Community distribution in Nigeria of ivermectin for onchocerciasis, a disease that this drug treats safely and effectively. (Photo: Kate Holt / Sightsavers (CC BY-NC 2.0)
Although it is too early to say that the drug is useless, it has clearly been overrated and does not translate into the nickname “wonder drug”.
First published by GroundUp.
Ivermectin has been touted as the silver bullet to the Covid-19 crisis. Several trials have suggested that this might have some benefits. But the largest trial to date comparing ivermectin to a placebo was published on Friday. He found no statistically significant benefit from ivermectin but possible harm from the drug.
Yet even this trial is too small to definitively address the questions about the safety and effectiveness of ivermectin. Nonetheless, while some future trials may find benefits, there is now no doubt that this is not a wonder drug; whatever its advantages, they were at best modest.
The latter trial was carried out in Argentina by Julio Vallejos and his colleagues. The results were published in BMC infectious diseases 2nd of July. Its main result was to see if ivermectin reduced hospitalizations 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 a fairly complicated dosage regimen that depended on the patient’s weight.
Incredibly, it was extremely difficult to find patients for the trial. Why? It seems that too many Argentines were already taking ivermectin. Out of 15,968 people who tested positive for Covid and excluded from participating in the trial, 12,356 were unable to participate because they were already taking ivermectin. (We also hear anecdotal reports from South Africans using ivermectin.)
Fourteen people in the ivermectin arm were hospitalized compared to 21 in the placebo arm. Besides that this was not a statistically significant difference, there were more people with diabetes, perhaps the most serious risk factor for severe 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). Obviously, ivermectin was not found to be beneficial in this trial.
There was a statistically significant difference in the results. Four people in the ivermectin arm were to be ventilated versus three in the placebo arm, but ivermectin patients had to be ventilated five days after joining the study versus ten days in the placebo arm. That doesn’t mean ivermectin is dangerous, but it certainly doesn’t bode well for a drug that some have been promoting so much.
This study confirms the results of a Colombian study published in March in the Journal of the American Medical Association, who also found no statistically significant benefit of ivermectin over placebo. This study had 476 participants.
Another clinical trial, as far as we can tell, had more participants on ivermectin (400), but it had no participants on the placebo; instead, the control arm took hydroxychloroquine, another over-hyped drug that is ineffective against Covid-19 and possibly harmful. This study was carried out in Egypt and posed several serious ethical and methodological problems; for example, the study was completed before it was recorded (this is very bad for reasons that would require another article to explain).
The Egyptian study is not the only ethically questionable ivermectin study. The open access scientific journal, Borders, in a scathing editorial, rejected a widely circulated article by Pierre Kory that was used by ivermectin advocates.
the Border editor, Frederick Fenter, wrote: “[I]It was revealed that the article made a series of strong and unsubstantiated claims based on studies with insufficient statistical significance, and sometimes without the use of control groups. Additionally, the authors have promoted their own specific ivermectin treatment, which is inappropriate for a review article and contrary to our editorial policies.
Meanwhile, the South African Department of Health has just update his review on ivermectin which was first published in January. This is a very detailed book written by some of the country’s foremost experts on the evaluation of medicine. The authors reviewed all published studies on ivermectin. They conclude:
“There is currently not enough evidence to recommend ivermectin for the treatment of Covid-19. Much of the evidence from RCTs consists of trials of low methodological quality, mostly with small sample sizes and disparate interventions and controls, limiting confidence in the conclusions regarding ivermectin. Existing evidence does not suggest any clinical or virological benefit. “
The problem with all of the trials reported here is that they are still too small to draw any firm conclusions. Many drugs have been suggested for Covid-19 over the past 15 months. The biggest success is the Recovery Trial which aims to identify treatments that may be beneficial for people hospitalized with suspected or confirmed Covid-19. In one year, he recruited nearly 40,000 patients and investigated ten treatments. The trial identified that dexamethasone, an inexpensive steroid, saves the lives of hospital patients. He also identified another beneficial treatment, tocilizumab, an anti-inflammatory drug, and ruled out several others.
Peter Horby, co-head of the trial said Nature Review Drug Discovery: “It is very clear that there has been a tremendous amount of wasted resources, on multiple malnourished or poorly designed trials. It’s really disappointing, but I guess it’s not surprising because we’re in a pandemic and everyone wants to try and do something. “
The problem may be about to be solved with ivermectin. The University of Oxford is leading the PRINCIPE trial which is also recruiting thousands of patients to test Covid treatments. In June, it was reported that this study will now include ivermectin. Hopefully this will definitely answer questions about ivermectin as a treatment for Covid-19.
We are reading people on social media who say they have taken ivermectin and have recovered from Covid. But the problem with such claims is that it is impossible to know that the ivermectin was the reason the person got better. They might as well pretend it was the brand of coffee they were drinking. In any case, the vast majority of people who contract Covid recover, regardless of the medications they take. We are less likely to hear from people who have taken ivermectin and have become very ill or have died.
The history of ivermectin mirrors that of hydroxychloroquine. Both drugs, while still untested, have become the obsession of conspiracy theorists who believe tens of thousands of medical experts as well as public health officials are fooling the public and deny everyone lifesaving treatments. Ivermectin continues to be promoted in publications such as news. To advocate its use before a well-conducted clinical trial shows that it is safe and effective is highly irresponsible. DM
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This notice was published: 2021-07-05 13:27:18