Research Studies on Chinese Herbal Medicine – Seeking FDA Approval

Traditional Chinese Herbal Medicine is making headway among medical researchers. In the past, many studies on Chinese Herbal Medicine were dismissed or lacked the credibility of western designed research studies because they were done in China, Japan and other Asian countries. Though theses studies had definite validity, they were not performed using western laboratory study protocol.

Recently, many studies of Chinese Herbal Medicine have been initiated in the US and Canada. The importance of this fact that cannot be under estimated U.S. designed studies by leading universities, such as Stanford, Yale, UCSF and UCLA lend a legitimacy to Chinese herbs that has been lacking in this country in the past.

Interestingly enough, many recent studies are on herbal formulas rather than single herbs. In Chinese herbal medicine, rarely is one herb used alone. Rather a combination of herbs are prescribed in one formula to increase or decrease the potency of a single herb, to ameliorate side effects and/or target certain areas of the body. The concept of using herbs in a cohesive formula was often lost on western researchers who persisted in studying the actions and efficacy of single herbs, such as Rx. Hypericum, commonly known as St. John’s Wort. This herb, which in fact, is a Chinese herb, but one that is rarely used, was very popular for a time as a self-treatment for depression until it was found to have significant antagonist effect on other prescription medications.

Invariably, herbs are found to have significant side effects when they are used alone. When an herb is used by itself, the dosage is often way to high, causing patients to have unwanted side effects. In combination with other herbs, an unwanted effect of an herb can be ameliorated by another herb, or group of herbs, in the formula. For example, a very cold herb when used alone can cause gastric upsets and/or diarrhea, similar to antibiotics. If combined in a formula, the cold aspect of the herb can be balanced with warmer herbs that allow the desired effect if the herb to act while not causing the unwanted side effect of gastric problems.

What are the herbal formulas that are being studied? There are three very interesting ones. All three are in clinical trials and, significantly, two are in the third phase of FDA approval.

MF101 – This twenty plus herb formula is being tested for menopausal symptoms of hot flashes, night sweats, and resulting insomnia. Data from phase 1 and 2 of the research is promising. Subjects of the study had a significant reduction in hot flashes and night sweats with this formula. The drug did not activate the estrogen receptor as in hormone replacement therapy (HRT), making it a possible treatment for breast cancer patients who are being treated with drugs, such as Taxol, that suppress the body’s estrogen, causing subsequent severe hot flashes, insomnia and night sweats. If this drug passes the third phase of the clinical trial, it could bring significant relief to the many thousands of women suffering from the side effects of chemotherapy for breast cancer.

PHY906 – this eighteen hundred year old formula of four ingredients is being investigated by Yale University and a start up company, PhytoCeutica. This classic formula of four herbs, Huang Qin (Rx. Scuttelleria), Bai Shao(Rx Peaonia), Da Zhao (Fr. Ziziphus jujuba), and Gan Cao (Glycyrrhiza) has been traditionally used for diarrhea, stomach cramps, nausea and vomiting. The aim of the study is to see whether the formula can be used to enhance the effect of anticancer agents. The drug is currently in the third phase of testing and looks promising for reducing chemotherapy-induced toxicities and enhancing the effectiveness of chemotherapeutic agents in the treatment of pancreatic, liver, and colorectal cancers.

T89 – this three herb combination of Dan Shen (Rx. Salviae Miltiorrhizae), San Qi (Rx. Notoginseng), and Borneol is under study to determine its effectiveness in treating angina pectoris. Both Dan Shen and San Qi have been used for centuries to move the blood and are known in Traditional medicine as being effective for coronary heart disease.
The formulation is being tested by Tasly Industries, a Chinese pharmaceutical company specializing in modernizing Traditional Chinese Medicine (TCM). T89, also called Dantonic pill, was approved by the SFDA (State Food and Drug Administration) of China in 1993. Since that time, more than 2 billion doses have been taken by 10 million patients. T89 is also used in Russia, South Africa, South Korea, Mongolia, Singapore and Vietnam. This product is in the Global Phase 3 clinical trial and FDA approval is being sought.

All three of these herbal pharmaceuticals show promise in providing significant relief for patients. Hopefully, with the clinical trials drawing to an end for T89 and PHY 906, FDA approval will come quickly.

About Francine Ball, L.Ac.

I am a licensed acupuncturist practicing in Walnut Creek, California. I have been in private practice since 1984. In my practice I see a wide variety of patients with many types of health problems from late stage cancer to allergies and infertility, and everything in between. The age of my patients range from infants to 96 years old. I have many children and teenage patients. My areas of specialty are internal medicine, infertility and neurology.
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