Concerns regarding the misinterpretation of statistical hypothesis testing in clinical trials for COVID-19
et al., Open Letter, Aug 2020
HCQ for COVID-19
1st treatment shown to reduce risk in
March 2020, now with p < 0.00000000001 from 424 studies, used in 59 countries.
No treatment is 100% effective. Protocols
combine treatments.
6,300+ studies for
210+ treatments. c19early.org
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Open letter signed by 38 professors and doctors regarding misinterpretation of statistics in HCQ RCTs.
Authors note1 that data from RCTs for early treatment in outpatients to date actually show favorable effects, especially in high-risk patients such as the elderly, where efficacy was up to three times higher than in young people. Because most samples were made up of young people without comorbidities, the studies were statistically inconclusive with the entire samples. Authors note that instead of the papers reporting this, they incorrectly claim that the treatment had no effect compared to the placebo. “This misinterpretation in statistical tests is well known and explained in most undergraduate books in the field,” says Watanabe. "An article published in Nature last year states that about 51% of the work on clinical trials with this type of result has incorrect conclusions."
9 meta analyses show significant improvements with hydroxychloroquine for mortality2-5,
hospitalization2,
recovery6,
combined death/hospitalization/cases7,
cases8,9, and
viral clearance10.
Currently there are 38 HCQ for COVID-19 early treatment studies, showing 76% lower mortality [61‑85%], 67% lower ventilation [-710‑99%], 31% lower ICU admission [1‑53%], and 41% lower hospitalization [28‑51%].
1.
veja.abril.com.br, veja.abril.com.br/saude/especialistas-contestam-estudos-que-nao-viram-beneficios-na-cloroquina/amp/.
2.
Landsteiner de Sampaio Amêndola et al., COVID-19 Infection in Rheumatic Patients on Chronic Antimalarial Drugs: A Systematic Review and Meta-Analysis, Journal of Clinical Medicine, doi:10.3390/jcm11226865.
3.
Risch, H., Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis, American Journal of Epidemiology, kwaa093, 27 May 2020, doi:10.1093/aje/kwaa093.
4.
Risch (B), H., Response to: “Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients” and “Re: Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis”, American Journal of Epidemiology, July 20, 2020, doi:10.1093/aje/kwaa152.
5.
Stricker et al., Hydroxychloroquine Pre-Exposure Prophylaxis for COVID-19 in Healthcare Workers from India: A Meta-Analysis, Journal of Infection and Public Health, doi:10.1016/j.jiph.2021.08.001.
6.
Prodromos et al., Hydroxychloroquine is effective, and consistently so used early, for Covid-19: A systematic review, New Microbes and New Infections, doi:10.1016/j.nmni.2020.100776.
7.
Ladapo et al., Randomized Controlled Trials of Early Ambulatory Hydroxychloroquine in the Prevention of COVID-19 Infection, Hospitalization, and Death: Meta-Analysis, medRxiv, doi:10.1101/2020.09.30.20204693.
8.
García-Albéniz et al., Systematic review and meta-analysis of randomized trials of hydroxychloroquine for the prevention of COVID-19, European Journal of Epidemiology, doi:10.1007/s10654-022-00891-4.
Watanabe et al., 6 Aug 2020, preprint, 42 authors.
