Abstract:Publication biases and collection limitations are the main disadvantages of a traditional meta-analysis based on aggregate patient data (APD) from published articles. Individual patient data (IPD) meta-analysis, as the gold standard of systematic review, is a possible alternative in this context. However, the publications relative to IPD meta-analyses are still rare compared with the traditional ones, especially in the research oriented to Chinese medicine (CM). In this article, the strengths and detailed functioning of IPD meta-analysis are described. Furthermore, the need for IPD meta-analysis to assess the treatments based on CM was also discussed. Compared with the traditional APD meta-analysis, the IPD meta-analysis might give a more accurate and unbiased assessment and is worth to be recommended to CM researchers.  
Keywords:meta-analysis;individual patient data;systematic review;randomized clinical trial;Chinese Medicine
Abstract:To assess the long-term (up to 6 months) safety profile of a 3-month regimen of NeuroAiD for acute ischemic stroke. A total of 190 patients with acute ischemic stroke were identified for eligibility in a randomized, double-blind, placebo-controlled clinical trial, of which 150 patients allocated to either receiving NeuroAiD (80 cases) or placebo (70 cases) were analyzed after dropouts due to absence of baseline data, early death, or noncompliance. Both groups received treatment for three months and followed up for another three months after the completion of the treatment. Occurrence of clinical adverse events and laboratory parameters were assessed at 1 month, 3 months (while under treatment) and 6 months (3 months after the completion of treatment). Statistical comparisons between groups were performed using chi-square test or t-test whenever appropriate. The two groups had comparable baseline characteristics. Mild nausea was more commonly reported in patients taking NeuroAid compared with placebo (P=0.01), of which 9 out of 10 were observed only during the first month of treatment. However, none of the adverse events reported were considered severe or required discontinuation of the study drug. There was no significant change observed in mean arterial blood pressure, haemoglobin, renal and liver laboratory parameters during treatment with NeuroAid and up to 3 months after completion of a 3-month regimen. NeuroAiD is safe and does not affect hematologic, hepatic, and renal functions during and long after completion of treatment.  
Abstract:To investigate the effect of Longbishu Capsule (癃闭舒胶囊, LBS), doxazosin, and combination therapy on benign prostatic hyperplasia (BPH). A randomized, double-blind, multi-center parallel trial was conducted involving 360 patients in hospitals in Beijing (108 cases), Heilongjiang (90 cases), Sichuan (90 cases), Shanghai (72 cases), China. They were randomly assigned with central randomization method to group A (LBS placebo plus doxazosin), group B (LBS plus doxazosin) or group C (LBS plus doxazosin placebo), 120 cases for each group. The international prostate symptom score, maximum urinary flow rate, postvoid residual urine volume and prostate volume were measured for evaluating the efficacy of the three treatments. At baseline, there was no significant difference in the measured variables among the three groups. After 12-month treatment, the three groups showed significant improvements in IPSS and maximum urinary flow rate from baseline (P<0.01). Although postvoid residual urine volume was not significantly different from the baseline in group A (P>0.05), it significantly decreased in group B and C (P<0.05). The incidence of adverse events were similar among the three groups. The treatment of LBS alone or LBS plus doxazosin was able to significantly improve IPSS in patients with BPH. The treatments may reduce the increase in prostate volume and postvoid residual urine volume as well.  
Keywords:benign prostatic hyperplasia;combination therapy;Longbishu Capsule;doxazosin;clinical progression;Chinese Medicine
Abstract:To discuss the correlation of tongue manifestation with the site of cerebral infarction in patients with acute cerebral infarction. From March 2008 to February 2009, 200 cases of hospitalized patients with first unilateral cerebral infarction were chosen in the Department of Neurology, Xuanwu Hospital. The correlation of different tongue color, fur texture, fur color with the site of cerebral infarction was analyzed. The site of cerebral infarction in patients were compared between different tongue color by Chisquare test (P=0.314), and further correspondence analysis demonstrated that there was correlation between red tongue and cortical-subcortical infarction group. The site of cerebral infarction in patients were compared between thick fur group and thin fur group, cortical-subcortical infarction occurred more frequently in the former (P=0.0008). The site of cerebral infarction in patients were compared between dry fur group, moist fur group and smooth fur group, correspondence analysis demonstrated there was correlation between dry fur and cortical-subcortical group. The site of cerebral infarction in the patients were compared between white fur group, white-yellow fur group and yellow fur group (P=0.010), and correspondence analysis demonstrated there was correlation between white fur and brainstem infarction; white-yellow fur has relationship with cortical infarction; subcortical infarction was weakly related with white-yellow fur; there was closer relationship between yellow fur and cortical-subcortical infarction. The change of tongue manifestation was associated with the site of cerebral infarction in patients, providing a new combining site for diagnosing cerebrovascular diseases by integrative medicine.  
Keywords:Cerebral Infarction;tongue manifestation;fur color;fur texture;Chinese Medicine
Abstract:To explore an approach to rapidly and accurately identify the compounds as biomarkers of Chinese medicine (CM) syndromes. The Fourier transform infrared (FT-IR) spectrometry was applied to investigate the characteristic components of a mice model of Kidney (Shen)-yang deficiency syndrome (KDS), and the remedial effect of a typical CM formula Shenqi Pill (肾气丸). Thirty-six females and 18 males of Balb/c mice were randomly divided into KDS, Shenqi or control group. The females and males of the same group freely were mated for 96 h, and the males were taken out and only the female mice were raised. Females of the KDS group were threatened by a ferocious cat every other day for 14 d. After delivery, the KDS, or gestational threatened, offspring were raised at standard condition for 11 weeks. Then 10 male offspring were randomly selected, anaesthetized and their representative organs, i.e. testes, kidneys, lungs and feet were collected, for the FT-IR scan. Mice of the Shenqi group were intragastric administered Shenqi Pill; while mice in the KDS and control groups were given the same volume of saline. The attenuated birth outcomes of the KDS group were displayed. The remarkable FT-IR differences of all organs between KDS mice and healthy control were mainly at 1,735–1,745 cm−1 (indicating the increased levels of lipids) and at 1,640–1,647 cm−1 and 1,539–1,544 cm−1 (displaying the decreased proteins). No statistic FT-IR difference between Shenqi and control mice was observed. In accordance with major traits of KDS, prenatal stress extensively impaired the building up of proteins and resulting in the excessive lipid storage, and FT-IR could effectively identify the biomarkers of KDS.  
Abstract:To test whether Shenfu Injection (参附注射液, SFI) might attenuate the impact of cerebral energy dysfunction after resuscitation in a pig model of cardiac arrest (CA). Thirty-four Wuzhishan miniature inbred pigs were randomly divided into three groups: the SFI group (n=12), the saline group (SA group, n=12), and the sham-operated group (sham group, n=10). Following successful return of spontaneous circulation (ROSC) from 8-min untreated ventricular fibrillation, animals received a continuous infusion of either SFI (0.2 mL/min) or saline for 6 h. Cerebral performance category score was evaluated at 24 and 48 h after ROSC, followed by positron emission tomography and computed tomography scans of cerebral glucose uptake. Surviving pigs were euthanized 48 h after ROSC, and the brains were removed for detecting mitochondrial function. Compared with the SA group, SFI treatment produced a better neurologic outcome 48 h after ROSC (P<0.05). However, there was no significant difference of survival rate between the SA and SFI groups (83.3% vs. 81.8%, P>0.05). After ROSC, the SA group showed a decrease in the maximum standardized uptake value of different regions in the brain tissue, where SFI treatment can ameliorate these decreases (P<0.01 or P<0.05). Improved mitochondrial respiratory properties and higher mitochondrial membrane potential were also found following SFI treatment compared with the SA group at 48 h after ROSC (P<0.05 or P<0.01). SFI treatment after resuscitation has significant neuroprotective effects against disruption of cerebral energy metabolism from CA by improving glucose uptake and by normalizing mitochondrial function.  
Abstract:To determine the effects of 5-hydroxymethyl furfural (5-HMF), an extract of Rehmannia glutinosa Libosch, on several down-regulated signaling molecules involved in learning and memory in hippocampal neurons. After cultured for 7 days, primary hippocampal neurons were divided into 5 groups: normal, corticosterone model, RU38486, 5-HMF, and donepezil group. Neuron survival rates were calculated 24 h later using SYTO13-PI double-fluorescence staining and an 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay. β-galactosidase activity was also assayed. Protein expressed by the glucocorticoid receptor (GCR), brainderived neurotrophic factor (BDNF), and N-methyl-D-aspartate receptor 2B (NR2B), as well as phosphorylationcyclic adenosine monophosphate (cAMP) response element binding protein (p-CREB), phosphorylation-extracellular signal-regulated kinase (p-ERK), and phosphorylation-synapsin (p-synapsin) were quantified with Western blot. Hippocampal neuron survival rates and the above-mentioned proteins were dramatically decreased (P<0.05), β-galactosidase activity was significantly increased in the model group. but the effect was reversed by 5-HMF, RU38486, and to a lesser extent by donepezil (P<0.05). 5-HMF extracts from the Chinese herb Rehmannia glutinosa Libosch could protect hippocampal neurons from glucocorticoid injury and from down-regulated signaling molecules in the GCR-BDNF-NR2B-p-ERK-p-CREB-p-synapsin signal transduction pathway.  
Keywords:5-hydroxymethyl furfural;signal transduction;learning and memory;Corticosterone;hippocampus neuron;Chinese Medicine
Abstract:To investigate the effects of curcumin on pain threshold and the expressions of nuclear factor κ B (NF-κ B) and CX3C chemokine receptor 1 (CX3CR1) in spinal cord and dorsal root ganglion (DRG) of the rats with sciatic nerve chronic constrictive injury. One hundred and twenty male Sprague Dawley rats, weighing 220–250 g, were randomly divided into 4 groups. Sham surgery (sham) group: the sciatic nerves of rats were only made apart but not ligated; chronic constrictive injury (CCI) group: the sciatic nerves of rats were only ligated without any drug treatment; curcumin treated injury (Cur) model group: the rats were administrated with curcumin 100 mg/(kg·d) by intraperitoneal injection for 14 days after CCI; solvent control (SC) group: the rats were administrated with the solvent at the same dose for 14 days after CCI. Thermal withdrawal latency (TWL) and mechanical withdrawal threshold (MWT) of rats were respectively measured on pre-operative day 2 and postoperative day 1, 3, 5, 7, 10 and 14. The lumbar segment L4–5 of the spinal cord and the L4, L5 DRG was removed at post-operative day 3, 7 and 14. The change of nuclear factor κ B (NF-κ B) p65 expression was detected by Western blotting while the expression of CX3CR1 was determined by immunohistochemical staining. Compared with the sham group, the TWL and MWT of rats in the CCI group were significantly decreased on each post-operative day (P<0.01), which reached a nadir on the 3rd day after CCI, and the expressions of NF-κ B p65 and CX3CR1 were markedly increased in spinal cord dorsal horn and DRG. In the Cur group, the TWL of rats were significantly increased than those in the CCI group on post-operative day 7, 10 and 14 (P<0.05) and MWT increased than those in the CCI group on post-operative day 10 and 14 (P<0.05). In addition, the administration of curcumin significantly decreased the positive expressions of NF-κ B p65 and CX3CR1 in spinal cord and DRG (P<0.05). Our study suggests that curcumin could ameliorate the CCI-induced neuropathic pain, probably through inhibiting CX3CR1 expression by the activation of NF-κ B p65 in spinal cord and DRG.  
Abstract:To investigate the effect of blood-activating Chinese medicinal compounds and water-draining Chinese medicinal compounds on tumor necrosis factor alpha (TNF-α) and nuclear factor kappaB (NF-κ B) expressions in rats with intracerebral hemorrhage (ICH) at the acute stage, and to monitor their therapeutic effect and mechanism of action on inflammation and cerebral edema. A rat model of cerebral hemorrhage was achieved by injecting autologous arterial blood into the caudate nucleus. A total of 168 rats were randomly divided into 4 groups: blood-activating medicine group (n=42), water-draining medicine group (n=42), sham operated group (n=42), and the model group (n=42). A series of brain samples were obtained at days 1, 3 and 5 after ICH from rats in all groups. Protein expression levels of TNF-α and NF-κ B were measured by immunohistochemical staining and gene expression levels of TNF-α and NF-κ B were measured by real-time fluorescent PCR. Compared to the sham operated group, protein expression levels of TNF-α and NF-κ B in the model group significantly increased (P<0.01). Protein and gene expressions of TNF-α from the blood-activating medicine group and water-draining medicine group significantly decreased when compared to those in the model group P<0.05). Meanwhile, compared to the model group, the expression of NF-κ B in the blood-activating medicine group significantly decreased (P<0.05), while expression of NF-κ B in the water-draining medicine group did not differ (P>0.05). Blood-activating Chinese medicinal compounds and water-draining Chinese medicinal compounds can alleviate inflammation of peripheral tissue and cerebral edema. However, the blood-activating Chinese medicinal compounds were more effective than the water-draining Chinese medicinal compounds. The possible effective mechanism may be by means of inhibiting the activation of NF-κ B so as to suppress the transcription of target genes including gene expression of TNF-α.  
Keywords:intracerebral hemorrhage;Cerebral Edema;tumor necrosis factor alpha;nuclear factor kappaB;blood-activating;water-draining;Chinese Medicine
Abstract:To investigate the effects of Modified Sanhuang Decoction (加味三黄汤, MSD) enema on the serum tumor necrosis factor alpha (TNF-α) and colonic mucosa interleukin-1β (IL-1β), interleukin-6 (IL-6) levels in experimental ulcerative colitis (UC) rats. Forty-five male Wistar rats were randomly divided into 4 groups: normal group (n=12), model group (n=11), salazosulfapyridine (SASP) group (n=11) and MSD group (n=11). The UC model was induced by 2,4,6-trinitrobenzene sulfonic acid (TNBS)/ethanol solution. Rats in the normal group and model group were clystered with 0.9% normal saline, while in the SASP group and MSD group were clystered with SASP and MSD enema, respectively. After drug administration (10 mL/kg body weight, for 7 days), colonic gross changes and colonic mucosa histology were observed, serum TNF-α and colonic mucosa IL-1β, IL-6 levels were tested by enzyme linked immunosorbent assay and radioimmunoassay, respectively. As compared with the normal group, the experimental UC rats, the colonic mucosal damage index scores (CMDIs), histopathological scores (HS) and the serum TNF-α and colonic mucosa IL-1β, IL-6 levels significantly increased (P<0.05 or P<0.01). In the MSD and SASP groups, the ulcer area significantly reduced, and edema disappeared. The CMDIs, HS, the serum TNF-α and colonic mucosa IL-1β, IL-6 levels in the MSD and SASP groups significantly decreased (P<0.05 or P<0.01) compared with the model group. The CMDIs in the MSD group were lower than that in the SASP group (P<0.05), but there were no significant differences in HS, serum TNF-α or colonic mucosa IL-1β, IL-6 levels between the MSD and SASP groups. MSD enema can improve colonic mucosa impairment and decrease serum TNF-α and colonic mucosa IL-1β, IL-6 levels in experimental UC.  
Abstract:To assess the methodological quality of clinical research on Chinese medicine (CM) applied by intra-arterial infusion in treating primary liver cancer (PLC). Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, and three Chinese databases, including Chinese BioMedical Database (CBM), China National Knowledge Infrastructure (CNKI) and China Academic Journal (VIP) were searched. Chinese articles were also searched manually in 16 journals. Two reviewers independently selected studies, the quality of literatures were assessed according to the Cochrane Collaboration method of quality assessment. A total of 14 articles met the inclusion criteria for this review. Only three of these articles described the randomization method used. None of the studies was blinded. All of the articles didn’t report the calculation of the sample size. Only six studies mentioned adverse reactions. All of the studies were of grade C according to the Cochrane Collaboration method. Six studies reported results of survival, and only two of these reported better efficacy in the treatment groups. The quality of studies concerned intra-arterial infusion of CM in treating with PLC was poor and the exact effect of these medicines still need evaluation. Well designed RCTs with large sample sizes, adequate follow-up data and reliable methods of assessment are needed to better appraise the real effect of CMs in the treatment of PLC patients.  
Abstract:In China, there are three basic clinical decision-making modes for patients, namely patients’ autonomous decision-making mode, family decision-making mode and patient and family codetermination. They were produced under the unique background of Chinese medicine, Confucian philosophy and law in China. In this paper, the concepts, advantages and disadvantages of these three decision-making modes were analyzed. In addition, some suggestions were put forward for the improvement. The first is that we suggest to establish standards for choosing decision-making modes; the second is to further learn and publicize relevant laws; thirdly, the legal system needs to be further refined; and the last one is to carry out ethical ward round.  
Keywords:patients’ clinical decision-making;Chinese Medicine;Confucianism;patients’ autonomous decision-making;family decision-making mode;patient and family codetermination;ethical ward round