Hepatitis begins as an acute disease (with manifestations of heat), which is described in Chinese medical terminology as a toxic heat syndrome. As the disease develops, it is said to manifest symptoms of accumulated dampness and liver qi stagnation. In the event that the disease becomes chronic, it is believed that the yin becomes deficient, there is blood stasis (mainly affecting the liver), and the qi is weakened (weakness of qi may be the cause of the acute disease becoming a chronic disease).
- Hu-chang is the herb that has been selected to treat the toxic heat syndrome. It is described as a cold, bitter, mildly pungent, and sour agent that clears up heat, detoxifies, invigorates blood, and disperses swelling. Antibacterial and antiviral effects have been demonstrated in pharmacology experiments with this herb.
- Curcuma is the herb that has been selected to treat the stagnant qi that develops. The herb is said to have a cool property, with a bitter and pungent flavor. It is traditionally used to regulate the flow of qi, resolve qi stagnation, disperse stagnant blood, and control pain. It is applied to treatment of liver pain and jaundice. Modern research shows that it stimulates gastric secretion and bile secretion, to improve appetite and improve digestion.
- Salvia is the herb that has been selected to treat blood stasis. It is described as having a mild cold property and bitter flavor. It is traditionally used to invigorate blood circulation, cool the blood, nourish the blood, and calm mental irritability. Modern research shows that it rectifies abnormal patterns of capillary bed circulation and successfully treats viral hepatitis when used in relatively large dosage.
- Ligustrum is the herb that has been selected to treat yin deficiency. It is described as having a neutral property and bitter taste. It is traditionally used for yin deficiency, internal heat, weakness of the lower back and legs, and insomnia. Recent studies indicate that it enhances immune functions and protects liver cells from damage.
- Licorice has been selected as the qi tonic herb. It is described as having a neutral property and sweet flavor. It is traditionally used to supplement the spleen, replenish qi, clear heat, remove toxin, and harmonize the stomach. It has been applied in the treatment of toxic swellings, diarrhea, thirst, cough, and palpitation. Recent studies show that it has anti-inflammatory action similar to that of the corticosteroids.
- Atractylodes has been selected as the herb to remove dampness. It is also a qi tonic herb. It is described as having a warm property, sweet, mildly bitter and aromatic flavor. Traditionally, it is used to supplement the spleen, tonify qi, dry dampness, deliver water, harmonize the stomach and spleen. It has been used for treatment of fatigue, loss of appetite, diarrhea, edema, spontaneous sweating, vomiting, and dizziness. Modern research shows that it promotes immune system functions, protects the liver from chemical injury, and has anticoagulant properties.
- Schizandra has been selected as an aid to the qi tonic (licorice) and the yin nourishing herb (ligustrum). It is traditionally described as having a warm property and sour flavor. It is used to nourish the kidneys, astringe the lungs, control diarrhea, and promote secretion of fluids (e.g., saliva). At higher dosage, it is said to reinforce the qi and nourish the yin. It has been applied to the treatment of fatigue, insomnia, amnesia, thirst, spontaneous sweating, cough, and thirst. Modern research shows that schizandra enhances adrenocortical function, promotes bile secretion, and reduces liver enzyme levels.
The complex formula has the properties of tonifying and regulating qi, of nourishing and astringing yin, of vitalizing blood, clearing heat and toxin, and drying dampness. Its quality is cooling, its taste is mainly sweet and bitter, with some sour and acrid (pungent) properties.
Chinese doctors recommend herbal dosages that have been recorded in the classical and modern Materia Medica publications. Modern clinical trials confirm the validity of these dosage suggestions. Generally speaking, when making a complex formula, the dosage of most ingredients is lower than would be utilized if the herb was selected as a sole ingredient, due to the expectation of synergistic action (attaining the same goal through complementary pathways). Because of the relatively short duration of treatment in this study, the dosage of each item has been selected at a relatively high level within the range that is usually recommended.
- Hu-chang is recommended to be used in the dosage range 9-30 grams/day. A daily dosage of 15 grams has been selected for this treatment. In higher dosage, the herb can cause dry mouth, bitter after taste, nausea, vomiting, abdominal pain, and diarrhea.
- Curcuma is usually recommended in the dosage range 4.5-9 grams/day. However, in a published trial for treatment of hepatitis, it was used in a dosage (as powder) of 15 grams/day. A daily dosage of 10 grams per day has been selected for this treatment. In higher dosage, this herb may cause abdominal aching and diarrhea.
- Salvia is recommended in the dosage of 6-15 grams for typical uses, but 15-30 grams to treat severe diseases, and up to 30-60 grams for severe blood stasis syndrome. The extract has been used intravenously in doses of 22.5 grams or higher (raw material equivalent) for treatment of hepatitis. A daily dosage of 20 grams has been selected for this treatment. Higher dosage may cause dry mouth, dizziness, lassitude, numb sensation of limbs, shortness of breath, nausea, vomiting, and gastrointestinal disturbance; these responses tend to subside of themselves without suspending treatment.
- Ligustrum is recommended in dosages of 6-15 grams per day. Doses of up to 50 grams per day (made as fluid extract) have been used successfully to treat bronchitis. A daily dosage of 15 grams has been selected for this treatment. Higher dosage may cause bloating and diarrhea.
- Licorice is recommended to be used in doses of 3-6 grams per day. Doses up to 18 grams per day have been used in treatment of tuberculosis. 7.5-15 grams per day have been used to treat gastric and duodenal ulcers. A daily dose of 15 grams has been selected for this treatment. Excessive dosage or long-term use of moderate dosage can cause an adverse reaction in up to 20% of patients, including possible symptoms of edema, weak limbs, spastic numbness, dizziness, headache, hypertension, hypokalamia.
- Atractylodes is recommended in the dosage range of 3-12 grams. Doses up to 60 grams per day have been used for short-term applications. A daily dose of 10 grams has been selected for this treatment. Adverse reactions to large dosage have not been described, but gastro-intestinal responses might be expected.
- Schizandra is recommended in the dosage range of 1.5-9 grams per day; with 6-9 grams per day recommended to reinforce qi and nourish yin. Up to 15 grams per day (powdered herb) have been used in the treatment of hepatitis. A daily dosage of 9 grams has been selected for this treatment. Higher dosage may cause heartburn, acid indigestion, stomach ache and anorexia.
The total dosage of the seven herbs is 94 grams. In a review of hepatitis formulas listed in modern Chinese books (at the ITM library), formulation characteristics were as follows: except for the one formula used temporarily at very high dosage, the formula size and dosage range is reasonably consistent at 9-12 herbs and 100-140 grams, typically 11-14 grams of each herb. In the formulation described in this article, the number of herbs is only 7, and the total dosage is just 94 grams (average, about 13 grams each). This reduction in number of ingredients-compared to that used in several recent trials with complex formulas-has been purposefully chosen to simplify the treatment protocol. A few clinical trials rely on one to three herbs. The relatively lower total dosage was deemed likely to be effective as the higher dosage treatments because of the careful selection of ingredients (focused formula design). It should be noted that there is an additional herb extract present in the “vitamin tablet,” namely silybum, thus raising the total number of herbs to 8 (the substitute item, Quercenol, contains other herb extracts, including those from green tea, sophora, and grape seed); the dosage of herbs is therefore slightly increased by the inclusion of the vitamin tablet. The additional vitamins and minerals may provide an action in the current protocol that would otherwise have been obtained from herb ingredients.
RESULTS OF ONE CHINESE CLINICAL TRIAL
In a clinical trial carried out at three test sites in China, there were 94 inpatients treated and evaluated, utilizing three therapies (at each site). The main test therapy was the formula now called Salvia/Ligustrum Tablets, taken with the vitamin tablet. The primary control therapy was a tablet of the same size and same dosage made with lentinus extract (shiitake mushroom, used in Japanese treatment of hepatitis B), atractylodes, and schizandra; the control patients also took the vitamin supplement. The third control group took a patent medicine made in China that was understood, by the Chinese researchers, to be the most effective one available.
As a result of 12 weeks treatment, in the Salvia/Ligustrum group and the Lentinus group there was marked improvement in symptoms and liver enzymes, more so than with the Chinese patent remedy. Antigen conversion from positive to negative occurred for HBeAg in 2/3 of patients treated by Salvia/Ligustrum or Lentinus Tablets, but in only 1/3 of those receiving the Chinese patent. HBsAg conversion occurred only in a few patients, 2 receiving Salvia/Ligustrum, 1 receiving Lentinus, and none receiving the Chinese patent. Nearly half (9/20) of those tested showed viral DNA conversion from positive to negative in those receiving Salvia/Ligustrum, and in one-third (7/21) of those receiving Lentinus, but only in about one-fourth (6/26) of those receiving the Chinese patent.
In sum, the Salvia/Ligustrum formula (used with a nutritional supplement) produced excellent results in treating hepatitis B patients. There were also obvious benefits, though less dramatic, for treatment with lentinus, schizandra, atractylodes, and the nutritional supplement. These treatments were superior to one that had been deemed the best available in China by the researchers. The study was conducted at the Hepo Medical Technical Research Institute in Beijing, the Haixia Hospital in Quanzhou (Fujian Province), and the Henan Medical Science Institute. Testing equipment and reagents were provided by the Tumor Virology Department of the Centers for Disease Control, Atlanta.
The original study design called for treatment of 200 patients. New government regulations in China require data on safety (such as laboratory animal tests) in order to carry out clinical trials, unless the herbs are in the form of decoction. This regulation halted (perhaps temporarily) continuation of the trial despite the fact that no significant adverse events were noted for any of the participants enrolled thus far.
Subhuti Dharmananda, Ph.D., Director, Institute for Traditional Medicine, Portland, Oregon