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      Impact of AYUSH interventions on COVID-19: a protocol for a living systematic review and meta-analysis

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          Abstract

          Background: The coronavirus disease 2019 (COVID-19) pandemic has created a great burden on governments and the medical fraternity globally. Many clinical studies from the Indian system of Traditional Medicines [Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy (AYUSH)] have been carried out to find appropriate solutions. Through a living systematic review and meta-analysis, this study aims to determine the effectiveness of the Traditional System of Indian Medicine (AYUSH system) in lowering the incidence, duration, and severity of COVID-19.

          Methods: We will search the following databases: Pubmed; the Cochrane central register of controlled trials (CENTRAL); the Clinical Trials Registry - India (CTRI); Digital Helpline for Ayurveda Research Articles (DHARA): AYUSH research portal; and World Health Organization (WHO) COVID-19 database. Clinical improvement, WHO ordinal scale, viral clearance, incidences of COVID-19 infection, and mortality will be considered as primary outcomes. Secondary outcomes will be use of O2 therapy or mechanical ventilator, admission to high dependency unit or emergency unit, duration of hospitalization, the time to symptom resolution, and adverse events. Two authors will independently search the articles, extract the data and disagreements will be resolved by the involvement of a third reviewer. Data will be synthesized, and the risk of bias will be assessed with RevMan 5.4 tool. Certainty of evidence will be assessed through the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) tool. The review will be updated bi-monthly with two updates.

          Conclusion: This living systematic review will be the first to address AYUSH interventions in COVID-19, synthesizing the full spectrum of Indian Traditional System of Medicine against COVID-19. It will facilitate professionals, guideline developers, and authorities with up to date synthesis on interventions periodically to make health-care decisions on AYUSH therapies in the management of COVID-19.

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          Most cited references15

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          RoB 2: a revised tool for assessing risk of bias in randomised trials

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            ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions

            Non-randomised studies of the effects of interventions are critical to many areas of healthcare evaluation, but their results may be biased. It is therefore important to understand and appraise their strengths and weaknesses. We developed ROBINS-I (“Risk Of Bias In Non-randomised Studies - of Interventions”), a new tool for evaluating risk of bias in estimates of the comparative effectiveness (harm or benefit) of interventions from studies that did not use randomisation to allocate units (individuals or clusters of individuals) to comparison groups. The tool will be particularly useful to those undertaking systematic reviews that include non-randomised studies.
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              New variant of SARS-CoV-2 in UK causes surge of COVID-19

              Tony Kirby (2021)
              For most of November, 2020, England was in lockdown to force down the incidence of COVID-19 cases that had steadily increased in the late summer and autumn. Other countries in the UK (Wales, Scotland, and Northern Ireland) had also been reimposing and subsequently lifting restrictions, since each of the four nations is in charge of its own COVID-19 control plans. For a while, the strategy in England appeared to have worked, with many areas that previously had high case incidence seeing rates drop sharply in November, including northwest England and Yorkshire, areas which had previously seen some of the highest incidence rates in the UK. However, it soon became apparent that the English lockdown had not had the same effect in every region. In Kent, a large county in the southeast, cases actually continued to increase during the lockdown, despite having the same restrictions as other regions. When, on Dec 2, 2020, England lifted its lockdown and moved back into a three-level tiered restrictions system, cases continued to increase sharply in Kent and then rapidly in Greater London and other parts of the southeast. And despite the approval of two vaccines in recent weeks, the UK now faces a race against time to vaccinate as many vulnerable and elderly people as possible. The reason: a new variant of SARS-CoV-2, which various modelling exercises have estimated to be up to 70% more transmissible than the previously circulating form of the virus. In September, 2020, this variant represented just one in four new diagnoses of COVID-19, whereas by mid-December, this had increased to almost two thirds of new cases in London. UK Prime Minister, Boris Johnson, decided with his scientific advisors that he had no credible alternative other than to impose even stricter restrictions on these parts of England, creating a new tier 4, which meant all non-essential shops and gyms closed, and people were asked to stay at home wherever possible (hospitality venues already had to close in tier 3). However, until late December, 2020, the proportion of cases caused by the new variant were much lower in other parts of the country, with the northwest region that includes Liverpool and Manchester recording only 1 in 20 new cases of COVID-19 that were due to the new variant. As a result, many parts of England continued in the lower tier of restrictions, until on Dec 30, 2020, Johnson, in response to surging numbers of new diagnoses including an all-time high of 53 000 on Dec 29, 2020, decided to move all parts of England into tier 3 or 4. This effectively meant that no restaurants, bars, or other hospitality venues would be open on New Year's Eve. However, the latest data (early January, 2021) shows that cases due to the new variant are increasing in all areas of the country, although the south and southeast continue to be the worst affected. Commentators have questioned the logic of this move, and called instead for an England-wide lockdown equivalent to tier 4 restrictions. Scotland, Wales, and Northern Ireland are already in such nationwide lockdowns. “It is good that the majority of the country is in tier 4 as there is evidence we need at least this level of restriction to prevent rapid spread of the new variant”, explains Andrew Hayward, Professor of Infectious Disease Epidemiology and Inclusion Health Research at University College London, London, UK. Hayward, who is a member of the UK Government's Scientific Advisory Group for Emergencies (SAGE), adds: “The areas that are not currently in tier 4 can expect rapid increases in new variant cases which will likely lead to them needing to move into tier 4. Doing that now, instead of later, would prevent unnecessary hospitalisations and deaths and may decrease the length of time they need to be in tier 4.” At the time that this article went to press, the UK Government had been determined that school children would all be returning to school, albeit in a staggered fashion, immediately after the Christmas and New Year holidays. However, this plan is now in doubt, with the government suggesting only primary school children and secondary school children who are in important exam years (essentially 16 and 18 year olds) will return to the classroom immediately. Then, on New Year's Day, 2021, the Government announced a sudden change in strategy—all primary schools in London were told not to reopen as planned on Jan 4. There were calls (including from teachers' unions) to delay reopening of primary schools in all of England for 2 weeks, but in a hastily arranged television interview on the morning of Sunday Jan 3, Johnson said that only primary schools in the areas worst affected by the new variant would not reopen. He told the BBC that there is “no doubt in my mind that schools are safe” but did not rule out further closures. The leader of the opposition Labour Party, Kier Starmer, said in response that the virus was out of control and further school closures were “inevitable”. Starmer is among those calling for an immediate nationwide lockdown. Hayward explains that the decision to close schools or not could be the key factor in whether or not cases continue to increase. He said: “There is a high likelihood tier 4 will be insufficient to reduce the R number to below 1. Cases will continue to increase, albeit more slowly. This is based on the observation that the new strain increased in Kent and the southeast during lockdown, which is a more severe restriction than the current tier 4. Schools and universities being open may make the difference between being able to reduce R below 1 or not.” Following the latest announcements from the Prime Minster, Hayward adds that: “Even though schools have been provided with detailed guidance, and financial and practical support, it will be extremely challenging to implement mass testing of all pupils within the expected timeframes along with serial testing of classroom and other contacts of positive cases. The uptake and impact of school mass testing programmes is highly uncertain, as is the extent to which the new strain will increase transmission in schools and from school children to the wider community.” © 2021 Caia Image/Science Photo Library 2021 Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. According to research published on Dec 29, 2020, by the UK Health Agency Public Health England, the new variant appears to be no worse than the previous dominant strain of SARS-CoV-2 in terms of the risk of hospital admission, severity of illness, or mortality. The UK is confronting this new variant during the same month that two vaccines against the virus have been approved; the Pfizer-BioNTech and the Oxford-Astra Zeneca vaccines. The Oxford vaccine in particular has raised hopes that the UK could regain control and turn the tide on the COVID-19 pandemic by as early as April 2021, since its storage requirements are a lot less complex than the deep cold required for the transport and storage of the Pfizer vaccine. This means that it will be far easier for vital vaccine supplies to reach, and be stored at, venues such as care homes for the elderly. Vaccinations with the new Oxford vaccine were due to begin across the UK on Jan 4, while vaccinations with the Pfizer-BioNTech vaccine continue. In another key policy shift, the UK's medical experts said it was crucial to inoculate as many vulnerable people as possible with the first dose, since this would offer the most protection, rather than giving people the regular two-dose schedule of either vaccine. The second dose, they explained, can be given in the subsequent weeks or months after mortality and admissions have hopefully stablised. At a media briefing on Dec 30, 2020, PM Johnson said: “The public must redouble its efforts to control the virus at this critical moment” before adding he was confident the country's situation will be “very much better” by April 5, 2021 (Easter weekend). “All of these measures in the end are designed to save lives and protect the NHS. For that very reason, I must ask you [the public] to follow the rules where you live tomorrow night and see in the new year safely at home.” However, the new variant has piled additional pressure on to the speed at which vaccination must be achieved. Hayward is worried that, just as had been possible in the first wave, very vulnerable people, such as the homeless, could be ruthlessly exposed due to plunging winter temperatures and the failure of the UK government to so far provide local authorities with the resources to house homeless people in single room accommodation, mainly hotels, which are mostly standing empty due to the temporary death of the tourism industry. Back in March, 2020, the government helped the appropriate agencies and organisations get everybody off the streets and into such accommodation. “Many homeless people have this time had to stay on the street because of the dangers of opening communal night shelters and alternative provision not being available. This new coronavirus variant especially could cause havoc and a huge surge of cases in people least equipped to face them”, says Hayward. The charity Crisis at Christmas has housed large numbers temporarily in single room accommodation over the Christmas period, but they will need to return to the streets in early January. Hayward warns that: “If there are severe cold weather spells after this it is likely communal shelters will need to open to prevent people freezing. Due to the government's failure so far to repeat their efforts of earlier this year, homeless people are currently facing a stark choice between the dangers of cold or the dangers of COVID-19.” The UK remains one of the most badly affected countries. As of Dec 30, 2020, it had recorded more than 2 million cases of infection and more than 70 000 deaths. Driven by the new variant's increased infectiousness, the UK has reported more than 50 000 cases a day (a new record) in the last few days of December and the first few days of the new year. Almost 1000 deaths were reported on Dec 30, 2020, alone, and there are fears that the pandemic may get very much worse in the country before it gets better. However, the hope is that deaths and hospitalisations will plummet as the number of elderly and vulnerable people receiving the vaccine sharply increases in the coming weeks. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/948152/Technical_Briefing_VOC202012-2_Briefing_2_FINAL.pdf
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                Author and article information

                Contributors
                Role: Funding AcquisitionRole: Project AdministrationRole: ResourcesRole: Writing – Review & Editing
                Role: Formal AnalysisRole: InvestigationRole: Writing – Original Draft Preparation
                Role: ConceptualizationRole: InvestigationRole: Writing – Original Draft Preparation
                Role: InvestigationRole: Writing – Original Draft Preparation
                Role: ConceptualizationRole: Project AdministrationRole: Writing – Review & Editing
                Journal
                F1000Res
                F1000Res
                F1000Research
                F1000 Research Limited (London, UK )
                2046-1402
                28 July 2021
                2021
                : 10
                : 674
                Affiliations
                [1 ]Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, 361008, India
                [2 ]World Health Organization, Regional Office for the South East Asia, Indraprastha Estate, Mahatma Gandhi Marg, New Delhi, 110002, India
                [1 ]Department of Ras Shastra and Bhaishajya Kalpana, All India Institute of Ayurveda, University of Delhi, New Delhi, Delhi, India
                [1 ]School of Medicine, Keele University, Keele, UK
                [1 ]Department of Rasa Shastra and Bhaishajya Kalpana, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India
                Author notes

                No competing interests were disclosed.

                Competing interests: No competing interests were disclosed.

                Competing interests: No competing interests were disclosed.

                Competing interests: No competing interests were disclosed.

                Author information
                https://orcid.org/0000-0001-6078-6031
                Article
                10.12688/f1000research.55109.1
                8822137
                6ae6bd2f-b644-407a-8ccd-7ad93086df18
                Copyright: © 2021 Thakar A et al.

                This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 22 July 2021
                Funding
                Funded by: World Health Organization Regional Office for South-East Asia New Delhi, India
                Award ID: GrantregistrationNo.2021/1088286-0dated15/01/2021
                This work is supported by World Health Organization Regional Office for South-East Asia New Delhi, India (Grant registration No. 2021/1088286-0 dated 15/01/2021).
                The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Study Protocol
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                ayurvedic medicine,ayush,complementary therapies,covid-19,systematic review and meta-analysis

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