Realgar (As4S4), a traditional Chinese medicine, induces acute promyelocytic leukemia cell death via the Bcl-2/Bax/Cyt-C/AIF signaling pathway in vitro.

Acute promyelocytic leukemia (APL) is a specific subtype of acute myelogenous leukemia (AML) characterized by the proliferation of abnormal promyelocytes. Realgar, a Chinese medicine containing arsenic, can be taken orally. Traditional Chinese medicine physicians have employed realgar to treat APL for over a thousand years. Therefore, realgar may be a promising candidate for the treatment of APL. Nevertheless, the underlying mechanism behind realgar therapy is largely unclear. The present study aimed to investigate the effect of realgar on cell death in the APL cell line (NB4) in vitro and to elucidate the underlying mechanism. In this study, after APL cells were treated with different concentrations of realgar, the cell survival rate, apoptotic assay, morphological changes, ATP levels and cell cycle arrest were assessed. The expression of Bcl-2, Bax, Cytochrome C (Cyt-C) and apoptosis-inducing factor (AIF) at the mRNA and protein levels were also measured by immunofluorescence, quantitative PCR (qPCR) and Western blotting. We found that realgar could significantly inhibit APL cell proliferation and cell death in a time- and dose-dependent manner. Realgar effectively decreased the ATP levels in APL cells. Realgar also induced APL cell cycle arrest at the S and G2/M phases. Following realgar treatment, the mRNA and protein levels of Bcl-2 were significantly downregulated, whereas the levels of Bax, Cyt-C, and AIF were significantly upregulated. In summary, realgar can induce APL cell death via the Bcl-2/Bax/Cyt-C/AIF signaling pathway, suggesting that realgar may be an effective therapeutic for APL.

Purification, structural characterization, and anticoagulant activity evaluation of chondroitin sulfate from codfish (Gadus macrocephalus) bones.

Chondroitin sulfate (CCS) was purified from discarded codfish (Gadus macrocephalus) bones, and its chemical structure and anticoagulant activity were assessed. CCS was obtained via enzymatic lysis and ion-exchange column chromatography, with a yield of approximately 0.15%. High-performance gel performance chromatography revealed CCS to be a largely homogeneous polysaccharide with a relatively low molecular weight of 12.3 kDa. FT-IR spectroscopy, NMR spectroscopy, and SAX-HPLC indicated that CCS was composed of monosulfated disaccharides (ΔDi4S 73.85% and ΔDi6S 19.06%) and nonsulfated disaccharides (ΔDi0S 7.09%). In vitro anticoagulation analyses revealed that CCS was able to significantly prolong activated partial thromboplastin time (APTT) and thrombin time (TT) (p < 0.05). At a CCS concentration of 5 µg/mL and 25 µg/mL, APTT and TT were approximately 1.08 and 1.12 times higher, respectively, compared to the negative control group. The results indicated that CCS might offer value as a dietary fiber supplement with the potential to prevent the incidence of coagulation-related thrombosis.

Sodium Butyrate More Effectively Mitigates the Negative Effects of High-Concentrate Diet in Dairy Cows than Sodium ß-Hydroxybutyrate via Reducing Free Bacterial Cell Wall Components in Rumen Fluid and Plasma.

The present study was aimed at investigating the effects of sodium butyrate and sodium ß-hydroxybutyrate on lactation and health of dairy cows fed a high-concentrate (HC) diet. Eighty mid-lactation dairy cows with an average milk yield of 33.75 ± 5.22 kg/d were randomly allocated to four groups (n = 20 per group) and were fed either a low-concentrate (LC) diet, a HC diet, the HC diet with 1% sodium butyrate (HCSB), or the HC diet with 1% sodium ß-hydroxybutyrate (HCHB). The feeding trial lasted for 7 weeks, with a 2-week adaptation period and a 5-week measurement period, and the trial started from 96 ± 13 d in milk. Sodium butyrate supplementation delayed the decline in milk production and improved milk synthesis efficiency and milk fat content. Additionally, it decreased the proinflammatory cytokines and acute phase proteins (APPs) in plasma, the leucocytes in blood, the somatic cell count (SCC) in milk, and the gene expression of pattern recognition receptors (PRRs) and proinflammatory cytokines in the mammary gland, due to decreasing the contents of bacterial cell wall components (lipopolysaccharide, LPS; peptidoglycan, PGN; and lipoteichoic acid, LTA) in the rumen and plasma, compared with the HC diet. Sodium ß-hydroxybutyrate supplementation also improved milk yield, milk synthesis efficiency and milk fat content and partially reduced the adverse effects caused by the HC diet, but it had no effect on decreasing bacterial cell wall components in the rumen and plasma, compared with the HC diet. Collectively, both sodium butyrate and sodium ß-hydroxybutyrate mitigated the negative effects of HC diet on lactation and health of dairy cows, with sodium butyrate being more effective than sodium ß-hydroxybutyrate.

The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial.

BACKGROUND: Common cold is one of the most frequently occurring illnesses in primary healthcare services and represents considerable disease burden. Common cold of Qi-deficiency syndrome (CCQDS) is an important but less addressed traditional Chinese medicine (TCM) pattern. We designed a protocol to explore the efficacy, safety, and optimal dose of Shen Guo Lao Nian Granule (SGLNG) for treating CCQDS. METHODS/DESIGN: This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. A total of 240 eligible patients will be recruited from five centers. Patients are randomly assigned to high-dose group, middle-dose group, low-dose group, or control group in a 1 : 1 : 1 : 1 ratio. All drugs are required to be taken 3 times daily for 5 days with a 5-day follow-up period. Primary outcomes are duration of all symptoms, total score reduction on Jackson's scale, and TCM symptoms scale. Secondary outcomes include every single TCM symptom duration and score reduction, TCM main symptoms disappearance rate, curative effects, and comparison between Jackson's scale and TCM symptom scale. ETHICS AND TRIAL REGISTRATION: This study protocol was approved by the Ethics Committee of Clinical Trials and Biomedicine of West China Hospital of Sichuan University (number IRB-2014-12) and registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-15006349).

The efficacy of QingfengGanke granule in treating postinfectious cough in pathogenic wind invading lungs syndrome: a multicenter, randomized, double-blind, placebo-controlled trial.

BACKGROUND: Postinfectious cough (PIC) significantly affects cough-related quality of life but still lacks effective treatments. This study aims to investigate the efficacy of QingfengGanke granule (QFGKG) in treating PIC induced by pathogenic wind invading lungs syndrome. METHODS: A multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted. A total of 180 eligible participants were randomly (1:1:1) assigned to group A (QFGKG 6 g plus QFGKG-matched placebo 6 g), group B (QFGKG 12 g), and group C (QFGKG-matched placebo 12 g). All herbal medications were orally administered twice daily for 10 consecutive days. The primary outcome was time to cough resolution, and secondary outcomes included time to cough alleviation, mean changes in cough symptom score (CSS), visual analogue scale (VAS) score, cough-specific quality of life questionnaire (CQLQ) score, and traditional Chinese medicine (TCM) syndrome score from baseline to Day 10, as well as adverse events. RESULTS: A total of 173 participants were included in the efficacy and safety analyses (group A, n = 57; group B, n = 57; group C, n = 59). The median time to cough resolution in groups A, B, and C was more than 10 days, 8 days, and more than 10 days, respectively (P < 0.0001), and the median time to cough alleviation was 4, 4, and 6 days, respectively (P < 0.0001). Compared with the placebo condition, groups A and B showed significantly greater improvements in CSS (P = 0.0005, P < 0.0001, respectively), VAS (P = 0.0002, P < 0.0001, respectively), CQLQ (P = 0.0258, P = 0.0003, respectively), and TCM syndrome (P = 0.0031, P < 0.0001, respectively). The time to cough resolution was faster in group B compared with group A (P = 0.0091). The adverse event profiles were comparable among the three groups. CONCLUSION: QingfengGanke granule is efficacious in the treatment of PIC induced by pathogenic wind invading lungs syndrome.

Efficacy and safety of Qing-Feng-Gan-Ke Granules in patients with postinfectious cough: study protocol of a novel-design phase III placebo-controlled, double-blind randomized trial.

BACKGROUND: Postinfectious cough (PIC) is a common condition that affects millions of people worldwide every year. There is Western medicine for this condition but the treatment effect is often incomplete. Traditional Chinese medicine (TCM) has been increasingly prescribed for patients with PIC. Preliminary trials on Qing-Feng-Gan-Ke-Granules (QFGKG) conveyed promising results in treating PIC. This protocol describes an ongoing phase III randomized controlled clinical trial, designed according to a novel methodology of "one study, one primary outcome", with the objective of evaluating the efficacy and safety of QFGKG in patients suffering from PIC. METHODS/DESIGN: This is a multicenter, phase III, randomized, double-blind, parallel-group, placebo-controlled clinical trial, comprising two simultaneously conducted study parts, part A and part B, intending to investigate two primary outcomes, i.e. time to cough resolution and cough symptom score, respectively. A total of 480 patients, aged 18 to 65 years, who complain of an ongoing persistent cough that has been lasting ≥ 3 weeks, will be recruited from six participating sites and then randomized to receive QFGKG 12.0 g twice daily or placebo 12.0 g twice daily. Each part will enroll 240 patients, with 180 patients being allocated to the QFGKG group and 60 to the placebo group. DISCUSSION: Although traditional Chinese medicine is a structured intervention that has shown some promise in treating persistent cough, existing unconvincing evidence has noted limitations. This is a rare well-designed and rigorously-controlled, randomized, double-blind trial to evaluate the effects and safety of a Chinese herbal medicine in patients with postinfectious cough, providing tangible benefits for clinical research. Results of this trial are inclined to be conjectured as more truthful by implementing separate study parts that specifically estimate exclusive primary outcome. It will not only provide robust clinical evidence on the efficacy and safety of QFGKG for postinfectious cough, but will also provide a critical piece of information on the availability and superiority of a novel methodology for future clinical trials. The current trial is ongoing with recruitment of the predetermined number of patients being in progress. TRIAL REGISTRATION: The two parts of this trial were separately registered with the Chinese Clinical Trial Registry: ChiCTR-TRC-13003278 (part A); and ChiCTR-TRC-13003337 (part B).

[Transurethral plasmakinetic enucleation of prostate and suprapubic small cut in the treatment of high risk and senior patient with benign prostatic hyperplasia and bladder stones].

OBJECTIVE: To explore the safety and efficiency of transurethral plasmakinetic enucleation of prostate (TUPKEP) and suprapubic small cut in the treatment of high-risk and senior patients with benign prostatic hyperplasia and bladder stones. METHODS: A retrospective review was conducted for 68 high-risk and senior patients with benign prostatic hyperplasia and bladder stones. All of them were treated by TUPKEP and suprapubic small cut. RESULTS: Operation was successfully performed in all 68 cases. And there was no instance of transurethral resection syndrome, shock, myocardial infarct, cerebral infarction, cerebral hemorrhage, permanent urinary incontinence or surgical site infection. Seven patients with temporal urinary incontinence recovered at a mean time of (9.48 ± 1.52) days post-operation. The mean operative duration was (48.63 ± 4.14) min and the mean volume of blood loss (50.97 ± 5.33) ml. The changes of maximum flow rate (Qmax), international prostatic symptom score (I-PSS) and quality-of-life (QOL) were statistically significant before and after operation. Qmax increased from (4.56 ± 0.35) to (18.82 ± 1.65) ml/s (P < 0.001), I-PSS decreased form (21.96 ± 1.89) to (11.23 ± 0.86) (P = 0.018) and QOL decreased from (4.94 ± 0.35) to (1.95 ± 0.32) (P = 0.011). CONCLUSION: The approach of TUPKEP and suprapubic small cut is both safe and effective in the treatment of high-risk and senior patient with benign prostatic hyperplasia and bladder stones and should be widely applied.

Treatment of common cold patients with the shi-cha capsule: a multicenter, double-blind, randomized, placebo-controlled, dose-escalation trial.

This study was designed to determine the therapeutic efficacy and safety of the Shi-cha capsule, a Chinese herbal formula, in the treatment of patients with wind-cold type common cold. In our multi-center, prospective, double-blind, randomized, placebo-controlled, dose-escalation trial, patients with wind-cold type common cold received 0.6 g of Shi-cha capsule plus 0.6 g placebo (group A), 1.2 g of Shi-cha capsule (group B), or 1.2 g placebo (group C), three times daily for 3 days and followed up to 10 days. The primary end point was all symptom duration. The secondary end points were main symptom duration, minor symptom duration, the changes in cumulative symptom score, main symptom score, and minor symptom score 4 days after the treatment, as well as adverse events. A total of 377 patients were recruited and 360 met the inclusive criteria; 120 patients constituted each treatment group. Compared with patients in group C, patients in groups A and B had significant improvement in the all symptom duration, main symptom duration, minor symptom duration, as well as change from baseline of cumulative symptom score, main symptom score, and minor symptom score at day 4. The symptom durations and scores showed slight superiority of group B over group A, although these differences were not statistically significant. There were no differences in adverse events. The Shi-cha capsule is efficacious and safe for the treatment of patients with wind-cold type common cold. Larger trials are required to fully assess the benefits and safety of this treatment for common cold.

Meta-analysis: traditional Chinese medicine for improving immune response in patients with unresectable hepatocellular carcinoma after transcatheter arterial chemoembolization.

OBJECTIVE: The aim of this study was to evaluate whether Traditional Chinese Medicine (TCM) improves immune response for unresectable hepatocellular carcinoma (UHCC) after transcatheter arterial chemoembolization (TACE) by using meta-analysis of data from the literature involving available randomized controlled trials of TCM in combination with TACE compared with that of TACE alone. METHODS: Literature retrieval was conducted through the Cochrane Library, MEDLINE, CENTRAL, Embase, CBMdisc, and CNKI, without language limitations. RESULTS: Based on our search criteria, we found 12 trials involving 1,008 patients. Our results showed that the differences of pooled weighted mean difference before and after treatment and 95% confidence intervals (CIs) were 13.63 (8.96-18.69; P = .0001) for the proportion of CD3(+) T cells, 10.56 (6.91-14.21; P = .0001) for the proportion of CD4(+) T cells, -3.40 (-6.83 to 0.03; P = .052) for the proportion of CD8(+) T cells, 0.54 (0.42-0.66; P = .0001) for the ratio of CD4(+)/CD8(+), and 12.34 (7.26-17.41; P = .0001) for the proportion of natural killer cells. No serious adverse events were reported. CONCLUSIONS: Traditional Chinese Medicine in combination with TACE improves the immune response of patients with UHCC. However, considering the strength of the evidence, additional randomized controlled trials are needed before TCM plus TACE can be recommended routinely.

Chinese herbs in treatment of influenza: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To investigate the efficacy and safety of Antiwei, a traditional Chinese prescription, in the treatment of influenza. METHODS: In a multi-center, randomized, double-blind, placebo-controlled trial, we recruited 480 adults aged 18 to 65 years within 36 h of onset of influenza-like symptoms. There were 225 patients with confirmed influenza. Eligible patients were randomly assigned 6 g of Antiwei (n = 360) or placebo (n = 120) twice daily for three days. All patients recorded their temperature and symptoms on diary cards during treatment. Analyses were performed in both the influenza-like population and the influenza-confirmed population. RESULTS: Antiwei increased patients' recovery by 17% (P < 0.001), and reduced the severity of illness measured by the median symptom score by 50% (P < 0.001) in both the influenza-like and the influenza-confirmed populations, compared to placebo. The influenza-confirmed patients reported reductions in the severity of fever (P = 0.002), cough (P = 0.023) and expectoration (P = 0.004) after one-day of treatment with Antiwei, compared to placebo. The adverse event profiles were similar for Antiwei and placebo. CONCLUSION: Antiwei was effective and well tolerated in treatment of natural influenza infection in adults. Antiwei represents a clinically valuable intervention in the management of influenza.

Treatment of functional constipation with the Yun-chang capsule: a double-blind, randomized, placebo-controlled, dose-escalation trial.

BACKGROUND AND AIM: Functional constipation is a common functional bowel disorder for which there is no reliable medical treatment. This study was designed to determine the therapeutic efficacy and safety of the Yun-chang capsule, a Chinese herbal formula, in the treatment of patients with functional constipation. METHODS: In our multi-center, prospective, double-blind, randomized, placebo-controlled, dose-escalation trial, patients with functional constipation received 70 mg of Yun-chang capsule plus 35 mg placebo (group A), 105 mg of Yun-chang capsule (group B), or 105 mg placebo (group C), three times daily for 2 weeks. The primary end-points were the changes in main symptom score and cumulative symptom score 2 weeks after the treatment. The secondary end-points were adverse events. RESULTS: A total of 140 patients were recruited and 132 met the inclusion criteria; 44 patients constituted each of the three treatment groups. Compared with patients in group C, patients in groups A and B had significant improvement in the main symptom score, cumulative symptom score, the change from baseline of the main symptom score, and the change from baseline of the cumulative symptom score at week 1 and week 2. The scores showed slight superiority of group B over group A at week 1 and week 2, although these differences were not statistically significant. There were no differences in adverse events. CONCLUSIONS: The Yun-chang capsule is efficacious and safe for the treatment of patients with functional constipation. Larger and longer-term trials are required to fully assess the benefits and safety of this treatment for functional constipation.

[Yunchang Capsule in treatment of functional constipation: a randomized, double-blinded controlled, multicenter trial].

BACKGROUND: Although there are some Chinese herbal medicines in treatment of constipation, but no multi-center randomized controlled trials have been carried out to prove their effectiveness. OBJECTIVE: To evaluate the safety and efficacy of Yunchang Capsule in treatment of functional constipation with deficiency of both qi and yin and internal accumulation of poisonous pathogenic factors syndrome, and to explore the clinical dosage. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: A randomized, double-blinded controlled, multicenter trial was conducted. A total of 240 patients with functional constipation from West China Hospital of Sichuan University, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, the First Affiliated Hospital of Tianjing University of Traditional Chinese Medicine and Fujian Academy of Traditional Chinese Medicine were randomly divided into three groups: low dose group (80 cases), high dose group (80 cases) and control group (80 cases). Patients in the low dose group were treated with two pills (0.35 g/pill) of Yunchang Capsule and one pill of Yunchang Capsule simulant for three times daily; patients in the high dose group were treated with three pills (0.35 g/pill) of Yunchang Capsule for three times daily; and patients in the control group were treated with three pills (0.35 g/pill) of Biantong Capsule for three times daily. The therapeutic course was 14 days. MAIN OUTCOME MEASURES: Clinical symptoms, syndromes, and adverse effects were observed before and after the treatment, and blood, urine and stool tests, hepatorenal function and electrocardiogram were also examined. RESULTS: Two cases were excluded, eleven cases were lost to follow-up, and there were 234 patients entered to intention-to-treat (ITT) analysis. After the treatment, the therapeutic effects were calculated by full analysis set (FAS) and per-protocol population set (PPS) analysis respectively. The effects on functional constipation in FAS showed the response rates in the low dose, high dose and control groups were 86.25% (69/80), 82.90% (63/76), and 70.52% (55/78) respectively, and PPS analysis showed the response rates were 85.71% (66/77), 83.56% (61/73), and 70.13% (54/77) respectively. There were no significant differences among the three groups (P>0.05). The effects on traditional Chinese medicine syndrome in FAS showed the response rates in the low dose, high dose and control groups were 78.75% (63/80), 69.74% (53/76), and 67.95% (53/78) respectively, and PPS analysis showed the response rates were 77.92% (60/77), 69.87%(51/73), and 67.53% (52/77) respectively. There were also no significant differences among the three groups (P>0.05). No severe adverse events were observed. CONCLUSION: Both low dose and high dose of Yunchang Capsule are effective and safe in treatment of functional constipation with deficiency of both qi and yin and internal accumulation of poisonous pathogenic factors syndrome.

[Aidi Injection as an adjunct therapy for non-small cell lung cancer: a systematic review].

OBJECTIVE: To assess methodological quality of clinical studies using Aidi Injection as an adjunct therapy for non-small cell lung cancer (NSCLC) and to evaluate the effects of Aidi Injection. METHODS: PubMed (1980-2008), Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2008), EMBASE (1984-2008), CancerLit (1996-2003), CBMdisc (1980-2008), CNKI database (1980-2008), Wanfang database (1980-2008), and Chongqing VIP database (1980-2008) were searched. The authors also hand-searched Chinese periodicals potentially related to the question. All randomized controlled trials comparing Aidi Injection with other treatment methods of NSCLC were included. Two reviewers selected studies, assessed the quality of studies, and extracted the data independently. The included studies were appraised and analyzed by Cochrane Collaboration Review Manager 5.0. RESULTS: Fourteen randomized controlled trials were included in the meta-analysis, but the quality of reports of the 14 included studies was poor. Aidi Injection combined with cobalt-60 or navelbine and platinol (NP) showed statistically significant differences in improving the response rate as compared with single use of cobalt-60 (P=0.000 2) or NP (P=0.04), and the relative risk (RR) and 95% confidence interval (CI) were 1.93 [1.36, 2.72] and 1.18 [1.00, 1.38], respectively. However, Aidi Injection combined with etoposide and platinol (EP), taxinol and platinol (TP) or gamma knife showed no significant differences as compared with single use of EP (P=0.60), TP (P=0.16) or gamma knife (P=0.34), respectively. The RR and 95% CI of EP, TP and gamma knife were 1.17 [0.65, 2.09], 1.27 [0.91, 1.78] and 1.08 [0.92, 1.26] respectively. Six studies indicated that Aidi Injection combined with NP or gamma knife could improve the quality of life.Six studies showed that Aidi Injection combined with NP or TP could improve the bone marrow hematopoietic function.Three studies indicated that Aidi Injection combined with NP could improve the immune function. Three studies showed that the combined therapy could not improve 1-, 2-, and 3-year survival rates. CONCLUSION: The results of meta-analysis indicate that Aidi Injection may have adjuvant therapeutic effects in treatment of NSCLC patients, but the sample size is too small and with poor quality, and the existence of publication bias is found.The effects of Aidi Injection need to be confirmed by large multicenter randomized controlled trials.

[Andrographolide drop-pill in treatment of acute upper respiratory tract infection with external wind-heat syndrome: a multicenter and randomized controlled trial].

OBJECTIVE: To evaluate the safety and efficacy of andrographolide drop-pill in treatment of acute upper respiratory tract infection with external wind-heat syndrome. METHODS: A multicenter, randomized controlled trial was conducted. In phase I, 202 patients with acute upper respiratory tract infection were randomly divided into two groups: trial group (n=101) and control group (n=101). In phase II, 276 patients with acute upper respiratory tract infection were randomly divided into two groups: trial group (n=138) and control group (n=138). The patients in the trial group received andrographolide drop-pill, at a dose of 1.5 g, three times a day; the patients in the control group received andrographolide tablet, at a dose of 1.5 g, three times a day. The therapeutic courses in both groups were 3 days. Clinical symptoms, physical signs, adverse effects, blood, urine and stool tests, hepatorenal function and electrocardiogram were examined before and after the treatment. RESULTS: After treatment in the phase I, the cure rates in the trial group and the control group were 44.55%, 42.57% (full analysis set, FAS) and 45.00%, 43.00% (per protocol set, PPS), and the total obvious rates were 94.06%, 94.06% (FAS) and 95.00%, 95.00% (PPS), respectively. There were no significant differences between the two groups (P>0.05). In the phase II, the cure rates in the trial group and the control group were 39.13%, 33.82% (FAS) and 38.69%, 33.58% (PPS), and the total obvious rates were 96.38%, 96.32% (FAS) and 96.36%, 96.27% (PPS), respectively. There were no significant differences between the two groups (P>0.05) too. No adverse effects were found in the trial. CONCLUSION: Andrographolide drop-pill is effective and safe in the treatment of acute upper respiratory tract infection with external wind-heat syndrome.

Traditional Chinese medicine plus transcatheter arterial chemoembolization for unresectable hepatocellular carcinoma.

OBJECTIVES: To compare the efficacy and safety of Traditional Chinese Medicine (TCM) plus transcatheter arterial chemoembolization (TACE) with that of TACE alone (therapy I versus therapy II, respectively) in treating unresectable hepatocellular carcinoma (UHCC) through a meta-analysis of all available randomized controlled trials. METHODS: Literature retrieval was conducted using the Cochrane Library, MEDLINE, EMBASE, CBMdisk, and CNKI in any language. Meta-analysis was performed on the results of homogeneous studies. Analyses subdivided by TACE frequency (subgroup A, <3 times; subgroup B, > or =3 times) were also performed, but were not done for both therapy I and therapy II. RESULTS: Based on our search criteria, we found 37 trials involving 2653 patients. Our results showed that therapy I, compared with therapy II, improved patient survival, quality of life, alleviation of symptoms, and tumor response, and was thus more therapeutically beneficial. Further analysis showed that subgroup A proved to be better for patients' survival and alleviation of symptoms, while the two subgroups were similar in improved tumor response. No serious adverse events were reported. CONCLUSIONS: Therapy I benefited patients with UHCC. Subgroup A improved the survival of patients and the amelioration of symptoms more than subgroup B. As in some trials, there were flaws in the methodological quality, and the data therefore have a risk of bias and of being insufficient for determining the effects of therapy I and subgroup A. Hence, further large-scale trials are warranted.

[Quality assessment of the report of randomized controlled trials on treatment of liver carcinoma with traditional Chinese medicine].

OBJECTIVE: To investigate the published randomized controlled trials (RCTs) concerning the treatment of liver carcinoma with TCM, and to assess their methodologic quality and quality of report. METHODS: Related RCT reports published from Jan. 2004 to June 2006 were retrieved by computerized and manual search, and the criteria of CONSORT statement (revised edition) were applied to assess the articles searched. RESULTS: Forty-six articles up to the RCTs inclusion standard were searched, among them, the method for randomized distribution sequence producing was described in 9 articles (19.57%), none mentioned randomization concealment and the estimation of the sample size. The blinded method was adopted in 3 articles (6.52%), the inclusion and exclusion criteria were reported in 18 (39.13%) and 1 (2.17%), respectively. Participant flow was reported in 3 (6.52%), but flow chart was not described in any article. Patients' compliance was reported in 5 (10.87%), and the concrete P value was reported in 6 (13.04%), but with no report involving the confidence interval. Adverse events were described in 15 (32.61%). Only 5 articles (10.87%) discussed the limitations of the present study in their section of discussion. CONCLUSION: The quality of RCTs reports on treatment of liver carcinoma with TCM are still in low quality, not meeting the CONSORT statement.

[Mahuang Zhisou Capsule in treatment of acute upper respiratory tract infection of external wind-cold syndrome: a multi-center, randomized controlled, and double-blind trial].

OBJECTIVE: To evaluate the efficacy and safety of Mahuang Zhisou Capsule (MHZSC), a compound traditional Chinese herbal medicine, in treatment of acute upper respiratory tract infection of wind-cold syndrome. METHODS: A multi-center, double-blind, double dummy, randomized controlled trial was conducted. A total of 240 patients were randomized into treatment group (120 cases, treated with MHZSC) and control group (120 cases, treated with Mahuang Zhisou Pill). The therapeutic course was 3 days. RESULTS: Seven cases were excluded and three cases lost to follow-up. Two hundred and thirty-three cases entered intention-to-treat (ITT) analysis and 230 cases fitted in per-protocol population set (PPS) analysis. After treatment, the therapeutic effect of upper respiratory tract infection was calculated by ITT and PPS analysis respectively. The significant response rate and total response rate in the treatment group were 78.07% and 98.25% (ITT and PPS), while the significant response rates in the control group were 70.59% (ITT) and 70.69%(PPS), and the total response rates were 95.80% (ITT) and 95.69% (PPS) respectively. There were no significant differences in clinical efficacy between the two groups (P>0.05). CONCLUSION: MHZSC is effective and safe in treatment of acute upper respiratory tract infection of external wind-cold syndrome.

[A multiple center, randomized, controlled, double-blinded and double-dummy trial of Yiqing Shuangjie Capsule and Tablet in treating acute upper respiratory tract infection with the syndrome of heat attacking the lung and Weifen].

OBJECTIVE: To evaluate the efficacy and safety of Yiqing Shuangjie Capsule and Tablet in treating acute upper respiratory tract infection with wind-warm syndrome. METHODS: The multiple center, double-blinded, double-dummy and randomized controlled method was conducted. Three hundred and sixty patients were randomly divided into the treatment group A (n=120, treated with Yiqing Shuangjie Capsule and Chaihuang analogues), treatment group B (n=120, treated with Yiqing Shuangjie Tablet and Chaihuang analogues) and the control group (n=120, treated with Chaihuang Tablet and Yiqing Shuangjie Capsule analogues). Every drug was administered 3 pills each time. Patients in the three groups were all treated for 5 days and three times daily. The accumulated scores of syndrome, clinical symptoms, adverse effect and body temperature were recorded before and after the treatment. The safety indexes, such as routine tests of blood, urine and stool, hepatic and renal function tests and electrocardiogram (ECG) were taken before and after the treatment. RESULTS: Three cases were excluded and eighteen cases lost to follow-up. There were 343 patients who entered to the intention-to-treat (ITT) analysis and 339 patients fitted in the per-protocol population set (PPS) analysis. After treatment, the therapeutic effects of respiratory tract infection were calculated by ITT and PPS analysis respectively. The rates of total obvious effect were 84.96% and 87.27% respectively in the treatment group A, and the total response rates were 96.46% and 97.27% respectively. The rates of total obvious effect were 85.47% and 86.20% respectively in the treatment group B, and the total response rates were 97.45% and 97.41% respectively. In the control group, the rates of total obvious effect both were 72.57%, and the total response rates both were 99.12%. There was significant difference among the three groups (P<0.05). The effects of traditional Chinese medicine syndrome were also detected by ITT and PPS analysis respectively. In the treatment group A, the total obvious effect rates were 84.07% and 85.46% respectively, and the total response rates were 96.46% and 97.27% respectively. In the treatment group B, the rates of total obvious effect were 88.89% and 89.65% respectively, and the total response rates were 97.44% and 97.41% respectively. In the control group, the rates of total obvious effect both were 72.57%, and total response rates both were 99.12%. There was also statistical significant difference among the three groups (P<0.05). ITT and PPS analysis had the same results. No adverse effect was found in the trial. CONCLUSION: Yiqing Shuangjie Capsule and Tablet are effective and safe in treating acute upper respiratory tract infection of wind heat syndrome without obvious adverse effect.

[Dinggui Oil Capsule in treating irritable bowel syndrome with stagnation of qi and cold: a prospective, multi-center, randomized, placebo-controlled, double-blind trial].

OBJECTIVE: To evaluate the efficacy and safety of Dinggui Oil Capsule in treating irritable bowel syndrome (IBS) with stagnation of qi and cold. METHODS: A prospective, randomized, placebo-controlled, double-blind clinical study was undertaken. One hundred and ninety-eight patients with IBS and syndrome of stagnation of qi and cold were randomly divided into high-dose Dinggui Oil group (DGO-H, 1.2 g, 3 times daily; n=66), low-dose Dinggui Oil group (DGO-L, 0.8 g, 3 times daily, n=66), and placebo group (placebo, 5.0 g, 3 times daily, n=66). Patients in the three groups were all treated for 2 weeks. RESULTS: The total significant effective rates for IBS were 54.1%, 28.8% and 21.9% in the DGO-H, DGO-L, and placebo groups, and the total effective rates for the syndrome of stagnation of qi and cold were 54.1%, 25.8% and 23.4% in the three groups, respectively. Dinggui Oil Capsule showed a higher efficacy than the placebo in relieving the abdominal pain (P<0.01). No adverse effects were found in this trial. CONCLUSION: Dinggui Oil Capsule is effective and safe in relieving abdominal pain due to IBS with stagnation of qi and cold.

Randomized controlled trial on treatment of bronchial asthma of qi-deficiency cold syndrome type by pingchuan yiqi granule.

OBJECTIVE: To evaluate the effect and safety of Pingchuan Yiqi Granule in treating bronchial asthma of qi-deficiency cold syndrome type (BS-QDC). METHODS: With the randomized, positive agent parallel controlled design adopted, the 80 subjects enrolled were assigned in the ratio of 3:1 to two groups, the 60 patients in the trial group were treated with PYG and the 20 in the control group treated with Ruyi Dingchuan Pill (RDP), with the therapeutic course consisting of 7 days for both groups. The clinical effects, effects on TCM syndrome and the changes of lung function after treatment were observed. RESULTS: The effect of the treatment on asthma in the trial group: clinically controlled rate was 6.67%, markedly effective rate 51.67%, improved rate 33.33% and ineffective rate 8.33%; and the corresponding rates in the control group were 5.00%, 50.00%, 30.00%, and 15.00% respectively. Comparison between the two groups showed insignificant difference (P>0.05). The effect on TCM syndrome in the treated group: clinically controlled rate was 11.67%, markedly effective rate 58.33%, effective rate 21.67% and ineffective rate 8.33%; and those in the control group were 10.00%, 50.00%, 30.00% and 10.00% respectively, also showing insignificant difference between the two groups (P>0.05). Lung function test showed that the change on forced expiratory volume in 1 second (FEV1) after treatment in the trial group was of statistical significance (P<0.05), but no significant difference was shown in the change of peak expiratory flow (PEF, P>0.05); while the changes in the control group were just the opposite, showing insignificance in FEV1 (P>0.05) but significance in PEF (P<0.05). Comparison of the therapeutic effect on lung function between the two groups showed no significant difference (P>0.05). No adverse reaction was found in either group in the course of treatment. CONCLUSION: PYG used to treat BS-QDC is effective and safe, it's effect is similar to that of RDP.