Randomized Double-blind Placebo-Controlled Clinical Studies On The Treatment Of Functional Diarrhea From The Perspective Of Spleen

Objective: To evaluate the safety and efficacy of TCM in treating functional diarrhea(F-D/FDi) from the perspective of spleen through observing the experiments before and after taking traditional materia medica, and to clarify the basic scientific connotation of TCM theory “spleen governing transportation and transformation” and “spleen governing blood”. To explain the mechanisms and laws of TCM in treating F-D/FDi from the perspective of spleen, then enrich and develop the theory of visceral manifestations.Methods: 60 cases of patients with F-D/FDi which meet the inclusion criteria were selected and divided into two groups by randomized, double-blind, placebo controlled clinical research design principles. According to clinical syndrome differentiation, the cases were divided into spleen deficiency and dampness retention group and spleen yang deficiency group with 30 cases in each. Safety inspection of two groups had been conducted before the experiment. The safety inspection includes blood, urine, and stool routine examination and fecal occult blood test, hepatic function(ALT?AST), renal function(Cr?BUN) and ECG. These tested were conducted before and after the experiment. All the medications of Chinese medicinal granula were allocated by the total group with 12 g a pack. The placebo group was given placebo. The experiment was conducted strictly by the randomized, double-blind principles.The treatment group: spleen deficiency and dampness retention group was given compound granules orally which includes Sunburn Astragalus?codonopsis?fried rhizoma atractylodis macrocephalae? poria?simmer Rosa banksiae?villosum?barley ?Dry ginger?Seeds of plantaginis?Sunburn licorice;Usage: one pack each time, three times a day, administered after dissolved for 4 weeks.The spleen yang deficiency group was given granules orally which includes Sunburn Astragalus?codonopsis?fried rhizoma atractylodis macrocephalae? poria?simmer Rosa banksiae?villosum?fried monkshood Dry ginger?nutmeg?Seeds of plantaginis?Sunburn licorice.Usage: one pack each time, three times a day, administered after dissolved for 4 weeks.The control group was given placebo which consists of placebo adding 1/20 granule. The usage and dosage were the same to the treatment group.Results: 1. There were 30 cases in treatment group, with 0 recovered case, 5 cases with remarkable effect, 23 cases with effect and 2 invalid cases, total effective rate was 93%; There were 30 cases in control group, with 0 recovered case, 1 cases with remarkable effect, 10 cases of effect and 19 invalid cases, total effective rate was 36%; indicates that treatment group clinical integrated effect is better than of control group, treatment group explicit efficiency is better than that of control group(P<0.05), and general impression treatment group has efficiency(53%) is better than control group(10%), both differences has statistics meaning(P<0.05).2.Two groups of syndromes in treating patients after treatment of TCM symptom score were improved compared with the results before treatment, there are differences compared with the control group(P<0.05), and for patients with functional diarrhea, frequent stools were significantly improved, the effect of treatment group was better than the that of control group(P<0.05).3. Two groups of syndromes of patients' quality of life after treatment in the treatment group was better than that of control group, showing a statistically significant difference(P<0.05);4. Functional diarrhea patients have different degrees of anxiety and depression.5. Spleen-deficiency syndrome patients in the treatment group after treatment with anxiety and depression were improved than those of control group, showing a statistically significant difference(P<0.05); spleen deficiency and dampness stagnancy syndrome after treatment in patients with anxiety, depression showing no significant difference in the control group(P>0.05).6. Functional diarrhea was found most in the 20-30 age group, male were more than female;7.Two groups of patients with no apparent adverse reaction during the treatment period, before and after the treatment of laboratory examination RBC, ECG?ALT?AST and BUN?Cr function and renal function were not found, and security.Conclusion:TCM "from the perspective of spleen" treatment in improving clinical symptoms in patients with functional diarrhea, diarrhea frequency, stool shape, quality of life and status of anxiety and depression, than the placebo group, the effective rate is higher than the placebo group.