M’sian study gets global attention
Research concludes no evidence to support ivermectin improves patient outcome
PETALING JAYA: The findings of a Health Ministry clinical study on the use of the deworming medication ivermectin for treating Covid19 patients has grabbed international media attention.
The study concluded that there is no evidence to support the use of ivermectin to improve the outcome for patients with Covid-19.
The results of the study, “Efficacy of Ivermectin Treatment on Disease Progression Among Adults With Mild to Moderate Covid-19 and Comorbidities” conducted from May to October last year, was published in the “Jama Internal Medicine Journal” on Friday and picked up by international news agencies.
The open-label, randomised clinical trial was conducted on 490 highrisk patients at 20 public hospitals and a Covid-19 quarantine centre in Malaysia, with the goal of shedding light on whether ivermectin, an inexpensive and widely available anti-parasitic drug, would be able to make a difference to the risk of these Covid-19 patients developing even more severe conditions, compared to a group that was given only “standard care”.
Researchers at the ministry’s Institute for Clinical Research administered ivermectin orally over five days during the first week of illness.
Severe disease (defined as requiring oxygen to help with breathing) developed in 21.6% of the patients given ivermectin and in 17.3% of those who received only standard care, said the team led by Dr Steven Lim Chee Loon as principal investigator, with co-investigators Dr Tay Kim Heng and Dr Hor Chee Peng.
The study found no statistically significant differences between the study and control groups in rates of intensive care unit admission, need for mechanical ventilation or deaths.
The study also revealed that those who had ivermectin experienced more adverse events.
“A total of 55 adverse events occurred in 44 patients (9%). Among them, 33 were from the ivermectin group, with diarrhoea being the most common adverse event,” said the investigators.
The authors acknowledged that one weakness of the study is that it was an open-label trial, where both the healthcare providers and the patients were aware of the drug or treatment being given, versus fully blind trials, where such information is concealed from both parties (usually until the study is over).
“Doctors and patients all knew which group the patients had been assigned to, and this could have introduced bias, potentially overestimating the effect of the drug,” the researchers said.
In November last year, the Health Ministry announced that ivermectin cannot be recommended for inclusion in Covid-19 treatment guidelines in the absence of clinical evidence.
As recently as December 2021, the US Food and Drug Administration (FDA) has not authorised or approved ivermectin for use in preventing or treating Covid-19 in humans or animals.
“Ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea. Currently, available data does not show ivermectin is effective against Covid-19.
“Clinical trials assessing ivermectin tablets for the prevention or treatment of Covid-19 in people are ongoing,” the FDA said.
The World Health Organisation (WHO) is also maintaining its position last espoused in March 2021, where it said the current evidence on the use of ivermectin to treat Covid-19 patients remains inconclusive.
“Until more data is available, WHO recommends that the drug only be used within clinical trials,” it said.
In a response to The Star, Health director-general Tan Sri Dr Noor Hisham Abdullah said the ministry has provided the platforms for quality research to take place.
“The Institute for Clinical Research study is being picked up globally. (We are) very proud of this achievement,” he said of the findings that have been picked up by news agencies such as Reuters and CNN.
The study can be read at: https://bit.ly/353nrw1