Dietary Supplements in Preconception Care

2. Dietary Supplements in Preconception Care Paula Gardiner MD MPH Katherine Gergen-Barnett MD Christine Pecci MD Brian Jack MD Boston University Medical School

3. How are herbs regulated in the U.S. ?

4. DSHEA’s Definition of Dietary Supplements • Product (other than tobacco) that contains one or more of the following dietary ingredients: • a vitamin, mineral, herb or other botanical, or amino acid • a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients

5. 1994 Dietary Supplement Health and Education Act • Supplements can be marketed without testing efficacy • Safety need not be proved before marketing • Require good manufacturing practices • Structure/function product claims allowed • Label claims do not require extensive evidence • FDA approval not needed for marketing claims

7. Various Forms • Oral • Encapsulated or tablet • Tinctures • Dried herb • Raw whole herb • Infusion (e.g. tea) • Decoction (boiled down tea) • Topical • Ointments • Essential Oils • Creams • Powders • Plasters • Poultices

8. Which supplements are women using ?

9. Overall Herbal Therapy Use in the U.S. 1997 (2) 2007 (4) 1990 (1) 2002 (3) U.S. Adult Population Using Herbal Therapies (1) Eisenberg DM et al. NEJM 1993; 1998 (3) Kaufman et al. JAMA 2002;287:337-44. (4) NHIS (Barnes et al. CDC No. 343, 2002). (5) NHIS (Barnes et al. CDC 2007).

11. Disclosure of Dietary Supplements Use to Medical Professional • 35% of adults taking herbs share this information with a health care professional • Cohen RJ, et al, Gardiner P et al, Blendon RJ, et al.

12. What about preconception?

13. Specific Aims • Factors associated with herb usage in women ages 18 to 45 (N=9067) • Rates of specific herb use • Rate of discussion of herb use with medical professionals

14. Methods • Secondary database analysis • National Health Interview Survey (2002) • The NHIS is an in-person household survey conducted by the Census Bureau for the National Center for Health Statistics • U.S. adults in civilian, non-institutionalized household population • 31,044 adults interviewed

15. Outcome Variable “DURING THE PAST 12 MONTHS, did you use natural herbs for your own health or treatment?” • 20% of women of reproductive age in the U.S. used an herb in the prior 12 months (n=1827)

17. Disclosure of Herb Use to Conventional Professional • 33 % of herb users disclosed their herb use to conventional medical professionals • 26% of women with chronic conditions used an herb in the last 12 months.

18. Outcome: Use of herbs Multivariate Regression Age, years • 18-29 - reference • 30-45 1.18 [1.03, 1.35] • Model was adjusted for race, income, over the counter and prescription medication use, and own health status

19. Outcome: Use of herbs Multivariate Regression • Education Level • < High School - reference • High School 1.41 [1.09, 1.82] • Some College 1.76 [1.39, 2.23] • College Grad 2.44 [1.89, 3.14]

20. Outcome: Use of herbs Multivariate Regression • Region • Northeast - reference • Midwest 0.77 [0.63, 0.93] • South 0.82 [0.68, 0.98] • West 1.41 [1.16, 1.71] • Insurance • Yes - reference • No 1.26 [1.08, 1.48]

21. Outcome: Use of herbs Multivariate Regression • Alcohol use in last 12 months • None - reference • Infrequent/light 1.43 [1.22, 1.66] • Moderate/heavy 1.66 [1.33, 2.06] • Unknown status 0.91 [0.54, 1.54] • Smoking Status • Never - reference • Current 1.18[1.01, 1.39] • Former 1.51 [1.26, 1.81]

22. Outcome: Use of herbs Multivariate Regression • Physical activity • Low - reference • Moderate 1.53[1.28, 1.84] • High 2.07[1.79, 2.39]

23. Conclusions • Nearly one in five women of reproductive age report using an herb in the last 12 months • Most commonly used herbs were: echinacea (46%), ginseng (21%), gingko (17%), and garlic (15%) • 33 % inform medical professionals about their use of natural herbs. • Factors were associated with herb use include: being older, uninsured, high physical activity, drinking alcohol, being a former smoker, living in the West, and being highly educated

24. What about pregnant women?

26. Boston Medical Center (BMC) Methods - a pilot cross-sectional survey of post-partum inpatients (n=160) and a chart review of birth outcomes English speaking, over 18 years old Patients were asked about: “herbs, plant medicines, and home remedies” use during pregnancy Outcomes - disclosure of herbal use with prenatal health care providers satisfaction with their providers’ counseling on herbs

27. Post Partum BMC • Age - 18-44 years of age • Education - 17% < than high school; 40% high school graduates; 43% some college • 65% - English is the primary language • 44% - Born outside of the United States

28. Racial Ethnic Groups

29. Prevalence • 43 % Herb use during pregnancy • 65 % prenatal vitamins during pregnancy

30. Specific Herb Use

31. Green Tea Cranberry Mother’s tea Pregnancy Tea Blue cohosh Floridix Haitian Tea Coconut juice Lemon Vitamin E Cinnamon Olive leaf Cloves Black seed Black seed’s in wine Omega fatty acids Other products

32. Is it documented in the chart?

33. Disclosure of Herb Use to Prenatal Provider • 19 % discussed their herb use with their prenatal care provider • 36% herb users • Of those who did discuss herb use, only 9% of women were satisfied with their providers counseling about herbs • 19% herb users

34. Limitations • English only • Term “herbs, plant medicines, and home remedies” may have been misleading to respondents leading to under reporting • Small sample size

35. Final Conclusions • Pregnant women use herbs • Many do not talk with their health care providers • Use a variety of different herbs • Difficult to study • Safety is a concern

36. Questions