Objective To assess the effectiveness and safety of trazodone versus alprazolam on adults’ generalized anxiety disorder (GAD). Methods Such databases as PubMed (1980 to May 2012), CBM (1990 to May 2012), VIP (1989 to May 2012), CNKI (1990 to May 2012) and WanFang Data (1990 to May 2012) were searched to collect the randomized controlled trials (RCTs) about trazodone vs. alprazolam for adults’ GAD. According to the inclusion and exclusion criteria, two reivewers screened literature, extracted data and assessed the quality of the included studies, then meta-analysis was conducted using RevMan 5.0 software. Results A total of 5 RCTs involving 403 patients were included. The results of meta-analysis showed that: a) After four-week treatment, there were no significant differences between the two groups in the HAMA scores (RR=1.04, 95%CI 0.95 to 1.13, P=0.38) and cure rate (RR=1.05, 95%CI 0.75 to 1.48, P=0.76); and b) The somnolence rate of the trazodone group was lower than that of the alprazolam group (RR=0.42, 95%CI 0.25 to 0.72, P=0.001). But there were no significant differences between the two groups in dizziness (RR=0.52, 95%CI 0.27 to 1.01, P=0.05), fatigue (RR=0.10, 95%CI 0.01 to 1.41, P=0.09), and poor appetite (RR=2.82, 95%CI 0.28 to 28.23, P=0.38). Conclusion There is no significant difference between razodone and alprazolam in the effectiveness when treating GAD, but razodone has lower side effects while alprazolam tends easily to cause somnolence. For the quantity limitation and low methodological quality of the included studies, this conclusion still needs to be further proved by more high quality RCTs.
Objective To assess the efficacy and safety of hyperbaric oxygen treatment for patients with post-stroke depression. Methods Randomized controlled trials (RCTs) about hyperbaric oxygen treatment with placebo or open control in patients with post-stroke depression were comprehensively retrieved in PubMed (1966 to 2012.12), EMbase (1974 to 2012.12), EBSCO (1965 to 2012.12), CENTRAL (2012.11), CBM (1978 to 2012.12), CNKI (1980 to 2012.12), and VIP (1989 to 2012.12). References of the included articles were also retrieved. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the quality of the included studies. Then, meta-analysis was performed using RevMan 5.0. Results Twelve trials involving 822 patients were included, all of which were randomized non-placebo controlled trials. The results of meta-analysis of 12 trials (n=822) showed, the improvement of depression symptoms in the HBO group was better than that in the control group (MD=4.82, 95%CI 3.12 to 6.52). However, funnel plot showed that publication bias was large. After removing three trials for sensitive analysis, the results showed that the improvement of depression symptoms in the HBO group was still better than that in the control group (MD=3.91, 95%CI 3.35 to 4.47). Adverse events were reported in 2 trials, including dizziness, palpitation, mild earache, tinnitus, etc. However, no severe adverse events occurred. Conclusion Current evidence indicates that, HBO can effectively reduce the score of HAMD and no serious adverse reactions occurred. It’s necessary to further carry out high quality randomized controlled trials with large sample size due to limited quality and quantity of the included studies, so as to assess its effectiveness and safety.
Objective To evaluate the effectiveness of topical fluoride on prevention of enamel demineralization during the orthodontic treatment in China. Methods The Cochrane Library（Issue 9, 2012), MEDLINE (1996 to 2012.10), EMbase (1974 to 2012.10), CNKI (1994 to 2012.10), VIP (1994 to 2012.10), WanFang data (1998 to 2012.10) and CBM (1978 to 2012.10) are searched for the randomized controlled trials (RCTs) and quasi-Randomized controlled trials (qRCTs) about topical fluoride preventing enamel demineralization during the orthodontic treatment. The bibliographies of the included studies were searched, too. Two reviewers evaluated the quality of the included studies and extracted data critically and independently, and then the extracted data were analyzed using RevMan 5.2 software. Results A total of 20 studies within 19 articles were included, which involved 26 323 teeth. The results of meta-analysis results show that, the rate of enamel demineralization of the fluoride varnish group (8.4%) was lower than that of the control group (16.0%) (OR=0.44, 95%CI 0.33 to 0.59, Plt;0.000 01); the rate of enamel demineralization of the fluoride coating group (8.3%) was lower than that of the control group (17.7%) (OR=0.46, 95%CI 0.35 to 0.60, Plt;0.000 01); the rate of enamel demineralization of the fluoride toothpaste group (9.0%) was lower than that of the control group (14.5%) (OR=0.59, 95%CI 0.49 to 0.71, Plt;0.000 01); the rate of enamel demineralization of the fluoride foam group (11.6%) was lower than that of the control group (18.2%) (OR=0.48, 95%CI 0.24 to 0.96, P=0.04); the rate of enamel demineralization of other groups (12.0%) was lower than that of the control group (21.8%) (OR=0.43, 95%CI 0.30 to 0.60, Plt;0.000 01). Two outcomes were low quality in the GRADE system and the other three are very low quality. Conclusion Current domestic evidence shows that topical fluoride is effective to prevent enamel demineralization during the orthodontic treatment. However, given the low methodological quality of most included studies, this conclusion still needs to be further proved by conducting more strictly-designed, high-quality and large-scale studies.
Objective To assess the efficacy of telbivudine in the treatment of chronic hepatitis B (CHB). Methods Randomized controlled trials (RCTs) of telbivudine therapy vs. lamivudine therapy in both Chinese and English were retrieved from seven electronic databases with a cut-off date in February 2010, including PubMed, EMbase, VIP, CBM, CNKI, and The Cochrane library. The meta-analyses and evaluation on methodology quality were performed for the included studies. Results Two RCTs as Grade-A study were included. The meta-analyses showed that telbivudine was superior to lamivudine in aspects of therapeutic response (RR=1.28, 95%CI 1.10 to 1.48, P=0.001), ALT normalization (RR=1.12, 95%CI 1.01 to 1.23, P=0.02), and PCR-negative HBV DNA or below the lower limit (RR=1.44, 95%CI 1.36 to 1.53, Plt;0.000 01), primary treatment failure (OR=0.28, 95%CI 0.18, to 0.43, Plt;0.000 01), viral breakthrough (OR=0.38, 95%CI 0.32 to 0.47, Plt;0.000 01) and viral resistance (OR=0.44, 95%CI 0.36 to 0.55, Plt;0.000 01). Conclusion Based on the current clinical evidence, telbivudine demonstrates superiority in comparison with lamivudine on all direct measures of antiviral efficacy for CHB. Because of the short follow-up duration and the small sample size of the included studies, it is expected to further discuss the long-term efficacy.
Objective To assess the clinical effectiveness and safety of paclitaxel liposomes and carboplatin for ovarian cancer. Methods The databases such as The Cochrane Library, PubMed, EMBASE, CNKI and CBM were searched to collect all randomized control trials (RCTs) about the clinical effectiveness and safety of paclitaxel liposomes and carboplatin for ovarian cancer. Literatures were screened according to the inclusive and exclusive criteria, the data were extracted, the methodological quality of the included studies was assessed in line with Cochrane Handbook 5.0.1, and Meta-analysis was performed by using RevMan 5.0.24 software. Results Three RCTs involving 214 patients were included. Meta-analysis showed that compared with the paclitaxel plus carboplatin group, the paclitaxel liposomes plus carboplatin group didn’t show significant differences in the total effective rate (P=0.62), while it was obviously superior in reducing the adverse events, such as muscle and joint pain (Plt;0.000 01), peripheral neurotoxicity (P=0.04), nausea or vomiting (P=0.000 2), facial blushing (P=0.03) and rashes (P=0.003). But there were no significant differences between the two groups in trichomadesis, dyspnea, diarrhea, bellyache and blood system abnormalities. Conclusion As current clinical evidences shows, the paclitaxel liposomes and carboplatin in treating ovarian cancer is as effective as the paclitaxel and carboplatin, and it can reduce some of the adverse reactions. Therefore, the paclitaxel liposomes and carboplatin is available for ovarian cancer as a new, safe and effective treatment. Due to small scale and low quality of the included studies, this conclusion has to be further proved with more high-quality, large-scale, and double-blind RCTs.
Objective To systematically assess the correlation between smoking and the risk of endometriosis, so as to offer scientific basis to health education and preventing decision. Methods A literature search was performed in The Cochrane Library, Pubmed, Embase, CBM, CNKI and Wanfang database to collect the case control studies on the correlation between smoking and endometriosis. Two reviewers independently screened the literatures according to the inclusion and exclusion criteria, extracted the data, assessed the quality, and then conducted Meta-analyses on the 13 included RCTs by using RevMan 5.0 software, with calculation of the OR value and 95%CI. Results A total of 13 case control studies involving 14260 cases were included, of which 1900 ones were endometriosis. The quality assessment indicated that 2 studies were in quality of Level A, 4 were Level B, 7 were Level C, totally meant low quality. Meta-analyses showed that compared with non-smokers, there was no increasing possibility of endometriosis in smokers (OR= 0.91, 95%CI 0.82 to 1.02). The geographical subgroup analyses showed there was no significant difference in the incidence of endometriosis between the non-smokers and smokers in North America (OR=0.96, 95%CI 0.84 to 1.08), but a significant difference was found between non-smokers and smokers in Europe (OR=0.72, 95%CI 0.54 to 0.97). Conclusion There is no causative relationship between smoking and incidence of endometriosis. However, more high-quality trials are expected for further study because of the heterogeneity and poor quality of the current included studies.
Objective To analyze the effects and recurrence rate of single miconazole and the miconazole plus living preparation of lactobacillus for the treatment of the uncomplicated vulvovaginal candidiasis. Methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2008) MEDLINE (1966 to January 2009); PubMed (1966 to January 2009); EMbase (1966 to January 2009); CNKI (1966 to January 2009), and the Chinese Biomedicine Database (CBM) (1966 to January 2009) to identify randomized controlled trials of single miconazole versus the miconazole plus living preparation of lactobacillus.The quality of the included trials was assessed. RevMan 5 software was used to conduct meta–analysis. Results Eight trials involving 5 156 patients were included in the effect analysis. Meta-analysis showed miconazole plus with living preparation of lactobacillus was better compared with just miconazole (RR=0.96, 95%CI 0.92 to 1.00, Z=2.12, P=0.03; RR=0.92, 95%CI 0.85 to 0.99, Z=2.17, P=0.03).Seven trials involving 4 852 patients were included in recurrence rate analysis. Meta-analysis showed miconazole plus living preparation of lactobacillus had lower recurrence rate compared with single miconazole (RR=3.72, 95%CI 1.94 to 7.13, Z=3.97, Plt;0.000 1; RR=12.85, 95%CI 8.27 to 19.96, Z=11.37, Plt;0.000 01). Conclusion Currently available evidence shows that the effect in the combined group is better, and the recurrence rate is lower.
Objective To assess the efficacy of Tongxinluo for diabetic kidney disease. Methods we conducted a systematic review of randomized controlled trials (RCTs) in which Tongxinluo was used to treat diabetic kidney disease. And we screened relevant studies according to predefined inclusion and exclusion criteria, evaluated the quality of the included studies, and performed meta-analyses by using The Cochrane Collaboration’s Revman 5.0 software. Results A total of 11 RCTs were enrolled in the review. The results of meta-analysis showed that Tongxinluo was better on attenuating 24 hour urinary protein,BUN and UAER; Tongxinluo was not superior to no treatment on the improvement of Scr and Ccr; Tongxinluo was better than no treatment on the Regulation of blood lipids, such as TC, TG, LDL-C. However, Tongxinluo might have similar effects on the improvement of HDL-C; Tongxinluo was better than no treatment on the improvement of FBG, but xuezhikang was not superior to no treatment on the improvement of P2BG and HbA1c. Tongxinluo was better than no treatment in decreasing plasma endothelin (ET). No significant adverse effects or Allergic reactions were reported. Conclusion The evidence currently available shows that Tongxinluo has some effect and is relatively safe in treating patients with diabetic kidney disease.Due to a high risk of selection bias and detection bias in the included studies, the evidence is insufficient to determine the effect of Tongxinluo. Further large-scale trials are required to define the role of xuezhikang in the treatment of DKD.
Objective To evaluate the effectiveness and safety of calcineurin inhibitor (CNI) withdrawal from target-of-rapamycin-inhibitor(TOR-I)-based immunosuppression in kidney transplant recipients. Methods We searched MEDLINE, EMbase, SCI, CBM and The Cochrane Library to screen randomized controlled trials (RCT) of calcineurin inhibitor (CNI) withdrawal from target-of-rapamycin-inhibitor-(TOR-I)-based immunosuppression in kidney transplant recipients. The search was updated in Semptember 2009. The quality of the included trials was assessed. RevMan 5.0 software was used for meta-analyses. Results A total of 14 reports from 10 RCTs were identified. Five RCTs were graded A and five graded B. The meta-analyses indicated: RR (95%CI) values of the 1, 2, 4-year acute rejection rates were 1.64 (1.19, 2.27), 1.53 (1.06, 2.22) and 1.21 (0.73, 1.98), respectively; RD (95%CI) values of 1, 2, 4-year patient survival rates were – 0.01 (– 0.02, 0.01), – 0.00 (– 0.03, 0.02) and 0.03 (– 0.01, 0.08), respectively; RD (95%CI) values of 1, 2, 4-year graft survival rates were 0.00 (– 0.02, 0.02), 0.00 (– 0.03, 0.04) and 0.07 (0.01, 0.12), respectively; and glomerular filtration rate WMD was 9.50 and 95%CI 2.96 to 16.03. Conclusion Based on the current evidence, compared to CNI, CNI withdrawal from sirolimus-based immunosuppression in kidney transplantation could be advantageous for renal function. One-year acute rejection rate and 4-year graft survival rate increase. One-year patient/graft survival and fouryear acute rejection rate remain virtually unvariable. The long-term results need further confirmation.
Object To collect and summarize high quality clinical evidence on the use of hyperbaric oxygen (HBO) in health care generally. Method We searched MEDLINE (1980-2006), The Cochrane Library (Issue 1, 2006) and the China Biomedicine Database (1982-2006) for systematic reviews, meta-analyses and randomized controlled trials. The quality of included studies was critically evaluated. Result Thirteen systematic reviews (12 Cochrane reviews) on HBO were included. Results showed that HBO had some beneficial effect on acute coronary syndrome, ischemic stroke, multiple sclerosis, malignant otitis externa, idiopathic sudden sensorineural hearing loss and tinnitus. It might also promote chronic wound healing and relieve radiation damage.Conclusions Since the avaliable randomized controlled trials for the systematic reviews we included are too small, further well-designed multicentre large-scale trials are needed to determine the efficacy and safety of HBO .