Therapeutic efficacy of Honey and Nigella sativa against COVID-19: A multi-center randomized controlled clinical trial (HNS-COVID-PK)
Sohaib Ashraf, et al
Dr Weeks’ Comment: eat the seeds and stop white sugar/ high fructose corn syrup and eat raw organic honey.
MedrxIV preprint
Abstract
BACKGROUND Coronavirus Disease 2019 (COVID-19 is causing havoc across the globe. Since no effective treatment exists for the disease, there is a dire need to find one. Honey and Nigella sativa (HNS) are two natural food ingredients with anti-inflammatory, anti-viral, anti-microbial and immune modulating properties. We investigated whether they could be beneficial in COVID-19 patients.
METHODS We conducted an add-on, randomized, open label, placebo-controlled clinical trial using parallel group design. This was a multi-center study with superiority framework conducted in RT-PCR confirmed COVID-19 adults showing moderate or severe disease. A study period of three months was defined. Patients presenting with multi-organ failure, ventilator support and chronic diseases (except diabetes mellitus and hypertension) were excluded. All patients receiving standard care were randomized into treatment and control groups. In the treatment group, patients received HNS in predefined doses for up to 13 days. Outcome measures (time taken for alleviation of symptoms, viral clearance, clinical status improvement and mortality etc) were assessed along the course of the trial.
RESULTS Of 1046 patients testing positive for the SARS-CoV-2, 210 with moderate and 103 with severe disease were randomized into treatment and control groups. For the moderate cases, 107 were assigned to the HNS group and 103 to the control group, whereas for the severe cases, 50 were assigned to the HNS group and 53 to the control group. In both the moderate and severe cases, HNS treatment was associated with an earlier alleviation of disease symptoms, by 3 and 7 days (HR: 6.11; 95% CI: 4.23-8.84, P<0.0001 and HR: 4.04; 95% CI, 2.46-6.64, P<0.0001) respectively. The treatment was also associated with significant earlier viral clearance in both the moderate and severe disease groups (4 days earlier reduction in median viral clearance time (moderate HR: 5.53; 95% CI: 3.76-8.14, P<0.0001 and severe HR: 4.32; 95% CI: 2.62-7.13, P<0.0001).). Also, a higher %age of patients cleared virus in the HNS group. Moreover, in the intention-to-treat analysis, the HNS groups led to a lower (better) clinical score on day 6 with resumption of normal activity among 63.6% of the moderate (OR: 0.07; 95% CI: 0.03-0.13, P<0.0001) and 28% of severe cases (OR: 0.03; 95% CI: 0.01-0.09, P<0.0001). Furthermore, a significant reduction in mortality among severe patients was observed in the HNS arm (4% versus 18.87%, OR: 0.18; 95% CI: 0.02-0.92, P=0.029). No HNS-related adverse effects were noted.
CONCLUSIONS The honey nigella sativa seed (HNS) treatment resulted in a significant reduction in in the severity of clinical symptoms, earlier viral clearance and reduced mortality in COVID-19 patients. In the current study, it represents a safe, effective, over the counter and affordable therapy for this disease and could potentially lower burden on health care systems across the World. It can be used alone or in combination with other treatments to achieve potentiating effects.