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Dietary Supplements in Preconception Care. Paula Gardiner MD MPH Katherine Gergen-Barnett MD Christine Pecci MD Brian Jack MD Boston University Medical School. How are herbs regulated in the U.S. ?. DSHEA’s Definition of Dietary Supplements.

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Dietary supplements in preconception care

Dietary Supplements in Preconception Care

Paula Gardiner MD MPH

Katherine Gergen-Barnett MD

Christine Pecci MD

Brian Jack MD

Boston University Medical School



Dshea s definition of dietary supplements
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


1994 dietary supplement health and education act
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


Various forms
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



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).


Disclosure of dietary supplements use to medical professional
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.



Specific aims
Specific Aims Professional

  • 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


Methods
Methods Professional

  • 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


Outcome variable
Outcome Variable Professional

“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)


Disclosure of herb use to conventional professional
Disclosure of Herb Use to Conventional Professional 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.


Outcome use of herbs multivariate regression
Outcome: Use of herbs ProfessionalMultivariate 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


Outcome use of herbs multivariate regression1
Outcome: Use of herbs ProfessionalMultivariate 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]


Outcome use of herbs multivariate regression2
Outcome: Use of herbs ProfessionalMultivariate 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]


Outcome use of herbs multivariate regression3
Outcome: Use of herbs ProfessionalMultivariate 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]


Outcome use of herbs multivariate regression4
Outcome: Use of herbs ProfessionalMultivariate Regression

  • Physical activity

    • Low - reference

    • Moderate 1.53[1.28, 1.84]

    • High 2.07[1.79, 2.39]


Conclusions
Conclusions Professional

  • 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



Boston medical center bmc
Boston Medical Center (BMC) Professional

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


Post partum bmc
Post Partum BMC Professional

  • 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


Racial ethnic groups
Racial Ethnic Groups Professional


Prevalence
Prevalence Professional

  • 43 % Herb use during pregnancy

  • 65 % prenatal vitamins during pregnancy


Specific Herb Use Professional


Other products

Green Tea Professional

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



Disclosure of herb use to prenatal provider
Disclosure of Herb Use to Professional 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


Limitations
Limitations Professional

  • English only

  • Term “herbs, plant medicines, and home remedies” may have been misleading to respondents leading to under reporting

  • Small sample size


Final conclusions
Final Conclusions Professional

  • 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


Questions
Questions Professional


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