-quarters of baseline smoking levels. Tobacco-withdrawal symptoms, craving for cigarettes, and weight gain in abstinent subjects were reduced by the active spray. Minor irritant side-effects were frequent in both active and placebo sprays, but only 2 subjects had the spray discontinued as a result. No serious adverse effects were encountered. Nasal nicotine spray combined with supportive group treatment is an effective aid to smoking cessation.

Administration, Intranasal↗

PubMed2006

Gastrazole (JB95008), a novel CCK2/gastrin receptor antagonist, in the treatment of advanced pancreatic cancer: results from two randomised controlled trials.

Gastrin has been shown to be a growth stimulant in pancreatic cancer cells. Gastrazole is a potent and selective gastrin receptor antagonist. Two randomised blinded trials were conducted to assess the effect of gastrazole in advanced pancreatic cancer. Patients with biopsy-proven, inoperable pancreatic carcinoma were recruited. Trial A compared protracted venous infusion (PVI) gastrazole with PVI placebo, whereas trial B compared PVI gastrazole with PVI fluorouracil (5-FU). Eighteen patients were randomised in trial A. Gastrazole produced significantly better survival compared to placebo (median 7.9 months vs 4.5 months; 1-year survival: 33 vs 11%, respectively; log rank P=0.02). No difference in toxicity was seen between gastrazole and placebo, except central venous catheter and pump complications. Ninety-eight patients were randomised in trial B. No significant survival difference was detected between gastrazole and 5-FU (median: 3.6 vs 4.2 months; 1-year survival: 13.2 vs 26.2%, respectively; log rank P=0.42). Toxicity of gastrazole was mild with significantly less diarrhoea (P=0.03), stomatitis (P<0.001) and hand- foot syndrome (P<0.001) compared to 5-FU. Quality of life (QoL) assessment showed similar QoL between gastrazole and 5-FU at baseline and no significant differences occurred with treatment either between arms or within arms. Compared to placebo, patients with advanced pancreatic cancer treated with gastrazole appeared to live longer, albeit in a very small trial and will require confirmation with large-scale randomised data. However, it did not produce survival advantage over PVI 5-FU. Lack of toxicity for gastrazole may allow its combination with cytotoxic drugs.

Adult↗

PubMed2003

Performance of hospital-at-home after a randomised controlled trial.

OBJECTIVE: To compare the performance of an admission-avoidance hospital-at-home scheme one year after the end of a randomised trial with its performance during the trial. METHODS: Observational study of patients admitted to the scheme during a period of 12-19 months after the trial ended. In addition to routine data from service records, patients were interviewed at three days, two weeks and three months after admission, using the same instruments as used in the trial. RESULTS: All 78 patients admitted to hospital-at-home during the follow-up period were included, and compared with the 95 patients admitted during the trial. The referral rate to hospital-at-home was the same (11 per month) as during the trial. During the trial, patients were randomised to hospital-at-home or hospital, meaning that hospital-at-home worked at about double the trial volume in the post-trial period. Baseline characteristics showed no statistically significant differences except that post-trial patients were less cognitively impaired. There were no statistically significant differences between the groups in survival at two weeks and three months, or in Barthel index, Sickness Impact Profile 68 and Philadelphia Geriatric Morale Scale. Length of stay in hospital-at-home was significantly shorter in the post-trial period (median of five days versus seven, P < 0.001), and more patients received a visit from their general practitioner during the period of admission (54% versus 38%, P = 0.04); otherwise there were no significant differences in process measures. CONCLUSION: Apart from working at higher volume and achieving a shorter length of stay, performance of the hospital-at-home scheme a year after the trial ended was little different from that reported during the trial. This is an example of an observational study providing evidence to support the generalisability of trial findings.

Aged↗