EMCU OFFERS TO TEST TRADITIONAL MEDICINE

MANZINI – Eswatini Medical Christian University (EMCU) Lecturer Vincent Madlopha, who is also a post-graduate research student in Pharmacology (microbial quality of herbal medicines), has offered tinyanga a once-in-a-lifetime opportunity to test safety, efficacy and quality of their herbal medicines.

This was during their meeting which was held at Ticantfwini, Manzini last week. Madlopha said EMCU could quickly reposition itself or collaborate with other universities in the country, to start conducting clinical trials on all herbal medicines that could be offered to them by traditional doctors. He said this process would mean the traditional remedies could get approval from the World Health Organisation (WHO).

Madlopha said they were aware that effective traditional medicine was being used, but without undergoing clinical trials. He said about eight per cent of 1 100 African herbal medicine’s raw materials were sold every year at International Herbal Markets.

modern

Moreover, he said more than 50 per cent of modern pharmaceuticals; cosmetics and nutraceuticals medicine came from herbal system or herbal medicine. In fact, he said more than 40 per cent of worldwide licensed drugs came from herbal medicine.
However, he mentioned that without safety, efficacy and quality data, no herbal medicine could meet the needed scientific standard to be sold and used everywhere in the world. In that regard, he emphasised that the clinical trials could be done in Eswatini.

He said there would be no need to take the samples to Kwazulu-Natal, South Africa because some of the research work could be shared with the University of Eswatini (UNESWA), which had some of the necessary equipment needed to conduct the research. The lecturer said these clinical trials of herbal medicine could take a minimum of two or 12 years to complete the six phases that were normally followed in Drug Discovery Science. He said the pre-clinical trial phase involved conducting of scientific research that provided some general information about dosing and toxic effects of a medication on the human body, using human cell cultures or animal models. He said this phase involved non-human efficacy and safety studies.

The main goal of this phase, according to Madlopha, was to test an initial idea to see if herbs had any medicinal effects or pharmacological properties. If the pre-clinical research was promising, he said it was moved forward to phase zero of the clinical trials, to see how well the drug worked in humans.

He said phase zero of a clinical trial was a therapeutic exploratory trial done with a very small number of people, usually less than 15. He said medicinal research scientists (MRS) used a very small dose of medication to make sure it was not harmful to humans, before they started using it in higher doses for later phases.

He said if the medication bioavailability acts differently than expected, the MRS would do some additional preclinical research to find the safest dose for better effect on the body before deciding whether to continue with the trial.

Regarding phase I of the clinical trial, he said it was about herbal therapeutic confirming safety. Through preclinical research, the MRS usually gets some general information about dosing, the effects of a medication on the human body can be unpredictable. Therefore, he said during phase I of a clinical trial, MRS spent several months looking at the effects of the medication on about 20 to 80 people who had no underlying health conditions.

In phase II, which was herbal therapeutic efficacy and safety confirmatory trial, Madlopha said it involved several hundred participants who were living with the condition that the new medication was meant to treat.
dose
He said participants were usually given the same dose that was found to be safe in the previous phase. He said the MRS monitored participants for several months or years to see how effective the medication was and to gather more information about any side effects it might cause.
The lecturer added that while phase II involved more participants than earlier phases, it was still not large enough to demonstrate the overall efficacy and safety of a medication. In fact, he said in this phase, the MRS could only see how well the treatment worked against the disease as more patients with the condition were involved.
If the treatment yields to levels of effectiveness and proves to be safe enough, he said the phase II herbal therapeutic efficacy and safety confirmatory trial would be moved to phase III. However, he said the effectiveness data collected at treating the condition during this phase helped MRS to decide and perfect methods for conducting phase III.
At phase three; herbal therapeutic efficacy and safety confirmatory trial, Madlopha said a large-scale safety and effectiveness study that involved up to 3 000 participants who had the condition would be involved. He said this trial stage could last for several years.
He said its purpose was to evaluate how the new medication worked in comparison to existing medication for the same condition. In order to move forward with the trial, he said the MRS needed to demonstrate that the medication was at least as safe and effective as existing treatment options.
approval
He added that approval of a new medication was largely hinged on phase three clinical trial data. He said this was because if the MRS demonstrated that the medication was at least as safe and effective as others already on the market, it was usually approved.
Moreover, he said in phase four; herbal therapeutic use trial was more like a post marketing surveillance that usually involved more than 3 000 participants who had the condition meant to be treated by new medication. In this phase, he said the MRS determined long term efficacy, safety and quality of the new medicine. Thereafter, he said an application letter, which would be accompanied by all the data collected from the five phases, would be sent to WHO. He said once WHO was satisfied; it would issue a certificate that gave the new medicine the green light to be used across the globe.

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