One step closer for US to recognized TCM

Herbal medicines are one of the most basic TCM therapies but their healing power remains unacknowledged in the West. [Provided to China Daily]

A Chinese herbal medicine for liver ailments has cleared a big hurdle with regulators in the United States, but there's still a long way to go.

For Tarek Hassanein, a professor of medicine at the University of California, San Diego School of Medicine, it took a long time to learn and finally to pronounce "fuzhenghuayu (FZHY)". That's the Chinese name of a patented Chinese drug that treats liver fibrosis, the scarring process of the liver from injuries and diseases.

The drug is the third patented Chinese medicine that has successfully completed Phase Two clinical trials in the United States. Compound Danshen Dripping Pill achieved that in 2010 and Xuezhikang Capsules did so early this year. Hassanein is one of the prime researchers supervising the trials in the US that test FZHY's efficiency and safety while treating American patients with liver disease, mostly hepatitis C.

Starting in 2010 and conducted in nine clinics, the trial was completed in early November, with 250 participants and 89 valid subjects.

"The preliminary data shows a trend that FZHY can stabilize the liver fibrosis in HCV-infected patients, and the tests show that FZHY is an anti-fibrotic with a good safety profile and is well-tolerated in the US population," Hassanein says.

"The completion of the trial confirms the ability of conducting random controlled trials on a botanical drug using a placebo as a control in the US and other Western countries."

Ren Dequan, retired deputy director of the State Food and Drug Administration of China, says the milestone makes patented Chinese herbal medicine one step closer to reality in the US market and even the world market, because the US agency has one of the world's strictest medicine approval and regulation systems.