Wednesday, June 15, 2011

Use of Botanical Supplements in Infants

From Medscape Pediatrics

An Expert Interview With Sara B. Fein, PhD

Laurie Scudder, DNP, NP

Posted: 06/03/2011






Editor's Note:
Use of dietary botanical supplements (DBS) and herbal teas by infants in the first year of life is worrisome for several reasons. 
Infants under 6 months of age should not be given anything except breast milk or formula unless recommended by a doctor (for example, vitamin or mineral supplements or medicines, including specific DBS if medically recommended.) 
Other concerns are the possibility of water intoxication in young infants and the wide variety of DBS given to infants. 
Some DBS reported as given to infants have the potential to cause side effects, including allergic reactions, or drug interactions if the infant also is taking other medications.
Infants, because of differences in their physiology and metabolism as well as, obviously, a much smaller body weight, may be more susceptible to adverse effects from DBS. 
Population-based studies of use of these products in US children have produced widely varying estimates ranging from < 1% to 5%, whereas studies in specific settings have been even higher. A survey of children participating in the special supplemental program Women, Infants, and Children (WIC) in 2 states reported a prevalence of 36%. 
The current study is the first to focus specifically on use in infants during the first year of life. Laurie Scudder DNP, NP, Clinical Editor of Medscape, spoke with Sara B. Fein, PhD, one of the study authors, to discuss the findings and the implications for clinical practice.
 
Medscape: Dr. Fein, could you review the impetus for this study? What factors contributed to the decision to examine the use of these agents in infants? Could you describe the specific types of products that were of interest?
Dr. Fein: The study was conducted as part of a large study of infant feeding and care practices in the United States, not because we had any prior concerns about this issue. The research was conducted in collaboration with the US Centers for Disease Control and Prevention, Office of Women's Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the Office of Dietary Supplements in the National Institutes of Health (NIH), the National Cancer Institute, and the Maternal and Child Health Bureau in the Health Services and Resources Administration. The Economic Research Service and the Food and Nutrition Service at the US Department of Agriculture (USDA) also participated. The sample was drawn from a nationally distributed, although not necessarily representative, consumer opinion survey administered between 2005 and 2007 to approximately 3000 mothers 18 years of age and older. We examined a number of topics related to infant feeding and care. For example, we included questions about infant formula, commercial baby foods, pacifiers, breast pumps, and more. We wanted to get as complete a picture as possible about the care and feeding of US infants. We included questions about dietary botanical supplements and teas because no data from the United States existed for a large sample of the general population of infants. Other studies have looked at use in children or special populations, like children with disabilities or chronic conditions. The US Food and Drug Administration (FDA) regulates supplements, and we believe that it helps us to know which population groups are using various products.
 
Medscape: Could you review for us the results of this study?
Dr. Fein: To summarize, our main findings were:
  • About 9% of mothers in the sample reported giving DBS and/or teas to their infants in the first year of life, although usually only for a short period of time. This figure is much higher than a previous figure of 0.8% reported from the National Health and Nutrition Examination Survey.Other studies also found much lower use estimates of anywhere from 3.9% to 5.0%.Because our sample over represents certain groups who may use DBS or teas more often, we believe that the true national prevalence rate of infant use is somewhere between 3% and 10%.
  • The mothers reported giving infants a variety of different DBS or teas, the most common of which included gripe water, chamomile, teething tablets, and unspecified tea. The ingredients in gripe water vary by brand but usually include ginger and fennel.
  • The 4 most common reasons that mothers reported feeding DBS or teas to their infants were to help with fussiness, digestion, colic, and relaxation.
  • The percentage of mothers who used DBS or teas to treat an illness increased with infant age.
  • We found that the most commonly reported sources of information about DBS and teas were friends or relatives (30%), the media (28%), and healthcare professionals (27%).
Medscape: Were there particular populations of women who tended to use these products?
Dr. Fein: We found that mothers who fed their infants DBS or teas were more likely to have used DBS themselves. This finding is consistent with findings in previous research.
Hispanic mothers were more likely to give DBS or teas to their infants than non-Hispanic white mothers. This finding is consistent with findings in previous research. We found that longer breast-feeding, a characteristic that has not been studied, was related to giving the infant DBS or teas.
 
Medscape: Were there regional variations in frequency of use, products used, or the reasons cited for use of these products?
Dr. Fein: We only looked at region by prevalence of use. Mothers in the West were more likely to give their infants DBS or teas. Use of these products in the Northeast, Midwest, and South was somewhat lower and, in all 3 regions, approximately equivalent.
 
Medscape: Were the results surprising to you and your fellow researchers?
Dr. Fein: Because we could not find any previous studies in infants, we did not know what to expect. However, we had not anticipated that the rate of use would be this high.
We also did not expect to find the variety of products that were given to infants. In addition to gripe water, chamomile, and teething tablets, mothers reported use of mint, fennel, anise, Echinacea, catnip, ginger, baby tea, tummy soother, herbal cold remedies, and unspecified teas.
Another category included a variety of products including flaxseed oil, garlic oil, goldenseal extract, grape extract, clove oil, comfrey, and numerous other products.
 
Medscape: What are the implications for practicing primary care clinicians? Are there particular adverse events that could result from use of these products that might alert a clinician to specifically inquire about their use?
Dr. Fein: Healthcare providers should recognize that infants under their care may have been given 1 or more of a wide variety of DBS and teas. Some dietary supplements contain active ingredients that have biological effects on the body that could make them unsafe for specific consumers because of health, age, or the medications that they are taking.
Experts recommend that infants younger than 6 months of age be given only breast milk or formula, along with medicines and certain vitamins if needed. Therefore, giving any form of tea at a young age is against recommendations.
One reason for the recommendation is that infants are growing rapidly and need the nutrients in breast milk or formula.
Giving teas would reduce the amount of milk that the infant could drink and thereby reduce the level of nutrition that they receive.
Also, consistently giving waterlike liquids can lead to water intoxication.
Other literature has discussed possible risks to infants from DBS because of differences in physiology, metabolism, and dose per body weight -- although our study did not evaluate these issues.
 
Medscape: Parent education is paramount. Can you discuss some of the specific recommendations that you would make for clinicians to best educate families in their practice?
Dr. Fein: The FDA generally recommends that consumers check with their healthcare providers about the use of any dietary supplement. However, our study found that only a quarter of women reported having consulted with a healthcare professional. Given the significant number of infants likely using these products, it is important that healthcare professionals specifically ask mothers about their use.
Asking about use of these products provides an opportunity to reiterate the American Academy of Pediatrics (AAP) recommendation that infants under 6 months of age only receive breast milk or formula unless they require a dietary supplement or medicine.
Parents should be encouraged to check with their healthcare professionals before they give any DBS to their infants and should be educated about the potential for adverse effects.
However, healthcare professionals should also be aware that in some populations use of these products is very common and consistent with cultural dietary patterns. The FDA Webpage on dietary supplements contains information about a variety of specific products.
 
Medscape: From a public health and policy perspective, are there regulatory or legislative interventions that are now indicated?
Dr. Fein: Our study was descriptive in nature, and it will be valuable to us in designing future studies. There have been no FDA policy changes resulting from this study; however, this type of information helps the agency better understand the public health impact of the products that we regulate.

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