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Use of natural health products in pregnancy is a very interesting area where more research is definitely needed. The prevalence of herbal medicine use during pregnancy is between 7% and 55%. These percentages depend upon the geographic area surveyed and the surveyed group's socio-cultural aspects and ethnicity. In Canada we have one study reporting that approximately 9% of pregnant women in Quebec use natural health products (NHPs) in pregnancy.2 In the U.S., a survey of midwives found that 45% to 93% of them had prescribed or administered a herbal or NHP to women during their pregnancy.3 The products they used most commonly were castor oil, evening primrose oil, black cohosh, and blue cohosh.
The question is, Why are women taking NHPs in pregnancy? In a study on pharmaceutical drug use by 295 pregnant women, 37% reported non-compliance with their existing medication regimen due to hesitation to use drugs during pregnancy.4 Women who learn they are pregnant are concerned about the safety of their fetus and may turn to NHPs rather than prescription medication.
About half of all pregnancies are unplanned and women of childbearing age may be taking herbal medicines as general treatment. They may be taking Evening Primrose oil, Cramp Bark or Black Cohosh to regulate periods or to help with menstrual cramping. In an unplanned pregnancy, what can typically happen is that by 4 weeks' gestation there is no period; by 5 weeks the woman begins to worry; by 6 weeks she does a home pregnancy test; it takes a week to see her doctor; and by 8 weeks she is confirmed pregnant. By this time, at 8 or 9 weeks, she has already passed through the time when there is the most risk of major malformations.
The importance of knowing about NHPs is to understand their potential dangers in women of childbearing age, particularly when it is known that they are trying to conceive. Provided below, is information on select NHPs, sorted by category.
Ginger is commonly used to treat nausea, including post-chemotherapy, and for motion sickness. For the treatment of nausea and vomiting in pregnancy, about 7 clinical studies have been published.
Willetts et al. conducted a randomized clinical trial in a population of 120 women at less than 20 weeks' gestation having symptoms of morning sickness.7 The women were given Ginger extract equivalent to
1,500 mg daily for 4 days. After 4 days, there was an improvement in nausea and retching. In follow-up
of birth outcomes, infants post-delivery had normal birth weight, gestational age, and APGAR scores, and the frequency of malformations was compatible with the normal population.
In other studies there have been variations in the dose. Fisher-Rasmussen et al. in 1990 gave a dose of
1000 mg,8 as did Vutyavanish et al. (as dried Ginger) in a randomized controlled trial in 70 women, published in 2001.9 Nausea and vomiting decreased significantly, and there were no adverse events on pregnancy or pregnancy outcome. Keating and Chez published a trial in 2002 where they used ginger syrup.10 Sripramote et al. gave 500 mg Ginger or 10 mg of Vitamin B6.11 Nausea and vomiting were decreased significantly, with no adverse effects on pregnancy and pregnancy outcome.
Additional studies include those published by Portnoi et al. in 2003,12 and by Smith et al. in 2004.13
Women suffering from nausea and vomiting of pregnancy commonly have difficulty swallowing capsules, therefore Ginger taken as a tea seems to work well.
In 2004 the American College of Obstetrics and Gynecology recommended Vitamin B6 as first-line treatment for nausea and vomiting of pregnancy, based chiefly on two clinical trials, Sahakian et al.14 and Vutyavanich et al.15 The first randomized controlled trial included 59 pregnant women. The dose of 25 mg given every 8 hours was found effective at reducing nausea and vomiting. The second trial was also randomized and controlled, with 342 pregnant women, investigated 10 mg Vitamin B6 given every 8 hours. They found that nausea was improved, but there was no effect on vomiting.
In midwifery and traditional herbal practice, there are herbal medicines used to prepare the uterus for labour, partus preparatus. Among these are Red Raspberry, Blue Cohosh, and Black Cohosh, which are
often administered by nurse midwives, naturopaths or herbalists. They can be given as single ingredients or as a mixture of agents.
Red Raspberry, commonly taken as a tea, is traditionally used for fertility. Some women take it as a labour aid during the last two months before delivery, whereas others take it throughout the pregnancy.
In a controlled clinical trial, 192 women were randomized at 32 weeks' gestation to receive 1.2 grams of Raspberry leaf tablets twice daily.16 No adverse effects to mothers or infants were reported. The active treatment shortened the second stage of labour and lowered the rate of forceps delivery.
In a retrospective observational study of 108 pregnancies, the 57 women who ingested Raspberry leaf were less likely to receive an artificial rupture of their membranes, or to require caesarean section (C- section), forceps or vacuum birth (vs. 51 controls).17
The mechanism of action of Red Raspberry is unclear. Human data show it to have either stimulatory or spasmolytic effects on the uterus, possibly being dose- and tissue-dependent. For example, in low doses Raspberry leaf might cause more contraction, while higher doses might have spasmolytic effects and decrease contraction. Red Raspberry might decrease contraction of tonic tissues and increase contraction of relaxed tissues. Animal data where raspberry was applied directly to rat uteruses did not show any direct effect.
Castor oil is commonly used as an potent laxative. It is used by midwives and pregnant women to initiate labour.
In a prospective cohort of 100 women with intact membranes at 40-42 weeks' gestation, 52 women received a 60 mL oral dose of Castor oil and 48 controls received no treatment.18 In the treated group,
30/52 women (57.7%) went into active labour within 24 hours as compared to 2/48 in control group
(4.2%). When Castor oil was successful at initiating labour, 83.3% of women delivered vaginally. The
Castor oil does not contain the deadly poison, ricin. Castor oil is hydrolyzed in the duodenum to ricinoleic acid by pancreatic lipase. Ricinoleic acid may have stimulant laxative effects, the exact mechanism of which are unknown. Possible mechanisms are that it has an osmotic effect in the large bowel, increasing fluid secretion, or has a direct irritant effect on the smooth muscle of the small intestine. Onset of bowel evacuation is in 2-6 hours.
In pregnancy, Castor oil induces labour by producing hyperemia in the intestinal tract, which causes reflex stimulation of the uterus.19 It may increase prostaglandin production (prostaglandin F2 alpha (PGF2 alpha)), which in turn stimulates uterine activity.18
The NHP that is most commonly used to induce labour, and that is of most concern, is Blue Cohosh. There have been 3 reports in the literature of cardiovascular side effects resulting from women using Blue
Cohosh in pregnancy. These were all cases of unsupervised use of the agent, and it appears that use was
beyond the therapeutic dose. One neonate experienced acute myocardial infarction, profound congestive heart failure and shock.20 In another, there was severe multi-organ hypoxic injury.21 And in the third case the adverse event was perinatal stroke.22 There is a fourth case report of abortifacient and nicotinic toxicity.23 When surveyed in 1999, 64% of Certified Nurse Midwives in the United States claimed to use Blue Cohosh during labour.3 They also reported that this herb is one that worries them most and which they use with the least amount of confidence.
Blue Cohosh's mechanism of action involves the glycosides caulosaponin and caulophyllosaponin and the chemical sparteine to induce labour contractions.24 Blue Cohosh causes constriction of coronary arteries, seems to decrease flow of oxygen to the heart and to be toxic to the myocardium, thus explaining the cardiovascular effects.25
Furthermore, other alkaloids, such as anagyrine and N-methylcytosine, may be teratogenic, and yet others
(e.g., taspine), embryotoxic. However, given the timing of use, these latter effects may not be relevant.
EVENING PRIMROSE OIL
Evening Primrose oil is a fatty acid commonly given by midwives to trigger cervical ripening.
In a parallel group retrospective study of quasi-experimental design, it was not shown that Evening Primrose oil actually induced cervical ripening. In two groups of 54 women at 37 weeks' gestation, one cohort took Evening Primrose oil and the other acted as a control. The findings indicated that the product did not shorten gestation or decrease the overall length of labour; rather, it increased the incidence of prolonged rupture of membranes, oxytocin augmentation, arrest of descent, and vacuum extraction.26
There has also been a case report of petechiae and ecchymoses in a newborn infant whose mother drank raspberry leaf tea and took 6.5 g of primrose oil (as 500 mg capsules, vaginally and orally) one week before giving birth.27
Atopic Disease Prevention
A meta-analysis of trials using probiotics during pregnancy was completed in 2008.28 Eleven randomized controlled trials were reviewed with a total of 1,505 patients. A number of strains of bacilli, when given to women during the last few weeks of gestation and then during the period of breastfeeding and/or given
to the breastfeeding child, resulted in some improvement in the prevention of atopic disease (mostly eczema) in the children followed for 2 to 4 years. There was no evidence that probiotics affected C-
section incidence, birth weight or pre-term delivery. There was a non-significant increase in birth weight by 45 grams (p = 0.699) and a non-significant increase in gestational age by 0.4 weeks (approx. 3 days) (p
= 0.336). The following are some of the studies and their findings.
Kalliomaki et al. published a trial of Lactobacillus rhamnosus GG (LGG) 1 x 1010 CFU given daily from
2-4 weeks pre-delivery.29 At 2 years of age, the frequency of atopic eczema in the LGG group was half that of the placebo group. At 4 years of age, the frequency of atopic disease remained lower in the LGG
group versus placebo. Kukkonen and colleagues published two separate studies in 2006 and 2007.30.31 In the earlier trial, LGG, L. rhamnosus, B. breve and Propionibacterium freudenreichii subsp. shermanii were given to women at 2-4 weeks pre-delivery and to infants postnatally to determine whether the
probiotics could affect the immune response to vaccination. There was no difference in antibody responses to diphtheria, tetanus or Haemophilus influenzae type b (Hib) vaccination versus placebo.
In the latter, Kukkonen et al. trial, 1,223 pregnant women with a family history of atopic disease were given either placebo or the same probiotics - LGG (5 x 109 CFU), L. rhamnosus (5 x 109 CFU), B. breve (2 x 108 CFU) and Propionibacterium freudenreichii subsp. shermanii (2 x 109 CFU) - plus galacto- oligosaccharides daily at 2-4 weeks pre-delivery and to infants postnatally.31 Infants of the actively treated mothers were more frequently colonized with Lactobacillus and Bifidobacterium spp at 3 to 6 months. At
2 years of age, they had a significant decrease in eczema and atopic eczema versus the placebo group.
Other studies of interest include those by Abrahamsson et al.,32 Kaplas et al.,33 Gueimonde et al.,34 and
Neri et al.35
Upper Respiratory Tract Infection
Echinacea is commonly given to treat upper respiratory tract infections.
A prospective study involved a cohort of 206 women using Echinacea in the 1st trimester vs. 206 controls.36 In the Echinacea group, there were 195 live births, 13 spontaneous abortions, 1 therapeutic abortion, and 6 major malformations. In the control group, there were 198 live births, 7 spontaneous abortions, 1 therapeutic abortion, and 7 major malformations. There were no statistically significant differences between the groups (the rates of spontaneous abortion were not significantly different), therefore, it was concluded that Echinacea did not pose an increased risk of malformations during pregnancy.
Herbs often given as immune stimulants during upper respiratory tract infections are those that contain berberine, such as Goldenseal (Hydrastis canadensis), Barberry (Berberis vulgaris), and Oregon Grape (Berberis aquifolium). There is some concern that berberine given around the time of birth can displace
albumin-bound bilirubin. This is based on animal data, where it has been shown in rats that berberine displaces bilirubin bound to albumin and may aggravate newborn jaundice (kernicterus). In that study, berberine was administered to rats daily (intraperitoneally) for one week.37 After the week, there was
ST. JOHN'S WORT
The entire evidence regarding the safety of St. John's Wort in pregnancy seems to have rested on one case report up until about one year ago. The case regards a 38-year-old woman who started taking St. John's Wort at 24 weeks gestation.38 Her pregnancy was unremarkable, with the exception of late onset thrombocytopenia, which the author did not attribute to St. John's Wort. The offspring was born healthy, had a normal birth weight, normal Apgar score, and physical examination and laboratory results were normal. The infant's behavioural assessment at 4 and 23 days was within normal limits.
In 2009 a prospective cohort study was conducted by Motherisk.39 They followed 54 pregnant women exposed to St. John's Wort during their pregnancy, 54 pregnant women on anti-depressant medications
during pregnancy, and 54 healthy pregnant women with no teratogenic exposure during pregnancy as
controls. It was found that the rates of major malformations were similar across the 3 groups (5%, 4% and
0%), keeping in mind that the major malformation rate in the general population is 3-5%.
In summary, there is some evidence regarding the safety of select NHPs, as well as some evidence of harm. For approximately 60% of NHPs, safety in pregnancy is unknown - nonetheless some women continue or initiate taking these products during pregnancy. To provide best care, clinicians and pharmacists must screen their patients for use of complementary and alternative medicines and stay up-to- date on research regarding such agents. Here are a few resources to turn to: Mills, Dugoua, Perri & Koren (2006)6 www.naturaldatabase.com,40 and www.naturalstandard.com.41 The on-line sites offer good evidence-based reviews of much of the NHP information available. More research is needed on NHPs. Regulatory intervention may be necessary for products that may be contraindicated in certain conditions or that should have dosing restrictions. We met with Health Canada regarding NHPs last year through Pregmedic, and hope to do more work with them in the future.
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2. Moussally K, Oraichi D, Bérard A. Herbal products use during pregnancy: prevalence and predictors.
Pharmacoepidemiol Drug Saf 2009;18(6):454-61.
3. McFarlin BL, Gibson MH, O'Rear J, Harman P. A national survey of herbal preparation use by nurse- midwives for labor stimulation. Review of the literature and recommendations for practice. J Nurse Midwifery 1999;44(3):205-16.
4. van Trigt AM, Waardenburg CM, Haaijer-Ruskamp FM, de Jong-van den Berg LT. Questions about drugs:
how do pregnant women solve them? Pharm World Sci 1994;16(6):254-9.
5. Mills E, Dugoua J-J, Perri D, Koren G. Herbal Medicines in Pregnancy and Lactation: An Evidence-Based
Approach. Toronto: Taylor & Francis, 2006.
6. Moore KL, Persaud TVN. The Developing Human: Clinically Oriented Embryology. Philadelphia: W.B.
7. Willetts KE, Ekangaki A, Eden JA. Effect of a ginger extract on pregnancy-induced nausea: a randomised controlled trial. Aust N Z J Obstet Gynaecol 2003;43(2):139-44.
8. Fischer-Rasmussen W, Kjaer SK, Dahl C, Asping U. Ginger treatment of hyperemesis gravidarum. Eur J Obstet Gynecol Reprod Biol 1991;38(1):19-24.
9. Vutyavanich T, Kraisarin T, Ruangsri R. Ginger for nausea and vomiting in pregnancy: randomized, double- masked, placebo-controlled trial. Obstet Gynecol 2001;97(4):577-82.
10. Keating A, Chez RA. Ginger syrup as an antiemetic in early pregnancy. Altern Ther Health Med 2002;8(5):89-91.
11. Sripramote M, Lekhyananda N. A randomized comparison of ginger and vitamin B6 in the treatment of nausea and vomiting of pregnancy. J Med Assoc Thai 2003;86(9):846-53.
12. Portnoi G, Chang LA, Karimi-Tabesh L, Koren G, Tan MP, Einarson A. Prospective comparative study of the safety and effectiveness of ginger for the treatment of nausea and vomiting in pregnancy. Am J Obstet Gynecol 2003;189(5):1374-7.
13. Smith C, Crowther C, Willson K, Hotham N, McMillian V. A randomized controlled trial of ginger to treat nausea and vomiting in pregnancy. Obstet Gynecol 2004;103(4):639-45.
14. Sahakian V, Rouse D, Sipes S, Rose N, Niebyl J. Vitamin B6 is effective therapy for nausea and vomiting of pregnancy: a randomized, double-blind placebo-controlled study. Obstet Gynecol 1991;78(1):33-6.
15. Vutyavanich T, Wongtra-ngan S, Ruangsri R. Pyridoxine for nausea and vomiting of pregnancy: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol 1995;173(3 Pt 1):881-4.
16. Simpson M, Parsons M, Greenwood J, Wade K. Raspberry leaf in pregnancy: its safety and efficacy in labor.
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17. Parsons M, Simpson M, Ponton T. Raspberry leaf and its effect on labour: safety and efficacy. Aust Coll
Midwives Inc J 1999;12(3):20-5.
18. Garry D, Figueroa R, Guillaume J, Cucco V. Use of castor oil in pregnancies at term. Altern Ther Health Med
19. Gennaro A. In: Remington: The Science and Practice of Pharmacy. 19th ed. Media: Lippincott Williams & Wilkins, 1996.
20. Jones TK, Lawson BM. Profound neonatal congestive heart failure caused by maternal consumption of blue cohosh herbal medication. J Pediatr 1998;132(3 Pt 1):550-2.
21. Gunn TR, Wright IM. The use of black and blue cohosh in labour. N Z Med J 1996;109(1032):410-1.
22. Finkel RS, Zarlengo KM. Blue cohosh and perinatal stroke. N Engl J Med 2004;351(3):302-3.
23. Rao RB, Hoffman RS. Nicotinic toxicity from tincture of blue cohosh (Caulophyllum thalictroides) used as an abortifacient. Vet Hum Toxicol 2002;44(4):221-2.
24. Reichert, R. Neonatal congestive heart failure associated with maternal use of blue cohosh. Quarterly Review of Natural Medicine 1998;Winter:265-267.
25. Edmunds J. Blue cohosh and newborn myocardial infarction? Midwifery Today Int Midwife 1999
26. Dove D, Johnson P. Oral evening primrose oil: its effect on length of pregnancy and selected intrapartum outcomes in low-risk nulliparous women. J Nurse Midwifery 1999;44(3):320-4.
27. Wedig KE, Whitsett JA. Down the primrose path: petechiae in a neonate exposed to herbal remedy for parturition. J Pediatr 2008 Jan;152(1):140, 140.e1.
28. Dugoua JJ, Machado M, Zhu X, Chen X, Koren G, Einarson TR. Probiotic safety in pregnancy: a systematic review and meta-analysis of randomized controlled trials of Lactobacillus, Bifidobacterium, and Saccharomyces spp. J Obstet Gynaecol Can 2009;31(6):542-52.
29. Kalliomäki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet 2001;357(9262):1076-9.
30. Kukkonen K, Nieminen T, Poussa T, Savilahti E, Kuitunen M. Effect of probiotics on vaccine antibody
responses in infancy--a randomized placebo-controlled double-blind trial. Pediatr Allergy Immunol
31. Kukkonen K, Savilahti E, Haahtela T, et al. Probiotics and prebiotic galacto-oligosaccharides in the prevention of allergic diseases: a randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol
32. Abrahamsson TR, Jakobsson T, Böttcher MF, et al. Probiotics in prevention of IgE-associated eczema: a double-blind, randomized, placebo-controlled trial. J Allergy Clin Immunol 2007;119(5):1174-80.
33. Kaplas N, Isolauri E, Lampi AM, Ojala T, Laitinen K. Dietary counseling and probiotic supplementation during pregnancy modify placental phospholipid fatty acids. Lipids 2007;42(9):865-70.
34. Gueimonde M, Sakata S, Kalliomäki M, Isolauri E, Benno Y, Salminen S. Effect of maternal consumption of lactobacillus GG on transfer and establishment of fecal bifidobacterial microbiota in neonates. J Pediatr Gastroenterol Nutr 2006;42(2):166-70.
35. Neri A, Rabinerson D, Kaplan B. Bacterial vaginosis: drugs versus alternative treatment. Obstet Gynecol
36. Gallo M, Sarkar M, Au W, et al. Pregnancy outcome following gestational exposure to echinacea: a prospective controlled study. Arch Intern Med 2000;160(20):3141-3.
37. Chan E. Displacement of bilirubin from albumin by berberine. Biol Neonate 1993;63(4):201-8.
38. Grush LR, Nierenberg A, Keefe B, Cohen LS. St John's Wort during pregnancy. J Am Med Assoc
39. Moretti ME, Maxson A, Hanna F, Koren G. Evaluating the safety of St. John's Wort in human pregnancy.
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40. Natural Medicines Comprehensive Database (August 3, 2010). http://www.naturaldatabase.com (August 3, 2010).
41. Natural Standard. The Authority on Integrative Medicine. www.naturalstandard.com (August 3, 2010).
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