The Clinical Research On The Treatment Of Sequelae Of Chronic Pelvic Inflammatory Disease (Syndrome Of Damp-heat And Blood Stagnation,Impairment Of Both Qi And Blood)with Caohong Capsule

Objective:This study is aimed to evaluate the efficacy and security of Caohong capsule in treating sequelae of chronic pelvic inflammatory disease (syndrome of damp-heat and blood stagnation,impairment of both Qi and blood), by comparing with placebo capsule treatment, and to provide clinical evidence for its application.Methods:48patients with sequelae of chronic pelvic inflammatory disease, which diagnosed as syndrome of damp-heat and blood stagnation impairment of both Qi and blood,were randomly divided into test group or control group equally, with double-blind, multiple-center method. Test group were treated with Caohong capsule, while control group with placebo capsule for8weeks. The clinical symptoms and signs were observed and effectiveness and security related dates were assessed of the two groups both before and after treatment.Results:(1) single symptom curative effect:all the symptoms in test group including lower abdominal pain, lack of energy, and abnormal leucorrhea, were alleviated significantly after the therapy of Caohong capsule; additionally, the curative effect of the test group was significantly better than that of the controlled group(p<0.05). The accompanied symptoms of dysmenorrheal and lumbosacral pain were improved significantly in test group (p<0.05), and there was significant difference between the two groups.(2) Primary syndrome curative effect:The evident cure rate in test group was40.7%, total effective rate was96.3%, while for control group was respectively0%and35.7%.The difference was statistically significant (P<0.05) in the same group. There was significant difference between the two groups, and the curative effect in test group on improving primary syndrome was superior to that of control group (P<0.05).(3) Symptoms curative effect:of TCM:the evident cure rate in test group was51.9%, total effective rate was96.3%; while for control group was respectively0%and 28.6%.The difference was statistically significant (P<0.05) in the same group. There was significant difference between the two groups, and the curative effects in test group on improving Symptoms curative effect of TCM was superior to that of control group (P<0.05).(4) local physical signs curative effect:for the test group, the evident cure rate was70.4%, total effective rate was100%, while for control group was respectively0%and21.4%.The difference was statistically significant (P<0.05) in the same group. There was significant difference between the two groups, and the curative effect in test group on improving local physical signs was superior to that of control group (P<0.05).(5) Comprehensive curative effect:for the test group, the evident cure rate was66.7%, total efficiency rate was100%; While for control group was respectively0%and21.4%.The difference was statistically significant (P<0.05) in the same group. The curative effect in test group on improving comprehensive curative effect was superior to that of control group(P<0.05).There was significant difference between the two groups.(6) Safety analysis:during the test, there were one case of adverse event in test group turned up diarrhea, which had no relation with drugs. There were2.1%incidence of adverse events totally, and its clinical application was safety.Conclusion:Caohong capsule was effectively worked for the sequelae of chronic pelvic inflammatory disease. It greatly alleviated the symptoms such as:abdominal pain, lack of energy,and abnormal leucorrhea, dysmenorrheal, lumbosacral pain, lusterless complexion, menstrual quantity or more menstrual extension, the healing rate and total effective rate were superior to placebo capsule. It is safe and convenient in clinical application and worthy of the further research and promotion.