Clinical Trail Of Cell-broken Pieces Of Traditional Chinese Medicine Sijunzi Decotion For Spleen Qi Deficiency Syndrome

ObjectiveRandomized,single-blind and multi-center clinical trial design method were used to evaluate the effect and safety of different doses of Sijunzi decoction of cell broken wall pieces on spleen qi deficiency syndrome,with the traditional Chinese medicine of Sijunzi decoction as a control.MethodAccording to the randomized,single-blind,positive control principle,72 patients who met the inclusion criteria were divided into three groups in a ratio of 1:1:1.Test group 1(the same dose of Si junzi cell-broken pieces with traditional decoction pieces),test group 2(one third dose of Si junzi cell-broken pieces with traditional decoction pieces)and control group(Si junzi traditional decoction pieces)were all treated for 4 weeks.Main efficacy indicators,secondary efficacy indicators,and safety indicators were observed before,during,and after treatment repectively,and statistical analysis was performed using SPSS 24.0 statistical software.Results1.The scores of TCM syndromes in the three groups were lower than those before treatment(FAS:P<0.001;PPS:P<0.001),and the test group 1 was superior to the test group 2(FAS:P<0.001;PPS:P=0.002)and control group(FAS:P=0.025;PPS:P=0.049);There was no significant difference between the test group 1 and control group(FAS:P=0.246;PPS:P=1.000).2.There was no statistically significant difference in the time of disappearance between the three groups(P>0.05).Therefore,it can be concluded that the three groups have comparable effects on the efficacy of spleen deficiency symptoms.3.The difference between the test group 1(100%)and the control group(58.33%)was statistically significant in terms of the disappearance rate of abdominal pain symptom(adjusted P=0.015).The difference between the test group 1(100%)and the test group 2(63.64%)and the test group 2(63.64%)and the control group(58.33%)were not statistically significant(adjusted P=0.031 and P=1.000);The test group 1(76.47%)was superior to the test group 2(33.33%)in terms of the disappearance rate of the faint sallow(adjusted P=0.014),but the difference between the test group 1(76.47%),the test group 2(33.33%)and the control group(41.18%)were not statistically significant(adjusted P=0.037 and P=0.647).The differences between the three groups were not statistically significant in the other symptoms of the disappearance rate of spleen-qi deficiency.4.The total effective rate of the test group 1(FAS:100.00%;PPS:100.00%)was greater than the test group 2(FAS:83.33%;PPS:84.21%),and the control group(FAS:78.26%,PPS:76.92%)was the lowest,but the differences of the three groups were not significant(FAS:P=0.059;PPS:P=0.127).5.The quality of life of the three groups was improved after treatment(P<0.01).The test group 1(19.82±14.02)was superior to control group(12.70±12.80)and the test group 2(8.00± 12.74).The difference between the test group 1 and the test group 2 was significant(P=0.010).The differences between the test group 1 and control group,the test group 2 and control group were not statistically significant(P=0.223 and P=0.679).6.There were no significant differences in safety indicators and in drug-related adverse events between the three groups(P>0.05).Therefore,there was no difference in safety between the three groups.ConclusionThe same dose of Sijunzi cell-broken pieces with traditional decoction pieces has better treatment of clinical symptoms of spleen qi deficiency syndrome and improvement of symptom disappearance rate and quality of life,which has higher efficiency than one third dose of Si junzi cell-broken pieces with traditional decoction pieces and Sijunzi traditional decoction pieces;One third dose of Si junzi cell-broken pieces with traditional decoction pieces is equivalent to the efficacy of Sijunzi traditional decoction pieces,which has good curative effect in improving the symptoms of spleen qi deficiency syndrome and improving the quality of life.The same dose and one third dose of Sijunzi cell-broken pieces with traditional decoction pieces are safe for clinical use.The use of one third dose of Si junzi cell-broken pieces with traditional decoction pieces can effectively could reduce the consumption of Chinese herbal medicines and save Chinese medicine resources,which is worthy of clinical promotion.