Complementary and alternative medicine (CAM) is an umbrella term that covers a number of healthcare modalities that generally fall outside the realm of the conventional medical model. Herbal medicine is considered to be a primary complementary and alternative therapy. In recent years, the use of herbal products has increased dramatically, particularly in developed countries, by people who wish to maintain good health and reduce the need for conventional drug therapy.
Echinacea products are among the most popular phytomedicines. While these remedies have a long history of use in pregnancy, during delivery, and for lactation, clinically relevant sources of information on the safety and risk of such products are lacking. Given the great variation in product composition and constituent concentration, the actual safety of Echinacea has not been easy to study in pregnancy and lactation. To date, there is only one published study that has examined the safety of Echinacea use during pregnancy for upper respiratory tract ailments.
There is an underlying baseline risk for malformations associated with every pregnancy, regardless of the mother’s exposure to a substance of concern. As a result, the primary objective of most studies done in pregnancy is to determine whether pregnancy outcome is associated with any increased risk for toxicity or malformations above this baseline.
Malformations are defined as defects in organ structure or function that can vary in severity, with the most severe being life-threatening or requiring major surgery. On the other hand, certain drugs are considered to be toxic rather than teratogenic. This includes substances that do not cause birth defects per se, but that can damage the fetus as a result of long-term exposure during pregnancy.
Over the years, Echinacea has become one of the most popular herbal remedies in pregnancy primarily due to its medical indications. Used both systematically and topically, it has been reported to improve the body’s defenses against viral and bacterial infections, as well as to prevent and treat common cold/flu season illnesses, all of which are very common ailments during pregnancy. The three major groups of constituents among several responsible for these effects are alkyl amides, caffeic acid derivatives, and polysaccharides.
Recommendations for Echinacea use are most frequently obtained through nonmedical sources, including word of mouth, friends, and family members. Consequently, the quality and accuracy of information provided on product type and pattern of use may not always be reliable.
Its broad range of reported medical applications appeal to many pregnant and lactating women, who often opt for this herb over manufactured drugs because they believe it to be safer. Although anecdotal evidence may support this use, sound scientific knowledge surrounding the wide array of supplement choices is lacking.
There appears to be a common misconception among patients and some practitioners alike that the terms “safe” and “natural” are interchangeable. Consequently, many women are inclined to believe that natural remedies are safer than pharmaceutical drugs. This perceived safety of natural products over manufactured drugs could increase the potential for adverse effects in both the mother and her developing fetus. This is due to the fact that many women initiate treatment with supplements such as Echinacea without obtaining medical advice; they either self-prescribe or take the advice of others. An added potential for concern is posed by the fact that many consumers may be unaware that unlike conventional medications, herbal products such as Echinacea are not under enforced regulations by the Food and Drug Administration. To further complicate matters, every country differs in their regulatory laws regarding these products. For example, minimal regulation exists in the United States, given that herbal products are classified as dietary supplements.
Echinacea has been reported to be the most common herb used prior to knowledge of pregnancy and continued throughout. In light of the fact that it is not subject to regulations normally applied to pharmaceuticals, it is vital for women of reproductive age to exercise both common sense as well as caution with use.
Possible implications of teratogenic or mutagenic effects are often suggested on the basis of in vitro and animal data. Although such data are certainly useful, they cannot be used to predict reproductive effects in humans because the teratogenic potential of a substance may vary considerably among species.
To date, in vitro studies of bacterial and mammalian cells as well as in vivo studies of mice have found no evidence of mutagenicity associated with Echinacea (). There are no human studies pertaining to the effect of Echinacea on female fertility at this time. Recent in vitro studies, however, suggest possible impaired male fertility associated with Echinacea use. This research found that high concentrations of Echinacea added directly to semen decreased sperm movement. But it is not always possible to extrapolate results stemming from in vitro research to humans, especially in light of the high concentrations used.
There are many implications for healthcare practitioners given the growing popularity of herbal therapy, combined with the lack of awareness for potential risks associated with unregulated products. Due to the lack of evidence-based data, health professionals caring for pregnant women are often confronted with the difficult task of counseling on the risks versus benefits of using Echinacea during pregnancy. A recent study compared the attitudes and practices of physicians and naturopaths with respect to herbal products in pregnancy. All naturopaths surveyed asked patients about both conventional and complementary therapy use. On the contrary, only 56% of physicians surveyed asked patients about complementary therapies during routine history taking. Despite the paucity of information for herbal use during pregnancy, naturopaths are more inclined to recommend herbal products in pregnancy. However, most pregnant women are generally under the care of conventional physicians. Lack of clinical evidence concerning safety in pregnancy was reported by these physicians to be the main reason for their hesitation, not because they deem them unsafe.
In an attempt to close this gap, the Motherisk Program conducted and published the first prospective controlled study on Echinacea use in pregnancy. The Motherisk Program is a teratogen information and counseling service that provides evidence-based data to pregnant and nursing women and their healthcare professionals on the safety/risk of exposures such as drugs, chemicals, radiation, and infectious diseases. In service since 1985, questions posed to the program over the years have mirrored changing trends in the general population. The popularity of herbal products is reflected in the visible increase in the number of inquiries regarding the effect of these remedies in pregnancy and lactation. In the past 3 years, the total number of calls to the program averaged 32,000, with approximately 5% of all calls related to herbal products, translating to more than 1,600 calls per year.
The overwhelming number of inquiries in combination with the paucity of data prompted the need to address the implications of Echinacea in pregnancy. While the primary objective of the study was to determine pregnancy outcome associated with Echinacea use, secondary endpoints looked at pattern of use. The study consisted of women who initially contacted the Motherisk Program regarding the safety of consuming Echinacea in pregnancy. The study cohort included 206 women exposed to this herb who were disease matched to a control group of 206 women who had subsequently decided not to use it. Results indicated that gestational use of Echinacea is not associated with an increased risk for malformations above the baseline risk. In addition, no significant differences were reported in pregnancy outcome, delivery method, or fetal distress. Capsules, tablets, and tinctures were the most popular of several formulations of Echinacea angustifolia and Echinacea purpurea species used by participants. About 81% of women reported Echinacea to be effective in improving their upper respiratory tract symptoms. Moreover, 95% rated their perception of risk for gestational use of this herb as low. This was a reflection of the general population’s perception that because herbal products are natural, they are safe.
It is well documented that consumption of herbal medicine can result in direct adverse effects, such as allergic reactions, nausea, vomiting, and sedation. Most medicinal plants contain scores of active ingredients, and unlike conventional medicinal drugs, concentrations of these elements differ from one crop to the next and even within the plant itself. As with any unregulated products, Echinacea use during pregnancy and lactation can be of concern, especially with issues of dosage variation, contamination, incorrect labeling, and interactions with other medications. For this reason, it is essential for pregnant and nursing mothers to be educated about these issues.
Length of Exposure
There is much controversy surrounding the issue as to whether Echinacea can be used for extended periods of time. The German Commission E does not recommend continuous use of Echinacea beyond 8 weeks. Theoretical concerns of hepatotoxic effects associated with long-term Echinacea use have been suggested, but never substantiated. Unknown implications of prolonged use prompted most women in the Echinacea study to limit use to a few days, as this was reportedly sufficient in alleviating the initial symptoms of a cold. Only two women reported use on a daily basis to maintain their immune system, with no resulting adverse pregnancy outcome.
It is critical to check labels as various other products can be found in combination with Echinacea. For example, goldenseal is contraindicated in pregnancy. While Echinacea may be safe, goldenseal, which is often contained in Echinacea products, contains pharmacologically active alkaloids that can lead to uterine-stimulating effects. Consequently, potential harm could be introduced to an unsuspecting pregnant woman. An added concern in purchasing Echinacea is the practice of substitution. Potential for product impurity and contamination through adulteration can lead to numerous complications in pregnancy.
Consumption of large amounts of alcohol-containing Echinacea tincture has been linked to possible theoretical risks for alcohol-related effects in the developing fetus. However, the pattern of use for Echinacea products is commonly on an intermittent and infrequent basis during pregnancy. The alcohol content found in the tincture form, when taken at maximal recommended dosage, will approximate to 1 to 2 mL (~1 tsp daily). Given that pregnant women tend to use much lower dosage for shorter periods than generally recommended, this minimal amount of alcohol is highly unlikely to have an effect on pregnancy outcome.
The potential for herbal remedies to interact with conventional pharmacotherapy exists, as many women do not reveal their use of herbs to their physicians. This may present significant concerns since many pregnant women consume Echinacea supplements concurrently with over-the-counter and prescription cold medications.
There is currently no information regarding the transfer of Echinacea into human milk or its impact on the nursing infant. This herb generally consists of nontoxic components and hence, little or no toxicity is expected when taken at recommended doses. It is important to obtain Echinacea from a reliable source, as use of adulterated products can lead to the possibility of exposing the infant to hidden contaminants that can excrete into the breast milk.
The Use of Echinacea in Pregnancy and Lactation: Conclusion
In view of the fact that over 50% of all pregnancies are unplanned, inadvertent gestational exposure may be inevitable for women who intend to discontinue use once pregnant. Given the widespread use of herbal supplements and the lack of evidence on safety, it is critical that special populations, such as pregnant and lactating women, consult their healthcare providers before using these products. Currently, there are no known contraindications to the use of Echinacea preparations during pregnancy and lactation. Nevertheless, a product cannot be assumed to be free of harmful effects purely based on anecdotal evidence or because it is derived from a natural source. The first prospective study assessing the safety of Echinacea use during pregnancy failed to detect any increased risk. However, due to the limited sample size of this single study, further investigation is necessary.