Objective To evaluate the effectiveness and safety of foscarnet sodium in the treatment of chronic hepatitis B. Methods We searched MEDLINE, EMbase, The Cochrane Library and CNKI from 1978 to June 2006. Randomized controlled trials of foscarnet sodium versus other drugs or no drugs in the treatment of chronic hepatitis B were identified. The quality of the included trials was evaluated by two reviewers independently. Meta-analysis was done using The Cochrane Collaboration’s RevMan 4.2.7. Results Seven studies (337 patients) were included; one compared foscarnet sodium versus interferon, and the other six compared foscarnet sodium versus no drugs. All the included studies were graded in terms of the quality of randomization, allocation concealment and blinding. All 7 studies were graded as level C. The meta-analysis showed that: ① foscarnet sodium was not significantly different from interferon in clinical efficacy, liver function, negative-conversion rate of virological markers and side effects. ② compared with the no drugs group, the negative-conversion rate of virological markers was significantly higher for the foscarnet sodium group, HBeAg (RR 6.20, 95%CI 1.76 to 21.79) and HBV-DNA (RR 4.13, 95%CI 1.32 to 12.86); but there were no significant differences in clinical efficacy, liver function and side effects. Conclusions Available evidence shows that: in the treatment of chronic hepatitis B the effectiveness and safety of foscarnet sodium are not significantly different from interferon, but only one trial is included in this review, so the evidence is weak. Compared with no drugs, foscarnet sodium significantly improves the negative-conversion rate of virological markers, but the evidence is insufficient to show whether foscarnet sodium could improve clinical efficacy and liver function, as well as reduce side effects.
Objective To evaluate the efficacy and safety of Tongxiening granule （TXNG） in the treatment of diarrhea-predominant irritable bowel syndrome （IBS） （stagnation of the liver-qi attacking the spleen）. Methods In a prospective, randomized, placebo-controlled, double-blind clinical trial, 60 patients with diarrhea-predominant IBS were randomly divided into the TXNG group （TXNG, 5.0g, 3 times daily; n =30） and the placebo group （placebo, 5. 0g, 3 times daily; n =30）. The treatment was administered for 3 weeks, and the follow-up was conducted for 4 weeks.Results （1）Abdominal pain： The cure rates were 57. 7% vs. 16. 0% （ by per-protocol analysis, PP） and 31.0% vs. 7.1% （ by intention-to-treat analysis （ITT） ; and the overall improvement rates were 92.3% vs. 44.0% （PP） and 82.7% vs. 39.3% （ITT） in the TXNG and the placebo groups respectively （ P 〈0. 05）. （2） Diarrhea ： the cure rates were 46. 2% vs. 20. 0% （PP） and 41.4% vs. 17. 9% （ITT） , and the overall improvement rates were 96. 2% vs 48. 0% （PP） and 86. 2% vs 42.9% （ITT） in the two groups respectively （P 〈0.05）. （3）Traditional Chinese medicine symptoms： the cure rates were 30.8% vs. 4.0% （PP） and 27.6% vs. 3.6% （ITT） ; and the overall improevment rates were 92.3% vs. 48.0% （PP） and 82.7% vs 42.9% （ITT） in the two groups respectively （P 〈0. 05）. The pain duration after treatment in the TXNG group was significantly shortened compared with the placebo group （7.6 ±4. 6d vs 14. 4 ±4. 3d, P =0. 0125）. After 4-week follow-up, it suggested that the recrudescent duration in symptoms related to IBS in the TXNG group was longer than that in the placebo group （11.5 ±5.3 d vs 6.2 ±6.9 d, P = 0. 019）. No adverse effects were found in the TXNG group. Conclusion It was demonstrated that TXNG is effective and safe in the treatment of diarrhea-predominant ms （stagnation of the liver-qi attacking the spleen）.
ObjectivesTo systematically review the efficacy and safety of bevacizumab combined with STUPP regimen for newly diagnosed glioblastoma.MethodsPubMed, EMbase, the Cochrane Library, CBM, CNKI, VIP and WanFang Data databases were searched to obtain randomized controlled trials (RCTs) of bevacizumab combined with STUPP regimen for newly diagnosed glioblastoma patients from inception to September 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using RevMan 5.3 software.ResultsA total of 6 RCTs involving 2 835 patients were included. The results of meta-analysis showed that: the bevacizumab combined with STUPP regimen group was superior to the control group on PFS (HR=0.69, 95%CI 0.62 to 0.77, P<0.000 01). But the adverse events rate at the three and above three levels was significantly higher than the control group (P<0.05).ConclusionsCurrent evidence shows that bevacizumab combined with STUPP regimen for newly diagnosed glioblastoma can significantly prolong the PFS. The treatment group performs not as well as the control group on adverse event rate. Due to the limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.
Objective To review systematically whether there is enough existing evidence that methylcobalamin is effective and safe in the treatment of the patients with diabetic peripheral neuropathy.Methods A Cochrane systematic review of all relevant randomized or quasi-randomized controlled trials of methycobalamin for diabetic peripheral neuropathy was performed. Clinical trials were searched from Cochrane Controlled Trials Register (Issue 4, 2003), MEDLINE (January 1966 to January 2004), EMBASE (January 1980 to January 2004), the Chinese Biological Medicine Database (1978 to January 2004), the Chinese Science and Technology Journal Full-text Database (1989 to January 2004) and references of all included trials. The selection of studies, data extraction and assessment of methodological quality were performed independently by two reviewers. The following outcomes were assessed: effectiveness of clinical signs and symptoms, sensory nerve and motor nerve conduction velocities and serious adverse events of methylcobalamin. Results Thirty randomized clinical trials including 1 949 patients met the inclusion criteria. The quality of the most included trials was of low level. The "funnel plot" of the comparison of thirteen studies of methylcobalamin with other B Vitamins studies showed symmetry, which indicated less possible publication bias and the result was partly reliable, but it could not indicate the whole publication biases. The results of meta-analysis indicated that methylcobalamin showed significantly positive effects on the improvement of the signs and symptoms of peripheral neuropathy, and the effects were better than the other vitamin B agents. The increase of some nerves conduction velocities by methylcobalamin was better than by the other vitamin B. No serious adverse events were observed during the treatment period.Conclusions Methylcobalamin appears to be a safe and effective treatment on diabetic peripheral neuropathy. However, the evidence is not b because of the low quality of most trials. Rigorously designed, randomized, double-blinded, placebo-controlled trials of methylcobalamin for diabetic peripheral neuropathy are needed to further assess the effect.
Objective To assess the efficacy and safety of adalimumab on plaque psoriasis. Methods We searched the MEDLINE (1966 to December 2009), Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 12, 2009), EMbase (1980 to December 2009), CBM (1978 to December 2009), and CNKI (1979 to December 2009) to collect randomized controlled trials (RCTs) of adalimumab for plaque psoriasis. The language was confined to English and Chinese. We screened the retrieved studies according to the predefined inclusion and exclusion criteria, evaluated the quality of included studies, and performed meta-analyses by using the Cochrane Collaboration’s RevMan 4.2 software. Results Three RCTs involving 1?630 patients with chronic moderate or severe plaque psoriasis were included and assessed. At the end of 4th, 8th, 12th and 16th week, the PASI 75s of subcutaneous injection every other week in adalimumab (EOW) group were obviously higher than that of placebo group and methotrexate group. While at the end of 24th week and 60th week, the PASI 75s showed no difference between adalimumab EOW and placebo group. Twelve weeks after subcutaneous injection each week with adalimumab (QW), PASI 75 was obviously higher than those of placebo and EOW groups. However, at the end of 24th week and 60th week, there was no significant difference between adalimumab QW and placebo followed by adalimumab EOW. At end of week 12-16, there was no difference between adalimumab EOW group and placebo group in the incidence of adverse effects, with the exception of pain on injection site and upper respiration viral infection. At week 12-60, there was no difference between adalimumab QW and EOW groups in the incidence of adverse effects, with the exception of all serious adverse effects. Conclusion The limited evidence indicates that subcutaneous injection of adalimumab every other week for 12-16 weeks is safe and efficient for patients with moderate or severe plaque psoriasis. The efficacy can’t be enhanced when the treatment is prolonged to 24 weeks. The once-a-week protocol has no obvious advantage over every other week protocol. More RCTs are required to verify these conclusions owing to the limitations of the present study.
Objective To assess the efficacy and safety of efalizumab in the treatment of psoriasis. Methods Randomized controlled trials (RCT) on efalizumab in the treatment of psoriasis were identified from The Cochrane Library ( issue 1, 2006) , specialized trials registered in Cochrane Skin Group (2006), MEDLINE (1966 - 2006) and EMBASE (1974 - 2006). The quality of the trials was assessed by two reviewers independently. RevMan 4.2.7 software provided by the Cochrane Collaboration was used for statistical analysis. Results Three RCTs involving 1 651 patients were included, all of which were of high methodological quality. All the patients were diagnosed as chronic moderate to severe plaque psoriasis with the age of 18-75 years. Meta-analysis indicated that at week 12, significantly more patients in both 1mg/kg/w and 2 mg/kg/w efalizumab subcutaneous groups achieved PASI50, PASI75, PASI90 improvement compared to the placebo group (Plt;0.0001), while there was no significant difference in PASI50, PASI75 and PASI90 responses between 1mg and 2mg efalizumab groups (P gt;0.05). No serious adverse effects were identified. Extended treatment for another 12w may contribute to further efficacy without increasing toxicty. Conclusions Efalizumab 12w therapy is safe and effective for treating adult patients with moderate to severe plaque psoriasis. More RCTs are required to assess the efficacy of the extended treatment.
Traditional randomized controlled trial and real-world study have different advantages in internal validity and external extensibility, respectively. With the development of evidence-based health decisions, randomized controlled trial was no longer the only golden standard of interventional study, the research evidence of the real world was gradually involved in health decisions. This study mainly analyzed the requirements of evidence and actual application of evidence in the evaluation of the effectiveness of NICE in the UK. It was found that NICE still used the results of randomized controlled trials as a primary basis. Although real-world research has developed rapidly in recent years, it was limited used in health decision because of its bias by design and other factors. However, in recent years, real-world evidence has played a significant role in the field of innovative drugs or diseases that lack therapeutic drugs. With the improvement of real-world research in experimental design and data analysis, it is expected that it will play a more important role in health decision-making.
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.
Objective To evaluate the efficacy and safety of Polyunsaturated phosphatidylcholine (PPC) for chronic hepatitis. Methods We searched EMBASE (1980May,2003), MEDLINE(1966May,2003), CBM (1979May,2003), The Cochrane Library Issue 2, 2003 and handsearched 8 related Chinese journals. Randomized controlled trials(RCT) comparing PPC versus placebo/no treatment for chronic hepatitis were included with no restrictions of blinding, language and publication. Two reviewers independently performed data extraction and assessed the quality . Data were entered and analyzed by RevMan 4.2 software supplied by the Cochrane Collaboration .Results Six high quality trials involving 568 patients were included. Four studies involving 451 patients showed the clinical effective rate of PPC for chronic hepatitis was 52.5% while the control group was 37.5% with statistical difference [RR1.81,95%CI(1.41,2.33),Z=4.69, Plt;0.00001].A meta-analysis involving three studies with 100 patients showed the PPC can statically improve histopathology of chronic hepatitis comparing with control group [RR 2.58,95%CI (1.61,4.15),Z=3.91,Plt;0.0001].No serious adverse events were reported.Conclusions PPC is a safe medicine used for treating chronic viral hepatitis and may relieve clinical symptoms and signs.At the same time ,it has positive effect on hepatic histopathology for patients .However ,more high quality clinical trials are required.
Objective To systematically evaluate the effectiveness and safety of Puerarin on diabetic peripheral neuropathy. Methods A systematic review and evaluation of all available relevant randomized or quasi-randomized controlled trials of Puerarin for diabetic peripheral neuropathy from Cochrane Controlled Trials Register (150 issue of 2003), Medline (1966-2003. 2), EMbase (1984-2001. 12. 4), and the Chinese Biological Medicine Database (1978-2003. 2) were performed. The selection of studies, data extraction, and assessment of methodological quality were performed independently by two reviewers. The following outcomes were assessed: effectiveness of clinical symptoms, sensory nerve and motor nerve conduction velocities, and severe adverse events of Puerarin. Results Ten randomized controlled clinical trials including 726 patients met the inclusion criteria. At the end of the treatment, compared to general treatment or vitamin B, Puerarin showed significant positive effects on the total effect rate of therapy and increased peripheral nerve conduction velocity. No severe adverse events were observed during the treatment period. However, most included trials show some degree of study design or analysis defect. Conclusions Our analysis suggests that Puerarin appears to be an effective and safe treatment for diabetic peripheral neuropathy. However, due to the low quality trials included in this review, more rigorously designed, randomized, double-blind, placebo-controlled trials of Puerarin for diabetic peripheral neuropathy are needed to further assess its usefulness in diabetes peripheral neuropathy patients.