Can Chinese remedy help women here

PHILADELPHIA - June 2, 2008

Lisa Stein is a busy homemaker and mother of four, but for two to three days every month her busy life is interrupted with bad menstrual cramps. "They're pretty debilitating, I would say they're severe, " she said. "They're very painful."

And on top of the pain, Lisa says she's bloated and irritable. Usually over-the-counter drugs like ibuprofen help,but she's not crazy about taking medication so she enrolled in a study to try something more natural. Dr. Larry Seidman of Philadelphia Clinical Research is leading the study. "This is an herbal treatment they've been using in China for over 2000 years," he said. During the trial, women will test what appear to be simple green capsules made up of five different plants.

Because it's a double-blind study, Lisa doesn't know if she was given the real pills or dummy pills. But because she didn't cramps this month, she thinks she got the real thing and it worked.

"I saw a vast improvement and I felt great this past month," Stein said, adding "I didn't have any pain and I didn't see any side effects."

Stein said the only down-side is she had to take three capsules three times a day in between her periods. But still she said it's worth it. Dr. Seidman says this study is one of very few to test herbal remedies because in order to sell natural products over-the-counter, manufacturers don't have to prove the product works. But the maker of this herbal remedy is going the extra step trying to prove to the Food and Drug Administration their product is both safe and effective.

"I think they're taking a risk in doing this but on the other hand, if they can get FDA-approval this will seriously legitimize their claims," Dr. Seidman said.

And it'll give women another option for dealing with that time of the month. Stein said she'd buy it in a heartbeat. "I thought it was great," she said.

The manufacturer says the pills are made in China but the safety standards have been reviewed by the FDA. The FDA has given permission to run the study here. Enrollment for this clinical trial is now over, but Philadelphia Clinical Research is currently running other women's health studies. (For information on other clinical trials, click on link or call 215-676-6696.)

There are similar herbal remedies now sold over-the-counter in the United States. They have not been scientifically proven.