The Efficiency And Safety Of Compound E Jiao Jiang In Treating Postpartum Anemia With Qi And Blood Deficiency Syndrome:A Randomized And Control LED Clinical Study

ObjectiveTo evaluate the efficacy and safety of compound E Jiao Jiang?cEJJ?in treating postpartum anemia?PA?with Qi and Blood deficiency.To elaborate the relationship between the red blood cell?RBC?,white blood cell?WBC?,iron metabolism index and the Qi-blood deficiency in PA women.To study the relationship between Qi-blood deficiency and quality of life?QOL?among PA women,and to assess the value of QOL used as a therapeutic indicator in the clinical research of TCM treating obstetric diseases.To evaluate the influence of adding obstetric items on the reliability and validity of the current syndrome scale of Qi-blood deficiency.MethodsIn this study,a randomized,parallel controlled clinical trial was designed to enroll PA patients with Qi-blood deficiency who delivered in two general hospitals.A total of 275 women met the inclusion criteria and were randomized into experimental group?oral cEJJ?and control group?oral Iron?.The laboratory index,the score of TCM symptoms,the score of QOL and the safety were evaluated before and 2nd,6th week after the treatment.Basing on the TCM theory of combination of disease and syndrome,and using the method of literature review,literature research,teaching materials review and expert consultation,we added two items about lochia and lactescence into the existing syndrome scale of Qi-blood deficiency,and a new syndrome scale of Qi-blood deficiency was formulated and used to assess PA patients.Statistical method was adopted to evaluate the reliability and validity of the new syndrome scale.ResultsWe enrolled 275 women in this project.A total of 19 cases were dropped off,all of which were lost to follow-up,and 4 cases were excluded due to a diagnosis of thalassemia in postpartum period.Eventually,252 women completed the trail,133 women in experimental group and 119 women in control group.At baseline,the demographic and clinical characteristics of the two groups were balanced and comparable.The results are as follows:1.Effect on red blood cell index:Two weeks after treatment,the effective rates of hemoglobin?Hb?,red blood cell volume distribution width?RDW?,immature reticulocyte fraction?IRF?,percentage of high fluorescent reticulocyte?HFR%?,percentage of middle fluorescent reticulocyte?MFR%?,and percentage of low fluorescent reticulocyte?LFR%?in the oral cEJJ group were apparently higher than those in the oral iron group,the differences between two groups were statistically significant?P<0.05?,while the effective rates of mean corpuscular volume?MCV?and reticulocyte count?Ret?were not significantly different between two groups?P>0.05?.Six weeks after treatment,the effective rates of red blood cell index mentioned above in cEJJ group were all slightly higher than those in iron group,but there was no significant difference between two groups?P>0.05?.2.Effect on iron metabolism index:Two weeks after treatment,the level of serum iron?SI?was significantly increased?P=0.001?while the level of serum ferritin?SF?was slightly decreased?P=0.308?after being treated with cEJJ.The level of SI and SF both were obviously increased after being treated with oral iron preparation(P_SI=0.002;P_SF<0.001).But there was no significant difference in the level of SI and SF between the two groups(P_SI=0.867,P_SF=0.085).Six weeks after treatment,the SI levels in the two groups were much higher than those before treatment?P<0.001?.The SF level in experimental group had little increase?P=0.193?,while it had markedly increase in control group?P<0.001?.The SI and SF levels in women treated with iron increased more significantly than those in women treated with cEJJ,there were significant differences between the two groups(P_SI<0.001;P_SF<0.001).3.Effect on TCM syndrome:Compared with the treatment of oral iron,two weeks after treatment,the treatment of cEJJ had greater improvement in Qi-blood deficiency and Blood deficiency.After six weeks,the improvement in Qi-blood deficiency,lochia and lactescence in the cEJJ group were significantly greater than those in iron group?P<0.001?.4.Effect on life quality:Treatment of cEJJ for two weeks later,PA women could obviously improve the QOL,and markedly increase the physical function?PF?,vitality?VI?,and role-emotional?RE?dimensions compared with the women treated by oral iron(P_QOL=0.026,P_PF=0.002,P_VI=0.0001,P_RE=0.038).Six weeks later,women treated by cEJJ had much better QOL,and much better VI and RE dimensions than women treated by iron(P_QOAL=0.019,P_VI=0.008,PRE=0.012).5.Correlativity:The Blood deficiency syndrome was negatively correlated with RBC count and Hb concentration(rRBC=-0.21,P_RBC<0.001;r_Hb=-0.14,P_Hb=0.028)and was positively correlated with Ret count,IRF and RDW(rRet-0.15,P_Ret=0.019;r_IRF=0.20,P_IRF=0.001;rRDW=0.37,P_RDW<0.001).The Qi-blood deficiency?QBD?,Qi deficiency syndrome?QD?and Blood deficiency syndrome?BD?was negatively correlated with the level of SI,respectively(r_QBDD=-0.20,P_QBD=0.002;r_QD=-0.16,P_QD=0.01;r_BD=-0.17,P_BD=0.006).But all of their absolute correlation coefficient values were small.6.Reliability and validity of the new syndrome scale:After adding two obstetric items,lochia and lactescence,the Cronbach' s a coefficient increased from 0.58 to o.62 and 0.65,respectively.The spearman-Brown coefficient increased from 0.62 to 0.69 and 0.74,respectively.Either way,the elevated coefficient indicates that the reliability of the new syndrome scale increases.The goodness of fit index?GPI?closed to 1 and the adjusted goodness of fit index?AGFI?equaled to 0.862 and less than 0.90,moreover the value of ?²/?df? less than 2,these suggest that the fitting degree of the model ispreferable and the validity of new scale increases.7.Safety analysis:After 2-week oral iron treatment,25 women had gastrointestinal side reactions,while women treated by cEJJ had no obvious side reaction.After 6-week treatment,22 women of oral iron group still had gastrointestinal side reactions,15 women of oral cEJJ group appeared symptoms of inflammation.7 of 141 patients?4.96%?lost to follow up in cEJJ group and 12 of 134 patients?8.96%?lost to follow up in iron group.All the above differences were significant statistically?P<0.05?.Conclusions1.Compared with oral iron therapy,oral cEJJ can increase the Hb concentration,and improve reticulocyte index more rapidly and significantly.But after long course of treatment,there was no significant difference between the two treatment methods for the maternal Hb concentration and reticulocyte index.Regardless of treatment course,no significant effect on the SF level of PA women treated by cEJJ.Oral cEJJ has fewer side effects and better patient compliance,and is worthy for being widely used in treatment of PA.2.Compared with oral iron therapy,cEJJ is markedly superior in improving the Qi-blood deficiency and the life quality of PA women.After short course treatment,the advantage of oral cEJJ is reflected in the improvement of blood deficiency syndrome,while after long course treatment,its advantage is reflected in the improvement of lochia and lactescence.Oral cEJJ treatment can improve the physical performance associated with the nutrition of limbs,muscles and bones,and can improve the mental activity including energy,spirit,emotion and feeling.3.It is recommended to use a specific Syndrome Scale in the clinical research of the treatment of PA with TCM.and to add some obstetric items,such as lactescence and lochia,in the Syndrome Scale.