A Novel Approach for Evaluation of Food Functions and Safety Applied in RR GM Soybeans

[Objective] This study aimed to evaluate tbe healthy risk of genetically modified （ GM ） soybeans by using a novel approach for functions and safety of food. [ Me^od] Different from traditional evaluation of substantial equivalence, three great innovations were performed in this study, involving in basic diet, evalu- ation approaches and principle, as well as the clarification of connotation differences between absolute and relative mass of organs. Hence a novel BDI-GS （Bendib Damage Index and General Score） evaluation approach was established and applied in comparative evaluation between RR GM and natural soybeans. Healthy male ICR mice during linear growth were selected; experimental mice were fed with 15% RR GM soybeans and 15% natural soybeans blending maize meal diets, and control mice were fed with single maize meal diet for 13 d; the mice were dissected after collecting blood samples and perfectly obtained nine organs or tissues to re- cord their masses and conduct statistical analyses. [Result] Plenty of matching information was obtained through simple design. The growth performance of treated mice was markedly of individual differences, some mice were thwarted due to regular intake of RR soybeans. Meanwhile, the functions and safety of RR soybeans were markedly lowered in overall nutritional and healthy effects than those of natural soybeans expressed in GS values, and presents some declines in nutrition and health of thymus, pancreas and spermary; especially, it can make thymus immune （P 〈0.05） in markedly lower level than that of natural soybeans. [ Conclusion] Therefore, major troubles and risks of RR soybeans intake are of personal risks in different degrees, in addition, it may increase sub-health and related chronic epi- demics risks, and herein it will presents certain safety issues. The creation of this novel evaluation system provides a simple and available evaluation approach for functions and potential risks revelation of food effects, and will yield far-reaching influences to safety evaluation and healthy development of GM foods, as well as public health.

Tacrolimus and mycophenolate mofetil as second-line treatment in autoimmune hepatitis:Is the evidence of sufficient quality to develop recommendations?

BACKGROUND The standard management of autoimmune hepatitis(AIH)is based on corticosteroids,alone or in combination with azathioprine.Second-line treatments are needed for patients who have refractory disease.However,high-quality data on the alternative management of AIH are scarce.AIM To evaluate the efficacy and safety of tacrolimus and mycophenolate mofetil(MMF)and the quality of evidence by using the Grading of Recommendations Assessment,Development and Evaluation approach(GRADE).METHODS A systematic review and meta-analysis of the available data were performed.We calculated pooled event rates for three outcome measures:Biochemical remission,adverse events,and mortality,with their corresponding 95%confidence intervals(CI).RESULTS The pooled biochemical remission rate was 68.9%(95%CI:60.4-76.2)for tacrolimus,and 59.6%(95%CI:54.8-64.2)for MMF,and rates of adverse events were 25.5%(95%CI:12.4-45.3)for tacrolimus and 24.1%(95%CI:15.4-35.7)for MMF.The pooled mortality rate was estimated at 11.5%(95%CI:7.1-18.1)for tacrolimus and 9.01%(95%CI:6.2-12.8)for MMF.Pooled biochemical remission rates for tacrolimus and MMF in patients with intolerance to standard therapy were 56.6%(CI:43.4-56.6)vs 73.5%(CI:58.1-84.7),and among non-responders were 59.1%(CI:48.7-68.8)vs 40.8%(CI:32.3-50.0),respectively.Moreover,the overall quality assessments using GRADE proved to be very low for all our outcomes in both treatment groups.CONCLUSION Tacrolimus and MMF are in practice considered effective for patients with AIH who are non-responders or intolerant to first-line treatment,but we found no high-quality evidence to support this statement.

Patient-reported Outcomes (PROs): An Approach to Evaluate Treatment Efficacy of Chinese Medicine or Integrative Medicine

Chinese medicine (CM) has been an experience based practice over the past three thousand years. The safety and efficacy of CM has been practised through experience, rather than nowadays’ modern scientific measurements. In this way, the development of CM has not been keeping pace with the advance in science and technology and the progress in orthodox medicine. In order to meet the requirements of modern science and technology, an evidence based approach must be adopted. Reassurance is needed to convince people for safety and efficacy of CM and give confidence to the evidence based demands ——“Tradition is confirmed by Modern Science” (1) .