With Comments from Russell H. Greenfield, MD
Multivitamins and AIDS
Source: Fawzi WW, et al. A randomized trial of multivitamin supplements and HIV disease progression and mortality. N Engl J Med 2004;351:23-32.
Goal: To determine whether vitamin and/or micronutrient supplementation has a beneficial effect on disease course in HIV-positive pregnant women.
Study Design: Double-blind, placebo-controlled trial using a factorial design.
Subjects: A total of 1,078 HIV-positive pregnant women in Tanzania.
Methods: Eligible subjects were randomized to receive one of four regimens: vitamin A alone (30 mg beta-carotene + 5,000 IU preformed vitamin A), a multivitamin not containing vitamin A (20 mg B1, 20 mg B2, 25 mg B6, 100 mg niacin, 50 mg B12, 500 mg vitamin C, 30 mg vitamin E, and 0.8 mg folic acid), the multivitamin plus vitamin A, and placebo. Blood tests were performed at study entry and every six months thereafter for measurement of T-cell subgroups. A random sample of 300 women was selected to assess the effects of supplements on viral load. The women were seen monthly at the study clinic, and stage of HIV was assessed according to World Health Organization (WHO) criteria. Survival was the primary outcome. Follow-up occurred for a median of 71 months.
Results: During the period of follow-up 343 women died, of those deaths 243 were deemed to be due to or related to AIDS. Of the 271 women who received multivitamins, 67 progressed to stage 4 disease or died as compared with 83/267 women who received placebo (24.7% vs. 31.1%). Adding vitamin A to the multivitamin regimen reduced some of the aforementioned benefits (26.1% died), while vitamin A alone produced effects not significantly different from those associated with placebo (29.0% died). The multivitamin regimen was also associated with reduced progression to WHO stage 4 disease and reduced progression to stage 3 disease or higher, and resulted in significantly higher CD4+ and CD8+ cell counts, as well as significantly lower viral loads.
Conclusion: Multivitamin supplementation significantly delays HIV disease progression in pregnant women.
Study strengths: Compliance with regimen was determined and was high in all groups (79% over the total follow-up period); excellent follow-up.
Study weaknesses: Cannot extrapolate results to those people already receiving antiretroviral therapy, nor to those who are relatively well nourished.
Of note: All women were offered standard doses of folic acid and iron; antiretroviral therapy was not offered to study participants (at time of study antiretroviral therapy was not available to the majority of women in Tanzania); the effect of multivitamins was strongest during the first two years, but beneficial effects were also observed at four years; multivitamins significantly reduced oral and gastrointestinal manifestations of HIV disease, including painful swallowing and dysentery, and lessened reported fatigue, rash, and acute upper respiratory tract infections; by contrast, vitamin A supplementation increased the risk of painful swallowing, and resulted in significantly lower CD8+ cell counts; dosages used in the multivitamin were multiples of the RDA for specific nutrients in response to the impaired absorption and increased metabolic utilization of nutrients known to be present in people with HIV; the annual retail cost of the multivitamins used in this study was $15 per person.
We knew that: More than 40 million people worldwide are infected with HIV, and less than 8% of the 6 million people with advanced AIDS eligible for antiretroviral treatment are receiving it; a study published earlier this year showed that administration of vitamin A to HIV-positive pregnant women results in a higher rate of transmission of HIV to the baby; observational studies strongly suggest a health benefit from multivitamin supplementation for HIV-positive men; oxidative stress increases HIV replication in vitro.
Comments: This well-done study addresses a low-cost intervention to help slow progression of one of the global scourges of the 21st century, and in a malnourished population of pregnant women, it appears to work. The researchers conclude that in HIV-positive pregnant women multivitamin supplementation delays the need for antiretroviral therapy, a treatment whose very mention brings up issues of cost and morality. The results of the study are compelling, and also speak to the need for supplementation specific to the needs of a given individual, since many multivitamin supplements contain vitamin A, now known to be potentially harmful to HIV-infected pregnant women and their offspring. While we await the results of similar studies performed in industrialized nations, it seems prudent to offer at least B-complex supplementation to people infected by HIV.
What to do with this article: Make copies to hand out to your peers.
Dr. Greenfield, Medical Director, Carolinas Integrative Health Carolinas HealthCare System Charlotte, NC, is Executive Editor of Alternative Medicine Alert.