The knowledge about the healing power of plants is probably as old as mankind itself. For centuries they have been used for therapeutic purposes all over the world - with success. But do we know why they work? Not always, and certainly not to the last detail. "Who cares, as long as they help," you might think. Unfortunately, things are not as simple as that in the conflicting fields of modern medicine. Phytopharmaceuticals, just like synthetically produced drugs, must also provide proof of efficacy. And not only to meet the requirements of authorities.
The unavoidable regulatory requirements "should rather be seen as a minimal platform on which a comprehensive knowledge of the chances and limits of phytotherapy can be built", rightly pleads e.g. Dr. med. Rainer Stange, Vice-President of the Society for Phytotherapy and researcher at the Immanuel Hospital Berlin, Department of Naturopathy. Herbal medicine should be given the importance it deserves in modern medicine. This importance depends not least on how comparable an herbal remedy is, in the sense of: "Plant A" works just as well as "chemical agent B". Patients should not rely on traditional knowledge alone, but rather be able to demand scientific data obtained using the most modern research methods.
What is rational phytotherapy at A.Vogel all about?
This approach is also followed by A.Vogel and so the company orients towards "rational phytotherapy". What is meant by this? So-called rational phytopharmaceuticals contain preparations of plant parts in a specific galenic form as "medicinally active substances" and "they are used in the sense of a scientifically oriented medicine". This means: These herbal remedies have been scientifically tested for their efficacy and safety, and have proven their therapeutic efficacy in controlled clinical trials as well as through medical experience. Like any other drug, rational phytopharmaceuticals have undergone a complex approval and registration process, can be sold in pharmacies, prescribed by doctors and reimbursed by health insurance companies.
How do "traditionally used phytopharmaceuticals" differ?"
Traditionally used phytopharmaceuticals" distinguish from this. The effectiveness of these agents has not been scientifically proven, but should be plausible. This plausibility is to be proven by means of the so-called tradition proof: For this purpose, the medical use must have been proven for more than 30 years without incident; of which more than 15 years in the EU. Traditional herbal medicinal products are subject to simplified approval conditions, they are only registered. Anyone can use them at their own discretion ("self-medication") and only certain strengths and dosages are possible. Traditional remedies can be purchased freely from health food stores, drugstores and retailers, as well as on the internet (although one should be critical of the quality of the products and not believe exaggerated promises of healing). Traditionally used phytopharmaceuticals are not reimbursed by the statutory health insurance funds.
Does "rational" still have anything to do with nature?
For those who trust in naturopathy or herbal remedies on principle, this division into "rationally" and "traditionally used" may not be immediately comprehensible. Doesn't "rational" sound a lot like "conventional medicine"? Yes and no. "Rational" is a constructed term, and holistic-minded scientists are of the opinion that this formerly deliberately created dichotomy runs counter to rather than promotes the concept of integrative medicine.
However: "Rational" should ideally be understood as a kind of seal of approval in herbal medicine. The better an herbal remedy is researched, the more is known about its ingredients, effects and side effects, the safer it is for the patient. And the better known this scientific evidence is in the medical profession, the more likely it is that a plant product will be prescribed instead of a synthetic drug. Because well-tested phytopharmaceuticals are particularly useful in the treatment of minor ailments, e.g. colds.
What do you need to know about research?
The extent to which herbal medicine should be subject to established research methods has been the subject of lively debate among phytoscientists for some time. Is this type of therapeutic research merely a continuation of conventional pharmacotherapy research, simply with other (= purely herbal) drugs? Or would it not be better to have peculiarities, such as special study models, with the help of which the full effect of a plant on humans can be described in a scientifically correct way? "This second position would inevitably entail the elaboration and examination of innovative points of view that would assign phytotherapy the character of a 'special therapeutic direction' (...)", says researcher Dr. Rainer Stange.
At international scientific level, evidence-based medicine (EbM) is considered the gold standard, and this in turn is the highest currency in everyday medical and clinical practice. What does that mean?
Evidence-based medicine is "the conscientious, explicit, and appropriate use of the best currently available health research data to make decisions in the treatment and care of specific patients. EbM involves the integration of individual clinical expertise with the best possible evidence from clinical research and patient preference." This definition goes back to David Sackett (see: British Medical Journal 1996; 312: 71–2). EbM attempts to make the results of medical research usable as a decision-making aid for therapeutic, health policy and health economic decisions.
A kind of hierarchy of evidence has been established, according to qualitative characteristics as well as the basic methodological approach. Meta-analyses (MA, systematic evaluation of several double-blind studies) rank at the top. The highest quality type of study is the prospective randomised controlled trial (RCT). Personal experience is rated as the lowest class of evidence.
Can meta-analyses in phytotherapy be trusted?
Complementary scientists raise the concern that the highly regarded meta-analyses may not always do full justice to phytotherapy. To this end, "provocative hypotheses" were established:
- a) Meta-analyses in phytotherapy show methodological weaknesses in the selection criteria of controlled double-blind trials.
- b) Often researchers are involved in meta-analyses who have neither clinical experience with phytotherapeutics nor sufficient knowledge of phytotherapeutic medicinal products (multi-substance mixtures) nor are specialists in the underlying disease under investigation.
- c) The usefulness of the results of phytotherapeutic meta-analyses is not discussed in terms of patient values. (Jörg Melzer, Wirksamkeitsnachweis in der Phytotherapie, UZH, 2014)
What does "Good Clinical Practice" (GCP) mean at A.Vogel?
This may perhaps illustrate why it is of eminent importance for manufacturers of phytopharmaceuticals to also conduct their own research.
At A.Vogel, the reference work for scientific studies is Good Clinical Practice (GCP). "This does not distinguish between phytotherapy or synthetic remedies," explains Roland Schoop, Head of Medicine at A.Vogel. "The same clinical assessment criteria apply. The studies are reviewed for scientificity and relevance by an ethics committee and by the drug regulatory authority, and they are usually conducted at university hospitals and by physicians in private practices."
Do the same clinical evaluation criteria lead to the same results?
In other words: Are phytopharmaceuticals as efficient as synthetic drugs? "There's no conclusive answer to that," says Roland Schoop. Comparative studies exist, e.g. between arnica preparations and ibuprofen. "These studies suggest that phytotherapeutics can work equally well as synthetics. However, it depends a lot on the indications studied, which are found in self-medication."
For A.Vogel, studies are clearly at focus: "The efficacy and safety in the consumer's assessment, but also from the physician's perspective," Roland Schoop said. Echinacea purpurea (purple coneflower), Salvia officinalis (sage) and Sabal serrulata (fruit of the saw palmetto) are at the centre of scientific interest.