In phase II clinical trial of Compound Prescription of Huangyaozi (Dioscorea bulbifera L.), 7 cases out of 37 developed (18.92%) impairment of liver function. As a result, the ethic committee required researchers to report all data of safety of the drug and have all subjects rechecked about their liver function so as to provided reasonable evidence for the scientifical evaluation of the relationship between the drug and the adverse event and the succedent suspending of the clinical trial.
Objective To assess the methodological quality of clinical studies using Shen-Mai injection as an adjunct therapy to tumor chemotherapy and to evaluate its efficacy and safety. Methods A comprehensive search strategy was designed to identify all randomized controlled trials (RCT) comparing Shen-Mai injection plus routine chemotherapy versus routine chemotherapy alone by searching for the CBMdisc (issue 3) and TCMLRS database (1981-2001). The methodological quality of the trials was assessed by two reviewers independently for which a meta analysis was perfermed. Results Thirteen RCTs met the inclusion criteria. methodological quality was poor (all the trials included were level C). Compared with the control group, the combined outcome of Shen-Mai injection increased the effect of chemotherapy (OR 1.73 95%CI 1.27 to 2.34, P＝0.000 4), reduced the side effect of bone marrow inhibition (OR 0.29, 95%CI 0.16 to 0.52, P＝0.000 04) in WBC counting and (OR 0.11, 95%CI 0.02 to 0.49, P＝0.004 in PLT count. And Shen-Mai injection relieved the symptoms of nausea and vomiting (OR 0.26, 95%CI 0.16 to 0.43, Plt;0.000 01). Conclusions The methodological quality of the trails using Shen-Mai injection should be improved. Based on the results of the review and the meta-analysis, Shen-Mai injection may have positive effects on chemotherapy in patients with malignant tumor, although the evidence is weak. No serious adverse events are reported. Further well-designed clinical trials should be performed.
Objective To evaluate the anti-tussive effect of a total alkaloid agent extracted from Papaver Somniferum L. on simple chronic bronchitis of which the syndrome was counterflow ascent of lung qi according to traditional Chinese medicine (TCM). Methods Randomised, double blind method, placebo control and add on design were applied. Forty-five patients with counterflow ascent of lung qi of simple chronic bronchitis were randomly divided into two groups: treatment group (n=21) with alkaloid agent and control group (n=24) with placebo. Results The incidences of obvious coughing in treatment and control groups were 66.67% and 70.83% (P=0.763 3) respectively. The cough alleviation time of patients was 14.64±16.30 h and 15.12±15.28 h (P=0.795 6) respectively. The loss of cough rates on the third day was 28.57%, 16.67% (P=0.337 7) respectively. The average scores decreased were 4.29 and 2.88 (P=0.054 8) respectively. Conclusions The study indicates that total alkaloid agent extracted from Papaver somniferum L. has no significant anti-tussive effect on patients with counterflow ascent of lung qi of simple chronic bronchitis treated with cefaclor sustained release capsules simultaneously. The trial was interrupted by the advice from experts who disagreed with the selection of drug indication.
Objective To evaluate the efficacy and safety of genus Phyllanthus for chronic HBV infection. Design a systematic review of randomized clinical trials. Methods Randomized trials comparing genus Phyllanthus versus placebo, no intervention, general non-specific treatment, other herbal medicine, or interferon treatment for chronic HBV infection were identified by electronic and manual searches. Trials of Phyllanthus herb plus interferon versus interferon alone were also included. No blinding and language limitations were applied. The methodological quality of trials was assesses, by the Jadadscale plus allocation concealment. Results Twenty-two randomized trials (n=1 947) were identified. The methodological quality was high in five double blind trials and rest was low. The combined results showed that Phyllanthus species had positive effect on clearance of serum HBsAg (relative risk 5.64, 95%C1 1.85 to 17.21) compared with placebo or no intervention. There was no significant difference on clearance of serum HBsAg, HBeAg and HBV DNA between Phyllanthus and interferon. Phyllanthus species were better than non-specific treatment or other herbal medicines on clearance of serum HBeAg, HBeAg, HBV DNA, and liver enzyme normalization. Analyses showed a better effect of the Phyllanthus plus interferon combination on clearance of serum (1.56, 1.06 to 2.32) and HBV DNA (1.52, 1.05 to 2.21) than interferon alone. No serious adverse events were reported. Conclusions Based on the review Phyllanthus species may have positive effect on antiviral activity and liver biochemistry in chronic HBV infection. However, the evidence is not b due to the general low methodological quality and the variations of the herb. Further large trials are needed.
ObjectivesTo assess the efficacy and safety of corticosteroid and antiviral agents for idiopathic facial nerve paralysis (IFNP) by network meta-analysis.MethodsPubMed, EMbase, The Cochrane Library, CBM, CNKI, WangFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) of corticosteroid and antiviral agents for IFNP from inception to January 31th, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. The meta-analysis was performed by R 3.3.3 and Stata 13.0 software.ResultsA total of 16 RCTs involving 3 061 patients were included. The results of network meta-analysis showed that: for the facial function recovery rates, corticosteroid plus antiviral agents was superior to placebo and antiviral agents alone at 3-month follow-up. Corticosteroid plus antiviral agents was superior to placebo, antiviral agents or corticosteroid alone at 6-month follow-up (if the satisfactory recovery was defined as a House-Brackmann grade class Ⅱ or below). When the follow-up exceeded 6 months, corticosteroid alone was superior to placebo and antiviral agents alone, corticosteroid plus antiviral agents was superior to placebo and antiviral agents alone. All of the differences above were statistically significant. For the sequelae, corticosteroid plus antiviral agents and corticosteroid alone were superior to placebo and antiviral agents alone. Corticosteroid plus antiviral agents was superior to corticosteroid alone. The differences were statistically significant. For the adverse events, there were no significant differences between any other pairwise comparisons of these different interventions.ConclusionConsidering the efficacy and safety, patients with IFNP treated corticosteroid plus antiviral agents are more likely to have a better recovery of facial function and less likely to develop sequelae, followed by corticosteroid alone. More high-quality, large scaled and multicenter RCTs are required to verify the conclusions above, and focus on the treatment of children and patients with severe facial paralysis.
Objective To identify and investigate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in 11 non-key Chinese medical journals so as to learn about the current status and problems. Methods Eleven non-key medical journals of TCM from 1995 to 2000 were hand searched to identify the RCT and controlled clinical trials (CCTs). Each identified RCT or CCT was page by page verified by handsearchers based on the criteria developed by the Cochrane Handbook; the RCTs’ design, randomization method description, blind, baseline comparison, inclusion and exclusion criteria, diagnostic criteria,criteria for theraputic effectiveness, sample size, statistical method，described outcome, side effects, and follow up etc. were analyzed. Results In the related journals from 1995 to 2000, a total of 66 volumes and 390 issues were checked. As a result, 22 739 clinical studies were identified, of which 1 416 RCTs, only 24 (1.69%) were done with double blinding. There were 141 CCTs from 1995 to 2000, the total number of RCT increased from 95 to 1 416 and most of studies were on digestives diseases. Most of these studies had no detailed randomization method description, only 38 (2.68%) studies provided a methodology description. In addition, 1 220 (86.16% ) described outcome index, 1 203 (84.96%) used statistical method，934 (65.96%) had baseline comparison，828 (58.47%) described diagnostic criteria, 197 (13.91%) had inclusion and exclusion criteria，finally only 89 (6.29%) reported side effects. Conclusions Although the number of RCT has increased in the 11 non-key medical journals of TCM in the past six years, the quality of these RCTs needs to be improved.
Clinical trial transparency, include clinical trial registration, unbiased reporting results and sharing individual participant data (IPD), is one of the most important revolutionary concepts following clinical epidemiology and evidence-based medicine in the medical field. Sharing IPD is a medical ethics issue reflected a new sense of worth and constructing new rules of clinical trials. Our viewpoint is that from the essential purpose of clinical research, IPD is a social public property. Sharing IPD is a one of the best ways for respecting the contributions of the participants, and one of the keys for changing face of clinical trials.
Objective To systematically review the effectiveness and safety of autologous implantation of stem cells for diabetic peripheral neuropathy (DPN). Methods Randomized controlled trials on relevant studies were retrieved in databases including CBM (1978-2011.6), CNKI (1979-2011.6), MEDLINE (1950-2011.6), PubMed (1950-2011.6), EMbase (1970-2011.6) and The Cochrane Library (Issue 3, 2011). References of the included studies were also retrieved. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assess the methodological quality of the included studies. Then, meta-analysis was performed using RevMan 5.0 software.Results Four RCTs involving 68 patients (136 limbs) were included, most of which were low in methodological quality. The results of meta-analysis indicated that, autologous stem cell therapy improved or even eliminated DPN symptoms including pain, numbness, and cold sensation in the limbs, intermittent limping, and rest pain. Compared with the routine therapy, autologous stem cell therapy improved tibial sensory nerve conduction velocity (MD=5.75, 95%CI 3.86 to 7.64, Plt;0.000 01), tibial motor nerve conduction velocity (MD=4.04, 95%CI 0.90 to 7.18, P=0.001), sural sensory nerve conduction velocity (MD=7.47, 95%CI 4.00 to 10.94, Plt;0.000 1), and sural motor nerve conduction velocity (MD=3.38, 95%CI 0.07 to 7.58, P=0.05), with no adverse reaction reported. Conclusion Current evidence shows that, autologous stem cell therapy is effective in treating DPN. Due to the lack of high quality studies, more high quality RCTs are needed to verify the above conclusion.
Objective To evaluate the efficacy and safety of amoxicillin/sulbactam (AMX/SBT) in the treatment of acute bacterial infections. Method A multicentre randomized controlled clinical trial was conducted. Ampicillin/sulbactam (AMP/SBT) was chosen as the control drug. 113 patients were enrolled in the study (58 cases in test group and 55 cases in control group). AMX/SUL and AMP/SUL were administered 4.5-6.0 g and 4.5-12.0 g every day respectively. Both drugs were given intravenously for 7-14 days. Results The cure rates and the efficacy rates of the two groups were 75.86%, 80.0% and 94.83%, 98.18% respectively. The β-lactamase producing rates were 67.35% , 69.57% and the bacterial clearance rates were 93.88%, 95.65%.There were no significant differences of the above results between the two groups (Pgt;0.05). There was no serious adverse drug reaction in AMX/SBT groups. Conclusion This study suggests that AMX/SBT is an effective and safe drug for treating acute bacterial infections.
The concept of clinical trial transparency has been promoted for more than 40 years. The act of clinical trial registration, report guidelines development, and data sharing has has been strongly pushed forward and become a common practice. The clinical trial process being the key procedure of trial operation and quality control, determines the accuracy of the results. However, the process report of clinical trials is insufficient. In this article, we summarize the importance of clinical trial process report and provide corresponding suggestions. We propose that medical journals, reporting guidelines developers and clinical trial registration platforms should work together to strengthen the process report of clinical trials and promote full transparency of clinical trials.