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Back To Vidyya Did US Study Harm Chinese Patients?

Dirty Endoscopes Used In H. Pylori Study

A U.S.-funded study in China might have accidentally exposed participants to the bacterium that causes stomach ulcers, prompting National Cancer Institute doctors to help administer antibiotics to up to 500 people.

It's still unclear if the research was to blame, cautioned Dr. Susan Nayfield, chief of the NCI unit that oversees international research safety. China already had one of world's highest rates of infection with the H. pylori bacterium.

But NCI and Chinese scientists are investigating whether study participants were infected by dirty endoscopes, tubes snaked down the throat to inspect the stomach, Nayfield said Thursday.

The NCI funded two studies in the rural Shandong province starting in 1989, to examine the prevalence of stomach cancer and H. pylori and to see if certain nutritional supplements affected either condition. H. pylori causes stomach ulcers, and is suspected to play a role in stomach cancer. China also has high rates of stomach cancer, relatively rare in this country.

Part of the first study, between 1989 and 1994, used endoscopes to examine participants' stomachs.

When the second study began in the late 1990s, scientists recorded more H. pylori infections than expected--a possible increase of 40 percent, Nayfield said.

Unknown to the NCI, Chinese health officials in the early 1990s declared endoscopes could be cleaned by wiping them with a special cloth instead of soaking them in a sterilizer, the method U.S. officials recommend when disposable endoscopes can't be used.

The question: Could dirty endoscopes be to blame, did infections rise overall in Shandong, or was there a testing error?

The NCI and an independent safety board couldn't say, but NCI scientists departed for China a few weeks ago to help provide antibiotics to clear up the infections.

Also, the scientists will test-clean endoscopes using the wiping method to see if H. pylori could survive that way, something no one yet knows, Nayfield said.

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Editor: Susan K. Boyer, RN
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