- Sep 25, 2007
Full article: https://www.groundup.org.za/article/ivermectin-flops-largest-trial-yet/
While it’s too soon to say that the drug is useless, it has clearly been overhypedIvermectin has been touted as the wonder drug solution to the Covid-19 crisis. Several trials have suggested it may have some benefit. But the largest trial yet comparing ivermectin to placebo was published on Friday. It found no statistically significant benefit from ivermectin but possible harm from the drug.
Yet even this trial is too small to definitively settle questions about ivermectin’s safety and efficacy. Nevertheless, even if some future trial does find benefit, there is now little doubt that this is not a wonder drug; whatever benefits it may have are at most modest.
This latest trial was conducted in Argentina by Julio Vallejos and colleagues. The results were published in BMC Infectious Diseases on 2 July. It’s main outcome was to see if ivermectin reduced hospitalisation in people with Covid-19.
The trial included 501 volunteers, 250 randomly assigned to take ivermectin and the remaining 251 were assigned to a placebo arm. The trial used quite a complicated dosing regimen that depended on patient weight.
Incredibly it was extremely hard to find patients for the trial. Why? Too many Argentinians it seems were already taking ivermectin. Of 15,968 people who tested positive for Covid and were excluded from taking part in the trial, 12,356 could not participate because they were already taking ivermectin. (We are also hearing anecdotal reports of South Africans using ivermectin.)
Fourteen people on the ivermectin arm were hospitalised versus 21 on the placebo arm. Besides this not being a statistically significant difference, there were more people with diabetes, perhaps the most serious risk factor for serious Covid, in the placebo arm; there were also more people with hypertension in the placebo arm (weight and age were well matched between the arms). Quite clearly ivermectin was not shown to be beneficial in this trial.
There was one statistically significant difference in outcomes. Four people on the ivermectin arm needed to be put on ventilators versus three in the placebo arm, but the ivermectin patients needed to be ventilated five days after they joined the study versus ten days for the placebo arm. This doesn’t mean ivermectin is unsafe, but it definitely doesn’t bode well for a drug that some have promoted so hard.
This study confirms the results of a Columbian one published in March in the Journal of the American Medical Association, which also found no statisticially significant benefit from ivermectin versus placebo. That study had 476 participants.
One other clinical trial, as far as we can tell, has had more ivermectin participants (400), but it had no placebo participants; instead the control arm took hydroxychloroquine, another overhyped drug that is ineffective against Covid-19 and possibly harmful. That study was conducted in Egypt and had several serious ethical and methodological problems; for example the study was completed before it was registered (this is very bad for reasons that would require another article to explain).
The Egyptian study is not the only ethically questionable ivermectin one. The open access science journal, Frontiers, in a scathing editorial, rejected a widely circulated article by Pierre Kory that has been used by ivermectin advocates.
The Frontier editor, Frederick Fenter, wrote: “t was revealed that the article made a series of strong, unsupported claims based on studies with insufficient statistical significance, and at times, without the use of control groups. Further, the authors promoted their own specific ivermectin-based treatment which is inappropriate for a review article and against our editorial policies.”