July 1, 2004
Measures, Changes in Method
Participants received periodic checkups for four years after delivering their infants and about 50% of the participants received checkups for more than five years after delivering. Researchers monitored participants to determine if the supplements affected the progression of HIV to severe symptoms, AIDS or death, according to the release. Researchers also examined the effect of the supplements on CD4+ cells and CD8+ cells and on viral load (NICHHD release, 6/30). Dr. Wafaie Fawzi, a professor of nutrition and epidemiology at Harvard and lead author of the study, said that the study was modified twice for ethical reasons, according to the Times. First, researchers removed vitamin A from the regimen because of evidence demonstrating an increased risk of mother-to-child HIV transmission. Second, researchers placed all participants on multivitamins until they delivered due to evidence that the vitamins prevented fetal death and premature birth, the Times reports. After the women delivered, the researchers put them back on their previous regimens, according to the Times (New York Times, 7/1).
The findings show that although the benefits of multivitamins are statistically significant, the results were not "dramatic," according to Reuters (Emery, Reuters, 6/30). Researchers found that 67 of the 271 participants who received multivitamins progressed to an advanced stage of disease, which the World Health Organization classifies as stage 4, or they died; compared with 83 of the 267 women in the placebo group (Fawzi et al., NEJM, 7/1). Researchers also found that although the number of deaths was lower in the multivitamin group, the finding was not statistically significant. In addition, women taking multivitamins had fewer symptoms associated with later-stage HIV -- including mouth infections, mouth ulcers or diarrheal diseases -- than those in the placebo group. Researchers also found that women receiving multivitamins had CD4+ cell counts an average of 48 cells higher than the CD4+ cell counts of those in the placebo group; viral load was also "modestly but significantly lower" in women receiving multivitamins, according to the NICHHD release (NICHHD release, 6/30). Fawzi said that although men were not included in the study, the benefits of multivitamins likely would apply to them, according to the AP/Newsday (AP/Long Island Newsday, 6/30).
Dr. Lynne Mofenson, head of NICHHD's pediatric and maternal AIDS branch, said, "The study is important for developing countries, especially for pregnant and postpartum women, who are a nutritionally vulnerable group" (Boston Globe, 7/1). Mofenson added that supplements "might buy time to allow people to go longer before they develop symptoms that require antiretroviral treatment" (Brown, Washington Post, 7/1). Fawzi said that the findings "clearly provide support for a recommendation of providing multivitamins as supportive care to those infected with HIV," adding, "The multivitamins would be useful in earlier stages of HIV disease, in order to delay the time until these antiretroviral drugs are necessary" (Boston Globe, 7/1). Although the multivitamins used in the research were made specifically for the study, they would be "quite easy to mass-produce," Fawzi said (New York Times, 7/1). He added, "It's a low-cost intervention that could result in major savings and be helpful to many individuals in terms of better quality of life" (AP/Long Island Newsday, 6/30). In an accompanying NEJM editorial, Drs. Barbara Marston and Kevin De Cock of the CDC in Kenya called for more research to support the findings, according to the AP/Newsday. Until then, doctors "would be justified in routinely prescribing [multivitamins as] nutritional support, since it may provide a benefit and does no harm" (AP/Long Island Newsday, 6/30).
Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2004 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.