Organon & Co. is an American pharmaceutical company headquartered in Jersey City, New Jersey. Organon specializes in the following core therapeutic fields: reproductive medicine, contraception, psychiatry, hormone replacement therapy (HRT), and anesthesia. Organon sells to international markets.
Following a 30-year development process, RTS,S/AS01E (GSK, Belgium) is the first malaria vaccine to reach Phase IV assessments. The World Health Organization-commissioned Malaria Vaccine Implementation Programme (MVIP) is coordinating the delivery of RTS,S/AS01E through routine national immunization programmes in areas of 3 countries in sub-Saharan Africa. The first doses were given in the participating MVIP areas in Malawi on 23 April, Ghana on 30 April, and Kenya on 13 September 2019. The countries participating in the MVIP have little or no baseline incidence data on rare diseases, some of which may be associated with immunization, a deficit that could compromise the interpretation of possible adverse events reported following the introduction of a new vaccine in the paediatric population. Further, effects of vaccination on malaria transmission, existing malaria control strategies, and possible vaccine-mediated selective pressure on Plasmodium falciparum variants, could also impact long-term malaria control. To address this data gap and as part of its post-approval commitments, GSK has developed a post-approval plan comprising of 4 complementary Phase IV studies that will evaluate safety, effectiveness and impact of RTS,S/AS01E through active participant follow-up in the context of its real-life implementation. EPI-MAL-002 (NCT02374450) is a pre-implementation safety surveillance study that is establishing the background incidence rates of protocol-defined adverse events of special interest. EPI-MAL-003 (NCT03855995) is an identically designed post-implementation safety and vaccine impact study. EPI-MAL-005 (NCT02251704) is a cross-sectional pre- and post-implementation study to measure malaria transmission intensity and monitor the use of other malaria control interventions in the study areas, and EPI-MAL-010 (EUPAS42948) will evaluate the P. falciparum genetic diversity in the periods before and after vaccine implementation. GSK’s post-approval plan has been designed to address important knowledge gaps in RTS,S/AS01E vaccine safety, effectiveness and impact. The studies are currently being conducted in the MVIP areas. Their implementation has provided opportunities and posed challenges linked to conducting large studies in regions where healthcare infrastructure is limited. The results from these studies will support ongoing evaluation of RTS,S/AS01E’s benefit-risk and inform decision-making for its potential wider implementation across sub-Saharan Africa.
Background: Individualisation is the process of arriving at the image of the patient for the selection of remedy. The customary way of individualisation of the patient is through the construction of totality of symptoms. The little explored area in Homoeopathy is individualisation solely based on personality characteristics. Objective: The objective of this study was to compare the effect of individualised homoeopathic medicine administered based on totality of symptoms vis-à-vis personality in patients suffering from knee osteoarthritis. Methods: The observational study includes 60 clinically diagnosed cases of osteoarthritis knee, of which 30 cases were administered the homoeopathic medicine selected on the basis of totality of symptoms and thirty cases based on personality. Randomisation was done using computer-generated numbers. The personality of the patients was assessed through the 44-item Big-Five Inventory. A self-made tool, transcribing trait items to rubrics of the homoeopathic repertory, was prepared. The knee osteoarthritis scores on physical function, pain and patient global estimate in Routine Assessment of Patient Index Data 3 (RAPID3) sheet, before and after treatment, were compared. Results: The paired difference mean of RAPID3 in totality of symptom-based administration was 4.06 and for personality-based administration was 1.92 with a standard deviation of 3.91 and 3.29, respectively. The test result is statistically significant at 0.05 level (P < 0.05). Conclusion: Administration of individualised Homoeopathy medicine based on totality of symptoms is found to be more effective as compared to individualised Homoeopathy medicine based on personality amongst patients suffering from osteoarthritis knee.
Introduction: The psychological impact of COVID-19 on healthcare workers has received attention from researchers seeking to understand the extent of the effects of the ongoing pandemic on this population. The aim to this systematic review and meta-analysis was to synthesise the currently available literature on the topic to determine the prevalence of mental health problems in healthcare workers. Methods: We conducted a systematic review and meta-analysis, searching PubMed, PsycINFO, Scopus and Cochrane register of clinical trials (CENTRAL) databases for articles published from December 2019 to May 31, 2020. We identified cross-sectional, case-control and cohort studies reporting prevalence of any International Classification of Diseases (ICD) or Diagnostic and Statistical Manual of Mental Disorders (DSM) mental health disorders in healthcare workers involved directly or indirectly in providing services during the COVID-19 pandemic. Studies reporting or having extractable prevalence data were also included. The prevalence proportion for individual outcome was extracted as an estimate of interest. We performed random-effects meta-analyses evaluated using Q statistic, I2 statistic, subgroup analyses, sensitivity analyses and assessed study quality. This review was done in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Meta-analysis Of Observational Studies in Epidemiology (MOOSE) guidelines. The study protocol was registered prospectively at PROSPERO, CRD42020182005. Results: We identified 988 studies of which 928 studies were excluded during screening for duplicates and did not meet the inclusion criteria. We further assessed 56 full-texts and finally included 17 studies for analysis with 34021 participants. The overall prevalence estimated were: depression 25.9% (95%CI 18.4-34.1, I2=99.5%), anxiety 24.5% (95% CI 17.9-31.9, I2=99.1%), insomnia or poor sleep quality or sleep disturbance 35.8% (95% CI 28.3-48.1, I2=99.2%), and stress 30.7% (95% CI 13-51.6, I2=99.9%). Conclusion: Healthcare workers who are dealing with the COVID-19 pandemic have a significant prevalence of depression, anxiety, insomnia and poor sleep quality, and stress. The healthcare workforce needs to practice self-care now more than ever, while healthcare managers and policy makers need to factor in the mental health consequences of COVID-19 on their workforce.Funding Statement: None.Declaration of Interests: None.
Depression is a common and often underdiagnosed mental disorder. Homeopathy has a major role in the treatment of depressive disorders. Homeopathic treatment takes personality and temperament of the patient into consideration for selection of medicine. As such it believes in the concept of individualization, thereby each patient suffering from depression may require a similimum, different from other patient. Three cases of depressive disorders treated by Nux vomica are presented. All the cases were improved; analysis was done by Hamilton depression rating scale.