Correlation of serum IgG antibodies to helicobacter pylori in chronic skin disorders: A case-control study

It is known that chronic idiopathic urticaria occasionally develops in association with Helicobacter pylori infection, but this relationship remains unproven. Also, many studies show. We investigated the role of H. pylori infection in patients of chronic idiopathic urticaria, other chronic skin disorders as well as healthy controls using urease breath test and immunoturbidimetry for anti H. pylori IgG antibodies. Three groups of eighty-nine patients each were taken as cases, controls and placebo controls respectively. All patients having IgG titer of 10U/ml or above and Urease Breath Test Positivity were considered positive. : The positive rate of anti H. Pylori IgG antibodies was 78.65% (70/89) in case group, 84.71% (22/89) in controls with other skin disorders and 32.58% (29/89) in placebo control group. While positive rate for Urease Breath Test were found to be 79.8% (71/89) in cases, 35.95% (32/89) in controls with other skin diseases and 32.58% (29/89) in placebo controls. In chronic idiopathic urticaria a high titer of anti H. pylori IgG and Urease Breath Test positivity suggests that inclusion of anti H. pylori therapy in it’s the management would be beneficial and would lead to lower rates of recurrence. Also, low positivity rates of Urease Breath Test and Anti H. pylori IgG in controls with other chronic skin diseases and placebo controls points towards no clear evidence to prove a causal relationship between these diseases and H. pylori infection.

Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop

Background The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. Objectives To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. Design To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. Setting A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. Results To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. Conclusions The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. Limitations Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. Future work Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. Funding Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council–National Institute for Health Research Methodology Research programme.

Placebo control in Covid-19 trials: A missed opportunity for international guidance

Vaccines preventing Covid-19 have been approved in several countries. Is it still ethically acceptable to use placebo controls during the development of other vaccine options? If two of the most influential international guidelines of biomedical research are consulted, the Declaration of Helsinki and the CIOMS-guidelines, the answer is “no”. We discuss the implications for ongoing vaccine research, and how placebo controls might be justified nevertheless. However, the ethical conflict remains highly problematic. We suggest that such ethical dilemmas should be avoided in the future by the introduction of a new system of global governance. Once vaccines are approved, a global regulation should oblige producers to provide the necessary amount of vaccine doses for the control groups of ongoing vaccine research.

The continued use of placebo arms in COVID-19 vaccine trials does not adequately protect the well-being of participants

Covid-19 vaccines are a critical tool for controlling the pandemic. While safe and effective vaccines have been developed, research is expected to continue for many years regarding the optimal implementation of existing vaccines in specific settings, and the development of second-generation vaccines that may offer advantages in terms of either efficacy or ease of implementation. Given this context, some commentators have argued that new Covid vaccine trials should be able to use placebo controls, and that existing studies should be able to continue with blinded participants in order to collect high quality, unbiased data. Using international ethics guidance documents, this paper argues against placebo controls, given the existence of proven effective interventions, and against protracted blinding once safety and efficacy milestones have been met. Instead, it advocates for study designs that allow for direct comparison between approved and experimental vaccines, which facilitates both data collection and greater access to vaccines.

Benefits of aerosolized phages for the treatment of pneumonia due to methicillin-resistant Staphylococcus aureus (MRSA): an experimental study in rats

Background The optimal method for delivering phages in the context of ventilator-associated pneumonia (VAP) is unknown. In the current study, we assessed the utility of aerosolized phages (aerophages) for experimental MRSA pneumonia. Methods Rats were ventilated for 4h before induction of pneumonia. Animals received either: 1) aerophages; 2) intravenous (IV) phages; 3) a combination of IV and aerophages; 4) IV linezolid; and 5) a combination of IV linezolid and aerophages. Phages were administered at 2, 12, 24, 48 and 72h, and linezolid at 2, 12, 24, 36, 48, 60 and 72h. The primary outcome was survival at 96h. Secondary outcomes were bacterial and phage counts in tissues, and histopathological scoring of the lungs. Results Aerophages (1) and IV phages (2) each rescued 50% of animals from severe MRSA pneumonia (P<0.01 compared to placebo controls). The combination of aerophages and IV phages rescued 91% of animals, which was higher than either monotherapy (P<0.05) (3). Standard-of-care antibiotic linezolid (4) rescued 38% of animals. Linezolid and aerophages (5), however did not synergise in this setting (55% survival). Conclusions Aerosolized phage therapy showed potential for the treatment of MRSA pneumonia in an experimental animal model and warrant further investigation for application in humans.

Alternative Uses of Hyperbaric Oxygen Therapy in Military Medicine: Current Positions and Future Directions

ABSTRACT Introduction Hyperbaric oxygen therapy (HBOT) is a commonly used treatment for a variety of medical issues, including more than a dozen currently approved uses. However, there are alternative proposed uses that have significant implications among an active duty military or veteran population as treatments for PTSD, mild traumatic brain injury (mTBI), and traumatic brain injury (TBI). These applications have seen a recent groundswell of support from the operator and veteran communities, raising the visibility of using HBOT for alternative applications. The current review will cover the existing evidence regarding alternative uses of HBOT in military medicine and provide several possibilities to explain the potential conflicting evidence from empirical results. Materials and Methods There were no inclusion or exclusion criteria for articles addressing currently approved HBOT uses as covered under the military health system. These references were provided for comparison and illustration as needed. For alternative HBOT uses, the review focuses explicitly upon three alternative uses in PTSD, mTBI, and TBI. The review addresses any piece of case study evidence, observational data, quasi-experimental design, or randomized-controlled trial that explored any or a combination of these issues within an active duty population, a veteran population, or a civilian population. Results The existing medical evidence does not support a consensus viewpoint for these alternative uses of HBOT. Based on the literature review, there are four competing positions to explain the lack of consistency among the empirical results. These possibilities are described in no particular order. First, an explanation suggests that the results are because of placebo effects. The combination of participant expectations and subjective symptom reporting creates the potential that reported improvements are because of placebo rather than casual mechanisms. Second, another position suggests that experiments have utilized sham conditions which induced therapeutic benefits. If sham conditions have actually been weakened active treatment conditions, rather than placebo controls, it could explain the lack of observed significant differences in randomized clinical trials. Third, there has been a substantial amount of heterogeneity both in the symptoms treated and the treatments applied. This heterogeneity could explain the inconsistency of the data and the difficulty in reaching a consensus viewpoint. Fourth, the HBOT treatments may actively treat some tangential medical issue the patient is having. The treatment would thus promote an environment of healing without directly treating either PTSD, mTBI, or TBI, and the reduction in orthogonal medical issues facilitates a pathway to recovery by reducing tangential medical problems. Conclusions The mixed empirical evidence does not support recommending HBOT as a primary treatment for PTSD, mTBI, or TBI. If applied under the supervision of a licensed military medical professional, the consistently safe track record of HBOT should allow it to be considered as an alternative treatment for PTSD, mTBI, or TBI once primary treatment methods have failed to produce a benefit. However, the evidence does warrant further clinical investigation with particular emphasis on randomized clinical trials, better placebo controls, and a need to develop a consistent treatment protocol.

The effects of analytic group therapy compared with pharmacotherapy in patients with anxiety disorders

Background: Psychotherapy and pharmacotherapy are both effective in the treatment of anxiety disorders. However, drugs in pharmacotherapy are often compared with placebo controls, and psychotherapy is mostly compared to patients in the waiting list as the controls. We aimed to compare the effects of analytic group therapy with pharmacotherapy in patients with anxiety disorders. Methods: In this clinical trial study in Tehran, 65 patients (10 males, 55 females) presenting with a primary diagnosis of panic disorder, generalized anxiety disorder, and/or mixed anxiety-depressive disorder (based on a structured clinical interview by a psychiatrist) were enlisted during the period from 2016 to 2018. The patients were randomly divided into two groups: drug therapy (group D, 33 patients), or drug therapy + analytic group therapy (group G, 32 patients). Anxiety was assessed in both groups before and immediately after treatment by the Persian version of the Hamilton Anxiety scale (HAM-A). Collected data were analyzed by SPSS statistical software version 21. Results: Both groups showed a statistically significant decline in HAM-A scores after the treatment. However, group G had a greater significant change in anxiety score compared to group D. The mean decline of HAM-A was 25.694.82 for group G and 23.214.64 for group D. The HAM-A score was significantly reduced in group G compared to group D (p = 0.039). Conclusion: This study showed that psychodynamic psychotherapy could improve the pharmacotherapy effects and is superior to pharmacotherapy alone.

Ceteris Paribus: An Epistemological Error with Ethical Consequences

Herein I call into question a common epistemological justification for placebo controls, and thereby problematize the use of placebo in many modern clinical trials. I demonstrate both the ethical harm and epistemic inferiority of placebo controls in certain knowledge contexts, arguing the standard of care should be the more acceptable comparator for novel treatments in such contexts.