The formulation of inclusive criteria is very important for the quality of systematic reviews as well as the reliability of results. However, among the systematic reviews based on randomized controlled trials (RCTs) published in Chinese periodicals, there are differences existing in the definition of inclusive criteria of RCTs, which may lead to the incomplete or inequitable inclusion. In addition, the relatively lower quality of domestic RCTs may also cause the possibility of bias. In this study, sampling analysis is applied to assess the current situation of both the RCTs definition for inclusive criteria of domestic systematic reviews and the types of practically included RCTs, so as to figure out the existing problems.
Objective To assess the effectiveness and safety of nedaplatin combined with 5-fluorouracil (5-Fu) for advanced esophageal cancer. Methods Such databases as PubMed, The Cochrane Library, EMbase, CBM, CNKI, VIP and WanFang Data were searched from the date of their establishment to May 4th, 2012 to collect the randomized controlled trials (RCTs) about nedaplatin combined with 5-Fu versus cisplatin combined with 5-Fu for advanced esophageal cancer. According to the inclusion and exclusion criteria, two reviewers independently screened literature, extracted data and assessed the quality of the included studies. Then meta-analysis was conducted using RevMan 5.1 software. Results A total of 15 RCTs invloving 863 patients were included. The results of meta-analysis suggested that, compared with cisplatin combined with 5-Fu, nedaplatin combined with 5-Fu could improve short-term effects (RR=1.31, 95%CI 1.14 to 1.52, P=0.000 2) and reduce gastrointestinal reaction and renal function impairment, but it was associated with aggravated myelosuppression, increase of thrombocytopenia and leukopenia, and decrease of hemoglobin. There were no significant differences between the two groups in liver function impairment, diarrhea and peripheral neurovirulence. Conclusion Nedaplatin combined with 5-fluorouracil can increase short-term effects and reduce gastrointestinal reaction and renal function impairment. However, nedaplatin is associated with aggravated myelosuppression, so it should be applied in clinic with cautious. Nedaplatin combined with 5-fluorouracil can be used as a replacement chemotherapy regimen for advanced esophageal cancer, but the evidence about long-term effects and safety is still required. For the quality and quantity limitation of the included studies which decreases the level of evidence, so the conclusion of this systematic review only provides some references for clinical practice and research.
Objective To systematically evaluate the effectiveness and safety of zoledronic acid combined with radiotherapy in treating bone metastasis of malignant tumor. Methods Such databases as PubMed, EMbase, The Cochrane Library (Issue 10, 2012), CBM, CNKI, VIP and WanFang Data were searched to collect randomized clinical trials (RCTs) on bone metastasis of malignant tumor from inception to October, 2012. References of included studies were also retrieved. Two reviewers independently screened studies according to exclusion and inclusion criteria, extracted data, and assessed the methodological quality. Then, meta-analysis was performed using RevMan 5.1 software. Results Twenty nine trials were included involving 2 021 patients. The results of meta-analysis showed that, compared with the radiotherapy alone group, zoledronic acid combined with radiotherapy improved the effectiveness rate of pain relieving at the end of treatment (OR=3.08, 95%CI 2.30 to 4.12, Plt;0.000 01), the effectiveness rate of pain relieving two weeks after treatment (OR=3.39, 95%CI 2.52 to 4.56, Plt;0.000 01), the quality of life (OR=2.74, 95%CI 1.66 to 4.52, Plt;0.000 01) and the ability of movement (OR=2.96, 95%CI 2.16 to 4.05, Plt;0.000 01). Zoledronic acid combined with radiotherapy also reduced the incidence of new bone metastasis (OR=0.21, 95%CI 0.10 to 0.45, Plt;0.000 1) and the incidence rate of bone-related events (OR=0.17, 95%CI 0.03 to 0.92, P=0.04). The adverse reactions of zoledronic acid combined with radiotherapy such as fever (OR=11.92, 95%CI 6.31 to 22.48, Plt;0.000 01) and hypocalcaemia (OR=8.82, 95%CI 1.61 to 48.36, P=0.01), significantly increased. Conclusion Compared with radiotherapy alone, zoledronic acid combined with radiotherapy can relieve bone metastatic pain, effectively enhance patients’ ability of movement, improve quality of life, and decrease new bone metastasis and the occurrence of bone-related events.
Objective To evaluate the clinical effectiveness and safety of radiotherapy (RT) combined with hyperthermia (HT) for locally-advanced non-small cell lung cancer (NSCLC). Methods The randomized controlled trials (RCTs) on RT plus HT vs. RT alone for locally-advanced NSCLC were searched in PubMed, The Cochrane Library, EMbase, VIP, CNKI, CBM and other electronic databases from inception to November 2011. Two reviewers independently screened studies according to the inclusion and exclusion criteria, extracted data and assessed quality of the included studies independently. Then meta-analyses were performed using RevMan 5.0.2. Results A total of 9 RCTs involving 527 cases were included. The results of meta-analyses showed that compared with the RT alone group, the RT plus HT group could increase the total effective rate (OR=2.08, 95%CI 1.44 to 3.02, P=0.000 1) and the progression-free survival rate (OR=4.85, 95%CI 1.88 to 12.48, P=0.001). However, there were no significant differences between the two groups in the overall survival rate (OR=1.13, 95%CI 0.64 to 1.98, P=0.68), symptoms improve rate (OR=3.37, 95%CI 1.68 to 6.78, P=0.000 6), and other acute adverse reactions. Conclusion Current results of systematic review show that radiotherapy combined with hyperthermia can obviously increase the total effective rate and improve the progression-free survival rate for locally-advanced NSCLC, and doesn’t increase the incidence of adverse reaction. Therefore, radiotherapy combined with hyperthermia is a fairly reasonable and effective treatment method for locally-advanced NSCLC.
ObjectivesTo evaluate the methodological and reporting quality of clinical guidelines and consensus for esophageal cancer.MethodsDatabases including PubMed, EMbase, Web of Science, CBM, WanFang Data and CNKI were electronically searched and major guideline websites such as GIN, NICE, NGC and Yimaitong were also searched to collect guidelines and consensus for esophageal cancer from inception to August 2018. Two reviewers independently screened the literatures and extracted data according to the inclusion and exclusion criteria and then evaluated the quality of the included guidelines using the AGREE II and RIGHT instruments.ResultsA total of 26 esophageal cancer guidelines and consensus were included. The mean scores for each domain of AGREE II was 49.63% for scope and purpose, 25.16% for stakeholder involvement, 23.42% for rigor of development, 49.25% for clarity of presentation, 16.91% for applicability, and 21.07% for editorial independence. The item with the highest reporting rate among the RIGHT evaluation items was 5 (84.62%), followed by 1a (80.77%), 1c (65.38%), 13a (65.38%), and 4 (61.54%), and the remaining items were all reported below 50%. Results of subgroup analysis showed that the guidelines and consensus developed based on the evidence-based medicine method had higher average scores in the six domains of AGREE II and the RIGHT score than the guidelines and consensus developed based on expert opinions or reviews. The foreign guidelines and consensus had higher average scores in the three domains of AGREE II (formulation rigor, clarity, editorial independence) and the RIGHT score than the domestic guidelines.ConclusionsThe methodological and reporting quality of the guidelines and consensus on esophageal cancer is low, with the guidelines and consensus in China even lower, requiring further improvement. It is suggested that the guideline developers should refer to the standards such as AGREE II and RIGHT to develop high-quality guidelines and promote their application, so as to better guide the standardized diagnosis and treatment of esophageal cancer.