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Results for “Randomised Controlled Trial”

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At least 1,225 records · Page 68Linked to original sources

PubMed1994

Effectiveness of training health professionals to provide smoking cessation interventions: systematic review of randomised controlled trials.

OBJECTIVE: To assess the effectiveness of interventions that train healthcare professionals in methods for improving the quality of care delivered to patients who smoke. DESIGN: Systematic literature review. SETTING: Primary care medical and dental practices in the United States and Canada. Patients were recruited opportunistically. SUBJECTS: 878 healthcare professionals and 11,228 patients who smoked and were identified in eight randomised controlled trials. In each of these trials healthcare professionals received formal training in smoking cessation, and their performance was compared with that of a control group. MAIN MEASURES: Point prevalence rates of abstinence from smoking at six or 12 months in patients who were smokers at baseline. Rates of performance of tasks of smoking cessation by healthcare professionals, including offering counselling, setting dates to stop smoking, giving follow up appointments, distributing self help materials, and recommending nicotine gum. METHODS: Trials were identified by multiple methods. Data were abstracted according to predetermined criteria by two observers. When possible, meta-analysis was performed using a fixed effects model and the results were subjected to sensitivity analysis. RESULTS: Healthcare professionals who had received training were significantly more likely to perform tasks of smoking cessation than untrained controls. There was a modest increase in the odds of stopping smoking for smokers attending health professionals who had received training compared with patients attending control practitioners (odds ratio 1.35 (95% confidence interval 1.09 to 1.68)). This result was not robust to sensitivity analysis. The effects of training were increased if prompts and reminders were used. There was no definite benefit found for more intensive forms of counselling compared with minimal contact strategies. CONCLUSIONS: Training health professionals to provide smoking cessation interventions had a measurable impact on professional performance. A modest, but non-robust, effect on patient outcome was also found, suggesting that training alone is unlikely to be an effective strategy for improving quality of care, unless organisational and other factors are also considered.

Behavior Therapy↗

PubMed2001

Two-year follow-up after a randomised controlled trial of self- and clinician-accompanied exposure for phobia/panic disorders.

BACKGROUND: Long-term follow-up has rarely been reported after self-exposure therapy for phobias. AIMS: Completion of such a follow-up. METHOD: Two-year follow-up was achieved in 68 (85%) of 80 patients with phobias who had completed a previous 14-week randomised controlled trial comparing therapist-accompanied self-exposure, self-exposure or self-relaxation. Measures were self-reported ratings of symptoms, satisfaction and use of other treatment. RESULTS: Improvement at week 14 was maintained 2 years later. Clinician-accompanied exposure and self-exposure did not differ on any measure. Compliance with self-exposure homework during weeks 0-8 predicted more improvement 2 years later. Patients who failed to improve with relaxation by week 14 improved after subsequent crossover to exposure. A need for more treatment for their phobias was still felt by 33 patients (49%). CONCLUSIONS: Patients with phobias maintained their improvement to 2-year follow-up after the end of self-exposure therapy.

Adult↗

PubMed2006

A randomised controlled trial of a home based exercise programme to reduce the risk of falling among people with Parkinson's disease.

OBJECTIVE: To evaluate the effectiveness of a personalised home programme of exercises and strategies for repeat fallers with Parkinson's disease (PD). METHOD: Patients with a confirmed diagnosis of idiopathic PD, independently mobile, living at home in the community, experiencing more than one fall in the previous 12 months and with intact gross cognitive function were invited to participate in this randomised controlled trial. Usual care was compared with a personalised 6 week, home based exercise and strategy programme. The primary outcomes were rates of falling at 8 weeks and 6 months. Whether participants had repeat fallen, nearly fallen or experienced injurious falls were also examined. Functional Reach, the Berg Balance Test, PD Self-assessment Scale and the Euro Quol were rated by a blinded assessor. RESULTS: Participants were randomised to the exercise (n = 70) and control (n = 72) groups. There was a consistent trend towards lower fall rates in the exercise group at both 8 weeks and 6 months and lower rates of injurious falls needing medical attention at 6 months. Lower rates of repeat near falling were evident for the exercise group at 8 weeks (p = 0.004) and 6 months (p = 0.007). There was a positive effect of exercises at 6 months on Functional Reach (p = 0.009) and quality of life (p = 0.033). No significant differences were found on other secondary outcomes measures. CONCLUSION: There was a trend towards a reduction in fall events and injurious falls with a positive effect of exercises on near falls and quality of life.

Accidental Falls↗

PubMed2006

Impact on hypertension control of a patient-held guideline: a randomised controlled trial.

BACKGROUND: Hypertension is generally poorly controlled in primary care. One possible intervention for improving control is the harnessing of patient expertise through education and encouragement to challenge their care. AIM: To determine whether encouraging patients to manage their hypertension in an 'expert' manner, by providing them with information in a clear clinical guideline, coupled with an explicit exhortation to become involved in and to challenge their own care if appropriate, would improve their care. DESIGN OF STUDY: Single blind randomised controlled trial of detailed guideline versus standard information. SETTING: Single urban general practice over 1 year. METHOD: Patient-held guideline with written explicit exhortation to challenge care when appropriate. Two hundred and ninety-four of 536 eligible patients on the practice hypertension register were recruited, all of whom were randomised into one of two groups. Two hundred and thirty-six patients completed the study. RESULTS PRIMARY OUTCOME: average systolic blood pressure. SECONDARY OUTCOMES: proportion of patients with blood pressure < 150 mmHg systolic and < 90 mmHg diastolic, average cholesterol, proportion of patients prescribed statins and aspirin according to guideline, hospital anxiety and depression score. No clinically, or statistically significant differences were found between intervention and control with respect to all parameters or in anxiety and depression levels. Statin and aspirin use improved throughout the course of the study in both groups. Statin use showed a trend (P = 0.02) in favour of control. CONCLUSION: In this study there was no clinically significant perceived benefit to patients as a result of providing them with a hypertension guideline. Patient guidelines are currently planned for many chronic illnesses. It is important to determine the utility of such interventions before scarce resources are applied to them.

Aged↗

PubMed1999

N of 1 randomised controlled trials of oral ketamine in patients with chronic pain.

Anecdotal reports suggest that the general anaesthetic drug ketamine, taken orally in low doses, can give rise to some extra analgesia in patients with refractory neuropathic pain. This study was designed to determine the proportion of patients with chronic neuropathic pain responding to oral ketamine, and then to separate the true treatment effect from non-specific effects by means of an n of 1 randomised controlled trial. Twenty-one patients gave informed consent and completed daily pain diaries and continued on their usual treatments (drug and non-drug) for the duration of the study. After a 'baseline' week, oral ketamine was taken once a day for 1 week. The dose of 20 mg was increased each day until an analgesic effect was noticed or adverse effects occurred, or until a maximum of 100 mg was reached. Those patients responding to oral ketamine were then entered into the n of 1 randomised trial which consisted of three treatment/placebo week pairs. Twelve patients did not progress to the n of 1 trial because of no benefit and/or intolerable adverse effects (dizziness, drowsiness etc.). Nine patients completed the n of 1 trial; there was no difference between the ketamine and placebo weeks in six patients; one patient demonstrated effective analgesia with ketamine, but it was of short duration and marred by unpleasant adverse effects; two patients showed some evidence of a beneficial response to ketamine, and continued with the oral ketamine after the trial. We conclude that oral ketamine only gave rise to an extra analgesic response in three out of 21 patients with chronic neuropathic pain (14%). Adverse effects limited the use of the drug in almost half of the patients. The n of 1 trial was useful in demonstrating no true therapeutic effect for the ketamine in two thirds of the patients progressing to that part of the trial.

Administration, Oral↗

PubMed2006

Does prenatal screening influence anxiety levels of pregnant women? A longitudinal randomised controlled trial.

OBJECTIVES: Questions addressed are: (1) Does offering prenatal screening increase anxiety? (2) Does receiving a negative screening result make women less anxious and does a positive screening result make women more anxious? (3) What are the long-term consequences on anxiety of offering screening and receiving a screening result? METHODS: Women were offered prenatal screening or no screening in a randomised controlled trial. State anxiety (STAI) and child-related anxiety (PRAQ-R) were measured. Questionnaires were filled in before prenatal screening was offered (T1), after the offer (T2), after the test result (T3), and in the third trimester of pregnancy (T4). RESULTS: Child-related anxiety levels were higher in women who chose to be screened compared to women who declined screening. Offering prenatal screening did not lead to increased anxiety levels. General anxiety increased in positively screened women, but decreased later in pregnancy. Women who were negatively screened or declined screening scored lower than the control group. CONCLUSION: For most women, offering prenatal screening and receiving the test result do not adversely affect anxiety. Giving pregnant women a choice to have prenatal screening done seems to have a small favourable effect on general feelings of anxiety.

Adult↗

PubMedDate not supplied

Oropharyngeal and nasopharyngeal suctioning of meconium-stained neonates before delivery of their shoulders: multicentre, randomised controlled trial.

BACKGROUND: Meconium aspiration syndrome (MAS) is a life-threatening respiratory disorder in infants born through meconium-stained amniotic fluid (MSAF). Although anecdotal data concerning the efficacy of intrapartum oropharyngeal and nasopharyngeal suctioning of MSAF are conflicting, the procedure is widely used. We aimed to assess the effectiveness of intrapartum suctioning for the prevention of MAS. METHODS: We designed a randomised controlled trial in 11 hospitals in Argentina and one in the USA. 2514 patients with MSAF of any consistency, gestational age at least 37 weeks, and cephalic presentation were randomly assigned to suctioning of the oropharynx and nasopharynx (including the hypopharynx) before delivery of the shoulders (n=1263), or no suctioning before delivery (n=1251). Postnatal delivery-room management followed Neonatal Resuscitation Program guidelines. The primary outcome was incidence of MAS. Clinicians diagnosing the syndrome and designating other study outcomes were masked to group assignment. An informed consent waiver was used. Analysis was by intention to treat. FINDINGS: 18 infants in the suction group and 15 in the no suction group did not meet entry criteria after random assignment. 87 in the suction group were not suctioned, and 26 in the no suction group were suctioned. No significant difference between treatment groups was seen in the incidence of MAS (52 [4%] suction vs 47 [4%] no suction; relative risk 0.9, 95% CI 0.6-1.3), need for mechanical ventilation for MAS (24 [2%] vs 18 [1%]; 0.8, 0.4-1.4), mortality (9 [1%] vs 4 [0.3%]; 0.4, 0.1-1.5), or in the duration of ventilation, oxygen treatment, and hospital care. INTERPRETATION: Routine intrapartum oropharyngeal and nasopharyngeal suctioning of term-gestation infants born through MSAF does not prevent MAS. Consideration should be given to revision of present recommendations.

Adult↗

PubMed1996

Randomised, controlled trial of efficacy of midwife-managed care.

BACKGROUND: Midwife-managed programmes of care are being widely implemented although there has been little investigation of their efficacy. We have compared midwife-managed care with shared care (ie, care divided among midwives, hospital doctors, and general practitioners) in terms of clinical efficacy and women's satisfaction. METHODS: We carried out a randomised controlled trial of 1299 pregnant women who had no adverse characteristics at booking (consent rate 81.9%). 648 women were assigned midwife-managed care and 651 shared care. The research hypothesis was that compared with shared care, midwife-managed care would produce fewer interventions, similar (or more favourable) outcomes, similar complications, and greater satisfaction with care. Data were collected by retrospective review of case records and self-report questionnaires. Analysis was by intention to treat. FINDINGS: Interventions were similar in the two groups or lower with midwife-managed care. For example, women in the midwife-managed group were less likely than women in shared care to have induction of labour (146 [23.9%] vs 199 [33.3%]; 95% CI for difference 4.4-14.5). Women in the midwife-managed group were more likely to have an intact perineum and less likely to have had an episiotomy (p = 0.02), with no significant difference in perineal tears. Complication rates were similar. Overall, 32.8% of women were permanently transferred from midwife-managed care (28.7% for clinical reasons, 3.7% for non-clinical reasons). Women in both groups reported satisfaction with their care but the midwife-managed group were significantly more satisfied with their antenatal (difference in mean scores 0.48 [95% CI 0.41-0.55]), intrapartum (0.28 [0.18-0.37]), hospital-based postnatal care (0.57 [0.45-0.70]), and home-based postnatal care (0.33 [0.25-0.42]). INTERPRETATION: We conclude that midwife-managed care for healthy women, integrated within existing services, is clinically effective and enhances women's satisfaction with maternity care.

Adult↗

PubMed1996

Randomised controlled trial of treatment of chronic suppurative otitis media in Kenyan schoolchildren.

BACKGROUND: The outcomes of treatment of chronic suppurative otitis media (CSOM) are disappointing and uncertain, especially in developing countries. Because CSOM is the commonest cause of hearing impairment in children in these countries, an effective method of management that can be implemented on a wide scale is needed. We report a randomised, controlled trial of treatment of CSOM among children in Kenya; unaffected schoolchildren were taught to administer the interventions. METHODS: We enrolled 524 children with CSOM, aged 5-15 years, from 145 primary schools in Kiambu district of Kenya. The schools were randomly assigned treatments in clusters of five in a ratio of two to dry mopping alone (201 children), two to dry mopping with topical and systemic antibiotics and topical steroids (221 children), and one to no specific treatment (102 children). Schools were matched on factors thought to be related to their socioeconomic status. The primary outcome measures were resolution of otorrhoea and healing of tympanic membranes on otoscopy by 8, 12, and 16 weeks after induction. Absence of perforation was confirmed by tympanometry, and hearing levels were assessed by audiometry. 29 children were withdrawn from the trial because they took non-trial antibiotics. There was no evidence of differences in timing of withdrawals between the groups. FINDINGS: By the 16-week follow-up visit, otorrhoea had resolved in a weighted mean proportion of 51% (95% CI 42-59) of children who received dry mopping with antibiotics, compared with 22% (14-31) of those who received dry mopping alone and 22% (9-35) of controls. Similar differences were recorded by the 8-week and 12-week visits. The weighted mean proportions of children with healing of the tympanic membranes by 16 weeks were 15% (10-21) in the dry-mopping plus antibiotics group, 13% (5-20) in the dry-mopping alone group, and 13% (3-23) in the control group. The proportion with resolution in the dry-mopping alone group did not differ significantly from that in the control group at any time. Hearing thresholds were significantly better for children with no otorrhoea at 16 weeks than for those who had otorrhoea, and were also significantly better for those whose ears had healed than for those with otorrhoea at all times. INTERPRETATION: Our finding that dry mopping plus topical and systemic antibiotics is superior to dry mopping alone contrasts with that of the only previous community-based trial in a developing country, though it accords with findings of most other trials in developed countries. The potential role of antibiotics needs further investigation. Further, similar trials are needed to identify the most cost-effective and appropriate treatment regimen for CSOM in children in developing countries.

Administration, Topical↗

PubMed2004

The efficacy of a specific balance-strategy training programme for preventing falls among older people: a pilot randomised controlled trial.

BACKGROUND: older people participate in exercise programmes to reduce the risk of falls but no study has investigated a specific balance strategy training intervention presented in a workstation format for small groups. OBJECTIVE: to determine whether a specific balance strategy training programmeme delivered in a workstation format was superior to a community based exercise class programme for reducing falls. DESIGN: a randomised controlled trial model. SETTING: Neurological Disorders, Ageing and Balance Clinic, Department of Physiotherapy, The University of Queensland. SUBJECTS: 73 males and females over 60 years, living independently in the community and who had fallen in the previous year were recruited. METHODS: all subjects received a falls risk education booklet and completed an incident calendar for the duration of the study. Treatment sessions were once a week for 10 weeks. Subject assessment before and after intervention and at 3 months follow-up included number of falls, co-morbidities, medications, community services and activity level, functional motor ability, clinical and laboratory balance measures and fear of falling. RESULTS: all participants significantly reduced the number of falls (P < 0.000). The specific balance strategy intervention group showed significantly more improvement in functional measures than the control group (P = 0.034). Separate group analyses indicated significantly improved performance in functional motor ability and most clinical balance measures for the balance group (P < 0.04). The control group only improved in TUG and TUGcog. CONCLUSIONS: the results provide evidence that all participants achieved a significant reduction in falls. Specific balance strategy training using workstations is superior to traditional exercise classes for improving function and balance.

Accidental Falls↗

PubMed2006

Subcutaneous sterile water injection for labour pain: a randomised controlled trial.

BACKGROUND: About 30% of women experience severe continuous low-back pain in labour, but limited options are available to reduce this pain especially in developing countries and remote areas. AIMS: To evaluate the efficacy of subcutaneous sterile water injection in reduction of labour pain compared with placebo. METHODS: One hundred (100) consecutive patients were enrolled in a double-blind randomised controlled trial. During the first stage of labour with planned normal vaginal delivery, the intervention group (n = 50) received 0.5 mL sterile water injected subcutaneously and the control group (n = 50) received normal saline as a placebo. Pain score was measured before and 10 and 45 min after the injection, using the faces rating scale. MAIN OUTCOME MEASURE: Low-back labour pain. RESULTS: The two groups were not significantly different regarding maternal age and weight, gestational age, parity and gravidity and degree of effacement. The median pain score was equal in both groups prior to the injection. Pain severity was reduced in both groups after the injection. However, the median pain score in the sterile water group was significantly lower than the placebo group 10 min (P < 0.01), as well as 45 min, after the injection (P < 0.01). CONCLUSION: Administering one subcutaneous injection of sterile water in a painful point of the lumbosacral area is effective in reducing low-back pain during labour.

Adult↗

PubMed1998

Randomised controlled trial of recombinant human growth hormone in prepubertal and pubertal renal transplant recipients. British Association for Pediatric Nephrology.

AIMS: To evaluate the efficacy (height velocity (HV), change in height standard deviation score (delta HSDS)), and safety (glomerular filtration rate (GFR), incidence of rejection, and calcium and glucose metabolism) of recombinant human growth hormone (rhGH) treatment after renal transplantation. DESIGN: A two year randomised controlled trial. SUBJECTS: Fifteen prepubertal and seven pubertal children: mean (SD) age, 13.0 (2.6) and 15.2 (2.4) years, respectively; mean (SD) GFR, 51 (30) and 48 (17) ml/min/1.73 m2, respectively. Six prepubertal and three pubertal children were controls during the first year; all received rhGH in the second year. RESULTS: In the first year, mean (SE) HV and delta HSDS in the prepubertal treated group increased compared with controls: 8.1 (0.9) v 3.7 (0.6) cm/year and 0.6 (0.1) v -0.3 (0.2), respectively. In the pubertal treated group, mean (SE) HV and delta HSDS were also greater: 10.1 (0.6) v 3.9 (1.3) cm/year and 0.6 (0.1) v -0.1 (0.2), respectively. Comparing all treated and control children, there was no significant change in GFR: treated group, mean (SE) 9.9 (5.4) ml/min/1.73 m2 v control group, -1.6 (7.6) ml/min/1.73 m2. There were also no differences in the incidence of rejection in the first year: eight episodes in 13 patients v five episodes in nine patients, respectively. Phosphate, alkaline phosphatase (ALP), parathyroid hormone (PTH), and fasting insulin concentrations rose during the first year of treatment, but not thereafter. In the second year of treatment, HV remained above baseline. CONCLUSION: Treatment with rhGH improves growth in prepubertal and pubertal children with renal transplants, with no significant change in GFR or the incidence of rejection. Phosphate, ALP, PTH, and insulin increased during the first year of treatment.

Adolescent↗

PubMed2005

Systematic review and meta-analysis of randomised controlled trials of gastro-oesophageal reflux interventions for chronic cough associated with gastro-oesophageal reflux.

OBJECTIVE: To evaluate the efficacy of treatment for gastro-oesophageal reflux disease (GORD) on chronic cough in children and adults without an underlying respiratory disease. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Cochrane, Medline, and Embase databases, references from review articles. INCLUDED STUDIES: Randomised controlled trials on GORD treatment for cough in children and adults without primary lung disease. Two reviewers independently selected studies and extracted paediatric and adult data on primary (clinical failure) and secondary outcomes. RESULTS: 11 studies were included. Meta-analysis was limited to five studies in adults that compared proton pump inhibitors with placebo. All outcomes favoured proton pump inhibitors: the odds ratio for clinical failure (primary outcome) was 0.24 (95% confidence interval 0.04 to 1.27); number needed to treat (NNT) was 5 (harm 50 to infinity to benefit 2.5). For secondary outcomes, the standardised mean difference between proton pump inhibitors and placebo was -0.51 (-1.02 to 0.01) for mean cough score at the end of the trial and -0.29 (-0.62 to 0.04) for change in cough score at the end of the trial. Subgroup analysis with generic inverse variance analysis showed a significant mean change in cough (-0.41 SD units, -0.75 to -0.07). CONCLUSION: Use of a proton pump inhibitor to treat cough associated with GORD has some effect in some adults. The effect, however, is less universal than suggested in consensus guidelines on chronic cough and its magnitude of effect is uncertain.

Adult↗

PubMed2003

Impact of on-site testing for maternal syphilis on treatment delays, treatment rates, and perinatal mortality in rural South Africa: a randomised controlled trial.

BACKGROUND: Syphilis remains a significant cause of preventable perinatal death in developing countries, with many women remaining untested and thus untreated. Syphilis testing in the clinic (on-site testing) may be a useful strategy to overcome this. We studied the impact of on-site syphilis testing on treatment delays and rates, and perinatal mortality. METHODS: We conducted a cluster randomised controlled trial among seven pairs of primary healthcare clinics in rural South Africa, comparing on-site testing complemented by laboratory confirmation versus laboratory testing alone. Intervention clinics used the on-site test conducted by primary care nurses, with results and treatment available within an hour. Control clinics sent blood samples to the provincial laboratory, with results returned 2 weeks later. RESULTS: Of 7134 women seeking antenatal care with available test results, 793 (11.1%) tested positive for syphilis. Women at intervention clinics completed treatment 16 days sooner on average (95% confidence interval: 11 to 21), though there was no significant difference in the proportion receiving adequate treatment at intervention (64%) and control (69%) clinics. There was also no significant difference in the proportion experiencing perinatal loss (3.3% v 5.1%; adjusted risk difference: -0.9%; 95% CI -4.4 to 2.7). CONCLUSIONS: Despite reducing treatment delays, the addition of on-site syphilis testing to existing laboratory testing services did not lead to higher treatment rates or reduce perinatal mortality. However on-site testing for syphilis may remain an important option for improving antenatal care in settings where laboratory facilities are not available.

Adult↗

PubMed2001

Systematic review of randomised controlled trials of sildenafil (Viagra) in the treatment of male erectile dysfunction.

BACKGROUND: Sildenafil (Viagra), a new oral drug for the treatment of erectile dysfunction, was licensed for use across Europe in 1998. AIM: To examine the effectiveness and safety of sildenafil as an oral treatment for erectile dysfunction. DESIGN OF STUDY: Systematic review and meta-analysis. SETTING: All published or unpublished randomised controlled trials comparing sildenafil with a placebo or alternative therapies. METHOD: Published studies were sought by computerised searches of electronic databases using the keywords 'sildenafil' and 'Viagra'. A hand search was also done of the British Medical Journal, Lancet, Journal of the American Medical Association, New England Journal of Medicine, British journal of General Practice, Drug, Inpharma and Scrip. An assessment of quality of all identified studies and data extraction was undertaken independently by two researchers. Results were combined in a meta-analysis where appropriate, using RevMan version 3. RESULTS: Twenty-one trials were identified. All trials showed a statistically significant improvement in erectile or sexual function in patients using sildenafil compared with a placebo. A meta-analysis of 16 trials reporting a global efficacy response showed that men were 3.57 (95% CI = 2.93-4.43) times as likely to have improved erections on sildenafil compared with those on a placebo. The number needed to treat to have one man with improved erections was two. The drug has a relatively safe side-effect profile. CONCLUSIONS: Available research shows that sildenafil is an effective treatment for male erectile dysfunction. Many trial participants had some baseline erectile function and it is probable that in clinical practice, where the erectile function tends to be more impaired, the number needed to treat may be higher.

Adult↗

PubMed1994

Randomised controlled trial of respiratory rehabilitation.

Disability associated with chronic obstructive pulmonary disease has led to the development of rehabilitation programmes that aim to increase exercise tolerance and improve quality of life. Many reports of the benefits of rehabilitation have been from uncontrolled trials and unsupervised programmes. In view of the commitment asked of patients, their families, and health-care professionals, rehabilitation should be justified by a demonstration of sustained improvement over conventional treatment. We undertook a prospective randomised controlled trial of respiratory rehabilitation in 89 subjects (44 men, 45 women) aged 66 (SD 7) years with severe but stable chronic obstructive pulmonary disease who received rehabilitation or conventional community care. The treatment group were rehabilitated as inpatients for 8 weeks and supervised as outpatients for 16 weeks. Primary outcome measures of exercise tolerance and quality of life were made at baseline and repeated at 12, 18, and 24 weeks. The difference between baseline and last follow-up was significant for 6 min walk distance (37.9 m [95% CI 10.8-65.0], p = 0.0067) and submaximal cycle time (4.7 min [2.1-7.3]). There were also significant differences in questionnaire assessment of dyspnoea (p = 0.0061), emotional function (p = 0.0150), mastery (p = 0.0002), and dyspnoea index (p = 0.0053). Improvements in exercise tolerance and quality of life can be achieved and sustained for 6 months in patients undergoing respiratory rehabilitation compared with those receiving conventional care.

Aged↗

PubMed1987

Regular alcohol use raises blood pressure in treated hypertensive subjects. A randomised controlled trial.

44 men with treated essential hypertension who were moderate to heavy drinkers took part in a randomised, controlled, crossover trial of the effects of alcohol intake on blood pressure. Usual antihypertensive treatment was maintained throughout 6 weeks of normal drinking and 6 weeks of drinking only a low-alcohol beer. Self-reported changes in alcohol consumption (mean [SEM] from 452 [30] ml ethanol/week during normal drinking to 64 [8] ml/week while drinking the low-alcohol beer) were confirmed by biochemical measurements. Mean systolic and diastolic blood pressures were significantly lower during the last 2 weeks of the low-alcohol period than during the normal-alcohol period, the mean difference in the supine readings being 5.0 (1.4) and 3.0 (0.9) mm Hg, respectively. Regression analysis suggested that reduction in alcohol intake contributed to the fall in both systolic and diastolic blood pressures independently of changes in weight. Thus, curtailing alcohol intake may lead to improved blood-pressure control and may reduce the need for antihypertensive drugs.

Adult↗

PubMed2000

Stapling procedure for haemorrhoids versus Milligan-Morgan haemorrhoidectomy: randomised controlled trial.

BACKGROUND: Surgical haemorrhoidectomy has a reputation for being a painful procedure for a fairly benign disorder. The circular transanal stapled technique for the treatment of haemorrhoids has the potential to offer a less painful rectal procedure in place of ablative perianal surgery. We compared the short-term outcome of the circular stapled procedure for haemorrhoids with current standard surgery in a randomised controlled trial. METHODS: 40 patients admitted for surgical treatment of prolapsing haemorrhoids were randomly assigned to Milligan-Morgan haemorrhoidectomy (n=20) or the circular stapled procedure. Under general anaesthesia patients underwent standardised diathermy excision haemorrhoidectomy or had a circumferential doughnut of rectal mucosa and submucosa above the dentate line excised and closed with a standard circular end-to-end stapling device. All patients received standardised preoperative and postoperative analgesic and laxative regimens. Patients completed linear analogue pain charts each day and were interviewed at 1, 3, and 6-10 weeks postoperatively. Summary measures of average pain experience were calculated from 10 cm linear analogue pain scores and were used as the primary outcome measure. FINDINGS: The stapled group had shorter anaesthesia time (median 18 [range 9-25] vs 22 [15-35] mins). Average pain in the stapled group was significantly lower than it was in the Milligan-Morgan group (2.1 [0.2-7.6] vs 6.5 [3.1-8.5], 95.1% CI difference medians 1.9-4.7, p<0.0001. Mann-Whitney U test). Average pain relative to what the patient expected was also significantly less in the stapled group (-2.8 [-4.4 to 1.3] vs 0.7 [-1.8 to 3.4]. Hospital stay and time to first bowel motion were not significantly different between groups. Return to normal activity was significantly shorter in the stapled group (17 [3-60] vs 34 [14-90]. Early and late complications, patient-assessed symptom control, and functional outcome appear similar after short-term follow-up. INTERPRETATION: The circular stapled technique offers a significantly less painful alternative to Milligan-Morgan haemorrhoidectomy and is associated with an earlier return to normal activity. Early symptom control and functional outcome appear similar. However, long-term symptomatic and functional outcome need further study.

Adult↗