Literature Study And Multi-center Clinical Verification Of Oral Chinese Medicine For Differential Treatment On Hemorrhoids

Objective To provide evidence for formulating traditional Chinese medicine standards for the diagnosis and treatments of hemorrhoid disease; To provide a model research process for common problems in the standardization research of other anorectal diseases.Methods Taking oral Chinese herbs treating hemorrhoid disease based on different TCM syndrome types for example. Following the principles and methods of DME (Design, Measurement and Evaluation in Clinical Research) and EBM (Evidence-Based Medicine), the work of literature searching, data mining and clinical sample survey were done with the purpose of looking for evidence for the syndrome types and clinical prescriptions of hemorroid disease. Finally, the results from above works were verified through multi-center clinical trials.Results1. Data mining combined with clinical sample survey and expert questionnaire showed that TCM syndrome types of hemorrhoid disease are:intestinal collaterals injury due to wind, qi stagnation and blood stasis, dampness-heat diffusing downward, spleen deficiency and qi sinking.2. According to the frequency of the usage of each herb and the characteristics of medicine compatibility for each syndrome type from literature, formulate prescriptions for each syndrome type of hemorrhoid disease in multi-center clinical trials. After7days of treatment, the results show that276patients completed treatment, who are of different syndrome types and symptoms.VAS scores of each group are lower after treatment, statistically significantly different from before (P<0.05). There was no statistically significant difference of gender distribution between the groups (P>0.05). There was statistically significant difference of age distribution between the groups (P<0.05). In all syndrome-type groups, the age of spleen-deficiency-and-qi-sinking group was older than others. And, in all single-symptom groups, the age of "prolapes" group was older than others.Conclusions1. Main types of syndrome for hemorrhoid disease from literature data mining, clinical sample survey and expert questionnaire were similar.2. The treatment on hemorrhoid disease with oral Chinese herbs based on different syndrome types can improve patients’clinical symptoms and the quality of life.