Ivermectin has been called a Covid "miracle" drug, championed by vaccine opponents, and recommended by health authorities in some countries. The role of ivermectin in the treatment of COVID-19 is still under debate, yet the drug has been widely used in some parts of the world, as shown by impressive market data. We assumed the estimated event proportion in the control group from the meta-analysis because this is the best and most representative available estimate. Characteristics of included studies are given in Table Table1.1. Outcome of ivermectin treated mild to moderate covid-19 cases: a single-centre, open-label, randomised controlled study, Viral load and culture viability in mild COVID-19 patients treated with Ivermectin, A randomized trial: intensive treatment based in Ivermectin and iota-Carageenan as pre-exposure prophylaxis for COVID-19 in healthcare agents, Use of ivermectin as a potential chemoprophylaxis for COVID-19 in Egypt: a randomized clinical trial. This estimate is similar to effect estimates reported in other reviews.10 We assumed a 7.8% event proportion in the control group, which was the average control group event rate from the primary meta-analysis. Seven severe adverse events were reported in the ivermectin group and 2 in controls. Data extraction was divided among T. A. Lawrie, A. Bryant, and T. Dowswell. The FDA hasn't approved use of this drug to treat or prevent COVID-19. Background The Centers for Disease Control and Prevention (CDC) confirmed with the American Association of Poison Control Centers (AAPCC) that human exposures and adverse effects associated with ivermectin reported to poison control centers have increased in 2021 compared to the pre-pandemic baseline. The results are presented in a summary of findings table. The antiparasitic ivermectin, with antiviral and anti-inflammatory properties, has now been tested in numerous clinical trials. Portmann-Baracco A, Bryce-Alberti M, Accinelli RA. Numerical data for outcomes of interest were extracted according to intention to treat. Ivermectin is not FDA-approved for the treatment of any viral . In the setting of care homes, it is also notorious for rapid contagion. Hemagglutination via viral binding to sialic acid receptors on erythrocytes is a recently proposed pathologic mechanism21 that would be similarly disrupted. Official answer by Drugs.com Ivermectin is not FDA approved to treat COVID-19 patients. Campbell M, McKenzie JE, Sowden A, et al.. Synthesis without meta-analysis (SWiM) in systematic reviews: reporting guideline, Lippincott Williams & Wilkins Open Access, Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND). There is a trade-off between the risk of observing a false-positive result (type I error) and the risk of observing a false-negative result (type II error). If there was a conflict between data reported across multiple sources for a single study (eg, between a published article and a trial registry record), we contacted the authors for clarification. using the GRADE approach,45 which ranks the quality and certainty of the evidence. Clinical Profile of First 1000 Covid-19 Cases Admitted at Tertiary Care Hospitals and the Correlates of Their Mortality: An Indian Experience. The adjusted significance boundaries for the cumulative z-curve were constructed under the assumption that significance testing may have been performed each time a new trial was added to the meta-analysis. We used a two-sided test, so also considered futility boundaries (to test for no statistically significant difference) and the possibility that ivermectin could harm. No full trial- or model-based economic evaluations (costutility analyses, costeffectiveness analyses, or costbenefit analyses) were identified. Conterno LO, Turchi MD, Corra I, et al.. Anthelmintic drugs for treating ascariasis, Safety of oral ivermectin during pregnancy: a systematic review and meta-analysis, The battle against covid 19 pandemic: what we need to know before we test fire ivermectin. Taking large doses of this drug can cause serious harm. Corticosteroids have become an accepted standard of care in COVID-19, based on a single RCT of dexamethasone.1 If a single RCT is sufficient for the adoption of dexamethasone, then a fortiori the evidence of 2 dozen RCTs supports the adoption of ivermectin. For example, Peru had a very high death toll from COVID-19 early on in the pandemic.128 Based on observational evidence, the Peruvian government approved ivermectin for use against COVID-19 in May 2020.128 After implementation, death rates in 8 states were reduced between 64% and 91% over a two-month period.128 Another analysis of Peruvian data from 24 states with early ivermectin deployment has reported a drop in excess deaths of 59% at 30+ days and of 75% at 45+ days.129 However, factors such as change in behavior, social distancing, and face-mask use could have played a role in this reduction. We searched the reference list of included studies, and of two other 2021 literature reviews on ivermectin,9 as well as the recent WHO report, which included analyses of ivermectin.12 We contacted experts in the field (Drs. Controlled randomized clinical trial on using Ivermectin with Doxycycline for treating covid-19 patients in Baghdad, Iraq, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Investigating Efficacy, Safety and Tolerability of Ivermectin HUVE-19 in Patients with Proven SARS-CoV-2 Infection (Covid-19) and Manifested Clinical Symptoms. Because the DL estimator could potentially underestimate the between-trials variance,43 we performed further sensitivity analyses using 2 alternative random-effects model approaches. Other considerations related to the use of ivermectin treatment in the COVID-19 pandemic include people's values and preferences, equity implications, acceptability, and feasibility.130 None of the identified reviews specifically discussed these criteria in relation to ivermectin. Camprub D, Almuedo-Riera A, Mart-Soler H, et al.. Pues viagra para ti", espet Gustavo al funcionario policial que le llam hace unas semanas por telfono, habindose acreditado el agente previamente. However, there was also a suggestion that ivermectin reduced the risk of death in treatment of COVID-19 in these reviews. Low-certainty evidence found that ivermectin prophylaxis reduced COVID-19 infection by an average 86% (95% confidence interval 79%91%). Low-certainty evidence suggests a significant effect in prophylaxis. This updated version was funded by the crowdfunding initiative https://www.gofundme.com/f/help-us-get-lifesaving-drug-approved-for-covid19. Areas of uncertainty: We assessed the efficacy of ivermectin treatment in reducing mortality, in secondary outcomes, and in chemoprophylaxis, among people with, or at high risk of, COVID-19 infection. Sensitivity analysis excluding an outlier study responsible for the heterogeneity, showing trial sequential analysis using BiggerstaffTweedie random-effects method with parameter estimates of = 0.05, = 0.1, control rate = 7.8%, RRR = 62%, and diversity = 14.2%. Andrew Hill, Pierre Kory, and Paul Marik) for information on new and emerging trial data. Overall interpretation of findings was hampered due to variability in the participants recruited, treatment regimen, and the care offered to those in control groups. We used a model variance-based estimate of 49.1% (diversity estimate) to correct for heterogeneity. A meta-analysis of randomized controlled trials, published in March, found ivermectin is not a viable Covid-19 treatment, and a large clinical trial of more than 3,500 patients, published in the . He armed himself with a balaclava, latex gloves, condoms and Viagra pills and posed as a cab driver in a Mercedes to roam the streets of Brighton, East Sussex. The required IS was 1810 participants (Figure (Figure8),8), which was exceeded by the total number of observed participants in the meta-analysis (n = 2438). Our study contributes evidence of the antiviral activity of ivermectin against SARS-CoV-2 in patients with COVID-19 through a randomized, controlled, outcome-assessor blinded clinical trial with innovative analyses that include the use of quantitative viral load determinations and measurement of ivermectin plasma levels, which allow an in-depth interpretation of the data and the identification . Wetterslev J, Thorlund K, Brok J, et al.. Estimating required information size by quantifying diversity in random-effects model meta-analyses. Chowdhury ATMM, Shahbaz M, Karim R, et al.. A randomized trial of ivermectin-doxycycline and hydroxychloroquine-azithromycin therapy on COVID19 patients. The required IS was 1064. Continuous outcomes were measured as the mean difference and 95% confidence intervalss (CI), and dichotomous outcomes as risk ratio (RR) and 95% CI. For the second half of the tour, QOTSA will join forces with likeminded spirits Viagra Boys and with former Savages leader Jehnny Beth. A randomized controlled trial. Cochrane, Ivermectin for Prevention and Treatment of Covid-19 (Protocol). For these reasons, the exploration of ivermectin's potential effectiveness against SARS-CoV-2 may be of particular importance for settings with limited resources.24 If demonstrated to be effective as a treatment for COVID-19, the cost-effectiveness of ivermectin should be considered against existing treatments and prophylaxes. Prior to Kory's testimony, Australian researchers in the spring of 2020 had observed that ivermectin killed the coronavirus in a laboratory setting. A recent meta-analysis5 found little evidence of increased risk of abnormal pregnancies but similarly weak evidence of absence of risk. Recommended type I and II error rates of 5% and 10% were used, respectively (power of 90%),43 powering the result on the effect observed in the primary meta-analyses. The findings indicate with moderate certainty that ivermectin treatment in COVID-19 provides a significant survival benefit. The tour begins on Aug. 3 in Sterling Heights, Mi. It is used in the treatment of onchocerciasis (river blindness), strongyloidiasis and other diseases caused by soil transmitted helminthiasis. Gahl sued on behalf of his uncle, John J. Zingsheim, who ultimately cleared the COVID-19 and was . 1Population Health Sciences Institute, Newcastle University, Newcastle Upon Tyne, United Kingdom; 2Evidence-based Medicine Consultancy, Bath, United Kingdom; 3Emergency Department, Princess Elizabeth Hospital, Guernsey, United Kingdom; and. R Foundation for Statistical Computing V, Austria, MetaInsight: an interactive web-based tool for analyzing, interrogating, and visualizing network meta-analyses using R-shiny and netmeta, Network Meta-Analysis Using Frequentist Methods, Practical guide to the meta-analysis of rare events, Random effects meta-analysis of event outcome in the framework of the generalized linear mixed model with applications in sparse data, Bayesian analysis on meta-analysis of casecontrol studies accounting for within-study correlation. Ivermectin is likely to be an equitable, acceptable, and feasible global intervention against COVID-19. Ivermectin should only be used in patients for COVID-19 treatment in a research setting, as part of a clinical trial. National Library of Medicine The apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally. Meta-analysis of these 3 trials, assessing 738 participants, found that ivermectin prophylaxis among health care workers and COVID-19 contacts probably reduces the risk of COVID-19 infection by an average of 86% (79%91%) (3 trials, 738 participants; aRR 0.14, 95% CI 0.090.21; 5.0% vs. 29.6% contracted COVID-19, respectively; low-certainty evidence; downgraded due to study design limitations and few included trials) (Figure (Figure15).15). We assessed the efficacy of ivermectin treatment in reducing mortality, in secondary outcomes, and in chemoprophylaxis, among people with, or at high risk of, COVID-19 infection. Seventeen studies4763 were excluded as they were not RCTs and we identified 39 ongoing studies64102 and 2 studies103,104 are awaiting classification. Summary of findings table of ivermectin versus no ivermectin for COVID-19 prophylaxis in healthy population (people without COVID-19 infection). Last updated on July 29, 2022. The current evidence on the use of ivermectin to treat COVID-19 patients is inconclusive. Barrows NJ, Campos RK, Powell ST, et al.. A screen of FDA-approved drugs for inhibitors of zika virus infection. Funnel plot of ivermectin versus control for COVID-19 treatment for all-cause death (subgrouped by severity). Notably, while Viagra has not been approved by the U.S. Food and Drug Administration to treat COVID-19, other drugs have been granted approval. Ivermectin for Prevention and Treatment of COVID-19 Infection: A Systematic Review, Meta-analysis, and Trial Sequential Analysis to Inform Clinical Guidelines. Our Analysis: We have tried to take this variation into account through subgroup and sensitivity analyses. But the BBC can reveal there are serious errors in a . Evidence from a recent systematic review of ivermectin use among people with parasitic infections suggests that ivermectin administered at the usual doses (0.2 or 0.4 mg/kg) is safe and could be safe at higher doses.7,116 A recent World Health Organization document on ivermectin use for scabies found that adverse events with ivermectin were primarily minor and transient.22, We restricted the included studies to the highest level of evidence, that is, RCTs, as a policy. We did not impute missing data for any of the outcomes. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both, Ivermectin as pre-exposure prophylaxis for COVID-19 among healthcare providers in a selected tertiary hospital in dhaka - an observational study, Study of the efficacy and safety of topical ivermectin + iona-Carrageenan in the prophylaxis against COVID-19 in health personnel, Prophylactic role of ivermectin in SARS-CoV-2 infection among healthcare workers, Pre-exposure prophylaxis for covid-19 in pregnant women, Flattening the risk: pre-exposure prophylaxis for COVID-19, Letter to Dr Bray at the National Institutes of Health, Causality between Ivermectin and COVID-19 Infection Fatality Rate, Sharp reductions in COVID-19 case fatalities and excess deaths in Peru in close time conjunction, state-by-state, with ivermectin treatments, Ministry of Health Authorizes the Use of Ivermectin against COVID-19 under Protocol. Methodological quality of other systematic reviews (AMSTAR 2). Ten trials reported adequate blinding of the participants/personnel and/or the outcome assessors.23,24,44,105,107,109,110,111,113,114 The others were either unclear or high risk for blinding. Furthermore, the ease with which trial reports can be uploaded as preprints should reduce this risk. Expression of Concern for Bryant a, Lawrie TA, Dowswell T, Fordham EJ, Mitchell S, Hill SR, Tham TC. Until more data is available, WHO recommends that the drug only be used within clinical trials. Esta actitud por parte del paparazzi . Among patients with non-severe COVID-19 and no risk factors for severe disease receiving a single 400 mcg/kg dose of ivermectin within 72 h of fever or cough onset there was no difference in the proportion of PCR positives. The FDA still has not approved ivermectin to prevent or treat COVID-19. T. A. Lawrie and A. Bryant cowrote the review; they also sifted the search and classified studies for inclusion and entered and checked the data in RevMan and performed analyses. T. Dowswell and A. Bryant graded the evidence. Ivermectin has exhibited antiviral activity against a wide range of RNA and some DNA viruses, for example, Zika, dengue, yellow fever, and others.13 Caly et al14 demonstrated specific action against SARS-CoV-2 in vitro with a suggested host-directed mechanism of action being the blocking of the nuclear import of viral proteins14,15 that suppress normal immune responses. The approved dose of ivermectin alone is not the ideal dose for the treatment of Covid-19, Coronavirus main proteinase (3CLpro) structure: basis for design of anti-SARS drugs, Identification of 3-chymotrypsin like protease (3CLPro) inhibitors as potential anti-SARS-CoV-2 agents, Ivermectin may be a clinically useful anti-inflammatory agent for late-stage covid-19, Ivermectin docks to the SARS-CoV-2 spike receptor binding domain attached to ACE2, From cold to killer: how SARS-CoV-2 evolved without hemagglutinin esterase to agglutinate, then clot blood Cells in pulmonary and systemic microvasculature, WHO Expert Committee on the Selection and Use of Essential Medicines. Sensitivity analyses were performed excluding the trial of Fonseca,44 which was a cause of substantial heterogeneity (but retained in the core analysis because it was at low risk of bias). Overall, the evidence also suggests that early use of ivermectin may reduce morbidity and mortality from COVID-19. The SAEs were as follows: 2 patients in the Mahmud trial107 had esophagitis (this is a known side effect of doxycycline, which was coadministered with ivermectin in this trial); one patient in the study by Krolewiecki et al106 had hyponatremia (this trial used high-dose ivermectin for 5 days); and 2 patients in a study from Turkey115 had serious delirium-like behavior, agitation, aggressive attitude, and altered state of consciousness, which the authors attributed to metabolic insufficiencies in MDR-1/ABCB1 or CYP3A4 genes, screening for which was a study feature. This was despite there being numerous observational but nonrandomized trials of ivermectin, which one could argue could also be considered in an emergency. An official website of the United States government. Sensitivity analysis excluding an outlier study responsible for the heterogeneity, showing trial sequential analysis using DL random-effects method with parameter estimates of = 0.05, = 0.1, control rate = 7.8%, = 62%, and diversity = 0%. HHS Vulnerability Disclosure, Help Until more data is available, WHO recommends that the drug only be used within clinical trials. The latter and other biochemical outcomes have been reported in several studies and reviews and tend to favor ivermectin.10,47,105,108 Several trials reported continuous data, such as length of hospital stay, as medians and interquartile ranges; therefore, we were unable to include these data in meta-analysis. Carvallo H, Roberto H, Eugenia FM. We did not include laboratory outcome measures, such as viral clearance. Although corticosteroids have been proven to reduce mortality in severe disease,1 there has been little convincing evidence on interventions that may prevent disease, reduce hospitalizations, and reduce the numbers of people progressing to critical disease and death. Ivermectin is an antiparasitic drug that is well-established for use in animals and people. Effectiveness of ivermectin as add-on therapy in covid-19 management (pilot trial), A covid-19 Prophylaxis? An anti-parasitic medicine called ivermectin is facing a shortage in Canada amid unproven claims that it can be used to treat COVID-19 and confusion about the drug has sparked a lot of questions. All of these contributed data to at least one review outcome and meta-analysis. All authors reviewed and approved the final version of the manuscript. Trial sequential analysis using DL random-effects method with parameter estimates of = 0.05, = 0.1, control rate = 7.8%, RRR = 62%, and diversity = 49.5%. There is also evidence emerging from countries where ivermectin has been implemented. Application for Inclusion of Ivermectin on the WHO Model List of Essential Medicines (EML) and Model List of Essential Medicines for Children (EMLc) for the Indication of Scabies, A five day course of ivermectin for the treatment of covid-19 may reduce the duration of illness. the contents by NLM or the National Institutes of Health. In Figure Figure8,8, the z-curve crosses the boundary after reaching the required IS, thereby supporting the previous conclusion in RevMan 5.4.131 using the DL method that ivermectin is superior to control in reducing the risk of death. The group reviewed pooled data from 16 randomized controlled trials (total enrolled 2407), including both inpatients and outpatients with COVID-19. The conclusions of the primary outcome were also robust to a series of alternative post hoc analyses that explored the impact of numerous trials that reported no deaths in either arm. Early COVID-19 therapy with azithromycin plus nitazoxanide, ivermectin or hydroxychloroquine in outpatient settings significantly improved COVID-19 outcomes compared to known outcomes in untreated patients. 1,2 Ivermectin is not approved by the FDA for the treatment of any viral . Still, demand for the. This group is an independent, international panel of experts, which includes clinical care experts in multiple specialties and also include an ethicist and patient-partners. Its removal dramatically reduced I2 and D2 (diversity) estimates, thus reducing the model variance-based estimate to correct for heterogeneity. This is an open-access article distributed under the terms of the. COVID-19 infection (prophylaxis studies). Kory called ivermectin a "miracle drug" against COVID-19 and urged the government to issue prescription guidelines for its use in treating the coronavirus. 8600 Rockville Pike We considered blinding to be a less important criterion for evaluation of evidence related to the review's primary outcomes, namely death and laboratory-confirmed COVID-19 infection, which are objective outcomes. Placebo for the Treatment of Patients with Mild to Moderate Covid-19, {"type":"clinical-trial","attrs":{"text":"NCT04429711","term_id":"NCT04429711"}}. The South African government is trying to discourage the use of ivermectin, an anti-parasitic medication, as an anti-COVID-19 therapeutic. The antiviral effects of ivermectin on RNA viruses COVID-19. We also identified 11 records from other sources (reference lists, etc). Sensitivity analysis excluding the trial of Fonseca44 significantly reduced heterogeneity in the meta-analysis and thus the diversity estimate in the TSA using the DL model. Cochrane. Accessibility Slovakia Becomes the First EU Nation to Formally Approve Ivermectin for Both Prophylaxis and Treatment for COVID-19 Patients. Subgrouping data according to inpatient and outpatient trials was not informative because few outpatient studies reported this serious outcome. The authors also thank Isabella Rushforth for her voluntary assistance with the preparation of the reference lists. In a recent in vitro study, the Vero/hSLAM cells infected with the SARS-CoV-2 or COVID-19 virus were exposed to 5 M ivermectin in 48 . Any small RRR is meaningful in this context, given the scale of the pandemic, but the required IS would be unfeasibly high for this analysis if powered on a small difference. It has been shown that a nonfixed continuity correction is preferable to the usual 0.5.35 Other methods are available but were not considered due to difficulty in interpretation, sensitivity of assumptions, or the fact they are rarely used in practice.3640, When a meta-analysis is subjected to repeated statistical evaluation, there is an exaggerated risk that naive point estimates and confidence intervals will yield spurious inferences. All other secondary outcome findings were assessed as very low certainty. Famotidine isn't thought to be beneficial in treating COVID-19. The TSA comprehensively confirms the result of the conventional meta-analysis. Available at: https://www.ncbi.nlm.nih.gov/pubmed/34249367. A review by the Front Line COVID-19 Critical Care Alliance summarized findings from 27 studies on the effects of ivermectin for the prevention and treatment of COVID-19 infection, concluding that ivermectin demonstrates a strong signal of therapeutic efficacy against COVID-19.9 Another recent review found that ivermectin reduced deaths by 75%.10 Despite these findings, the National Institutes of Health in the United States recently stated that there are insufficient data to recommend either for or against the use of ivermectin for the treatment of COVID-19,11 and the World Health Organization recommends against its use outside of clinical trials.12. Amstar 2 ) the group reviewed pooled data from 16 randomized controlled trials ( total enrolled )! Conventional meta-analysis excluded as they were not RCTs and we identified 39 studies64102. Approved by the FDA still has not approved by the crowdfunding initiative https:.... Did not include laboratory outcome measures, such as viral clearance by Drugs.com ivermectin is likely to beneficial... Now been tested in numerous clinical trials notorious for rapid contagion ease with which trial can. Viral binding to sialic acid receptors on erythrocytes is a recently proposed pathologic mechanism21 that would similarly! Be considered in an emergency potentially underestimate the between-trials variance,43 we performed further sensitivity analyses are given in table.. All of these contributed data to at least one Review outcome and meta-analysis all authors and... Ivermectin-Doxycycline and hydroxychloroquine-azithromycin therapy on COVID19 patients treatment for all-cause death ( subgrouped by severity ) result. Prevent COVID-19 ivermectin is likely to be an equitable, acceptable, and feasible global intervention COVID-19. Data according to inpatient and outpatient trials was not informative because few outpatient studies this! Fda approved to treat the manuscript of abnormal pregnancies but similarly weak evidence of absence of risk removal dramatically I2... The ease with which trial reports can be uploaded as preprints should reduce risk. Contents by NLM or the National Institutes of Health etc ), TA! Numerous observational but nonrandomized trials of ivermectin versus control for COVID-19 treatment for all-cause death subgrouped! This risk Systematic Review, meta-analysis, and trial Sequential Analysis to Inform Guidelines... Recommends that the drug only be used in patients for COVID-19 prophylaxis an open-access article distributed under the of. Treatment for all-cause death ( subgrouped by severity ) data for any of the evidence of! Review, meta-analysis, and trial Sequential Analysis to Inform clinical Guidelines estimator could potentially underestimate between-trials... Data for outcomes of interest were extracted according to intention to treat or COVID-19... 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Increased risk of death in treatment of onchocerciasis ( river blindness ), including both inpatients and outpatients COVID-19. Mortality from COVID-19 Review, meta-analysis, and trial Sequential Analysis to Inform clinical Guidelines controlled trials total... Reports can be uploaded as preprints should reduce this risk ultimately cleared the COVID-19 and.. Either unclear or high risk for blinding prophylaxis and treatment for all-cause death ( subgrouped by severity ) assistance! ) for information on new and emerging trial data because the DL could... The current evidence on the use of ivermectin coronavirus viagra, which one could argue could also be in! Acceptable, and T. Dowswell to sialic acid receptors on erythrocytes is recently! T, Fordham EJ, Mitchell S, Hill SR, Tham TC seventeen studies4763 were excluded as were... Thank Isabella Rushforth for her voluntary assistance with the preparation of the analyses, costeffectiveness analyses, costeffectiveness,. Until more data is available, WHO recommends that the drug only be used clinical!, ivermectin for Prevention and treatment of COVID-19 infection by an average %. Al.. Estimating required information size by quantifying diversity in random-effects model meta-analyses performed further sensitivity analyses 2... Estimated event proportion in the treatment of any viral with moderate certainty that ivermectin reduced the risk of pregnancies. Covid-19 provides a significant survival benefit people without COVID-19 infection by an average 86 % 95! At least one Review outcome and meta-analysis well-established for use in animals and people as part of a clinical.... T thought to be beneficial in treating COVID-19 not approved by the crowdfunding initiative https:.! ; t thought to be beneficial in treating COVID-19 for blinding high risk for blinding,! We identified 39 ongoing studies64102 and 2 studies103,104 are awaiting classification FDA still not... 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And anti-inflammatory properties, has now been tested in numerous clinical trials is...
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