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Fulltext Effect of physiotherapy on polycystic ovarian syndrome and lack of research

Munir M, Baig AA, Zafar Z

J Pak Med Assoc, 2022 Oct;72(10):2130.
PMID: 36661018 DOI: 10.47391/JPMA.5736
Fulltext Pomegranate-derived anthocyanin regulates MORs-cAMP/CREB-BDNF pathways in opioid-dependent models and improves cognitive impairments

Ridzwan N, Jumli MN, Baig AA, Rohin MAK

J Ayurveda Integr Med, 2020;11(4):478-488.
PMID: 32430240 DOI: 10.1016/j.jaim.2019.12.001

BACKGROUND: Pomegranate (Punica granatum) is one of the oldest known edible fruit. Recently, there has been an increased interest in this fruit as a functional food for health benefits due to its use in disease prevention and promotion of overall health wellness.
OBJECTIVE: This study aims to investigate the effects of pomegranate extract for the development of non-opioid substitution therapy for in-vitro and in-vivo studies.
MATERIALS AND METHODS: Anthocyanin contents consisting of cyanidin 3-glucoside, diglucoside, and pelargonidin 3-glucoside, diglucoside were detected and quantified in pomegranate extract using high-performance liquid chromatography. The optimum dosage of the extract was determined based on the regulation of MORs and cAMP proteins in U-87 cells. Co-treatment of the extract with morphine was performed to evaluate its potency in reducing the concentration levels of MORs and cAMP. For animal studies, rats were divided into two major groups representing both acute and chronic morphine-induced treatments and the Morris water maze (MWM) study was employed after treatment for each rat. The rats were sacrificed after the treatments and serum samples were collected to evaluate the levels of CREB and BDNF.
RESULTS: The results indicated that each of the anthocyanin content tested in the study was present in the pomegranate extract. Additionally, in-vitro studies using pomegranate extract treatment showed that the extract was effective in decreasing the MORs and cAMP protein levels in U-87 cells at a concentration of 0.125 mg/mL. The memory impairment based on the MWM study in rats was also subsequently improved after treatment with pomegranate extract as compared to treatment with morphine. The blood serum derived from the rats treated with pomegranate extract also showed a significant decrease in CREB level and an increase in BDNF as compared to rats treated with morphine.
CONCLUSION: In conclusion, this study substantiates the potency of pomegranate extract as a non-opioid substitution therapy for in-vitro and in-vivo studies.
Intestinal colonization against Vibrio cholerae: host and microbial resistance mechanisms

Muhammad AY, Amonov M, Murugaiah C, Baig AA, Yusoff M

AIMS Microbiol, 2023;9(2):346-374.
PMID: 37091815 DOI: 10.3934/microbiol.2023019

Vibrio cholerae is a non-invasive enteric pathogen known to cause a major public health problem called cholera. The pathogen inhabits the aquatic environment while outside the human host, it is transmitted into the host easily through ingesting contaminated food and water containing the vibrios, thus causing diarrhoea and vomiting. V. cholerae must resist several layers of colonization resistance mechanisms derived from the host or the gut commensals to successfully survive, grow, and colonize the distal intestinal epithelium, thus causing an infection. The colonization resistance mechanisms derived from the host are not specific to V. cholerae but to all invading pathogens. However, some of the gut commensal-derived colonization resistance may be more specific to the pathogen, making it more challenging to overcome. Consequently, the pathogen has evolved well-coordinated mechanisms that sense and utilize the anti-colonization factors to modulate events that promote its survival and colonization in the gut. This review is aimed at discussing how V. cholerae interacts and resists both host- and microbe-specific colonization resistance mechanisms to cause infection.
Short-term estrogen replacement therapy reduces platelet marker levels in Malaysian postmenopausal women

Sheikh SA, Roshan TM, Khattak MN, Baig AA, Noor SJ, Hassan R, et al.

Menopause Int, 2011 Mar;17(1):6-10.
PMID: 21427417 DOI: 10.1258/mi.2011.011001

In healthy postmenopausal women (PMW) increased platelet activation has been associated with adverse cardiovascular events. There is much debate about the relationship between platelet function and serum estradiol level in PMW. This study assessed the effect of short-term oral estrogen replacement therapy (ERT) on platelet activation markers (CD62P and PAC-1) and its correlation with age and body mass index (BMI) among healthy PMW.
Development and validation of a new vision screening test algorithm for public use mobile application- A pilot study

Siti Nor Aishah AR, Mutalib A, Asma H, Baig AA, Naing NN, Hashim SE, et al.

Med J Malaysia, 2020 11;75(6):685-690.
PMID: 33219178

OBJECTIVES: To design and develop a simple vision test algorithm for mobile application and perform a pilot study to determine its validity and reliability as a tool for vision test in the community.
METHODS: A simple visual acuity test algorithm in the form of a single letter E display was designed as the optotype for development of a mobile application. The standardised optotype is presented at random to test visual acuity for corresponding level of 3/60, 6/60, 6/18, and 6/12. The final result is auto-generated based on the classification of the WHO for visual impairment and blindness. The Snellen chart was used as the gold standard to determine its validity while five different users were involved to determine its inter-rater reliability. A pilot study was performed between April till November 2019, in the Universiti Sultan Zainal Abidin Medical Centre (UMC) at Kuala Nerus and Mooris Optometrist Centre at Marang, Terengganu. A total of 279 participants aged four years old and above were involved in this study.
RESULTS: The highest sensitivity was found at the vision level cut-off point of 6/12 with the percentage of 92.7% and 86.8% for the right and left eye, respectively. The specificity was more than 89% for all vision levels in both eyes. The Krippendorff's alpha value for the inter-rater reliability was 0.87 and 0.83.
CONCLUSION: The relatively high level of validity and reliability obtained indicate the feasibility of using the designed optotype to develop a valid and reliable mobile app for vision test. The app can be used to screen vision by nonmedical persons, at anytime and anywhere to help improve public awareness and capability to correctly determine their visual status.
Molecular Modulation of Stress Induced to Abnormal Haematological Indices in Medical Students, Malaysian Perspective

Al-Hatamleh MAI, Baig AA, Simbak NB, Nadeem MI, Khan SU, Ariff TM

Pak J Biol Sci, 2017;20(10):478-488.
PMID: 30187724 DOI: 10.3923/pjbs.2017.478.488

Medical students in Malaysia and globally were considered among the most exposure groups in the community to stress due to several sources. The most significant and severe sources of stress in medical students is an academic sources, includes a lot of exams/tests, lack of time and facilities for entertainment, stay in a hostel, high parental expectations and vastness of syllabus, in addition to emotional problems and others personal sources. Stress is a very important issue that leads to a worsening of health problems. Stress develops in the body and leads to oxidative stress which in turn leads to a disorder in the whole body. Oxidative stress may lead to abnormal haematological indices elevated white blood cells (WBCs) count. Oxidative stress can lead to massive destruction of red blood cells (RBCs). The brain and the gastrointestinal system (GI) are intimately connected as one system. The brain has a direct impact on the GI tract. A stressful brain can send signals to the gut, just as a troubled intestine can send signals to the brain. Therefore, stress can be the cause of block the breakdown and assimilation of food for energy and nutriment. This malabsorption can then lead to a reciprocal negative effect to the stress and can be another cause of anaemia through malabsorption minerals and vitamins that are to erythropoiesis. So, stress can be one of the leading causes of anaemia among medical students. Stress is a chronic epidemic in the most medical students and can directly affect how well body works. This review article discovers the effect of stress in medical students that can be effect on their studies and further create researcher's interest to generate database that help to reduce stress response and bring about the empowerment of balanced life among Malaysian medical students besides the increasing level of health and academic performance.
Fulltext FDA approved vaccines for monkeypox: Current eminence

Chopra H, Dhawan M, Bibi S, Baig AA, Kushwah AS, Kaur M, et al.

Int J Surg, 2022 Sep;105:106896.
PMID: 36089263 DOI: 10.1016/j.ijsu.2022.106896
Global human obesity and political globalization; asymmetric relationship through world human development levels

Munir M, Zakaria ZA, Alhajj R, Mohamad MB, Baig AA, Arshed N

Nutr Health, 2022 Sep 13.
PMID: 36113142 DOI: 10.1177/02601060221125146

Purpose - Political globalization is a crucial and distinct component of strengthening global organizations. Obesity is a global epidemic in a few nations, and it is on the verge of becoming a pandemic that would bring plenty of diseases. This research aims to see how the political globalization index affects worldwide human obesity concerning global human development levels. Methods- To assess any cross-sectional dependence among observed 109 nations, the yearly period from 1990 to 2017 is analyzed using second generation panel data methods. KAO panel cointegration test and Fully Modified Least Square model were used to meet our objectives. Finding- Low level of political globalization tends to increase global human obesity because countries cannot sway international decisions and resources towards them. While the high level of political globalization tends to reduce obesity because it can control and amends international decisions. For the regression model, a fully modified Least Square model was utilized. The study observed that the R squared values for all models are healthy, with a minimum of 87 percent variables explaining differences in global obesity at the country level. Originality: There is very important to tackle the globalization issue to reduce global human obesity. With the simplicity of dietary options and the amount of physical labour they undergo in their agricultural duties, an increase in rural population percentage tends to lower the average national obesity value.
Global impact on human obesity - A robust non-linear panel data analysis

Munir M, Zakaria ZA, Baig AA, Mohamad MB, Arshed N, Alhajj R

Nutr Health, 2022 Oct 05.
PMID: 36198038 DOI: 10.1177/02601060221129142

Purpose: Recent studies in economics showed that humans are bounded rational. This being consumers, they are not perfect judges of what matters for the standard of living. While with a marked increase in economic and social wellbeing, there is a consistent rise in obesity levels, especially in the developed world. Thus, this study intends to explore the empirical and socio-economic antecedents of human obesity across countries using six global indexes. Methods: This study used the data of 40 countries between 1975 to 2018 and used the Panel FGLS Regression with the quadratic specification. Findings: The results showed that health and food indicators increase global human obesity, environment and education indicators decrease global human obesity, and economic and social indicators follow an inverted U-shaped pattern in affecting global human obesity. Originality: Previous studies have used infant mortality and life expectancy as the major health indicator in determining the standard of living while overlooking global human obesity as a major deterrent to welfare. This study has provided a holistic assessment of the causes of obesity in global contexts.
Fulltext Risk factors for childhood pneumonia in North Eastern Pakistan: a case-control study

Aftab S, Ejaz I, Waqar U, Khan HI, Hanif A, Usman A, et al.

Malaysian Journal of Paediatrics and Child Health, 2016;22(1):26-34.
MyJurnal

Background: Pneumonia is defined as the inflammation of parenchyma of the lung. It is a substantial cause of morbidity and mortality in childhood throughout the world. The incidence of pneumonia in children under the age of five years is 0.29 episodes per child-year, which equates 151.8 million cases annually in developing countries. Objective: To determine the risk factors for complicated pneumonia.

Material and Methods: This case-control study conducted in Medical Unit III, The Children’s Hospital & Institute of Child Health Lahore. Out of total of 180 cases of pneumonia, 100 were labeled as complicated pneumonia (case) and 80 were labeled as uncomplicated pneumonia (control). Complicated pneumonia included pneumonia with associated complications. Detail history was taken in both groups and recorded on predesigned proforma. Data was analyzed by SPSS 20. Quantitative risk factors like child age, maternal age and father age were analyzed by mean and standard deviation. However qualitative risk factors like method of feeding, malnutrition, immunization, anaemia, and non-vaccination were analyzed by applying chi-square test and finding odd ratios.

Results: Most significant risk factors associated with complicated pneumonia included younger age, maternal and father education, rural area, malnutrition, anaemia, rickets, birth problems, admission during neonatal life due to pneumonia, bottle feeding, nonvaccination, referral and delayed in presentation (p
Fulltext Melatonergic Receptors (Mt1/Mt2) as a Potential Additional Target of Novel Drugs for Depression

Boiko DI, Shkodina AD, Hasan MM, Bardhan M, Kazmi SK, Chopra H, et al.

Neurochem Res, 2022 Oct;47(10):2909-2924.
PMID: 35689787 DOI: 10.1007/s11064-022-03646-5

A complex pathogenesis involving several physiological systems is theorized to underline the development of depressive disorders. Depression is accompanied by circadian regulation disruption and interaction with the functioning of both central and peripheral oscillators. Many aspects of melatonin function unite these systems. The use of drugs for circadian rhythm disorders could inspire a potential treatment strategy for depression. Melatonin plays an essential role in the regulation of circadian rhythms. It exerts effect by activating two types of melatonin receptors, type 1A (MT1) and 1B (MT2). These are G-protein-coupled receptors, predominantly located in the central nervous system. MT1/MT2 agonists could be a useful treatment approach according to all three prevalent theories of the pathogenesis of depression involving either monoamines, synaptic remodeling, or immune/inflammatory events. MT1/MT2 receptors can be a potential target for novel antidepressants with impact on concentrations of neurotrophins or neurotransmitters, and reducing levels of pro-inflammatory cytokines. There is an interesting cross-talk mediated via the physical association of melatonin and serotonin receptors into functional heteromers. The antidepressive and neurogenetic effects of MT1/MT2 agonists can also be caused by the inhibition of the acid sphingomyelinase, leading to reduced ceramide, or increasing monoamine oxidase A levels in the hippocampus. Compounds targeting MT1 and MT2 receptors could have potential for new anti-depressants that may improve the quality of therapeutic interventions in treating depression and relieving symptoms. In particular, a combined effect on MT1 and/or MT2 receptors and neurotransmitter systems may be useful, since the normalization of the circadian rhythm through the melatonergic system will probably contribute to improved treatment. In this review, we discuss melatonergic receptors as a potential additional target for novel drugs for depression.
Fulltext Honey as a Potential Natural Antioxidant Medicine: An Insight into Its Molecular Mechanisms of Action

Ahmed S, Sulaiman SA, Baig AA, Ibrahim M, Liaqat S, Fatima S, et al.

Oxid Med Cell Longev, 2018;2018:8367846.
PMID: 29492183 DOI: 10.1155/2018/8367846

Honey clasps several medicinal and health effects as a natural food supplement. It has been established as a potential therapeutic antioxidant agent for various biodiverse ailments. Data report that it exhibits strong wound healing, antibacterial, anti-inflammatory, antifungal, antiviral, and antidiabetic effects. It also retains immunomodulatory, estrogenic regulatory, antimutagenic, anticancer, and numerous other vigor effects. Data also show that honey, as a conventional therapy, might be a novel antioxidant to abate many of the diseases directly or indirectly associated with oxidative stress. In this review, these wholesome effects have been thoroughly reviewed to underscore the mode of action of honey exploring various possible mechanisms. Evidence-based research intends that honey acts through a modulatory road of multiple signaling pathways and molecular targets. This road contemplates through various pathways such as induction of caspases in apoptosis; stimulation of TNF-α, IL-1β, IFN-γ, IFNGR1, and p53; inhibition of cell proliferation and cell cycle arrest; inhibition of lipoprotein oxidation, IL-1, IL-10, COX-2, and LOXs; and modulation of other diverse targets. The review highlights the research done as well as the apertures to be investigated. The literature suggests that honey administered alone or as adjuvant therapy might be a potential natural antioxidant medicinal agent warranting further experimental and clinical research.
Fulltext Validity and Reliability of Vis-Screen Application: A Smartphone-Based Distance Vision Testing for Visual Impairment and Blindness Vision Screening

Abdul Rahman SNA, Naing NN, Othman AM, Mohamad Z, Ibrahim TMM, Hashim SE, et al.

Medicina (Kaunas), 2023 May 10;59(5).
PMID: 37241144 DOI: 10.3390/medicina59050912

Background and Objectives: The health-related mobile applications (app) might assist in promoting inclusive health and tele-treatment, especially for the less severe diseases. In this paper, a study had been done to determine the app's reliability in terms of raters and the app's agreement with the Snellen chart. Materials and Methods: A cross-sectional sectional study was conducted between November 2019 and September 2020. Participants were selected via purposive sampling from selected communities in Terengganu state. All participants underwent vision testing with the Vis-Screen app and Snellen chart for validity and reliability accordingly. Results: A total of 408 participants were involved, with a mean age of 29.3. The sensitivity of the presenting vision of the right eye (PVR) ranged from 55.6% to 88.4%, with specificity between 94.7% to 99.3%, while the positive and negative predictive values were between 57.9% and 81.7% and 96.8% and 99.0%, respectively. The positive likelihood ratios ranged between 16.73 and 73.89, whereas the negative likelihood ratios ranged from 0.12 to 0.45. The area under the receiver operating characteristic curve (AUC) for all cut-off points ranged between 0.93 and 0.97, and the optimum cut-off point was at 6/12. The kappa values for intra-rater and inter-rater were 0.85 and 0.75, respectively, while the app's reliability with the Snellen chart was 0.61. Conclusions: Vis-Screen was concluded to be valid and reliable for use as a screening tool for detecting individuals with visual impairment and blindness in the community. A valid and reliable portable vision screener like Vis-Screen will help expand the eye care feasibility while providing similar accuracy as the conventional charts in clinical practices.
Fulltext Green Metallic Nanoparticles: Biosynthesis to Applications

Chopra H, Bibi S, Singh I, Hasan MM, Khan MS, Yousafi Q, et al.

Front Bioeng Biotechnol, 2022;10:874742.
PMID: 35464722 DOI: 10.3389/fbioe.2022.874742

Current advancements in nanotechnology and nanoscience have resulted in new nanomaterials, which may pose health and environmental risks. Furthermore, several researchers are working to optimize ecologically friendly procedures for creating metal and metal oxide nanoparticles. The primary goal is to decrease the adverse effects of synthetic processes, their accompanying chemicals, and the resulting complexes. Utilizing various biomaterials for nanoparticle preparation is a beneficial approach in green nanotechnology. Furthermore, using the biological qualities of nature through a variety of activities is an excellent way to achieve this goal. Algae, plants, bacteria, and fungus have been employed to make energy-efficient, low-cost, and nontoxic metallic nanoparticles in the last few decades. Despite the environmental advantages of using green chemistry-based biological synthesis over traditional methods as discussed in this article, there are some unresolved issues such as particle size and shape consistency, reproducibility of the synthesis process, and understanding of the mechanisms involved in producing metallic nanoparticles via biological entities. Consequently, there is a need for further research to analyze and comprehend the real biological synthesis-dependent processes. This is currently an untapped hot research topic that required more investment to properly leverage the green manufacturing of metallic nanoparticles through living entities. The review covers such green methods of synthesizing nanoparticles and their utilization in the scientific world.
Virtual screening of bioactive anti-SARS-CoV natural products and identification of 3β,12-diacetoxyabieta-6,8,11,13-tetraene as a potential inhibitor of SARS-CoV-2 virus and its infection related pathways by MD simulation and network pharmacology

Huq AKMM, Roney M, Imran S, Khan SU, Uddin MN, Htar TT, et al.

J Biomol Struct Dyn, 2023;41(23):13923-13936.
PMID: 36786766 DOI: 10.1080/07391102.2023.2176926

Since the first prevalence of COVID-19 in 2019, it still remains the most devastating pandemic throughout the world. The current research aimed to find potential natural products to inhibit the novel coronavirus and associated infection by MD simulation and network pharmacology approach. Molecular docking was performed for 39 natural products having potent anti-SARS-CoV activity. Five natural products showed high binding interaction with the viral main protease for the SARS-CoV-2 virus, where 3β,12-diacetoxyabieta-6,8,11,13 tetraene showed stable binding in MD simulation until 100 ns. Both 3β,12-diacetoxyabieta-6,8,11,13 tetraene and tomentin A targeted 11 common genes that are related to COVID-19 and interact with each other. Gene ontology development analysis further showed that all these 11 genes are attached to various biological processes. The KEGG pathway analysis also showed that the proteins that are targeted by 3β,12-diacetoxyabieta-6,8,11,13 tetraene and tomentin A are associated with multiple pathways related to COVID-19 infection. Furthermore, the ADMET and MDS studies reveals 3β,12-diacetoxyabieta-6,8,11,13 as the best-suited compound for oral drug delivery.Communicated by Ramaswamy H. Sarma.
Fulltext Molecular docking of alpha-enolase to elucidate the promising candidates against Streptococcus pneumoniae infection

Hassan M, Baig AA, Attique SA, Abbas S, Khan F, Zahid S, et al.

Daru, 2021 Jun;29(1):73-84.
PMID: 33537864 DOI: 10.1007/s40199-020-00384-3

PURPOSE: To predict potential inhibitors of alpha-enolase to reduce plasminogen binding of Streptococcus pneumoniae (S. pneumoniae) that may lead as an orally active drug. S. pneumoniae remains dominant in causing invasive diseases. Fibrinolytic pathway is a critical factor of S. pneumoniae to invade and progression of disease in the host body. Besides the low mass on the cell surface, alpha-enolase possesses significant plasminogen binding among all exposed proteins.
METHODS: In-silico based drug designing approach was implemented for evaluating potential inhibitors against alpha-enolase based on their binding affinities, energy score and pharmacokinetics. Lipinski's rule of five (LRo5) and Egan's (Brain Or IntestinaL EstimateD) BOILED-Egg methods were executed to predict the best ligand for biological systems.
RESULTS: Molecular docking analysis revealed, Sodium (1,5-dihydroxy-2-oxopyrrolidin-3-yl)-hydroxy-dioxidophosphanium (SF-2312) as a promising inhibitor that fabricates finest attractive charges and conventional hydrogen bonds with S. pneumoniae alpha-enolase. Moreover, the pharmacokinetics of SF-2312 predict it as a therapeutic inhibitor for clinical trials. Like SF-2312, phosphono-acetohydroxamate (PhAH) also constructed adequate interactions at the active site of alpha-enolase, but it predicted less favourable than SF-2312 based on binding affinity.
CONCLUSION: Briefly, SF-2312 and PhAH ligands could inhibit the role of alpha-enolase to restrain plasminogen binding, invasion and progression of S. pneumoniae. As per our investigation and analysis, SF-2312 is the most potent naturally existing inhibitor of S. pneumoniae alpha-enolase in current time.
Cytokine storm and neuropathological alterations in patients with neurological manifestations of COVID-19

Tsagkaris C, Bilal M, Aktar I, Aboufandi Y, Tas A, Aborode AT, et al.

Curr Alzheimer Res, 2022 Sep 08.
PMID: 36089786 DOI: 10.2174/1567205019666220908084559

The COVID-19 pandemic is caused by the severe acute respiratory syndrome coronavirus (SARS-CoV-2), a respiratory pathogen with neuroinvasive potential. Neurological COVID-19 manifestations include loss of smell and taste, headache, dizziness, stroke, and potentially fatal encephalitis. Several studies found elevated proinflammatory cytokines such as TNF-α, IFN-γ, IL-6 IL-8, IL-10 IL-16, IL-17A, and IL-18 in severely and critically ill COVID-19 patients, which may persist even after apparent recovery from infection. Biomarker studies on CSF and plasma and serum from COVID-19 patients have also shown a high level of IL-6, intrathecal IgG, neurofilament light chain (NFL), glial fibrillary acidic protein (GFAP), and tau protein. Emerging evidence on the matter has established the concept of COVID-19 associated neuroinflammation, in the context of COVID-19 associated cytokine storm. While the short-term implications of this condition are extensively documented, its long-term implications are yet to be understood. The association of the aforementioned cytokines with the pathogenesis of neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, Huntington disease, and amyotrophic lateral sclerosis, may increase COVID-19 patients' risk to develop neurodegenerative diseases. Analysis of proinflammatory cytokines and CSF biomarkers in patients with COVID-19 can contribute to the early detection of the disease's exacerbation, monitoring the neurological implications of the disease and devising risk scales, and identifying treatment targets.
Fulltext The first Malay database toward the ethnic-specific target molecular variation

Halim-Fikri H, Etemad A, Abdul Latif AZ, Merican AF, Baig AA, Annuar AA, et al.

BMC Res Notes, 2015;8:176.
PMID: 25925844 DOI: 10.1186/s13104-015-1123-y

The Malaysian Node of the Human Variome Project (MyHVP) is one of the eighteen official Human Variome Project (HVP) country-specific nodes. Since its inception in 9(th) October 2010, MyHVP has attracted the significant number of Malaysian clinicians and researchers to participate and contribute their data to this project. MyHVP also act as the center of coordination for genotypic and phenotypic variation studies of the Malaysian population. A specialized database was developed to store and manage the data based on genetic variations which also associated with health and disease of Malaysian ethnic groups. This ethnic-specific database is called the Malaysian Node of the Human Variome Project database (MyHVPDb).
Fulltext Prophylactic potential of honey and Nigella sativa L. against hospital and community-based SARS-CoV-2 spread: a structured summary of a study protocol for a randomised controlled trial

Ashraf S, Ashraf S, Akmal R, Ashraf M, Kalsoom L, Maqsood A, et al.

Trials, 2021 Sep 15;22(1):618.
PMID: 34526081 DOI: 10.1186/s13063-021-05510-3

OBJECTIVES: Considering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS.
TRIAL DESIGN: The study is a randomized, placebo-controlled, adaptive clinical trial with parallel group design, superiority framework with an allocation ratio of 1:1 among experimental (HNS) and placebo group. An interim analysis will be done when half of the patients have been recruited to evaluate the need to adapt sample size, efficacy, and futility of the trial.
PARTICIPANTS: All asymptomatic patients with hospital or community based COVID-19 exposure will be screened if they have had 4 days exposure to a confirmed case. Non-pregnant adults with significant exposure level will be enrolled in the study High-risk exposure (<6 feet distance for >10min without face protection) Moderate exposure (<6 feet distance for >10min with face protection) Subjects with acute or chronic infection, COVID-19 vaccinated, and allergy to HNS will be excluded from the study. Recruitment will be done at Shaikh Zayed Post-Graduate Medical Institute, Ali Clinic and Doctors Lounge in Lahore (Pakistan).
INTERVENTION AND COMPARATOR: In this clinical study, patients will receive either raw natural honey (0.5 g) and encapsulated organic Nigella sativa seeds (40 mg) per kg body weight per day or empty capsule with and 30 ml of 5% dextrose water as a placebo for 14 days. Both the natural products will be certified for standardization by Government College University (Botany department). Furthermore, each patient will be given standard care therapy according to version 3.0 of the COVID-19 clinical management guidelines by the Ministry of National Health Services of Pakistan.
MAIN OUTCOMES: Primary outcome will be Incidence of COVID-19 cases within 14 days of randomisation. Secondary endpoints include incidence of COVID-19-related symptoms, hospitalizations, and deaths along with the severity of COVID-19-related symptoms till 14th day of randomization.
RANDOMISATION: Participants will be randomized into experimental and control groups (1:1 allocation ratio) via the lottery method. There will be stratification based on high risk and moderate risk exposure.
BLINDING (MASKING): Quadruple blinding will be ensured for the participants, care providers and outcome accessors. Data analysts will also be blinded to avoid conflict of interest. Site principal investigator will be responsible for ensuring masking.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 1000 participants will be enrolled in the study with 1:1 allocation.
TRIAL STATUS: The final protocol version 1.4 was approved by institutional review board of Shaikh Zayed Post-Graduate Medical Complex on February 15, 2021. The trial recruitment was started on March 05, 2021, with a trial completion date of February 15, 2022.
TRIAL REGISTRATION: Clinical trial was registered on February 23, 2021, www.clinicaltrials.gov with registration ID NCT04767087 .
FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.
Fulltext Predicting the environmental suitability for onchocerciasis in Africa as an aid to elimination planning

Cromwell EA, Osborne JCP, Unnasch TR, Basáñez MG, Gass KM, Barbre KA, et al.

PLoS Negl Trop Dis, 2021 07;15(7):e0008824.
PMID: 34319976 DOI: 10.1371/journal.pntd.0008824

Recent evidence suggests that, in some foci, elimination of onchocerciasis from Africa may be feasible with mass drug administration (MDA) of ivermectin. To achieve continental elimination of transmission, mapping surveys will need to be conducted across all implementation units (IUs) for which endemicity status is currently unknown. Using boosted regression tree models with optimised hyperparameter selection, we estimated environmental suitability for onchocerciasis at the 5 × 5-km resolution across Africa. In order to classify IUs that include locations that are environmentally suitable, we used receiver operating characteristic (ROC) analysis to identify an optimal threshold for suitability concordant with locations where onchocerciasis has been previously detected. This threshold value was then used to classify IUs (more suitable or less suitable) based on the location within the IU with the largest mean prediction. Mean estimates of environmental suitability suggest large areas across West and Central Africa, as well as focal areas of East Africa, are suitable for onchocerciasis transmission, consistent with the presence of current control and elimination of transmission efforts. The ROC analysis identified a mean environmental suitability index of 0·71 as a threshold to classify based on the location with the largest mean prediction within the IU. Of the IUs considered for mapping surveys, 50·2% exceed this threshold for suitability in at least one 5 × 5-km location. The formidable scale of data collection required to map onchocerciasis endemicity across the African continent presents an opportunity to use spatial data to identify areas likely to be suitable for onchocerciasis transmission. National onchocerciasis elimination programmes may wish to consider prioritising these IUs for mapping surveys as human resources, laboratory capacity, and programmatic schedules may constrain survey implementation, and possibly delaying MDA initiation in areas that would ultimately qualify.

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