CHINESE HERBAL THERAPY FOR UTERINE FIBROIDS

by Subhuti Dharmananda, Ph.D., Director, Institute for Traditional Medicine, Portland, Oregon

BACKGROUND

Uterine fibroids are known by many names, including uterine myoma, leioma, fibroma, fibromyoma, or as hysteromyoma; these are equivalent designations for benign growths of smooth muscle tissue in the uterine wall. Occasionally, the fibroid grows outside the uterine wall as an "exterior" mass in the abdominal cavity. The fibroid masses occur in about 20% of women over the age of 20, with most frequent occurrence between ages 35 and 45 (affecting 40% of women in this age range). However, the fibroids frequently go unnoticed until they grow rapidly during a peri-menopausal phase around age 41-45. Most often, fibroids decline substantially with menopause. The strategy for non-surgical treatment is to limit the size and symptoms of the fibroid(s) until spontaneous shrinkage occurs with menopause, typically just a few years after the initial diagnosis. Only 10-20% of fibroid cases require surgery; interventions such as Chinese medicine may remove the need for surgery in some of these cases, especially if treated early.

Small uterine myomas are usually asymptomatic, but larger masses can cause excessive menstrual bleeding, and very large fibroids can contribute to miscarriage, abdominal pain, profuse bleeding (with resultant anemia) and other symptoms for which surgical removal of the fibroids is recommended. Modern laser surgery and the new non-surgical method of fibroid embolization are distinct improvements over total hysterectomy or major abdominal surgery, but women may still seek natural approaches to resolving the masses. It is important to become familiar with fibroids and the treatment options so that patients can be properly advised. Many times, the expectations for "alternative" treatments are excessive: that a brief and convenient treatment without adverse effects will make even large fibroids vanish. On the other hand, fears of modern medical treatment are sometimes blown out of proportion; most women recover fully within weeks of conservative surgery, though there is always a risk of complications, some of which may be serious.

Chinese doctors believe that uterine myomas up to the size of a goose egg can be successfully treated with herbs to reduce the size to a comfortable level and, in many cases, to eliminate them. Larger myomas are usually treated with surgery in China as they are elsewhere, though pre-treatment with Chinese herbs may reduce the complications of surgery. To better understand the sizing of uterine myomas, the following table is provided; most gynecologists rank the size in centimeters; this table shows the measurement of some well-known objects. A "goose egg," as designated in the Chinese literature, is about 6.5 cm; a "fist-sized" mass is about the 10 cm. In a woman who has never had children, the average uterus is about 8 cm x 5 cm (and 2.5 cm thick); women who have had children will have a slightly larger uterus. Shrinkage of "grapefruit sized" fibroids is not usually expected and attempting to do so might be an unnecessary burden for the patient.

The effectiveness of the Chinese herbal treatments for small to medium size fibroids has been demonstrated by clinical trials conducted in China and Japan. American practitioners of Chinese medicine have frequently reported success in treating fibroids, at least to the extent of alleviating common symptoms and thus avoiding surgery for their patients.

CHINESE MEDICAL THEORY OF ABDOMINAL MASSES, SUCH AS FIBROIDS

The first depiction of uterine fibroids in the Chinese literature was in the Ling Shu (ca. 100 B.C.), which defined shijia, a stony tumor (shi = stone; jia = mass). From this text arose the general concept of abdominal masses as zhengjia, which denotes two types of masses: zheng refers to one in fixed position that is painful, and jia is a mass that can be moved, and only hurts when pressure is applied. These masses were described in the Ling Shu (1) scroll on water swellings, zheng corresponds to uterine masses and jia corresponding to intestinal masses (bracketed statements are inserted to aid explanation of the text):

Cold qi is a guest [that is, it takes residence there] in the outer [wall of the] intestines, and battles with the protective qi. The qi does not receive nourishment, and because cold qi and protective qi are tied together [in battle], indigestion comes from internal confusion. The sick qi then rises [e.g., upward flux of stomach qi], and sick flesh is born [below]. At the commencement of its birth, the mass is as large as a chicken's egg. Gradually, it increases its sized until it reaches the its conclusion with a shape like carrying a child. For a long time, that is, with years intervening, if the hand is then used to press [on the abdomen], it will feel solid, but if it is pushed, it will move [hence, it is due to an accumulation of stagnated qi]. The menstrual period will be in accord with the tides [i.e., will be regular]. [These are the symptoms when the intestines are affected…alternatively,] the abdominal masses begin in the middle of the womb. Cold qi is a guest at the mouth of the womb. The mouth of the womb is blocked and obstructed. Qi cannot penetrate. Sick blood should leak out but does not leak. The bleeding at times is detained and stops, day by day, [the womb] will increase in size so that the appearance will be like pregnancy. The menses do not respond to the tides [they are irregular].

Based on these concepts, one of the earliest methods of herb therapy for the uterine mass was to use the five ingredient formulation called Guizhi Fuling Wan (Cinnamon and Hoelen Formula), first described in the Jingui Yaolue (ca. 220 A.D.). The cold qi is dispelled by using cinnamon twig; the water stagnation is dispelled by hoelen (poria); the blockage and obstruction of blood flow is treated by the combination of persica, red peony, and moutan. In the Jingui Yaolue (2), the situation was described whereby menstrual bleeding would cease for three months, followed by incessant bleeding indicating that a mass had formed. This scenario is consistent with the concept that the womb is blocked and obstructed (hence the lack of bleeding), but then it develops a mass, which causes the incessant bleeding. The condition was distinguished from pregnancy, where menstrual bleeding would stop, and a mass would begin to form in the abdomen, but incessant bleeding would not follow. Guizhi Fuling Wan halts the incessant bleeding by removing the mass.

In the modern text Practical Therapeutics of Traditional Chinese Medicine (3), the distinction of the two mass types as understood today is presented:

Zheng describes solid masses (concretions) with defined physical form and fixed location, accompanied by pain in a specific location. In these cases, pathological changes have taken place in the visceral organs; thus, these patterns usually involve the blood. Jia, on the other hand, describes masses without a distinct physical form (conglomerations), manifesting and dispersing without apparent pattern. Accompanying pain is not fixed in location. In these cases, pathological changes have taken place in the bowel organs. Hence, these patterns involve qi. Despite the differences between zheng and jia, the two are closely related in terms of pathogenesis and are difficult to differentiate, hence the use of the compound term zhengjia.

An extensive review of the theoretical basis for the etiology and treatment of abdominal masses, including fibroids, is found in the Advanced Textbook of Traditional Chinese Medicine and Pharmacology (4); it is reproduced here with only slight editing. Gynecological examinations were not a practice in China until the recent introduction of modern techniques, so fibroids could not be specifically identified and differentiated during the development of the theories outlined here. Fibroids are now frequently diagnosed before they reach a size that causes pain, which had been one of the first signs of a problem for people lacking modern routine examinations and an integral part of the ancient description of the masses.

For the more serious and advanced stage masses described here, symptoms described, such as pain and loss of appetite (and accompanying weakness and weight loss), may not be presented as significant symptoms by patients today because analgesics and other therapies already have been skillfully employed to minimize those effects. Further, some of the cases included in the description may be cancers of the reproductive or abdominal organs, which produce severe systemic effects as they progress. The masses are here divided into two broad groups: qi masses (called ju; these are like the ones referred to as jia) and blood stasis masses (called ji; like those referred to as zheng). Parenthetical statements are added for explanation of the original text.

Background

The most marked symptoms of abdominal masses, which are called jiju (that is: ji-type masses and ju-type masses), are abdominal distention and pain. Ji refers to visible abdominal masses (that is, they cause an observable protrusion or are easily felt by palpation), which produce pain with a fixed location. They involve the blood system and are generally caused by disorders of the zang organs (e.g., liver, spleen). Since ji forms over a period of time, the pathological condition is severe and so ji is difficult to cure. Ju refers to invisible masses that produce pain without a fixed location (generalized abdominal aching, or pains that occur in different places at different times). It involves the qi system, and is mostly caused by disorders of the fu organs (e.g., gallbladder and stomach). Ju feels like a mass when qi accumulates, but this mass disappears when qi disperses. Since this type of mass forms over a short period, its pathological condition is mild and it is generally easier to deal with than ji. Abdominal tumors (e.g., fibroids), enlargement of the liver and spleen, hyperplastic intestinal tuberculosis, functional gastrointestinal disturbances, and incomplete intestinal obstructions can be diagnosed and treated according to the following descriptions.

Etiology and Pathogenesis

Among the causes of abdominal masses are mental depression, an improper diet, and attacks by pathogenic cold-dampness or toxin-heat. The (underlying) internal cause of abdominal masses is a deficiency in the body's anti-pathogenic qi (normal qi). Classics on traditional Chinese medicine hold that "People with strong resistance (those with strong qi) do not have abdominal masses, only weak people (those with weak qi) are likely to suffer from them." Abdominal masses gradually develop when the body's antipathogenic qi fails in its struggle against the attacking pathogenic factors. This disease is principally related to the liver and spleen. The stagnation of the qi and the blood and phlegm retention play a major role in the pathogenesis of abdominal masses. The three basic causes are:

1. Mental Depression and Qi and Blood Stagnation. Mental depression causes the stagnation of liver qi, which produces ju lumps. This leads to blood stagnation, which over a long period forms masses, thus producing ji masses.
2. Improper Diet and Production of Turbid Phlegm. An improper diet refers to voracious eating or overindulgence in alcohol. This damages the spleen and stomach, producing turbid dampness whose accumulation forms phlegm; this further results in qi and blood stagnation. These combine with phlegm to cause abdominal masses.
3. Attack by and Retention of Pathogenic Factors. When pathogenic cold, dampness, heat, or toxins attack, they may remain for a long time. This impairs the functions of the affected zangfu organs, causing qi and blood stagnation and turbid phlegm. Over a long time, abdominal masses are produced.

Any one or combination of these causes may produce abdominal masses. For example, abdominal masses can be caused by pathogenic wind-cold combined with phlegm due to improper diet, or by mental depression coupled with wind-cold and phlegm.

Differentiation and Treatment

The pathological changes that occur with ji and ju are different. In the ju syndrome, the disease is located in the qi system and the basic principle of treatment is to soothe the liver, regulate and circulate qi, and disperse accumulation, with the major focus on regulating qi. In the ji syndrome, the blood system is affected and treatment seeks to activate blood circulation and remove stasis, soften hardness and disperse the masses, with the major focuses on treating the blood.

If ju syndrome is treated properly in its initial stages, then the symptoms will improve and the disease may even be cured. A prolonged ju syndrome produces blood stagnation, thus transforming itself into a ji syndrome. According to the duration of the disease and its pathological manifestations, ji syndrome is divided into initial, middle, and late stages. Since the abdominal masses are small and soft during the initial stage, and the resistance (qi) is still strong, treatment aims at eliminating pathogenic factors. The masses increase in size and become harder during the middle stage because the body's resistance is weaker than the pathogenic factors; elimination of the masses must therefore be combined with reinforcing the resistance. At the late stage, the abdominal mass becomes very hard and the resistance is greatly damaged. Treatment then focuses on strengthening resistance; strong drugs for eliminating pathogenic factors should not be used (as they may further weaken the qi).

Ju Syndromes (Qi Masses)

Ju usually involves liver qi stagnation and/or retention of food and accumulation of phlegm.

Liver Qi Stagnation: Qi accumulates and flows to the chest, hypochondrium, epigastrium, and lower abdomen, causing pain in these areas. This condition changes according to the patient's emotional state. Other manifestations include mental depression, a thin and sticky tongue coating, and a taut pulse. Mental depression leads to liver qi stagnation, which causes accumulation of qi and its movement in all directions, resulting in distensive pain. Qi accumulates following mental depression and disperses when the patient is free of emotional stress. A taut pulse suggests liver disorders.

An example of herbal treatment is Muxiang Shenqi San (Saussurea Qi-Smoothing Powder). In the recipe, citrus, blue citrus, chih-ko, saussurea, melia, lindera, cardamom, atractylodes, cnidium, and cyperus help the qi to circulate and soothe the liver; cinnamon bark, acrid and warm in nature, disperses cold and helps the qi to circulate; licorice, sweet and mild, relieves pain in the middle burner. If there are any indications of heat, such as a bitter taste in the mouth and a red tongue, then cinnamon bark should not be used and Zuojin Wan (comprised of coptis and evodia) should be added to dissipate any liver heat. The presence of grief, weeping, and absent-mindedness is due to liver qi stagnation and heart deficiency; in this case, the decoction of licorice, wheat, and jujube can be prescribed to nourish the heart, clam the mind, and relieve qi stagnation.

Retention of Food and Phlegm: Retained food in the intestinal tract impairs transportation and transformation, and thus produces phlegm-dampness, which, combined with retained food, blocks the qi circulation, thereby causing abdominal pain, constipation, and a poor appetite. When this condition is combined with stagnant qi, cord-like masses occur in the abdomen; these disappear when the qi of the fu organs circulates freely and retained food is sent downwards. An example of treatment is Liu Me Tang (Decoction of Six Ground Herbs). In this recipe, rhubarb, chih-shih (or chih-ko), and areca seed separate retained food from stagnant qi by relieving constipation; aquilaria, saussurea, and lindera circulate qi. If liver qi combines with phlegm to block the throat, Banxia Houpo Tang (Pinellia and Magnolia Combination) can be added to circulate qi and resolve phlegm. Although in most cases ju syndrome is caused by an excess of pathogenic factors, repeated attacks may damage the spleen qi. In this case, Xiang Sha Liu Junzi Tang (Saussurea and Cardamom Combination) can be prescribed at the same time as the other herbs to replenish qi and invigorate the spleen.

Ji Syndromes (Blood-Stasis Masses)

Ji syndromes are divided into three stages: qi and blood stagnation; retention of stagnant blood; and qi deficiency with accumulation of blood stasis.

Initial Stage: Qi and Blood Stagnation. Stagnant qi and blood form abdominal masses. At the initial stage, pathogenic factors move to the blood system from the qi system. The masses have only recently formed and so they are still soft to the touch. Distensive pain, a blue tongue, and a taut pulse are indications of stagnant blood caused by liver qi stagnation. An example of herb therapy is Da Qiqi Tang (Major Decoction of Seven Qi-Regulating Herbs) combined with Shixiao San (Powder for Dissipating Blood Stasis). In the former, citrus, blue citrus, platycodon, and pogostemon circulate qi and disperse masses; cinnamon twig, sparganium, zedoaria, and cyperus remove vascular obstruction by providing warmth. In the latter formula, typha and pteropus active blood circulation, remove stasis, and relieve pain.

Middle Stage: Retention of Stagnant Blood. The protracted presence of abdominal masses and gradual aggravation of blood stagnation explain the hard enlarged masses and fixed pain. The stagnation of qi and blood impairs the ability of the spleen and stomach to transport and transform, giving rise to a dark gray complexion, emaciation, lassitude, and a poor appetite. The accumulation of stagnant qi and blood causes disharmony between the nutrient qi (yingqi) and the defensive qi (weiqi) which brings fever (or feverish feeling) and an aversion to cold. Amenorrhea, a purple tongue, and an unsmooth pulse are all caused by the internal accumulation of stagnant blood. A taut and smooth pulse suggests liver hyperactivity.

An example of treatment is Shaofu Zhuyu Tang (Decoction of Lower Palace). In the formula, persica, carthamus, tang-kuei, cnidium, pteropus, and red peony activate blood circulation and remove stasis; cyperus, lindera, and corydalis circulate qi, relieve pain, and assist in the removal of stasis; and licorice replenishes qi and relieves pain in the middle burner. Melia, sparganium, and zedoaria can be added to circulate qi and blood. If abdominal masses are hard and produce pain that is aggravated by pressure, Biejiajian Wan (Turtle Shell Pills; a large formula including many animal materials, indicated for masses with poor appetite, emaciation, and abdominal pain) can be administered to remove blood stasis, soften the masses, and relieve pain. In order to eliminate pathogenic factors and reinforce resistance, the above two formulas can be taken alternately with Liu Junzi Tang (Six Major Herbs Combination). If the abdominal masses increase in size and feel hard and painful, eupolyphaga (and other strong agents for dispersing blood stasis) and sargassum should be added to resolve stasis, relieve accumulation, and soften the masses.

Late Stage: Anti-Pathogenic Qi Deficiency and Accumulation of Blood Stasis. Prolonged accumulation of blood stasis in the vessels gives rise to hard masses and violent pain. This also damages the spleen and stomach qi and impairs transport and transformation; thus the appetite is greatly reduced and emaciation results. Accumulation of blood stasis also prevents the production of new blood, leading to extreme deficiency of nutrient qi; its symptoms include sallow or dark-yellow complexion. A purple tongue is the result of blood stasis; a gray and coarse tongue coating or a red and glossy tongue without coating, a thready and rapid or taut and thready pulse are indications of fluid depletion and consumption of qi and blood.

As an example of treatment, Bazhen Tang (Tang-kuei and Ginseng Eight Combination) combined with Pill for Relieving Masses can be used. In the former, the ingredients of Si Junzi Tang and Siwu Tang greatly replenish qi and blood. In cases of extreme yin fluid deficiency with signs of a glossy red tongue without a coating, rehmannia, adenophora, and dendrobium are prescribed to nourish yin and produce fluids. Xiaoliu Wan (The Pill for Relieving Masses; with sparganium, zedoaria, cyperus, areca seed, sappan, arca shell, pteropus, etc.) softens the masses, resolves stasis, and activates blood circulation. This therapy gradually achieves therapeutic results. In the treatment of ji syndromes at any stage, external application of herbs can also be adopted.

Summary of Concepts Presented by the Advanced Textbook Chapter on Abdominal Masses

CLINICAL PRACTICE IN CHINA

Several reports about traditional Chinese medicine treatments for uterine myoma were published during the period 1980-1993, and relatively few have appeared since then, probably because of the widespread introduction into China of surgical methods for treating fibroids and a conclusion that the herb therapies had been adequately tested to reveal their level of effectiveness. A representative selection of herbal treatment strategies is presented in the following summary of descriptions found in books and journals.

A review of the early portion of this literature was presented by Dr. Hong-yen Hsu in 1984 (5). Herbal therapies involve qi-regulating herbs, herbs to vitalize blood and dispel stasis, and agents for removing food stagnation and resolving phlegm masses. First, he mentions the book Essentials of Conformation in Chinese Medicine and four recommended therapies, laid out here to display the common categories of herbal effects and overlapping ingredients:

*Cang Fu Daodan Wan, with areca, zedoaria, and sparganium removed, is mentioned in this text, but the version of formula presented here is more commonly recommended.

The first two rows include citrus materials (chenpi, qingpi, zhike) and the next row the aromatic qi-regulating herbs cyperus or saussurea; all these items are used to regulate qi and resolve accumulations. The next two rows allow for listing of blood-vitalizing herbs (sparganium zedoaria, corydalis); and the next two rows are for phlegm-resolving herbs (platycodon, pinellia, clam shell, and arisaema). A final row lists other ingredients, which are mainly those to improve digestive functions and invigorate circulation of qi. As described in Practical Therapeutics (3), Da Qiqi Tang is best for cases where qi stagnation dominates; Xiang Leng San is best for cases where blood stasis dominates, and the two kaiyu (resolving stagnation) formulations are most suited for cases of phlegm-damp accumulation. Recommendations similar to these are relayed in the Encyclopedia of Practical Traditional Chinese Medicine (see Appendix 1).

Hsu also presents treatment options from the book Chinese Obstetrics. It lists Guizhi Fuling Wan (Cinnamon and Hoelen Formula) as the ancient formula of choice for use today in both China and Japan. The book also lists the above formulations, and adds a mass-resolving formula comprised mainly of sparganium, zedoaria, leech, tang-kuei, persica, rhubarb, calamus gum, sargassum, cinnamon, aconite, and astragalus. A similar mass-reducing formula is described in the book as one of the Chinese treatments for ovarian tumors, which presents initially as a simple lower abdominal mass, like a fibroid: zedoaria, tang-kuei, red peony, areca seed, laminaria, saussurea, cinnamon, turtle shell, rhubarb, persica, succinum. The combination of turtle shell, rhubarb, persica, and succinum is also used as a basis for treating endometrial cysts.

In a Japanese book quoted by Hsu, Survey of Chinese Medicine, its authors point out that "curing egg-sized uterine myomas with Chinese herb formulas is possible, but a larger size proves difficult to cure. Only in one case that they know of was a patient with a fist-sized myoma cured after using Wenjing Tang (Tang-kuei and Evodia Combination) long term. The cure probably had something to do with the patient's menopause." Japanese doctors usually prescribe formulas with cinnamon twig, persica, and moutan for dispelling blood stasis in the lower abdomen. Examples are Guizhi Fuling Wan (Cinnamon and Hoelen Formula), Taohe Zhengqi Tang (Persica and Rhubarb Combination), and Zhechong Yin (Cinnamon and Persica Combination); rhubarb is included in treatments when constipation is presented

In the book An Illustrated Guide to Antineoplastic Chinese Herbal Medicine (1990), three formulas for hysteromyoma are outlined. One is used for toxic syndromes, as occur with malignancies, but the other two are used mainly for common fibroids. A tested formula is Gong Zheng Tang (Decoction of Uterine Palace), with the following ingredients:

The original report about Gong Zheng Tang (Decoction of Uterine Palace) was presented in English in the Journal of the American College of Traditional Chinese Medicine (6). 136 cases of uterine myoma were treated with that formula, which might be modified as needed by adding 2-3 herbs (e.g., codonopsis and pseudostellaria for qi deficiency; millettia and peony for blood deficiency; atractylodes and hoelen for stomach/spleen deficiency; or lycium, morus fruit, and eclipta for liver/kidney deficiency). In addition, sparganium extract was injected intramuscularly for seven days starting with the onset of menstruation. The course of treatment ranged from 1-8 months. It was reported that 72 of the cases (53%) were cured and that another 37 cases (26%) were significantly improved. Of 38 cases where the myoma was the size of a fist, only 6 were cured (16%), but of 98 cases in which the size was that of a goose or duck egg, 66 were cured (67%). It was stated that "surgical measures are advised for large tumors." Of 22 cases that did not respond to therapy, half of them resorted to surgery. The cure rates reported here may be somewhat high, since ultrasound and other definitive tests were not conducted to confirm elimination of the fibroids; the data mainly refers to alleviation of symptoms and of easily palpable masses.

The other formulation mentioned in the Illustrated Guide is a modification of Cinnamon and Hoelen Formula, with sparganium, zedoaria, tang-kuei, astragalus, and crataegus added. Review articles about treatment of uterine myoma repeatedly mention Cinnamon and Hoelen Formula as a central therapy. Four sample reports help illustrate the reliance on this ancient prescription. A modified version called Gui Ling Xiaoliu Wan (Cinnamon and Hoelen Mass Reducing Pill) is made by adding turtle shell and pangolin scale (7). The herbs are powdered, made into honey pills (with about 6.6 grams of herbs per pill) and taken two pills per day for three months (on all days except during menstruation). For patients requiring higher doses or modified formulations, a decoction would be used in place of pills. It was claimed that 18 of 30 patients were cured (symptoms alleviated, little if any uterine enlargement remaining) and that 5 were notably improved.

Another example is use of Cinnamon and Hoelen Formula with a variety of modifications according to syndrome such as (8):

• larger fibroids or those resistant to treatment: add turtle shell and pangolin scale
• obesity with phlegm-damp syndrome: add pinellia, fritillaria, prunella, sargassum, and laminaria
• qi deficiency: add codonopsis, astragalus, and atractylodes
• blood deficiency: add tang-kuei and gelatin
• qi stagnation: add blue citrus, bupleurum, sparganium zedoaria, melia, corydalis, typha, and pteropus.

The formulas were administered in decoction form, with typical individual ingredient amounts of 9 grams (less for cinnamon twig, at 3-6 grams) per daily dose, given in two divided doses. Treatment time was 3-10 months, and it was reported that of 28 patients, 12 were cured and 14 others improved.

A similar study relied on the use of Cinnamon and Hoelen formula as a decoction, modified with the addition of achyranthes, oyster shell, and salvia plus others according to syndrome; the decoctions would have about 80-120 grams of herbs (9). There were 100 patients treated with these formulas, and it was claimed that 46 cases had the mass eliminated, and 34 had it shrunk by at least half. Treatment time was 1-7 months. In another study (10), a pill of Cinnamon and Hoelen Formula plus turtle shell, oyster shell, artemisia, blue citrus, dipsacus, phellodendron, astragalus, and selaginella (often used as an anticancer herb) was used; the herbs were powdered and formed into pills with honey, about 6.6 grams of herbs per pill, one pill taken each time, three times daily. Of 60 patients treated, 43 were said to be cured and 11 markedly improved using from 1-9 months of treatment. In several additional clinical reports on fibroid treatment, three herbs in Guizhi Fuling Tang were retained: persica, red peony, and moutan, but the herbs that give the formula its name, cinnamon and hoelen, were replaced by others that vitalize blood and regulate qi, such as zedoaria and cyperus. In others, the Cinnamon and Hoelen Formula was retained intact, and herbs were added to address bleeding, anemia, pain, or qi deficiency.

In a Japanese study of the mechanism of action of Cinnamon and Hoelen Formula, it was mentioned that shrinkage of uterine myoma occurred in 62% of the 110 cases treated, and that the treatments alleviated excessive menstrual bleeding and resulting anemia as well as dysmenorrhea (11). There were no significant changes in plasma levels of several hormones, including LH, FDH, PRL, and estradiol, indicating that the mechanism of action did not involve reduction of hormone stimulus to fibroid growth. It was noted that small myomas with smooth surface generating elevated levels of CA-125 appeared to be most responsive to treatment; elevated CA-125 often indicates adenomyosis, a fibroid-like condition with small masses of the uterine wall.

As indicated by these recommendations and studies, a wide range of formulas, most with qi and blood regulating properties, as well as herbs for warming the abdomen and herbs for resolving phlegm accumulation, have been used to accomplish reduction of fibroids. Complete resolution of fibroids has been reported several times, and substantial reduction of myoma size is apparently common in all but the largest or most aggressively growing fibroids. Treatment times are typically in the range of 1-8 months, with some lasting up to 10 months.

REFERENCES

1. Wu Jingnuan (translator), Ling Shu, or The Spiritual Pivot, 1993 Taoist Center, Washington, D.C.
2. Hsu HY and Wang SY, Chin Kuei You Lueh, 1983 Oriental Healing Arts Institute, Long Beach, CA.
3. Yan Wu and Fischer W, Practical Therapeutics of Traditional Chinese Medicine, 1997 Paradigm Publications, Brookline, MA.
4. State Administration of Traditional Chinese Medicine, Advanced Textbook on Traditional Chinese Medicine and Pharmacology, (vol. 3) 1996 New World Press, Beijing.
5. Hsu HY, Chinese herb therapy for uterine myomas, Bulletin of the Oriental Healing Arts Institute 1984; 9(6): 294-298.
6. Cheung CS and Carney L (translators), Preliminary report of 136 cases of uterine myoma treated by Gong Zheng Tang, Journal of the American College of Traditional Chinese Medicine 1982 (1): 64-66.
7. Pang Huali, Treatment of hysteromyoma with Gui Ling Xiaoliu Wan-A report of 30 cases, Beijing Journal of Traditional Chinese Medicine 1989; (6): 31-31.
8. Zhang Zhuen, et al., Clinical observation of 28 cases of hysteromyoma healed by integrated traditional and western medicine, Chinese Journal of Integrated Traditional and Western Medicine 13(3): 180-181.
9. Yang Shenshan, A modified Ghuzhi Fuling Wan for the treatment of 100 cases of hysteromyoma, Zhejiang Journal of Traditional Chinese Medicine 1984; 19(4): 180.
10. Huang Chunduan, Guizhi Fuling Wan in treating 60 cases of hysteromyoma, New Traditional Chinese Medicine 1982; (10): 24-26.
11. Sakamoto S, et al., Pharmacotherapuetic effects of Guizhi Fuling Wan on human uterine myomas, American Journal of Chinese Medicine 1992; 20 (3-4): 313-317.
12. Xu Xiangcai (chief editor), The English-Chinese Encyclopedia of Practical Traditional Chinese Medicine, (vol. 12) 1989 Higher Education Press, Beijing.
13. Shao Nianfang, The Treatment of Knotty Diseases with Chinese Acupuncture and Chinese Herbal Medicine, 1990 Shandong Science and Technology Press, Jinan.

APPENDIX 1. Additional Descriptions of Fibroid Treatment Strategies

The English-Chinese Encyclopedia of Practical Traditional Chinese Medicine (12) presents uterine fibroids in three categories: qi stagnation, blood stasis, and phlegm-dampness. The recommended formulas include two mentioned previously, namely Xiang Leng Wan (which is indicated in this text for cases where qi stagnation dominates, rather than blood stasis) and Kaiyu Erchen Tang (which is indicated for phlegm-dampness). The formula recommended for blood-stasis dominating is:

Huoyu Sanjie Fang Zedoaria
Sparganium
Cnidium
Chih-ko
Prunella
Cyathula
Cinnamon twig
Persica
Red peony
Tang-kuei
Salvia
Oyster shell

Modifications recommended include:

• For copious menses and abdominal pain, remove prunella and oyster shell, but add typha and pteropus;
• For persistent bleeding, remove sparganium and zedoaria but add pseudostellaria and san-chi.

The formulas are presented in this text with dosage recommendations for preparation as decoctions, where the amount of each ingredient is typically 6-12 grams, except high doses of oyster shell and salvia, each at 30 grams. The total dosages range from 75-150 grams for a one day dose of the decoction, which is to be divided into two servings, one taken in the morning and one in the evening.

The formula is similar to Xiao Liu Fang (see Appendix 2), the main difference is inclusion of ingredients from Cinnamon and Hoelen Formula here: cinnamon, persica, and red peony, and the replacement of rhubarb by salvia. A similar prescription was recommended by Shao Nianfang in his book on treatment of difficult diseases (13). For uterine myomas that originate with liver qi stagnation and develop as a blood stasis mass, he recommended a formula similar to that above, with zedoaria, sparganium, citrus, blue citrus, bupleurum, cyperus, cnidium, persica, melia, corydalis, red peony, and moutan; the formula details to be adjusted as needed, with some added herbs. He commented:

Excessive menstrual bleeding is a common symptom of uterine myoma, and is due to stagnation. To resolve stagnation will arrest bleeding. Therefore, be not afraid to use drugs to soften the hardness, to activate the blood and resolve stagnation, such as zedoaria, sparganium persica, and typha, assisted with some hemostatic herbs. San-chi is very precious because of its effect, combining activating blood, resolving stagnation, and hemostasis. In chronic cases, with deficiency of spleen and kidney, with qi unable to control blood flow, be brave to use reinforcing in those cases, that is, to restore the qi and the capacity to resolve stagnation thereby.

In other words, use blood-vitalizers even though there is bleeding, and use tonics even though there is accumulation, so long as the differential diagnosis indicates the appropriate underlying cause.

APPENDIX 2: Xiao Liu Fang

A clinical study about treatment of uterine fibroids with tracking of results by ultrasound was published by Jiang Xinglei and Luo Xianchu (Clinical observation on Xiao Liu Pian applied to treat 30 cases of hysteromyoma, Chinese Journal of Integrated Traditional and Western Medicine 1992; 12(3): 185-186). The formula ingredients are aimed at strongly dispersing both qi and blood stagnation. Thirty patients (ages 26-50) were treated. TCM diagnosis revealed 22 cases suffering from a combination of qi and blood stagnation and 8 cases with qi deficiency with blood stagnation. In general, the tongues of the patients looked dark, and the pulses felt deep, or string-like, small, and uneven. As a result of herbal therapy, 15 patients experienced either elimination of the fibroid or substantial reduction in fibroid size, and 13 more had some degree of fibroid shrinkage with symptoms alleviated. Of 21 cases examined by ultrasound, the average myoma size was 6.35 cm before treatment and only 3.54 cm after treatment. Symptoms associated with the fibroids included excessive bleeding, pain, and a bloated feeling, and these were virtually eliminated in all but 2 cases.

The formula that was used in a clinical trial, which was called Xiao Liu Pian (Mass Reducing Tablets), had the following ingredients reported:

Salvia
Eupolyphaga
Pangolin scale
Rhubarb
Prunella
Bupleurum
Blue citrus
Cyperus
Ginseng, white
San-chi
Gelatin
Cremastra

In this formulation, salvia, eupolyphaga, pangolin scale, and rhubarb serve to vitalize blood circulation and remove stasis; prunella bupleurum, blue citrus, and cyperus regulate qi and overcome qi stagnation that forms masses; ginseng tonifies qi; oyster shell softens masses; san-chi and gelatin help restrain excessive bleeding; cremastra (maocigu or shancigu) is an "antitumor" herb used to resolve a toxin that contributes to formation of the lump. According to the report, the herbs were prepared as an extract (using "appropriate amounts"), with the resulting material formed into tablets with 0.3 grams extract per tablet. The tablets were administered at a dosage of 20 each time, three times daily (providing a total of 18 grams of extract, derived from about 100 grams of raw materials). This formula was administered continuously (except during menstruation) for three months.

For the past 10 years, ITM has made available to U.S. practitioners a related formula, Xiao Liu Fang. The clinical response to this formula in the hands of Western practitioners and patients is not known because there has not been a means of formal reporting. However, to attempt to attain results comparable with the Chinese report, one should observe the following:

1. In the Chinese clinical trial, the dosage of extracted herb material was 18 grams per day (6 grams, three times daily). Xiao Liu Fang (or Huayu Sanjie Fang, also available), as provided by ITM, is in the form of loose powders that were made by extracting the herbs into hot water and then spray-drying the concentrated liquid. To match the amount of herbs used in the clinical trial, the dosage should be 6 grams each time, three times daily. A teaspoon of the powder is approximately 3 grams; so the dosage is 2 teaspoons each time, three times daily. For convenience, a patient could take 3 teaspoons twice daily. The powder is placed in a cup, boiled water is added, the mixture is stirred, and then consumed as a tea.
2. San-chi (sanqi) is not readily available as an extract and is normally not prepared as an extract in China. Xiao Liu Fang does not include this ingredient. San-chi may help prevent fibroid bleeding; bleeding can worsen during the use of blood-vitalizing herbs, so the inclusion of san-chi may be helpful. ITM has san-chi (also known as tien-chi ginseng) available in a tablet form (Pine Mountain brand), which is to be taken 2-4 tablets each time along with the dose of herb powder, for a total of 6 tablets/day.
3. The formula should be taken daily, except during menstruation, for a three-month period. For larger fibroids, Turtle Shell Tablets, made with additional blood-vitalizing herbs, can be used as an adjunct. For women with cold-damp symptoms, a second granule formula, Cinnamon and Hoelen Formula, can be taken along with Xiao Liu Fang. After the three-month course of therapy, the patient should continue taking herbs to consolidate the effects. A more convenient tablet-to replace the granules-may be used for this follow-up treatment, relying on a formulation such as Sparganium 12 (Seven Forests, see below). This tablet is initially taken at the dosage of 6 tablets (or more for those of large body weight), three times daily, and then the dosage may be tapered when fibroid symptoms have been absent for at least one month. This formula should be used for about three months and may need to be taken for longer periods.
4. Symptom alleviation is an expected result of therapy, but fibroid shrinkage may be limited. In the Chinese women who were monitored for fibroid size, the average amount of shrinkage was slightly less than 50%. Although some women experienced disappearance of fibroids, this was not the general case. Fibroids tend to shrink spontaneously after menopause, so that if the fibroid size is not too large and symptoms are not a significant problem until menopause, surgery is unnecessary.

In deriving Xiao Liu Fang from Xiao Liu Pian, white ginseng was deleted as a non-essential ingredient (qi tonification should be applied as a separate formula if needed and can be given in pill form); the insect eupolyphaga is replaced by sparganium and zedoaria (two herbs that are commonly used for blood-stasis masses, especially fibroids); pangolin scale, not currently available, is replaced by arca shell, which is reputed to vitalize blood and resolve masses; and cremastra, a rarely-used herb that is not available in the U.S. as an extract, is replaced by dandelion (both serve as "anti-toxin" herbs). Xiao Liu Fang, like Xiao Liu Pian, regulates qi (with bupleurum, blue citrus, cyperus), cracks static blood (sparganium, zedoaria, rhubarb, salvia, arca shell), and resolves masses (prunella, oyster shell). Sparganium 12, which is the tablet that can be used in follow-up therapy, is similar to Xiao Liu Fang, but has added tonic herbs (tang-kuei, achyranthes, and dipsacus) for nourishing the liver and kidney; these herbs also vitalize blood circulation. This formula does not include herbs for cleaning toxin and controlling bleeding, the problems that should have been resolved by the initial therapy with Xiao Liu Fang. For additional information about bleeding with fibroids, see the article: "The qi keeps the blood within the vessels: the story of Gui Pi Tang."

September 2003