Double Blind

Background: The double-blind, placebo-controlled food challenge (DBPCFC) is the “gold standard” for diagnosis of food hypersensitivity. Skin prick tests and RASTs are sensitive indicators of food-specific IgE antibodies but poor predictors of clinical reactivity. Previous studies suggested that high concentrations of food-specific IgE antibody were predictive of food-induced clinical symptoms. Because the CAP System FEIA (Pharmacia Diagnostics, Uppsala, Sweden) provides a quantitative assessment of allergen-specific IgE antibody, this study was undertaken to determine the potential utility of the CAP System FEIA in diagnosis of IgE-mediated food hypersensitivity. Methods: Sera from 196 patients with food allergy were analyzed for specific IgE antibodies to egg, milk, peanut, soy, wheat, and fish by CAP System FEIA. Sera were randomly selected from 300 stored samples of children and adolescents who had been evaluated by history, skin prick tests, and DBPCFCs. The study population was highly atopic; all patients had atopic dermatitis, and approximately 50% had asthma and allergic rhinitis at the time of initial evaluation. The performance characteristics of the CAP System FEIA were compared with those of skin prick tests and the outcome of DBPCFCs or “convincing” histories of anaphylactic reactions. Results: The prevalence of specific food allergies in the study population varied from 22% for wheat to 73% for egg. Allergy to egg, milk, peanut, and soy accounted for 87% of confirmed reactions. The performance characteristics of skin prick tests and CAP System FEIA (egg, milk, peanut, fish) were comparable, with excellent sensitivity and negative predictive accuracy but poor specificity and positive predictive accuracy. The performance characteristics of the CAP System FEIA for soy and wheat were poor. For egg, milk, peanut, and fish allergy, diagnostic levels of IgE, which could predict clinical reactivity in this population with greater than 95% certainty, were identified: egg, 6 kilounits of allergen-specific IgE per liter (kUA/L); milk, 32 kUA/L; peanut, 15 kUA/L; and fish, 20 kUA/L. Conclusions: When compared with the outcome of DBPCFCs, results of CAP System FEIA are generally comparable to those of skin prick tests in predicting symptomatic food hypersensitivity. Furthermore, by measuring the concentrations of food-specific IgE antibodies with the CAP System FEIA, it is possible to identify a subset of patients who are highly likely (>95%) to experience clinical reactions to egg, milk, peanut, or fish. This could eliminate the need to perform DBPCFCs in a significant number of patients suspected of having IgE-mediated food allergy. (J Allergy Clin Immunol 1997;100:444-51.)

Psoriatic arthritis (PsA), an inflammatory arthritis associated with psoriasis usually seronegative for rheumatoid factor, has emerged as a more common and severe disease than previously appreciated. The disease is multifaceted. Thus the assessment of PsA requires attention to peripheral joint involvement, axial disease, dactylitis, and enthesitis, as well as the skin manifestations. In addition, the assessment of patient reported features such as patient assessment of disease activity, pain, fatigue, quality of life, and the new concept of participation are important. The assessment of damage and the assessment of tissue histology are also important outcome measures. This article summarizes these features of PsA as well as current knowledge on the instruments available for the assessment of these domains.

Background: Evidence-based pharmacological treatment options for patients with persistent inguinal postherniorrhaphy pain are lacking. Methods: Twenty-one male patients, with severe, unilateral, persistent inguinal postherniorrhaphy pain, participated in a randomized, double-blind, placebo-controlled crossover trial, receiving lidocaine patch (5%) and placebo patch treatments in periods of 14 days separated by a 14-day wash-out period. Pain intensities (at rest, during movement, and pressure evoked [Numerical Rating Scale]) were assessed before treatment and on the last 3 days of each treatment period. Patients were a priori divided into two subgroups based on quantitative sensory testing (+/− thermal “hyposensitivity”). Skin biopsies for intraepidermal nerve fiber density assessment were taken at baseline, and quantitative sensory testing was performed before and after each treatment period. The primary outcome was change in pain intensity assessed as the difference in summed pain ...

Objective
In spite of interventions being put in place to reduce the burden of maternal anaemia and malaria in Ghana, these problems continue to impact negatively on pregnancy outcomes. It is unclear whether there are some other factors that limit the effectiveness of current interventions.
The aim of this study was to explore whether there are benefits associated with the addition of zinc to the routine malaria chemoprophylaxis, iron and folic acid intervention package for pregnant women in Ghana.

Design
A double-blind, randomised controlled trial (RCT) was conducted in the Upper West Region of Ghana.

Results
Iron-zinc supplementation reduced the risk of increased malaria parasitaemia associated with high maternal serum ferritin and haemoglobin (Hb) concentrations. Iron-zinc supplementation was associated with reduced malaria parasite densities, F (1, 20) = 4.744, p = 0.042.
Iron and zinc provided in the ratio of 1:1 prevented a significant decline in maternal iron stores of pregnant women. Adjusted geometric mean serum ferritin concentration in the Iron-zinc Group was significantly higher than in the Control Group (22.9 µg/L versus 16.9 µg/L), F (1, 156) = 6.336, p = 0.013.

Conclusions
Joint iron and zinc supplementation appears to be a better option than iron-only supplementation in malaria-endemic areas.

To date, antidepressant drugs show limited efficacy, leaving a large number of patients experiencing severe and persistent symptoms of major depression. Previous open-label clinical trials have reported significant sustained improvements with deep brain stimulation (DBS) of the subcallosal cingulate gyrus (SCG) in patients with severe, chronic treatment-resistant depression (TRD). This study aimed to confirm the efficacy and measure the impact of discontinuation of the electrical stimulation. We conducted a 6-month double-blind, randomized, sham-controlled crossover study in implanted patients with previous severe TRD who experienced full remission after chronic stimulation. After more than 3 months of stable remission, patients were randomly assigned to 2 treatment arms: the ON-OFF arm, which involved active electrode stimulation for 3 months followed by sham stimulation for 3 months, and the OFF-ON arm, which involved sham stimulation for 3 months followed by active stimulation fo...

Elevated blood pressure, particularly systolic blood pressure, increases the risk of cardiovascular and renal complications in patients with diabetes. Current national guidelines set the blood pressure goal for those with diabetes at < 130/80 mm Hg, which is lower than the goal for the general population (<140/90 mm Hg). Achieving this goal, however, remains difficult, with blood pressure control rates being lower for patients with diabetes than for those without diabetes. Large clinical trials have demonstrated that in most cases, patients will require 2 or more antihypertensive agents to achieve goal blood pressure. The renin-angiotensin-aldosterone system plays a key role in regulation of blood pressure. The angiotensin AT1 receptor blockers (ARBs), which block the effects of angiotensin II, not only lower blood pressure but also provide target-organ protection. These agents are generally well-tolerated, with a side effect profile similar to placebo. Clinical comparisons of...

El uso de placebos y diseños a doble ciego ha cumplido un papel crucial en la investigación clínica en Medicina. Su aplicación a la investigación de resultados en psicoterapia ha sido controversial. Muchos autores niegan la posibilidad de su
aplicación debido a que el terapeuta debería conocer la condición del procedimiento aplicado. Se presenta  detalladamente un estudio en el que se utilizó
un procedimiento placebo correspondiente a
EMDR (Eye Movement Desensitization and Reprocessing
- Desensibilización y Reprocesamiento por Movimientos Oculares) con un Diseño Experimental de Caso Único. Los objetivos fueron los siguientes: poner a prueba la viabilidad de
la implementación de un placebo de tipo psicológico en EMDR y la aplicación de un diseño a doble ciego en el estudio de resultados en EMDR. Se seleccionaron tres pacientes que sufrían de Trastorno por Estrés Postraumático. Se estableció
una línea de base de la sintomatología presentada. Luego, los sujetos fueron asignados ale atoriamente a tres condiciones experimentales durante tres sesiones: (a) aplicación del protocolo EMDR sin ningún tipo de estimulación aplicación
del protocolo EMDR con estimulación bilateral auditiva simultánea (no alternada) (placebo 2) y (c) aplicación del protocolo estándar de EMDR con estimulación auditiva bilateral alternada (tratamiento activo). Tales procedimientos resultaron igualmente creíbles para el paciente y para el terapeuta. Es to
permitió el desarrollo de un diseño de investigación a doble ciego para la investigación de resultados en EMDR. Finalmente, se discuten algunas posibles aplicaciones e implicancias de la introducción del uso de placebos psicológicos y diseño a doble ciego en la investigación en psicoterapia.
ABSTRACT
Double blind design and placebos have been of crucial importance in medical clinical research. Their use in outcomes research in the field of psychotherapy has been controversial, though. Their feasibility in such case has been denied by many authors based on the assumption that the psycho therapist would need to know the nature of the applied procedure. In view of this, the author has conducted a pilot feasibility study on three subjects within the context of his doctoral dissertation. Said dissertation aims at establishing the role of alternating bilateral auditory stimulation in the process ing of traumatic memories as used in the EMDR (Eye Movement Desensitization and Re processing) technique. To such end, the EMDR basic principles and procedures are introduced -with particular
attention to alternating bilateral auditory stimulation- and a pilot study using placebos during EMDR administration is presented in detail. The goals of this study are testing the feasibility of: (a) using a psychological placebo in EMDR therapy,
and (b) applying a double blind design study in EMDR outcomes research. A single case experimental designwas performed on three different patients suffering from PTSD (Posttraumatic Stress Disorder). A symptomatology baseline was established through out three weekly sessions using the DTS (Davidson Trauma Scale) and the OQ-45.2 (Outcomes Questionnaire 45.2).
First, three CDs were recorded -one with no sound at all (CD-1, silence condition); another one with auditory stimulation consisting of a tic-tac sound recorded in monaural condition, and reproduced simultaneously over both earphones at a rate of one beat per second (CD-2, monaural condition) and a third one with alternating bilateral auditory stimulation consisting of the exact same sound recorded in stereophonic condition, and reproduced alternatively over the left and right earphones (CD-3, stereo condition)-. At a second stage, these three experimental conditions were assigned randomly to the three subjects, who were administered: (a) EMDR protocol without any type of stimulation, with no sound coming out of the earphones using CD-1 (placebo 1), (b) EMDR protocol with simultaneous bilateral auditory stimulation using CD-2 (placebo 2), and (c) EMDR protocol with alternating bilateral auditory stimulation using CD-3 (active treatment). In all cases, the experimental conditions were implemented during three full
sessions in which the CDs were reproduced for the subjects through earphones, instead of speakers, to ensure that the psychotherapist was unaware of the actual conditions. Subsequently, the standard EMDR protocol (i.e., with alternating bilateral auditory stimulation) was administered to each subject until the end of the treatment, determined either by the symptoms being resolved or the maximum of ten sessions being completed. As a result of this pilot study, the author concludes that the feasibility of using double blind studies and placebos in EMDR psychotherapy has indeed been established. Since no apparent difficulties in the administration of the placebos were detected during the study, the use of psychological placebos seems viable. Such procedure is equally
credible for the patient as well as for the psychotherapist, which renders possible the development of a double blind design in EMDR outcomes research. It should be noted, though, that the credibility of the placebo was not formally assess ed, but
rather was perceived through the author’s informal observation. Developing assess ment criteria and formal tools to evaluate the credibility of placebo procedures is advisable if future investigations on the subject are to be carried. Even though this study was conducted under a Single Case Experimental Design, the placebo procedure employed could be easily adapted for its use in between group’s designs. Finally, some of the possible applications and consequences regarding the introduction of placebos and double blind design in psychotherapy research are discussed.

Technological advancements has offered many solutions to the important current issues such as the growing numbers of run away children, wandering Alzheimer’s patients and lost pets in the society, yet most branches of current technologies are not capable of encompassing all of these key problems. My research proposes a solution that is practical, durable and reliable -- a proximity sensor device powered by
other users in the area with a process known as “crowdsourcing”, by using their mobile devices as receiving stations of the service, extensively increasing the effectiveness of this service in especially urban and suburban areas where there is a high population density.

BackgroundLithium and quetiapine are considered standard maintenance agents for bipolar disorder yet it is unclear how their efficacy compares with each other.AimsTo investigate the differential effect of lithium and quetiapine on symptoms of depression, mania, general functioning, global illness severity and quality of life in patients with recently stabilised first-episode mania.MethodMaintenance trial of patients with first-episode mania stabilised on a combination of lithium and quetiapine, subsequently randomised to lithium or quetiapine monotherapy (up to 800 mg/day) and followed up for 1 year. (Trial registration: Australian and New Zealand Clinical Trials Registry - ACTRN12607000639426.)ResultsIn total, 61 individuals were randomised. Within mixed-model repeated measures analyses, significant omnibus treatment × visit interactions were observed for measures of overall psychopathology (Brief Psychotic Rating Scale (BPRS), P = 0.005, Clinical Global Impressions - Bipolar, seve...

Evaluate the efficacy and safety/tolerability of cryoneurolysis for reduction of pain and symptoms associated with knee osteoarthritis (OA). Randomized, double-blind, sham-controlled, multicenter trial with a 6-month follow-up in patients with mild-to-moderate knee OA. Patients were randomized 2:1 to cryoneurolysis targeting the infrapatellar branch of the saphenous nerve (IPBSN) or sham treatment. The primary endpoint was the change from baseline to Day 30 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain score adjusted by the baseline score and site. Secondary endpoints, including visual analogue scale (VAS) pain score and total WOMAC score, were tested in a pre-defined order. The intent-to-treat population consisted of 180 patients (n=121 active treatment, n=59 sham treatment). Compared to the sham group, patients who received active treatment had a statistically significant greater change from baseline in the WOMAC pain subscale score at Day 30 (p=0.0004), Da...