Core38: Traditional herbal active substances

🌿 High-yield / 要点：Traditional herbal active substances may use simplified marketing if medicinal use is proven for ≥30 years, but they can still cause side effects and serious drug interactions.

Regulatory concept / 規制上のポイント

• Simplified marketing procedure.
• Clinical examination is not necessarily required.
• Quality control is required: active ingredient amount should not deviate.
• Listed in National Health Authority registers.
• Side effects can be reported.
• Instructions for use are available.
• Applicant must prove medicinal use for at least 30 years.
• Often OTC, so patients may not report usage.

Relatively safe examples / 比較的安全な例

Plant product	Use	Key point
Spear plantain	Syrup/candy for dry cough, throat irritation	No severe side effect or interaction noted
Ginkgo biloba	Cognitive function improvement	GI discomfort, restlessness
Milk thistle	Liver damage prevention/treatment	Mechanism unknown; no severe interaction noted

Risky examples / 相互作用が重要な例

Product	Main interaction	Risks
St. John’s wort	Serotonergic drugs; CYP induction CYP3A4/CYP1A2	Serotonin syndrome; reduced effect of warfarin, oral contraceptives, antivirals; allergy, photosensitivity, GI/CNS effects
Grapefruit	CYP inhibition CYP3A4/CYP1A2/CYP2C9; effect may last ~72 h	Increased drug side effects; affects many drugs; may also inhibit gastric drug absorption

Remember / 覚え方

• Traditional ≠ harmless
• St. John’s wort = CYP inducer + serotonin syndrome risk
• Grapefruit = CYP inhibitor with long interaction effect
• Always ask about OTC/herbal products