scholarly journals Cannabidiol Use as Treatment for Refractory Epilepsies

2021 ◽  
Author(s):  
Catarina Secundino Tavares de Araújo ◽  
Maria Clara Coppieters Gusmão ◽  
Rodrigo Mesquita Costa Braga
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Refractory Epilepsy ◽  
Drug Adverse Effects ◽  
Adults And Children ◽  
Short And Long Term ◽  
Dose Dependent ◽  
Alternative Drugs

Introduction: Refractory epilepsies have a great impact in patients’ quality of life. Thus, studies with alternative drugs are extremely important to seek for effective treatments to control the condition, and cannabidiol (CBD) has shown promising results. Objectives: To analyze CBD’s efficacy as an alternative treatment of patients with refractory epilepsy. Design and setting: this study is a literature review from Universidade Federal da Bahia. Methods: We searched the following formula on PubMed: [cannabidiol] AND [epilepsy]. The inclusion criteria were clinical trials published from 2016-2021. Results: 25 articles were found, from which 18 were selected and, from those, 1092 patients were analyzed. All studies pointed to a reduction in frequency and/or intensity of epileptic crisis in adults and children with refractory epilepsy using CBD, independently of the etiology. In Laux’s study, they noted reductions of 50% and 44% in motor and total seizures (respectively). Moreover, Birnbaum’s study showed that using CBD with a meal may cause variability of exposure of patients to the drug. Adverse effects were dose dependent, mainly diarrhea, sleepiness and less appetite. The interaction between CBD and anticonvulsants was not shown to have a prejudicial or neutralizing effect. Conclusion: CBD was shown to be capable of attenuating attacks in patients with refractory epilepsy. However, more randomized clinical trials are needed to analyze the efficacy and the safety of these medications in the short and long term.

scholarly journals Omalizumab for the treatment of chronic spontaneous urticaria: a systematic review

2021 ◽  
Vol 7 (6) ◽  
pp. 852
Author(s):  
Nishitha Gopal Rao ◽  
Hai Xia Jing ◽  
Ahmed Raihan Kabir ◽  
Rohit Surthi
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Clinical Symptoms ◽  
Chronic Spontaneous Urticaria ◽  
Double Blind ◽  
H1 Antihistamines ◽  
Online Library ◽  
Dose Dependent

<p class="abstract">Chronic spontaneous urticaria (CSU) is a mast cell-driven skin disease characterized by the recurrence of transient wheals, angioedema or both lasting for more than 6 weeks duration. Omalizumab is a newer humanized anti IgE immunoglobulin along with many new antibody treatments has shown beneficial effect in treatment of chronic spontaneous urticaria. Although many randomized clinical trials have been conducted, as of now, the effectiveness of omalizumab in the real world management of CSU is largely unknown. A systematic review of all studies should be done. The objective was to study the efficacy and safety of different doses of omalizumab in the treatment of chronic spontaneous urticaria which was refractory to treatment with H1 antihistamines. Suitable studies were recognized after searching Wiley online library, PubMed, Google scholar, NEJM/NEJ dermatology, JAAD, JACI, clinicaltrials.gov. Only randomized, double-blind, placebo-controlled clinical trials with omalizumab versus antihistamine or leukotriene antagonists as placebo were involved in this study. 10 randomized, placebo-controlled studies were involved with 1692 patients with CSU. Patients treated with omalizumab (75-600 mg every 4 weeks) had reduced UAS7 score, improved QoL (quality of life), reduced WISS, when compared to the placebo group. The effects of omalizumab were found to be dose dependent, with maximum reduction in UAS7 at a dose of 300 mg when given at an interval of 4 weeks’ duration. The incidences of adverse events were almost similar in both control and placebo groups and across various dose ranges. The best effect in reduction of clinical symptoms and QoL in CSU patients was found at a dose of 300 mg subcutaneous injection once a month of omalizumab for 12 to 24 weeks. Omalizumab was found to reduce the clinical symptoms and signs in patients with CSU who were symptomatic despite treatment with upscaling dose of H1 antihistamines.</p>

scholarly journals Adverse Events Associated With Anti-IL-23 Agents: Clinical Evidence and Possible Mechanisms

2021 ◽  
Vol 12 ◽  
Author(s):  
Yi Ru ◽  
Xiaojie Ding ◽  
Ying Luo ◽  
Hongjin Li ◽  
Xiaoying Sun ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Cochrane Library ◽  
The Cochrane Library ◽  
Specific Symptoms

BackgroundAnti-interleukin (IL)-23 agents are widely used for autoimmune disease treatment; however, the safety and risks of specific symptoms have not been systematically assessed.ObjectivesThe aim of this study was to summarize the characteristics and mechanisms of occurrence of five immunological and non-immunological adverse events caused by different anti-IL-23 agents.MethodsThe Cochrane Library, EMBASE, PubMed, and Web of Science databases were searched for eligible randomized clinical trials published from inception through May 1, 2020. Randomized clinical trials that reported at least one type of adverse event after treatment were included, regardless of sex, age, ethnicity, and diagnosis. Two investigators independently screened and extracted the characteristics of the studies, participants, drugs, and adverse event types. The Cochrane Handbook was used to assess the methodological quality of the included randomized clinical trials. Heterogeneity was assessed using the I2 statistic. Meta-regression was applied to determine the sources of heterogeneity, and subgroup analysis was used to identify the factors contributing to adverse events.ResultsForty-eight studies were included in the meta-analysis, comprising 25,624 patients treated with anti-IL-23 agents. Serious immunological or non-immunological adverse events were rare. Anti-IL-12/23-p40 agents appeared to cause adverse events more easily than anti-IL-23-p19 agents. The incidence of cancer did not appear to be related to anti-IL-23 agent treatment, and long-term medication could lead to mental diseases. The prevention of complications should be carefully monitored when administered for over approximately 40 weeks to avoid further adverse reactions, and the incidence of infection was the highest among general immunological adverse events.ConclusionsThe application of anti-IL-23 agents induced a series of immunological and non-immunological adverse events, but these agents tend to be well-tolerated with good safety profiles.

Quality of life measurements in major depression

1996 ◽  
Vol 11 (3) ◽  
pp. 123-126 ◽  
Author(s):  
P Bech
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Major Depression ◽  
External Validity ◽  
Randomized Clinical Trials ◽  
Internal Validity ◽  
Efficacy And Safety ◽  
Quality Of Life Measurements

SummaryIn randomized clinical trials in patients with major depression quality of life is considered as an important dimension of treatment outcome in relation to clinical efficacy and safety. The internal validity, reliability, as well as external validity of quality of life scales have been analysed. It is concluded that such scales have their most appropriate applicability in medicine and long-term trials with antidepressants.

Antenatal glucocorticoids: where are we after forty years?

2014 ◽  
Vol 6 (2) ◽  
pp. 127-142 ◽  
Author(s):  
C. J. D. McKinlay ◽  
S. R. Dalziel ◽  
J. E. Harding
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Later Life ◽  
Current Evidence ◽  
Mortality And Morbidity ◽  
Increased Risk ◽  
Elective Cesarean ◽  
Short And Long Term ◽  
Synthetic Glucocorticoids

Since their introduction more than forty years ago, antenatal glucocorticoids have become a cornerstone in the management of preterm birth and have been responsible for substantial reductions in neonatal mortality and morbidity. Clinical trials conducted over the past decade have shown that these benefits may be increased further through administration of repeat doses of antenatal glucocorticoids in women at ongoing risk of preterm and in those undergoing elective cesarean at term. At the same time, a growing body of experimental animal evidence and observational data in humans has linked fetal overexposure to maternal glucocorticoids with increased risk of cardiovascular, metabolic and other disorders in later life. Despite these concerns, and somewhat surprisingly, there has been little evidence to date from randomized trials of longer-term harm from clinical doses of synthetic glucocorticoids. However, with wider clinical application of antenatal glucocorticoid therapy there has been greater need to consider the potential for later adverse effects. This paper reviews current evidence for the short- and long-term health effects of antenatal glucocorticoids and discusses the apparent discrepancy between data from randomized clinical trials and other studies.

QUALITY OF LIFE PROBLEMS OF GYNECOLOGICAL CANCER PATIENTS

2017 ◽  
Vol 63 (3) ◽  
pp. 368-374
Author(s):  
Olga Churuksaeva ◽  
Larisa Kolomiets
Keyword(s):  
Quality Of Life ◽  
Gynecological Cancer ◽  
Social Aspects ◽  
Cancer Data ◽  
Life Problems ◽  
Anticancer Treatment ◽  
Short And Long Term ◽  
The Relationship

Due to improvements in short- and long-term clinical outcomes a study of quality of life is one of the most promising trends in oncology today. This review analyzes the published literature on problems dealing with quality of life of patients with gynecological cancer. Data on quality of life with respect to the extent of anticancer treatment as well as psychological and social aspects are presented. The relationship between quality of life and survival has been estimated.

scholarly journals CTNI-01. EFFECT OF STEREOTACTIC RADIOSURGERY COMPARED TO WHOLE-BRAIN RADIOTHERAPY FOR LIMITED BRAIN METASTASIS ON LONG TERM COGNITION AND QUALITY OF LIFE: A POOLED ANALYSIS OF RANDOMIZED CLINICAL TRIALS

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii40-ii41
Author(s):  
Joshua Palmer ◽  
Brett Klamer ◽  
Karla Ballman ◽  
Paul Brown ◽  
Jane Cerhan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Clinical Trials ◽  
Whole Brain Radiotherapy ◽  
Pooled Analysis ◽  
Cognitive Outcomes ◽  
Phase Iii ◽  
Brain Radiotherapy ◽  
Over Time

Abstract PURPOSE We investigated the long term impact of SRS and WBRT in two large prospective phase III trials. METHODS Patients with 1–4 BMs +/- resection were randomized to SRS or WBRT. Cognitive deterioration was a drop of &gt;1 standard deviation from baseline in &gt;2/6 cognitive measures (CM). Quality of life (QOL) scores were scored 0–100 point scale. CM and QOL scores were modeled using baseline adjusted Linear Mixed Models (LMM) with uncorrelated random intercept for subject and random slopes for time. Differences over time between groups and the effect of &gt;2 cognitive scores with &gt;2 SD change from baseline were assessed. RESULTS 88 patients were included with median follow up of 24 months. We observed decreasing CM over time (SRS: 4/6; WBRT: 5/6). Mean CM was significantly higher in SRS for Total recall and Delayed Recall at 3, 6, 9, 12 months. More patients in WBRT arm declined 1 SD in &gt;1 and &gt;2 CM at the 3, 6, 9, and 12 months. A 1 SD decline in &gt;3 CM at 1 year was 21% SRS vs 47% WBRT (p=0.02). SRS had fewer patients with a 2 SD decline in &gt;1 CM at every time point. SRS had fewer patients with a 2 SD decline at &gt;2 and &gt;3 CM. WBRT had lower QOL at 3 months, but switched to SRS having lower QOL at 24 months for PWB, EWB, FWB, FactG, BR, and FactBR (p&lt; 0.05). A 2 SD decline in cognition decreased mean FWB by 6.4 units (95% CI: -11, -1.75; p=0.007) and decreased QOL by 5.1 units (95% CI: -7.7, -2.5; p&lt; 0.001). CONCLUSIONS We report the first pooled prospective study demonstrating the long term outcomes of patients with BMs after cranial radiation. WBRT was associated with worse cognitive outcomes. Impaired cognition is associated with worse QOL.

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