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Nmsolutions.noORIGINAL INVESTIGATION Pregnancy Outcome Following Gestational
Exposure to Echinacea
A Prospective Controlled Study
Michael Gallo, BSc; Maumita Sarkar, BSc; Waisze Au, BSc; Kimberlee Pietrzak, MD; Beatriz Comas, MD;Michael Smith, MD; Thomas V. Jaeger, PhD; Adrienne Einarson, RN; Gideon Koren, MD Background: Echinacea products are among the most
nancy; 112 women used the herb in the first trimester.
popular phytomedicines on the North American market.
There were a total of 195 live births, including 3 sets of Since at least half of all pregnancies are unplanned, many twins, 13 spontaneous abortions, and 1 therapeutic abor- women inadvertently use echinacea in their first trimes- tion. Six major malformations were reported, including ter. Presently, there is a paucity of information regarding 1 chromosomal abnormality, and 4 of these malforma- the gestational safety of this herb. The primary objective tions occurred with echinacea exposure in the first tri- of this study was to evaluate the safety of echinacea in preg- mester. In the control group, there were 206 women nancy when used for upper respiratory tract ailments.
with 198 live births, 7 spontaneous abortions, and 1therapeutic abortion. Seven major malformations were Patients and Methods: The study group consisted of
reported. There were no statistical differences between women who were prospectively followed up after con- the study and control groups for any of the end points tacting the Motherisk Program regarding the gestational use of echinacea. This cohort was disease-matched towomen exposed to nonteratogenic agents by maternal age, Conclusions: This first prospective study suggests
alcohol, and cigarette use. Rates of major and minor mal- that gestational use of echinacea during organogenesis formations between the groups were compared.
is not associated with an increased risk for major mal-formations.
Results: A total of 206 women were enrolled in the study
group after using echinacea products during preg-
Arch Intern Med. 2000;160:3141-3143 in the United States in- Evidence from in vivo and in vitro studies creased by 385% between demonstrates that extracts of echinacea in- 1990 and 1997,1 with mar- crease the function of certain elements of ket sales estimated at $3.4 the cell-mediated immune system.10-12 billion.2 Echinacea products are among the Adverse effects following oral admin- most popular phytomedicines in North istration appear to be rare, limited to taste America, representing almost 10% of the abbreviations and transient numbness of herbal market in the United States in 1995.3 the tongue.13,14 Mild allergic symptoms may Three members of the genus Echinacea are be experienced by individuals with aller- used medicinally: Echinacea angustifolia DC gies to the sunflower (Asteraceae) fam- (narrow-leaved purple coneflower), Echi- ily.5 A number of authoritative texts cau- nacea purpurea (L) Moench (common tion against the use of echinacea products purple coneflower), and Echinacea pallida in progressive conditions such as tuber- (Nutt) (pale purple coneflower).4 While culosis, human immunodeficiency virus echinacea has been used historically for a infection, and multiple sclerosis.14,15 While number of indications, including skin and the Commission E monographs suggest From the Motherisk Program, arthritic conditions, it is primarily used that E pallida has no effect on preg- Division of Clinical today for the prevention and treatment of nancy,15 the safety of this herb in preg- Pharmacology, Hospital for upper respiratory tract infections.5,6 nancy is yet to be established. Given the Sick Children and the While echinacea is being used by mil- popularity of this herb and the fact that at University of Toronto lions in North America, results of con- least half of all pregnancies are un- (Messrs Gallo, Sarkar, and Au, trolled trials have been conflicting.6-9 Ques- planned,16 it is important to establish the Ms Einarson; and Dr Koren), tions of trial design, variable routes of fetal safety of these products.
and the Canadian College ofNaturopathic Medicine administration, and the selection of prod- The primary objective of this pro- (Drs Pietrzak, Comas, Smith, ucts in which echinacea is the only ingre- spective study was to determine the fetal and Jaeger), Toronto, Ontario. dient prevent this phytomedicine from be- safety following gestational use of echi- (REPRINTED) ARCH INTERN MED/ VOL 160, NOV 13, 2000 2000 American Medical Association. All rights reserved.
Table 1. Characteristics of Pregnancies
PATIENTS AND METHODS
in the Study and Control Groups
The study group consisted of women who contactedthe Motherisk Program, a teratogen information ser- vice at the Hospital for Sick Children in Toronto, On- tario, regarding the gestational exposure to echinaceabetween 1996 and 1998. During the initial counsel- ing, intake forms were completed to record details of 195/206 (94.7)† pregnancy and exposure. Women who had used echi- Spontaneous abortion nacea during pregnancy were prospectively followed Therapeutic abortion up, with standardized forms completed to collect de- tails on demographics, medical and obstetrical histo- Cesarean delivery ries, concurrent drug use, and pregnancy outcome.
Maternal weight gain, kg§ This study group was matched to a control group Gestational age, wk§ by disease (upper respiratory tract ailments), mater- Birth weight, g§ 3451.9 ± 579.7 .89 ¶ nal age (±2 years), alcohol use, and cigarette use. The control group consisted of pregnant women who had Major malformations contacted the Motherisk Program regarding the safetyof echinacea for an upper respiratory tract ailment *Unless otherwise indicated.
but subsequently did not use it or used a nonterato- †Includes 3 sets of twins.
¶Excluding twins, P = .58.
genic antibiotic instead.
#Fisher exact test.
With the outcome of pregnancy being the primary §Values are mean ± SD.
focus of this study, the rates of major malformations werecompared between the study and control groups. A ma-jor malformation was defined as any anomaly that has Table 2. Major Malformations
an adverse effect on either the function or the social ac-ceptability of the child.17 Rates of minor malformations, Echinacea Group (n = 195)
Control Group (n = 198)
pared. With patient consent, documentation was re-quested from the child's primary physician to confirm Left inguinal hernia (surgical repair)* Ventricular septal defect pregnancy outcome information. This protocol was ap- proved by the hospital's research ethics board.
Syndactylyl (2nd and 3rd toes)* Cranial synostosis An additional questionnaire recorded the patient's Duplicate renal pelvis (left kidney)* Hypospadias (surgery required) perception of risk after gestational exposure to echina- cea, efficacy as reported by the patient, and recommen- Trisomy 18 syndrome ventricular septal defect (2) dations made by the patient's health care provider.
The rates of malformations between the groups *Malformations reported following first-trimester exposure to echinacea.
were compared using the Fisher exact test. Statisti-cal analysis of pregnancy outcomes and neonatal com-plications were compared using the x2 and Mann- ferent (Table 1). There were 6 major malformations in- Whitney rank sum tests whenever appropriate.
cluding 1 chromosomal abnormality, and 6 minormalformations in the echinacea-exposed group. With first-trimester use of the herb, 4 major and 2 minor malfor-mations were reported. In the control group, 7 major and nacea products. A secondary objective was to character- 7 minor malformations occurred (Table 2).
ize patterns of use of this herb in Canada.
Capsule and/or tablet formulations of this phytomedi- cine were used by 114 (58%) of the 198 respondents, while 76 (38%) of the respondents used tinctures. The dosageof capsules and/or tablets used varied from 250 to 1000 A total of 206 women were enrolled and prospectively fol- mg/d. Tincture dose varied from a minimum of 5 to 10 to lowed up after gestational use of echinacea. In the study a maximum of 30 drops per day. The percentage of alco- group, 112 women (54%) used echinacea in the first tri- hol content of echinacea tinctures may vary, but in our co- mester, with 17 (8%) exposed in all 3 trimesters. There hort, it was between 25% and 45%. Duration of use also were 195 live births, including 3 sets of twins; 13 spon- varied but was normally continuous for 5 to 7 days. The taneous abortions; and 1 therapeutic abortion. The disease- different brands used covered 2 species of echinacea, E an- matched control group consisted of 206 women with 198 gustifolia and E purpurea. Only 1 woman in the cohort re- live births, 7 spontaneous abortions, and 1 therapeutic abor- ported using E pallida. The respondents rated their per- tion. No statistical difference was seen between the 2 groups ception of risk after gestational use of echinacea as low in terms of pregnancy outcome, delivery method, mater- (95%), medium (3%), and high (2%). Most participants nal weight gain, gestational age, birth weight, or fetal dis- (81%) reported that echinacea improved the symptoms of tress (Table 1).
their upper respiratory tract ailment.
Rates of malformations between the study and con- Use of echinacea by the study group was often at trol groups were also not statistically significantly dif- the suggestion of a friend or relative (70%). One hun- (REPRINTED) ARCH INTERN MED/ VOL 160, NOV 13, 2000 2000 American Medical Association. All rights reserved.
ing that the product is safer, even though studies are not Table 3. Patterns of Echinacea Use
available.Withoutproperevidence-basedinformation,healthcare providers are often left with the difficult task of esti- mating the reproductive risks of such remedies.
Echinacea use suggested by While a number of clinical trials have been conducted, definitive evidence regarding the efficacy of this medicinal herb is still lacking.8 In this cohort, self-reported efficacy Complementary health care provider of echinacea for upper respiratory tract ailments was over 80%. This study was not designed to address efficacy, but with the placebo effect documented between 30% and 40%,19 Recommendation of health care the high reported rate of efficacy may be important.
provider regarding safety This study, limited by its sample size and the lack of standardization of dosages, had 80% power to detect Consult Motherisk Program a 3.5-fold increase in the rate of major malformations with Advised against use a=.05 and a 95% confidence interval. This first prospec-tive study suggests that gestational use of echinacea dur-ing organogenesis is not associated with a detectable in- dred twenty study group respondents (60%) consulted creased risk for major malformations.
a health care provider regarding gestational use, with 48%of the health care providers suggesting that the herb was Accepted for publication April 18, 2000. safe (Table 3). Alternate over-the-counter remedies were
Corresponding author: Michael Gallo, BSc, The Moth- recommended to 15% of the respondents.
erisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children, 555 Univer- sity Ave, Toronto, Ontario, Canada M5G 1X8 (e-mail:email@example.com). Millions of people in North America regularly consumephytomedicines, many using these products in preg- nancy under the potentially false assumption that "natu-ral" is synonymous with "safe." To the authors' knowl- 1. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in edge, this is the first prospective study to examine fetal the United States, 1990-1997. JAMA. 1998;280:1569-1575.
safety after gestational use of a phytomedicine, specifi- 2. Johnston B. One-third of nation's adults use herbal remedies. HerbalGram. Sum- cally, echinacea. After controlling for different maternal mer 1997; No. 40:49.
3. Brevoort P. The U.S. botanical market: an overview. HerbalGram. 1996;No. 36:49-57.
characteristics, including maternal disease, the rates of ma- 4. Hopps C. Echinacea: a literature review. HerbalGram. 1994;No. 30:33-47.
jor malformations between the study and control groups 5. Tyler VE. Herbs of Choice: The Therapeutic Use of Phytomedicinals. Bingham- were not statistically different. Moreover, the observed ton, NY: Pharmaceutical Products Press; 1994:182-184.
malformations did not follow any specific clustering.
6. Melchart D, Linde K, Worku F, et al. Immunomodulation with echinacea: a sys- Although several formulations of echinacea are avail- temic review of controlled clinical trials. Phytomedicine. 1994;1:245-254.
7. Melchart D, Linde K, Worku F, et al. Results of five randomized studies on the able, capsules, tablets, and tinctures were the most popu- immunomodulatory activity of preparations of echinacea. J Altern Complement lar. Women in this cohort generally used the herb for short periods and were often unaware that the standard dosage 8. Dorn M, Knick E, Lewith G. Placebo-controlled, double-blind study of Echinacea is 1 g of dried herb or 1 to 2 mL of tincture 3 times a day.14 pallidae radix in upper respiratory tract infections. Complement Ther Med.
This indicates that the over-the-counter industry as a whole 9. Melchart D, Walther E, Linde K, Brandmaier R, Lersch C. Echinacea root ex- may lack proper guidelines. In this cohort, the alcohol con- tracts for the prevention of upper respiratory tract infections: a double-blind, pla- tent of the echinacea tinctures varied between 25% and 45%.
cebo-controlled randomized trial. Arch Fam Med. 1998;7:541-545.
At a maximum dosage of 30 drops daily, this is equivalent 10. Proksch A, Wagner H. Structural analysis of 4-0-methyl-glucuronoarabinoxylan to approximately 1 mL (1⁄ with immuno-stimulating activity from Echinacea purpurea. Phytochemistry. 1987; 6 tsp) of alcohol daily. This mi- nuscule amount of alcohol over a 5- to 7-day period is highly 11. Bauer VR, Jurcuc K, Puhlmann J, Wagner H. Immunologic in vivo and in vitro stud- unlikely to have an effect on the outcome of pregnancy.
ies on echinacea extracts [in German]. Arzneimittelforschung. 1988;38:276-281.
No brand appeared to be the preferred choice, and 2 popu- 12. Roesler J, Steinmuller C, Kiderlen A, Emmendorffer A, Wagner H, Lohmann-Matthes lar North American species, E angustifolia and E purpurea, ML. Application of purified polysaccharides from cell cultures of the plant Echina-cea purpurea to mice mediates protection against systemic infections with Listeria were used. Although chemical constituents do differ be- monocytogenes and Candida albicans. Int J Immunopharmacol. 1991;13:27-37.
tween the species, no one chemical constituent or group 13. Parnham M. Benefit-risk assessment of the squeezed sap of the purple cone- of constituents appears to be responsible for the medici- flower (Echinacea purpurea) for long-term oral immunostimulation. Phytomedi- nal properties.6 The 3 species of echinacea are often con- sidered clinically interchangeable.18 14. Newall CA, Anderson LA, Phillipson JD. Herbal Medicines: A Guide for Health Care Professionals. London, England: Pharmaceutical Press; 1996:101.
Prescription and over-the-counter pharmaceuticals are 15. Blumenthal M, Busse WR, Goldberg A, et al, eds. Complete German Commis- usually used with caution in pregnancy. In contrast, many sion E Monographs: Therapeutic Guide to Herbal Medicines. Klein S, Rister RS, women in the study group used echinacea during organo- trans.Boston, Mass: Integrative Medicine Communications;. 1998:122.
genesis and with the knowledge of being pregnant; they per- 16. Skrabanek P. Smoking and statistical overkill. Lancet. 1992;340:1208-1209.
17. Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Little- ceived the risk to be low. Some of the health care provid- ton, Mass: Publishing Sciences Group Inc; 1977:65.
ers consulted also felt that gestational use of echinacea was 18. Boon H, Smith M. The Botanical Pharmacy. Toronto, Ontario: Quarry Press; 1999.
unlikely to be a concern, with almost half of them suggest- 19. Brown WA. The placebo effect. Sci Am. January 1998;278:90-95.
(REPRINTED) ARCH INTERN MED/ VOL 160, NOV 13, 2000 2000 American Medical Association. All rights reserved.
Final Report Snap ‘n Dose David Xue (Programmer) Niraj Mistry (Apper) Pooja Viswanathan (Programmer) Total Report Word Count (excluding title page & sample projects page): 2485 (Penalty - 0) Total Apper Context Word Count: 499 (Penalty - 0) Final Report Introduction Fever is the most common and concerning reason for which parents bring their children