RJ Berry and the China Study on Folic Acid
Categories: General
April 27th, 2012 2:33 pm ET - Curt Shannon
Editor’s Note: In 2012 we will mark the 20th anniversary of the US Public Health Service recommendation that women of childbearing age should consume 400 micrograms (mcg) of folic acid every day to help prevent certain neural tube defects (NTDs) – spina bifida and anencephaly. Several CDC scientists were involved in the research that led up to the recommendation, or contributed to the subsequent work on folic acid that continues today, including Joseph Mulinare, Robert J. Berry, J. David Erickson, and Godfrey Oakley. The four blogs in this series tell their stories.
The China study, officially named the Sino American Cooperative Project on Neural Tube Defects, was conducted in two areas during the mid-1990s: in northern China where the background rate was high, and in southern region China where the background rate was comparable to the US. Because there was no folic acid fortification and no other vitamins given to study participants, the study represented a “pure” test of the lone effect of 400 micrograms of folic acid.
The study involved two years of recruitment, between October 1, 1993 and September 30, 1995, with a total of 247,831 women participating. “It’s a number I’ll never forget,” says Robert J. (RJ) Berry, MD, MPHTM, who led the study. Among the 130,142 women who took folic acid at any time before or during pregnancy, 102 fetuses or infants were identified with neural tube defects. Of the 117,689 women who had not taken folic acid, 173 fetuses or infants had neural tube defects.
“In the north, the rate among non-pill takers was 4.8 per thousand. The rate among women who took it at the right time and had the highest compliance was 0.7 per thousand. “That’s an 85 percent reduction, which is unbelievable,” says Berry. “In the south—which started at a much lower value at 1 per thousand—it went down to .6 per thousand, so that’s a 40 percent decrease.”
The study generated a massive organizing effort among thousands of Chinese village doctors who served as intermediaries between the project and the participants. Each month doctors visited the homes of the participants to check on how they were doing, collect the old pill bottle and supply a new one, and compile a report on how many pills were left in the old bottle, which could determine the compliance rate. Each woman averaged about six months of pill-taking.
Results of the China study were published in 1999 in the New England Journal of Medicine. The paper, which was titled “Prevention of Neural Tube Defects with Folic Acid in China,” was written by Berry, Joe Mulinare, J. David Erickson, and others from CDC, as well as colleagues in China. “It completely settled the debate about whether folic acid alone was [acting as a preventive against NTDs] and at this level of 400 micrograms,” recalls Berry. “So this was a catalyst for a lot of countries to move forward in getting folic acid to their people.”
Folic acid has largely been the focus of Berry’s career at CDC, where he continues to work on the issue. Last year he returned to China and went to a site chosen for a new joint project with the National Cancer Institute. He and members of his team visited several townships and at one point went to a middle school where Berry got very emotional. “The Chinese have an exercise period in school when everyone runs around the track in a squad for 20 minutes. As we were watching them, I realized there were kids out there who—if we hadn’t done what we did—would have died or would be paralyzed. That was quite a moment.”
Another “moment” occurred back in 1994 when the unit Berry was working with in China nominated him for a Friendship Award, the highest honor that China gives to foreigners. “It was a big deal, “says Berry, “and I was interviewed by a group of reporters. One of the questions was—‘Will you remember this in the future?’ And I said there isn’t any possibility that I could ever forget. What we’re doing is so important, I’ll be proud of this forever.”
For more information about CDC’s folic acid success story, go to the CDC Works for You 24/7 story, Folic Acid: Helping to Prevent Birth Defects. For more detailed information on folic acid, visit the CDC Folic Acid Web Page. Thanks to Faye McDonald Smith of CDC who wrote the original article on which this blog was based.
RJ Berry, who lived in China during the 1990s to conduct a study on folic acid, recently visited a township in Taicang City, Jiangsu Province. The woman in the white coat worked on the original project on folic acid and the other women had children born during 1994 through 1996. Photo courtesy of RJ Berry
The study involved two years of recruitment, between October 1, 1993 and September 30, 1995, with a total of 247,831 women participating. “It’s a number I’ll never forget,” says Robert J. (RJ) Berry, MD, MPHTM, who led the study. Among the 130,142 women who took folic acid at any time before or during pregnancy, 102 fetuses or infants were identified with neural tube defects. Of the 117,689 women who had not taken folic acid, 173 fetuses or infants had neural tube defects.
“In the north, the rate among non-pill takers was 4.8 per thousand. The rate among women who took it at the right time and had the highest compliance was 0.7 per thousand. “That’s an 85 percent reduction, which is unbelievable,” says Berry. “In the south—which started at a much lower value at 1 per thousand—it went down to .6 per thousand, so that’s a 40 percent decrease.”
The study generated a massive organizing effort among thousands of Chinese village doctors who served as intermediaries between the project and the participants. Each month doctors visited the homes of the participants to check on how they were doing, collect the old pill bottle and supply a new one, and compile a report on how many pills were left in the old bottle, which could determine the compliance rate. Each woman averaged about six months of pill-taking.
Results of the China study were published in 1999 in the New England Journal of Medicine. The paper, which was titled “Prevention of Neural Tube Defects with Folic Acid in China,” was written by Berry, Joe Mulinare, J. David Erickson, and others from CDC, as well as colleagues in China. “It completely settled the debate about whether folic acid alone was [acting as a preventive against NTDs] and at this level of 400 micrograms,” recalls Berry. “So this was a catalyst for a lot of countries to move forward in getting folic acid to their people.”
Chinese middle school children exercising in squads. “As we were watching them, I realized there were kids out there who—if we hadn’t done what we did—would have died or would be paralyzed,” says RJ Berry, who most recently visited China in February 2011. Photo courtesy of RJ Berry
Another “moment” occurred back in 1994 when the unit Berry was working with in China nominated him for a Friendship Award, the highest honor that China gives to foreigners. “It was a big deal, “says Berry, “and I was interviewed by a group of reporters. One of the questions was—‘Will you remember this in the future?’ And I said there isn’t any possibility that I could ever forget. What we’re doing is so important, I’ll be proud of this forever.”
For more information about CDC’s folic acid success story, go to the CDC Works for You 24/7 story, Folic Acid: Helping to Prevent Birth Defects. For more detailed information on folic acid, visit the CDC Folic Acid Web Page. Thanks to Faye McDonald Smith of CDC who wrote the original article on which this blog was based.
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