A budding opportunity

Exploring the potential of Herbal Medicinal Products

Herbal Medicinal Products (HMPs) have nothing to do with homeopathy or food supplements. And they also differ from conventional drugs. Beatrice Bachmeier is examining the role they might play in the healthcare system – and has to overcome widespread skepticism in the process.

Because they are considered soothing and expectorant, flowers of the mullein plant (Verbascum densiflorum) are often added to cough tea.
Photo: Uwe Dettmar

It happened again just recently, this time during a lecture on “Staying Healthy in Old Age” that Beatrice Bachmeier, chemist and Professor of Drug Health Service Research at the Institute of Pharmaceutical Biology, was giving at the university. One of her colleagues was listening in one of the back rows. When Bachmeier began to talk about the possibilities offered by HMPs, quite a few members of the audience, as her colleague reported afterwards, started rolling their eyes, shaking their heads and murmuring that homeopathy should not be encouraged under any circumstances as it is all humbug and quackery.

Although such reactions come as no surprise to Bachmeier, she nevertheless finds them dismaying or even annoying. “They didn’t understand that I was talking about HMPs. I didn’t mention the word homeopathy at all,” she says. “Something happens in people’s minds: You say ‘HMPs’ and lots of people immediately associate it with homeopathy. We need to do something about this, as it’s the biggest misunderstanding you can imagine.”

Because, to make this clear right at the beginning, HMPs differ from homeopathy. Nor do they have anything to do with food supplements either, although they are sometimes mistakenly included in this group.

On the one hand, it is easy to define what HMPs are because this is regulated by the Medicinal Products Act. They are drugs that contain exclusively herbal substances, such as leaves, flowers or roots, or herbal preparations (tinctures, juices). HMPs may contain just one or several herbal substances as active ingredients. They may not contain any animal or synthetic additives. And their purpose must be to cure, alleviate or prevent certain diseases, damage or complaints.

Hardly distinguishable for laypeople

Cyclosporin A is an active ingredient derived from Tolypocladium inflatum, a tubular fungus commonly found in Norway. It suppresses the immune system and is administered after organ transplants, among other things. Photo: public domain, Yikrazuul, via Wikimedia Commons

There is, however, another side to it. Although the Medicinal Products Act regulates exactly what HMPs are and what distinguishes them from homeopathy or food supplements, it is not easy for laypeople to spot this difference when they go to a pharmacy or drugstore. Valerian/hop preparations for better sleep are available both as HMPs and food supplements and can be obtained both from pharmacies and drugstores. They are often even displayed next to each other on the shelf. “It really isn’t easy to tell the difference. There are pharmacy-only products and ones that are sold elsewhere, products that are only available with a prescription and ones that are available without,” says Bachmeier. “How can you tell the difference? If it’s an herbal medicine, then it says it on the packet. It’s compulsory.”

And what distinguishes HMPs from conventional ones, apart from the fact that the latter are produced synthetically? “HMPs are a blessing and a curse because they have various targets in the body. Some people call them ‘dirty drugs’ because you don’t know exactly all their sites of action,” says Bachmeier.

Normal drugs, on the other hand, are optimized for the specific target region where they are supposed to bind and take effect. Typically, the pathomechanism of the disease is analyzed first and then the drug is designed accordingly.

Widespread prejudices

It can therefore be concluded that there are indeed a few differences between the two types of medication. Effectiveness, side effects, which diseases they are for – corresponding statements circulate on the internet, at least. But which of them are true?

The first claim is that synthetic drugs work quickly, whereas HMPs need longer to take effect. Bachmeier says: “Effectiveness varies considerably. If the molecule in a conventional medicine is directed specifically at its target, it can indeed have a faster effect. With HMPs, we can’t generalize, as some exert their therapeutic effect within a few hours, whereas others take days or weeks to unfold their full effect.”

The second claim is that HMPs have a weaker, gentler effect in comparison to synthetic drugs. Bachmeier: “Yes, that’s what people always say. But HMPs are not always gentle either. Everything that exhibits pharmacological activity can also have undesired side effects. The worst toxins come from nature, just as do very potent drugs. Cyclosporin A, for example, is extracted from a fungus and used as an immunosuppressant in organ transplantation. Nobody would say in this case that a synthetic drug is more potent.”

The third claim is that getting the dosage right is easier with conventional medicines. Bachmeier: “Yes, that’s correct, but only to a certain extent, as clinical studies on synthetic drugs are often only conducted with men. This makes it difficult to calculate exactly the right dosage for women or children.”

A way to avoid antibiotics

This means that it is not possible to make any one-to-one comparisons between HMPs and synthetic drugs. But perhaps there is no need to either. Perhaps they could simply assume a different, complementary role in healthcare.

An example is uncomplicated urinary tract infections (uUTIs). They are largely caused by bacteria, it is mostly women who are affected, and doctors usually prescribe antibiotics to treat them. “Women usually notice an uUTI very early on,” says Bachmeier. “If they were to start taking a certain herbal medicine straight away, before it gets worse, they might not need an antibiotic.”

This would have a positive impact in several respects. On the one hand, if antibiotics are prescribed and taken less often, this helps combat the increasing problem of resistance. The more frequently an antibiotic is taken, the more likely it is that bacterial pathogens will become resistant to it and new antibiotics will be needed to achieve the antibacterial effect (see also “Resistant pathogens in our sights” on p. 40). In addition, it would help the environment if fewer antibiotics were around. On the one hand, the pharmaceutical industry has to make them, says Bachmeier, and their production is more harmful to the environment than that of HMPs. And, on the other hand, they end up via wastewater in the environment, in lakes and rivers, in groundwater and then in the food chain. “I’m not a proponent of treating life-threatening diseases with HMPs,” says Bachmeier. “But they can make a valuable contribution to healthcare if used skillfully.”

In reality, however, they have no chance to do so because far too little research is conducted on HMPs and as a result of the lack in knowledge they are not integrated sufficiently in therapeutic strategies, says Bachmeier. Much more needs to be known about their efficacy and side effects as well as interactions with other active substances or medication.

Effectiveness studies

Research with HMPs is, however, a special challenge. Conventional drugs have a targeted effect and often trigger a change in a serum marker or another parameter that is easy to measure in the laboratory. Plants with their various pharmacologically active ingredients can have many different effects. It is the interaction of these different potential mechanisms that then triggers a therapeutic effect. Because of this complexity, however, scientists have not yet managed to develop an easily measurable laboratory marker that sheds light on the efficacy of HMPs in patients.

That is why Bachmeier is taking a different approach: To find out whether an herbal medicine works, she wants to evaluate patient data and interview patients. After all, patients notice very well if they feel better or not. “The patient doesn’t say to their doctor ‘My brain natriuretic peptide level is high’ or ‘My CRP is high’. They say ‘It hurts here’,” says Bachmeier. “And during the course of treatment, the patient can judge quite well themself whether their symptoms are fading.”

A survey will shed light on whether goldenrod (Solidago virgaurea, above) or monk’s pepper (Vitex agnus-castus, below) can help women affected by cystitis or menstrual cramps. Photo 1: Nele Bößneck, Photo 2: Markus Bernards

Bachmeier now wants to record and evaluate such patient input. Very limited secondary data on the use of HMPs from patient interviews already exist, and Bachmeier and her team are analyzing such data. Additionally, she is currently also conducting a survey herself.

For this purpose, she and her team have developed two online questionnaires on the subject of gynecological complaints. One is for patients and the other for healthcare professionals such as doctors, medical assistants and pharmacists. Bachmeier wants to know how medicines, especially HMPs, are utilized in the real-world of everyday practice in Germany. Which medicines do patients prefer? Do they trust in HMPs? How effective are they? What are the obstacles? Are they too expensive? What do healthcare professionals know about them? Do they have any concerns? If so, which? Initial results from a pilot study with over 300 respondents are already available, but it is only now that the survey is really getting off the ground.

Their analysis of a pharmacoepidemiological database had already revealed the following: “Monk’s pepper helps women with menstrual cramps. Black cohosh helps women going through menopause. And bearberry and goldenrod help women with uUTIs,” says Bachmeier. “Very few, around two to five percent, didn’t notice any effect whatsoever from HMPs. By contrast, most of them, over 70 percent in fact, stated that the therapeutic effect of HMPs was ‘very good’ or ‘good’.”

It is findings like these that could contribute in the long term to the use of HMPs for complementary treatment or prevention in healthcare. But there is still a long way to go. Nevertheless, Beatrice Bachmeier believes that it is the right route to take because, as she says: “If we want to create the best possible healthcare system, we should make maximum use of the entire toolbox of medicinal therapies at our disposal.”

Photo: private

About / Beatrice Bachmeier After completing her undergraduate at the University of Regensburg and her doctoral and postdoctoral degrees at LMU Munich, Beatrice Bachmeier worked as a researcher in Germany and abroad, conducting laboratory experiments on substances that influence the growth of tumor cells. A colleague asked her if she would like to test whether curcumin inhibited growth in tumor cells, and this was how she started investigating the mechanisms of action of plant ingredients. She then focused her research on the effectiveness of therapeutic interventions in the real world of everyday clinical practice. In July 2021, she left the Technical University of Munich to join Goethe University Frankfurt as Professor of Drug Health Service Research.
b.bachmeier@em.uni-frankfurt.de

Photo: Luise Aedtner

The author / Jan Schwenkenbecher born in 1989, is a freelance science journalist and lives in the Rhine-Main region. He studied psychology in Giessen and Mainz and then learnt the art of journalism during practical training at the Süddeutsche Zeitung newspaper.
jan.schwenkenbecher@posteo.de

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