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Terms modified by Single-blind Selected AbstractsA randomised controlled trial of moxibustion for breech presentationBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 6 2005Francesco Cardini Objectives To evaluate the efficacy of moxibustion for the correction of fetal breech presentation in a non-Chinese population. Design Single-blind randomised controlled trial (RCT). Setting Six obstetric departments in Italy. Sample Healthy non-Chinese nulliparous pregnant women at 32,33 weeks + 3 days of gestational age with the fetus in breech presentation. Methods Random assignment to treatment or observation. Treatment consisted of moxibustion (stimulation with heat from a stick of Artemisia vulgaris) at the BL 67 acupuncture point (Zhiyin) for one or two weeks. Two weeks after recruitment, each participant was subjected to an ultrasonic examination of the fetal presentation. Main outcome measure Number of participants with cephalic presentation in the 35th week. Results The study was interrupted when 123 participants had been recruited (46% of the planned sample). Intermediate data monitoring revealed a high number of treatment interruptions. At this point no difference was found in cephalic presentation in the 35th week (treatment group: 22/65, 34%; control group: 21/58, 36%; RR 0.95; 99% CI 0.59,1.5). Conclusions The results underline the methodological problems evaluating of a traditional treatment transferred from a different cultural context. They do not support either the effectiveness or the ineffectiveness of moxibustion in correcting fetal breech presentation. [source] Effect of a nutritional liquid supplement designed for the patient with diabetes mellitus (Glucerna SR) on the postprandial glucose state, insulin secretion and insulin sensitivity in healthy subjectsDIABETES OBESITY & METABOLISM, Issue 3 2006M. Gonzįlez-Ortiz Aim:, To identify the effect of a nutritional liquid supplement designed for the patient with diabetes mellitus (Glucerna SR) in single administration on the postprandial glucose state, insulin secretion and insulin sensitivity in healthy subjects. Methods:, A randomized, single-blind, cross-over, clinical trial was carried out in 14 young, healthy, non-obese, volunteers. A basal metabolic profile, which included glucose level, insulin, total cholesterol, high-density lipoprotein and low-density lipoprotein cholesterol, triglycerides, creatinine, and uric acid, was measured. Subjects received a single administration of 300 kcal, gauged with water at 350 ml, of each of the following (at least 3 days apart): glucose 75 g, polymeric supplement (Ensure high calcium) 315 ml or Glucerna SR 323 ml. At the beginning of each administration and 30, 60, 90 and 120 min later, glucose and insulin concentrations were measured. Areas under the curve of glucose and insulin were calculated. First-phase and total insulin secretions and insulin sensitivity were also estimated. Results:, Glucose level at 120 min was significantly lower after receiving Ensure high calcium or Glucerna SR. Administration of Glucerna SR resulted in a significant reduction in the areas under the curve of glucose and insulin, as well as in total insulin secretion with a tendency to be lower in their first phase. Insulin sensitivity was increased. Conclusions:, A single administration of Glucerna SR to healthy subjects decreased the postprandial glucose and insulin states, as well as the insulin secretion; insulin sensitivity increased. [source] Comparison of Outcomes of Two Skills-teaching Methods on Lay-rescuers' Acquisition of Infant Basic Life Support SkillsACADEMIC EMERGENCY MEDICINE, Issue 9 2010Itai Shavit MD ACADEMIC EMERGENCY MEDICINE 2010; 17:979,986 © 2010 by the Society for Academic Emergency Medicine Abstract Objectives:, The objective was to determine if lay-rescuers' acquisition of infant basic life support (BLS) skills would be better when skills teaching consisted of videotaping practice and providing feedback on performances, compared to conventional skills-teaching and feedback methods. Methods:, This pilot-exploratory, single-blind, prospective, controlled, randomized study was conducted on November 12, 2007, at the Rappaport Faculty of Medicine, Technion,Israel Institute of Technology, Haifa, Israel. The population under study consisted of all first-year medical students enrolled in the 2007,2008 year. BLS training is part of their mandatory introductory course in emergency medicine. Twenty-three students with previous BLS training were excluded. The remaining 71 were randomized into four and then two groups, with final allocation to an intervention and control group of 18 and 16 students, respectively. All the students participated in infant BLS classroom teaching. Those in the intervention group practiced skills acquisition independently, and four were videotaped while practicing. Tapes were reviewed by the group and feedback was provided. Controls practiced using conventional teaching and feedback methods. After 3 hours, all subjects were videotaped performing an unassisted, lone-rescuer, infant BLS resuscitation scenario. A skills assessment tool was developed. It consisted of 25 checklist items, grouped into four sections: 6 points for "categories" (with specific actions in six categories), 14 points for "scoring" (of accuracy of performance of each action), 4 points for "sequence" (of actions within a category), and 1 point for "order" of resuscitation (complete and well-sequenced categories). Two blinded expert raters were given a workshop on the use of the scoring tool. They further refined it to increase scoring consistency. The main outcome of the study was defined as evidence of better skills acquisition in overall skills in the four sections and in the specific skills sets for actions in any individual category. Data analysis consisted of descriptive statistics. Results:, Means and mean percentages were greater in the intervention group in all four sections compared to controls: categories (5.72 [95.33%] and 4.69 [92.66%]), scoring (10.57 [75.50%] and 7.41 [43.59%]), sequence (2.28 [57.00%] and 1.66 [41.50%]), and order of resuscitation (0.96 [96.00%] and 0.19 [19.00%]). The means and mean percentages of the actions (skill sets) in the intervention group were also larger than those of controls in five out of six categories: assessing responsiveness (1.69 [84.50%] and 1.13 [56.50%]), breathing technique (1.69 [93.00%] and 1.13 [47.20%]), chest compression technique (3.19 [77.50%] and 1.84 [46.00%]), activating emergency medical services (EMS) (3.00 [100.00%] and 2.81 [84.50%]), and resuming cardiopulmonary resuscitation (0.97 [97.00%] and 0.47 [47.00%]). These results demonstrate better performance in the intervention group. Conclusions:, The use of videotaped practice and feedback for the acquisition of overall infant BLS skills and of specific skill sets is effective. Observation and participation in the feedback and assessment of nonexperts attempting infant BLS skills appeared to improve the ability of this group of students to perform the task. [source] Mailed treatment to augment primary care for alcohol disorders: A randomised controlled trialDRUG AND ALCOHOL REVIEW, Issue 1 2009DAVID KAVANAGH Abstract Introduction and Aims. Remote delivery of interventions is needed to address large numbers of people with alcohol use disorders who are spread over large areas. Previous correspondence trials typically examined its effects as stand-alone treatment. This study aimed to test whether adding postal treatment to general practitioner (GP) support would lower alcohol use more than GP intervention alone. Design and Methods. A single-blind, randomised controlled trial with a crossover design was conducted over 12 months on 204 people with alcohol use disorders. Participants in an immediate correspondence condition received treatment over the first 3 months; those receiving delayed treatment received it in months 3,6. Results. Few participants were referred from GPs, and little intervention was offered by them. At 3 months, 78% of participants remained in the study. Those in immediate treatment showed greater reductions in alcohol per week, drinking days, anxiety, depression and distress than those in the delayed condition. However, post-treatment and follow-up outcomes still showed elevated alcohol use, depression, anxiety and distress. Greater baseline anxiety predicted better alcohol outcomes, although more mental distress at baseline predicted dropout. Discussion and Conclusions. The study gave consistent results with those from previous research on correspondence treatments, and showed that high levels of participant engagement over 3 months can be obtained. Substantial reductions in alcohol use are seen, with indications that they are well maintained. However, many participants continue to show high-risk alcohol use and psychological distress.[Kavanagh D, Connolly JM. Mailed treatment to augment primary care for alcohol disorders: A randomised controlled trial. Drug Alcohol Rev 2009;28:73,80] [source] Sensitivity and reproducibility of indirect calorimetry in measurement of resting metabolic rateDRUG DEVELOPMENT RESEARCH, Issue 8 2008Cecilia Karlsson Abstract The aim of this study was to assess indirect calorimetry measurement of resting metabolic rate (RMR) with respect to sensitivity and reproducibility in a human study population suitable for early clinical studies to evaluate new anti-obesity candidate drugs. Twenty-four overweight, but otherwise healthy males were included in this randomized, single-blind, placebo-controlled, crossover study. Three different doses of epinephrine (0.005, 0.01, 0.03,µg · kg fat-free mass (FFM),1 · min,1) were used as active treatment. There were two identical study periods, separated by a 4-week washout. Increases in RMR were seen with all tested concentrations of epinephrine when compared with placebo. Changes in RMR of ,1.8% could be detected with 90% power in this crossover study design. The RMR values measured at the two study periods revealed a highly significant correlation (Spearman correlation 0.803, P=0.0007). To conclude, indirect calorimetry is a sensitive and robust means of measuring RMR. The method can be used to assess RMR in diverse clinical settings, even when considering modest differences. Drug Dev Res 69: 2008. © 2008 Wiley-Liss, Inc. [source] Efficacy of repetitive transcranial magnetic stimulation in alcohol dependence: a sham-controlled studyADDICTION, Issue 1 2010Biswa R. Mishra ABSTRACT Objective To study the anticraving efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) of the right dorsolateral pre-frontal cortex (DLPFC) in patients with alcohol dependence. Methods We performed a prospective, single-blind, sham-controlled study involving 45 patients with alcohol dependence syndrome (according to ICD-10 DCR), with Clinical Institute of Withdrawal Assessment in Alcohol Withdrawal (CIWA-Ar) scores ,10. Patients were allocated to active and sham rTMS in a 2 : 1 ratio, such that 30 patients received active and 15 patients sham rTMS to the right DLPFC (10 Hz frequency, 4.9 seconds per train, inter-train interval of 30 seconds, 20 trains per session, total 10 sessions). The Alcohol Craving Questionnaire (ACQ-NOW) was administered to measure the severity of alcohol craving at baseline, after the last rTMS session and after 1 month of the last rTMS session. Results Two-way repeated-measures analysis of variance (ANOVA) showed significant reduction in the post-rTMS ACQ-NOW total score and factor scores in the group allocated active rTMS compared to the sham stimulation. The effect size for treatment with time interaction was moderate (,2 = 0.401). Conclusions Right dorsolateral pre-frontal high-frequency rTMS was found to have significant anticraving effects in alcohol dependence. The results highlight the potential of rTMS which, combined with other anticraving drugs, can act as an effective strategy in reducing craving and subsequent relapse in alcohol dependence. [source] Multiple attack study on the available triptans in Italy versus placeboEUROPEAN JOURNAL OF NEUROLOGY, Issue 7 2005C. Vollono The aim of the study is to evaluate the efficacy and tolerability of the five triptans that are commercially available in Italy (zolmitriptan 2.5 mg, rizatriptan 10 mg, sumatriptan 100 mg, almotriptan 12.5 mg and eletriptan 40 mg). The study was conducted in single-blind versus placebo and its duration was 18 months. At the Headache Centre of the ,Agostino Gemelli' Hospital in Rome we selected 42 patients, suffering from headache with and without aura (International Headache Society Committee on Headache Classification, 1988 Cephalalgia 8:1,96), whose headache frequency ranged between 1- and 4-monthly crises. For a total of 25 crises, for every five consecutive crises, a different triptan was taken. The end-points of the study were as follows: response at 2 h, ,pain free' at 2 h and ,sustained pain free' (at 24 h). The intra-patient consistency and the tolerability were also evaluated. Thirty patients completed the study and the statistical analysis was only applied to these patients. No substantial difference in terms of the efficacy of the triptans was noted; all triptans were well tolerated. These results suggest the possibility of testing different triptans in the same patient in order to identify the ideal drug for every patient. [source] Vinpocetine treatment in acute ischaemic stroke: a pilot single-blind randomized clinical trialEUROPEAN JOURNAL OF NEUROLOGY, Issue 1 2001V. L. Feigin The aim of the study was to assess the safety and feasibility of a clinical trial on the effect of vinpocetine, a synthetic ethyl ester of apovincamine, in acute ischaemic stroke. Thirty consecutive patients with computed tomography verified diagnosis of acute ischaemic stroke, who could receive drug treatment within 72 h of stroke onset, were enrolled. The patients were randomly allocated to receive either low-molecular weight dextran alone or in combination with vinpocetine. Poor outcome was defined as being dead or having a Barthel index of <,70 or a Rankin score of 3,5. Intention-to-treat analysis was applied. One-tenth of all hospitalized patients with acute ischaemic stroke were eligible for the trial. Thirty eligible patients were treated with either low-molecular weight dextran alone (mean age 57.9 ± 11.6 years, n = 15) or in combination with vinpocetine (mean age 60.8 ± 6.6 years, n = 15). The two treatment groups were comparable with respect to major prognostic variables. A relative risk (RR) reduction of poor outcome at 3 months follow-up was 30% (RR = 0.7; 95% confidence interval [CI] 0.1,3.4), as defined by the modified Barthel Index, and 60% as defined by the modified Ranking score (RR = 0.4, 95% CI: 0.1,1.7). The National Institute of Health (NIH,NINDS) Stroke Scale score was marginally significantly better in the vinpocetine treated group at 3 months of follow-up (P = 0.05, anova). No significant adverse effects were seen. This pilot study shows that a full-scale randomized double-blind, placebo-controlled trial of vinpocetine treatment in acute ischaemic stroke is feasible and warranted. [source] Improvement of the comprehension of written information given to healthy volunteers in biomedical research: a single-blind randomized controlled studyFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 2 2007Adeline Paris Abstract Writing an informed consent form (ICF) for biomedical research is a difficult task. We conducted a multicenter single-blind randomized controlled trial to identify whether a working group or the systematic improvement in lexico-syntactic readability or an association of the two could increase the comprehension of the written information given to healthy volunteers enrolled in biomedical research. Participants were randomized to read one of four versions of the ICF: unchanged ICF (A), ICF with systematic lexico-syntactic readability improvement (B), ICF modified by a working group (C), and ICF modified by the working group followed by systematic lexico-syntactic improvement (D). The primary end-point was the objective comprehension score at day 0 for each study group. The scores of objective comprehension at day 0 were statistically different between the four study groups (anovaP = 0.020). The pairwise analysis showed an improvement in the working group vs. the unchanged group (P = 0.003), and a tendency to improvement in the group who read the ICF modified using lexico-syntactic readability and in the group who read the ICF modified using the two methods (P = 0.020 and 0.027 respectively). We conducted a two-way anova to identify some characteristics of the population which could explain this score. There was a significant interaction between the type of informed consent document (ICD) and the gender. Improving the ICD in phase I biomedical research leads to better comprehension, whether the method used is systematic lexico-syntactic improvement or a review by a working group. The improvement is specifically observed in men compared with women. Conversely, while both methods diverge in their effect on lexico-syntactic readability, their association is not mandatory. We suggest that in all phase I clinical trials, the ICF be improved by either method. [source] The efficacy of telmisartan compared with perindopril in patients with mild-to-moderate hypertensionINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 2004I. Nalbantgi Summary In this study, efficacy of the angiotensin II type 1 receptor blocker telmisartan given as monotherapy was compared with that of perindopril monotherapy in patients with mild-to-moderate hypertension. After a 2-week, single-blind, placebo run-in period, 60 patients were randomised to double-blind, once-daily treatment with telmisartan 80 mg or perindopril 4 mg for 6 weeks. Clinic and ambulatory blood pressure measurements and clinical laboratory evaluation were performed at the end of the placebo run-in and active treatment phases. Both telmisartan and perindopril significantly (p < 0.0001) reduced clinic systolic blood pressure (SBP) and diastolic blood pressure (DBP) compared with baseline values. Also, both drugs significantly (p < 0.0001) reduced 24-h mean ambulatory SBP and DBP compared with baseline. Comparison of the mean hourly antihypertensive activities showed that the reduction in mean ambulatory DBP for the last 8 h of the dosing interval was significantly greater (p < 0.05) in telmisartan-treated patients. A 24-h mean DBP of <85 mmHg was observed in 66.6% of the telmisartan-treated patients but in only 46.6% of the perindopril-treated patients (p < 0.05). It is concluded that telmisartan and perindopril both produce significant reductions in clinic SBP and DBP, but the mean reduction in ambulatory DBP during the last 8 h of the dosing interval is greater in patients treated with telmisartan. [source] Continuation and long-term maintenance treatment with Hypericum extract WS® 5570 after successful acute treatment of mild to moderate depression , rationale and study designINTERNATIONAL JOURNAL OF METHODS IN PSYCHIATRIC RESEARCH, Issue 3 2004Chairman, S. Kasper Professor Abstract Unipolar major depression is often a chronic disease that may require lifelong prophylaxis. Recovery from an acute episode is followed by 4-6 months of relapse prevention. After that, long-term maintenance treatment is administered to avoid recurrence. We present the rationale and design of an ongoing double-blind, randomized, placebo-controlled trial investigating the efficacy of Hypericum extract WS® 5570 in relapse prevention in recurrent unipolar depression. An estimated sample of 425 adults with recurrent, mild to moderate major depression (ICD-10 and DSM-IV criteria), ,3 previous episodes (last 5 years) and a total score ,20 points on the 17-item Hamilton Rating Scale for Depression (HAMD) will be included. After a one-week wash out patients receive 3 × 300 mg/day WS® 5570 single-blind for 6 weeks. Responders are randomized to 26 weeks of double-blind continuation treatment with 3 × 300 mg/day WS® 5570 or placebo. Patients completing continuation treatment without relapse enter 52 weeks of double-blind maintenance treatment, where those treated with WS® 5570 are re-randomized to 3 × 300 mg/day WS® 5570 or placebo. The primary outcome measure is the time to relapse during continuation treatment (HAMD ,16, clinical diagnosis of depression, or premature treatment termination for inefficacy). Hypericum extract, with its favourable tolerability profile, could be an interesting option for long-term prophylaxis. The trial was designed according to current consensus and guidance. Notably, it includes long-term prophylactic treatment with the same drug and the same therapeutic dose applied during acute treatment, uses well-defined outcome measures and provides a clear distinction between relapse and recurrence. Copyright © 2004 Whurr Publishers Ltd. [source] Resistance and Agility Training Reduce Fall Risk in Women Aged 75 to 85 with Low Bone Mass: A 6-Month Randomized, Controlled Trial,JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 5 2004Teresa Liu-Ambrose PhD Objectives: To compare the effectiveness of group resistance and agility-training programs in reducing fall risk in community-dwelling older women with low bone mass. Design: A randomized, controlled, single-blind 25-week prospective study with assessments at baseline, midpoint, and trial completion. Setting: Community center. Participants: Community-dwelling women aged 75 to 85 with low bone mass. Intervention: Participants were randomly assigned to one of three groups: resistance training (n=32), agility training (n=34), and stretching (sham) exercises (n=32). The exercise classes for each study arm were held twice weekly. Measurements: The primary outcome measure was fall risk (derived from weighted scores from tests of postural sway, reaction time, strength, proprioception, and vision), as measured using a Physiological Profile Assessment (PPA). Secondary outcome measures were ankle dorsiflexion strength, foot reaction time, and Community Balance and Mobility Scale score. Results: Attendance at the exercise sessions for all three groups was excellent: resistance training (85.4%), agility training (87.3%), and stretching program (78.8%). At the end of the trial, PPA fall-risk scores were reduced by 57.3% and 47.5% in the resistance and agility-training groups, respectively, but by only 20.2% in the stretching group. In the resistance and agility groups, the reduction in fall risk was mediated primarily by improved postural stability, where sway was reduced by 30.6% and 29.2%, respectively. There were no significant differences between the groups for the secondary outcomes measures. Within the resistance-training group, reductions in sway were significantly associated with improved strength, as assessed using increased squat load used in the exercise sessions. Conclusion: These findings support the implementation of community-based resistance and agility-training programs to reduce fall risk in older women with low bone mass. Such programs may have particular public health benefits because it has been shown that this group is at increased risk of falling and sustaining fall-related fractures. [source] Short-term anti-plaque effect of two chlorhexidine varnishesJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 8 2005Jan Cosyn Abstract Background: Chlorhexidine (CHX) varnishes have been mainly used for the prevention of caries in high-risk populations. Reports regarding their anti-plaque effect on a clinical level are limited to non-existing as opposed to their microbiological impact on plaque formation. Aim: The aim of this preliminary investigation was to evaluate the anti-plaque effect of two CHX varnishes applied on sound enamel in relation to a positive control, a negative control and to one another. Methods: Sixteen healthy subjects volunteered for this randomized-controlled, single-blind, four-treatment,four-period crossover-designed clinical trial. A 3-day plaque re-growth model was used to determine de novo plaque accumulation following CHX rinsing, Cervitec® application, EC40® application and no therapy. The amount of plaque was measured using the Quigley and Hein plaque index and "automatic image analysis" (AIA). Results and Conclusions: Varnish treatment resulted in significantly higher plaque levels than CHX rinsing irrespective of the varnish that was used (p0.002), implying that the latter is likely to remain the gold standard as an anti-plaque agent. However, highly significant differences were also found in favour of both varnish systems when compared with no therapy (p<0.001), which indicates that varnish treatment is an effective means of inhibiting plaque formation in a short time span. Cervitec® exhibited slightly, yet significantly, higher plaque levels in comparison with EC40® as determined by AIA (p=0.006). Large-scale trials with a longer observation period are necessary to substantiate these results. [source] Development of methods to enhance extrinsic tooth discoloration for comparison of toothpastesJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 1 20042. Two-product clinical study Abstract Background: Extrinsic staining of teeth is considered to be unsightly and a number of ,whitening' toothpastes have been formulated to inhibit or remove such tooth discoloration. The aim of this study was to compare the stain prevention of two toothpastes. Method: The study was a single-blind, randomised, placebo-controlled, crossover design, balanced for residual effects involving 24 healthy dentate volunteers. The treatments were as follows: (1) a whitening toothpaste product, (2) an experimental toothpaste formulation and (3) water. For each 4-day rinse period, subjects were rendered stain free on the teeth and tongue. Approximately on the hour from 09:00 to 16:00 hours, subjects rinsed with chlorhexidine mouth rinse for 1 min followed by warm black tea for 1 min. The treatment interventions were at 09:00 and 16:00 hours and before the chlorhexidine rinse. The toothpastes were rinsed as 3 g/10 ml water slurries and water as a 10 ml rinse each for 2 min. On day 5, subjects were scored for tooth and tongue stain intensity and area, and the product of these was calculated. The washout period was at least 9 days. Results: Treatment differences for the teeth were highly significant but not for the tongue. Paired contrasts for tooth stain intensity, area and product were mostly all significantly in favour of reduced staining by the experimental formulation compared with water and the whitening product. There were no significant differences between water and the whitening product. Conclusions: Using a forced dietary staining method, the data support a tooth stain-inhibitory/-removal action for the experimental formulation, but not the whitening product. [source] Stain, plaque and gingivitis reduction by combining chlorhexidine and peroxyborateJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 1 2000L. J. M. M. Gründemann Abstract Background: Previous studies have shown that using an oxidising agent in addition to chlorhexidine reduces staining. Aim: The purpose of the present study was to investigate whether, compared to chlorhexidine alone, the use of an oxidising mouthrinse as an adjunct to chlorhexidine is efficacious in reducing stain, plaque and gingivitis. Method: This study had a single-blind, 2-group parallel design, including a 14-day experimental non-brushing period during which 1 group (n=14) used chlorhexidine alone (CHX) (chlorhexidine mouthrinse, 0.12% Oral-B® laboratories, Ireland), and the other (n=14) used chlorhexidine in combination with an oxidising agent (sodiumperborate-monohydrate-Bocasan®, Oral-B laboratories, Ireland). Patients were randomly assigned to either group. All participants received a scaling and polishing before the start of the trial. No oral hygiene instructions were given. Since, at the start of the experiment, all stain and plaque were removed, only the gingival condition was evaluated at baseline by means of bleeding on marginal probing. The examination after 14 days of rinsing included the evaluation of plaque, bleeding on marginal probing and stain (GMSI: gingival modification of the stain index). Results: The results showed at day 14, a significant difference between the 2 groups for plaque (CHX: 0.18, CHX+PER: 0.08, p=0.03) and gingival bleeding (CHX: 0.38, CHX+PER: 0.21, p<0.001). The proportion of stained surfaces was less in the CHX+PER group (28%), than in the chlorhexidine group (48%) (p=0.04). Conclusions: In conclusion, the adjunctive use of an oxidising agent peroxyborate to chlorhexidine, proved to be superior to chlorhexidine alone with regard to the inhibition of plaque and development of gingivitis. In addition, the proportion of stained surfaces was significantly less when adding the oxidising mouthrinse to chlorhexidine. [source] Desensitizing Agent Efficacy during Whitening in an At-Risk PopulationJOURNAL OF ESTHETIC AND RESTORATIVE DENTISTRY, Issue 1 2004RALPH H. LEONARD Jr. DDS. ABSTRACT Background: Nightguard vital bleaching (NGVB) has gained acceptance among dentists and patients as a simple and effective procedure to lighten discolored teeth. Although the efficacy and predictability of NGVB have been well established, it has been documented that patients undergoing the procedure may experience side effects such as tooth sensitivity (TS) and gingival irritation (GI). A previous NGVB study suggested that selected participants might benefit from a regimen of a desensitizing agent (DSA)to decrease or prevent TS during whitening. Purpose: The purpose of this study was to determine whether the daily use of an active DSA (UltraEZTM, Ultradent Products Inc., South Jordan, UT, USA) during NGVB would decrease TS in a population at risk for TS when compared with a placebo. Materials and Methods: Forty subjects participated in this single-blind randomized clinical trial. All participants had indicated that they had preexisting TS or other risk factors for TS during NGVB. To evaluate TS caused by the tray alone, participants wore custom-fitted maxillary whitening trays containing no DSA or whitening solution during week 1. Next, participants were randomly assigned to apply either the active DSA or placebo daily for 14 days in the trays for 30 minutes prior to whitening. The placebo was the same formulation as UltraEZ but without the desensitizing agents (3% potassium nitrate and 0.11% by weight fluoride ion). The bleaching solution was a 10% carbamide peroxide whitening solution (OpalescenceTM, Ultradent Inc.). Post treatment, participants were followed up for 1 week, during which time they used neither trays nor solutions. Throughout the study, participants completed a daily diary to record their perceptions of TS and the time spent wearing the tray with the whitening solution. Results: Forty-one percent of the active group had at least 1 day of TS during treatment compared with 78% of the placebo group. The difference was statistically significant (p= .027) using the two-tailed Fisher exact test. [source] CA-125 levels in ruptured and unruptured tubal ectopic pregnanciesJOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH (ELECTRONIC), Issue 4 2006Erdal Malatyalioglu Abstract Aim:, This prospective, single-blind and controlled clinical study aimed to research if CA-125 levels could be a useful test in the differential diagnosis of intact and ruptured tubal ectopic pregnancy. Methods:, Sixty-five women with tubal ectopic pregnancy of 5,10 weeks' duration (27 women with ruptured tubal ectopic pregnancy [REP] and 38 women with unruptured tubal ectopic pregnancy [UREP]) and 65 women with normal intrauterine pregnancy (NIUP) of the same gestational age were studied prospectively. Serum CA-125 levels were measured in all women and these levels were compared among the REP, UREP, and NIUP groups. Results:, The mean CA-125 levels didn't show any significant difference between the REP and NIUP groups (P > 0.05). The mean CA-125 levels of these two groups were higher than that in the UREP group (P < 0.01, P < 0.001, respectively). The dispersion ratios of the CA-125 levels had a statistically significant difference between the REP and UREP groups (,2: 42.44, P < 0.0001). CA-125 levels weren't correlated with gestational weeks in the REP and UREP groups (r: 0.005, P > 0.05; r: 0.008, P > 0.05, respectively). Conclusion:, In intact tubal ectopic pregnancies, expectant or managed with medical treatment, the increase of CA-125 levels in the serial measurements could be a supplementary test for an early diagnosis of tubal rupture. [source] Diclofenac sodium and occlusal splint therapy in TMJ osteoarthritis: a randomized controlled trialJOURNAL OF ORAL REHABILITATION, Issue 10 2008C. MEJERSJÖ Summary, The aim of the study was to compare treatment with diclofenac sodium (Voltaren 3 × 50 mg) to occlusal splint therapy in a randomized, single-blind controlled trial of patients with a diagnosis of temporomandibular joint (TMJ) osteoarthritis (OA) in accordance with Research Diagnostic Criteria for temporomandibular disorders. Patients with general joint disorders or restrictions against medication with non-steroidal anti-inflammatory drug were not included. Twenty-seven females and two males (aged 36,76 years) included, answered a standardized questionnaire and were clinically examined and they underwent TMJ tomography. The treatment was randomized to either splint (n = 15) or diclofenac (n = 14). The temperatures over the TMJs were determined. The patients were re-examined 1 week, 1 month and 3 months after the start of treatment. A 1-year follow-up was carried out using questionnaires. After 1 week of treatment with diclofenac, significant reductions of pain and discomfort, TMJ tenderness and joint pain on jaw movements were noted. The splint therapy gave a significant reduction of reported symptoms after 1 month of treatment. Both treatments gave few adverse effects and were on an equal level. Estimation of the degree of inflammation by measuring the surface temperature over the TMJ was not reliable. Structural changes of the symptomatic TMJs were radiographically found in 82%, the contralateral, symptom-free TMJ had changes in 36%. There was a discrepancy between the clinical and the radiographical findings. Diclofenac gave a more rapid improvement, but both treatments gave a significant reduction of symptoms of TMJ OA within 3 months which remained at the one-year follow-up. [source] Effects of Alcohol on Polysomnographically Recorded Sleep in Healthy SubjectsALCOHOLISM, Issue 9 2006Bernd Feige Background: After studying the sleep of alcohol-dependent patients at the beginning and over the course of abstinence in earlier studies, our interest in the current study focused on the direct effect of 2 doses of alcohol [0.03 and 0.1% blood alcohol level (BAL)] on healthy sleep. This is the first polysomnographic study testing the impact of 2 doses of alcohol ingestion (thus reflecting "normal" social drinking and alcohol abuse) in a single-blind randomized design in healthy volunteers. The study evaluated a short-term acute drinking period for 3 and 2 days of withdrawal from alcohol not only for polysomnographic variables but also for subjective estimates of sleep quality. Methods: In a crossover design with a 1-week interval, healthy subjects received alcohol to raise their blood alcohol to either 0.03 or 0.1% BAL at bedtime for 3 consecutive nights after an alcohol-free baseline night. Objective (polysomnography) and subjective sleep (questionnaires) was recorded each night. During the following 2 days, alcohol was discontinued with simultaneous measurements of sleep to gauge withdrawal effects. Results: At a dose of alcohol leading to BAL of 0.03%, no clear effects could be detected. Following an evening BAL of 0.1%, a hypnotic-like effect (shortened sleep latency, reduced number of wake periods, decreased stage 1 sleep) occurred primarily during the first half of the night with signs of rebound effects being already present during the second half of the night (increased stage 1 sleep). At this dose, alcohol significantly increased slow-wave sleep (SWS) in the first half of the night and reduced REM density in the beginning of the night. After discontinuation of the higher alcohol dose, REM sleep amount increased. No significant withdrawal or rebound effects could be observed for parameters of sleep continuity during the 2 nights after discontinuation from alcohol at a BAL of 0.1%. Conclusions: Owing to the small sample size, the results of this study need to be interpreted with caution. Short-term moderate alcohol consumption (BAL 0.03%) did not significantly alter objective or subjective parameters of sleep. Higher doses of alcohol resulting in a BAL level of 0.10% immediately before going to bed mainly influenced sleep in the first half of the night, resembling the effects of a short-acting hypnotic drug, including a suppression of phasic aspects of REM sleep (REM density). Interestingly, analysis of the latter part of these nights indicated the immediate presence of withdrawal effects (increased light sleep). No statistically significant effects on sleep parameters were observable during the 2 nights of withdrawal from alcohol at the higher BAL. Interpreted carefully, our data indicate that negative effects on sleep occur already with short-term use of alcohol at doses of BAL of 0.10%, despite hypnotic-like effects during the first hours of sleep, especially during the latter part of the night. [source] Efficacy and safety of pimobendan in canine heart failure caused by myxomatous mitral valve diseaseJOURNAL OF SMALL ANIMAL PRACTICE, Issue 3 2005P. J. Smith Objectives: To evaluate the clinical efficacy and safety of pimobendan by comparing it with ramipril over a six-month period in dogs with mild to moderate heart failure (HF) caused by myxomatous mitral valve disease (MMVD). Methods: This was a prospective randomised, single-blind, parallel-group trial. Client-owned dogs (n=43) with mild to moderate HF caused by MMVD were randomly assigned to one of two groups, which received either pimobendan (P dogs) or ramipril (R dogs) for six months. The outcome measures studied were: adverse HF outcome, defined as failure to complete the trial as a direct consequence of HF; maximum furosemide dose (mg/kg/day) administered during the study period; and any requirement for additional visits to the clinic as a direct consequence of HF. Results: Treatment with pimobendan was well tolerated compared with treatment with ramipril. P dogs were 25 per cent as likely as R dogs to have an adverse HF outcome (odds ratio 4.09, 95 per cent confidence interval 1.03 to 16.3, P=0.046). Clinical Significance: R dogs had a higher overall score and thus may have had more advanced disease than P dogs at baseline (P=0.04). These results should be interpreted cautiously but such a high odds ratio warrants further investigation. [source] A randomized, single-blind, placebo-controlled, split-face study with pimecrolimus cream 1% for papulopustular rosaceaJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 6 2008AA Karabulut Abstract Background, Rosacea is a common inflammatory skin disorder for which the pathogenesis is unclear. Currently, there is no cure for rosacea, and it seems that standard therapies have focused mainly on minimizing inflammation. Objectives, The aim of this study is to investigate the potential efficacy, tolerability and safety profile of 1% pimecrolimus cream for the treatment of rosacea. Methods, Twenty-five patients with papulopustular rosacea were enrolled to a randomized, single-blinded, placebo-controlled, split-face trial of pimecrolimus cream 1% consisting 4 week treatment and 2 week follow-up period. The patients were instructed to apply first the ,left side cream' labelled placebo cream (Ultrabase cream, Intendis GmbH, Berlin, Germany) to the left hemi-face then the ,right side cream' labelled 1% pimecrolimus cream (Elidel; Novartis Pharma, Nuremberg, Germany) to the right hemi-face, twice daily. They were informed to apply a standard amount of each cream with the fingertip-unit and not allowed to use any other agent concomittantly other than sunblock. Clinical evaluation and subjective severity assessment were obtained along with photographic documentation at baseline, first, second, and fourth weeks of the therapy and at the follow-up visit. Rosacea severity score for each sign of erythema, papules, pustules, oedema, and telengiectesia were graded from 0 to 3. Patients were questioned for the subjective symptoms, overall improvement on appearance and side-effects. Results, Twenty-four patients completed the study with an exceptional compliance and tolerable safety profile. One patient withdrew from the study due to severe flare-up reaction affecting both hemi-faces. The mean baseline total rosacea severity scores were 5.06 + 1.29 for both sides and reduced to 2.5 ± 1.06 vs. 3.25 ± 1.24 on pimecrolimus vs. placebo applied sides without the significance (P = 0.06). There was not any significant difference concerning each rosacea sign scores and total rosacea severity scores except for the significant improvement in erythema score and total rosacea severity score obtained on the pimecrolimus-applied hemi-face at 2nd week of therapy (P =0.01 and P = 0.03, respectively). The reduction rates of the mean subjective severity scores at 4th week were 49.77% vs. 38.89% for pimecrolimus vs. placebo, respectively, without a statistical significance (P = 0.15). Subjective symptoms responded well in 54.16% of patients concerning pimecrolimus application compared with 12.50% for the placebo application. The side-effects were mostly transient local irritations. Conclusion, Our data implicated that pimecrolimus cream is not superior to placebo except for its efficacy on erythema. We believe that pimecrolimus cream can be a treatment option for rosacea patients with high erythema score for whom an initial accelerated improvement is needed. We believe further studies with topical pimecrolimus cream on larger study groups with different subtypes and severity of rosacea will clarify the potential effect of pimecrolimus cream for the treatment of rosacea. [source] Pulse itraconazole vs. continuous terbinafine for the treatment of dermatophyte toenail onychomycosis in patients with diabetes mellitusJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 10 2006AK Gupta Abstract Background, Oral terbinafine and oral itraconazole are two of the most common agents used for the treatment of toenail dermatophyte onychomycosis. Despite the fact that diabetic patients are more likely to have onychomycosis than normal individuals are, there is little research into the efficacy of standard oral regimens of terbinafine and itraconazole for onychomycosis in the diabetic population. Study design, We present a prospective, randomized, single-blind, parallel group, comparator-controlled, multi-centre study designed to assess the efficacy of the pulse itraconazole (200 mg twice daily, 1 week on, 3 weeks off, for 12 weeks) vs. continuous terbinafine (250 mg once daily for 12 weeks) oral therapies in the treatment of dermatophyte toenail distal and lateral subungual onychomycosis (DLSO) in the diabetic population. Efficacy parameters, Primary efficacy measures included mycological cure rate (negative KOH and culture) and effective cure (mycological cure plus nail plate involvement of 10% or less) at Week 48. Results, At Week 48, mycological cure was attained by 88.2% (30 of 34) and 79.3% (23 of 29) of patients in the itraconazole and terbinafine groups, respectively (P not significant). Effective cure (mycological cure with , 10% of nail plate involvement) was attained by 52.9% (18 of 34) of the itraconazole group and 51.7% (15 of 29) of the terbinafine group (P not significant). Three itraconazole patients experienced side effects in the form of gastrointestinal problems. There were no serious adverse events and no interactions with concomitant medications recorded. Discussion, Both continuous terbinafine and itraconazole pulse therapy are effective and safe in the management of dermatophyte toenail onychomycosis in people with diabetes. [source] Effect of lesogaberan, a novel GABAB -receptor agonist, on transient lower oesophageal sphincter relaxations in male subjectsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 11 2010G. E. BOECKXSTAENS Aliment Pharmacol Ther,31, 1208,1217 Summary Background, Transient lower oesophageal sphincter relaxations (TLESRs) are a major mechanism behind gastro-oesophageal reflux disease (GERD). Aim, To assess the effect of lesogaberan (AZD3355) , a novel peripherally active GABAB receptor agonist , on TLESRs. Methods, Twenty-four healthy men were enrolled in this single-blind, placebo-controlled, randomized, single-centre, three-period crossover phase 1 study. Subjects were randomized to receive single oral doses of lesogaberan (0.8 mg/kg), baclofen (40 mg) and placebo, separated by washout periods of ,7 days. Subjects finished a meal 1 h after the dose. Oesophageal manometry and pH-metry measurements were taken during the 3 h after the meal. Results, Twenty-one subjects completed the study. Compared with placebo, lesogaberan 0.8 mg/kg significantly reduced the number of TLESRs by 36% [geometric mean ratio (GMR): 0.64; 95% confidence interval (CI): 0.51,0.82] and significantly reduced the number of acid reflux episodes (mean reduction: 1.6; 95% CI: 0.34,2.9). Lesogaberan also significantly increased lower oesophageal sphincter (LES) pressure by 39% compared with placebo (GMR: 1.39; 95% CI: 1.18,1.64). Comparable results were observed with baclofen. Similar numbers of adverse events were reported by subjects taking lesogaberan and placebo. Conclusion, Compared with placebo, lesogaberan significantly reduced TLESRs and acid reflux episodes and increased LES pressure. [source] High-dose ecabet sodium improves the eradication rate of Helicobacter pylori in dual therapy with lansoprazole and amoxicillinALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 11 2000H. Kagaya The additive effect of ecabet sodium in combination with dual therapy on Helicobacter pylori eradication was evaluated. Methods: H. pylori -positive chronic gastritis patients were randomly assigned to one of the following three groups and medicated for 2 weeks. Group LA: dual therapy (lansoprazole 30 mg o.d. plus amoxicillin 750 mg b.d.). Group LA1E: dual therapy plus ecabet sodium (1 g b.d.). Group LA2E: dual therapy plus ecabet sodium (2 g b.d.). Patients were evaluated 4 weeks after the cessation of treatment by culture and 13C-urea breath test. Results: Seventy-one patients (mean age, 56.6 years; range, 26,79 years; 40 males, 31 females) were enrolled in this prospective, single-blind study, and 68 completed the protocol. The eradication rates per protocol patient were 43% in group LA, 62% in group LA1E, and 79% in group LA2E, and those on the intention-to-treat basis were 42% in group LA, 57% in group LA1E and 79% in group LA2E. The eradication rate in group LA2E was significantly higher than group LA (P=0.032 in per protocol, P=0.022 in intention-to-treat). Adverse effects were observed in 10 patients in this study. There were no severe adverse effects caused by ecabet sodium. Conclusion: High-dose ecabet sodium increases eradication rates of H. pylori in dual therapy with lansoprazole and amoxicillin. [source] A randomized, controlled, single-blind trial of teaching provided by a computer-based multimedia package versus lectureMEDICAL EDUCATION, Issue 9 2001Christopher Williams Background Computer-based teaching may allow effective teaching of important psychiatric knowledge and skills. Aims To investigate the effectiveness and acceptability of computer-based teaching. Method A single-blind, randomized, controlled study of 166 undergraduate medical students at the University of Leeds, involving an educational intervention of either a structured lecture or a computer-based teaching package (both of equal duration). Results There was no difference in knowledge between the groups at baseline or immediately after teaching. Both groups made significant gains in knowledge after teaching. Students who attended the lecture rated their subjective knowledge and skills at a statistically significantly higher level than students who had used the computers. Students who had used the computer package scored higher on an objective measure of assessment skills. Students did not perceive the computer package to be as useful as the traditional lecture format, despite finding it easy to use and recommending its use to other students. Conclusions Medical students rate themselves subjectively as learning less from computer-based as compared with lecture-based teaching. Objective measures suggest equivalence in knowledge acquisition and significantly greater skills acquisition for computer-based teaching. [source] Randomized study of sertraline and low-dose amitriptyline in patients with Parkinson's disease and depression: Effect on quality of lifeMOVEMENT DISORDERS, Issue 8 2006Angelo Antonini MD Abstract We assessed the effect of 3-month treatment of sertraline (50 mg) or low-dose amitriptyline (25 mg) on depression and quality of life in 31 patients with Parkinson's disease in a prospective single-blind randomized study. Both drugs significantly reduced the Hamilton Depression Rating Scale (HDRS-17) score. Completion rate was 75% for sertraline (12 of 16) and 73% for amitriptyline (11 of 15). Responder rate (HDRS-17 score reduction , 50%) was 83.3% for sertraline and 72.7% for amitriptyline. Sertraline but not amitriptyline treatment determined a significant benefit on quality of life (PDQ-39 scale). We found no change in Unified Parkinson's Disease Rating Scale scores. However, the improvement in specific PDQ-39 subscores (mobility, activities of daily living, and stigma) suggests that depression affects patient self-perception of motor function and further emphasizes the need for its treatment. © 2006 Movement Disorder Society [source] The Dual Chamber and VVI Implantable Defibrillator (DAVID) TrialPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 7p1 2003Bruce L. Wilkoff Introduction: The devices used to prove the benefit of ICD therapy had only VVI pacing but most current ICD devices provide dual chamber pacing therapy. The DAVID trial sought to measure the impact of dual chamber pacing at 70 bpm (DDDR-70) vs. ventricular backup pacing at 40 bpm (VVI-40) in patients with standard indications for ICD implantation but without indications for bradycardia pacing. Methods: This single-blind, multicenter, parallel-group, randomized clinical trial enrolled 506 patients with indications for ICD therapy between 10/2000 and 9/2002. All patients had an LVEF ,0.40, no indication for pacemaker therapy and no persistent atrial arrhythmias. ICDs with dual chamber, rate-responsive pacing capability were implanted and programmed to VVI-40 or DDDR-70. Results: The combined endpoint of mortality or hospitalization for congestive heart failure (CHF) at one year was 16.1% (VVI-40) vs. 26.7% (DDDR-70), (p , 0.03), mortality 6.5% vs. 10.1% (p , 0.15) and CHF hospitalization 13.3% vs. 22.5% (p , 0.07). Conclusion: For ICD patients, DDDR-70 pacing exhibits no clinical advantage over VVI-40 pacing and may increase CHF and mortality. [source] Two-Minute Skin Anesthesia Through Ultrasound Pretreatment and Iontophoretic Delivery of a Topical Anesthetic: A Feasibility StudyPAIN MEDICINE, Issue 1 2008Egilius L. H. Spierings MD ABSTRACT Background and Objectives., The pain associated with percutaneous procedures is a significant source of distress in clinical practice, especially in children. Topical anesthetics require 30,60 minutes to provide skin anesthesia; with iontophoresis, they minimally require 10 minutes, and with ultrasound pretreatment, 5 minutes. In this study, we assessed the feasibility of providing skin anesthesia to needle prick with the combination of ultrasound pretreatment and 2-minute low-voltage (1 mA) iontophoresis. We compared it with sham-ultrasound pretreatment and with standard, 10-minute high-voltage (4 mA) iontophoresis. Methods., This is a single-blind, randomized, controlled, crossover study in healthy volunteers, specifically for the purpose of the study subjected to standardized needle prick. They rated the absolute pain associated with the needle prick on a 10-cm visual analog scale, with 0 being "no pain" and 10 being "extremely painful." Results., Of the 31 subjects who consented to the study, 30 were randomized and completed the study. The mean duration of the ultrasound pretreatment was 21.4 seconds (range: 6,85). The absolute pain scores for the ultrasound plus 2-minute low-voltage iontophoresis and the standard, 10-minute high-voltage iontophoresis were not statistically significantly different (0.9 ± 0.31 vs 0.46 ± 0.20; P = 0.49). However, they were statistically significantly different from the sham-ultrasound plus 2-minute low-voltage iontophoresis pain score (2.6 ± 0.55) (P = 0.0001 and 0.0012, respectively). Conclusions., Ultrasound pretreatment plus 2-minute low-voltage iontophoresis provides better skin anesthesia than sham-ultrasound plus 2-minute low-voltage iontophoresis, and similar to standard, 10-minute high-voltage iontophoresis. [source] A cognitive aid for neonatal resuscitation: a randomized controlled trialPEDIATRIC ANESTHESIA, Issue 7 2009M.D. Bould Introduction:, Anaesthetists are among several health care practitioners responsible for neonatal resuscitation in Canada. The Neonatal resuscitation program (NRP) courses are the North American educational standard. NRP has been shown to be an effective way of learning skills and knowledge but retention has been found to be problematic [1]. The use of cognitive aids is mandatory in industries such as aviation, to avoid dependence on memory when decision making in critical situations. Visual cognitive aids have been studied retrospectively in resuscitation and performance was found to correlate to the frequency of use of the aid [2]. Cognitive aids have been found to be of benefit in an unblinded prospective study [3]. We aimed to conduct the first blinded study on the effect of a cognitive aid on the performance of simulated resuscitation. Methods:, We conducted a single-blind randomized controlled trial to investigate whether the presence of a cognitive aid improved performance in a simulated neonatal resuscitation. After ethics board approval we recruited 32 anaesthesia residents who had previously passed the NRP. Subjects were randomized to an intervention group that had a poster detailing the NRP algorithm and a control group without the poster. The cognitive aid was positioned so that it could not be seen on the video recordings of the simulation that was used to assess performance. The scenario was piloted to confirm adequate blinding. Both groups had their performance in a simulated neonatal resuscitation recorded and subsequently analyzed by a peer, an expert anaesthetist and an expert neonatologist, using a previously validated checklist. A further rater observed the scenario in real time to examine frequency of use of the cognitive aid. Results:, The inter-rater reliability of the checklist was excellent with an intraclass correlation coefficient of 0.88. Consequently the mean of the scores assigned by all three raters was used for analysis. The median checklist score in the control group 18.2 [15.0,20.5 (10.7,25.3)] was not significantly different from that in the intervention group 20.3 [18.3,21.3 (15.0,24.3)] (P = 0.08). Retention of NRP skills and knowledge of was poor: when evaluated by the neonatologist none of the subjects correctly performed all life-saving interventions necessary to pass the checklist. Although only one subject in the intervention group did not use the aid at all, only 26.7% used the aid frequently and none used it extensively. Discussion:, Retention of skills after NRP training was poor. Our study confirms previous findings of poor retention of skills after NRP training: Kaczorowski et al. investigated family medicine trainees and found that none of 44 residents that were retested 6,8 months after an NRP course would have passed the course due to errors in life-saving interventions [1]. Previous research has shown that the presence of a cognitive aid can improve performance in the simulated management of a rare, high stakes scenario: malignant hyperthermia [3]. Our negative findings contrast with this and another previous study [2]. A potential reason for this discrepancy is that the raters in the previous studies were not blinded to group allocation, nor were the rating scales used validated. The infrequent use of the cognitive aid may be the reason that it did not improve performance in. Further research is required to investigate whether cognitive aids can be useful if their use is incorporated into NRP training. Conclusion:, A randomized single-blinded trial found that a cognitive aid did not improve performance at simulated resuscitation, in contrast to previous retrospective and unblended studies. Retention of skills and knowledge after resuscitation training remains an ongoing challenge for medical educators. [source] Does inhaling menthol affect nasal patency or cough?,PEDIATRIC PULMONOLOGY, Issue 6 2008MRCPCH, Priti Kenia MD (Paediatrics) Abstract Objective There is widespread use of menthol in over-the-counter medications, despite scant information on any beneficial effects. Our aim was to assess the effect of menthol on nasal air flow, perception of nasal patency and cough challenge testing. Materials and Methods Subjects comprised 42 healthy children aged 10 and 11 in a school setting. We used a single-blind pseudo-randomized cross-over trial to compare the effect of an inhalation of either menthol or placebo(eucalyptus oil). Baseline and post-intervention measurements were made on each of 2 consecutive days. Main outcome measures were (i) nasal expiratory and inspiratory flows and volumes, measured by spirometer, (ii) perception of nasal patency, assessed with a visual analogue scale (VAS), and (iii) the number of coughs in response to nebulized citric acid. Results There was no effect of menthol on any of the spirometric measurements. Following menthol, there was a significant increase in the perception of nasal patency (mean difference in log VAS (menthol-placebo),=,,0.207, 95%CI ,0.329, ,0.085). The cough count after menthol inhalation was reduced when compared to baseline but the change was not different from that after placebo (mean difference in cough count (menthol-placebo),=,,1.71, 95%CI ,4.11, 0.69). Conclusion Menthol has no effect on objective measures of flow but significantly increases the perception of nasal patency. It may not be possible to extrapolate these findings to younger children and those with rhinitis. Extending the study of menthol to these groups, including investigations of the efficacy and safety profiles, will provide further valuable evidence for its common use. Pediatr Pulmonol. 2008; 43:532,537. © 2008 Wiley-Liss, Inc. [source] | |||||||||||||||||||||||||||||||