OBJECTIVE: To discuss the types of control groups in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the design of control group in future clinical studies in this therapeutic area. METHODS: A search of the Cochrane Library was conducted in July 2005 to identify RCTs of CHM, and 66 RCTs with CHM for type 2 diabetes mellitus were obtained as the basis for further analysis. RESULTS: Of 66 RCTs with CHM for type 2 diabetes mellitus, 61 (92.4%) trials had both a treatment group and a control group. Twenty-seven (40.9%) RCTs compared CHM plus conventional drug vs conventional drug, 24 (36.4%) compared CHM vs conventional drug, 5 (7.6%) compared CHM vs placebo, 3 (4.5%) compared CHM plus conventional drug vs conventional drug plus placebo, 3 (4.5%) compared CHM plus conventional drug vs other CHM, 1 (1.5%) compared CHM vs no treatment, 1 (1.5%) compared CHM plus placebo vs conventional drug plus placebo, 1 (1.5%) compared CHM vs CHM plus conventional drug vs conventional drug vs placebo, and 1 (1.5%) compared CHM vs conventional drug vs CHM plus conventional drug. CONCLUSION: A variety of control groups were used in RCTs of CHM for type 2 diabetes mellitus, including placebo, active, and no treatment control groups. Justification for selecting particular types of control groups were not provided in the trials reviewed in this study. Different control groups may be appropriate according to the study objectives, and several factors should be considered prior to selecting control groups in future RCTs of CHM. RECOMMENDATIONS: (1) Investigators of CHM who design clinical trials should understand the rationale for selecting different types of control groups; (2) Control groups for RCTs should be selected according to study objectives; (3) Active control groups should select interventions for comparisons that have the strongest evidence of efficacy and prescribe them as recommended; (4) Placebo control groups should select a placebo that mimics the physical characteristics of test intervention as closely as possible and is completely inert; (5) No treatment control groups should only be used when withholding treatment is ethical and objectives outcomes will not be subject to bias due to absent blinding; (6) Crossover control groups may be appropriate in chronic and stable conditions.

Objective To investigate the effects of D-limonene on the proliferation and ras P21 expression in human bladder carcinoma EJ cell.Methods The cell proliferation was measured by XTT assay.The expression of ras mRNA was detected by real-time PCR,and the expression of its protein product was analyzed by Western Blot.Results The proliferation of EJ cell was inhibited by exposure to 2 mmol/L and 4 mmol/L D-limonene for 48h.The optical density (A) was 0.801±0.016 and 0.148±0.008,respectively.There were significant differences between the experimental groups and the control group (1.2181±0.031,P<0.05).The expressions of ras P21 and its protein product of EJ cell were decreased obviously when exposure to 1 mmol/L of D-limonene for 48h.The expres-sions were significantly different compared with the control group(P<0.05).Conclusions D-limo-nene could inhibit human bladder carcinoma EJ cell proliferation,which is in a dose-dependant man-ner.In a lower dose (<1 mmol/L),D-limonene can decrease the expression of ras mRNA and its protein product.

Objective To summarize diagnostic methods and surgical management experience of penetrating chest trauma . Methods The clinical data of 603 patients in our department during the past 10 years were analyzed retrospectively in respects of features of injury ,diagnostic methods ,surgical management and outcome ,etc .Results Location of the wounds :the wounds on the left anterior chest wall had 151 cases ,on the left posterior chest wall 134 cases ,on the right anterior chest 137 cases ,on the right posterior chest 108 cases ,on the bilateral chest 22 cases ,on the root of the neck 35 cases ,on the upper abdome 16 cases .In 453 ca‐ses examined by CT ,96 .03% of these cases were found to be abnormal .In 252 cases examined by X ray ,71 .03% of these cases were found to be abnormal .166 underwent thoracotomy ,26 underwent VATS(Video assisted Thoracoscopic Surgery ) .411 under‐went non operative management .583 were cured ,76 cases developed complications .20 were died .Conclusion Multi spiral CT is a rapidly and accurate diagnostic method to penetrating chest trauma .Incision of thoracotomy is employed according to the lethal damage and the most serious injury organ .

Objective:To investigate the neuroprotective effect of long-term prophylactic use of buphthalein on mice with permanent distal middle cerebral artery occlusion and its relationship with the nuclear factor erysid 2 related factor 2 (Nrf2) pathway.Methods:Nrf2 + /+ wild-type and Nrf2 -/- knockout mice were randomly divided into control group (equal volume vegetable oil), low-dose butylphthalide group (20 mg/kg) and high-dose butylphthalide group (60 mg/kg), with 6 mice in each group. The drug was administered once a day by gavage for 1 month, and then a permanent middle cerebral artery occlusion model was induced by electrocoagulation. After the model was made, the drug was continued and the mice were sacrificed on the 10 th day. The modified Longa grading scale and the rotating rod test were used to evaluate neurological deficits on the 3 rd and 10 th day after the model was made. After the mice were sacrificed, the cerebral infarct volume was measured by triphenyltetrazolium chloride staining. The brain water content was measured by dry and wet weight method. The expression of Nrf2 pathway related factors, including Nrf2, heme oxygenase 1 (HO-1) and NAD(P)H quinone oxidoreductase 1 (NQO1) were measured by quantitative real-time PCR and Western blotting. Results:On the 10 th day after modeling, compared with the Nrf2 -/- control group, the neurological deficit was significantly milder, the volume of cerebral infarction and brain water content were significantly smaller, and the mRNA and protein levels of Nrf2, HO-1 and NQO1 were significantly higher in the Nrf2 + /+ control group, and the differences were statistically significant ( P<0.05). For Nrf2 + /+ mice, compared with the control group, the cerebral infarct volume was significantly reduced ( P<0.05), the brain water content was significantly reduced ( P<0.05), and the neurological function recovery was significantly better ( P<0.05), and the levels of Nrf2, HO-1, and NQO1 mRNA and protein were significantly higher in the high-dose butylphthalide group (all P<0.05). For Nrf2 -/- mice, there were no significant differences in neurological function, cerebral infarction group volume, brain water content, Nrf2, HO-1, NQO1 mRNA and protein levels among the groups. Conclusion:Long-term butylphthalide pretreatment can significantly improve the neurological function, reduce cerebral infarction volume, reduce brain water content, and increase Nrf2, HO-1, NQO1 mRNA and protein expression levels in mice with permanent distal middle cerebral artery occlusion, suggesting butylphthalide may play a neuroprotective effect by up-regulating the expression of Nrf2 gene and its downstream antioxidant stress factors HO-1 and NQO1.

Objective To investigate the effect of high frequency (10 Hz),low frequency (1 Hz) and theta burst stimulation (TBS) mode of repetitive transcranial magnetic stimulation (rTMS) on the recovery of motor function in hemiplegic patients following acute ischemic stroke.Methods Seventy-two patients with hemiplegia after acute ischemic stroke were randomly grouped with the random number table.They were treated with low frequency (n=18),high frequency (n=18),and TBS (n=18) rTMS or sham stimulation (control group,n=18),once a day,for 2 weeks.Fugl-Meyer Assessment (FMA) and National Institutes of Health Stroke Scale (NIHSS) were used to evaluate neurological function in all patients before rTMS treatment (on the day before the first treatment) and after treatment (on the day after the last treatment).Results After treatment,the FMA and NIHSS scores in the 4 groups were significantly improved compared with before treatment (all P<0.05).After rTMS treatment,the FMA and NIHSS scores were improved significantly in the high frequency group,low frequency group and TBS group compare with the control group (all P<0.05).There were no significant differences among all the treatment groups.Conclusion sHigh frequency,low frequency and TBS rTMS can improve the recovery of motor function in hemiplegic patients following acute ischemic stroke.There were no significant differences among all the treatment modes.

Objective To investigate the clinical effects of comprehensive rehabilitation treatment for patients with a diabetic foot. Methods Fifty-two patients with one diabetic foot were randomly divided into a rehabilitation group ( n =26 ) and a control group ( n =26).The patients in the control group received conventional treatment including health education,basic medical therapy and focal treatment of the foot.In addition to the conventional treatment,the rehabilitation group was treated with aerobic exercise,Beecher's exercise regimen,infrared therapy and ultrashortwave therapy 6 days a week for 4 weeks.The therapeutic effect and quality of life were evaluated before and after treatment. Results The effectiveness rate of the rehabilitation group was significantly higher than that of the control group ( 88.46％ vs 73.08％ ) after treatment.The quality of life scores in both groups were significantly better than those before treatment,including on the social relationship dimension,the physiological function dimension,the mental/psychology dimension and the therapy influence section.Average quality of life scores in the rehabilitation group had improved significantly more than in the control group. Conclusion Comprehensive rehabilitation is beneficial to prevent the progress of diabetic foot and to improve the quality of life of patients with a diabetic foot.

Objective To study the best diagnostic imaging procedure after acute stroke.Methods 53 patients with acute stroke were recruited within 72 hours after symptom onset.CT was performed in all patients firstly, then T1 weighted-imaging( T1 WI), T2 weighted-imaging( T2WI ), gradient recalled echo T2 * weighted-imaging( GRE-T2 * WI) and diffusion-weighted imaging(DWI) were examined at 1.5T.Furthermore 15 patients with ischemic stroke received perfusion-weighted imaging(PWI) examination.Results 15 patients with acute cerebral hemorrhage and one patient of hemorrhagic brain tumor appeared clear on GRE-T2 * WI.3 patients with transient ischemic attack(TIA) were normal on T1WI ,T2WI ,GRE-T2* WI and DWI.18 cases with cerebral infarction appeared normal on GRE-T2 * WI within 6 hours after symptom onset, and 7 cases of them underwent PWI examination, the signal intensity of 3 cases were PWI ≥ DWI and of 4 cases were PWI = DWI.14 patients appeared hyperintense on GRE-T2 * WI within 6 ～72 hours after symptom onset.8 patients of them underwent PWI examination,the signal intensity of 6 cases were PWI≥DWI and of 2 cases were PWI = DWI.Of 14 patients,7 patients appeared as 1 ～ 18 dot or patchy hypointense whose diameter was about 2 ～ 5mm on GRE-T2 * WI.Another case of headache with hemiplegia and the side of the limb didnt show abnormalities on the CT, but showed a low signal in ambient cistern on T2 * WI and was proved to be subarachnoid hemorrhage.Conclusion After acute stroke,multi-sequence MRI enables the "one-stop shopping" imaging of cerebral hemorrhage,cerebral infarction and TIA in a shorter time,makes the state of micro-bleeding clear,determines ischemic penumbra,and even guides for thrombolytic treatment.

OBJECTIVE: To discuss the quality of reporting in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the reporting of future clinical studies in this therapeutic area. METHODS: A search of the Cochrane Library was conducted to identify RCTs of CHM. A revised CONSORT checklist designed for CHM clinical studies was implemented. The revised CONSORT checklist contained 63 items, including the following new items added specifically for CHM: (1) "syndrome of disease" based on Chinese medicine theories; (2) rationale of CHM formula; (3) formula composition; (4) preparation form of CHM; (5) quality control of CHM. RESULTS: The overall reporting quality of the RCTs as assessed with the revised CONSORT checklist varied between 19% and 44%, with a median score of 32% (standard deviation 8%). CONCLUSION: The overall quality of reporting of RCTs of CHM evaluated with a revised CONSORT checklist was poor, reflecting the need for improvements in reporting future clinical trials in this area. RECOMMENDATIONS: To improve the quality of reporting of RCTs of CHM, we recommend adopting a revised CONSORT checklist that includes items specific to CHM. We also recommend that editors of CHM journals require authors to use a structured approach to presenting their trials as a condition of publication.

Objective To study the expression and the function of DKK2 and to explore its potential mechanisms in breast cancer.Methods The expression of DKK2 was detected by RT-PCR in normal breast tissues and breast cancer cells.we have transfected DKK2 into breast cancer cell lines MDA-MB-231 and MCF-7.The cells before transfection were used as control group and marked with Vector.The cells after transfection were used as experimental group and marked with DKK2.Furthermore by qRT-PCR and Western-blot,the expression of DKK2,Notch signaling pathway and related factors were analyzed.We also detected the function of DKK2 by cloning assay,Transwell assay and proliferation assay.Results No expression of DKK2 was found in breast cancer cell lines MDA-MB-231 or MCF-7,with relatively high expression in normal breast tissue.The number of apoptotic cells was 2.57±1.18 before transfectionin in cell line MDA-MB-231,and 49.53±8.27 after transfection.The difference was statistically significant between the two groups (P＜0.005).The relative colony formation rate of MDA-MB-231 cells and MCF7 cells after transfection accounted for 20.44％ and 15.21％,respectively.The difference was statistically significant by t test.The number of apoptosis cells in MB231/DKK2 group was 49.53± 8.27 and that in MB231 / Vector group was 2.57±1.18.The difference was statistically significant (P＜0.005).The number of migrated cells in MB231/DKK2 group was 112.0±8.1 and that in MB231/Vector group was 178.0±12.0.The difference was statistically significant (P＜0.005).The mRNA expression of Notch 1 in group MB231/Vector was recorded as 1.The mRNA expression of JAG1 in MB231/DKK2 group was 0.2891.The difference was also statistically significant (P＜0.005).Conclusions Restored expression of DKK2 in silenced breast cells suppresses breast cancer cell proliferation and migration through repressing Notch signaling.DKK2-Notch signaling pathway may be its potential molecular mechanism to function in breast cancer.DKK2 may be one of the target genes for early diagnosis and treatment of breast cancer.

OBJECTIVETo determine the genomic structure of low density lipoprotein receptor related protein 5 (LRP5) gene.

METHODScDNA sequence encoding LRP5 was used to screen genomic clones containing LRP5 gene by computer hybridization approach. By comparing the cDNA sequence of LRP5 with the genomic sequences, the genomic structure of LRP5 was determined, and then it was conformed by amplifying and sequencing the sequences of exons and splicing junction.

RESULTSThe genomic sequence of LRP5 gene was 131.6 kb in length, containing 23 exons and 22 introns. Three single nucleotide polymorphisms were detected within the coding sequences of LRP5 gene, namely A459G in exon 2, C2220T in exon 10 and G4416C in exon 21. Four polymorphic markers, D11S1917, D11S4087, D11S1337 and D11S4178, located in the 5' flank sequence, introns 1, 4, and 13 of the LRP5 gene, respectively.

CONCLUSIONThe characterization of genomic structure of LRP5 gene allows the investigators to detect disease-causing mutation within the gene and further study the function of LRP5 gene.

Base Sequence ; DNA ; chemistry ; genetics ; Exons ; Genes ; genetics ; Humans ; Introns ; LDL-Receptor Related Proteins ; Low Density Lipoprotein Receptor-Related Protein-5 ; Polymorphism, Single Nucleotide ; Receptors, LDL ; genetics ; Sequence Analysis, DNA