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Results for “Randomised Controlled Trial”

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PubMed2026

Whole cell inactivated poly-bacterial preparation MV130 effect on nasal mucosal immunity and experimental human pneumococcal carriage: double-blind randomised controlled trial with controlled human infection model.

BACKGROUND: Bacterial mucosal immunotherapy has shown protection of children and adults from both viral and bacterial respiratory infections, offering the potential to reduce antimicrobial use, and hence also control antimicrobial resistance (AMR). Pneumococcal carriage of vaccine type Streptococcus pneumoniae remains high in Malawi despite infant conjugate vaccination and AMR is increasing. We compared nasal inflammation following sublingual bacterial immunotherapy including S. pneumoniae (MV130, Inmunotek, Spain) or placebo and determined the effect in an experimental human pneumococcal carriage model. METHODS: A double-blind, randomised, placebo-controlled trial in healthy adult volunteers was conducted at Queen Elizabeth Central Hospital in Blantyre, Malawi. Participants were randomly allocated to receive MV130 or placebo sublingually once daily for 42 days. Mucosal inflammation (neutrophil to T cell ratio, NTR) was measured in nasal micro-biopsies. Post-treatment, participants were challenged with 160,000 CFU/naris S. pneumoniae 6B (Spn6b). Experimental pneumococcal carriage rates post inoculation were compared between the two arms. All participants completing the study were included in the analysis. Prospective trial registration: PACTR202403820001276. FINDINGS: 107 participants were enrolled and randomised to MV130/placebo between May and December 2024. There were no serious adverse events, complete compliance was good (72%) and all adverse events were mild. 96 participants (53 male, 43 female) completed the study with 52 participants randomised to MV130 and 44 to placebo. There was no difference in mucosal inflammation (neutrophil to T cell ratio) at day 14 of the intervention MV130 NTR median = 0.737 (IQR 0.294, 2.059) and placebo NTR = 0.831 (IQR 0.450, 2.073), p = 0.64. Secondary analyses showed a rise in mucosal neutrophils after MV130 treatment and after experimental pneumococcal inoculation. There was no difference in nasal or serum anti-pneumococcal immunoglobulin or in experimental pneumococcal carriage proportion between MV130 (12/52, 23%) and placebo (10/44, 23%) groups (unadjusted risk ratio 1.02 (CI 0.49-2.12) p = 1.0). INTERPRETATION: MV130 induced non-specific mild neutrophil inflammation of the nasal mucosa but had no protective effect against experimental human pneumococcal carriage. FUNDING: Wellcome Trust.

Humans↗

PubMed2004

Randomised, controlled trial of N-acetylcysteine for treatment of acute exacerbations of chronic obstructive pulmonary disease [ISRCTN21676344].

BACKGROUND: Prophylactic treatment with N-acetylcysteine (NAC) for 3 months or more is associated with a reduction in the frequency of exacerbations of chronic obstructive pulmonary disease (COPD). This raises the question of whether treatment with NAC during an acute exacerbation will hasten recovery from the exacerbation. METHODS: We have examined this in a randomised, double-blind, placebo controlled trial. Subjects, admitted to hospital with an acute exacerbation of COPD, were randomised within 24 h of admission to treatment with NAC 600 mg b.d. (n = 25) or matching placebo (n = 25). Treatment continued for 7 days or until discharge (whichever occurred first). To be eligible subjects had to be > or = 50 years, have an FEV1 < or = 60% predicted, FEV1/VC < or = 70% and > or = 10 pack year smoking history. Subjects with asthma, heart failure, pneumonia and other respiratory diseases were excluded. All subjects received concurrent treatment with prednisone 40 mg/day, nebulised salbutamol 5 mg q.i.d and where appropriate antibiotics. FEV1, VC, SaO2 and breathlessness were measured 2 hours after a dose of nebulised salbutamol, at the same time each day. Breathlessness was measured on a seven point Likert scale. RESULTS: At baseline FEV1 (% predicted) was 22% in the NAC group and 24% in the control group. There was no difference between the groups in the rate of change of FEV1, VC, SaO2 or breathlessness. Nor did the groups differ in the median length of stay in hospital (6 days for both groups). CONCLUSIONS: Addition of NAC to treatment with corticosteroids and bronchodilators does not modify the outcome in acute exacerbations of COPD.

Clinical Trial↗

PubMed2006

Effect of family style mealtimes on quality of life, physical performance, and body weight of nursing home residents: cluster randomised controlled trial.

OBJECTIVE: To assess the effect of family style mealtimes on quality of life, physical performance, and body weight of nursing home residents without dementia. DESIGN: Cluster randomised trial. SETTING: Five Dutch nursing homes. PARTICIPANTS: 178 residents (mean age 77 years). Two wards in each home were randomised to intervention (95 participants) or control groups (83). INTERVENTION: During six months the intervention group took their meals family style and the control group received the usual individual pre-plated service. MAIN OUTCOME MEASURES: Quality of life (perceived safety; autonomy; and sensory, physical, and psychosocial functioning), gross and fine motor function, and body weight. RESULTS: The difference in change between the groups was significant for overall quality of life (6.1 units, 95% confidence interval 2.1 to 10.3), fine motor function (1.8 units, 0.6 to 3.0), and body weight (1.5 kg, 0.6 to 2.4). CONCLUSION: Family style mealtimes maintain quality of life, physical performance, and body weight of nursing home residents without dementia. TRIAL REGISTRATION: Clinical trials NCT00114582.

Aged↗

PubMed1997

Randomised controlled trial of ketanserin and aspirin in prevention of pre-eclampsia.

BACKGROUND: Pre-eclampsia is associated with extensive endothelial-cell damage and platelet activation, resulting in lower production of vasodilator prostaglandins and increased release of the vasoconstrictors thromboxane A2 and serotonin. Damage to endothelial-cell serotonin-1 receptors leaves vasoconstriction and platelet aggregation mediated by serotonin-2 receptors unopposed. We investigated the role of ketanserin, a selective serotonin-2-receptor antagonist, in lowering the rate of pre-eclampsia among pregnant women with mild to moderate hypertension. METHODS: We recruited 138 pregnant women into a double-blind, randomised, placebo-controlled trial. They had diastolic blood pressure persistently more than 80 mm Hg before 20 weeks' gestation. 69 women received ketanserin and 69 received placebo. Both groups also received aspirin. Patients were initially given two tablets daily, increased to four tablets daily in diastolic blood pressure was more than 90 mm Hg. Primary outcomes were the development of pre-eclampsia and severe hypertension, and perinatal mortality. FINDINGS: There were significantly fewer cases of pre-eclampsia (two vs 13; relative risk 0.15 [95% CI 0.04-0.66], p = 0.006) and severe hypertension (six vs 17; p = 0.02) in the ketanserin than in the placebo group. There was also a trend towards less perinatal mortality (one vs six deaths) but this was not significant (p = 0.28). Rates of abruptio placentae and pre-eclampsia before 34 weeks' gestation were lower in the ketanserin group, and mean birthweight was significantly higher. INTERPRETATION: We found an association between the addition of ketanserin to aspirin and a decrease in the number of cases of pre-eclampsia and severe hypertension, as well as improved pregnancy outcome among patients with mild to moderate midtrimester hypertension.

Adult↗

PubMed1999

Corticosteroids in IgA nephropathy: a randomised controlled trial.

BACKGROUND: IgA nephropathy is progressive in most cases and has no established therapy. In this randomised trial, we assessed the efficacy and safety of a 6-month course of steroids in this disorder. METHODS: Between July, 1987, and September, 1995, we enrolled 86 consecutive patients from seven renal units in Italy. Eligible patients had biopsy-proven IgA nephropathy, urine protein excretion of 1.0-3.5 g daily, and plasma creatinine concentrations of 133 micromol/L (1.5 mg/dL) or less. Patients were randomly assigned either supportive therapy alone or steroid treatment (intravenous methylprednisolone 1 g per day for 3 consecutive days at the beginning of months 1, 3, and 5, plus oral prednisone 0.5 mg/kg on alternate days for 6 months). The primary endpoint was deterioration in renal function defined as a 50% or 100% increase in plasma creatinine concentration from baseline. Analyses were by intention to treat. FINDINGS: Nine of 43 patients in the steroid group and 14 of 43 in the control group reached the primary endpoint (a 50% increase in plasma creatinine) by year 5 of follow-up (p<0.048). Factors influencing renal survival were vascular sclerosis (relative risk for 1-point increase in score 1.53, p=0.0347), female sex (0.22, p=0.0163), and steroid therapy (0.41, p=0.0439). All 43 patients assigned steroids completed the treatment without experiencing any important side-effects. INTERPRETATION: A 6-month course of steroid treatment protected against deterioration in renal function in IgA nephropathy with no notable adverse effects during follow-up. An increase in urinary protein excretion could be a marker indicating the need for a second course of steroid therapy.

Administration, Oral↗

PubMed2000

Glycine antagonist (gavestinel) in neuroprotection (GAIN International) in patients with acute stroke: a randomised controlled trial. GAIN International Investigators.

BACKGROUND: Early treatment may improve acute ischaemic stroke outcome. Gavestinel is a selective antagonist at the glycine site of the N-methyl-D-aspartate (NMDA) receptor, and is neuroprotective in animal models of ischaemic stroke. METHODS: We did a randomised, double-blind, placebo-controlled trial to test whether gavestinel could improve functional outcome after acute stroke in human beings. Conscious patients with stroke involving limb weakness received either gavestinel at an intravenous loading dose of 800 mg followed by 200 mg every 12 h for five doses, or matching placebo, within 6 h of stroke onset. Stratification variables were age and stroke severity. A computed tomography brain scan within 18 h of stroke onset identified the primary efficacy population with ischaemic stroke. Outcome was assessed by an independent observer with the Barthel index at 3 months. Three outcome categories were applied: good (Barthel index 95-100), moderate (60-90), and poor (0-55 or dead). Analysis was by intention to treat. FINDINGS: Of 1804 patients randomised, 16 received no treatment, and 333 had primary intracranial haemorrhage. 891 patients received gavestinel and 897 received placebo. Outcome in 721 patients who received gavestinel and were analysed for the primary endpoint at 3 months was good in 246 (34.1%), moderate in 136 (18.8%), and poor in 339 (47.0%), compared with 256 (34.9%), 133 (18.1%), and 345 (47.0%), respectively, of 734 patients who received placebo (p=0.8). Mortality at 3 months was 147 (20.4%) in the gavestinel group and 138 (18.8%) in the placebo group. Outcomes within preplanned subgroup and secondary analyses were also neutral. There were no significant differences in serious side-effects between the groups. INTERPRETATION: Treatment with gavestinel within 6 h of acute ischaemic stroke did not improve outcome.

Acute Disease↗

PubMed2003

Oral topiramate for treatment of alcohol dependence: a randomised controlled trial.

BACKGROUND: Topiramate, a sulphamate fructopyranose derivative, might antagonise alcohol's rewarding effects associated with abuse liability by inhibiting mesocorticolimbic dopamine release via the contemporaneous facilitation of gamma-amino-butyric acid activity and inhibition of glutamate function. We aimed to see whether topiramate was more effective than placebo as a treatment for alcohol dependence. METHODS: We did a double-blind randomised controlled 12-week clinical trial comparing oral topiramate and placebo for treatment of 150 individuals with alcohol dependence. Of these 150 individuals, 75 were assigned to receive topiramate (escalating dose of 25-300 mg per day) and 75 had placebo as an adjunct to weekly standardised medication compliance management. Primary efficacy variables were: self-reported drinking (drinks per day, drinks per drinking day, percentage of heavy drinking days, percentage of days abstinent) and plasma gamma-glutamyl transferase, an objective index of alcohol consumption. The secondary efficacy variable was self-reported craving. FINDINGS: At study end, participants on topiramate, compared with those on placebo, had 2.88 (95% CI -4.50 to -1.27) fewer drinks per day (p=0.0006), 3.10 (-4.88 to -1.31) fewer drinks per drinking day (p=0.0009), 27.6% fewer heavy drinking days (p=0.0003), 26.2% more days abstinent (p=0.0003), and a log plasma gamma-glutamyl transferase ratio of 0.07 (-0.11 to -0.02) less (p=0.0046). Topiramate-induced differences in craving were also significantly greater than those of placebo, of similar magnitude to the self-reported drinking changes, and highly correlated with them. INTERPRETATION: Topiramate (up to 300 mg per day) is more efficacious than placebo as an adjunct to standardised medication compliance management in treatment of alcohol dependence.

Administration, Oral↗

PubMed2000

Randomised controlled trial of the efficacy of misoprostol used as a cervical ripening agent prior to termination of pregnancy in the first trimester.

BACKGROUND: Misoprostol is being used increasingly in clinical practice for cervical ripening in first-trimester abortions, but because of lack of good evidence of its effectiveness, administration consensus has not been reached on dosage, route of administration, time of administration pre-operatively and gestational age group. In this study we tested the hypothesis that self-administration of 600 micrograms vaginal misoprostol is feasible and when used 2-4 hours pre-operatively results in sufficient cervical dilatation to make suction curettage easier. METHODS: A double-blind, randomised, placebo-controlled trial was undertaken. Two hundred and seventy-eight women scheduled for termination of pregnancy of up to 12 weeks' duration by manual vacuum aspiration were assigned to receive either 600 micrograms misoprostol pre-operatively, or placebo. The achievement of 'satisfactory' (> or = 7 mm) baseline cervical dilatation after 2-4 hours was evaluated as the primary outcome. Secondary outcome measurements included ease and duration of the procedure. Side-effects such as pre-operative bleeding, gastro-intestinal complaints and pain as well as adverse events were noted in all cases. FINDINGS: Self-administration of vaginal misoprostol was successful in all women and 273 women were evaluated for main end-points. A significantly larger proportion of patients in the treatment group reached cervical dilatation of > or = 7 mm (67.3% v. 30.9%, P < 0.0001). The side-effects were minimal and comparable in the two groups. In the treatment group the mean procedure duration was significantly shorter (220 seconds v. 321 seconds, P = 0.0013) and the procedure was more likely to be rated by the operator as 'easy' (81.8% v. 63.3%, P = 0.0082). This resulted in a significant reduction in treatment failure in the < 70-day gestation group (5.0% v. 14.7%, P = 0.005). CONCLUSION: It is feasible, safe and effective for 600 micrograms misoprostol to be self-administered vaginally 2-4 hours pre-operatively for cervical priming prior to manual vacuum aspiration. Further research is needed to establish optimal use in the first trimester and to determine patient acceptance.

Abortifacient Agents, Nonsteroidal↗

PubMed1998

Effectiveness of the postcoital test: randomised controlled trial.

OBJECTIVES: To investigate the impact of the postcoital test on the pregnancy rate among subfertile couples and on the number of other diagnostic tests and treatments. DESIGN: Randomised controlled study. SETTING: A university and two non-university teaching hospitals in the Netherlands. SUBJECTS: New couples at infertility clinics, 1 March 1993 to 1 October 1995; randomisation to an intervention group (series of infertility investigations that include the postcoital test) or to a control group (series excluding the test). MAIN OUTCOME MEASURE: Cumulative pregnancy rate. RESULTS: Of 736 consecutive new couples, 444 fulfilled the inclusion criteria and consented to participate (intervention group, 227; control group, 217). Treatment was given more often in the intervention group than in the control group (54% v 41%; difference 13% (95% confidence interval 4% to 22%)). Yet cumulative pregnancy rates at 24 months in the intervention group (49% (42% to 55%)) and the control group (48% (42% to 55%)) were closely similar (difference 1% (-9.0% to 9.0%)). CONCLUSION: Routine use of the postcoital test in infertility investigations leads to more tests and treatments but has no significant effect on the pregnancy rate.

Adolescent↗

PubMed2003

Tapering off long-term benzodiazepine use with or without group cognitive-behavioural therapy: three-condition, randomised controlled trial.

BACKGROUND: Benzodiazepine withdrawal programmes have never been experimentally compared with a nonintervention control condition. AIMS: To evaluate the efficacy and feasibility of tapering off long-term benzodiazepine use in general practice, and to evaluate the value of additional group cognitive-behavioural therapy (CBT). METHOD: A 3-month randomised, 3-month controlled trial was conducted in which 180 people attempting to discontinue long-term benzodiazepine use were assigned to tapering off plus group CBT, tapering off alone or usual care. RESULTS: Tapering off led to a significantly higher proportion of successful discontinuations than usual care (62% nu. 21%). Adding group CBT did not increase the success rate (58% v. 62%). Neither successful discontinuation nor intervention type affected psychological functioning. Both tapering strategies showed good feasibilityin general practice. CONCLUSIONS: Tapering off is a feasible and effective way of discontinuing long-term benzodiazepine use in general practice. The addition of group CBT is of limited value.

Aged↗

PubMed2004

A randomised controlled trial comparing remifentanil and fentanyl for induction of anaesthesia in CABG surgery.

INTRODUCTION: In a prospective randomised trial we studied haemodynamic stability during induction of anaesthesia for CABG surgery in patients receiving remifentanil-propofol or fentanyl-propofol anaesthesia. METHODS: Fifty-four patients scheduled for elective CABG surgery were studied. Anaesthesia was induced with propofol and pancuronium. The patients were randomly assigned to two groups according to the opioid used during the induction. The remifentanil group received 0.5 microg kg(-1) min(-1) of the drug and the fentanyl group received 5 microg kg(-1). We measured blood pressure, central venous pressure and heart rate continuously for 15 min before and 30 min after orotracheal intubation. We also recorded use of rescue medication for maintaining the mean arterial pressure between 65 and 85 mmHg. RESULTS: After induction of anaesthesia the mean arterial pressure and heart rate decreased significantly in both groups (P<0.05). After orotracheal intubation the mean arterial pressure and heart rate increased significantly in the fentanyl group but not in the remifentanil group (P<0.05). The incidence of hypertonic events necessitating the use of rescue medication was significantly higher in the fentanyl group (P<0.05). CONCLUSIONS: Our results show more stable haemodynamics after induction of anaesthesia in CABG surgery in patients receiving remifentanil-propofol than in patients receiving fentanyl-propofol.

Analgesics, Opioid↗

PubMed2006

The superficial cervical plexus block for postoperative pain therapy in carotid artery surgery. A prospective randomised controlled trial.

OBJECTIVES: Rapid and reliable neurological evaluation soon after carotid artery surgery is feasible with modern methods of general anesthesia, but postoperative pain therapy remains a challenge. Use of opioids can mask neurological deficits. We investigated whether superficial cervical plexus block reduced postoperative opioid consumption after carotid endarterectomy. DESIGN: Prospective, randomised, double-blinded, placebo controlled trial. METHODS: 46 patients undergoing unilateral carotid endarterectomy under general anesthesia were randomized to either superficial cervical block with ropivacaine (n=23) or placebo (n=23). A patient controlled analgesia device (PCA) delivering morphine was provided for all patients. Subjective pain levels (visual analog scale, VAS) were recorded. The primary outcome was total morphine consumption on discharge from the recovery room. Secondary outcomes included arterial pCO2 (as an indicator of central nervous effects of morphine) and patient satisfaction. RESULTS: No adverse effects of the superficial cervical plexus block were reported. Four patients in the placebo group were excluded because of other drug use post-operatively. Per protocol analysis compared 23 patients in ropivacaine group and 19 patients in the placebo group. The ropivacaine group had a significant reduction in morphine consumption (3.8+/-2.0 versus 12.9+/-4.0, p<0.001), lower maximal pain scores (2.6+/-2.0 versus 5.8+/-1.6, p<0.001), and paCO2 levels (39.0+/-2.6 versus 41.9+/-3.4, p=0.008) at discharge from the recovery room. Patient satisfaction (1=very good to 6=insufficient) was substantially higher in the ropivacaine group (1.7+/-0.7 versus 3.1+/-1.2, p<00.01). CONCLUSION: The significant and clinically relevant lower morphine consumption and pain score, as well as the substantially higher patient satisfaction demonstrate that superficial cervical plexus block provides effective pain relief for patients undergoing carotid endarterectomy.

Aged↗

PubMed2006

Aprotinin in the management of Achilles tendinopathy: a randomised controlled trial.

BACKGROUND: Achilles tendinopathy is a common condition, which can become chronic and interfere with athletic performance. The proteinase inhibitor aprotinin (as injection) has been found to improve recovery in patellar tendinopathy (evidence level 1b) and Achilles tendinopathy. Internationally this therapy is being used based on this limited knowledge base. AIM: To evaluate whether aprotinin injections decrease time to recovery in Achilles tendinopathy. METHOD: A prospective, randomised, double blind, placebo controlled trial was performed comparing saline (0.9%) plus local anaesthetic injections and eccentric exercises with aprotinin (30,000 kIU) plus local anaesthetic injection and eccentric exercise. Three injections were given, each a week apart. In total, 26 patients, with 33 affected tendons, were enrolled for this study. RESULTS: At no follow up point (2, 4, 12, or 52 weeks) was there any statistically significant difference between the treatment group and placebo. This included VISA-A scores and secondary outcome measures. However, a trend for improvement over placebo was noted. CONCLUSION: In this study on Achilles tendinopathy, aprotinin was not shown to offer any statistically significant benefit over placebo. Larger multicentre trials are needed to evaluate the efficacy of aprotinin in Achilles tendinopathy.

Achilles Tendon↗

PubMed2004

Preventing postnatal depression in mothers of very preterm infants: a randomised controlled trial.

OBJECTIVE: To test whether a cognitive-behaviour therapy intervention program reduces the prevalence of depression during the first postnatal year in mothers of very preterm babies. DESIGN: Prospective, single blind, randomised, controlled study. SETTING: Perinatal centre in Western Australia. PARTICIPANTS: One hundred and ninety-nine out of 673 English-speaking mothers of infants admitted to the neonatal unit. INTERVENTION: A six-session cognitive-behaviour therapy intervention program provided by a research midwife between weeks two and six after birth. Women in the control group received standard care. MAIN OUTCOME MEASURES: Depression and anxiety disorders occurring in the first year assessed by a clinical psychologist at structured interview using the Schedule for Affective Disorders and Schizophrenia (SADS) at 2 weeks, 2, 6 and 12 months. RESULTS: One hundred and one women were randomised to the intervention group and 98 to the control group. Fifty-four mothers (27%) in the trial were diagnosed with minor or major depression in the 12 months following very preterm delivery, 29 (29%) in the intervention group and 25 (26%) in the control group (relative risk 1.1 [95% CI 0.80-1.5]). There were no differences in the time of onset or the duration of the episodes of depression between the groups. Overall, 74 mothers (37%) of the 199 met criteria for a diagnosis of psychological morbidity during the first year. CONCLUSIONS: Our intervention program did not alter the prevalence of depression in these mothers. Rates of depression and stress reactions are high in these mothers.

Adult↗

PubMed1989

Comparison of the renal effects of angiotensin converting enzyme inhibitor and calcium antagonist in hypertensive type 2 (non-insulin-dependent) diabetic patients with microalbuminuria: a randomised controlled trial.

Seven of eight hypertensive Type 2 (non-insulin-dependent) diabetic patients with microalbuminuria completed a randomised crossover trial to compare the renal effects of angiotensin converting enzyme inhibitor (enalapril) and calcium antagonist (nicardipine). Four-week fixed oral maintenance dosages of enalapril (10-20 mg/day) and nicardipine (60-120 mg/day) significantly (p less than 0.05) lowered the systolic and diastolic blood pressures without altering renal blood flow, glomerular filtration rate and filtration fraction. Both drugs significantly reduced (p less than 0.05) urinary albumin excretion rate and fractional clearance of albumin to similar extents. Total renal vascular resistance decreased significantly by nicardipine (p less than 0.05) and non-significantly by enalapril. Plasma osmotic pressure, plasma aldosterone concentration, total serum protein concentration, serum electrolytes and HbA1c remained unchanged by these drugs, whereas plasma renin activity was significantly higher (p less than 0.05) in the enalapril than in the control and nicardipine phases. These results suggest that both drugs have similar renal function preserving effects with a concomitant hypotensive action in hypertensive Type 2 diabetic patients with microalbuminuria, and that the angiotensin converting enzyme inhibitor may not have advantageous renal effects when compared to the calcium antagonist and vice versa. Both drugs might be useful for treatment of high blood pressure in hypertensive diabetic patients, if long-term studies of these drugs can be shown to benefit the patients over other conventional antihypertensive therapies.

Aged↗

PubMedDate not supplied

Writing to patients: a randomised controlled trial.

It has been suggested that consultants should consider writing directly to patients with a summary of their outpatient consultation. In a controlled trial involving consecutive new referrals to a haematology outpatient clinic, we randomised patients to receive either a personal letter from their consultant summarising their consultation (n = 77) or a brief note thanking them for attending the clinic (n = 73). Patients were assessed for recall of and satisfaction with the consultation by a single independent observer, using standardised methods. At the second visit to outpatients, the patients' median percentage recall of items discussed during the consultation was 67% (IQ range 50-80%) in the intervention group, versus 57% (IQ range 43-76%) in the control group (p = 0.3). Strongly positive views on the personal letter were expressed by patients and referring clinicians. The findings suggest that although personal letters do not substantially improve recall of the clinical encounter, they are feasible, highly valued by patients and acceptable to referring clinicians.

Adolescent↗

PubMed1999

Effect of formoterol on clinical parameters and lung functions in patients with bronchial asthma: a randomised controlled trial.

AIMS: To determine the role of formoterol in the treatment of children with bronchial asthma who are symptomatic despite regular use of inhaled corticosteroids. METHODS: A randomised, double blind, parallel group, placebo controlled study to investigate the effects of inhaled formoterol (12 microg twice a day) in 32 children with moderate to severe bronchial asthma. The study consisted of two week run in periods and six week treatment periods, during both of which the patients continued their regular anti-inflammatory drugs. The efficacy parameters were symptom scores, bronchodilator use, daily peak expiratory flow rates (PEFR), methacholine hyper-reactivity, forced expiratory volume in one second (FEV1), lung volumes, and airway conductance. RESULTS: Formoterol treatment for six weeks decreased symptom scores, PEFR variability, and the number of rescue salbutamol doses, and increased morning and evening PEFR significantly. No adverse reactions were seen. CONCLUSION: These findings suggest that inhaled formoterol is effective in controlling chronic asthma symptoms in children who are symptomatic despite regular use of inhaled corticosteroids.

Adolescent↗

PubMed2002

Plasmapheresis in severe sepsis and septic shock: a prospective, randomised, controlled trial.

OBJECTIVE: To determine the therapeutic efficacy and safety of plasmapheresis in the treatment of patients with severe sepsis and septic shock. DESIGN: Prospective, randomised, clinical trial with a planned, midstudy, interim analysis. SETTING: Intensive care unit in a university hospital in Archangels, Russia. PATIENTS: Consecutive patients with severe sepsis or septic shock. INTERVENTIONS: One hundred and six patients were randomised to receive either standard therapy or an add-on treatment with plasmapheresis. MEASUREMENTS AND RESULTS: The primary endpoint was 28-day survival. Septic shock was diagnosed in 57% of the plasmapheresis-treated patients and 54% of the control patients. Mean APACHE III score at entry was 56.4 in the plasmapheresis group and 53.5 in the control group. The 28-day, all-cause mortality rate was 33.3% (18/54) in the plasmapheresis group and 53.8% (28/52) in the control group. This represents a relative risk for fatal outcome in the plasmapheresis group of 0.61, an absolute risk reduction of 20.5% and a number of patients needed to treat of 4.9. Apart from six transient episodes of hypotension and one allergic reaction to fresh frozen plasma, no adverse reactions were attributable to the plasmapheresis treatment in this study. CONCLUSIONS: Plasmapheresis may be an important adjuvant to conventional treatment to reduce mortality in patients with severe sepsis or septic shock. Plasmapheresis is a safe procedure in the treatment of septic patients. A prospective randomised multicentre trial is warranted to confirm our results and to determine which subgroups of septic patients will benefit most from this treatment modality.

APACHE↗