Sarkhy Ahmed A, Al-Hussaini Abdulrahman A, Nobili Valerio
Department of Pediatric, Gastroenterology Unit, King Khalid University Hospital; Prince Abdullah Bin Khalid Celiac Disease Research Chair, King Saud University, Riyadh, Saudi Arabia.
Saudi J Gastroenterol. 2014 May-Jun;20(3):143-53. doi: 10.4103/1319-3767.132983.
To systemically evaluate the efficacy of adjuvant vitamin E on the outcomes of nonalcoholic fatty liver disease (NAFLD) and/or nonalcoholic steatohepatitis (NASH) in children.
We searched MEDLINE, PUBMED, EMBASE, the Cochrane Central Register Controlled Trials, and the Cochrane Database of Systematic Reviews over the period between January 1980 and September 2012 for the studies that examined the role of adjuvant vitamin E given at any dose or duration, alone or in combination with other interventions, on the outcome of pediatric NAFLD. The outcomes are alanine aminotransferase (ALT) normalization and histological improvement.
Five randomized trials were eligible to be included in our analysis, with a total of 270 participants. There was no statistically significant difference in the effect of adjuvant vitamin E on normalizing serum ALT [risk ratio (RR) =1.18, confidence interval (CI) =0.92-1.53, P = 0.77 for heterogeneity, I2 = 0%]. Sensitivity analysis showed that using higher doses of vitamin E, a longer duration of therapy or adding vitamin C did not change the effect on the measured outcome. Only two studies looked at histological changes as an outcome. We observed substantial heterogeneity between the two studies.
Our meta-analysis did not find a significant effect of adjuvant vitamin E over placebo in normalizing serum ALT. Data on the long-term effect of adjuvant vitamin E on histological improvements in NAFLD patients are still lacking. Larger, well-designed randomized controlled trials (RCTs) in children with histological endpoints are still needed to answer this question.
系统评价辅助使用维生素E对儿童非酒精性脂肪性肝病(NAFLD)和/或非酒精性脂肪性肝炎(NASH)结局的疗效。
我们检索了1980年1月至2012年9月期间的MEDLINE、PUBMED、EMBASE、Cochrane中心对照试验注册库和Cochrane系统评价数据库,以查找研究辅助使用任何剂量或疗程的维生素E,单独使用或与其他干预措施联合使用,对儿童NAFLD结局影响的研究。结局指标为丙氨酸氨基转移酶(ALT)正常化和组织学改善。
五项随机试验符合纳入我们分析的条件,共有270名参与者。辅助使用维生素E使血清ALT正常化的效果无统计学显著差异[风险比(RR)=1.18,置信区间(CI)=0.92 - 1.53,异质性P = 0.77,I² = 0%]。敏感性分析表明,使用更高剂量的维生素E、更长的治疗疗程或添加维生素C均未改变对测量结局的影响。只有两项研究将组织学变化作为结局指标。我们观察到这两项研究之间存在显著异质性。
我们的荟萃分析未发现辅助使用维生素E在使血清ALT正常化方面比安慰剂有显著效果。关于辅助使用维生素E对NAFLD患者组织学改善的长期影响的数据仍然缺乏。仍需要在有组织学终点的儿童中开展更大规模、设计良好的随机对照试验(RCT)来回答这个问题。