A randomized controlled trial of variceal compression as an adjunct to endoscopic variceal sclerosis

Endoscopic variceal sclerosis is effective at eradicating oesophageal varices and prolonging survival, but early rebleeding before varices have been obliterated remains a problem. A randomized controlled trial was therefore conducted to determine whether more rapid variceal obliteration and hence a lower morbidity and mortality in the first month could be achieved by compressing the varices after the first injection of sclerosant. Forty patients bleeding from previously untreated varices were studied. There was no demonstrable benefit from post-sclerosis variceal compression in terms of early death from rebleeding (compression, 3 of 19; no compression, 3 of 21 in the first month), total number of patients rebleeding (compression, 5 of 19; no compression, 6 of 21 in the first month), or speed of variceal obliteration (percentage of variceal columns obliterated at 1 month: compression, 13%; no compression, 26%). This study shows that post-sclerosis variceal compression by means of the Williams overtube and Sengstaken tamponade does not improve the efficacy of endoscopic variceal sclerosis.     

A controlled trial of a school-based intervention to improve asthma management.

The present study investigated schools as an appropriate context for an intervention designed to produce clinical and psychological benefits for children with asthma. A total of 193 out of 219 (88.1%) children with asthma (aged 7-9 yrs) from 23 out of 24 (95.8%) schools completed the study. Intervention schools received a staff asthma-training session, advice on asthma policy, an emergency beta2-agonist inhaler with spacer and whole-class asthma workshops. Nonintervention schools received no asthma-related input. Intervention children required less general practitioner-prescribed preventer medication despite no differences in symptom control compared with the nonintervention asthmatic group. Increased peer knowledge of asthma may have mediated improved active quality of life in the intervention group, together with increased self-esteem in young females. Those females not receiving the intervention, but identified as being asthmatic within the classroom, and thus possibly stigmatised, reported decreased self-esteem. Lower self-esteem in young males was associated with pet ownership. No change was found in staff knowledge, the establishment of asthma policies or school absences which were low even before intervention. In conclusion, a whole-school intervention can improve the health of children with asthma when followed with support for all children but effects are likely to be modified by sex and the home environment.     

A prospective randomized controlled trial of intravenous ciprofloxacin as an adjunct to corticosteroids in acute, severe ulcerative colitis

BACKGROUND: The role of antibiotics in the treatment of ulcerative colitis is controversial. This study aims at assessing the therapeutic role of ciprofloxacin as an adjunct to corticosteroids in acute severe ulcerative colitis. METHODS: In this prospective, randomized, double-blind, placebo-controlled trial, 55 consecutive patients fulfilling the criteria of Truelove and Witts for severe ulcerative colitis were randomized on admission to the hospital to receive intravenously ciprofloxacin (400 mg b.i.d.) (n = 29) or placebo (n = 27). All patients received parenteral nutrition, intravenous hydrocortisone (100 mg q.i.d.) and hydrocortisone enemas (100 mg b.i.d.). Patients were assessed after 10 days of continuous treatment, or at any time a severe complication occurred. RESULTS: At study entry, there were no significant differences between treatment groups in any patient or disease-related parameter. Twenty-three of 29 patients (79.3%) treated with ciprofloxacin and 20 of 26 patients (77%) treated with placebo showed substantial improvement and were given oral steroids (P > 0.1). Six patients in each group did not improve (n = 10) or developed complications (n = 2). Nine of these 12 patients underwent emergency colectomy; three patients consented to receive intravenous cyclosporin but did not achieve remission of colitis and they underwent elective colectomy. There were no perioperative or late deaths. CONCLUSIONS: A short course of intravenous ciprofloxacin does not seem to augment the effect of corticosteroids for patients with acute, severe ulcerative colitis.     

Double-blind, randomised, controlled trial assessing controller medications in asthma

BACKGROUND: The motive behind conducting this study was to determine if better control of asthma can be achieved by adding a second controller medication and to assess its use to reduce the dose of inhaled steroids. OBJECTIVES: The study aimed to determine whether either oral sustained-release theophylline or montelukast added to inhaled steroids improved clinical symptoms and pulmonary function test parameters when compared to high-dose steroids alone. METHODS: Ninety patients with incompletely controlled asthma were allocated, in a randomised, double-blind fashion, to one of three treatment groups: group A: double dose of inhaled budesonide (400 microg b.i.d.), group B: 400 mg oral sustained-release theophylline plus budesonide (200 microg b.i.d.) and group C: 10 mg montelukast plus budesonide (200 microg b.i.d.). The primary endpoints were forced expiratory volume in 1 s (FEV(1)) and mean morning peak expiratory flow rate (PEFR). RESULTS: All three groups had improved FEV(1) and PEFR at 8 weeks (p < 0.001). Group C increased their PEFR by 18.7 l/min (95% confidence interval, CI, 12.4-25.1) more than group A and by 19.8 l/min (95% CI 13.4-26.1) more than group B (both p = 0.001). Similarly, group C had a 114 ml (95% CI 45-183 ml) greater improvement in FEV(1) than group A and a 95 ml (95% CI 26-164 ml) greater improvement than group B (both p = 0.01). CONCLUSIONS: Addition of montelukast to budesonide is safe and results in greater improvement in pulmonary function test parameters than high-dose budesonide treatment or addition of theophylline.     

A randomised controlled feasibility trial of Group Cognitive Behavioural Therapy for people with severe asthma

Objectives: Evidence for the efficacy of Cognitive Behavioural Therapy (CBT) in asthma is developing but it is not known if this translates to benefits in severe asthma or if a group approach is acceptable to this patient group. This study aimed to assess the feasibility and acceptability of Group-CBT in severe asthma. Method: This was a two-centre, randomised controlled parallel group feasibility study. Eligible participants (patients with severe asthma and a clinically significant diagnosis of anxiety and/or depression – Hospital Anxiety and Depression Scale (HAD) score greater than 8 for the anxiety or depression sub-scale) received Group-CBT in weekly sessions for eight consecutive weeks and usual care or usual care only. Follow-up was for 16 weeks and end points were: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire, HAD, Dyspnoea-12, EuroQual-5D and EuroQuol-VAS. Results: 51 patients were randomised: 36% (51 out of 140) consent rate and attrition at week 16 was 12. Screening logs indicated that study take-up was influenced by patients living long distances from the treatment centre and inability to commit to the weekly demands of the programme. Drop-out was higher in Group-CBT compared due to inability to commit to the weekly programme because of poor health. Participants who contributed to focus group discussions reported that Group-CBT contributed to a better understanding of their illness and related approaches to anxiety management and acceptance of their asthma condition. Although weekly face-to-face sessions were challenging, this was the preferred method of delivery for these participants. Conclusions: This feasibility study shows that Group-CBT warrants further investigation as a potentially promising treatment option for patients with severe asthma. It has been possible but not easy to recruit and retain the sample. Options for a less demanding intervention schedule, such as less frequent face-to-face visits and the use of web-based interventions, require careful consideration.     

Efficacy of bispectral monitoring as an adjunct to nurse-administered propofol sedation for colonoscopy: a randomized controlled trial

BACKGROUND AND AIMS: Bispectral (BIS) monitoring provides an objective, non-invasive measure of the level of consciousness in sedated patients. BIS has been shown to lag behind the level of sedation during induction and emergence of sedation with propofol. In this study, we sought to determine whether BIS is a useful adjunctive maneuver to registered nurse-administered propofol sedation (NAPS) as measured by reductions in recovery time and doses of propofol administered. METHODS: A randomized controlled trial of 102 outpatients presenting for colonoscopy was performed. BIS values were recorded continuously in all subjects. Patients were randomized to receive NAPS with BIS visible to nurse and endoscopist versus BIS invisible to nurse and endoscopist. In phase 1 (47 patients), the nurse and endoscopist team were instructed to consider BIS (when visible) as only adjunctive information with regard to titrating sedation. In phase 2 (55 patients), the nurse endoscopist team was instructed to use BIS as the primary endpoint for titration of sedation, and to target BIS to greater than 60 (60-70 is deep sedation). RESULTS: In phase 1, the mean (SD) BIS value from scope-in (SI) to scope-out (SO) for BIS was 59.3 (9.9) and was not different from controls at 59.9 (10.1; p= 0.82). The mean (SD) propofol dose (mg/min) was 15.8 (5.6) and 17.2 (6.2) for BIS and controls, respectively (p= 0.45). The mean (SD) recovery time with BIS visible in phase 1 was 20.6 min (5.5) versus 19.2 min (4.5) in controls (p= 0.34). In phase 2, the mean (SD) BIS from SI to SO in those randomized to have BIS visible was 64.1 (5.4) versus 63.1 (8.5) in controls (p= 0.58). The mean (SD) dose of propofol (mg/min) was 16.1 (11.2) and 16.4 (12.3) for BIS and control groups, respectively (p= 0.92). The mean (SD) recovery time in phase 2 with BIS visible was 18.7 (3.5) versus 20.1 (5.6) in controls (p= 0.27). CONCLUSIONS: BIS did not lead to reductions in mean propofol dose or recovery time when used as an adjunct to NAPS for colonoscopy, or when used as the primary target for sedation. No clinically important role for BIS monitoring as an adjunct to NAPS has yet been established.     

One or two operator technique and quality performance of colonoscopy: A randomised controlled trial

BackgroundThe two-operator technique for colonoscopy, with the endoscopy assistant actively advancing and withdrawing the scope, is still commonly practiced in Europe. As uncontrolled data has suggested that the one-operator technique is associated with a higher adenoma detection rate, we tested the hypothesis that the two-operator-technique can achieve comparable performances in terms of adenoma detection.MethodsNon-inferiority trial in which consecutive adult outpatients were randomised to undergo colonoscopy by one (one-operator) or by four endoscopists. Each performed half the procedures by one-operator and half by two-operator technique independently of routine clinical practice. Main outcome measure was adenoma detection rate.Results352 subjects (49% males, mean age 60 ± 12.1 years) were randomised to one (n = 176) or to two-operator technique (n = 176) colonoscopy. No significant differences were found in adenoma detection (33% vs. 30.7%, p = 0.65), or cecal intubation rate, procedure times, and patient tolerability. No differences were found in the subgroup analysis according to routinely adopted colonoscopy technique.ConclusionsThis study does not confirm a higher adenoma detection rate for one-operator technique colonoscopy. Changing current practice to improve adenoma detection rate for endoscopists routinely using two-operator technique is not warranted.     

A randomised controlled trial of the reciprocating syringe in arthrocentesis

OBJECTIVE: To evaluate the outcomes of arthrocentesis with the new highly controllable, one handed reciprocating procedure syringe compared with a conventional syringe. METHODS: 100 arthrocentesis procedures were randomised between the reciprocating syringe and the conventional syringe. Outcome measures included patient pain, procedure duration, operator satisfaction, synovial fluid volume, cell counts, and complications. RESULTS: 50 arthrocentesis procedures with the conventional syringe resulted in a mean (SD) procedure time of 3.39 (1.88) minutes, a mean VAPS (patient pain) score of 5.35 (3.15), and a mean VASS (operator satisfaction) score of 4.88 (1.92); 30 of the 50 subjects experienced moderate to severe pain (VAPS score 5 or greater) during arthrocentesis. In contrast, the reciprocating syringe resulted in a reduced procedure time of 1.94 (1.14) minutes (p<0.001), a reduced VAPS (patient pain) score of 2.54 (1.60) (p<0.001), and an increased VASS (operator satisfaction) score of 8.91 (0.79) (p<0.001). Only five of the 50 of subjects experienced moderate to severe pain with the reciprocating syringe. Synovial cell counts were similar between the two syringes (p>0.05), but there was a trend toward greater volume (greater synovial fluid yield) and fewer red blood cells with the reciprocating syringe. CONCLUSIONS: Arthrocentesis with a conventional syringe results in moderate to severe pain in 60% of subjects. The reciprocating syringe prevents significant pain, reduces procedure time, and improves physician performance of arthrocentesis. The reciprocating syringe is superior to the conventional syringe in arthrocentesis.     

Cardiac resynchronization therapy as an adjunct to conventional surgical treatment for heart failure

From March 2004 through October 2007, we prospectively evaluated the benefits of cardiac resynchronization therapy as an adjunct to conventional procedures in patients who were undergoing surgery for heart failure.Twenty severely symptomatic patients (14 men and 6 women, with a mean age of 70 +/- 8 years) who displayed advanced cardiomyopathy, QRS duration > or =130 ms, or mechanical dyssynchrony, underwent isolated or combined coronary artery revascularization and mitral valve overreduction. In all patients, an epicardial lead was secured to the left ventricular wall at the end of the procedure and its extremity was brought into a subclavian pocket. In 5 patients, a resynchronization device was implanted at the time of surgery; in 8, it was implanted at a later date; the remaining 7 patients are awaiting implantation. One patient died postoperatively of low-output syndrome. There was 1 noncardiac late death. Eighteen patients were alive at a mean postoperative follow-up of 21.6 +/- 15.2 months (range, 1-43 mo). There were no subsequent hospital admissions after discharge. New York Heart Association functional class and left ventricular performance were significantly and lastingly improved when cardiac resynchronization therapy was added to the surgical procedure. Despite the limitations inherent in the small number of patients and the relatively short duration of follow-up, this study suggests that patients with dilated cardiomyopathy and left ventricular dyssynchrony in whom surgical correction is indicated may benefit from cardiac resynchronization therapy using a resynchronization device connected to an epicardial lead secured to the left ventricle at the time of surgery.