Association of vitamin D status with all-cause mortality and outcomes among Chinese individuals with diabetic foot ulcers.

AIMS/INTRODUCTION: The aim of this study was to examine the correlation between serum vitamin D concentrations and prognosis among Chinese individuals with diabetic foot ulcers (DFUs). MATERIALS AND METHODS: We retrospectively recruited 488 adults with DFUs in West China Hospital from 1 January 2012 to 31 December 2019. After telephone follow up, 275 patients were finally included. We compared serum vitamin D concentrations among DFUs patients with different prognostic status, and examined the association of vitamin D status with prognostic variables by Kaplan-Meier analysis. Cox proportional hazards models were used to estimate hazard ratios and 95% confidence intervals for all-cause mortality. RESULTS: The median concentration of serum vitamin D of patients with DFUs was 37.78 nmol/L (interquartile range 27.91-50.66 nmol/L), with 31.6% having vitamin D deficiency (<30 nmol/L) and 42.2% having insufficient vitamin D (<50 nmol/L). During a median follow-up period of 52 months, 65 patients died, with an all-cause mortality of 23.64%. Vitamin D deficiency was independently linked to increased all-cause mortality after multivariable adjustments (hazard ratio 0.565, 95% confidence interval 0.338-0.946, P = 0.030). There were no significant differences between vitamin D concentrations and other outcomes of DFUs. Patients who suffered amputations had a tendency of lower vitamin D concentrations (34.00 [interquartile range 26.90-41.81] vs 40.21 [interquartile range 29.60-53.96] nmol/L, P = 0.053). CONCLUSIONS: Vitamin D deficiency was significantly associated with increased all-cause mortality in Chinese individuals with DFUs. Vitamin D supplementation might be a potential therapy for DFUs to prevent premature death and improve outcomes.

Effectiveness and safety of Danmu extract syrup for acute upper respiratory tract infection in children: A real-world, prospective cohort study.

AIM: To evaluate the effectiveness and safety of Danmu Extract Syrup for the treatment of acute upper respiratory tract infection (AURI) in children. METHODS: In this prospective cohort study, we enrolled children with AURI in the pediatric outpatient department and emergency department of West China Second Hospital. According to the treatment, they were divided into two groups: Danmu Extract Syrup Group (Danmu Group) and Xiaoer Chiqiao Granule Group (Chiqiao Group). The primary outcome was time to symptom remission, and the secondary outcomes were defervescence time, relief time, admission rate, and adherence. We used restricted mean survival time (RMST) to quantify the treatment effects and test noninferiority for primary outcome. Propensity score matching (PSM) was used to adjust confounding. Subgroup analysis and sensitivity analysis were used to verify the robustness of results. RESULTS: We enrolled 1036 children with AURI, including 516 in Danmu Group and 520 in Chiqiao Group. After PSM, no significant difference was observed in the baseline characteristics of the two groups. The primary results showed that the RMST difference was -3 h (95% CI: -15.1 to 9.1) and the upper limit of the 95% CI was less than the noninferiority margin of 11 h. There was no statistical difference in the secondary outcomes except for defervescence between the two groups. The results of safety analysis showed that the incidence of adverse events occurred is 4.1% in Danmu Group, which was lower than the incidence of Chiqiao Group (6.9%). CONCLUSION: This study indicated that Danmu extract syrup is noninferiority to Chiqiao Granule for AURI in children.

Evidence-based topical treatments (azelaic acid, salicylic acid, nicotinamide, sulfur, zinc, and fruit acid) for acne: an abridged version of a Cochrane systematic review.

OBJECTIVE: The effects of topical azelaic acid, salicylic acid, nicotinamide, sulfur, zinc, and fruit acid (alpha-hydroxy acid) for acne are unclear. We aimed to assess the effects of these topical treatments by collecting randomized controlled trials. METHODS: We searched The Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS up to May 2019. We also searched five trials registers. Two review authors independently extracted data and assessed risk of bias. Meta analyses were performed by using Review Manager 5 software. RESULTS: We included a total of 49 trials involving 3880 participants. In terms of treatment response (measured using participants' global self-assessment of acne improvement, PGA), azelaic acid was probably less effective than benzoyl peroxide (RR = 0.82, 95% CI 0.72-0.95). However, there was probably little or no difference in PGA when comparing azelaic acid to tretinoin (RR = 0.94, 95% CI 0.78-1.14). There may be little or no difference when comparing salicylic acid to tretinoin (RR = 1.00, 95% CI 0.92-1.09). There were no studies measured PGA when evaluating nicotinamide. With respect to alpha-hydroxy acid, there may be no difference in PGA when comparing glycolic acid to salicylic-mandelic acid (RR = 1.06, 95% CI 0.88-1.26). We were uncertain about the effects of sulfur and zinc. Adverse events associated with these topical treatments were always mild and transient. CONCLUSIONS: Moderate-quality evidence was available for azelaic acid and low- to very-low-quality evidence for other topical treatments. Risk of bias and imprecision limit our confidence in the evidence.

Quality assessment of reporting of randomization, allocation concealment, and blinding in traditional Chinese medicine RCTs: a review of 3159 RCTs identified from 260 systematic reviews.

BACKGROUND: Randomized controlled trials (RCTs) which are of poor quality tend to exaggerate the effect estimate and lead to wrong or misleading conclusions. The aim of this study is to assess the quality of randomization methods, allocation concealment and blinding within traditional Chinese medicine (TCM) RCTs, discuss issues identified for current TCM RCTs, and provide suggestions for quality improvement. METHODS: We searched Chinese Biomedical Database (CBM, 1978 to July 31, 2009) and the Cochrane Library (Issue 2, 2009) to collect TCM systematic reviews and meta-analyses according to inclusion/exclusion criteria, from which RCTs could be identified. The quality assessment involved whether the randomization methods, allocation concealment and blinding were adequate or not based the study reported. Stratified analyses were conducted of different types of diseases published in different journals (both Chinese and foreign) using different interventions. SPSS 15.0 software was used for statistic analyses. RESULTS: A total of 3159 RCTs were included, of which 2580 were published in Chinese journals and 579 in foreign journals. There were 381 (12%) RCTs which used adequate randomization methods; 207 (7%) RCTs which used adequate allocation concealment and 601 (19%) which used adequate blinding; there were 130 (4%) RCTs which both used adequate randomization methods and allocation concealment; and there were only 100 (3%) RCTs which used adequate randomization methods, allocation concealment, as well as blinding. In the RCTs published in foreign journals, the adequate randomization methods, allocation concealment and blinding accounted for a relatively large proportion (25%, 26%, and 60%, respectively) and increased with years, while in the RCTs published in Chinese journals, only the adequate randomization methods improved over time. The quality of non-drug intervention (chiefly acupuncture) RCTs was higher than that of drug intervention RCTs. In drug intervention, the quality of listed drugs is higher than the others. The quality of all included RCTs of all types of diseases was generally poor and no studies that were large in size and of high quality were found. CONCLUSION: The quality of the current TCM RCTs as judged by their publications is generally poor, especially those published in Chinese journals. In future, researchers of TCM RCTs should attach more importance to experimental design and methodological quality, receive relevant training, and improve reporting quality using the Consolidated Standards of Reporting Trials (CONSORT) statement, so as to improve the quality of TCM clinical research and ensure truth and reliability of conclusions.

The reporting quality, scientific rigor, and ethics of randomized placebo-controlled trials of traditional Chinese medicine compound formulations and the differences between Chinese and non-Chinese trials.

BACKGROUND: An increasing number of randomized placebo-controlled trials involving traditional Chinese medicine (TCM) compound formulations have been implemented worldwide. OBJECTIVE: The aim of this study was to assess the reporting quality, scientific rigor, and ethics of randomized placebo-controlled trials of TCM compound formulations and compare these differences between Chinese and non-Chinese trials. METHODS: English-language databases included the following: PubMed, OVID, EMBASE, and Science Citation Index Expanded. Chinese-language databases included the following: Chinese Biomedical Literature Database, Wanfang Database, Chinese Scientific and Technological Periodical Database, and the China National Knowledge Infrastructure. All were searched from respective inception to March 2009 to identify randomized placebo-controlled trials involving TCM compound prescriptions. Two reviewers independently assessed the retrieved trials via a modified Consolidated Standard of Reporting Trials (CONSORT) checklist and some evaluation indices that embodied the TCM characteristics or the scientific rigor and ethics of placebo-controlled trials. Trial publishing time was divided into 3 intervals: phase 1 (≤1999); phase 2 (2000-2004); and phase 3 (2005-2009). The number and percentage of trials reporting each item and the corresponding differences between Chinese (mainland China, Hong Kong, and Taiwan) and non-Chinese (eg, Japan, United States, Australia, Korea, and United Kingdom) trials were calculated. Moreover, the influence of trial publishing time on the reporting of CONSORT items and the differences in the number of items reported for each time interval between Chinese and non-Chinese trials were assessed. RESULTS: A total of 324 trials from China and 51 trials from other countries were included. A mean of 39.7% of the CONSORT items across all Chinese trials and 50.2% of the items across all non-Chinese trials were reported. The number of the reported CONSORT items all increased over time in both groups and the gap between Chinese articles and non-Chinese articles gradually decreased. Additionally, of the 324 Chinese articles, 137 (42.28%) reported TCM syndrome type, 113 (34.88%) reported the diagnostic criteria of diseases for TCM, and 69 (21.30%) reported efficacy evaluation indices of TCM. Of the non-Chinese articles, 3 (5.88%) reported TCM syndrome type and 1 (1.96%) reported the diagnostic criteria of diseases and evaluation indices of efficacy for TCM. It was found that 45.37% and 6.17% of Chinese articles reported the standard intervention for the diseases being treated and the emergency plan, respectively, compared with 23.53% and 9.80% for the non-Chinese articles; 33.02% and 10.49% of Chinese articles reported informed consent and ethics committee approval, respectively, compared with 92.16% and 82.35% for the non-Chinese articles. With regard to placebo ethics, 38.89% of the Chinese trials and 23.53% of the non-Chinese trials found it would not be ethically acceptable to use placebo alone in the control group. CONCLUSIONS: The data indicate that the reporting quality of the included trials on TCM compounds has improved over time, but still remains poor regardless of Chinese or non-Chinese trials. Across all trials, particularly Chinese trials, the reporting of the CONSORT items was inadequate (39.7%). The difference in the mean number of the reported CONSORT items between Chinese trials and non-Chinese trials narrowed from phase 1 (10.0 vs 13.8) to phase 3 (14.4 vs 17.4). Moreover, a large number of trials, especially non-Chinese trials (94.1%), were lacking syndrome differentiation of TCM. More importantly, in many placebo-controlled trials, especially Chinese trials, the use of placebo was not justified and was ethically contradictory.

Randomized trials published in some Chinese journals: how many are randomized?

BACKGROUND: The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. METHODS: The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. RESULTS: From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9-7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18-2.13, and relative risk 14.42, 95% confidence interval 9.40-22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83-14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0-81.0). CONCLUSION: Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing to a lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed.

Tongxinluo capsule for acute stroke.

BACKGROUND: Tongxinluo capsules are a compound of Chinese traditional medicine which contain substances that are thought to have vasodilatory, antiplatelet, anticoagulant, thrombolytic and even lipid-lowering properties, and therefore may improve outcome after acute ischaemic stroke. To date the evidence of its effect has not been systematically reviewed, making it difficult to derive robust conclusions about its actual benefits, and indeed, possible harms. OBJECTIVES: To assess the effectiveness and possible harms of tongxinluo capsule for acute cerebral infarction compared with control. SEARCH STRATEGY: We searched the Cochrane Stroke Group trials register (last searched on 24 January 2008) the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 4, 2007), MEDLINE (1995 to 2006), EMBASE (1995 to 2006), China National Knowledge Infrastructure (CNKI, 1994 to 2006), CBM (Chinese Biomedical Database) (1995 to 2006), Current Controlled Trials (www.controlled-trials.com), National Research Register (http://www.update-software.com/national/). We handsearched 30 journals (1995 to 2006), and contacted drug companies and the principal of included trials. SELECTION CRITERIA: Randomised controlled trials comparing tongxinluo with placebo or open control (or tongxinluo plus standard therapy versus standard therapy alone) in people with definite acute stroke. We excluded trials if they sought to recruit patients with transient ischaemic attacks (TIA), intracerebral haemorrhage, heart failure, or renal failure. DATA COLLECTION AND ANALYSIS: Two review authors extracted data and assessed trial quality. MAIN RESULTS: Only two poor quality studies with a total of 232 participants were included in this review. Neither study reported any of our pre-specified outcomes, so no reliable estimate of the effect of treatment on major clinical outcomes could be obtained. AUTHORS' CONCLUSIONS: It was not possible to reliably determine whether tongxinluo has a favourable or unfavourable effect in acute ischaemic stroke. High quality trials are required to assess the efficacy and safety of tongxinluo capsule for acute ischaemic stroke.

Dengzhanhua preparations for acute cerebral infarction.

BACKGROUND: Dengzhanhua preparations are widely used in China. Many controlled trials have been undertaken to investigate the efficacy of dengzhanhua preparations in the treatment of acute cerebral infarction. OBJECTIVES: To assess whether dengzhanhua preparations are effective and safe at improving outcomes in patients with acute cerebral infarction. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched October 2007), the Chinese Stroke Trials Register (last searched June 2006), the trials register of the Cochrane Complementary Medicine Field (last searched June 2006), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 2 2006), MEDLINE (1966 to June 2006), EMBASE (1980 to June 2006), AMED (the Allied and Complementary Medicine Database, 1985 to June 2006), the China Biological Medicine Database (CBM-disc, 1979 to June 2006), and Chinese Knowledge Infrastructure (CNKI,1994 to October 2007). We also searched the reference lists of relevant articles. SELECTION CRITERIA: Randomised and quasi-randomised controlled clinical trials of dengzhanhua preparations regardless of duration, dosage and route of administration in patients with confirmed acute cerebral infarction. DATA COLLECTION AND ANALYSIS: Two review authors independently applied the inclusion criteria, assessed trial quality, and extracted the data. MAIN RESULTS: We included nine trials, all conducted in China, involving 723 participants. The method of randomisation and concealment was poorly described. The included trials compared dengzhanhua injection plus routine therapy with routine therapy alone. Patients were enrolled up to one week after the onset of stroke. No trials reported data on the pre-specified primary or secondary outcomes. In a post-hoc comparison of dengzhanhua injection plus routine therapy versus routine therapy alone, dengzhanhua injection showed a statistically significant benefit on the outcome 'marked neurologic improvement' (relative risk 1.53; 95% confidence interval 1.36 to 1.72). No serious adverse effects were reported. AUTHORS' CONCLUSIONS: Due to the generally low methodological quality and small sample size of the included trials in this systematic review, we could not draw a firm conclusion.

Green tea and gastric cancer risk: meta-analysis of epidemiologic studies.

OBJECTIVE: To evaluate the association between green tea consumption and the risk of gastric cancer. METHODS: Electronic search of the Cochrane Library, MEDLINE, EMBASE and Chinese Bio-medicine Database, which have articles published between (1966 and 2006), was conducted to select studies for this meta-analysis. RESULTS: This meta-analysis included 14 epidemiologic studies, with a total number of 6123 gastric cancer cases and 134006 controls. The combined results based on all studies showed that green tea consumption was not associated with the risk of gastric cancer [odds ratio (OR)=0.98, 95% confidence interval (CI)=0.77-1.24]. The summary OR from all population-based case-control studies showed a minor inverse association between green tea consumption and risk of gastric cancer (OR=0.68, 95% CI=0.49-0.92), while no associations were noted from hospital-based case-control studies (OR=1.12, 95% CI=0.70-1.77) and cohort studies (OR=1.56, 95% CI=0.93-2.60). No associations were noted both in males (OR=1.10, 95% CI=0.76-1.60) and females (OR=0.99, 95% CI=0.64-1.51). The summary OR from seven studies suggest that the highest consumption level of green tea was more than 5 cups per day and no associations were noted (OR=0.99, 95% CI=0.78-1.27). CONCLUSIONS: The results of this meta-analysis indicated that there is no clear epidemiological evidence to support the suggestion that green tea plays a role in the prevention of gastric cancer.

The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China.

BACKGROUND: The number of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) is increasing. However, there have been few systematic assessments of the quality of reporting of these trials. OBJECTIVE: This study was undertaken to evaluate the quality of reporting of RCTs in TCM journals published in mainland China from 1999 to 2004. METHODS: Thirteen TCM journals were randomly selected by stratified sampling of the approximately 100 TCM journals published in mainland China. All issues of the selected journals published from 1999 to 2004 were hand-searched according to guidelines from the Cochrane Centre. All reviewers underwent training in the evaluation of RCTs at the Chinese Centre of Evidence-based Medicine. A comprehensive quality assessment of each RCT was completed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist (total of 30 items) and the Jadad scale. Disagreements were resolved by consensus. RESULTS: Seven thousand four hundred twenty-two RCTs were identified. The proportion of published RCTs relative to all types of published clinical trials increased significantly over the period studied, from 18.6% in 1999 to 35.9% in 2004 (P < 0.001). The mean (SD) Jadad score was 1.03 (0.61) overall. One RCT had a Jadad score of 5 points; 14 had a score of 4 points; and 102 had a score of 3 points. The mean (SD) Jadad score was 0.85 (0.53) in 1999 (746 RCTs) and 1.20 (0.62) in 2004 (1634 RCTs). Across all trials, 39.4% of the items on the modified CONSORT checklist were reported, which was equivalent to 11.82 (5.78) of the 30 items. Some important methodologic components of RCTs were incompletely reported, such as sample-size calculation (reported in 1.1% of RCTs), randomization sequence (7.9%), allocation concealment (0.3 %), implementation of the random-allocation sequence (0%), and analysis of intention to treat (0%). CONCLUSION: The findings of this study indicate that the quality of reporting of RCTs of TCM has improved, but remains poor.

WITHDRAWN: Medicinal herbs for esophageal cancer.

BACKGROUND: Esophageal cancer is the seventh leading cause of cancer death worldwide. Traditional Chinese medicinal herbs are sometimes used as an adjunct to radiotherapy or chemotherapy for this type of cancer. OBJECTIVES: To assess the efficacy and possible adverse effects of the addition of Chinese medicinal herbs to treatment with radiotherapy or chemotherapy for esophageal cancer. SEARCH STRATEGY: We searched the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register, The Cochrane Library, MEDLINE, EMBASE, AMED (Allied and Complementary Medicine Database), CBM (Chinese Biomedical Database), China National Knowledge Infrastructure, the Chinese Cochrane Centre Controlled Trials Register and CISCOM (The Research Council for Complementary Medicine) (up to June 2004). Databases of ongoing trials, the internet and reference lists were also searched. SELECTION CRITERIA: Randomised controlled trials comparing the use of radiotherapy or chemotherapy with and without the addition of Chinese medicinal herbs. DATA COLLECTION AND ANALYSIS: At least two review authors extracted data and assessed trial quality. MAIN RESULTS: Two studies were included. The numbers of participants in these two trials were 42 and 80, 122 in total. Both studies were analysed separately because of the differences in interventions used. Although one study reported a positive result, the majority of outcome measurements from the two studies showed no significant benefit with the addition of Chinese herbal medicines to radiotherapy or chemotherapy. There was statistically significant improvement in quality of life with the additional Huachansu injection, however, no statistically significant improvement was found in short-term therapy effects, one-year survival rate or the adverse effect of radiation-induced esophagitis. AUTHORS' CONCLUSIONS: The included studies were of low quality. The results suggest Zhenxiang capsules or Huachansu injection may not improve short-term therapy effects or one-year survival rate when used as adjunct treatment to chemo- or radiotherapy in the treatment of esophageal cancer. The quality of life may be improved by Huachansu injection. The results suggest that more high-quality trials on Huachansu injection and other Chinese herbal medicines are needed in the future.

[Clinical trial registration system and evidence-based medicine].

The authors briefly introduced the management of clinical test for new drug development, clinical trials for drugs prepared in hospital and post-market drugs, and other types of clinical trials. The mechanism of WHO International Clinical Trial Register Platform (WHO ICTRP), Chinese Clinical Trial Register (ChiCTR) and Chinese Clinical Trial Registration and Publishing Collaboration (ChiCTRPC) were also introduced. The authors suggested the trialists to practice the basic philosophy of evidence-based medicine as the rules of their thought and action, and considered that this is the inner guarantee system for the validity of clinical trials.

A systematic review of Chinese medicinal herbs for acute bronchitis.

OBJECTIVES: To assess the effectiveness and safety of Chinese medicinal herbs for treating uncomplicated acute bronchitis. DATA SOURCES: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which includes the Cochrane Acute Respiratory Infections Group's specialized register; The Chinese Cochrane Centre's Controlled Trials Register; MEDLINE; EMBASE; and the Chinese Biomedical Database (CBM). METHODS: We only included randomized controlled trials. At least two authors extracted data and assessed trial quality. MAIN RESULTS: Four trials reported the time to improvement of cough, fever, and rales associated with bronchitis and showed that patients treated with Chinese herbs had a shorter duration of signs and symptoms. Two trials reported the proportion of patients with improved signs and symptoms at follow-up and showed that Chinese herbs were beneficial in terms of relief of signs and symptoms. Thirteen (13) trials analyzed the data on physician global assessment of improvement at follow-up. Nine (9) of 13 trials showed that Chinese herbs were superior to routine treatment and the other four trials showed a similar effect to routine treatment. In general, Chinese herbs appeared beneficial. Only one trial reported adverse effects during treatment. CONCLUSIONS: There are insufficient quality data to recommend the routine use of Chinese herbs for acute bronchitis. The benefit found in this systematic review could be due to publication bias and study-design limitations of the individual studies. In addition, the safety of Chinese herbs is unknown due to the lack of toxicological evidence on these Chinese herbs, though adverse events are rarely reported.

Chinese medicinal herbs for influenza: a systematic review.

BACKGROUND: Influenza is an acute respiratory communicable disease which can cause high morbidity and mortality in an epidemic. Traditional Chinese medicinal herbs following a particular theory may be a potential medicine of choice. OBJECTIVES: We aim to assess the therapeutic effect and adverse reaction of traditional Chinese medicinal herbs in the treatment of uncomplicated influenza. SEARCH STRATEGY: We searched the Cochrane Library, MEDLINE, EMBASE, CBM, and handsearched the relevant Chinese journals. SELECTION CRITERIA: Randomised and quasi-randomised trials compared with placebo, or with other chemical drugs normally used in care, or various other Chinese medicinal herbs amd chemical drugs with herbal preparations compared with simple chemical drugs were also included. DATA COLLECTION AND ANALYSIS: At least two reviewers extracted data and assessed trial quality. MAIN RESULTS: We included 8 relevant studies, most of which were of low quality. Because of the clinical heterogeneity, we did not perform a summary meta-analysis. Some of the studies showed positive results favouring Traditional Chinese medicinal herb treatment compared to antiviral or antipyretic-analgesic drugs or the combination of them. Only three studies mentioned adverse reactions but no detailed data were acquired in the included studies. REVIEWERS' CONCLUSIONS: The small number of included studies and participants, as well as the low quality of most studies, made the evidence far from conclusive for clinical decision making. More high quality randomised controlled trials (RCTs) with similar interventions are required to strengthen the evidence for the efficacy and safety of certain herbal preparations.

Anticancer activity of litchi fruit pericarp extract against human breast cancer in vitro and in vivo.

Litchi fruit pericarp (LFP) extract contains significant amounts of polyphenolic compounds and exhibits powerful antioxidative activity against fat oxidation in vitro. The purpose of this study is to confirm the anticancer activity of LFP extract on human breast cancer in vitro and in vivo, and to elucidate the mechanism of its activity. Human breast cancer cells were tested in vitro for cytotoxicity, colony formation inhibition, BrdU incorporation, and gene expression profiling after treatment with LFP extract. Seven nude mice bearing human breast infiltrating duct carcinoma orthotopically were tested for its anticancer activity and expression of caspase-3 in vivo by oral administration of 0.3% (0.3 mg/ml) of LFP water-soluble crude ethanolic extract (CEE) for 10 weeks. LFP extract demonstrated a dose- and time-dependent inhibitory effect on cell growth (IC(50) = 80 microg/ml), and it significantly inhibited colony formation and BrdU incorporation of human breast cancer cells. Oligonucleotide microarray analysis identified 41(1.22%) up-regulated and 129 (3.84%) down-regulated genes after LFP water-soluble CEE treatment; the predominantly up-regulated genes were involved in various biological functions including cell cycle regulation and cell proliferation, apoptosis, signal transduction and transcriptional regulation, and extracellular matrix/adhesion molecules; and down-regulated genes were mainly associated with adhesion, invasion, and malignancy of cancer cells. A 40.70% tumor mass volume reduction and significant increase of casepase-3 protein expression were observed in vivo experiment. The findings in this study suggested that LFP extract might have potential anticancer activity on both ER positive and negative breast cancers, which could be attributed, in part, to its DNA damage effect, proliferating inhibition and apoptosis induction of cancer cells through up-regulation and down-regulation of multiple genes involved in cell cycle regulation and cell proliferation, apoptosis, signal transduction and transcriptional regulation, motility and invasiveness of cancer cells; ADP-ribosyltransferase (NAD+; poly (ADP-ribose) polymerase)-like 1 (ADPRTL1), Cytochrome P450, subfamily I (CYP1A1) and Hyaluronan-mediated motility receptor (HMMR) might be the main molecular targets at which LFP water-soluble CEE acted.

Potential anticancer activity of litchi fruit pericarp extract against hepatocellular carcinoma in vitro and in vivo.

Litchi fruit pericarp (LFP) extract contains significant amounts of polyphenolic compounds, and exhibits powerful antioxidative activity against fat oxidation in vitro. The purpose of this study is to confirm the anticancer activity of LFP extract against hepatocellular carcinoma in vitro and in vivo, and to elucidate the mechanism of its activity. Human hepatocellular carcinoma cell line was tested in vitro for cytotoxicity, colony formation inhibition, and cell cycle distribution through flow cytometry after treatment with water-soluble crude ethanolic extract (CEE) from LFP. Murine hepatoma bearing-mice were fed doses of 0.15, 0.3, and 0.6g/kg/day of water-soluble CEE in DH(2)O p.o. for 10 days, respectively, to test the anticancer activity and BrdU incorporation of cancer cells in vivo. LFP extract demonstrated a dose- and time-dependent inhibitory effect on cancer cell growth; IC(50) was 80microg/ml, and significantly inhibited colony formation in vitro, tumor growth and BrdU incorporation into cancer cells in vivo. The tumor inhibitory rates at doses of 0.15, 0.3, and 0.6g/kg/day were 17.31% (P>0.05), 30.77% (P<0.05), and 44.23% (P<0.01), respectively. BrdU labeled tumor cells of treated animals were 11.80+/-2.79%, and were significantly lower than that in untreated controls (23.00+/-5.42%, P<0.05). Our findings showed that LFP extract exhibited potential anticancer activity against hepatocellular carcinoma in vitro and in vivo through proliferating inhibition and apoptosis induction of cancer cells.

Saponins from Chinese Buckeye Seed reduce cerebral edema: metaanalysis of randomized controlled trials.

To evaluate the effects of saponins from Chinese Buckeye Seed in the treatment of cerebral edema in patients with stroke or cerebral trauma, a metaanalysis of randomized controlled trials was conducted. Randomized trials that compare the effects of treatment with saponins from Chinese Buckeye Seed to placebo treatment, to lack of treatment, to non-specific treatment, or to mannitol treatment for cerebral edema were identified with electronic and manual searches. No blinding and language limitations were applied. The methodological quality of trials was assessed with the Jadad scale plus allocation concealment. The metaanalysis was performed where data were available. Forty-one randomized controlled trials involving 4066 patients were identified. The methodological quality of the trials was generally low. The combined results showed that intravenous administration of saponins from Chinese Buckeye Seed increased the total effective rate, reduced the mortality and the incidence of renal function impairment in comparison to control treatment. No serious adverse event was reported. Based on the metaanalysis, saponins from Chinese Buckeye Seed can reduce cerebral edema in patients with stroke or cerebral trauma. However, the evidence is not sufficient due to the generally low methodological quality of the studies. Further trials are needed with sufficiently numerous group size and rigorous design.

Potential anticancer activity of tanshinone IIA against human breast cancer.

Tanshinone IIA is a derivative of phenanthrene-quinone isolated from Danshen, a widely used Chinese herbal medicine. It has antioxidant properties and cytotoxic activity against multiple human cancer cell lines, inducing apoptosis and differentiation of some human cancer cell lines. Our purpose was to confirm its anticancer activity on human breast cancer in vitro and in vivo and to elucidate the mechanism of its activity. Human breast cancer cells were tested in vitro for cytotoxicity, colony formation inhibition, BrdU incorporation and gene expression profiling after treatment with tanshinone IIA. Seven nude mice bearing human breast infiltrating duct carcinoma orthotopically were tested for anticancer activity and expression of caspase-3 in vivo by s.c. injection of tanshinone IIA at a dose of 30 mg/kg 3 times/week for 10 weeks. Tanshinone IIA demonstrated a dose- and time-dependent inhibitory effect on cell growth (IC50 = 0.25 microg/ml), and it significantly inhibited colony formation and BrdU incorporation of human breast cancer cells. Oligonucleotide microarray analysis identified 41 upregulated (1.22%) and 24 downregulated (0.71%) genes after tanshinone IIA treatment. Upregulated genes were involved predominantly in cycle regulation, cell proliferation, apoptosis, signal transduction and transcriptional regulation; and downregulated genes were associated mainly with apoptosis and extracellular matrix/adhesion molecules. A 44.91% tumor mass volume reduction and significant increase of casepase-3 protein expression were observed in vivo. Our findings suggest that tanshinone IIA might have potential anticancer activity on both ER-positive and -negative breast cancers, which could be attributed in part to its inhibition of proliferation and apoptosis induction of cancer cells through upregulation and downregulation of multiple genes involved in cell cycle regulation, cell proliferation, apoptosis, signal transduction, transcriptional regulation, angiogenesis, invasive potential and metastatic potential of cancer cells. ADPRTL1 might be the main target at which tanshinone IIA acted.

[Systematic review of benefits and harms of artemisinin-type compounds for preventing schistosomiasis].

OBJECTIVE: To assess the benefits and harms of artemisinin-type compounds for preventing schistosomiasis. METHOD: The quality of included randomised controlled trials with the people at risk of contacting schistosomiasis were evaluated and Meta-analysis was conducted. RESULTS: We found ten randomised controlled trials relating to our question. Of them, four trials were multi-centre studies, others were single centre studies. Numbers of participants in the trials ranged from 318 to 5,098, total 12,829. The total OR of 0.11 (95% CI 0.06 to 0.21) indicated that those who were administrated artemisinin-type compounds were significantly less infected with Schistosoma japonica than those who were administrated placebo. CONCLUSION: Artemisinin-type compounds are effective drug for preventing Schistosomiasis japonica infection. Fifteen days interval schemes of artesunate and artemether be considered preferable to seven days interval scheme and were associated with very few side effects. More high quality controlled trials are required for assessing which scheme is the better. These studies should be large.

[Cost analysis of Shenqi Fuzheng injection on reducing adverse effects during chemotherapy].

OBJECTIVE: The goals of this work was to analyse the cost of Shenqi Fuzheng injection-an extraction of a Chinese traditional herbs on reducing adverse effects in lung cancer patients during chemotherapy. METHODS: In a randomized cross-over trial, each patient completed two identical cisplatin-based chemotherapy cycles, one with Shenqi Fuzheng injection, another without Shenqi Fuzheng injection. Adverse effects and change scores of quality of life (QOL) during chemotherapy were compared in tow cycles. The direct cost dealing with adverse effect and cost-effectiveness analysis were taken. RESULTS: One hundred and thirty were enrolled with 123 of whom were evaluable. The patient characteristics were well balanced between the two groups. The chemotherapy cycles with Shenqi Fuzheng injection spent 220.5 more Chinese yuan, but the adverse effect of leukopenia, thrombocytopenia and vomiting were slight different and the change of score of several QOL domains showed significant better as compared to those in another cycle. CONCLUSION: Shenqi Fuzheng injection could reduce the severity of toxicity related to chemotherapy and improve the QOL of patients and had some benefits in terms of cost-effectiveness.