Chinese Herbal Medicine Xingnaojing Injection () for Hypoxic Ischemic Encephalopathy in Newborns: A Systematic Review and Meta-Analysis.

OBJECTIVES: To evaluate the efficacy and safety of Chinese herbal medicine Xingnaojing Injection () for newborns with hypoxic ischemic encephalopathy (HIE). METHODS: Literatures were identified by searching the PubMed, EMBASE, Cochrane Library, Cochrane Central, and four Chinese literature databases from the establishment of database to October in 2013. Relevant reference lists were also screened. Two reviewers independently evaluated the methodological quality of included studies. We also conducted the meta-analysis. RESULTS: Thirteen trials involving 1,169 patients were included. There was no trial reported death or disability at the end of follow-up period. Meta-analysis of 4 trials (n=371) showed that there was no significant difference in the reduction of mortality [risk ratios (RR)=0.48, 95% confidence intervals (CI, 0.21, 1.13), P=0.09] between the Xingnaojing and control groups. Meta-analysis of 5 trials (n=359) showed that there was significant difference in reducing the major neurodevelopmental disability [RR=0.36, 95% CI (0.19, 0.66), P=0.001]. Meta-analysis of 6 trials (n=447) showed that there was significant difference in the author self-defined symptom improvement [RR=1.25, 95% CI (1.14, 1.37), P<0.01]. No fatal side-effects were reported. CONCLUSION: Based on the limited evidence, the routine use of Xingnaojing Injection for treatment of HIE in newborns is not recommended. Further well-conducted trials are justified.

Sodium valproate for the treatment of Tourette׳s syndrome in children: a systematic review and meta-analysis.

The aims are to evaluate the efficacy and safety of sodium valproate for children with Tourette׳s syndrome (TS). We searched PubMed, EMBASE, the Cochrane library, Cochrane Central, CBM, CNKI, VIP, WANG FANG database and relevant reference lists. Five RCTs (N=247) and five case series (N=163) studies were included. Only one RCT (93 patients) evaluated total YGTSS scores and there was significant difference in the reduction of total YGTSS scores between sodium valproate and the control group (3.50±4.59 vs 7.86±7.03, P<0.01). One RCT (30 patients) evaluated motor and vocal tics, and there was significant difference in the reduction of motor and vocal tics scores between sodium valproate and haloperidol (10.45±4.15 vs 14.92±3.01, P<0.01). Meta-analysis of three RCTs (N=124) showed there was no significant difference in the reduction of the number of tics between sodium valproate and the positive control group [Relative Risk (RR)=1.09, 95%CI (0.92, 1.30), P=0.30]. The pooled proportion in five case series studies which used tics symptom improvement self-defined by authors was 80.7% (95% CI: 73.7-86.2, I(2)=0). No fatal side effects were reported. In conclusion, based on the limited evidence, the routine use of sodium valproate for treatment of TS in children is not recommended. Further well-conducted trials that examine long-term outcomes are required.

10-year trend in quantity and quality of pediatric randomized controlled trials published in mainland China: 2002-2011.

BACKGROUND: Quality assessment of pediatric randomized controlled trials (RCTs) in China is limited. The aim of this study was to evaluate the quantitative trends and quality indicators of RCTs published in mainland China over a recent 10-year period. METHODS: We individually searched all 17 available pediatric journals published in China from January 1, 2002 to December 30, 2011 to identify RCTs of drug treatment in participants under the age of 18 years. The quality was evaluated according to the Cochrane quality assessment protocol. RESULTS: Of 1287 journal issues containing 44398 articles, a total of 2.4% (1077/44398) articles were included in the analysis. The proportion of RCTs increased from 0.28% in 2002 to 0.32% in 2011. Individual sample sizes ranged from 10 to 905 participants (median 81 participants); 2.3% of the RCTs were multiple center trials; 63.9% evaluated Western medicine, 32.5% evaluated traditional Chinese medicine; 15% used an adequate method of random sequence generation; and 10.4% used a quasi-random method for randomization. Only 1% of the RCTs reported adequate allocation concealment and 0.6% reported the method of blinding. The follow-up period was from 7 days to 96 months, with a median of 7.5 months. There was incomplete outcome data reported in 8.3%, of which 4.5% (4/89) used intention-to-treat analysis. Only 0.4% of the included trials used adequate random sequence allocation, concealment and blinding. The articles published from 2007 to 2011 revealed an improvement in the randomization method compared with articles published from 2002 to 2006 (from 2.7% to 23.6%, p = 0.000). CONCLUSIONS: In mainland China, the quantity of RCTs did not increase in the pediatric population, and the general quality was relatively poor. Quality improvements were suboptimal in the later 5 years.