Research

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OBSTETRICS

Herbal use before and during pregnancy

Cheryl S. Broussard, PhD; Carol Louik, ScD; Margaret A. Honein, PhD, MPH;
Allen A. Mitchell, MD; and the National Birth Defects Prevention Study
OBJECTIVE: We estimated the prevalence and patterns of herbal use

among US women before and during pregnancy.

STUDY DESIGN: The National Birth Defects Prevention Study is an on-

going, population-based, case-control study. This analysis included

4239 women from 10 centers in the United States who delivered infants
without major birth defects from 1998 2004.
RESULTS: The prevalence of reported herbal use 3 months before or

during pregnancy was 10.9%. During pregnancy, prevalence was 9.4%

and was highest in the first trimester. Higher prevalence was associated

with age greater than 30 years and education greater than 12 years.
Use varied considerably by state (517%). Ginger and ephedra were the
most commonly reported products early in pregnancy; teas and chamomile were most commonly reported throughout pregnancy.
CONCLUSION: Potentially 395,000 US births annually involve antenatal

exposure to herbal products. Health care providers should inquire routinely about herbal use and educate patients about what little is known
regarding risks of these products.
Key words: drug safety, ephedra, herbal preparation, pregnancy

Cite this article as: Broussard CS, Louik C, Honein MA, et al. Herbal use before and during pregnancy. Am J Obstet Gynecol 2010;202:443.e1-6.

ccording to the 2002 National

Health Interview Survey, an estimated 38 million US adults per year use
herbal therapies.1 The reported prevalence of herbal use is higher among
women than among men.1 There is a lack
of published US data on the frequency of
herbal use among women of childbearing age in general; published estimates specifically during pregnancy range from 4.1
45.2%, but these were based on sample
sizes of only 150 734 women.2-5 Studies
have shown that many patients do not
disclose use of herbals to their health care

providers; estimates of nondisclosure

range from 2558%.1,4,6-8
Under the Dietary Supplement Health
and Education Act of 1994, the responsibility for ensuring safety before marketing rests with the manufacturers, and
the US Food and Drug Administration
(FDA) can take regulatory action only if
it can prove that a product is unsafe once
it reaches the market.9 Therefore, in contrast to prescription and newer over-thecounter medications, herbal products

From the Epidemic Intelligence Service, Office of Workforce and Career Development (Dr
Broussard), and the Division of Birth Defects and Developmental Disabilities (Drs Broussard
and Honein), Centers for Disease Control and Prevention, Atlanta, GA; and the Slone
Epidemiology Center at Boston University (Drs Louik and Mitchell), Boston, MA.
Presented at the 11th Annual Meeting of the National Birth Defects Prevention Network,
Washington, DC, Feb. 11-13, 2008, and the 57th Annual Epidemic Intelligence Service
Conference, Atlanta, GA, April 14-18, 2008.
Received May 29, 2009; revised Aug. 27, 2009; accepted Oct. 19, 2009.
Reprints: Cheryl S. Broussard, PhD, Centers for Disease Control and Prevention, 1600 Clifton Rd.,
MS E-86, Atlanta, GA 30333. gnp2@cdc.gov.
This study was supported in part by cooperative agreements under Program Announcement
02081 from the Centers for Disease Control and Prevention to the centers participating in the
National Birth Defects Prevention Study, listed in the Acknowledgments section of the full-length
article at www.AJOG.org.
The findings are conclusions in this article are those of the authors and do not necessarily
represent the official position of the Centers for Disease Control and Prevention.
0002-9378/free Published by Mosby, Inc. doi: 10.1016/j.ajog.2009.10.865

For Editors Commentary, see Table of Contents

usually are marketed without the benefit

of clinical trials to demonstrate either efficacy or safety.
Safety concerns related to herbal products have emerged. These safety concerns
have been attributed to the herbal ingredient itself (eg, ephedra and kava),10,11 interactions between a herbal product and
other pharmaceuticals (eg, Ginkgo biloba
and blood-thinning agents, ginseng, and
insulin),12,13 and contamination of products by unlabeled toxins (eg, lead and mercury).14,15 Herbal use surrounding pregnancy raises particular concerns, because
many herbals are marketed specifically for
symptoms that occur commonly during
pregnancy, such as nausea and vomiting.16
More importantly, our ignorance of the
potential harm to the pregnant woman is
complicated by our even greater ignorance
of the potential effects on fetal safety.
Because little is known about the extent of herbal use among pregnant
women, we estimated the prevalence and
pattern of use among women immediately before and during pregnancy.

M ATERIALS AND M ETHODS

To estimate the prevalence of herbal use
among a population-based sample of
women who delivered liveborn infants
with no major birth defects, we used data
from the National Birth Defects Prevention Study (NBDPS). The NBDPS is an
ongoing, population-based, case-con-

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trol study involving case infants with

major structural birth defects and control infants without such defects, conducted in 10 centers across the United
States: Arkansas, California, Georgia,
Iowa, Massachusetts, New Jersey, New
York, North Carolina, Texas, and Utah.
Each center defined a study region with
between 35,000 75,000 births per year,
which in some cases was statewide and in
other cases was a region in a state.
The control infants are a random sample of live births drawn from the same
source population as the case infants,
with the selection occurring from either
birth certificates or hospital birth
records. About 900 mothers of control
infants are interviewed each year, and
only control mothers were included in
this analysis. The study was approved by
the institutional review boards of the
Centers for Disease Control and Prevention and all participating study centers.
The study uses a computer-assisted
telephone interview to collect data from
mothers about exposures in the 3
months before pregnancy and throughout pregnancy, the latter defined as the
time period from conception (ie, 2 weeks
after the last menstrual period) to delivery. Each month was a 30-day period,
and, for this analysis, trimesters were defined as 3-month periods (first trimester:
pregnancy months 13; second trimester: pregnancy months 4 6; and third
trimester: pregnancy months 79, which
some mothers did not reach, because
they delivered in the second trimester).
Interviews are conducted from 6 weeks
to 2 years after the estimated date of delivery (EDD), with a mean and median
time to interview for control mothers of
8.9 and 7.7 months, respectively, after
the EDD.
The questionnaire item related to
herbal use stated: Did you use any herbs
or folk medicines to treat any medical
conditions, to lose weight, or just to keep
you healthy? This question covered the
time period from 3 months before pregnancy to the date of the childs birth.
Analysis was restricted to control mothers who had answered this particular
question.
From among the responses provided
by study participants, herbal products in
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this analysis were defined as products
containing a plant, plant part, or plant
extract (excluding topicals) (eg, black
cohosh, chamomile oil, ephedra, and
Ginkgo biloba). Products were classified
using the Slone Drug Dictionary from
Boston Universitys Slone Epidemiology
Center,17 which links the reported substances to their active ingredients. We included herbal teas that were reported
in response to the specific herbal question or in any other section of the
questionnaire.
When herbal exposure was reported in
an alternate section of the questionnaire
(eg, vitamin use section or maternal illness
section), the reason for use was attributed
to that topic. We excluded exposure to single herbals in mainly vitamin-dominated
multivitamin supplements.
The herbal question was added in mid2000; therefore, for this analysis, we included only women interviewed after this
time, which corresponds to participants
with EDDs between mid-1998 and the end
of 2004 (4239/5958 total controls). The
participation rate in the maternal interview was approximately 69% among control mothers for this time period.
STATA 8 software (Stata Corp, College Station, TX) was used for all analyses. We cross-tabulated herbal use with
each sociodemographic characteristic of
interest to determine the prevalence associated with each of these factors. The 3
months prior to pregnancy and the 3 trimesters of pregnancy were each considered a distinct period for purposes of
this analysis, and prevalence of herbal
use was calculated for each of the 4 periods. Percentages of mothers taking each
herbal product were tabulated and
ranked to determine the most commonly reported herbals.

R ESULTS
Overall, 462 (10.9%) of the 4239 control
mothers reported use of any herbal
product in the 3 months before pregnancy or during pregnancy. The prevalence of herbal use by state varied considerably, with the lowest use in Iowa and
North Carolina (5.4% and 6.1%, respectively) and the highest in Utah (16.5%)
(Table 1). Use increased with age and

American Journal of Obstetrics & Gynecology MAY 2010

also was greatest among women with

more than a high school education and
among women with a household income
of $20,000 or more per year. Hispanics
reported the highest prevalence of herbal
use of all racial or ethnic groups studied.
In the 3 months before pregnancy, the
overall prevalence of herbal use was
5.7%. Only 65 mothers reported herbal
exposure limited to the 3 months before
pregnancy (ie, none were exposed during pregnancy); therefore, the overall
prevalence of herbal use anytime during
pregnancy was 9.4%.
During pregnancy, the prevalence was
highest (6.9%) during the first trimester,
but a substantial proportion of women
took herbals during the latter trimesters
as well (5.1% and 5.2% during the second and third trimesters, respectively);
275 (6.5%) mothers were exposed during more than 1 of the 4 periods, and 87
(2.1%) mothers were exposed in all 4
periods.
Timing of pregnancy recognition was
available for all but 2 participants included in the analysis. Of these 4237
pregnancies, 52% were recognized by the
mother during the first month, 37% during the second month, and 12% during
the third month or beyond. Herbal use
was significantly higher after pregnancy
recognition (7.6% vs 6.1%; P .003).
Among reported products, the most
common herbals (each taken by 3% of
mothers) were herbal teas, ephedra and
ephedra-containing products (which
also tended to include ginger, ginseng, or
both), chamomile, echinacea, and ginger
(Table 2). The other common products
(reported by 0.5% of mothers) were
cranberry extract, raspberry leaf, mint or
peppermint, and primrose oil. A total of
33 of 119 herbal tea users also took another type of herbal product. Excluding
the 86 women who used herbal teas only,
the prevalence of all other herbal products used 3 months before or during
pregnancy was 8.9%.
Distribution of use of these most common products differed somewhat by trimester. As shown in Table 2, ginger was
used predominantly during the first trimester, likely because of its claim to prevent nausea and vomiting during pregnancy. Ephedra was used both before

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Research

TABLE 1

Sociodemographic characteristics of control mothers by reported herbal

use 3 months before and during pregnancy, 1998 2004
Maternal characteristic

Reported herbal
product use, n (%)

No reported herbal
product use, n

Odds ratio

95% confidence
interval

Maternal age at delivery, y

.......................................................................................................................................................................................................................................................................................................................................................................

20

39 (8.8)

404

1.0

Referent

2024

88 (8.8)

907

1.0

0.71.5

2529

120 (10.7)

999

1.3

0.91.8

3034

141 (13.0)

946

1.5

1.12.2

3539

62 (12.4)

440

1.5

1.02.2

40

12 (12.9)

81

1.5

0.83.1

.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
................................................................................................................................................................................................................................................................................................................................................................................

Maternal education, y

.......................................................................................................................................................................................................................................................................................................................................................................

12

68 (9.2)

671

1.2

0.91.7

80 (7.7)

954

1.0

Referent

310 (12.7)

2126

1.7

1.32.3

.......................................................................................................................................................................................................................................................................................................................................................................

12 (high school)

.......................................................................................................................................................................................................................................................................................................................................................................

12

................................................................................................................................................................................................................................................................................................................................................................................

Household income

.......................................................................................................................................................................................................................................................................................................................................................................

$20K

114 (8.8)

1181

1.0

Referent

$20K

330 (12.3)

2351

1.5

1.21.8

.......................................................................................................................................................................................................................................................................................................................................................................
................................................................................................................................................................................................................................................................................................................................................................................

Study site

.......................................................................................................................................................................................................................................................................................................................................................................

Arkansas

50 (9.2)

493

0.7

0.51.1

California

75 (13.1)

499

1.1

0.71.5

Georgia

53 (12.5)

372

1.0

Referent

Iowa

24 (5.4)

419

0.4

0.20.7

Massachusetts

66 (12.1)

480

1.0

0.71.4

New Jersey

33 (10.3)

286

0.8

0.51.3

New York

40 (12.1)

290

1.0

0.61.5

North Carolina

18 (6.1)

276

0.5

0.30.8

Texas

60 (11.9)

444

0.9

0.61.4

Utah

43 (16.5)

218

1.4

0.92.1

.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
................................................................................................................................................................................................................................................................................................................................................................................

Maternal race or ethnicity

.......................................................................................................................................................................................................................................................................................................................................................................

Non-Hispanic white

260 (10.5)

2208

1.0

Referent

Non-Hispanic black

46 (9.8)

425

0.9

0.71.3

123 (12.5)

863

1.2

1.01.5

33 (11.1)

264

1.1

0.71.6

.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................

Hispanic

.......................................................................................................................................................................................................................................................................................................................................................................

Other

................................................................................................................................................................................................................................................................................................................................................................................
2

Maternal body mass index, kg/m

.......................................................................................................................................................................................................................................................................................................................................................................

Underweight (18.5)

17 (7.2)

218

0.6

0.41.0

Normal (18.5 to 25)

260 (11.6)

1979

1.0

Referent

Overweight (25 to 30)

98 (10.6)

825

0.9

0.71.2

Obese (30)

67 (10.1)

597

0.9

0.61.1

.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
................................................................................................................................................................................................................................................................................................................................................................................
a

Maternal smoking in first trimester

.......................................................................................................................................................................................................................................................................................................................................................................

Smoked

77 (9.8)

710

0.9

0.71.1

384 (11.2)

3052

1.0

Referent

.......................................................................................................................................................................................................................................................................................................................................................................

Did not smoke

................................................................................................................................................................................................................................................................................................................................................................................

Broussard. Herbal use before and during pregnancy. Am J Obstet Gynecol 2010.

(continued )

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TABLE 1

Sociodemographic characteristics of control mothers by reported herbal

use 3 months before and during pregnancy, 1998 2004 (continued)
Reported herbal
product use, n (%)

Maternal characteristic

No reported herbal
product use, n

Odds ratio

95% confidence
interval

Year of estimated date of delivery

.......................................................................................................................................................................................................................................................................................................................................................................

19982000

115 (12.1)

839

1.2

0.91.6

2001

82 (10.3)

711

1.0

0.71.4

2002

75 (10.6)

631

1.1

0.81.5

2003

99 (11.1)

791

1.1

0.81.5

2004

91 (10.2)

805

1.0

Referent

.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
................................................................................................................................................................................................................................................................................................................................................................................
b

Time to interview

.......................................................................................................................................................................................................................................................................................................................................................................

6 mo

159 (11.9)

1183

1.0

Referent

6 to 12 mo

203 (11.0)

1635

0.9

0.71.2

12 to 18 mo

77 (10.8)

635

0.9

0.71.2

18 mo

22 (6.7)

306

0.5

0.30.9

.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
................................................................................................................................................................................................................................................................................................................................................................................
a

Included 1 month before pregnancy and first trimester; Time to interview could not be calculated for 1 control subject because of a missing interview date.

Broussard. Herbal use before and during pregnancy. Am J Obstet Gynecol 2010.

pregnancy and during the first trimester

of pregnancy (but not later in pregnancy); in contrast, herbal teas and chamomile were used throughout all 4 periods of pregnancy.
Although there appeared to be no substantial differences in the use of herbal
teas, echinacea, or ginger by year of EDD
(Figure), the prevalence of ephedra use
declined substantially from 20022004,
and chamomile use was reported more
commonly by women with EDDs in the
years 1998 2000.
Reported reasons for herbal use often
were nonspecific, because they generally
were attributed to the topic section of the

questionnaire in which the herbal was reported. The most common reasons given
for use, corresponding to topic areas in the
interview, were as remedies or vitamins,
and for respiratory conditions, morning
sickness, and urinary tract infections. Of
note, a considerable proportion (approximately 40% of the multiple-component
products or 9% of all products) of the
herbals had intended uses that included
weight loss or body enhancement.

C OMMENT
If we assume that our control mothers
were representative of the 4.2 million

births each year in the United States,18

our findings project that 9.4%, or an estimated 395,000 such births, will involve
antenatal exposure to at least 1 herbal
product. Furthermore, the fact that use
of herbal products was greatest during
the first trimester raises concerns about
fetal safety, because this is a critical period of fetal organ development.19 Of
note, in April 2004, the FDA withdrew
ephedra from the market because of concerns about cardiovascular effects, such
as increased blood pressure and irregular
heart rhythm among adults10 (which
could have implications for fetal risk);
our survey documented that use de-

TABLE 2

Top reported herbals used in the 3 months before and during

pregnancy among control mothers, 1998 2004
Herbal product

Any use,
n (%)a

Use <3 months

before pregnancy,
n (%)

Use during
pregnancy,
n (%)

First
trimester use,
n (%)

Second
trimester use,
n (%)

Third
trimester use,
n (%)b

Herbal teas

119 (2.8)

51 (1.2)

109 (2.6)

77 (1.8)

66 (1.6)

75 (1.8)

Ephedra

49 (1.2)

48 (1.1)

25 (0.6)

25 (0.6)

1 (0.0)

0 (0.0)

Chamomile

43 (1.0)

20 (0.5)

42 (1.0)

29 (0.7)

31 (0.7)

27 (0.6)

Echinacea

40 (0.9)

30 (0.7)

25 (0.6)

19 (0.4)

14 (0.3)

7 (0.2)

Ginger

24 (0.6)

3 (0.1)

24 (0.6)

22 (0.5)

10 (0.2)

6 (0.1)

................................................................................................................................................................................................................................................................................................................................................................................
................................................................................................................................................................................................................................................................................................................................................................................
................................................................................................................................................................................................................................................................................................................................................................................
................................................................................................................................................................................................................................................................................................................................................................................
................................................................................................................................................................................................................................................................................................................................................................................
a

Any use is defined as any reported use from 3 months before pregnancy through the end of pregnancy; b n 4239, except for the third-trimester denominator, which excluded 14 women who
delivered during the second trimester (n 4225).

Broussard. Herbal use before and during pregnancy. Am J Obstet Gynecol 2010.

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FIGURE

Time period for top reported herbal use

3 months before and during pregnancy
4
Reported product use (%)

clined subsequent to that withdrawal,

but even with that decline, we estimated
that there were 21,000 71,400 ephedraexposed births per year over the course
of the study period.
Slone Survey data restricted to women
of childbearing age (18 44 years) found
an approximate 10% prevalence of herbal
use during the period 1998 2000 and
about 15% use during the period
20012002.20 Among the few studies that
have considered herbal use among pregnant women, Tsui et al4 reported a prevalence of 20% before pregnancy and 13%
during pregnancy, and a recent Quebec
study reported 15.4% used herbals in the
year before pregnancy and 9% used herbals during pregnancy,21 although that
study had some methodologic limitations.
One US study and 1 Swedish study also
found an association of herbal use with
advanced maternal education.3,22 An
Australian study found, as we did, that
herbal use was highest during the first
trimester compared with immediately
before pregnancy or during the subsequent 2 trimesters.23
This study was subject to several limitations. The self-reported exposure assessment, combined with the variable time to
interview, might have led to exposure misclassification or a lack of specificity in defining the mothers herbal exposure, particularly because the herbal interview
question was open ended. Because onefifth of control mothers were interviewed
1224 months after the EDD, these interviews relied on womens recall of exposures up to 3 years in the past.
There has thus far been no consensus
on how best to ascertain herbal use in
population surveys. In the NBDPS,24 the
Behavioral Risk Factor Surveillance System,25 the National Health and Nutrition Examination Survey,26 the Infant
Feeding Practices Study,27 the Boston
University Slone Epidemiology Centers
Birth Defects Study,28 and the Slone Survey,29 each has taken a slightly different
approach to questioning participants
about herbal use.
A workshop held as part of the planning for the National Childrens Study
summarized some of the approaches
used in previous studies.30 It has been
shown that ascertainment of medication

Research

3.5
3
2.5
2
1.5
1
0.5
0
1998-2000

2001

2002

2003

2004

Year of EDD

Because the herbal question was added in 2000 but time intervals from EDD to interview varied, we
created a time period of 1998 2000 to provide a similar number of participants as the single-year
periods for comparison; 1998 2000, n 954; 2001, n 793; 2002, n 706; 2003, n 890;
2004, n 896.
EDD, estimated date of delivery.
Broussard. Herbal use before and during pregnancy. Am J Obstet Gynecol 2010.

exposure improves with the specificity of

the question,31 and it is reasonable to extrapolate this observation to herbals.
Visual aids have been particularly
helpful, specifically for identification of
herbals. Because no pictures or examples
of herbals were provided in our study, it
is possible that herbal use might have
been overreported or underreported.
Furthermore, unlike prescription and
over-the-counter medications, the ingredients in herbal products cannot reliably be predicted from the users description of the product or even brand
name because, due to the nature of the
herbal product industry, proprietary
blends can change, and labeled ingredients might be inaccurate.32 Our estimates are conservative in that we excluded from our definition of herbals
those multivitamin products that might
contain a single herbal component.

A previous analysis comparing demographic and health factors of NBDPS

control infants with those from natality
data of target populations found the
control participants to be generally representative of their base populations,
particularly in terms of maternal and paternal age, previous live births, maternal
smoking, and maternal diabetes.33 This
study also showed that the extent to which
these controls were representative of the
general population might be affected by
the selection method, which differed by
study center (hospital-based or birth certificate-based control selection).
In conclusion, we found that use of
herbal products during the period just
before and during pregnancy was relatively common among US women. Because of remarkably limited knowledge
regarding the effects of herbals on the developing fetus, it is critical that we focus

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attention on the study of the risks and

relative safety of herbal products in pregnancy. As more data accumulate, the
NBDPS will attempt to evaluate the fetal
risks and safety of herbal products taken
by pregnant women, including the effects of specific herbal products on selected birth defects and interactions between herbals and over-the-counter and
prescription medications.
In the meantime, health care providers
should recognize that, despite the widespread use of herbal products by women
of childbearing age, many herbal users
do not disclose their use to a medical professional.1,4,6-8 Providers should therefore
attempt, in a routine and nonjudgmental
fashion, to query patients about their use
of herbals, and to counsel them that the
fact that a substance is natural does not
necessarily mean that it is safe for the
fetus.34
Providers also should inform patients
that it would be prudent to err on the
side of caution regarding use of these
products during and surrounding pregnancy, because little is known about
their potential risks.
f
ACKNOWLEDGMENTS
Coding of drug information in the NBDPS used
the Slone Drug Dictionary, under license from the
Slone Epidemiology Center at Boston University,
Boston, MA. We wish to thank the study participants, interviewers, and collaborators at all of the
Centers for Birth Defects Research and Prevention: University of Arkansas for Medical Sciences,
Little Rock, AK (Charlotte Hobbs, MD; U50/
CCU613236); California March of Dimes, Oakland, CA (Gary Shaw, DrPH; U50/CCU913241);
University of Iowa, Iowa City, IA (Paul Romitti,
PhD; U50/CCU713238); Massachusetts Department of Public Health, Boston, MA (Marlene
Anderka, PhD; U50/CCU113247); New York
State Department of Health, Albany, NY (Charlotte Druschel, MD; U50/CCU223184); University
of North Carolina School of Public Health, Chapel
Hill, NC (Andrew Olshan, PhD; Robert Meyer,
PhD; U50/CCU422096); Texas Department of
State Health Services, Austin, TX (Mark Canfield,
PhD; Peter Langlois, PhD; U50/CCU613232);
Utah Department of Health, Salt Lake City, UT
(Marcia Feldkamp, PhD, PA, MSPH; U50/
CCU822097).

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