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Single Blind (single + blind)
Selected AbstractsRandomized-controlled study comparing post-operative pain between coblation palatoplasty and laser palatoplasty,CLINICAL OTOLARYNGOLOGY, Issue 2 2006Belloso A. Objectives:, This study aimed to evaluate differences in post-operative pain comparing KTP laser-assisted uvulopalatoplasty without tonsillectomy (LAUP) with a new described surgical method: coblation uvulopalatoplasty with tonsillectomy (CP). We also evaluate the impact of each surgical technique in reduction of snoring loudness. Material and methods:, Single blind randomized-controlled trial. From a population of 41 consecutive patients on the waiting list for uvulopalatoplasty for simple snoring, the study group was reduced to 17 CP and 13 LAUP. Post-operative pain and reduction of snoring loudness were recorded using visual analogue scales (VAS) during the first 15 post-operative days. Post-operative snoring loudness was documented for 1-year period. Results:, Both groups had similar post-operative pain during the first seven post-operative days. A statistically significant reduction in post-operative pain was observed in the CP group after day 8, and maintained until the end of the study. Reduction of snoring loudness was significant in both groups, but no differences were observed between them. Discussion:, Coblation uvulopalatoplasty compared with LAUP demonstrates a reduction in post-operative pain, significant after the first post-operative week. The collateral thermal injury caused by laser is responsible for the slow-healing rate and maintained post-operative pain. Coblation dissociates tissue at lower temperatures with minimal collateral thermal injury and consequently faster and less painful recovery. Both surgical procedures have significant and similar reduction in snoring loudness. Conclusions:, Both methods are adequate treatment options for snoring. The less painful recovery in CP promotes this surgical technique as our preferred choice for palate surgery. [source] The use of lubrication in flexible fibreoptic nasendoscopy: a randomized controlled trialCLINICAL OTOLARYNGOLOGY, Issue 4 2005D.D. Pothier Objectives:, To determine how lubrication of the endoscope prior to flexible fibreoptic nasendoscopy affects levels of patient discomfort and pain during endoscopy. To assess the extent to which lubrication affects the ease of nasendoscopy and the quality of the image obtained. Design:, Single blind, randomized controlled trial. Setting:, Outpatient clinic of the Department of Otolaryngology at a secondary level referral centre. Participants:, A total of 150 participants selected sequentially from patients requiring a nasendoscopy where the endoscope would be passed far enough to view the larynx. Patients requiring topical anaesthetic were excluded. All participants who were entered in the study completed the study. Endoscopy was performed by all grades of medical staff. Main outcomes measures:, Levels of discomfort and pain experienced by the participants were assessed by a visual analogue scale (VAS). Difficulty of passing the scope was indicated by the endoscopist using a VAS, as was the quality of image obtained. Results:, There was no significant difference between mean scores for pain or discomfort of the lubricated and unlubricated groups (P = 0.46 and P = 0.82 respectively). Scores for difficulty of passing the scope were significantly lower in the lubricant group (P = 0.003) but loss of image was significantly greater (P = 0.008). Conclusions:, Lubrication of the endoscope prior to nasendoscopy does not reduce levels of discomfort or pain for the patient, but increases ease in insertion for the operator. However, this may be at the expense of reduced image quality. [source] Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapyDIABETES OBESITY & METABOLISM, Issue 2 2009R. E. Pratley Aim:, To evaluate the efficacy and safety of alogliptin, a potent and highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor, in combination with glyburide in patients with type 2 diabetes inadequately controlled by sulphonylurea monotherapy. Methods:, After a 2-week screening period, adult patients 18,80 years of age entered a 4-week run-in/stabilization period in which they were switched from their own sulphonylurea medication to an equivalent dose of glyburide (open label) plus placebo (single blind). After the run-in period, patients were randomly assigned to double-blind treatment with alogliptin 12.5 mg (n = 203), alogliptin 25 mg (n = 198), or placebo (n = 99) for 26 weeks. The primary end-point was change from baseline to week 26 in glycosylated haemoglobin (HbA1c). Secondary end-points included clinical response rates and changes in fasting plasma glucose, ,-cell function (fasting proinsulin, insulin, proinsulin/insulin ratio, and C-peptide, and homeostasis model assessment ,-cell function), body weight, and safety end-points [adverse events (AEs), clinical laboratory tests, vital signs and electrocardiographic readings]. Results:, The study population had a mean age of 57 years and a mean disease duration of 8 years; it was well balanced for gender (52% women) and was mainly white (71%). The mean baseline HbA1c was approximately 8.1% in each group. Significantly greater least squares (LS) mean reductions in HbA1c were seen at week 26 with alogliptin 12.5 mg (,0.38%) and 25 mg (,0.52%) vs. placebo (+0.01%; p < 0.001), and more patients in the alogliptin 25-mg group had HbA1c levels ,7.0% at week 26 (34.8%, p = 0.002) vs. placebo (18.2%). Proportionately more patients in the alogliptin 12.5 mg (47.3%) and 25 mg (50.5%) groups had an HbA1c reduction ,0.5% from baseline compared with patients in the placebo group (26.3%; p < 0.001). Minor improvements in individual markers of ,-cell function were seen with alogliptin, but no significant treatment group differences were noted relative to placebo. Minor LS mean changes in body weight were noted across groups (placebo, ,0.20 kg; alogliptin 12.5 mg, +0.60 kg; alogliptin 25 mg, +0.68 kg). AEs were reported for 63,64% of patients receiving alogliptin and 54% of patients receiving placebo. Few AEs were treatment limiting (2.0,2.5% across groups), and serious AEs (2.0,5.6%) were infrequent, similar across groups, and generally considered not related to treatment. The incidences of hypoglycaemia for placebo, alogliptin 12.5 mg and alogliptin 25 mg groups were 11.1, 15.8 and 9.6% respectively. Conclusions:, In patients with type 2 diabetes inadequately controlled by glyburide monotherapy, the addition of alogliptin resulted in clinically significant reductions in HbA1c without increased incidence of hypoglycaemia. [source] Enhanced Left Ventricular Endocardial Border Delineation with an Intravenous Injection of SonoVue, a New Echocardiography Contrast Agent:ECHOCARDIOGRAPHY, Issue 8 2000A European Multicenter Study The safety and efficacy of SonoVue (also referred to as BR1), a new contrast agent for delineating endocardial border of the left ventricle after intravenous administration, was assessed. Two hundred and eighteen patients with suspected coronary artery disease undergoing fundamental echocardiography for the assessment of left ventricle were enrolled in a prospective multicenter, single blind, cross-over study with random sequence allocation of four different doses of SonoVue. Endocardial border definition in the apical and parasternal views was scored as O = not visible, 1 = barely visible, and 2 = well visualized before and after contrast enhancement. Analysis was performed by two pairs of off-site observers. Safety of SonoVue was also assessed. Results of our study indicated that the mean improvements in the endocardial border visualization score were as follows: 3.1 ± 7.8 (95% CI, 2.5 and 3.7) for 0.5 ml, 3.4 ± 8.0 (95% CI, 2.8 and 4.0) for 1 ml, 3.4 ± 7.9 (95% CI, 2.8 and 4.0) for 2 ml, and 3.7 ± 8.0 (95% CI, 3.1 and 4.3) for 4 ml (P < 0.05 for all doses from baseline). Changes from baseline in endocardial visualization scores were also seen in the apical views (P < 0.05) and they were dose-dependent (P < 0.001). Similar enhancements of endocardial visualization scores were observed in the apical views in patients with suboptimal baseline echocardiographic images. Diagnostic confidence for assigning a score and image quality also were significantly better following contrast enhancement. No significant changes in the laboratory parameters and vital signs were noted following contrast enhancement, and the side effects were minimal. It was concluded that SonoVue is safe and effective in delineating endocardial border, including in patients with suboptimal baseline images. [source] Safety and efficacy of solvent/detergent-treated antihaemophilic factor with an added 80 °C terminal dry heat treatment in patients with haemophilia AHAEMOPHILIA, Issue 3 2000J. S. Powell Plasma-derived factor VIII concentrates remain an important resource for haemophilia A patients. To improve the safety of these preparations, various methods of viral removal and inactivation have been used that are designed to eliminate both enveloped and non-enveloped viruses. There have been rare reports that some viral inactivation processes altered the immunogenicity of some concentrates, leading to the development of factor VIII inhibitors in previously treated haemophilia A patients. This study evaluated the safety, efficacy and lack of neo-antigenicity of a highly purified factor VIII preparation which undergoes both solvent/detergent treatment and final dry heat treatment at 80 °C for 72 h. The study included: (i) a single blind, single-dose crossover pharmacokinetic study in 18 previously treated patients, comparing sibling lots of the unheated preparation (Koate® -HP) and the heat-treated preparation (Koate® -DVI), and (ii) an extended home treatment programme for 36 patients at two haemophilia treatment centres primarily to assess immunogenicity. Clinical parameters were assessed at regular intervals. The results confirm that Koate® -HP and Koate® -DVI are bioequivalent, and that Koate® -DVI is safe and efficacious for treatment of acute bleeding episodes and for surgery. Furthermore, the heat-treated preparation is not associated with the development of inhibitors in previously treated patients. [source] Collaboration, facilities and communities in day care services for older peopleHEALTH & SOCIAL CARE IN THE COMMUNITY, Issue 1 2001Sarah Burch BA Abstract Collaborative working in care for older people is often seen as a desirable goal. However, there can be problems with this approach. This paper reports on a single blind randomized controlled trial which was carried out to compare outcomes of rehabilitation in two settings: a day hospital and social services day centres augmented by visiting therapists. The subjects were 105 older patients. Principal outcome measures were the Barthel Index, Philadelphia Geriatric Centre Morale Scale and the Caregiver Strain Index. Two aspects of the trial are examined here. Firstly, we investigated whether trial patients were more disabled than regular day centre attendees. Levels of health and well being amongst trial patients were compared with those of a random sample of 20 regular attendees from both of the participating day centres and an additional voluntary sector day centre. Secondly, key staff from the different settings were interviewed to assess how well the day centre model had worked in practice. Trial patients were significantly more disabled than regular day centre attendees according to the Barthel Index (P < 0.001), but this difference was no longer significant after three months of treatment. The day centre model had several problems, principally discharge policy, acceptability, facilities and attitudes of staff and regular attendees. Positive aspects of the day centre model, as well as successful rehabilitation, included shared skills, knowledge and resources. This paper suggests that collaborative working in day centres requires multipurpose facilities. If health staff maintain a permanent presence, benefits can include improved joint working, easier access to health care and the use of rehabilitative therapy as a preventative strategy. Day care settings can be analyzed as representing different types of communities. Allowing older users a greater degree of choice in facilities may increase the acceptability of care. [source] Effects of acupressure on menstrual distress in adolescent girls: a comparison between Hegu,Sanyinjiao Matched Points and Hegu, Zusanli single pointJOURNAL OF CLINICAL NURSING, Issue 7-8 2010Huei-Mein Chen Aim and objectives., To examine a comparison between Hegu and Sanyinjiao matched points and Hegu, Zusanli single point on adolescent girls' menstrual distress, pain and anxiety perception. Background., Primary dysmenorrhoea is a major cause of temporary disability, with a prevalence ranging from 60,93%, depending upon the population and study. No one has yet compared the effects of single point and multiple point acupressures. Design., A single blind randomised experimental study was used. Methods., Adolescents (n = 134) randomly assigned to experimental groups Zusanli (n = 30), Hegu (n = 33) and Hegu,Sanyinjiao Matched Points (n = 36) received acupressure intervention protocol for 20 minutes, while the control group (n = 35) did not receive any acupressure intervention. Four instruments were used to collect data: (1) the Visual Analog Scale for Pain; (2) the Menstrual Distress Questionnaire Short Form; (3) the Short-Form McGill Pain Questionnaire and (4) the Visual Analog Scale for Anxiety. Results., During the six-month follow-up, acupressure at matched points Hegu and Sanyinjiao reduced the pain, distress and anxiety typical of dysmenorrhoea. Acupressure at single point Hegu was found, effectively, to reduce menstrual pain during the follow-up period, but no significant difference for reducing menstrual distress and anxiety perception was found. Zusanli acupressure had no significant effects of reducing menstrual pain, distress and anxiety perception. Conclusion., This controlled trial provides preliminary evidence that six-month acupressure therapy provides female adolescents with dysmenorrhoea benefits. Relevance to clinical practice., Acupressure is an effective and safe non-pharmacologic strategy for the treatment of primary dysmenorrhoea. We recommend the use of acupressure for self-care of primary dysmenorrhoea at Hegu and Sanyinjiao matched points and single point Hegu, as pressure placement at these points is easy for adolescent girls to learn and practice. [source] A chlorhexidine varnish implemented treatment strategy for chronic periodontitisJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 7 2005Short-term clinical observations Abstract Objectives: The aim of this study was to investigate the clinical outcome of a subgingivally applied chlorhexidine varnish when used as an adjunct to scaling and root planing (SRP) in the treatment of chronic periodontitis. Material and methods: A randomized controlled, single blind, parallel trial was conducted on the basis of 16 volunteers suffering from chronic periodontitis. The control group received oral hygiene instructions and was scaled and root planed in two sessions. The test group received the same instructions and treatment, however, all pockets were additionally disinfected using a chlorhexidine varnish. The gingival index, plaque index, bleeding on probing, probing pocket depth (PPD) and clinical attachment level (CAL) were recorded at baseline and subsequently after 1 and 3 months. Results: Both treatment strategies showed significant reductions in PPD and CAL at both follow-up visits by comparison with baseline levels (p<0.001). Yet, at study termination, combination therapy resulted in additional pocket reductions between 0.73 and 1.23 mm (p<0.02), and clinical attachment gains between 0.63 and 1.09 mm (p<0.02). Conclusions: These findings suggest that a varnish-implemented strategy may improve the clinical outcome for the treatment of chronic periodontitis in comparison with SRP alone. [source] Effect of toothpaste on the plaque inhibitory properties of a cetylpyridinium chloride mouth rinseJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 3 2003S. Sheen Abstract Background and aims: Cetylpyridinium chloride (CPC) mouth rinses have moderate plaque inhibitory activity when used alone but rarely have shown adjunctive benefits to tooth brushing with toothpaste. Several explanations for this apparent anomaly can be proferred, including loss of antiseptic activity due to interactions with toothpaste ingredients. The aim of this study was to measure the effect of toothpaste on the plaque inhibitory properties of a CPC mouth rinse using paired rinses of CPC, toothpaste slurry (TP) and water (W). Methods: The study was a single blind, randomised, seven-treatment, cross over design balanced for residual effects, involving 21 healthy, dentate subjects. The paired rinses were: W-CPC, CPC-W, TP-CPC, CPC-TP, W-TP, TP-W and W-W. Rinsing with solutions or slurries was done for 60 s twice per day. On day 1, subjects were rendered plaque free, suspended tooth cleaning and commenced the allocated rinse regimen. On day 5, plaque was scored by index. A 2½ day wash out of normal oral hygiene was allowed between each regimen. Results: The order from lowest to highest plaque scores was as follows: W-CPC = CPC-W < CPC-TP < TP-CPC , W-TP < TP-W < W-W. Several differences in pairs of treatments were statistically significant, the most relevant of which were significantly less plaque with W-CPC compared to TP-CPC, TP-W and W-TP, and significantly more plaque with W-W compared to all other regimens except TP-W. Conclusions: Toothpaste, whilst possessing some plaque inhibitory activity, when used immediately before a CPC mouth rinse adversely affected the plaque inhibitory action of this antiseptic. This in part may explain the reported lack of adjunctive benefits of CPC rinses to normal oral hygiene practices and supports the suggestion, made for chlorhexidine rinses, that their use should follow toothpaste by at least 60 min. Zusammenfassung Die Wirkung von Zahnpasta auf die plaquehemmenden Eigenschaften einer Mundspüllösung mit Cetylpyridinium-Chlorid Grundlagen und Ziel: Cetylpyridinium-Chlorid (CPC) Mundspüllösung haben, wenn sie alleine verwendet werden, eine moderate plaquehemmende Aktivität. Es wurde jedoch selten gezeigt, dass sie zusätzlich zum Zähneputzen Vorteile haben. Mehrere Erklärungen für diese offensichtliche Anomalie können angeboten werden, einschließlich des Verlusts der antiseptischen Aktivität wegen einer Interaktion mit Inhaltstoffen der Zahnpasta. Ziel dieser Studie war es, die Wirkung der Zahnpasta auf die plaquehemmenden Eigenschaften einer CPC-Mundspüllösung zumessen. Es wurde CPC zusammen mit Zahnpasta-Lösung (TP) oder zusammen mit Wasser (W) verwendet. Methoden: Die randomisierte, einfach-blinde-Studie hatte ein 7-Behandlungs- Crossover-Design und war ausgeglichen hinsichtlich der Resteffekte. Einundzwanzig gesunde und bezahnte Personen wurden aufgenommen. Die paarweisen Spülungen waren: W-CPC, CPC-W, TP-CPC, CPC-TP, W-TP, TP-W und W-W. Die Spülungen wurden zweimal pro Tag für 60 Sekunden durchgeführt. An Tag-1 wurde bei der Teilnehmern Plaquefreiheit hergestellt, sie enthielten sich der Mundhygiene und begannen die zugewiesenen Spülungen. An Tag-5 wurde die Plaque mittels Index beurteilt. Zwischen den Spülmaßnahmen war eine 2,5-tägige Auswaschperiode mit normaler Mundhygiene erlaubt. Ergebnisse: Die Reihenfolge vom niedrigsten zum höchsten Plaquewert war W-CPC = CPC-W < CPC-TP < TP-CPC [source] Effectiveness of teaching an early parenting approach within a community-based support service for adolescent mothersRESEARCH IN NURSING & HEALTH, Issue 1 2008Jane E. Drummond Abstract A single blind, pre-test, post-test design was used to test the effectiveness of the Keys to Caregiving Program in enhancing adolescent mother,infant interactions. Participants were sequentially allocated to groups in order of referral. The outcome was the enhancement of maternal and infant behaviors that exhibited mutual responsiveness as measured by the Nursing Child Assessment Teaching Scale. Issues with recruitment and collaboration with the community agencies made achieving a desirable sample size difficult. Pre-tests and post-tests were completed for 13 participants. While the sample size was insufficient to confidently establish whether or not the Keys to Caregiving produced a between groups treatment effect, mothers within the treatment group evidenced significantly greater contingent responsiveness over time than those within the control group. © 2007 Wiley Periodicals, Inc. Res Nurs Health 31:12,22, 2008 [source] | ||||||||||