The Double Blind, Randomized And Controlled Clinical Trial Of WuguJiangzhi Capsule On Treating Hyperlipidemia Patients

Hyperlipidemia is an independent risk factor of atherosclerosis and coronary heart disease, it has been confirmed that the reduction of lipid could improve endothelial function, suppress the progression of atherosclerosis, stabilize the plaque, reduce the morbility and mortality of acute coronary syndrome. Therefore, the effective reduction of lipid has been one of the main methods of preventing and treating cerebrovascular disease. Traditional Chinese Medicine is a unique theory system and has some special therapeutic effect on hyperlipidemia. In present clinical trial, we applied WuguJiangzhi (WGJZ) capsule to treat hyperlipidemia, the main ingredient of which is chitosan extracting from natural Oriental latrine fly larvina, with the function of heat-clearing and detoxicating, releasing dyspeptic disease.Objective: The present clinical trial was designed to observe the clinical effect and safety of WGJZ capsule on hyperlipidemia (phlegm and turbid repression disorder), providing the reliable evidence for clinical application. Methods: One hundred and twenty hyperlipidemia patients were selected from October 2003 to June 2005, with diagnosed by traditional Chinese medicine phlegm and turbid repression syndrome. The 120 patients were randomly divided into the Xuezhikang (XZK) capsule group (control group) and the WGJZ group, each with 60 cases. Double-blind, double-simulation, parallel and control trial methods were performed. Patients in the WGJZ group were given WGJZ capsule (4 capsule po Tid, 0.3g/ capsule) and sham XZK capsule (2 capsule po Bid, 0.3g/ capsule);patients in the control group were given sham WGJZ capsule (4 capsule po Tid, 0.3g/ capsule) and XZK capsule (2 capsule po Bid, 0.3 g/ capsule). Six weeks later, serum lipid, clinical symptoms and safety were assessed. The results were uncovered twice blindly. Results: All the 120 cases completed the research with good compliance. Six weeks later, the lipid control rate in the WGJZ group was 18.33%, the markedly effective rate was 41.67%, the total effective rate was 76.67%, while in the control group was 36.67%, 28.33% and 80% respectively. This result showed that WGJZ capsule had a good effect on decreasing serum lipid, but there was no statistically significant difference between groups(P>0.05). Compared with pre-therapy, total cholesterol (TC) significantly decreased in both groups after treatment;but there was no significant difference in HDL-c. All above showed that the effect of WGJZ capsule is simular to that of XZK capsule on hyperlipidemia. After treatment, total traditional Chinese medicine symptom score significanty reduced in both group, and there was no significant difference between groups. Each single symptom score significantly reduced in both groups except body obesity, especially heaviness of head, chest distress, vomiting phlegm, tasteless in mouth, etc. There was no adverse reactions relatied with drugs. Conclusion: This clinical trial demonstrated that WGJZ capsule is an effective and safe drug for treating hyperlipidemia patients with TCM syndrome of phlegm and turbid repression syndrome, providing reliable effect evidence for further clinical application.