Clinical efficacy of traditional Chinese medicine formula granules of clear heat e-vil and detoxification in treating hyperuricemia and its safety evaluation / 药学实践杂志

ABSTRACT

Objective To evaluate traditional Chinese medicine (TCM ) formula granules of clear heat evil and detoxifica‐tion treating hyperuricemia clinical efficacy and safety through randomized ,placebo controlled ,blinded clinical trial .Methods 120 patients with hyperuricemia syndrome of damp heat and blood stasis were selected ,randomly divided into control and treat‐ment groups ,60 cases in each group ,in a period of 4 weeks of treatment and observation .The basic treatment was given to both two groups (diet ,exercise etc);in addition ,the control group had placebo while treatment group was given TCM clean heat evil and detoxifying formula granules .The clinical efficacy of the products was evaluated by compariment of TCM clinical symptoms before and after treatment as well as serum uric acid ,lipids (TC ,TG ,LDL‐C) ,fasting blood sugar ;meanwhile ob‐serving complete blood counts (CBC) ,liver function (ALT ,AST ) ,kidney function (BUN ,Cr) ,electrocardiogram (ECG) and adverse reactions to evaluate its safety .Results After 4 weeks of treatment with TCM clear heat evil and detoxifying formula granules ,the treatment group symptom total efficiency was 84% ,while the placebo control group symptom total efficiency was 25% ,the difference is significant statisticly (P<0 .001);the treatment group of TCM clean heat evil and detoxifying formula granules significantly reduced in the blood uric acid ,compared with before treatment (P<0 .01) ,as well as compared with the placebo control group (P<0 .05);after treatment the TCM clear heat evil and detoxifying formula granules significantly re‐duced in the LDL‐C level (P<0 .05) compared with before treatment .Comparing before treatment with after treatment ,there was no significant difference between the two groups ,in routine blood tests ,liver and kidney functions ,or ECG (P> 0 .05) . There were no side effects or adverse events in either groups in period of treatment and observation .Conclusion TCM clear heat evil and detoxifying formula granules is curative for the hyperuricemia and obviously improve the clinical symptoms for hy‐peruricemia in patients with damp heat and blood stasis .It is a safe and efficient formulation to reduce uric acid .