Phyto Therapeutics: Differences, Myths, and the Evolution of Science

Phyto therapeutics have been gaining ground in global medicine by representing the convergence between popular tradition and regulated science. While the popular — and sometimes even ancestral — use of medicinal plants is deeply rooted in many cultures, phyto therapeutics arise from a rigorous process that transforms this knowledge into safe, standardized, and replicable treatments.

The challenge lies in distinguishing what is empirical use, subject to variability and risks, from what is defined as a prescription phyto therapeutic, regulated by health agencies and supported by clinical evidence.

What are phyto therapeutics and why they cannot be confused with popular remedies

It is common to mistake “herbal tea” or “supplement” for a medicine. The difference, however, is profound.

• Phyto therapeutics: developed from standardized plant extracts, submitted to preclinical and clinical testing, and registered with regulatory agencies (e.g., ANVISA, EMA, FDA). They include prescribing information, defined dosage, and safety monitoring.

• Traditional products: based only on popular or historical use, without rigorous clinical trials.

• Dietary supplements: may contain plant extracts, but are not classified as medicines and therefore do not need to demonstrate therapeutic efficacy.

This distinction ensures that phyto therapeutics are reliable, reproducible, and prescribed within formal medical practice.

Phytocomplex and pharmacology: a symphony of molecules

While synthetic drugs concentrate on a single isolated active molecule (such as paracetamol or fluoxetine), phyto therapeutics rely on the concept of the phytocomplex: a set of bioactive substances that act in combination.

This complexity offers advantages — such as synergistic effects (one compound enhancing another) and modulation of side effects — but also presents challenges:

• Controlling chemical variability between batches.

• Identifying chemical markers to guarantee equivalence.

• Demonstrating specific mechanisms of action, since different molecules act on multiple pharmacological targets.

For example, in Hypericum perforatum (St. John’s Wort), both hypericin and hyperforin contribute to antidepressant effects, but alone they cannot reproduce the results of the complete extract.

From cultivation to formulation: traceability and good practices

The process of turning a plant into medicine follows Good Agricultural and Collection Practices (GACP), which include:

• Accurate botanical identification (avoiding confusion between similar species).

• Control of soil, climate, and harvesting, since environmental factors change the chemical profile.

• Standardized drying and extraction processes.

In the laboratory, high-resolution techniques such as HPLC, LC-MS, and DNA barcoding ensure consistency of the final extract. Complete traceability — from the field to the finished product — is one of the pillars that differentiates phyto therapeutics from popular preparations.

Pharmaceutical standardization: the heart of phyto therapeutics

The pharmaceutical stage is where science guarantees that each capsule or tablet contains the same quantity and quality of active compounds. This is achieved through:

• DER (Drug-Extract Ratio): proportion between the amount of plant material used and the extract obtained.

• Chemical markers: compounds used as quality references.

• Stability testing: ensuring that the medicine maintains potency during its shelf life.

• Purity testing: eliminating risks of contamination by heavy metals, pesticides, or microorganisms.

Without these controls, a patient could take the same dose at different times and obtain completely different results — a common issue with unregulated products.

Clinical evidence: the line between tradition and science

Traditional use may indicate promising directions, but it does not replace the need for randomized controlled clinical trials (RCTs). Some examples reinforce that phyto therapeutics are only different from popular products when supported by replicable scientific evidence:

• Hypericum perforatum (St. John’s Wort): demonstrated efficacy comparable to antidepressants in mild-to-moderate depression in several meta-analyses, though with risk of drug interactions.

• Echinacea: widely used for colds, but with inconsistent results in clinical trials, showing that not all traditions translate into proven efficacy.

• Ginkgo biloba: studied for cognitive improvement, shows modest efficacy in some contexts but requires strict quality control to avoid ineffective batches.

Safety and pharmacovigilance: breaking the “natural is always safe” myth

The myth that natural products are harmless is dangerous. Plants can cause serious adverse reactions. Documented cases include:

• Kava (Piper methysticum): associated with hepatotoxicity.

• Ephedra (Ma Huang): linked to severe cardiovascular events, leading to prohibition in several countries.

This is why phyto therapeutics are subject to pharmacovigilance systems similar to those applied to synthetic drugs, monitoring adverse effects and ensuring post-marketing safety.

Drug interactions: the invisible risk

One of the most critical points is the potential interaction between phyto therapeutics and conventional medicines. The examples below highlight why prescription phyto therapeutics must be accompanied by professional supervision and detailed prescribing information warning of known interactions:

• St. John’s Wort (Hypericum perforatum): induces cytochrome P450 enzymes, reducing serum levels of contraceptives, anticoagulants, and antivirals.

• Ginkgo biloba: may increase bleeding risk in patients using anticoagulants.

  
  

Regulation: the difference between supplement and medicine

In Brazil, ANVISA establishes strict criteria for classifying products as phyto therapeutics. Proof of the following is required:

• Clinical efficacy.

• Safety at therapeutic doses.

• Quality standardization.

• Good Manufacturing Practices (GMP).

While supplements and traditional products can reach the market with far fewer requirements, prescription phyto therapeutics follow standards equivalent to synthetic drugs, ensuring therapeutic reliability.

Ancestral knowledge: innovation with responsibility

Innovation in phyto therapeutics is only ethical when it acknowledges and values indigenous and traditional communities. Historically, many laboratories exploited this knowledge without fair retribution. Today, sustainable and transparent models seek to correct this imbalance, guaranteeing fair partnerships and shared benefits.

Phyto therapeutics will only achieve full legitimacy by combining cutting-edge science with respect for the origins of knowledge.

Main myths about phyto therapeutics

1. “Natural products have no side effects” – every bioactive substance can pose risks.

2. “If it works in tradition, it doesn’t need science” – empirical efficacy does not replace clinical trials.

3. “Herbal remedies don’t interact with medicines” – interactions are real and can be serious.

4. “All plant-based products are the same” – without standardization, efficacy cannot be guaranteed.

   
   

The future of phyto therapeutics

The outlook points to applications in critical areas of mental health and psychiatry, such as:

• Substance use disorders.

• Treatment-resistant depression.

• Severe psychiatric conditions requiring new therapeutic approaches.

The combination of green biotechnology, advanced pharmaceutical development, and global regulation positions phyto therapeutics as protagonists of the next wave of pharmaceutical innovation.

Conclusion: science applied to tradition

Phyto therapeutics represent the maturity of phytotherapy, transforming popular knowledge into evidence-based medicine. They differ from empirical uses because they are built on three pillars: pharmaceutical standardization, clinical validation, and regulatory oversight.

By debunking myths and offering safe therapeutic alternatives, they consolidate themselves as an ethical and scientific response to global health challenges.

Ayamed’s vision

At Ayamed, we believe true innovation is born from the union of rigorous science, pharmaceutical technology, and respect for ancestral knowledge. Our focus is on developing prescription phyto therapeutics that meet the highest regulatory standards, offering new solutions for patients with substance use disorders, treatment-resistant depression, and severe psychiatric conditions.

👉 Discover how Ayamed is leading the transformation of phyto therapeutics into real, safe, and sustainable healthcare alternatives for the future.