In 1971 a Chinese chemist isolated an active compound from sweet wormwood plant- an act that many today consider as the breakthrough of the 20th century. The name of the chemist was Tu Youyou and the compound was Artemisinin.

Through turning to traditional medicine, the now Nobel Prize Laureate moved the proverbial needle in the fight against malaria and in the process saved millions of lives in Africa.

Dr. Irene Chege’s exploits in assessing the efficacy of key traditional medicine components in management of Type 2 Diabetes draws some parallels.  

Both women embarked on a brave journey to take an “outside of the box” approach to find solutions for diseases that have historically claimed millions of lives.

Today as we mark The African Traditional Medicines Day, we look at Dr. Irene’s perspectives in relation to the contribution of traditional medicines to conventional medicine including safety and efficacy concerns.

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In the current patient centered approach to therapy, do you think there is space for traditional medicines? Can they replace conventional medicines?

Probably not replace, but traditional medicines can definitely be integrated into conventional practice.

For that to happen though, there first needs to be extensive evidence-based research on the traditional medicines in question.

And thereafter proper capacity building done for all health care cadres.

So, I can’t completely discredit and say, ‘traditional medicines should not be used for patients.’ If the training is there and adequate research has taken place, it’s something that probably could be beneficial to patients.

You have done extensive studies around traditional medicine and herbal formulations. One in particular that stands out for me is the one whose objective was to determine the safety and effectiveness of local herbal medicines used in the management of Type 2 Diabetes Mellitus. What herbal medicines were these and what were your key findings?

Obviously due to confidentiality agreements I can’t share exactly which herbal medicines or formulations were included in the study.

However, what I can do say is that we included 3 herbalists in the study.

The first one ended up dropping out of the study almost immediately as he was not comfortable revealing the contents of his mixtures.

The second herbalist provided the individual contents of his concoction but in my analysis, there was no evidence of glucose lowering effect.  

The third herbalist also provided individual contents of his mixture and on examination there were indeed signs of pharmacological action.

How were you sure about the source of these ingredients?

They were all freshly harvested individual ingredients from the forests. Mixing and processing were all done in the confines of the university.

My supervisors and I, and of course the herbalists were the only ones privy to the exact ingredients used.

Are there any safety related issues that came up?

[Nods] Yes, there were 2 extremes;

One herbal formulation had such pronounced blood glucose reducing effect that some patients would go into hypoglycemia.

The second had absolutely no effect and therefore patients experienced treatment failure. It goes without saying that we had to stop in this cohort.

Remember before conducting in humans, I had to do animal studies, where I harvested and examined key organ tissues for any adverse reactions.

So, I weighed the organs, studied their histology and made specific conclusions.

The message was consistent, even in animals there were some safety concerns, particularly with hypoglycemia. So, the element of dosing accuracy came into question.

Just also to mention, some patients included in the study had such deep-rooted beliefs on efficacy of the herbal medicines they were taking that they did not bother to monitor their glucose levels. This obviously was a mistake.

Other patients were also taking both traditional and conventional medicines simultaneously with the thinking that this strategy would maximize efficacy. This also brought up issues of drug-drug/food-drug interactions.

Did the patients tell you how they came about taking herbal medicines? Were they for example influenced by anyone?

Firstly, some patients had turned to traditional medicines since they lacked trust in the safety of conventional medicines.

They had the belief that there was an inherent risk in taking conventional medicines especially for extended periods of time. The potential ‘side effects’ of these medicines had created fear in them.

Secondly, there was influence from testimonies from friends and fellow patients.

In fact, I remember a patient who kept claiming that she was completely cured from diabetes attributing this to the concoctions she was taking.

The interesting thing was that we followed her up for some time and she actually appeared to have normal blood sugars. (Laughs)

Third was desperation. Some patients were at a point where they were willing to try whatever was out there to have their condition ‘cured.’

Just to be clear, I think it’s quite risky to stop standard treatment without consulting your doctor.

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READ ALSO: Dr. Joyce Gikunda: The pharmacist who dared to dream of beauty (africanpharmaceuticalreview.com)

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There are 34 research institutes in 26 countries in Africa dedicated to traditional medicine research and development. Seeing you have done extensive research in this field. What do you find as the biggest challenges with respect to research on traditional medicines?

I think the biggest challenge is lack of information sharing.

Herbalists are extremely secretive with their formulations and rightfully so because some confided to me that previously their ‘discoveries’ had been ‘taken over’ by large research institutions without being adequately credited or compensated.

In fact, the only reason they agreed to share with me was because of the rapport they had with my supervisors; Prof. Faith Okalebo and Prof. Anastacia Guantai from The University of Nairobi.

What about funding?

There were grants available, I mean I received one. However, in my experience, this type of research is extremely costly. So, despite getting a grant to conduct the study, I also had to dip into my own pockets to fund a huge part of the budget.

Why so costly?

The sheer number of people that need to be involved in the study is enormous; botanists, herbalists, doctors, nurses, pharmacy team, laboratory technicians. It was overwhelming but worth it.

Field travel and laboratory related costs were also quite high.

As well, what you need to understand is that one herbalist’s mixture may content a series of ingredients which all have to be individually analyzed.

For instance, in my study one of the concoctions had seven ingredients which I had to examine one by one. That takes money.  

And ethical approvals, did you experience any road blocks there?

I would not call them road blocks, let’s just say the ethics approval process was extremely rigorous and therefore time consuming. Which is completely understandable since my study involved use of both animal and human subjects. This obviously elicits quite a number of ethical issues.

For example, I had to submit all standard operating procedures for all activities I was going to undertake.

There was a bit of back and forth but fortunately in the end I got the necessary approvals.

Quality, safety and efficacy is key when it comes to all types of medicines. When I look at the cGMP, the standards are quite high.  What is your opinion on traditional medicine, specifically those manufactured by herbalists (I am aware some herbalists are doing encapsulation)? Should they be subjected to the same standards as conventional medicines?

I think all facilities ‘manufacturing’ traditional medicines should be cGMP compliant. After all, they are still being consumed by humans and some have been proven to have pharmacological action.

For safety purposes I believe it is important to be compliant to international standards.

Secondly to penetrate foreign markets with these products it is important that they are manufactured with the highest level of quality. As we know, Europe in particular is quite strict on quality when it comes to all types of health products.

Personally, I believe these products need to be at the standard of conventional medicines if not better.

WHO also stated that as of last year, 30 countries have integrated traditional medicine into their national policies and 39 countries have established regulatory frameworks for traditional medicine practitioners, compared to only one in 2000.  Why do you think it has taken over 2 decades for this to happen and why do you think some countries are reluctant to do the same?

I think some of the countries have not understood the importance of traditional medicines and don’t have a good rapport with the herbalists.

It’s only through these relationships that the field can be developed and cemented through policies and regulations.

Since it is a growing sector, may be the regulatory bodies should charge subsidized fees when it comes to registration and quality control tests so that these products are not locked out due to costs.

These institutions may also be lacking capacity to regulate traditional medicine products so capacity building has to take place

There is also an inherent fear of biopiracy, so the herbalists are fearful to approach the regulatory bodies as they lack intellectual property (IP) protection.

Currently 17 countries, as opposed to zero in 2000, have frameworks for the protection of intellectual property rights and traditional medical knowledge. Clearly there is still room for improvement but what are some of the IP related challenges in traditional medicine that probably inhibit progression in the field?

It is virtually impossible to gain IP rights for a plant. This is nature and therefore doesn’t qualify for protection. However, for a processed final product that can be done.

In my view intellectual protection should be done in the institutions of learning. Herbalists should bring their products to these institutions and immediately a contract is drawn up that covers both parties.

After extensive studies have taken place and product provides repeatable findings, then I believe they should be compensated.

I think the herbalists should own a considerable amount of IP rights however bulk of it should remain with the universities. I believe it is the universities who have the funds, equipment and scientific talent to see these kinds of projects through.

Another important aspect to mention is that herbalists are dying with information they have collected for decades. I think its important for knowledge to be shared however the IP agreements need to be conceivably fair.

In your view, could there be opportunities for pharmacists to explore in this field?

I believe if you have a keen interest in research, this is an area you can thrive particularly if you align yourself with a learning institution.

Since there are many herbals and herbal components, the key is to narrow down on specific ingredients and carry out targeted studies on the same.

Alternatively, pharmacists can identify medicinal and aromatic plants that have documented pharmacological action and engage in large-scale cultivation. This could be commercially lucrative.

And that works for animals as well. There are animals that have shown promise in traditional medicine therapies. They can also create a niche for themselves through this.

What partnerships do you think are key to harnessing the full benefits of traditional medicine?

First and foremost; Universities and other learning institutions.

Apart from providing the infrastructure and equipment to do the research, creating awareness to health care students could propel the sector forward. For example, in our University, complementary medicine has been integrated into the syllabus for Medicine students. This can also be cascaded to nursing, dental and other health related courses.

Second is regulatory bodies. National drug regulatory agencies need to work closely with key stakeholders including herbalists to develop standards and guidelines in ensuring the products are safe, efficacious and of good quality.

Third is funding groups. If more funds can be pumped into research on traditional medicines, I believe the growth of the sector will be expedited.

What is your advice to patients, particularly those with chronic illnesses and are taking or thinking about starting to take herbal medicines to manage their conditions?

I think with the current frameworks as they are and paucity of data, it is extremely risky to take herbal medicines to manage chronic conditions.

For instance, imagine if a diabetic patient in the deep ends of a village, resolves to manage their condition with unregistered herbal products.

If these products are ineffective, this patient will end up with diabetic complications and eventually death. There could also be issues of undocumented adverse drug reactions.

All therapy has to be backed by evidence-based research and supervised by a trained healthcare professional.

How do you plan to commemorate African Traditional Medicine Day?

[Laughs]

You know the funny thing is, as a family [especially mum], we have always been huge fans of herbal therapies in management of minor symptoms such as sore throats, coughs and colds.

In the kitchen you will rarely miss honey, turmeric, lemons, ginger and the like.

So, I will probably call and inform them about the day and see hopefully how we can commemorate the day.

 

 

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