Traditional Chinese medicine (TCM), an important component of complementary and alternative medicine, has evolved over thousands of years with its own unique system of theories, diagnostics and therapies. TCM has been increasingly used in the last decades and become well known for its significant role in preventing and treating cancer. We believe that TCM possesses advantages over Western medicine in specific aspects at a certain stage of cancer treatment. Here we summarize the advantages of TCM from three aspects: preventing tumorigenesis; attenuating toxicity and enhancing the treatment effect; and reducing tumor recurrence and metastasis.

Acupuncture is widely used as an alternative therapy with few side effects because of its simple manipulation and low cost. However, accidents may occur if the practitioner uses it improperly. Early in the Qin dynastuy, the Canon of Medicine mentioned that improper use of acupuncture could cause injury to the body and even death, and it systematically described the occurrence and prevention of acupuncture accidents. Physicians in the successive dynasties frequently reported it, and nealized that the manipulation skills were significantly important in preventing the occurrence of acupuncture accidents.Since the 1950s, acupuncture accidents had been effectively prevented because of the improving of acupuncture instruments, enhancing of the quality of the practitioners, popularizing of sterilization and disseminating of anatomic knowledge. Nevertherless, with the renovating of acupuncture techniques, new accidents may occur constantly. The prevention of acupuncture accidents still should be an arduors task for acupuncturists. Nowadays, acupuncture therapy is being used in more than 140 countries, and acupuncture accidents due to improper application are incrcasing. Prevention of acupuncture accidents has become a global issue deserving of great attention.

Diabetes is a leading cause of morbidity and mortality in the world. There is currently an active search for antidiabetic drugs with greater effectiveness with fewer and less adverse side effects. Although numerous individual herbs have been experimentally or clinically reported to possess antidiabetic effects, considerably less research has been conducted on polyherbal compounds. It is believed that herbal compounds containing multiple plant products have synergistic antidiabetic effects and could enhance the desired actions. Several polyherbal formulations have been studied as therapeutic agents in diabetes management. To describe the current state of research on polyherbal compounds in the treatment of diabetes, an extensive review of literature was undertaken on several major databases. This paper presents what is known about the efficacy of these polyherbal formulations and compare their antidiabetic effects with those of current oral hypoglycemic drugs as reference. The percent decrease in blood glucose, lipids and other biochemical parameters achieved by each product in diabetic animals and patients is reported. Also, the possible mechanisms responsible for hypoglycemic action of polyherbal formulations are discussed.

Objective

To evaluate the correlations between clinical symptoms and treatment efficacy in patients with rheumatoid arthritis (RA).

Methods

Four hundred and thirteen patients were included in the clinical trial from 9 clinical centers. They were randomly divided into Western medicine-treated group with 204 cases and Chinese herbal drug-treated group with 209 cases. Eighteen clinical symptoms were evaluated before and after treatment. The Western medicine therapy included voltaren extended release tablets, methotrexate and sulfasalazine. The Chinese herbal drug therapy included glucosidorum Tripterygii totorum tablets and Yishen Juanbi Tablets combined with treatment based on syndrome differentiation. The American college of rheumatology 20 (ACR20) was used as efficacy evaluation criteria.

Results

In the Chinese herbal drug-treated group, clinical symptoms such as arthralgia and tenderness of joints were positively correlated with the efficacy after 12-week treatment, while frequent urination at night was negatively correlated. In the same group, tenderness of joints and fever were positively correlated with the efficacy after 24-week treatment, while deep-colored and turbid urine was negatively correlated. In the Western medicine-treated group, tenderness of joints and thirst were positively correlated with the efficacy after 12-week treatment, while vertigo was negatively correlated. And in the same group, tenderness of joints was positively correlated with the efficacy after 24-week treatment, while heaviness of limbs was negatively correlated to the efficacy. The statistical results showed that the treatment efficacy was improved when the correlated symptoms were included in the indications.

Conclusion

The treatment efficacy of RA is correlated with some symptoms, so further studies should proceed on these correlations in order to achieve better treatment outcome.

BACKGROUND: Chronic lung diseases, including bronchial asthma, chronic obstructive pulmonary disease (COPD),chronic bronchitis, allergic rhinitis and repeated respiratory tract infection (RRTL) in infants, exacerbate frequently in winter because of respiratory viral infections and low temperature. Summer acupoint application therapy (SAAT) is thought to be effective in reducing exacerbation frequency of chronic lung diseases in winter. It is a kind of therapy using a herbal mixture for external application on special acupoints during summer. The herbal mixture basically contains Semen Sinapis Albae, Herba Asari,Radix Euphorbiae Kansui and Rhizoma Cory dal is. The acupoints include Feishu (BL13), Dazhui (GV14) and Danzhong (CV17). Through a large-scale multicenter trial based on three years of clinical observation, and retrospective and prospective analyses, this study aims to explore the efficacy of SAAT.METHODS AND DESIGN: In this clinical observation trial, patients who have been diagnosed with bronchial asthma,COPD,chronic bronchitis, allergic rhinitis or RRTL will be enrolled from 13 centers. All patients enrolled will be treated with SAAT over a two-year period by medical practitioners. After this, an initial case report form (CRF) will be completed and forwarded to the central study site (China Academy of Chinese Medical Sciences, Beijing, China). The CRF is designed to investigate patients’ history of medical treatment (including SAAT) and chronic lung disease exacerbation, also self-reported health condition. For retrospective analyses, the authors will focus on those who have accepted SAAT before enrollment and will collect their SAAT history and chronic lung disease exacerbation history, to evaluate the effects of SAAT. For prospective analyses, medical students will follow up with patients by phone interviews in winter once a year. The primary outcome is frequency of chronic lung disease exacerbation in winter. The secondary outcomes include conditions of lung disease recovery, non-SAAT therapy, and a self health report.DISCUSSION: The authors aim to collect 7 400 patients from July 2008 to August 2009. The final follow-up has been completed in December 2010. To reduce the selection bias, a total of 13 clinical centers from different areas of China have participated in this study. The results from this study will provide a high-quality evidence base for evaluating the efficacy of SAAT in reducing exacerbation frequency of chronic lung diseases in winter.TRIAL REGISTRATION NUMBER: This trial has been registered in Chinese Clinical Trial Registry (Identifier： ChiCTR-TNRC-10001292).

Objective: To observe the effects of kidney-tonifying Chinese herbal medicine on the synthesis and secretion of gonadotropin releasing hormone (GnRH) and the related neurotransmitters and neuropeptides, and to explore the mechanism of the regulative effect of Chinese herbal medicine on the hypothalamic-pituitary gonadotrophic function. Methods: Female Sprague-Dawley rats during the period of normal adolescent initiation (160-180 g, 1.5 monthes) were randomly divided into three groups. The control group was fed with normal saline and the two experimental groups were fed with Chinese herbal medicine for nourishing yin to reduce fire (Zi Yin Xie Huo, ZYXH) or nourishing kidney to replenish essence (Yi Shen Tian Jing, YSTJ) respectively. The dosage was 5 ml/d for 30 days by gastric gavage. Integrated optic densities of the GnRH and neuropeptide Y (NPY) in medial preoptic area (MPOA), arcuate nucleus (ARC) and median eminence (ME) of hypothalamus were determined by immunohistochemistry method and image processing. The content of GnRH in homogenate of hypothalamus preoptic area was determined by radioimmunoassay (RIA). The releasing amount of monoamine neurotransmitters from medial basal hypothalamus (MBH) was determined by brain slices incubation and high pressure liquid chromatography (HPLC). The releasing amount of GnRH and NPY from POA was determined by push-pull perfusion and RIA, and the releasing amount of monoamine neurotransmitters from this site was determined by HPLC.Results: ZYXH could inhibit the synthesis and secretion of GnRH from periodic and tonic secretory centers of GnRH, while YSTJ could stimulate the synthesis and secretion of GnRH from the both secretory centers of GnRH. ZYXH could inhibit the activity of GnRH neurons via diminishing the releasing of norepinephrine (NE) from tonic secretory center of GnRH, increasing the releasing of dopamine (DA) in periodic secretory center of GnRH and increasing the synthesis and releasing of NPY from the both secretory centers of GnRH, it hence inhibited the hypothalamic-pituitary gonadotrophic function. YSTJ could stimulate the activity of GnRH neurons via diminishing the synthesis and releasing of NPY from tonic secretory center of GnRH, it hence promoted the hypothalamic-pituitary gonadotrophic function.Conclusion: Chinese herbal medicine for tonifying the kidney could modulate hypothalamic-pituitary gonadotrophic function via regulating the synthesis and secretion of GnRH and the related neurotransmitters (NE, DA) and neuropeptides (NPY).

In July 2002, the Women's Heath Initiative (WHI) clinical trial, designed to clarify the risks and benefits of combination hormone replacement therapy (HRT) to the postmenopausal women declared that interim safety review after an average follow-up of 5.2 years found that a combination of estrogen and progestin frequently prescribed to postmenopausal women in USA increased the risk of invasive breast cancer, heart disease, stroke, and pulmonary embolism while reduced bone fractures and colorectal cancer. The overall risks of HRT outweigh the benefits, which provides an opportunity for traditional Chinese medicine (TCM) going abroad. A variety of clinical and experimental evidences have showed that TCM exerts quite satisfactory effect on relieving postmenopausal symptoms with little adverse effect, hence a potential role to replace or to improve HRT or to reduce the side effect induced by HRT.

Fructus Xanthii is commonly used in rhinology, especially used in treatment of chronic rhinitis and sinusitis. But Fructus Xanthii is toxicant, and it maybe result in poisoning when used excessively, without preparation or in inappropriate preparation. This article reviewed all poisoning cases from 1960 to 2000, its toxicology and methods for detoxification.

Pulmonary-fibrosis (PF) is the result of interstitial lung disease which has different causes and it is one of the most intractable diseases in respiratory system. The PF is characterized by progressive difficulty of breath and dying of respiratory failure, seriously threatening the health of people. Immunosuppressive drugs and glucocorticoids have been widely adopted as the main methods in treatment, but the results are not satisfactory and the side effects are obvious. Many specialists have tried traditional Chinese medicine in recent years with satisfactory effect, indicating that the prospect of using traditional Chinese medicine in the treatment of PF is optimistic. This article outlines the researches about using traditional Chinese medicine in the treatment of PF.

Objective: To define the weighting coefficients of the symptoms and signs in the diagnosis of corresponding traditional Chinese medicine (TCM) syndrome elements of ulcerative colitis based on expert questionnaire investigation.
Methods: The questionnaire included eight syndrome elements of location and 11 syndrome elements relating to disease characteristics. Experts who answered the questionnaire were titled as associate chief physician or above, and had been practicing as professionals in general practice of medicine of digestive system for a long time. They came from 15 third-grade class-A hospitals (6 provinces and Beijing) in China. The weighting coefficients of the symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis were identified preliminarily based on consent degree of the experts (mean value and variation coefficient).
Results: There were 9, 6, 14, 5, 9, 8, 12 and 2 symptoms and signs corresponding to 8 TCM syndrome elements related to disease location and the ranges of weighting coefficients were listed as follows: liver, from 7.49 to 4.18; heart, from 6.90 to 5.51; spleen, from 7.96 to 5.55; lung, from 6.30 to 5.27; kidney, from 7.82 to 5.71; stomach, from 7.53 to 6.15; large intestine, from 8.40 to 6.70; bowel collaterals, from 8.49 to 6.41. Numbers of symptoms and signs corresponding to 11 TCM syndrome elements related to disease nature were 13, 8, 17, 18, 17, 18, 6, 11, 2, 10 and 11 and the ranges of weighting coefficients were listed as follows: qi deficiency, from 7.44 to 5.60; blood deficiency, from 7.90 to 5.59; yin deficiency, from 6.88 to 4.91; yang deficiency, from 7.54 to 5.57; dampness, from 7.91 to 4.96; excess heat (fire), from 7.13 to 5.69; excess cold, from 7.51 to 6.14; qi stagnation, from 7.38 to 5.88; qi sinking, from 7.65 to 7.43; blood stasis, from 7.60 to 5.79; fluid retention, from 7.08 to 4.46.
Conclusion: On the basis of previous document research and clinical research in ulcerative colitis, the expert questionnaire can collect consensus opinions of experts. The weighting coefficients of the symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis are defined preliminarily. Thereby it will lay the foundation for establishing differentiation criteria of ulcerative colitis based on TCM syndrome elements.

The usage of Swietenia mahagoni, a popular medicinal plant in India and some African countries, dates back to ancient times for its curative properties in diseases like malaria, diabetes, and diarrhea. It is also used as an anti-pyretic, bitter tonic and astringent. Its pharmacological activities are being widely explored. Although many important groups of phytochemicals have been identified and isolated from various parts of the plant, most of these researches have been focused on seeds. Toxicological studies have established the safety of many of these plant extracts, and found insignificant side effects. Here we present a comprehensive review of all the pharmacological effects and constituent phytochemicals of the plant.

Natural products, either as pure compounds or as standardized plant extracts, provide extensive opportunities for new drug leads because of the unmatched availability of chemical diversity. In contrast to modern medicines, herbal medicines are frequently used to treat chronic diseases. Standardization guarantees the content of one or more active constituents and marker compounds. The plant environment and genetic factors could significantly affect the biochemical components of the plant extract, in which plants are still the most abundant and cost-effective resource for drug innovation. Production of botanical drugs requires genetically uniform monocultures of the source plant in fully standardized conditions, to assure the biochemical consistency and to optimize the safety and efficacy of every crop. The present review article illustrates about the methods for standardization of herbal medicine and how the goal of preparing herbal medicines of consistent quality and effects can be achieved.

OBJECTIVE: To observe the facial spectrum and color of different points, the positions of heart, liver, spleen, lung and kidney of traditional Chinese medicine reflecting on the face, in healthy participants and those with a sub-health status, so as to provide an objective basis for health evaluation.METHODS: The health condition of 470 subjects without acute and chronic conditions was assessed using the Health Evaluating Questionnaire H20 V2009. The subjects were diagnosed with health (more than 80 score) or sub-health (score between 60 and 80) status according to the questionnaire score. The subjects with a sub-health status were also analyzed using the five-viscera syndrome differentiation of traditional Chinese medicine using the form for collecting information according to the four examinations. Then for gathering the facial color information, CIE L*a*b and C values and reflections of wavelengths ranged from 400 to 700 nm were measured using a CM-2600D spectrophotometer on 8 points of the face, including the frontal part, glabellas, nose, mandible, two cheeks and eyelids.RESULTS: L value of the sub-health group was higher than that of the health group (P<0.05), and a, b and C values were lower than those of the health group (P<0.05), suggesting that the facial complexion of the sub-health group was pale/whiter than the health group. The reflectance rates of wavelengths (from 400 to 550 nm) of the sub-health group were higher than those of the health group (P<0.05), which suggested that the facial complexion of the sub-health group was partially green. The a, b and C values of the forehead, glabellas and nose of subjects in the sub-health group were apparently different from the health subjects. L values of five-viscera types were significantly different from people of a health status (P<0.05). There were some differences in color values among the five-viscera groups: lung group’s color values were significantly different from the others in terms of a, b and C values. The spectral reflectance of different viscera groups of the sub-health group also showed certain differences: reflectance of wavelengths at 400 to 490 nm in the lung group and at 520 to 580 nm in the spleen group showed significant difference from the other groups, and the lung group was lower and the spleen group was higher than the others.CONCLUSION: There are some differences in facial spectrum and color in different sites of the face in sub-health status of different viscera syndrome types, which can provide an objective basis for health evaluation.

Objective: To explore the experience of the process of Tai Chi exercise
Methods: The study was conducted in a local park in Beijing of China where varying numbers of community members gathered to practice Tai Chi every day. Volunteers meeting the inclusion and exclusion criteria were recruited after signed an informed consent form. In-depth interview and the participatory observation were used to know of the real feeling of practicing Tai Chi. The qualitative data obtained from the interviews were analyzed by using Colaizzi seven-step method to find the subjects.
Results: Six volunteers having a long-time Tai Chi exercise were recruited in this qualitative study, and their real experience was summarized in the physiological level, psychological level, social level and cultural level. In the physiological level, Tai Chi improves the health and exercise of Tai Chi assists the elderly to develop good living habits. In the psychological level, Tai Chi practice guides the person to inner peace, relieves tension, improves depressive mood state, and makes the elderly regain self worth. In the social level Tai Chi is a good form of community practice. In the cultural level, Tai Chi roots in yin and yang culture and integrates internal and external exercises.
Conclusion: Tai Chi is good for body and mind health and the community of practice is very important for practitioners. Tai Chi gains popularity for its benefits to health and psychological adjustments, and its cultural connotation.

The concept of "three-yin and three-yang" in Shanghan Lun (Treatise on Cold Pathogenic Diseases), a classic written by Zhang Zhongjing in Han Dynasty, has been always the focus of dispute in successive dynasties. The essence of "three-yin and three-yang" has not been fully revealed up till now. Through studying the six divisions of day and night, the six diseases, the combination of syndromes, the complicated diseases, the complete recovery time and the space division of "three-yin and three-yang", the authors draw a conclusion that the "three-yin and three-yang" in Shanghan Lun is a concept of time-sequence, which is associated with the location of disease in space. So it is suggested that the "six diseases" in Shanghan Lun is a categorization for exogenous febrile diseases, and this categorization reveals a sort of inner relationship between the emergence, development, transformation of the febrile diseases and the time.

Chinese herbal formulas can well present the characteristics of traditional Chinese medicine (TCM) with their simple, convenient, inexpensive and effective uses. However, due to the high cost of production, manufacturing pharmacies inside the hospital closed down one after another, which rendered the difficult situation of developing preparation of Chinese herbal formulas. The Pudong New Area of Shanghai, as a pilot region for comprehensive reforms on national development of TCM, vigorously explores the standardized research on and application of hospital-made Chinese herbal formulas. The Health Bureau of the Pudong New Area, based on the Shuguang Hospital, has established a clinical evaluation center for hospital-made Chinese herbal formulas. Through screening, manufacturing, quality control, unified allocation, and standardized clinical evaluation, the clinical evaluation center has summarized its experience on these processes.

Objective

To prepare the Praval bhasma (PB) and to perform its characterization. 

OBJECTIVE: To investigate the effects of manual acupuncture at Shenmen (HT7) or Taiyuan (LU9) on the attention function of the brain, and to lay an experimental foundation for researching brain function and integration mechanisms of the human brain in relation to acupuncture stimulation.METHODS: Ten healthy young college students were selected as experimental subjects. P3a and P3b potentials were induced by novel stimulation and target stimulation with vision and were observed using Neuroscan event-related potentials system at time windows of ms 330-430 or 400-600 ms for observing the change of intensity distribution of P300 after manual acupuncture at HT7 or LU9.RESULTS: The amplitude of P3a and P3b decreased significantly after manual acupuncture at HT7 or LU9, but the degree of decreases affected by the acupoints was different. The decrease of the amplitude of P3a due to acupuncture at HT7 was more significant than acupuncture at LU9 (P<0.05).CONCLUSION: The attention function of the brain is affected by manual acupuncture at HT7 or LU9 and manual acupuncture at HT7 has a greater influence on the attention function of the brain.

In recent years, Delphi method has been widely applied in traditional Chinese medicine (TCM) clinical research. This article analyzed the present application situation of Delphi method in TCM clinical research, and discussed some problems presented in the choice of evaluation method, classification of observation indexes and selection of survey items. On the basis of present application of Delphi method, the author analyzed the method on questionnaire making, selection of experts, evaluation of observation indexes and selection of survey items. Furthermore, the author summarized the steps of application of Delphi method in TCM clinical research.

Currently, the model of the research evaluation system of traditional Chinese medicine (TCM) is set up through imitating that of western medicine. The application of quantitative research to TCM does promote the advance of modernization of TCM, which explore the part of TCM that can be measured in quantitative method. However, TCM has a background of profound philosophy and culture. The priority of TCM can not be expressed through quantitative research alone. On the contrary, qualitative research is more suitable to most research area of TCM. In TCM clinical research, the priority of TCM should be fully explored. It is very significant to set up the effectiveness evaluation system of TCM, especially by applying qualitative research to the diagnosis and the evaluation of treatment results and combining quantitative research.

Objective: To observe the changes in content of monoamine neurotransmitters in the serum of rhesus macaques, and explore the role of serum monoamine neurotransmitters in premenstrual syndrome (PMS) and liver-qi depression induced by anger-in emotion.

Methods: Social level pressure was applied on 24 female macaques to induce the angry emotional reaction, and then nine of the low-status macaques with anger-in emotional reaction were screened out and were divided into anger-in emotion group, PMS and liver-qi depression group (model group) and Jingqianshu Granule group. Macaques in the last two groups were suffered extruding in a pack cage for inducing PMS liver-qi depression. After 5 d of extruding, experimental animals were evaluated according to the emotional evaluation scale, meanwhile, macaque serum of follicular phase and middle-late luteal phase was collected to analyze the content of serum norepinephrine, dopamine, and 5-hydroxytryptamine.

Results: Compared with the normal control group, the scores of depression of the model group and the anger-in emotion group evaluated with emotional evaluation scale were significantly increased (P<0.01, P<0.05); while the score of the model group was significantly higher than that of the anger-in emotion group (P<0.05), and it returned to normal after Jingqianshu Granule treatment. As compared to the normal control group, serum monoamine neurotransmitter levels of the model group and the anger-in emotion group were increased (P<0.05, P<0.01), and the serum monoamine neurotransmitter levels of the model group were significantly higher than those of the anger-in emotion group (P<0.05), while there was no significant difference when compared with the normal control group after the treatment.

Conclusion: Anger-in emotion can induce liver-qi depression syndrome which is related to the changes in monoamine neurotransmitters.

On the basis of medical literature review and clinical research experience, the authors analyzed the reasons for low recognition rate of depression and poor progress of traditional Chinese medicine (TCM) differentiation of depression in this paper and put forward that depressive episode symptoms and the corresponding common terminology classification of Chinese and Western medicine should be the breakthrough points. Through symptom stratification and combination, as well as distinguishing between primary and secondary symptoms, the comprehensive integrative medicine clinical assessment of depression was explored so as to further obtain expert consensus and provide a methodology reference for the TCM differentiation of depression and the research of etiology and pathogenesis.

Objective: To establish Caco-2 (a human colon adenocarcinoma cell line) cell monolayer model and the standard operation procedure for studying and assessing intestinal absorption of chemical components of traditional Chinese medicine.Methods: Caco-2 cell monolayer model was established and evaluated by morphology feature using scanning electron microscope, inverted microscope and transepithelial electrical resistance (TEER) assay. Additionally, the model was further tested for the activity of alkaline phosphatase and the apparent permeability (P_app) of standard compounds, i.e. propranolol and atenolol, which were the control substances for high and poor transcellular transport marker, respectively.Results: The integrality of cell monolayer, cell differentiation (reflected by expression of alkaline phosphatase and cell monolayer morphology), and the P_app value of standard compounds in the established Caco-2 cell model were satisfactory. All parameters tested were in good agreement with those reported in the literature.Conclusion: The established Caco-2 cell model can be used to study the intestinal absorption of orally administrated chemical components of traditional Chinese medicine and their absorption mechanism.

Objective

To study the efficacy and safety of Fuzheng Huayu Capsule (FZHY Capsule) against liver fibrosis with chronic hepatitis B.

Methods

Multicentric, randomized, double blinded and paralleled control led trial was conducted on patients (aged between 18 and 65) with liver fibrosis in chronic hepatitis B．Indexes observed: (1) hepatic histological changes and HBV markers were observed at 0 and 24th week during the treatment; serological indexes (HA, LN, P-Ⅲ-P, Ⅳ-C) were determined and B ultrasound examination of spleen and liver was taken at 0, 12th, 24th week; liver function (during the period of follow-up, liver function and serological indexes for liver fibrosis were evaluated) were observed at 0, 6th, 12th, 18th, 24th week; (2) indexes for safety: blood and urine routine tests, renal function and ECG were examined.

Results

(1) Enrollment and demographic data: There was no significant difference between the trial (110 cases) and control group (106 cases) in demographic feature, vital signs, course of illness,history for drug anaphylaxis, history of previous therapy, liver function, serological indexes for liver fibrosis, liver histological examination (99 cases for test group, 96 cases for control group), HBV markers, and renal function, etc. (2) Histological pathological examination: 93 cases of liver histological examination were taken, of these 50 cases for the trial group and 43 cases for control group which turned out to be at S mean value of 2.33 and 2.11 respectively pretreatment according to criteria for liver fibrosis staging. Post-treatment, the trial showed a significant decrease with S value of 1.80 compared to that of pretreatment; however, there was no significant improvement in control group before and after the treatment with S mean value of 2.14. There was significant difference in reversing rate (decrease at least 1 stage according to criteria for liver fibrosis staging) between the trial (52%) and control (23.3%) after liver biopsy. The trial had a rather good effect on improving inflammatory activity and was superior to control group with a marked decrease of mean value of inflammatory activity and score of inflammation (P<0.05). (3) Serological indexes for liver fibrosis: There was a significant decrease in HA, LN, P-Ⅲ-P, Ⅳ-C content in test group after 12 and 24 weeks' treatment compared to that of pretreatment; the differences of HA, LN, P-Ⅲ-P, Ⅳ-C between 12 , 24 weeks' treatment and pretreatment were significantly greater than control group (P<0.01 or 0.05); the effectual was defined as 2 of 4 indexes lowered more than 30% of the baseline, according to this criteria, the trial was 72.7%, while control group 27.4% (P<0.01). (4) Liver function: Obvious improvement of serum Alb, ALT, AST, GGT was seen in 2 groups; compared with control group, marked improvement of GGT and Alb in the trial (P<0.05); the effective rate of serum ALT in the trial group was 72.7%, while control 59.4%. (5) No changes of significant difference between pre- and post-treatment in routine tests for blood and urine, renal function and ECG, etc. There was also no difference in the stable rate of ALT and serological indexes for liver fibrosis between the trial and control group 12 weeks after withdrawal (P<0.05).

Conclusion

Fuzheng Huayu Capsule has good effect on alleviating liver fibrosis in chronic hepatitis B without any adverse effect and is superior to Heluo Shugan Capsule. Fuzheng Huayu Capsule is a safe and effective medicine for the treatment of liver fibrosis in chronic hepatitis B.