Clinical efficacy of traditional Chinese medicine formula granules of clear heat evil and detoxification in treating hyperuricemia and its safety evaluation

SUN Hui; ZHANG Shasha; LIAN Weiwei

doi:10.3969/j.issn.1006-0111.2016.01.021

Message Board

Respected readers, authors and reviewers, you can add comments to this page on any questions about the contribution, review, editing and publication of this journal. We will give you an answer as soon as possible. Thank you for your support!

Name

E-mail

Phone

Title

Content

Verification Code

Objective To evaluate traditional Chinese medicine (TCM) formula granules of clear heat evil and detoxification 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 treatment 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 observing 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 reduced 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 hyperuricemia in patients with damp heat and blood stasis. It is a safe and efficient formulation to reduce uric acid.

Clinical efficacy of traditional Chinese medicine formula granules of clear heat evil and detoxification in treating hyperuricemia and its safety evaluation

Department of Immunology, First People's Hospital of Huzhou, Huzhou 313000, China

Received Date: 2015-04-24

Rev Recd Date: 2015-09-23

Key words:

Abstract: Objective To evaluate traditional Chinese medicine (TCM) formula granules of clear heat evil and detoxification 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 treatment 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 observing 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 reduced 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 hyperuricemia in patients with damp heat and blood stasis. It is a safe and efficient formulation to reduce uric acid.

HTML

Reference (12)

[1]	黄凤楼,刁孟元,陈学波.29 234 例体检人群血清尿酸水平的流行病学调查[J].中国疗养医学,2011,20(1):83-84.
[2]	Brodov Y,Behar S,Boyko V,et a1 .Effect of the metabolic syndrome and hyperuricemia on outcome in patients with coronary artery disease(from the bezafibrate infarction prevention study) [J].Am J Cardiol,2010,106(12):1717-1720.
[3]	马培奇.降尿酸药物研究进展[J].上海医药,2012,33(3):18-20.
[4]	中国医师协会心血管内科医师分会,中国医师协会循证医学专业委员会.无症状高尿酸血症合并心血管疾病诊治建议中国专家共识[J].中国全科医学,2010,13(11):1145-1149.
[5]	何敛.尿酸与人脐静脉血管内皮细胞功能的体外研究[D].北京:北京中医药大学,2010:10-12.
[6]	唐盛,吴潮清,王浩宇,等.广西城乡居民高尿酸血症流行病学及与肾损害关系调查分析[J].中国全科医学,2011,14 (29) :3377-3379.
[7]	李宁,袁招红,孙蔚华.1 626 例体检人群高尿酸血症患病率及危险因素分析[J]. 赣南医学院学报,2013,33(3):367-369.
[8]	谢微波,王永红,张明军,等.重庆市 9 528 名体检人群高尿酸血症现状及脂代谢异常、高血压、体重超标关系的研究[J].重庆医科大学学报,2008,33(7):843-846.
[9]	陆祯.高尿酸血症与代谢综合征的相关性研究[J].中国医药指南,2012,10 (28):125-126.
[10]	丁立新,贺娓利,吉漩.降低血清尿酸水平对胰岛素抵抗、胰岛β细胞功能影响的研究[J].临床合理用药杂志,2012,5(11):28-29.
[11]	杨保林.高尿酸血症中医论治己见[J].中国中医药,2012,8(9):20-21.
[12]	田素英,陈周全.山慈菇中秋水仙碱醇提工艺的优选[J].中草药,2002,33(8):708-710.

Message Board

Clinical efficacy of traditional Chinese medicine formula granules of clear heat evil and detoxification in treating hyperuricemia and its safety evaluation

doi: 10.3969/j.issn.1006-0111.2016.01.021

Abstract

References

Proportional views

通讯作者: 陈斌, bchen63@163.com

Article Metrics

Related

Proportional views