Herbal medicine development: a plea for a rigorous scientific foundation.

Science, including rigorous basic scientific research and rigorous clinical research, must underlie both the development and the clinical use of herbal medicines. Yet almost none of the hundreds or thousands of articles that are published each year on some aspect of herbal medicines, adheres to 3 simple but profound scientific principles must underlie all of herbal drug development or clinical use. Three fundamental principles that should underlie everyone's thinking about the development and/or clinical use of any herbal medicine. (1) There must be standardization and regulation (rigorously enforced) of the product being studied or being used clinically. (2) There must be scientific proof of a beneficial clinical effect for something of value to the patient and established by rigorous clinical research. (3) There must be scientific proof of safety (acceptable toxicity) for the patient and established by rigorous clinical research. These fundamental principles of science have ramifications for both the scientist and the clinician. It is critically important that both the investigator and the prescriber know exactly what is in the studied or recommended product and how effective and toxic it is. We will find new and useful drugs from natural sources. However, we will have to learn how to study herbal medicines rigorously, and we will have to try to convince the believers in herbal medicines of the wisdom and even the necessity of a rigorous scientific approach to herbal medicine development. Both biomedical science and practicing physicians must enthusiastically accept the responsibility for searching for truth in the discovery and development of new herbal medicines, in the truthful teaching about herbal medicines from a scientific perspective, and in the scientifically proven clinical use of herbal medicines.