Remedial therapy after stroke: a randomised controlled trial.

Of 1094 patients with a confirmed stroke admitted to Northwick Park, a district general hospital, 364 (33%) died while in hospital, 215 (20%) were fully recovered when discharged, and 329 (30%) were too frail or too ill from diseases other than stroke to be considered for active rehabilitation. Only 121 (11%) were suitable for intensive treatment. They and 12 patients referred direct to outpatients were allocated at random to one of three different courses of rehabilitation. Intensive was compared with conventional rehabilitation and with a third regimen which included no routine rehabilitation, but under which patients were encouraged to continue with exercises taught while in hospital and were regularly seen at home by a health visitor. Progress at three months and 12 months was measured by an index of activities of daily living. Improvement was greatest in those receiving intensive treatment, intermediate in those receiving conventional treatment, and least in those receiving no routine treatment. Decreasing intensity of treatment was associated with a significant increase in the proportions of patients who deteriorated and in the extent to which they deteriorated. Probably only a few stroke patients, mostly men, are suitable for intensive outpatient rehabilitation, but for those patients the treatment is effective and realistic.     

Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial.

OBJECTIVE: To evaluate rehabilitation after myocardial infarction. DESIGN: Randomised controlled trial of rehabilitation in unselected myocardial infarction patients in six centres, baseline data being collected on admission and by structured interview (of patients and spouses) shortly after discharge and outcome being assessed by structured interview at six months and clinical examination at 12 months. SETTING: Six district general hospitals. SUBJECTS: All 2328 eligible patients admitted over two years with confirmed myocardial infarction and discharged home within 28 days. INTERVENTIONS: Rehabilitation programmes comprising psychological therapy, counselling, relaxation training, and stress management training over seven weekly group outpatient sessions for patients and spouses. MAIN OUTCOME MEASURES: Anxiety, depression, quality of life, morbidity, use of medication, and mortality. RESULTS: At six months there were no significant differences between rehabilitation patients and controls in reported anxiety (prevalence 33%) or depression (19%). Rehabilitation patients reported a lower frequency of angina (median three versus four episodes a week), medication, and physical activity. At 12 months there were no differences in clinical complications, clinical sequelae, or mortality. CONCLUSIONS: Rehabilitation programmes based on psychological therapy, counselling, relaxation training, and stress management seem to offer little objective benefit to patients who have experienced myocardial infarction compared with previous reports of smaller trials.     

Analgesic effect of breast feeding in term neonates: randomised controlled trial

ObjectivesTo investigate whether breast feeding is effective for pain relief during venepuncture in term neonates and compare any effect with that of oral glucose combined with a pacifier.DesignRandomised controlled trial.Participants180 term newborn infants undergoing venepuncture; 45 in each group.InterventionsDuring venepuncture infants were either breast fed (group 1), held in their mother''s arms without breast feeding (group 2), given 1 ml of sterile water as placebo (group 3), or given 1 ml of 30% glucose followed by pacifier (group 4). Video recordings of the procedure were assessed by two observers blinded to the purpose of the study.ResultsMedian pain scores (interquartile range) for breast feeding, held in mother''s arms, placebo, and 30% glucose plus pacifier groups were 1 (0-3), 10 (8.5-10), 10 (7.5-10), and 3 (0-5) with the Douleur Aiguë Nouveau-né scale and 4.5 (2.25-8), 13 (10.5-15), 12 (9-13), and 4 (1-6) with the premature infant pain profile scale. Analysis of variance showed significantly different median pain scores (P<0.0001) among the groups. There were significant reductions in both scores for the breast feeding and glucose plus pacifier groups compared with the other two groups (P<0.0001, two tailed Mann-Whitney U tests between groups). The difference in Douleur Aiguë Nouveau-né scores between breast feeding and glucose plus pacifier groups was not significant (P=0.16).ConclusionsBreast feeding effectively reduces response to pain during minor invasive procedure in term neonates.

What is already known on this topic

Current pharmacological treatments are not appropriate for pain relief during minor procedures like venepuncture or heel prick in newborn infantsOral sweet solutions, non-nutritive sucking, and skin to skin contact reduce procedural pain in newborn infants

What this study adds

Breast feeding during a painful procedure effectively reduces the response to pain in newborn infantsThe analgesic properties of breast feeding are at least as potent as the combination of sweet solutions and a pacifier     

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.     

"Right" stay in hospital after sugery: randomised controlled trial.

A randomised controlled trial was carried out on 100 patients to compare the effects of discharge after certain pre-specified clinical criteria had been fulfilled--"right" stay--with those of discharge at an arbitrary 10 days after surgery--"fixed" stay. The operations concerned (cholecystectomy and vagotomy) were more hazardous than those previously included in studies of early discharge. Patients in the right-stay group were discharged, on average, 7-6 days after operation--that is, two days earlier than those in the fixed-stay group. In terms of clinical progress, social factors such as return to work, and the acceptability to patients and relatives of the implications of right stay, patients in this group fared as well as those in the fixed-stay group, and in some respects slightly better. Right stay entailed the transfer of some work from hospital to community medical and nursing staff, but this also was acceptable. The concept and use of the right-stay principle is of value in planning the postoperative discharge of suitable patients.     

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.     

Zinc supplementation during pregnancy: a double blind randomised controlled trial.

OBJECTIVE--To see whether zinc supplementation during pregnancy improves maternal and fetal outcome. DESIGN--Prospective study started at booking and continued till discharge of mother and baby from the maternity hospital. Mothers were randomly assigned to receive zinc supplementation or placebo in a double blind trial. SETTING--Mothers booking at one hospital. PATIENTS--Women booking before 20 weeks of gestation who agreed to take part in the study. 494 Mothers were followed up till the end of pregnancy. There was no difference between the groups given zinc and placebo in their social or medical backgrounds. INTERVENTIONS--Mothers in the active treatment group received one capsule of 20 mg elemental zinc daily and those in the placebo treated group a capsule identical in appearance and taste with the active capsule but which contained inert substances. MAIN OUTCOME MEASURE--Various adverse outcomes were tested, including maternal bleeding, hypertension, complications of labour and delivery, gestational age, Apgar scores, and neonatal abnormalities. The main outcome measure was birth weight. RESULTS--There were no differences whatsoever between mothers given a zinc supplement and those given a placebo. CONCLUSION--Zinc supplementation in pregnancy in the United Kingdom does not seem to offer any benefits to the mother or her fetus.     

Heart disease prevention project: a randomised controlled trial in industry.

Twenty-four factories or other occupational groups, employing 18 210 men aged 40 to 59, were formed into matched pairs. One of each pair was allocated randomly to receive a five to six year programme of medical examinations and intervention to reduce the levels of the main coronary risk factors. Men at factories in the intervention group were given advice on dietary reduction of plasma cholesterol concentrations, stopping or reducing cigarette smoking, regular exercies for the sedentary and reduced energy intake for the overweight, and hypertension was treated. The programme was delivered mainly through existing occupational medical services, helped by a small central staff. Personal consultations were largely confined to men with a high risk of developing coronary heart disease. Changes in risk factors were assessed by regular standardised examinations of random samples of men. The spread of information by general propaganda proved easy, but a change in habits seemed to require personal contact. Small but significant reductions occurred, mainly in the high-risk group, but these were not sustained when pressure was relaxed.     

Effectiveness of geriatric rehabilitative care after fractures of the proximal femur in elderly women: a randomised clinical trial.

OBJECTIVE--To compare postoperative collaborative care between orthopaedic surgeons and physicians in geriatric medicine with routine orthopaedic care in elderly women with proximal femoral fracture. DESIGN--Exclusion of patients dying before fit enough to enter trial, those with pathological fractures, those likely to be discharged within seven days of entering the trial, and those remaining unfit for transfer to a peripheral hospital. Remainder allocated to two groups: treatment group and control group. SETTING--District hospital acute admission ward and rehabilitation ward. PATIENTS--144 sequentially admitted elderly women with proximal fracture of the femur; 36 excluded on above criteria and remainder entered into trial. INTERVENTION--Both treatment and control groups (n = 54 in each) received physiotherapy and other services. The treatment group also received thrice weekly supervision by a geriatrician. END POINTS--Physical independence, residence after discharge, and length of hospital stay. MEASUREMENTS AND MAIN RESULTS--At discharge significantly more patients in treatment group were independent in terms of activities of daily living than controls (41 v 25) and their median stay was 24 days (range 8-197) compared with 41 (9-365) (95% confidence intervals for difference 2 to 25). Significantly fewer treatment patients were discharged to institutional care (10% v 32%; 95% confidence interval for difference 6% to 37%) and more to their own homes (63% v 38%; 95% confidence interval for difference 6% to 44%). These beneficial effects were consistent across a range of ages and mental state. CONCLUSIONS--Both hospital and patient benefited when postoperative rehabilitation was provided in a setting specialising in such care for elderly patients with trauma.     

Blood pressure reduction in elderly: a randomised controlled trial of methyldopa.

A total of 123 out of 549 elderly residents of local authority welfare homes in Nottinghamshire were found at screening to have a standing or lying diastolic blood pressure of 100 mm Hg or more. These 123 subjects were randomly allocated to simple observation or to treatment with methyldopa. The cumulative mortality was similar in the observed and treated groups and in the normotensive group from which the subjects had been separated. Thus moderate hypertension, whether treated or not, was not a major risk predictor in the elderly population studied.     

Evaluation of a stroke family care worker: results of a randomised controlled trial.

OBJECTIVE: To examine the effect of contact with a stroke family care worker on the physical, social, and psychological status of stroke patients and their carers. DESIGN: Randomised controlled trial with broad entry criteria and blinded outcome assessment six months after randomisation. SETTING: A well organised stroke service in an Edinburgh teaching hospital. SUBJECTS: 417 patients with an acute stroke in the previous 30 days randomly allocated to be contacted by a stroke family care worker (210) or to receive standard care (207). The patients represented 67% of all stroke patients assessed at the hospital during the study period. MAIN OUTCOME MEASURES: Patient completed Barthel index, Frenchay activities index, general health questionnaire, hospital anxiety and depression scale, social adjustment scale, mental adjustment to stroke scale, and patient satisfaction questionnaire; carer completed Frenchay activities index, general health questionnaire, hospital anxiety and depression scale, social adjustment scale, caregiving bassles scale, and carer satisfaction questionnaire. RESULTS: The groups were balanced for all important baseline variables. There were no significant differences in physical outcomes in patients or carers, though patients in the treatment group were possibly more helpless less well adjusted socially, and more depressed, whereas carers in the treatment group were possibly less hassled and anxious. However, both patients and carers in the group contacted by the stroke family care worker expressed significantly greater satisfaction with certain aspects of their care, in particular those related to communication and support. CONCLUSIONS: The introduction of a stroke family care worker improved patients'' and their carers'' satisfaction with services and may have had some effect on psychological and social outcomes but did not improve measures of patients'' physical wellbeing.     

Treatment of acute mountain sickness by simulated descent: a randomised controlled trial.

OBJECTIVE--To evaluate the therapeutic efficacy of a portable hyperbaric chamber for treatment of acute mountain sickness. DESIGN--Controlled randomised trial over two mountaineering seasons. SETTING--High altitude research laboratory at 4559 m above sea level. SUBJECTS--64 climbers with acute mountain sickness randomly allocated to different treatments. INTERVENTIONS--One hour of treatment in the hyperbaric chamber at a pressure of 193 mbar or 20 mbar as control or bed rest. MAIN OUTCOME MEASURES--Symptoms of acute mountain sickness before, immediately after, and 12 hours after treatment. Permitted intake of analgesic and antiemetic drugs in the follow up period. RESULTS--Treatment with 193 mbar caused greater relief of symptoms than did control treatment or bed rest. During the 12 hour follow up period intake of analgesics was similar (58-80% of subjects in each group). Symptom scores had improved in all subjects after 12 hours with no significant differences between groups. CONCLUSIONS--One hour of treatment with 193 mbar in a portable hyperbaric chamber, corresponding to a descent of 2250 m, leads to a short term improvement in symptoms of acute mountain sickness but has no beneficial long term effects attributable to pressurisation.     

Day hospital rehabilitation--effectiveness and cost in the elderly: a randomised controlled trial.

The effectiveness and cost of day hospital care in rehabilitation were studied in a randomised controlled trial in 120 elderly patients who were assessed at referral and six weeks and five months later in activities of daily living skills and mood. Day hospital patients were compared with a control group, who were managed as they would have been before the availability of day hospital care. Day hospital patients showed a significant improvement in performance of activities of daily living at six weeks but not at five months; however, they had a sustained improvement in mood. The cost of day hospital rehabilitation was one third greater than that of rehabilitation by alternative means. In its current form the geriatric day hospital is not a cheap alternative to other means of rehabilitation. Expensive components of the day hospital should be critically re-examined and renewed emphasis placed on sufficient inpatient beds, domiciliary services, and day care centres.     

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.     

Improvement in bronchial hyper-responsiveness in patients with moderate asthma after treatment with a hypnotic technique: a randomised controlled trial.

A prospective, randomised, single blind, and controlled trial of a hypnotic technique was undertaken in 39 adults with mild to moderate asthma graded for low and high susceptibility to hypnosis. After a six week course of hypnotherapy 12 patients with a high susceptibility score showed a 74.9% improvement (p less than 0.01) in the degree of bronchial hyper-responsiveness to a standardised methacholine challenge test. Daily home recordings of symptoms improved by 41% (p less than 0.01), peak expiratory flow rates improved by 5.5% (p less than 0.01), and use of bronchodilators decreased by 26.2% (p less than 0.05). The improvement in bronchial hyper-reactivity occurred without a change in subjective appreciation of the degree of bronchoconstriction. A control group 17 patients and 10 patients undergoing treatment with low susceptibility to hypnosis had no change in either bronchial hyper-responsiveness or any of the symptoms recorded at home. This study shows the efficacy of a hypnotic technique in adult asthmatics who are moderately to highly susceptible to hypnosis.     

A randomised controlled trial of surgery for glue ear.

OBJECTIVE--To assess the effect of five different surgical treatments for glue ear (secretory otitis media) on improvement in hearing and, assuming one or more treatments to be effective, to identify the appropriate indications for surgery. DESIGN--Randomised controlled trial of children receiving (a) adenoidectomy, bilateral myringotomy, and insertion of a unilateral grommet; (b) adenoidectomy, unilateral myringotomy, and insertion of a unilateral grommet; (c) bilateral myringotomy and insertion of a unilateral grommet; and (d) unilateral myringotomy and insertion of a grommet. Children were followed up at seven weeks, six months, 12 months, and 24 months by symptom history and clinical investigations. SETTING--Otolaryngology department in an urban hospital. PATIENTS--149 Children aged 4-9 years who were admitted for surgery for glue ear and who had no history of previous operations on tonsils, adenoids, or ears and no evidence of sensorineural deafness. Inadequate follow up information on levels of hearing and on middle ear function was obtained from 22. MAIN OUTCOME MEASURES--Mean hearing loss (dB) of the three worst heard frequencies between 250 and 4000 Hz, results of impedance tympanometry, and parental views on their child''s progress. RESULTS--In the 127 children for whom adequate information was available ears in which a grommet had been inserted performed better in the short term (for at least six months) than those in which no grommet had been inserted, irrespective of any accompanying procedure. Most of the benefit had disappeared by 12 months. Adenoidectomy produced a slight improvement that was not significant, though was sustained for at least two years. The ears of children who had had an adenoidectomy with myringotomy and grommet insertion, however, continued to improve so that two years after surgery about 50% had abnormal tympanometry compared with 83% of those who had had only myringotomy and grommet insertion, and 93% of the group that had had no treatment. Logistic regression analyses identified preoperative hearing level as the single best predictor of good outcome from surgery. Other variables contributed little additional predictive power. CONCLUSIONS--If the principal objective of surgery for glue ear is to restore hearing then our study shows that insertion of grommets is the treatment of choice. The addition of an adenoidectomy will increase the likelihood of restoration of normal function of the middle ear but will not improve hearing. When deciding appropriate indications for surgery, a balance has to be made between performing unnecessary operations and failing to treat patients who might benefit from surgical intervention. Preoperative audiometry scores might be the best predictor in helping to make this decision.     

Prevention of respiratory complications after abdominal surgery: a randomised clinical trial.

OBJECTIVE--To evaluate the prevention of respiratory complications after abdominal surgery by a comparison of a global policy of incentive spirometry with a regimen consisting of deep breathing exercises for low risk patients and incentive spirometry plus physiotherapy for high risk patients. DESIGN--Stratified randomised trial. SETTING--General surgical service of an urban teaching hospital. PATIENTS--456 patients undergoing abdominal surgery. Patients less than 60 years of age with an American Society of Anesthesia classification of 1 were considered to be at low risk. OUTCOME MEASURES--Respiratory complications were defined as clinical features consistent with collapse or consolidation, a temperature above 38 degrees C, plus either confirmatory chest radiology or positive results on sputum microbiology. We also recorded the time that staff devoted to prophylactic respiratory therapy. RESULTS--There was good baseline equivalence between the groups. The incidence of respiratory complications was 15% (35/231) for patients in the incentive spirometry group and 12% (28/225) for patients in the mixed therapy group (P = 0.40; 95% confidence interval -3.6% to 9.0%). It required similar amounts of staff time to provide incentive spirometry and deep breathing exercises for low risk patients. The inclusion of physiotherapy for high risk patients, however, resulted in the utilisation of an extra 30 minutes of staff time per patient. CONCLUSIONS--When the use of resources is taken into account, the most efficient regimen of prophylaxis against respiratory complications after abdominal surgery is deep breathing exercises for low risk patients and incentive spirometry for high risk patients.     

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.