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Results for “Randomised Controlled Trial”

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At least 1,063 records · Page 59Linked to original sources

PubMed2003

Randomised controlled trial of nurse continence advisor therapy compared with standard urogynaecology regimen for conservative incontinence treatment: efficacy, costs and two year follow up.

OBJECTIVE: To compare the efficacy and labour costs of nurse continence advisors and urogynaecologists in conservative management of urinary incontinence. DESIGN: Single centre randomised controlled trial of patients with mild or moderate leakage. SETTING: Tertiary urogynaecology unit. SAMPLE: One hundred and forty-five consecutive patients with stress and/or urge incontinence. METHODS: Standardised conservative therapy regimens, provided by nurse continence advisors and urogynaecologists. MAIN OUTCOME MEASURE: One-hour pad test, frequency volume charts, a 20-point incontinence score and two quality of life tests, staff treatment times and costs. RESULTS: Of 110 women who completed 12-week treatments, 64% of the women in the nurse continence advisor group (n = 58) and 52% of women treated by urogynaecologists (n = 52) were asymptomatic (dry pad test; OR 1.63, 95% CI 0.71-3.75). There was no significant difference between clinician groups for change in pad test result (P = 0.71), voids/day (0.43), incontinence score (P = 0.57) or quality of life scores (urogenital distress inventory, P = 0.27; Incontinence Impact Questionnaire, P = 0.41). Despite the expected longer consultation times for the advisor group (median 160 min, interquartile range [IQR] 130-210) versus the urogynaecologist group (median 90 min, IQR 60-120), the per capita labour cost for advisor treatment (median AU$59.20, IQR 48.10-77.70) was lower than for treatment given by urogynaecologists (median cost AU$ 189.70, IQR 120.60-250.70, Mann-Whitney U test, P < 0.0001). At 2.5 years, 23/58 patients (40%) treated by advisor and 27/52 patients (52%) treated by urogynaecologist group, who had been cured and discharged, were available for contact. Of these, 29% of women in the nurse continence advisor group and 41% of those treated by urogynaecologists remained continent (on 20-point score). Quality of life improvement persisted equally in both groups. These data should be interpreted cautiously due to a 24% dropout rate. CONCLUSIONS: The reduction in urine leakage and improvement in quality of life observed in patients treated by nurse continence advisors and urogynaecologists were similar at 12 weeks and 2 years, but lower costs arose from treatment provided by nurse advisors. We suggest that conservative treatment by the nurse continence advisor could be used more widely in mild to moderate incontinence.

Aged↗

PubMed1999

Early compared with delayed inhaled nitric oxide in moderately hypoxaemic neonates with respiratory failure: a randomised controlled trial. The Franco-Belgium Collaborative NO Trial Group.

BACKGROUND: Inhaled nitric oxide improves oxygenation in severely hypoxaemic term neonates, which lessens the need for extracorporeal-membrane oxygenation. Improvement in other relevant outcomes remains unknown, and safety of inhaled nitric oxide is uncertain in preterm neonates. We did a randomised controlled trial to assess use of inhaled nitric oxide in preterm and near-term neonates. METHODS: We randomly assigned 204 preterm (< 33 weeks) and near-term (> or = 33 weeks) neonates with oxygenation indices from 12.5 to 30.0 and 15 to 40, respectively, 10 parts per million (ppm) inhaled nitric oxide (n=105) or control ventilation therapy without nitric oxide (n=99). The primary endpoint was the oxygenation index at 2 h. Analysis was done by intention to treat. FINDINGS: 12 neonates were excluded, leaving 97 (45 preterm) in the nitric-oxide group and 95 (40 preterm) in the control group. The decline in oxygenation index at 2 h was greater in the nitric-oxide group than in the control group (median 6.2 (IQR 8.4)) [corrected] vs -2.9 [12.4], p=0.005), but was significant only in near-term neonates (p=0.03). Survivors assigned nitric oxide spent fewer days on mechanical ventilation and in the neonatal intensive-care unit, but this was also significant only in near-term neonates (6 [3] vs 7 [3] days, p=0.05, and 9 [6] vs 12 [9] days, p=0.02, respectively). INTERPRETATION: Low-dose inhaled nitric oxide early in the course of neonatal respiratory failure improves oxygenation and shortens duration of mechanical ventilation and the length of stay in intensive care. Inhaled nitric oxide was not, however, significantly beneficial in preterm neonates.

Administration, Inhalation↗

PubMed2002

Randomised controlled trial comparing the effectiveness of electroacupuncture and TENS for low back pain: a preliminary study for a pragmatic trial.

The objective of this study was to compare the effectiveness of electroacupuncture and TENS for low back pain when the electroacupuncture is applied in a clinically realistic manner. The study was designed as an evaluator-blinded randomised controlled trial (RCT). The study was performed at the Tsukuba College of Technology Clinic in Japan. Twenty subjects, who suffered from low back pain (LBP) without sciatica, were recruited, using leaflets in Tsukuba city. Subjects were allocated to either an electroacupuncture (EA) group (10 patients) or a transcutaneous electrical nerve stimulation (TENS) group (10 patients). The procedure for EA was in accordance with standard practice at our clinic. The main outcome measures were a pain relief scale (100 mm visual analogue scale: VAS) and a LBP score recommended by the Japanese Orthopaedic Association (JOA Score). Mean VAS value during the 2-weeks experimental period of the EA group was significantly smaller than that of the TENS group (65 mm vs 86 mm; 95% CI, 4.126 - 37.953). JOA Score in the EA group improved significantly while that in the TENS group showed no change. Although some placebo effect may be included, EA appeared more useful than TENS in the short-term effect on low back pain. We suggest that more realistic acupuncture interventions based on standard practice should be employed in pragmatic RCTs.

Activities of Daily Living↗

PubMed2001

Assessment of impact of information booklets on use of healthcare services: randomised controlled trial.

OBJECTIVES: To investigate the effect of patient information booklets on overall use of health services, on particular types of use, and on possible interactions between use, deprivation category of the area in which respondents live, and age. To investigate the possibility of a differential effect on health service use between two information booklets. DESIGN: Randomised controlled trial of two patient information booklets (covering the management and treatment of minor illness). SETTING: 20 general practices in Lothian, Scotland. PARTICIPANTS: Random sample of patients from the community health index (n=4878) and of those contacting out of hours services (n=4530) in the previous 12 months in each of the study general practices. INTERVENTION: Booklets were posted to participants in intervention groups (3288 were sent What Should I Do?; 3127 were sent Health Care Manual). Patients randomised to control group (2993) did not receive a booklet. MAIN OUTCOME MEASURES: Use of health services audited from patients' general practice notes in 12 months after receipt of booklet. RESULTS: Receipt of either booklet had no significant effect on health service use compared with a control group. However, nine out of ten matched practices allocated to receive Health Care Manual had reduced consultation rates compared with matched practices allocated to What Should I Do? CONCLUSION: Widespread distribution of information booklets about the management of minor illness is unlikely to reduce demand for health services.

Family Practice↗

PubMed2005

Results of a multicentre, randomised controlled trial of intra-arterial urokinase in the treatment of acute posterior circulation ischaemic stroke.

BACKGROUND: Patients with ischaemic stroke due to occlusion of the basilar or vertebral arteries may develop a rapid deterioration in neurological status leading to coma and often to death. While intra-arterial thrombolysis may be used in this context, no randomised controlled data exist to support its safety or efficacy. METHODS: Randomised controlled trial of intra-arterial urokinase within 24 h of symptom onset in patients with stroke and angiographic evidence of posterior circulation vascular occlusion. RESULTS: Sixteen patients were randomised, and there was some imbalance between groups, with more severe strokes occurring in the treatment arm. A good outcome was observed in 4 of 8 patients who received intra-arterial urokinase compared with 1 of 8 patients in the control group. CONCLUSIONS: These results support the need for a large-scale study to establish the efficacy of intra-arterial thrombolysis for acute basilar artery occlusion.

Aged↗

PubMed1998

Day-case or short-stay admission for arthroscopic knee surgery: a randomised controlled trial.

The Royal Colleges, The Audit Commission, and politicians have encouraged day-case care for patients undergoing arthroscopic knee surgery. However, there remains both public and professional concern regarding the acceptability and safety of this form of management, although there are clear economic benefits. In a prospective randomised controlled trial, 50 patients underwent arthroscopic surgery as a day-case and 50 patients were admitted overnight. Outcome was assessed by postal questionnaire 4 weeks after discharge. A linear visual analogue scale was used to measure pain levels. The response rate was 93%. The diagnoses and types of arthroscopic surgery were similar in both groups. In total, 94% of day-cases and 91% of patients admitted overnight expressed overall satisfaction. Pain after discharge was similar in both groups. Day-case management was preferred by 90% of day-case patients and by 64% of those admitted overnight. Of patients in the day-case group, 12% had to be admitted overnight because of recovery problems, but 7% of patients randomised to overnight stay discharged themselves. One patient admitted overnight required readmission because of a wound haematoma. Patients who had received day-case management returned to work significantly faster than those who had been admitted. Modern anaesthetic techniques with special attention to anti-emesis and pain control have reduced postoperative morbidity to acceptable levels. Provided that patients are properly selected and well informed, day-case care is preferable for the majority of patients undergoing arthroscopic surgery of the knee.

Adult↗

PubMed2006

Sunflower therapy for children with specific learning difficulties (dyslexia): a randomised, controlled trial.

The aim of the study was to determine the clinical and perceived effectiveness of the Sunflower therapy in the treatment of childhood dyslexia. The Sunflower therapy includes applied kinesiology, physical manipulation, massage, homeopathy, herbal remedies and neuro-linguistic programming. A multi-centred, randomised controlled trial was undertaken with 70 dyslexic children aged 6-13 years. The research study aimed to test the research hypothesis that dyslexic children 'feel better' and 'perform better' as a result of treatment by the Sunflower therapy. Children in the treatment group and the control group were assessed using a battery of standardised cognitive, Literacy and self-esteem tests before and after the intervention. Parents of children in the treatment group gave feedback on their experience of the Sunflower therapy. Test scores were compared using the Mann Whitney, and Wilcoxon statistical tests. While both groups of children improved in some of their test scores over time, there were no statistically significant improvements in cognitive or Literacy test performance associated with the treatment. However, there were statistically significant improvements in academic self-esteem, and reading self-esteem, for the treatment group. The majority of parents (57.13%) felt that the Sunflower therapy was effective in the treatment of learning difficulties. Further research is required to verify these findings, and should include a control group receiving a dummy treatment to exclude placebo effects.

Acupressure↗

PubMed2005

Teledentistry for screening new patient orthodontic referrals. Part 1: A randomised controlled trial.

OBJECTIVE: The primary aim was to evaluate the validity of a teledentistry system for screening new patient orthodontic referrals. The secondary aims were to evaluate whether the teledentistry system affected i) referral rates ii) inappropriate referral rates iii) number of failed appointments. STUDY DESIGN: Randomised controlled trial. SAMPLE: Fifteen dental practices in Greater Manchester, UK, were randomly allocated to either a teledentistry test group (n = 8) or a control group (n = 7). They referred 327 patients over a 15 month period. METHOD: Practitioners in the test group referred patients to one of two consultant orthodontists via a 'store and forward' teledentistry system consisting of photographs sent as email attachments. The decision to accept or not accept a referral on this basis was compared with the same decision choice when the same patient was subsequently seen on a new patient clinic. This measured the validity of the system with the clinic's decision used as the gold standard. Patients in the control group were referred using the usual letter system. Referral rates, inappropriate referrals and number of failed appointments were then compared between the teledentistry and control groups. RESULTS: The sensitivity (true positive value) of the teledentistry system was high at 0.80 with a positive predictive value of 0.92. The specificity (true negative value) was slightly lower at 0.73 with a negative predictive value of 0.50. The inappropriate referral rate for the teledentistry group was 8.2% and for the controls 26.2% (p = 0.037). There was no statistically significant difference in clinic attendance between teledentistry and control groups (p = 0.36). CONCLUSIONS: Teledentistry is a valid system for positively identifying appropriate new patient orthodontic referrals. However, there is a risk that a patient is not accepted on the teledentistry system who would benefit from a full clinical examination. Teledentistry could be a significant factor in reducing the inappropriate referral rate. Patient participation in a teledentistry system does not appear to mean they are any more likely to attend their hospital appointment.

Adolescent↗

PubMed1999

A meta-analysis of randomised controlled trials (RCT) among healthy normotensive and essential hypertensive elderly patients to determine the effect of high salt (NaCl) diet of blood pressure.

To examine the effect of chronic NaCl ingestion on blood pressure (BP) in the elderly, a meta-analysis was undertaken of 11 randomised controlled trials of which five included patients > or =60 years of age only and six included patients with a mean age close to 60 years. The following databases were used: Medline, Embase, Current Contents, The Cochrane Library, the AMI and IPA databases. Mean erect systolic and diastolic blood pressures (SBP/DBP) on chronic (> or =9 weeks) high and low NaCl diets were recorded, the pooled mean effect, the pooled standard error and 95% confidence intervals (Cl) were calculated and linear regression was used to evaluate the potential association between NaCl intake and BP. When all trials were pooled, a chronic high NaCl diet significantly increased mean SBP and DBP by 5.58 mm Hg (95%Cl 4.31-6.85) and 3.5 mm Hg (95%Cl 2.62-4.38) respectively. There was a significant association between the level of NaCl intake and SBP (P = 0.05, r2 = 0.37) but not DBP (P = 0.76, r2 = 0.01). When trials were pooled separately, a chronic high NaCl diet increased SBP by 5.46 mm Hg (95%Cl 3.56-7.36) and DBP by 2.63 mm Hg (95%Cl 1.18-4.08) in trials including patients > or =60 years of age only, and increased SBP by 3.27 mm Hg (95%Cl 1.23-5.31) and DBP by 2.69 mm Hg (95%Cl 1.44-3.94) in trials including patients with a mean age close to 60 years. These data suggest that a chronic high NaCl diet in elderly patients with essential hypertension is associated with an increase in SBP and DBP, the association is significant for both SBP and DBP but more marked for SBP than DBP, the effect is more pronounced the older the patient and NaCl dose strongly predicts SBP in older patients.

Aged↗

PubMed2001

A pilot study to assess the viability of a randomised controlled trial of methods of supplementary feeding of breast-fed pre-term babies.

OBJECTIVES: to compare the impact of two methods of supplementary feeding of pre-term babies (bottle vs cup) on subsequent breast feeding and to assess the feasibility of using a randomised controlled trial (RCT) to investigate the topic. DESIGN AND METHOD: small scale prospective RCT. Data on breast feeding, as defined as the exclusive method of feeding, were collected. A range of relevant bio-data was also collected and their impact on breast feeding assessed. SETTING: a special care baby unit in a District General Hospital in the UK. PARTICIPANTS: over a three-month period, all pre-term babies (32-37 weeks' gestation) who fulfilled the inclusion criteria and has been born to mothers who had expressed a pre-partum desire to breast feed, who had consented to take part, were included (n=14). PROCEDURE: the eligible babies were randomly allocated to supplementary feeding of breast milk, via either a cup or a bottle. Whether or not the baby was being breast fed at discharge was noted. FINDINGS: the study suggested that this RCT framework is a viable method of investigating baby feeding. Because of the small-scale nature of the project, the actual database must be treated with extreme caution. No significant differences were found between the two groups in terms of breast feeding. However, the mothers reported high levels of support and also the breast-feeding rates were above the national averages. These two findings could have contributed to the non-significant results observed in this analysis. CONCLUSIONS: if the present findings could be supported by further research, then the non-significant results relating method of supplementary feeds to subsequent breast feeding could be explained by reference to three factors. Firstly, there is, in fact, no real effect of method of supplementary feeding and subsequent breast feeding; secondly, the method adopted differed from existing research and thus may be expected to produce non-corroborative results; and finally, the overall levels of breast feeding within the Unit generally were higher than the national average. The relevance of the RCT for investigating this subject is also discussed with reference to the present data set. Further experimental work to develop these ideas and to identify causal links is required.

Bottle Feeding↗

PubMed2004

A randomised controlled trial of a tailored multifaceted strategy to promote implementation of a clinical guideline on induced abortion care.

OBJECTIVE: To evaluate the effectiveness and efficiency of a tailored multifaceted strategy, delivered by a national clinical effectiveness programme, to implement a guideline on induced abortion. DESIGN: Cluster randomised controlled trial. SETTING AND PARTICIPANTS: All 26 hospital gynaecology units in Scotland providing induced abortion care. INTERVENTION: Following the identification of barriers to guideline implementation, intervention units received a package comprising audit and feedback, unit educational meetings, dissemination of structured case records and promotion of a patient information booklet. Control units received printed guideline summaries alone. MAIN OUTCOME MEASURES: Compliance with five key guideline recommendations (primary outcomes) and compliance with other recommendations, patient satisfaction and costs of the implementation strategy (secondary outcomes). RESULTS: No effect was observed for any key recommendation: appointment with a gynaecologist within five days of referral (odds ratio 0.89; 95% confidence interval 0.50 to 1.58); ascertainment of cervical cytology history (0.93; 0.36 to 2.40); antibiotic prophylaxis or screening for lower genital tract infection (1.70; 0.71 to 5.99); use of misoprostol as an alternative to gemeprost (1.00; 0.27 to 1.77); and offer of contraceptive supplies at discharge (1.11; 0.48 to 2.53). Median pre-intervention compliance was near optimal for antibiotic prophylaxis and misoprostol use. No intervention benefit was observed for any secondary outcome. The intervention costs an average of pound 2607 per gynaecology unit. CONCLUSIONS: The tailored multifaceted strategy was ineffective. This was possibly attributable to high pre-intervention compliance and the limited impact of the strategy on factors outside the perceived control of clinical staff.

Abortion, Induced↗

PubMed1999

Befriending as an intervention for chronic depression among women in an inner city. 1: Randomised controlled trial.

BACKGROUND: Earlier work on the protective role of social support in onset and course of depressive disorder suggested that its provision might be relevant for outcome. AIMS: To evaluate volunteer befriending as an intervention among women with chronic depression in inner London. METHOD: A randomised controlled trial, with a waiting list control design, with outcome measured as Present State Examination (PSE)-based full or partial remission after one year. RESULTS: A statistically significant effect upon remission was found for befriending. Other treatments monitored naturalistically did not relate to remission, nor did initial duration of chronic episode or comorbidity, but there was an association with initial PSE score. The findings are discussed in relation to standard drug-trial results and to another befriending intervention with the elderly. CONCLUSIONS: The results are not unpromising. Additional trials with less restricted intake conditions, and in more naturalistic general practice settings, might confirm volunteer befriending as a useful adjunct to current treatments.

Adult↗

PubMed2004

Eliciting patients' concerns: a randomised controlled trial of different approaches by the doctor.

BACKGROUND: Although a 'patient-centred' approach to general practice consultation is widely advocated, there is mixed evidence of its benefits. AIM: To measure the costs and benefits of using a prompt to elicit patients' concerns when they consult for minor illness. DESIGN OF STUDY: An open randomised controlled trial. SETTING: Four training semi-rural general practices in the south- east of the United Kingdom. METHOD: Patients identified during the first part of the consultation as having a self-limiting illness were randomised to a second part of the consultation that was conducted 'as usual' or involved a written prompt to elicit the patient's concerns. After each consultation the doctor noted the diagnosis and the consultation length and the patient self-completed a questionnaire containing measures of satisfaction, enablement and anxiety. RESULTS: One hundred and ten patients were studied. Patients in the elicitation group reported a small but significant increase in the 'professional care' score of the consultation satisfaction questionnaire (88.2 versus 80.9, mean difference = 7.3, 95% confidence interval = 2.0 to 12.6) but no other benefits were detected. Consultations in the elicitation group, however, were longer by about a minute. CONCLUSION: Given the pressures on consultation time in general practice there must be questions about the practical value of eliciting patients' concerns if the benefit of doing so is small and the cost large.

Anxiety↗

PubMed2002

Evaluating a mental health assessment for older people with depressive symptoms in general practice: a randomised controlled trial.

BACKGROUND: There is a lack of evidence on the most effective primary care management of older people with minor depression. AIM: To evaluate a follow-up assessment by the community mental health team (CMHT) for older people with depressive symptoms identified by practice nurses at a health check for people over the age of 75 years. DESIGN OF STUDY: A pragmatic randomised controlled trial. SETTING: A single large general practice in Leicestershire. METHOD: Patients receiving a health check administered by a practice nurse and scoring 5 or more on the 15-item Geriatric Depression Scale (GDS15) were randomised to either follow-up by the CMHT or routine general practitioner (GP) care. The GDS15 score was measured at the subsequent health check 18 months later. RESULTS: Forty-seven patients were randomised to CMHT assessment and 46 to routine GP care. Uptake of the intervention was 72% (n = 34). At the follow-up health check a greater proportion of the control group had improved GDS15 scores (P = 0.08). Following assessment, the CMHT recommended their further involvement in the care of 12 patients and this was authorised by patients' GPs in six cases. CONCLUSIONS: A follow-up mental health assessment by a member of the local CMHT was not effective in improving outcomes for mildly depressed older people. Other than random error possible reasons for this include the length of follow-up and a failure to meet raised expectations among the intervention group. If complex referral procedures do not improve outcomes for this group, then specialist community services should play a more prominent part in the training of practice staff to care for their depressed older patients.

Aged↗

PubMed2000

Costs and benefits of community postnatal support workers: a randomised controlled trial.

OBJECTIVES: This study aimed to measure the effect and the total cost per woman of providing postnatal support at home, based on a Dutch model. The research hypothesis was furnished by some existing evidence that postnatal support could reduce the risk of postnatal depression and encourage breastfeeding. DESIGN: The randomised controlled trial aimed to measure differences in health status in a group of women who were offered postnatal support from a community midwifery support worker (SW) compared with a control group of women who were not offered this support. Women were followed-up by postal questionnaire at 6 weeks and 6 months postnatally. SETTING AND SUBJECTS: All women who delivered a baby at the recruiting hospital were eligible to take part in the trial if they lived within the study area, were aged 17 years or over, and could understand English. INTERVENTION: The intervention consisted of the SW offering practical and emotional support and to help women rest and recover after childbirth. The SW offered ten visits in the first 28 days postnatally, for up to 3 hours per day. The SW's activities included housework, talking with the mother, and care for the baby or other siblings. The service was provided in addition to routine visits by the community midwife. MAIN OUTCOME MEASURES: The primary outcome was the general health perception domain of the Short Form-36 at 6 weeks. Secondary outcomes were mean Edinburgh Postnatal Depression Scale (EPDS), Duke Functional Social Support (DUFSS) scores and breastfeeding rates. RESULTS: The 623 randomised women were well-matched by group with a good response to follow-up. At 6 weeks there was no evidence of a significant difference between the two groups for the primary outcome. There was a non-significant trend for the control group to have better mean DUFSS and EPDS scores at 6 weeks. Breastfeeding rates were not significantly different at follow-up. At 6 months, both groups had similar health status. Satisfaction with the service was higher than for all other services received. The incremental cost of introducing the service comprised setting up and running the service. There were no differences between the groups in other resource use (general practitioner contacts, hospital services, prescriptions or medicines bought for mothers and babies) to 6-month follow-up. The total mean NHS cost to 6-month follow-up for the intervention group was pound180 per woman greater than for the control group (confidence interval, pound79.60, pound272.40). CONCLUSIONS: Although women valued the service, there was no evidence of any health benefit at the 6-week or 6-month follow-up, no difference in use of NHS services, and the additional cost of the service provision would be around pound 180 per woman.

Adolescent↗

PubMed2002

Efficacy, tolerability, and upper gastrointestinal safety of celecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials.

OBJECTIVE: To determine the efficacy, gastrointestinal safety, and tolerability of celecoxib (a cyclo-oxygenase 2 (COX 2) inhibitor) used in the treatment of osteoarthritis and rheumatoid arthritis. DESIGN: Systematic review of randomised trials that compared at least 12 weeks' celecoxib treatment with another non-steroidal anti-inflammatory drug (NSAID) or placebo and reported efficacy, tolerability, or safety. Trials identified from manufacturer and by searching electronic databases and evaluated according to predefined inclusion and quality criteria. Data combined through meta-analysis. PARTICIPANTS: 15 187 patients with osteoarthritis or rheumatoid arthritis. MAIN OUTCOME MEASURES EFFICACY: Western Ontario and McMaster universities osteoarthritis index; American College of Rheumatology responder index and joint scores for rheumatoid arthritis. Tolerability: withdrawal rates for adverse effects. Gastrointestinal safety: incidence of ulcers, bleeds, perforations, and obstructions. RESULTS: Nine randomised controlled trials were included. Celecoxib and NSAIDS were equally effective for all efficacy outcomes. Compared with those taking other NSAIDs, in patients taking celecoxib the rate of withdrawals due to adverse gastrointestinal events was 46% lower (95% confidence interval 29% to 58%; NNT 35 at three months), the incidence of ulcers detectable by endoscopy was 71% lower (59% to 79%; NNT 6 at three months), and the incidence of symptoms of ulcers, perforations, bleeds, and obstructions was 39% lower (4% to 61%; NNT 208 at six months). Subgroup analysis of patients taking aspirin showed that the incidence of ulcers detected by endoscopy was reduced by 51% (14% to 72%) in those given celecoxib compared with other NSAIDs. The reduction was greater (73%, 52% to 84%) in those not taking aspirin. CONCLUSION: Celecoxib is as effective as other NSAIDs for relief of symptoms of osteoarthritis and rheumatoid arthritis and has significantly improved gastrointestinal safety and tolerability.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed1997

Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics: use of pain intensity and visual analogue scales.

The aim of this study was to examine whether mean data from categorical pain intensity and visual analogue scales for both pain intensity and relief could be used reliably to derive dichotomous outcome measures for meta-analysis. Individual patient data from randomised controlled trials of single-dose analgesics in acute postoperative pain were used. The methods used were as follows: data from 132 treatments with over 4700 patients were used to calculate mean %maxSPID (categorical pain intensity), %maxVAS-SPID (visual analogue pain intensity) and %maxVAS-TOTPAR (visual analogue pain relief); these were used to derive relationships with the number of patients who achieved at least 50% pain relief (%maxTOTPAR). Good agreement was obtained between the actual number of patients with > 50%maxTOTPAR and the number calculated for all three measures. For SPID, verification included independent data sets. For calculations involving each measure, summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of less than 0.25 patients per treatment arm. Reports of randomised trials of analgesics frequently describe results of studies in the form of mean derived indices, rather than using discontinuous events, such as number of proportion of patients obtaining at least 50% pain relief. Because mean data inadequately describe information with a non-normal distribution, combining such mean data in systematic reviews may compromise the results. Showing that dichotomous data can reliably be derived from mean SPID, VAS-SPID and VAS-TOTPAR as well as TOTPAR data in previously published acute pain studies makes much more information accessible for meta-analysis.

Analgesics↗

PubMed1999

Pragmatic randomised controlled trial of local corticosteroid injection and naproxen for treatment of lateral epicondylitis of elbow in primary care.

OBJECTIVE: To compare the clinical effectiveness of local corticosteroid injection, standard non-steroidal anti-inflammatory drugs, and simple analgesics for the early treatment of lateral epicondylitis in primary care. DESIGN: Multicentre pragmatic randomised controlled trial. SETTING: 23 general practices in North Staffordshire and South Cheshire. PARTICIPANTS: 164 patients aged 18-70 years presenting with a new episode of lateral epicondylitis. INTERVENTIONS: Local injection of 20 mg methylprednisolone plus lignocaine, naproxen 500 mg twice daily for two weeks, or placebo tablets. All participants received a standard advice sheet and co-codamol as required. MAIN OUTCOME MEASURES: Participants' global assessment of improvement (five point scale) at four weeks. Pain, function, and "main complaint" measured on 10 point Likert scales at 4 weeks, 6 months, and 12 months. RESULTS: Over 2 years, 53 subjects were randomised to injection, 53 to naproxen, and 58 to placebo. Prognostic variables were similar between groups at baseline. At 4 weeks, 48 patients (92%) in the injection group were completely better or improved compared with 30 (57%) in the naproxen group (P<0.001) and 28 (50%) in the placebo group (P<0.001). At 12 months, 43 patients (84%) in the injection group had pain scores </=3 compared with 45 (85%) in the naproxen group and 44 (82%) in the placebo group (P>0.05). CONCLUSIONS: Early local corticosteroid injection is effective for lateral epicondylitis. Outcome at one year was good in all groups, and effective early treatment does not seem to influence this.

Adolescent↗