Deficiencies in i-TECH study report


Wong Ang Peng

The I-TECH study was designed to study specifically advanced cases of Covid-19 patients, aged 50 and above and with at least one comorbidity, using low doses of ivermectin plus standard care compared to standard care alone.– AFP pic, November 9, 2021.

THE results of the just released summarised report of the Health Ministry’s I-TECH (Ivermectin Treatment Efficacy in Covid-19 High Risk Patients) are as anticipated, a construct of hidden truth, and currently irrelevant. There are several deficiencies in the report.

Those familiar with research methodology had anticipated that the outcome of the I-TECH study would be statistically non-significant because it was underpowered (n=500).

It was not expected to produce a probability value beyond the alpha threshold of 5%. The mean value between the two treatment arms was expected to be small. 

The outcome of a clinical study is limited to how the study is designed. The I-TECH study was designed to study specifically advanced cases of Covid-19 patients, aged 50 and above and with at least one comorbidity, using low doses of ivermectin plus standard care compared to standard care alone.

Hence, the negative I-TECH results cannot and must not be generalised to implicate all types of Covid-19 cases, including asymptomatic and those with mild symptoms (categories 1 and 2), or for prophylaxis.

Several studies on ivermectin had concluded that it worked best as prophylaxis and in early Covid cases. Dosage was also important.

Advanced cases need higher dosage, more frequency and longer duration of treatment. Treating a disease that inflicts simultaneously on different bodily systems through different pathways requires a multi-prong approach, including use of other micronutrients and biomedical medication. Ivermectin should not be a stand-alone medication for Covid-19.

Embarking on a clinical trial without first conducting a thorough literature search to understand what others have studied is a waste of time and resources.

Research is conducted to explore the frontier of scientific knowledge, explore the unknown and what others have not covered. Previous studies have established that ivermectin might not work well in advanced Covid cases, and if used, the dosage matters.

The I-TECH study has clearly overstepped the bounds of research governance.

In reporting the results of scientific studies, restraining the use of exaggeration and rhetorical language is a norm. There must be no over-claim.

The tone of the report should reflect humility. It should strive to avoid conveying the impression that the study has the ultimate and conclusive finding.

In fact, great pains are taken to stress on the limitations of the study. The concluding text is almost always to encourage more rigorous studies.

The tone and language in the I-TECH summarised report has a tinge of arrogance and has no place in scientific writing.

The report seems to fault ivermectin and highlighted the adverse event in the ivermectin arm, mostly of diarrhoea.

News editors must be careful not to report adverse events as side effects. They have different connotations.

‘While an adverse event may or may not be due to the investigative agents (ivermectin plus the standard care medications), side effects are attributable to them.

Furthermore, who among those who wrote the I-TECH report could tell specifically whether it was ivermectin or any of the standard care medication that caused the diarrhoea?

Bear in mind that the subjects were above 50 years old and not healthy. In addition, loose bowel is often a temporary healing crisis and a positive sign but mistaken by many as a negative symptom.

It was mentioned in the report that there were 13 deaths out of the 490 subjects, favouring the ivermectin group. How many deaths in each group was not specifically mentioned other than the given odds ratio of 0.30, which to the keen minds interpreted as 3:10 (ivermectin versus standard care).

This means the ivermectin arm has 70% fewer death cases, which corroborates the studies of Kory et al (69%), Bryant et al (62%), Lawrie et al (83%), and Nardelli et al (79%) (ivmmeta.com).

If there were only two death cases in the ivermectin arm, or the number of subjects increased to 600 and the trend of death persisted, the I-TECH study would have found statistical significance in the secondary outcome measure.

Although there was no statistical significance in the mortality outcome, to the doctors treating Covid patients, it has much clinical significance. 

There are several deficiencies in the I-TECH report. It contributes little to the current need to arrest the highly infectious and virulent Delta variant and a growing number of coronavirus mutations, rising trend of hospitalisation for the fully vaccinated, and amid growing controversy about safety of Covid-19 vaccines.

To the physicians who built their trust on ivermectin based on their clinical experience and reading non-mainstream scientific reports, and to the tens of thousands of patients who have benefitted from the so-called “horse deworming” drug, the latest revelation of the I-TECH report is not relevant. – November 9, 2021.

* Captain Dr Wong Ang Peng is a researcher with an interest in economics, politics, and health issues. He has a burning desire to do anything within his means to promote national harmony. Captain Wong is also a member of the National Patriots Association.



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