By analyzing current research status and considering our own previous research results, we hold that research on active substance of Chinese herbal formula should be focused on the effect of active components according to its functions, thus determining the main effective components of traditional Chinese medicine (TCM) compound prescriptions. Study of compatibility of effective components should be carried out and compound prescriptions composed of effective components should be developed. It is a pivotal way to deepen research on active components of TCM compound prescription by further analyzing the compatibility of effective components and the relationship between functional components and active components by multilink and multitarget methods.

Recently many researches have demonstrated that insulin resistant (IR), as an important pathologic process, is increasingly involved with a series of diseases such as central obesity and diabetes. Hypertension is highly associated with IR. The relationships between IR and glucose or lipid metabolism disorders are well established. However, association of IR with hypertension is less covered. Current researches on insulin resistance and pathogenesis of hypertension are reviewed in this paper, which holds that traditional Chinese medicine treatment on IR in patients with hypertension has a good prospect.

Osteoporosis is characterized by reduced bone mass and impaired micro-architectural structure, leading to an increased susceptibility to fractures. It is a complex, multifactorial disorder resulting from genetic factors, environmental factors and gene-environment interactions. Currently there are three opinions on the main pathogenesis of primary osteoporosis in traditional Chinese medicine: kidney deficiency, spleen deficiency, and spleen-kidney deficiency, in which disagreement remains. In this paper, the authors combine the modern etiology of osteoporosis to explain scientific connotation of the three opinions, aiming to comprehend the pathogenesis of primary osteoporosis and strengthen the communication between traditional Chinese medicine and Western medicine, and trying to evaluate the clinical curative effect on osteoporosis.

Background

Chaihu Injection (CI), which is widely used in treatment of febrile diseases, is an aqueous solution of Chaihu (Radix Bupleuri Chinensis) or Nanchaihu (Radix Bupleuri Scorzonerifolii) prepared by steam distillation.

Objective

This study aims at finding out the possible causes for adverse drug reaction or adverse event (ADR/AE) caused by CI and assessing its safety based on existing evidence.

Search strategy

 Manual search was not conducted. Electronic search was conducted by two authors in China National Knowledge Internet (CNKI) database and Chongqing VIP database (VIP). The search ended in June 30th, 2009.

Inclusion criteria

Studies of ADR/AE induced by CI were collected comprehensively without considering language of literature and outcome indicators. Search results were not limited by patient’s age, gender, race, primary disease, etc. Interventions were using CI alone or CI combined with other drugs (Chinese herbal medicine decoction or other drugs containing Chaihu were excluded).Data extraction and analysis: Two authors conducted data extraction independently. Microsoft Excel software was used to develop data extraction forms. Because of heterogeneity of the studies, only a descriptive analysis was conducted.

Results

Totally 83 studies with 203 cases were included in this review. Without the yield data and total amount of using, we cannot tell the incidence of ADR/AE induced by CI as well as assess the risk and safety of CI. The constituent ratio of severe cases was higher in children and old people than in other age groups. For most intramuscular cases, ADR/AE happened in 30 min after injection (constituent ratio of cumulative incidence in 30 min was 93.8%); for intravenously guttae patients, 4 cases of ADR/AE happened in the process of infusion; for first users, constituent ratio of cumulative incidence in 30 min and constituent ratio of cumulative incidence of severe cases in 30 min were higher than cases who had used CI before. Most ADRs/AEs were caused by incorrect use of CI, such as excessive doses (5 cases), intravenously guttae administration (6 cases), and violating incompatibility rules (7 cases). The incidence ratios of ADR and AE for severe and mild cases were 1.7︰1 and 1.1︰1, respectively; the ratios of the three relevant levels described as definitely related, most probably related and possibly related in the two types (severe and mild) of cases were 25︰14︰5 and 44︰9︰16, respectively.

Conclusion

Present evidence with low level shows that incorrect use is the main cause of ADR/AE of CI. Whether CI is proper for children and old people still needs further research. Training for correct use of CI is necessary for medical workers. Much improvement in reporting ADR/AE based on “Recommendations for Reporting Adverse Drug Reactions and Adverse Events of Traditional Chinese Medicine” is in need.

Background

Many randomized controlled trials (RCTs) and reviews concluded that acupuncture is not an effective treatment for low back pain (LBP) and there is no difference between real acupuncture and sham acupuncture in the treatment of LBP.

Objective

This study aims to evaluate the most recently published RCTs and reviews from the clinical protocol, which is used by professional acupuncturists.Data sources and synthesis: English-language studies were identified through searches of The Cochrane Library, PubMed/MEDLINE and EMBASE, limited to those published between January 2007 and January 2010. Eighteen trials studying conditions related to LBP conditions treated by acupuncture or acupuncture as one of the co-interventions were eligible.Study appraisal methods: A critical clinical qualitative evaluation is the core methodology of this study. The study design employs daily used clinical skills and knowledge with supplementary statistical concepts to evaluate the quality and reliability of the selected RCTs and reviews. Five evaluation criteria were established for the assessment of the selected RCTs and reviews. By implementing the evaluation criteria, which are similar to the inclusion and exclusion criteria used in RCTs, the weaknesses, limitations or errors of RCTs and reviews can be identified, despite the strength of internal validity produced by statistical calculations.

Results

Various terms are used when describing LBP conditions. However, 16 RCTs or 88% of the trials did not establish a medical diagnosis. No trials had objective measurements as a clinical standard for assessing outcomes. Furthermore, significant variation existed due to the numerous treatment methods or therapists used in the RCTs included in the study. Various co-interventions were used in 10 or 55% of the trials, among them, 6 or 33% of the trials used non-steroidal anti-inflammatory drugs (NSAID) or analgesics. Due to the lack of diagnostic status, the accuracy of the external validity was put into question. No logistic regression models were used in any of the selected RCTs and reviews to resolve the degree of heterogeneity.

Conclusion

All selected RCTs either partially met the evaluation criteria or did not fulfill the evaluation criteria while being compared. The major problem existing in all RCTs was the lack of accurate medical diagnosis and a lack of objective measurements to judge the clinical outcomes, which in turn, created incorrect eligibility criteria, improper matches and inaccuracies in data recording before entry into statistical calculations. As a consequence of the subjective nature of measurements, conclusions of RCTs and RCT-based reviews were biased due to overgeneralized or cross-generalized estimations, which infer that alternative explanations cannot be excluded. In addition, the range of variables created in the treatment procedure was difficult to control or estimate, in turn, threatening the reliability of RCTs’ estimations. For these reasons, creating appropriate diagnostic criteria before randomization and constructing a related objective outcome measurement, which are more relevant to clinical practice, should be considered in future RCTs and systematic review studies.

Objective

To screen common traditional Chinese medicine (TCM) syndrome factors of chronic renal failure (CRF) via questionnaire investigation among experts.

Methods

A questionnaire was developed based on the results of our previous researches. The investigation was carried out with the questionnaire among experts who are engaged in clinical research and treatment of nephrosis with the title of chief or associate chief physician from 15 hospitals in China. Common TCM syndrome factors of CRF were obtained based on the data analysis of the mean value on general evaluation, cumulative percentage and coefficient of variation.

Results

A total of 114 sets of the questionnaire were sent out and all of them were returned back, 113 of which were effective. The recovery rate was 100%. The TCM syndrome factors were regarded as common factors of CRF syndrome if the cumulative percentage was more than or equal to 60% and the coefficient of variation was less than or equal to 0.35. The syndrome factors related to the disease location were the kidney, spleen, stomach, heart, and lung; the syndrome factors related to the disease type were dampness, turbid toxin, blood stasis, water retention, and phlegm which belong to excess type, and qi deficiency, yin deficiency, yang deficiency, blood deficiency, and essence deficiency which belong to deficiency type.

Conclusion

The common TCM syndrome factors of CRF were obtained from the representative experts through the questionnaire investigation among the experts. The results enable us to have a deeper understanding of the disease in view of TCM compared with the previous literature data and may contribute to the establishment of TCM syndrome diagnosis criteria of the disease in the future.

Objective

To evaluate the consistency of tongue manifestation and pulse condition observed by traditional Chinese medicine clinicians.

Methods

Field investigation and direct inquiry were performed in the study. Two physicians from the same department judged tongue manifestation and pulse condition independently. The consistency among observers was assessed by means of Kappa statistics.

Results

A total of 55 patients were included in the study. There were 13 inconsistent cases (23. 6%) in tongue body observation and 7 cases (12.7%) in form of the tongue observation. The observation consistency of tongue body (Kappa=0.649) and form of the tongue (Kappa=0.752) were good. There were 24 inconsistent cases (43.6%) in tongue fur observation, the consistency of which was moderate (Kappa = 0. 525). There were 22 inconsistent cases (40%) in pulse condition diagnosis, the diagnosis consistency of which was also moderate (Kappa=0.562).

Conclusion

Observation and diagnosis consistency of tongue manifestation and pulse condition were moderately the same between different clinicians. By analyzing the reasons of inconsistency, it is necessary to improve the consistency in three aspects, such as the detailed-oriented criterion, the attitude of researchers and better training of researchers.

Background

The incidence of colorectal cancer is high among the elderly. Traditional Chinese medicine (TCM) has been widely used in the treatment for colorectal cancer of old people. However, controlled trials with large sample size evaluating the effect of TCM are rare.

Objective

This research aimed to evaluate the survival benefit of using TCM syndrome differentiation treatment for elderly patients with stage Ⅱ or Ⅲ colorectal cancer. Design, setting, participants and interventions: A total of 78 patients over 70 with resected stage Ⅱ or Ⅲ colorectal cancer were selected from the First Department of Oncology, Longhua Hospital of Shanghai University of Traditional Chinese Medicine, and Department of Anorectal Surgery, Changhai Hospital of Second Military Medical University. Patients were assigned to either integrated treatment group or Western medicine group by their own wills.Main outcome measures: Cox regression analysis was performed to determine all the potential factors which may affect prognosis such as gender, primary site, pathological type, TNM stage, chemotherapy period, radiotherapy and TCM therapy.

Results

A total of 78 cases were included in this study with 37 cases in integrated treatment group and 41 cases in Western medicine group. Cox regression analysis suggested that the TNM stage (P=0.001) and TCM therapy (P=0.021) were independent prognostic factors. The hazard ratio [Exp(β)] of TCM therapy was 0.393, and 95% confidence interval (CI) was 0.178-0.870. Median disease-free survival (DFS) of Western medicine group was 41.293 months. DFS of integrated treatment group did not reach the median at the time of analysis. There was significant difference between the two groups (P=0.012). The 1-, 2-, 3-, 4-, and 5-year DFS rates of Western medicine group were 87.7%, 69.6%, 63.4%, 46.5%, and 29.6%, respectively. The 1-, 2-, 3-, 4-, and 5-year DFS rates of integrated therapy group were 100%, 86.3%, 74.6%, 74.6%, and 74.6%, respectively.

Conclusion

TCM syndrome differentiation and treatment is important for improving the prognosis of stage Ⅱ or Ⅲ colorectal cancer in elderly patients. Integrated treatment shows benefit for reducing relapse and metastasis rates, and prolonging survival for elderly patients. The influence of integrated treatment needs to be further evaluated.

Objective

 To observe the effects of Yiqi Huoxue Formula (YQHXF), a compound Chinese herbal medicine, on transforming growth factor-β (TGF-β)/smad signal transduction pathway and connective tissue growth factor (CTGF) in rats with renal interstitial fibrosis.

Methods

Unilateral ureteral obstruction (UUO) rat model was established and the rats were randomly divided into 5 groups: untreated group, high-, medium-, and low-dose YQHXF groups and fosinopril sodium group. Another group with sham operation was set as control. All rats were administered with corresponding drugs for 3 weeks. After the last administration, each rat was sacrificed and weighed and the serum was separated for creatinine (Cr) and blood urea nitrogen (BUN) detection. Kidneys of the rats were taken out, and mRNA and protein expressions of TGF-β, smad2, smad7 and CTGF were measured with real-time fluorescent quantitative reverse transcription-polymerase chain reaction and Western blotting respectively; fibrosis of the kidney tissue was observed with hematoxylin-eosin (HE) staining and Masson trichrome staining.

Results

Compared with sham-operation group, Cr and BUN in serum of UUO groups were increased, while high-dose YQHXF treatment decreased the UUO-induced increase of Cr and BUN levels. HE staining and Masson staining results showed that the renal tubular epithelial cells in untreated group got atrophied; lumens of renal tubules expanded; fibroplastic proliferation and inflammatory cell infiltration were observed in renal interstitium; the number of glomerulus decreased and collagen increased significantly compared with sham-operation group. In the high- and medium-dose YQHXF groups and fosinopril sodium group, the histopathological changes of inflammatory cell infiltration, fibroplastic proliferation, expansion of lumens of renal tubules was improved as compared with the untreated group. The mRNA and protein expressions of TGF-β, smad2 and CTGF in untreated group were higher than those in sham-operation group (P<0.05), and the mRNA and protein expressions of smad7 in untreated group were lower than those in the sham-operation group (P<0.05). Compared with untreated group, high- and medium-dose of YQHXF significantly down-regulated the mRNA and protein expressions of TGF-β, smad2 and CTGF (P<0.01, P<0.05), and up-regulated the mRNA and protein expressions of smad7 (P<0.01, P<0.05).

Conclusions

The mRNA expression of CTGF in UUO rats may be regulated by TGF-β/smad signaling transduction pathway. YQHXF might inhibit the expression of CTGF through down-regulation of TGF-β and smad2 and up-regulation of smad7, thus inhibiting the progression of renal interstitial fibrosis.

Objective

To observe the effects of Yiqi Huayu Recipe, a Chinese compound herbal medicine, on apoptosis of dorsal root ganglion (DRG) neurons and expression of caspase-3 in rats after lumbar nerve root compression injury.

Methods

A total of 40 male Sprague-Dawley rats were randomly allocated into 4 groups: control group, untreated group, Methycobal group and Yiqi Huayu Recipe group. Surgery was performed on rats of untreated group, Methycobal group and Yiqi Huayu Recipe group to place a micro-silica gel on right L4 DRG, while control group received skin and paravertebral muscle incision only. Rats in Methycobal group and Yiqi Huayu Recipe group were given Methycobal by intramuscular injection and Yiqi Huayu Recipe intragastrically respectively. Rats in control group and untreated group received saline intragastrically as equal amount as Yiqi Huayu Recipe group. The compressed nerve roots were harvested at the 10th day after treatment. Apoptosis of DRG neurons was detected by terminal deoxynucleoitidyl transferase-mediated nick-end labeling. Caspase-3 activity and mRNA expression in compressed nerve roots were detected with spectrophotography and real-time polymerase chain reaction respectively.

Results

Apoptosis of DRG neurons was significantly increased in the rat model. The apoptosis index of untreated group was higher than that of control group (P<0.01). Yiqi Huayu Recipe and Methylcobal could reduce the apoptosis of DRG neurons, and both groups showed a lower apoptosis index than untreated group (P<0.01). Caspase-3 activity and its gene expression were significantly increased in untreated group. The levels of caspase-3 activity and its gene expression in untreated group were higher than those in control group (P<0.05 or P<0.01). Yiqi Huayu Recipe and Methylcobal could reduce the overexpression of caspase-3 mRNA, and statistically significant differences were found between the untreated group and Yiqi Huayu Recipe group or Methylcobal group (P<0.01).

Conclusion

Lumbar nerve root compression results in overexpression of caspsae-3 in nerve root tissue and increase of DRG neuron apoptosis. Yiqi Huayu Recipe can inhibit the overexpression of caspase-3 and alleviate the apoptosis of DRG neurons after nerve injury.

Objective

Immune system is involved in the etiology and pathophysiologic mechanisms of inflammation. Medicinal plants are an important source of substances which are claimed to induce non-specific immunomodulatory effects. In view of this and on account of the interleukin (IL)-6’s role in inflammation and pain induction, this study investigated the effects of Achillea santolina extracts on inflammation which was induced by complete Freund’s adjuvant (CFA) in male Wistar rats.

Methods

Both methanolic and defatted extracts prepared from aerial parts of the plant were examined. Inflammatory symptoms such as hyperalgesia and paw edema in CFA-injected rats’ paw were measured by radiant heat and plethysmometer during different stages of study respectively. Serum IL-6 level was checked by rat standard enzyme-linked immunosorbent assay specific kit.

Results

The results indicated dose-related effects of methanolic extract on paw edema, hyperalgesia and serum IL-6 level reduction in rats. Methanolic extract of A. santolinaexhibited significant antihyperalgesic and anti-inflammatory effects during pretreatment and short-term treatment at dose of 200 mg/kg and there was no significant difference between 200 and 400 mg/kg doses of this extract. Defatted extract did not show significant effect on CFA-induced inflammation during different stages of treatment (P>0.05). Short-term treatment with methanolic extract at dose of 200 mg/kg was more effective than indomethacin in edema, hyperalgesia and serum IL-6 level reduction (P<0.01, P<0.01 and P<0.05 respectively).

Conclusion

These results suggest that methanolic extract of A. santolina possesses potent anti-inflammatory and immunomodulatory activities during pretreatment and short-term administration.

In order to elucidate the mechanisms of Chinese herbal medicine, much work has been done based on chemical constituent-target in the molecular system. It cannot comply with the holistic efficacy of Chinese herbal medicine. Thus, the authors of this paper proposed to study the functional target adopted from Western medicine. The data of Chinese herbal function were collected from 2005 edition of The People’s Republic of China Pharmacopoeia. A total of 135 functional targets were found, and a network about functional target and mode of action was built. The authors also explored the applications of functional target and the network combined with Sijunzi Decoction and Mahuang Decoction. The results, reflecting the feature of Chinese herbal medicine, will not only be helpful to elucidate the holistic mechanisms of Chinese herbal medicine, but also beneficial to studying the theory of Chinese formulas and developing new formulas.