Placebo-controlled clinical study is the ethical issue being debated all over the time.The ethics committee plays an important role in the assurance of the scientificalness of clinical research without violation of ethics.This article introduces the main points considered in the placebo-controlled clinical study in Medical Ethics Committee of Guang'anmen Hospital of China Academy of Traditional Chinese Medicine.These points are as follows,the benefit of the subject greater than the risk,considerations on the benefit / risk of the subjects,the disposal of compensation measures and adverse events in research program and fully informed consent as well as the model of final resolution.

The informed consent right of people who are investigated should be respected during the epidemiology survey,and there're many ethical problems about the way of inquiry,the fund of investigation,the protection of personal secrets and the compensation to people who are investigated.We should strengthen the training of investigators in order to promote the development of epidemiblogy survey.

Objective To study the effect of serum contained Erzhi Tiangui Granule on the secretion function of ovarian granulosa cells from primary senile mice. Methods The serum with decoction from primary senile mice was added to cultured granulosa cells and incubated for 48 h. Then the concentration of estradiol (E2), progesterone (P) and inhibin B (INHB) in cultured medium were measured by chemiluminescence immunoassay (CLIA) and Sandwich ELISA respectively. Results The serum contained Erzhi Tiangui Granule could increase the secretion of E2, P and INHB. Conclusion Erzhi Tiangui Granule can improve the ovarian function of primary senile mice by regulating the secretion function of granulosa cells.

Objective To observe the efficacy of Qingre Jiangzhuo prescription in the treatment of overweight subjects of type 2 diabetes mellitus. Methods Two hundred and four cases were divided into 2 groups in a randomized, paralleled, contrast, prospective study. The control group was treated with metformin tablet and the trial group was treated with Qingre Jiangzhuo prescription. The efficacy and safety of the two groups were compared on HbAlc, FBG, P2BG, TC, TG, BMI and AE after 12 weeks. Results After treatment, all indexes of the trial group were markedly improved compared with before treatment (P 0.05). The rate of AE in the trial group was less than that in the control group. Conclusion Qingre Jiangzhuo prescription has curative effect on type 2 diabetes mellitus patients with better safety.

Objective To evaluate the effect and safety of Yufeng Ningxin drop pills in treating nervous headache with blood- stasis syndrome.Methods A double- blind,randomized,parallel- control and multi- center trial was carried out.Treatment group was treated by Yufeng Ningxin drop pills (15 pills,tid) and placebo tablet (5 tablets,tid); Yufeng Ningxin tablet (5 tablets,tid) and placebo drop pills(15 pills,tid) served as positive control.The course of treatment lasted 4 weeks.There were 60 patients in every group.Results No significant differences were found in total therapeutic effect rate( 90 % in both two groups) ,effective rate in relieving symptoms and signs( 95 % in treatment group and 91.6 % in control group) ,attacking frequency of headache,lasting- time of headache,average lasting- time of each time of headache,severity of headache,scoring of headache and scoring of symptoms and signs between the two groups.Conclusion Both Yufeng Ningxin drop pills and Yufeng Ningxin tablet are effective and safe in treating nervous headache.No obvious adverse reaction is found. 

Objective To investigate the mastery degree of GCP (Good Clinical Practice) in Guang’anmen Hospital of China Academy of Chinese Medical Sciences (hereinafter referred to as“Guang’anmen Hospital”). Methods Totally 338 clinical researchers, covering 18 clinical professional sections and medical clinical trial institutions, in Guang’anmen Hospital with both qualification of clinical trials and GCP certificate were investigated in 23th-27th June 2014. The investigation was in the written answer sheet form, including four noun explanations and 36 multiple choice questions, which were related to GCP. Results 338 researchers could accurately explain the concepts of 4 nouns, and 57 (16.86%) researchers could do all multiple choice questions correctly. 141 (41.72%) researchers chose 1 wrong answer and 89 (26.33%) researchers chose 2 wrong answers. 39 (11.54%) researchers failed to answer 3-4 questions. Only 12 (3.55%) researchers failed to answer 5 or more questions. Conclusion The mastery degree of clinical researchers with qualification of clinical trials and GCP certificate in Guang’anmen Hospital is satisfied. In the future, pertinence and diverse training should be strengthened, in order to improve the overall level of the mastery degree of GCP.

The re-evaluation of clinical post-marketing herbs in special populations, such as children, the aged, pregnant women, lactating women, has attracted attention in our country. The media is drug adverse reaction reports and package insert. The safety of combined administration in aged and children's growth should have been taken long-term follow-up study. Perfecting traditional chinese medicine FDA system will be beneficial to the re-evaluation of clinical postmarketing herbs in pregnant women. Dose-effect study in children also should cause the concern of researchers.
Adverse Drug Reaction Reporting Systems ; Aged ; Child ; Drugs, Chinese Herbal ; adverse effects ; Female ; Humans ; Medicine, Chinese Traditional ; adverse effects ; Polypharmacy ; Pregnancy ; Product Surveillance, Postmarketing

OBJECTIVETo compare the efficacies ofentecavir and adefovir in patients with chronic hepatitis B (CHB) and cirrhosis when administered as monotherapies using a 240-week course.

METHODSNinety patients diagnosed with CHB and cirrhosis (compensated or decompensated) were randomly divided into two treatment groups for administration of either entecavir (0.5 mg/day, oral; n =38) or adefovir (10 mg/day, oral; n =52) for 240 weeks. All participants underwent B-ultrasound and were tested for levels of HBV-DNA, alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen, creatinine, alpha-fetoprotein (AFP) and various serological markers of the hepatitis B virus at baseline and at treatment weeks 24, 48, 96, 144, 192, and 240. Instances of drug-related complications and adverse reactions were recorded. Patients who did not achieve complete virological response by treatment week 48 or who experienced virological breakthrough at any time during the study course were recorded and started on an appropriate combination therapy regimen. Statistical analyses were carried out using the t-test, chi-square test, and Cox regression modeling.

RESULTSThe dropout rate in the entecavir group was 2.6% and in the adefovir group was 13.5%. At treatment week 240, significantly more patients in the entecavir group had undetectable serum HBV-DNA (91.9% vs. adefovir group: 57.8%; x2=10.362, P=0.001), a negative conversion rate of hepatitis B e antigen (HBeAg) (46.2% vs. adefovir group: 24%; x2=5.055, P=0.025), and rate of HBeAg seroconversion (23.1% vs. adefovir group: 8%, P=0.047).The entecavir group and the adefovir group showed no significant differences upon per-protocol analysis and intention-to-treat analysis, nor in the rates of hepatocellular carcinoma development (entecavir group: 8.1% vs. adefovir group: 6.7%; x2=0.000, P=1.000) or mortality (entecavir group: 8.1% vs. adefovir group: 4.4%; x2=0.051, P=0.821). The possibility of achieving undetectable serum HBV-DNA was 2.761 times higher in the entecavir group than in the adefovir group (95.0% CI: 1.630 to 4.679). The possibility of HBeAg seroconversion was 0.192 times higher for males than for females (95.0% CI: 0.046 to 0.806).

CONCLUSIONCompared to adefovir, entecavir provides high efficiency and rapid viral suppression as a monotherapy for CHB patients when administered in a 240-week course.

Adenine ; analogs & derivatives ; Aged ; Alanine Transaminase ; Antiviral Agents ; Aspartate Aminotransferases ; Biomarkers ; Carcinoma, Hepatocellular ; Female ; Guanine ; analogs & derivatives ; Hepatitis B e Antigens ; Hepatitis B, Chronic ; Humans ; Liver Cirrhosis ; Liver Neoplasms ; Male ; Organophosphonates ; Time Factors ; alpha-Fetoproteins

ObjectiveTo confirm the clinical efficacy and safety of Yishen Yangxin Anshen tablets in the treatment of insomnia （heart-blood deficiency and kidney-essence insufficiency syndrome）. MethodA randomized block， double-blind， placebo-controlled， multi-center clinical trial design method was adopted， and a total of 480 patients with insomnia due to deficiency of heart blood and insufficiency of kidney essence （treatment group-control group 3∶1） from seven hospitals （Guang'anmen Hospital， China Academy of Chinese Medical Sciences， The First Clinical Hospital， Jilin Province Academy of Traditional Chinese Medicine（TCM）， The Second Affiliated Hospital of Liaoning University of TCM， The First Affiliated Hospital of Henan University of Chinese Medicine， Henan Province Hospital of TCM， Hebei General Hospital， The First Hospital of Hunan University of Chinese Medicine） were enrolled. The treatment group was given Yishen Yangxin Anshen tablets and the control group received placebo tablets （4 tablets/time， 3 times/day， 4 weeks of administration， 4 weeks of follow-up after drug withdrawal）. The sleep dysfunction rating scale （SDRS） score， pittsburgh sleep quality index （PSQI） score， TCM， polysomnography （PSG） indicators from four hospital （Guang'anmen Hospital， China Academy of Chinese Medical Sciences， Henan Province Hospital of TCM， Hebei General Hospital， The First Hospital of Hunan University of Chinese Medicine）， and other efficacy indicators were compared between the two groups before and after treatment. Through general physical examination， laboratory examination， and observation of adverse events， the safety of the drugs was evaluated. ResultThe baseline indexes of the two groups showed no significant difference and thus the two groups were comparable. After treatment， the total score of SDRS in the treatment group was lower than that in the control group （P<0.01）. After drug withdrawal for 4 weeks， the total score of SDRS demonstrated no significant change in the treatment group as compared with that at the end of treatment， indicating that the rebound change of curative effect was not obvious. After treatment， the total score of PSQI in the treatment group decreased as compared with that in the control group （P<0.01）， and the change of total score of PSQI in the treatment group was statistically significant （P<0.05） after drug withdrawal for 4 weeks but small， indicating that the rebound change of curative effect was not obvious. After treatment， the total effective rate about the TCM symptoms in the treatment group was higher than that in the control group （χ²=137.521，P<0.01）. After treatment， the disappearance rates of single indexes in the treatment group， such as difficulty in falling asleep， easily waking up after sleeping， early awakening， short sleep time， dreamfulness， palpitation， forgetfulness， dizziness， mental fatigue， and weakness of waist and knee， increased compared with those in the control group （P<0.01）. After treatment， the treatment group demonstrated fewer awaking times （AT）， longer total sleep time （TST）， lower ATA/TST ratio， and higher sleep efficiency （%） than the control group （P<0.05）. No abnormal value or aggravation related to drugs was observed in either group. The incidence of adverse events in the treatment group and the control group was 5.57% and 8.40% respectively. No serious adverse events or adverse events leading to withdrawal happened in either group. ConclusionYishen Yangxin Anshen tablets is effective and safe for patients with insomnia of deficiency of heart-blood and insufficiency of kidney-essence.

ObjectiveTo evaluate the clinical efficacy and safety of Tongluo Mingmu capsules in the treatment of diabetic retinopathy with blood stasis， collateral obstruction， and Qi and Yin deficiency syndrome. MethodA randomized， double-blind， positive-control， and multi-center clinical trial design method was used. 416 patients with diabetic retinopathy with blood stasis， collateral obstruction， and Qi and Yin deficiency syndrome in four test centers were included （the ratio of the treatment group to the control group was 3∶1）. On the basis of standardized hypoglycemic treatment， the treatment group was given both four Tongluo Mingmu capsules and two Calcium Dobesilate capsule agents three times a day， while the control group were given both two Calcium Dobesilate capsules and four Tongluo Mingmu capsule agents three times a day. The course of treatment was 12 weeks. The curative effect of Tongluo Mingmu capsules was evaluated by comparing the comprehensive curative effect of diabetic retinopathy， traditional Chinese medicine（TCM） syndrome score， corrected visual acuity， fundus changes， fundus fluorescence angiography， and other curative effect indexes before and after treatment in the two groups. At the same time， general examination， laboratory examination， and adverse events were performed to evaluate the safety of the drug. ResultThe baseline demographic data and disease characteristics of the treatment group and the control group were balanced and comparable， with the difference not statistically significant. After 12 weeks of treatment， the total effective rate of the comprehensive curative effect of diabetic retinopathy in the treatment group （61.0%， 189/310） was better than that in the control group （44.1%， 45/102）， and the difference was statistically significant （χ²=8.880， P<0.01）. The total effective rate of TCM syndromes in the treatment group （88.4%， 259/293） was better than that in the control group （69.9%， 65/93）， and the difference was statistically significant （χ²=17.927， P<0.01）. The disappearance rate of dry eyes （χ²=8.305）， dull complexion （χ²=4.053）， lassitude （χ²=10.267）， shortness of breath （χ²=8.494）， and dry stool （χ²=8.657） in the treatment group was higher than that in the control group， and the difference between the groups was statistically significant （P<0.05， P<0.01）. In terms of improving corrected visual acuity （χ²=8.382）， fundus changes （χ²=6.026） ， the treatment group was significantly better than the control group （P<0.05）. During the trial， the incidence of adverse events in the treatment group and the control group was 1.3% and 2.9%， respectively. There was no significant difference between the two groups. In addition， there were no serious adverse events and adverse events leading to withdrawal in both groups. ConclusionTongluo Mingmu capsules can improve the comprehensive curative effect of diabetic retinopathy and enhance the efficacy of TCM syndromes， visual acuity， fundus changes， and fundus fluorescein angiography， with great safety. Therefore， it can provide a new alternative therapeutic drug for patients with diabetic retinopathy.