CHINESE HERBS AND PREGNANCY:
WHERE TO DRAW THE LINE?
Conception, pregnancy, and childbirth are a natural process experienced by most women. Reproduction is the essence of life from the biological view, and it plays an extraordinarily important part in the lives of most people even if they can avoid direct involvement with further child-bearing.
Although it is an entirely natural process, the road from conception to childhood is fraught with hazards. Today, well over half the conceptions that take place do not lead to a healthy child delivered by natural methods. A very large proportion of conceptions end quite early in spontaneous abortion, a natural process of eliminating reproducing cells that are genetically defective or incompatible with the mother; many of these conceptions are not even recognized as pregnancies, but rather as delayed or skipped menstrual periods.
In a study published in the January 24/31 issue of Journal of the American Medical Association, it was found that about 26% of U.S. women experienced early termination of pregnancy that was recognized as such; 97% of these were spontaneous and 3% were induced. Miscarriages increase in frequency with fertility problems, delayed childbearing, history of gynecological infections, and with stressful life. Premature births are well-known at all hospitals, which have developed methods of keeping many infants alive who are born from three weeks to three months prior to normal delivery time; it is only the medical interventions that can keep the premature baby alive and healthy. A huge number of children are born in the U.S. by Cesarean section; a procedure that is deemed, at the time it is performed, either necessary for the health of the baby or for protecting the life of the mother. A number of babies delivered either vaginally or by Cesarean have various conditions that lead to impairment either immediately or later in life. These impairments can be physical or mental or both. While it is difficult to know for certain to what extent mental disorders are present at birth versus those dependent on the environment in which a child lives, it appears that at least a portion of many difficulties related to mental function have some basis at the time of birth or before, especially in response to maternal use of certain drugs. A number of infants die during their first year of life from weaknesses in their systems, including weak or abnormal immune function leading to fatal infection.
Most women in the U.S. are now well aware that what they do from the time of conception (and sometimes before) to the time of birth can be critical in how things develop both for themselves and their child. The potential of drugs to cause harm, exemplified by thalidomide in 1958 and crack cocaine, alcohol, and tobacco 20 years later, is understood, if too often still ignored. Many pharmaceutical drugs are not recommended for use during pregnancy either because of known or suspected problems or because not enough is known to say that they are safe. Even the daily diet may cause problems: chronic ingestion of excess sugar may lead to hyperglycemia and increased risk of miscarriage while deficiency of nutrients, such as folic acid, may lead to increased incidence of neural tube defects in the developing fetus.
Along come Chinese herbs. These are substances that are, for all practical purposes, new to Americans since about 1976 (less than twenty years at this writing), and which did not become widely available until this decade. While they have a vast history of use (more than 2.000 years), they were utilized for the longest time in a culture which—like all others—did not keep statistics about outcomes of using the herbs, and in a culture—like most others in the past—in which women had many pregnancies and it was expected that a fair number of pregnancies wouldn’t work out. In China, doctors have been thinking about giving herbs to pregnant women for a very long time—the subject is mentioned in the Jin Gui Yao Lue (Prescriptions from the Golden Cabinet) written about 1,800 years ago. Preventing conception and inducing abortions with Chinese herbs has also been on the minds of Chinese women and Chinese doctors for at least that long (and more recently, men have considered herbal birth control, as a result of the discovery of gossypol).
Details of Chinese thinking and experience in relation to use of herbs during pregnancy have been presented in a number of English language books, mostly in technical books studied by a limited number of herb prescribers. But, before applying any of this information, a question must first be raised: What is the risk that American women are willing to take in terms of pregnancy outcome when considering using Chinese herbs during pregnancy. For example, if it were indicated that a particular herbal preparation that a women wishes to take to resolve some health problem had a one in ten thousand chance of causing either a spontaneous abortion, a miscarriage, or a birth defect, would she be willing to take the preparation? Let’s say that the health problem of concern is sinus congestion, or let’s say it is influenza, or perhaps a bout of herpes, or an injury to the foot? How might the answer change as the risk increased to one in a thousand or decreased to one in one hundred thousand? How might the answer change as the health problem to be treated shifted from the common cold to a pregnancy-threatening disorder?
The situation that currently exists with most Chinese herbs is that the risk is unknown. There are a few herbs for which it is known or strongly suspected that a risk exists; but that risk will vary with a number of factors including the dosage used, the duration of using the herbs, the form of administration, and the phase of gestation during which it is used. There are some herbs for which a risk seems highly doubtful because of the extensive knowledge that has been accumulated in modern research about the ingredients in the herbs. But, for most herbs, there is little known—this includes many of the herbs which are “contraindicated” during pregnancy and which might, in fact, be safe when used properly.
If a woman uses herbs during pregnancy for which the risk is not established and then experiences one of the many problems that can occur—one or more of which affect over half of all conceptions—what is the appropriate answer to the question that might then be raised: “did the herbs cause or contribute to the problem?”
Given the current situation in the U.S. in which consumer safety is a dominant issue, is it acceptable to give any Chinese herbs during pregnancy? What if the women is concerned about a miscarriage and wants to take steps to avoid it? In other words, what if there is also a chance that the herbs might improve the outcome of the pregnancy?
Because of the uncertainties involved, ITM has not produced any formulas specifically for use during pregnancy. In a subscriber series distributed by ITM, the first Clinical Tips report is on the issue of use of Chinese herbs during pregnancy. In phone consultations, if a practitioner asks whether or not a formula can be used during pregnancy, the formula is first described in terms of whether or not it is technically contraindicated during pregnancy, and then it is stated that its safety has not been tested, and that none of the formulas are designed for use during pregnancy. Many practitioners are frustrated: a simple yes or no would do fine. Given that option, the answer is no. Yet, that is also a cause for some frustration as practitioners often like to utilize their expertise in Chinese medicine to treat their patients, including pregnant patients, who are concerned about, or suffering from some health problem. If the woman instead uses a drug therapy, or if she has complications from the health problem, is that not more serious than using the herbs cautiously (meaning moderate dosage, short duration)?
Alternative suggestions are sometimes given: salt water washes or topical herbs for sinus problems, bed rest and ginger tea for common cold, influenza, and morning sickness, and acupressure, massage, and other gentle treatments. There is often no need to rely on ingesting Chinese herbs that might be the cause of or be blamed for some problem during the pregnancy. Despite the safety of some commonly accepted methods, the one mentioned here that involves ingestion of herbs—ginger tea—has already been challenged. Gingerole, a component of the essential oil of ginger, is a mitogen (affects cell reproduction) in certain laboratory tests and this could suggest that it has some influence on the developing cells if consumed in large enough quantity.
If a woman is using Chinese herbs prior to pregnancy (and they are helping) should she stop when she becomes pregnant? Or, if the herbs are contraindicated during pregnancy and she stops when she knows she became pregnant, what about the time between conception and the knowledge of pregnancy? These concerns, which are frequently expressed, demonstrate the angst generated by lack of data on Chinese herbs. Who would like to volunteer for the clinical trial to see if the use of herbs is dangerous during pregnancy? Are rat trials conducted in China sufficient? (in the U.S., approved drugs are usually tested on a few animal species before being given the green light for use during pregnancy and then data is collected by a national system to seek out problems that might still arise in human users).
What people do in China regarding herbs during pregnancy might not be satisfactory here. A consumer complaint made in China doesn’t have the same impact as one does here (its not that Chinese people care any less than we do, but they don’t have the structure established for the American style response). Therefore, the rule of thumb in the U.S. is for a woman to stop taking herbs when she learns that she is pregnant. If concerned about possible toxic effects of herbs during the first few days of pregnancy before the conception is verified, then high dosage decoctions ought not to be used (lower dosage forms are unlikely to cause a problem in the short time that they might be used at the beginning of pregnancy) in the absence of appropriate birth control methods.
There is one herb formula
which ITM recommends for use during pregnancy, and that is Tang-kuei and Peony
Formula (Dang Gui Shao Yao San). It has just six ingredients, although
certain additions are considered acceptable, such as eucommia or cuscuta (for
kidney deficiency syndrome), gelatin (for blood deficiency), and/or scute (for
heat or damp heat). This formula is
recommended because it is extensively used in China and Japan and has been
monitored in many large-scale clinical trials with pregnant women. The formula was first recommended for use
during pregnancy in the Jin Gui Yao Lue,
and has been used regularly for the past 1,800 years. Animal studies have been done, showing no teratogenic effects
(tendency to cause birth defects). The
experience with the formula is overwhelmingly positive. It is used for treating female infertility,
for morning sickness, anemia during pregnancy, and to prevent miscarriage. It has been approved by the Japanese
Ministry of Health. The formula can be
made as a tea and is available as a powder, granule, capsule, tablet, and
tincture from various suppliers in the U.S., but is not sold in stores, only
prescribed by health professionals. It
does not treat sinus congestion, common cold, influenza, herpes eruptions, or
injuries, but it may be used in the same manner that Western herbalists use
raspberry leaves during pregnancy: as a nutrient tonic. The additions to the formula that are
considered “acceptable” are deemed so because of extensive experience in their
use and detailed knowledge of the active ingredients; still, one might be more
cautious about changing the widely-used base formula. Tang-kuei and Peony Formula is also used to help treat functional
infertility, and may be especially useful for women who delayed childbearing
until their late 30’s.
While all this positive experience does not rule out any rare unfavorable outcomes, it is the only refuge for those who wish to make use of Chinese herbs during pregnancy. Consider the case of a woman who has put off child-bearing until her late thirties; a woman who may have had a history of gynecological infections, of abortions and/or use of hormonal birth control, and who has now been trying to become pregnant for some time without success or has had one or more recent miscarriages in the attempt. This certainly seems like a case for employing herbs through a pregnancy. Of course, this is also a relatively higher risk situation, with or without herbs, compared to a younger woman. Tang-kuei and Peony Formula is the correct choice if herbs are to be used at all.
There are other formulas recommended by herbal authorities for use during pregnancy. An example is Pinellia and Hoelen Formula suggested by Japanese doctors for treatment of toxemia of pregnancy. Alternatives to Tang-kuei and Peony Formula include Tang-kuei and Cuscuta Formula (An Tai Yin), Loranthus and Cuscuta Combination (Shou Tai Wan), and Tang-kuei Formula (Dang Gui San). But the research on these formulas is far less extensive, and therefore the confidence in there being a low risk of using them is not as great.
The drive to treat disorders with Chinese herbs is a strong one among those who have seen excellent results with herbs in a large number of non-pregnant patients. Those working in China may have relatively little hesitancy about using herbs during pregnancy because neither the women being treated nor the practitioners perceive a substantive risk. Nonetheless, there is a tendency for Chinese physicians to proclaim that Chinese herbs are free of side-effects when, in fact, side-effects can and do occur. In the U.S., many women take far higher risks with alcohol, tobacco, and other drugs, but a growing number of women are pursuing all practical means of reducing their risks. This latter group, which is also likely to seek Chinese medicine as a means of avoiding the side-effects of modern medical therapy, wish to be assured that Chinese herbs will not cause any problems during pregnancy. The only way to assure no such problems is to use no such herbs.
July 1996