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Results for “Randomised Controlled Trial”

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At least 487 records · Page 27Linked to original sources

PubMed1999

Multifaceted shared care intervention for late life depression in residential care: randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of a population based, multifaceted shared care intervention for late life depression in residential care. DESIGN: Randomised controlled trial, with control and intervention groups studied one after the other and blind follow up after 9.5 months. SETTING: Population of residential facility in Sydney living in self care units and hostels. PARTICIPANTS: 220 depressed residents aged >/=65 without severe cognitive impairment. INTERVENTION: The shared care intervention included: (a) multidisciplinary consultation and collaboration, (b) training of general practitioners and carers in detection and management of depression, and (c) depression related health education and activity programmes for residents. The control group received routine care. MAIN OUTCOME MEASURE: Geriatric depression scale. RESULTS: Intention to treat analysis was used. There was significantly more movement to "less depressed" levels of depression at follow up in the intervention than control group (Mantel-Haenszel stratification test, P=0.0125). Multiple linear regression analysis found a significant intervention effect after controlling for possible confounders, with the intervention group showing an average improvement of 1.87 points on the geriatric depression scale compared with the control group (95% confidence interval 0.76 to 2.97, P=0.0011). CONCLUSIONS: The outcome of depression among elderly people in residential care can be improved by multidisciplinary collaboration, by enhancing the clinical skills of general practitioners and care staff, and by providing depression related health education and activity programmes for residents.

Aged↗

PubMed2000

Nurse management of patients with minor illnesses in general practice: multicentre, randomised controlled trial.

OBJECTIVE: To assess the acceptability and safety of a minor illness service led by practice nurses in general practice. DESIGN: Multicentre, randomised controlled trial. SETTING: 5 general practices in south east London and Kent representing semi-rural, suburban, and urban settings. PARTICIPANTS: 1815 patients requesting and offered same day appointments by receptionists. INTERVENTION: Patients were assigned to treatment by either a specially trained nurse or a general practitioner. Patients seen by a nurse were referred to a general practitioner when appropriate. MAIN OUTCOME MEASURES: The general satisfaction of the patients as measured by the consultation satisfaction questionnaire. Other outcome measures included the length of the consultation, number of prescriptions written, rates of referral to general practitioners, patient's reported health status, patient's anticipated behaviour in seeking health care in future, and number of patients who returned to the surgery, visits to accident and emergency, and out of hours calls to doctors. RESULTS: Patients were very satisfied with both nurses and doctors, but they were significantly more satisfied with their consultations with nurses (mean (SD) score of satisfaction 78.6 (16. 0) of 100 points for nurses v 76.4 (17.8) for doctors; 95% confidence interval for difference between means -4.07 to -0.38). Consultations with nurses took about 10 minutes compared with about 8 minutes for consultations with doctors. Nurses and doctors wrote prescriptions for a similar proportion of patients (nurses 481/736 (65.4%) v doctors 518/816 (63.5%)). 577/790 (73%) patients seen by nurses were managed without any input from doctors. CONCLUSION: Practice nurses seem to offer an effective service for patients with minor illnesses who request same day appointments.

Acute Disease↗

PubMed2001

Cost effectiveness of computer tailored and non-tailored smoking cessation letters in general practice: randomised controlled trial.

OBJECTIVES: To develop and evaluate, in a primary care setting, a computerised system for generating tailored letters about smoking cessation. DESIGN: Randomised controlled trial. SETTING: Six general practices in Aberdeen, Scotland. PARTICIPANTS: 2553 smokers aged 17 to 65. INTERVENTIONS: All participants received a questionnaire asking about their smoking. Participants subsequently received either a computer tailored or a non-tailored, standard letter on smoking cessation, or no letter. MAIN OUTCOME MEASURES: Prevalence of validated abstinence at six months; change in intention to stop smoking in the next six months. RESULTS: The validated cessation rate at six months was 3.5% (30/857) (95% confidence interval 2.3% to 4.7%) for the tailored letter group, 4.4% (37/846) (3.0% to 5.8%) for the non-tailored letter group, and 2.6% (22/850) (1.5% to 3.7%) for the control (no letter) group. After adjustment for significant covariates, the cessation rate was 66% greater (-4% to 186%; P=0.07) in the non-tailored letter group than that in the no letter group. Among participants who smoked <20 cigarettes per day, the cessation rate in the non-tailored letter group was 87% greater (0% to 246%; P=0.05) than that in the no letter group. Among heavy smokers who did not quit, a 76% higher rate of positive shift in "stage of change" (intention to quit within a particular period of time) was seen compared with those who received no letter (11% to 180%; P=0.02). The increase in cost for each additional quitter in the non-tailored letter group compared with the no letter group was pound 89. CONCLUSIONS: In a large general practice, a brief non-tailored letter effectively increased cessation rates among smokers. A tailored letter was not effective in increasing cessation rates but promoted shift in movement towards cessation ("stage of change") in heavy smokers. As a pragmatic tool to encourage cessation of smoking, a mass mailing of non-tailored letters from general practices is more cost effective than computer tailored letters or no letters.

Adolescent↗

PubMed2003

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 pound 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.

Child Day Care Centers↗

PubMed2006

Self management for men with lower urinary tract symptoms: randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of self management as a first line intervention for men with lower urinary tract symptoms. DESIGN: Randomised controlled trial. SETTING: A teaching hospital and a district general hospital in London. PARTICIPANTS: 140 men (mean age 63 (SD 10.7) years), recruited between January 2003 and April 2004, referred by general practitioners to urological outpatient departments with uncomplicated lower urinary tract symptoms. INTERVENTIONS: Self management and standard care (n=73) or standard care alone (n=67). The self management group took part in three small group sessions comprising education, lifestyle advice, and training in problem solving and goal setting skills. MAIN OUTCOME MEASURES: The primary outcome measure was treatment failure measured at 3, 6, and 12 months. Symptom severity (international prostate symptom score; higher scores represent a poorer outcome) was used as a secondary outcome. RESULTS: At three months, treatment failure had occurred in 7 (10%) of the self management group and in 27 (42%) of the standard care group (difference=32%, 95% confidence interval 18% to 46%). Corresponding differences in the frequency of treatment failure were 42% (27% to 57%) at six months and 48% (32% to 64%) at 12 months. At three months, the mean international prostate symptom score was 10.7 in the self management group and 16.4 in the standard care group (difference=5.7, 3.7 to 7.7). Corresponding differences in score were 6.5 (4.3 to 8.7) at six months and 5.1 (2.7 to 7.6) at 12 months. CONCLUSIONS: Self management significantly reduced the frequency of treatment failure and reduced urinary symptoms. Because of the large observed benefit of self management, the results of this study support the case for a large multicentre trial to confirm whether self management could be considered as first line treatment for men with lower urinary tract symptoms. TRIAL REGISTRATION: National Research Register N0263115137; Clinical trials NCT00270309 [ClinicalTrials.gov].

Ambulatory Care↗

PubMed2006

Use of standardised outcome measures in adult mental health services: randomised controlled trial.

BACKGROUND: Routine use of standardised outcome measures is not universal. AIMS: To evaluate the effectiveness of standardised outcome assessment. METHOD: A randomised controlled trial, involving 160 representative adult mental health patients and paired staff (ISRCTN16971059). The intervention group (n=101) (a) completed monthly postal questionnaires assessing needs, quality of life, mental health problem severity and therapeutic alliance, and (b) received 3-monthly feedback. The control group (n=59) received treatment as usual. RESULTS: The intervention did not improve primary outcomes of patient-rated unmet need and of quality of life. Other subjective secondary outcome measures were also not improved. The intervention reduced psychiatric inpatient days (3.5 v.16.4 mean days, bootstrapped 95% CI1.6-25.7), and hence service use costs were 2586 UK pounds (95% CI 102-5391) less for intervention-group patients. Net benefit analysis indicated that the intervention was cost-effective. CONCLUSIONS: Routine use of outcome measures as implemented in this study did not improve subjective outcomes, but was associated with reduced psychiatric inpatient admissions.

Adult↗

PubMedDate not supplied

Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial.

BACKGROUND: Endovascular aneurysm repair (EVAR) is a new technology to treat patients with abdominal aortic aneurysm (AAA) when the anatomy is suitable. Uncertainty exists about how endovascular repair compares with conventional open surgery. EVAR trial 1 was instigated to compare these treatments in patients judged fit for open AAA repair. METHODS: Between 1999 and 2003, 1082 elective (non-emergency) patients were randomised to receive either EVAR (n=543) or open AAA repair (n=539). Patients aged at least 60 years with aneurysms of diameter 5.5 cm or more, who were fit enough for open surgical repair (anaesthetically and medically well enough for the procedure), were recruited for the study at 41 British hospitals proficient in the EVAR technique. The primary outcome measure is all-cause mortality and these results will be released in 2005. The primary analysis presented here is operative mortality by intention to treat and a secondary analysis was done in per-protocol patients. FINDINGS: Patients (983 men, 99 women) had a mean age of 74 years (SD 6) and mean AAA diameter of 6.5 cm (SD 1). 1047 (97%) patients underwent AAA repair and 1008 (93%) received their allocated treatment. 30-day mortality in the EVAR group was 1.7% (9/531) versus 4.7% (24/516) in the open repair group (odds ratio 0.35 [95% CI 0.16-0.77], p=0.009). By per-protocol analysis, 30-day mortality for EVAR was 1.6% (8/512) versus 4.6% (23/496) for open repair (0.33 [0.15-0.74], p=0.007). Secondary interventions were more common in patients allocated EVAR (9.8% vs 5.8%, p=0.02). INTERPRETATION: In patients with large AAAs, treatment by EVAR reduced the 30-day operative mortality by two-thirds compared with open repair. Any change in clinical practice should await durability and longer term results.

Aged↗

PubMed2006

Routine ultrasound examination at 12 or 18 gestational weeks for prenatal detection of major congenital heart malformations? A randomised controlled trial comprising 36,299 fetuses.

OBJECTIVE: To compare the rate of prenatal diagnosis of heart malformations between two policies of screening for heart malformations. DESIGN: Randomised controlled trial. SETTING: Six university hospitals, two district general hospitals. SAMPLE: A total of 39 572 unselected pregnancies randomised to either policy. METHODS: The 12-week policy implied one routine scan at 12 weeks including measurement of nuchal translucency (NT), and the 18-week policy implied one routine scan at 18 weeks. Fetal anatomy was scrutinised using the same check-list in both groups, and in both groups, indications for fetal echocardiography were ultrasound findings of any fetal anomaly, including abnormal four-chamber view, or other risk factors for heart malformation. In the 12-week scan group, NT >or=3.5 mm was also an indication for fetal echocardiography. MAIN OUTCOME MEASURE: Prenatal diagnosis of major congenital heart malformation. RESULTS: In the 12-week scan group, 7 (11%) of 61 major heart malformations were prenatally diagnosed versus 9 (15%) of 60 in the 18-week scan group (P= 0.60). In four (6.6%) women in the 12-week scan group, the routine scan was the starting point for investigations resulting in a prenatal diagnosis versus in 9 (15%) women in the 18-week scan group (P=0.15). The diagnosis was made <or=22 weeks in 5% (3/61) of the cases in the 12-week scan group versus in 15% (9/60) in the 18-week scan group (P=0.08). CONCLUSIONS: The prenatal detection rate of major heart malformations was low with both policies. The 18-week scan policy seemed to be superior to the 12-week scan policy, although the differences in prenatal detection rates were not statistically significant.

Female↗

PubMedDate not supplied

Nutritional supplementation of very old people at hospital discharge increases muscle strength: a randomised controlled trial.

BACKGROUND: Undernutrition is common in older people admitted to hospital, but little is known about how nutritional state changes after discharge. OBJECTIVE: This randomised controlled trial was designed to examine the effect of oral nutritional supplementation of undernourished very old people prepared to take supplements after hospital discharge following acute illness. METHODS: Participants aged>or=75 years with a BMI or=5% during an acute hospital stay were allocated at random to either oral nutritional supplementation for 8 weeks from hospital discharge or to usual care. Primary outcome was change in weight, secondary outcomes were handgrip strength and anthropometry. RESULTS: Of 198 patients eligible to participate, 136 patients (mean age 85 years) were randomised and 76/136 (56%) completed the study. Twenty percent (13/66) of the intervention group withdrew after only 2 weeks, citing intolerance of the supplements. Using intention-to-treat analysis, body weight increased by a mean of 1.6 and 2.2% in the control and intervention groups, respectively, but this between-group difference was not significant (p = 0.188). However, handgrip strength increased more (p=0.055) in the intervention group (13.9%) than in the control group (7.2%). CONCLUSIONS: Oral nutritional supplementation was associated with a greater increase in handgrip strength than in non-supplemented controls and this observation merits further study.

Aged↗

PubMed2004

Randomised controlled trial and economic evaluation of a chest pain observation unit compared with routine care.

OBJECTIVES: To measure the effectiveness and cost effectiveness of providing care in a chest pain observation unit compared with routine care for patients with acute, undifferentiated chest pain. DESIGN: Cluster randomised controlled trial, with 442 days randomised to the chest pain observation unit or routine care, and cost effectiveness analysis from a health service costing perspective. SETTING: The emergency department at the Northern General Hospital, Sheffield, United Kingdom. PARTICIPANTS: 972 patients with acute, undifferentiated chest pain (479 attending on days when care was delivered in the chest pain observation unit, 493 on days of routine care) followed up until six months after initial attendance. MAIN OUTCOME MEASURES: The proportion of participants admitted to hospital, the proportion with acute coronary syndrome sent home inappropriately, major adverse cardiac events over six months, health utility, hospital reattendance and readmission, and costs per patient to the health service. RESULTS: Use of a chest pain observation unit reduced the proportion of patients admitted from 54% to 37% (difference 17%, odds ratio 0.50, 95% confidence interval 0.39 to 0.65, P < 0.001) and the proportion discharged with acute coronary syndrome from 14% to 6% (8%, -7% to 23%, P = 0.264). Rates of cardiac event were unchanged. Care in the chest pain observation unit was associated with improved health utility during follow up (0.0137 quality adjusted life years gained, 95% confidence interval 0.0030 to 0.0254, P = 0.022) and a saving of pound 78 per patient (- pound 56 to pound 210, P = 0.252). CONCLUSIONS: Care in a chest pain observation unit can improve outcomes and may reduce costs to the health service. It seems to be more effective and more cost effective than routine care.

Algorithms↗

PubMed2005

Effect of increased convective clearance by on-line hemodiafiltration on all cause and cardiovascular mortality in chronic hemodialysis patients - the Dutch CONvective TRAnsport STudy (CONTRAST): rationale and design of a randomised controlled trial [ISRCTN38365125].

BACKGROUND: The high incidence of cardiovascular disease in patients with end stage renal disease (ESRD) is related to the accumulation of uremic toxins in the middle and large-middle molecular weight range. As online hemodiafiltration (HDF) removes these molecules more effectively than standard hemodialysis (HD), it has been suggested that online HDF improves survival and cardiovascular outcome. Thus far, no conclusive data of HDF on target organ damage and cardiovascular morbidity and mortality are available. Therefore, the CONvective TRAnsport STudy (CONTRAST) has been initiated. METHODS: CONTRAST is a Dutch multi-center randomised controlled trial. In this trial, approximately 800 chronic hemodialysis patients will be randomised between online HDF and low-flux HD, and followed for three years. The primary endpoint is all cause mortality. The main secondary outcome variables are fatal and non-fatal cardiovascular events. CONCLUSION: The study is designed to provide conclusive evidence whether online HDF leads to a lower mortality and less cardiovascular events as compared to standard HD.

Journal Article↗

PubMed2006

Randomised controlled trial of near-patient testing for glycated haemoglobin in people with type 2 diabetes mellitus.

BACKGROUND: Tight glycaemic control in people with type 2 diabetes can lead to a reduction in microvascular and possibly macrovascular complications. The use of near-patient (rapid) testing offers a potential method to improve glycaemic control. AIM: To assess the effect and costs of rapid testing for glycated haemoglobin (HbA1c) in people with type 2 diabetes. DESIGN OF STUDY: Pragmatic open randomised controlled trial. SETTING: Eight practices in Leicestershire, UK. METHOD: Patients were randomised to receive instant results for HbA1c or to routine care. The principal outcome measure was the proportion of patients with an HbA1c <7% at 12 months. We also assessed costs for the two groups. RESULTS: Of the 681 patients recruited to the study 638 (94%) were included in the analysis. The mean age at baseline was 65.7 years (SD = 10.8 years) with a median (interquartile range) duration of diabetes of 4(1-8) years. The proportion of patients with HbA1c < 7% did not differ significantly between the intervention and control groups (37 versus 38%, odds ratio 0.95 [95% confidence interval = 0.69 to 1.31]) at 12 months follow up. The total cost for diabetes-related care was 390 UK pounds per patient for the control group and 370 UK pounds for the intervention group. This difference was not statistically significant. CONCLUSION: Near-patient testing for HbA1c alone does not lead to outcome or cost benefits in managing people with type 2 diabetes in primary care. Further research is required into the use of rapid testing as part of an optimised patient management model including arrangements for patient review and testing.

Aged↗

PubMed2001

Randomised controlled trial of self management leaflets and booklets for minor illness provided by post.

OBJECTIVE: To assess the effectiveness of providing information by post about managing minor illnesses. DESIGN: Randomised controlled trial. SETTING: Six general practices. PARTICIPANTS: Random sample of 4002 patients from the practice registers. INTERVENTION: Patients were randomised to receive one of three kinds of leaflet or booklet endorsed by their general practitioner: control (surgery access times), booklet, or summary card. MAIN OUTCOME MEASURES: Attendance with the 42 minor illnesses listed in the booklet. Perceived usefulness of leaflets or booklets, confidence in managing illness, and willingness to wait before seeing the doctor. RESULTS: 238 (6%) patients did not receive the intervention as allocated. Of the remaining 3764 patients, 2965 (79%) had notes available for review after one year. Compared with the control group, fewer patients attended commonly with the minor illnesses in the booklet group (>/=2 consultations a year: odds ratio 0.81, 95% confidence interval 0.67 to 0.99) and the summary card group (0.83; 0.72 to 0.96). Among patients who had attended with respiratory tract infections in the past year there was a reduction in those attending in the booklet group (0.81; 0.62 to 1.07) and summary card group (0.67; 0.51 to 0.89) compared with the control group. The incidence of contacts with minor illness fell slightly compared with the previous year in the booklet (incidence ratio 0.97; 0.84 to 1.13) and summary card groups (0.93; 0.80 to 1.07). More patients in the intervention groups felt greater confidence in managing illness (booklet 32%, card 34%, control 12%, P<0.001), but there was no difference in willingness to wait score (all groups mean=32, P=0.67). CONCLUSION: Most patients find information about minor illness provided by post useful, and it helps their confidence in managing illness. Information may reduce the number attending commonly with minor illness, but the effect on overall contacts is likely to be modest. These data suggest that posting detailed information booklets about minor illness to the general population would have a limited effect.

Adult↗

PubMed2004

Population based randomised controlled trial on impact of screening on mortality from abdominal aortic aneurysm.

OBJECTIVE: To assess whether screening for abdominal aortic aneurysms in men reduces mortality. DESIGN: Population based randomised controlled trial of ultrasound screening, with intention to treat analysis of age standardised mortality. SETTING: Community based screening programme in Western Australia. PARTICIPANTS: 41,000 men aged 65-83 years randomised to intervention and control groups. INTERVENTION: Invitation to ultrasound screening. MAIN OUTCOME MEASURE: Deaths from abdominal aortic aneurysm in the five years after the start of screening. RESULTS: The corrected response to invitation to screening was 70%. The crude prevalence was 7.2% for aortic diameter > or = 30 mm and 0.5% for diameter > or = 55 mm. Twice as many men in the intervention group than in the control group underwent elective surgery for abdominal aortic aneurysm (107 v 54, P = 0.002, chi2 test). Between scheduled screening and the end of follow up 18 men in the intervention group and 25 in the control group died from abdominal aortic aneurysm, yielding a mortality ratio of 0.61 (95% confidence interval 0.33 to 1.11). Any benefit was almost entirely in men aged between 65 and 75 years, where the ratio was reduced to 0.19 (0.04 to 0.89). CONCLUSIONS: At a whole population level screening for abdominal aortic aneurysms was not effective in men aged 65-83 years and did not reduce overall death rates. The success of screening depends on choice of target age group and the exclusion of ineligible men. It is also important to assess the current rate of elective surgery for abdominal aortic aneurysm as in some communities this may already approach a level that reduces the potential benefit of population based screening.

Aged↗

PubMed1997

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.

Activities of Daily Living↗

PubMed2000

A randomised controlled trial of the effects of a cross-cut feeding teat on infant feeding, crying, waking and sleeping behaviour.

UNLABELLED: Feedback from mothers using a "cross-cut" teat indicated its use for problem feeders, particularly "windy" or "colicky" babies. The manufacturer commissioned a trial to see whether this observation was clinically valid. A randomised controlled trial comparing the cross-cut teat with a standard single-hole teat was designed. Both teats were identical in construction apart from the feed hole at the tip of the teat. A standard teat pierced with one hole is usually sold as slow, medium or fast flow rate, depending on the size of the hole. The cross-cut has two slits in the form of a cross opening in response to the baby's sucking. The stronger the suck the wider the cross opens, thus making the flow rate of the teat controlled by the baby. There is therefore no need to change to a teat with a faster flow rate as the baby grows. RESULTS: Babies fed with the cross-cut teat cried less and spent more time awake and content than babies fed with the standard teat.

Bottle Feeding↗

PubMed2004

Efficacy and safety of valdecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials.

Our objective was to determine the efficacy and safety of valdecoxib (a cyclo-oxygenase 2 inhibitor) in the treatment of arthritis. Randomised, controlled trials comparing 10 or 20mg valdecoxib with placebo or non-steroidal anti-inflammatory drugs (NSAIDs) in patients with active osteoarthritis or rheumatoid arthritis. The manufacturer provided clinical trial reports. Data were combined through meta-analysis. Main outcomes were patient global rating of arthritis, arthritis pain, Western Ontario and McMaster Universities indices for osteoarthritis, American College of Rheumatology indices for rheumatoid arthritis, discontinuation, endoscopic ulcers, clinically significant upper gastrointestinal or renal events. Nine trials (five in osteoarthritis, four in rheumatoid arthritis) were included with 5726 patients. Overall, valdecoxib 10 and 20mg were superior to placebo and equivalent in efficacy to maximum daily doses of NSAIDs. Significantly fewer discontinuations because of gastrointestinal adverse events (4% versus 8%), or endoscopic ulcers of 3mm or more (5% versus 13%) occurred with valdecoxib compared with NSAIDs. Clinically significant upper gastrointestinal events occurred in 2/2733 (0.1%) with valdecoxib compared with 8/1846 (0.4%) with NSAIDs. Rates of clinically significant renal events were the same (2-3%) for valdecoxib and NSAIDs. At an appropriate dose valdecoxib was as effective as NSAIDs in osteoarthritis and rheumatoid arthritis. There were fewer gastrointestinal adverse event withdrawals and endoscopically detected ulcers. Convincing evidence of reduced major gastrointestinal adverse events could not be addressed by the trials.

Arthritis, Rheumatoid↗

PubMed2006

Six sessions of manual therapy increase knee flexion and improve activity in people with anterior knee pain: a randomised controlled trial.

QUESTION: What are the effects of manual therapy on pain, range of motion, and activity in patients with anterior knee pain? DESIGN: Randomised controlled trial. PARTICIPANTS: Thirty-eight ambulatory care patients (one dropout) with anterior knee pain. INTERVENTION: The experimental intervention consisted of six sessions of manual therapy, while the control intervention was to remain on the waiting list for two weeks. OUTCOME MEASURES: Pain was measured using the Patellofemoral Pain Severity Questionnaire. Active knee flexion and extension was measured from photographs. Activity was measured by having the participants step up and down a 15 cm step, leading with the painful leg as many times as they could in a 60 second period. Measurements were taken before and after intervention by a blinded assessor. RESULTS: The experimental group decreased their pain by -8 mm (95% CI to 1 p =0.08) and pain on stairs by-10, (95% CI -22 to 2 p = 0.10) compared with the control group. They increased their active knee flexion by 10 deg (95% CI TO 16, p = 0.004) and and the number of steps in 60 seconds by 5 (95% CI 2 TO 8, p = 0.001) compared with the control group. CONCLUSION: Manual therapy is effective improving knee flexion and stair climbing i patients with anterior knee pain. There is a trend towards a small improvement in pain.

Adolescent↗