Top

Trials

Published in:

01-12-2022 | Febuxostat | Study protocol

Efficacy of Chinese herbal medicine Jiangniaosuan formula for treatment of hyperuricemia: study protocol for a double-blinded non-inferiority randomized controlled clinical trial

Authors: Yafang Guo, Hong Lu, Jing Gan, Dongdong Li, Jiandong Gao, Changming Zhang

Published in: Trials | Issue 1/2022

Abstract

Background

Jiangniaosuan formula (JNSF) is commonly used in China for treating hyperuricemia, but there is little research-based evidence to support its use. This randomized controlled trial aims to assess the efficacy and safety of JNSF.

Methods

A total of 72 patients with hyperuricemia will be selected and randomly assigned in a ratio of 1:2 to receive either Western medicine, i.e., febuxostat 40 mg (WG group; n = 24), or Chinese herbal medicine, i.e., Jiangniaosuan formula + febuxostat 20 mg (WJNSG group; n = 48). After 12 weeks, the WJNSG will be randomly divided into two groups of 24 patients each; one group (WJNSG; n = 24) still will receive febuxostat 20 mg + Jiangniaosuan formula, and the other group (JNSG; n = 24) will continue to receive Jiangniaosuan formula + placebo. Participants will be followed up at 4-week intervals. The primary outcome will be the change in serum uric acid level, and the secondary outcome will be the change in traditional Chinese medicine (TCM) syndrome scores. Serum creatinine, blood glucose, and insulin levels will also be measured.

Discussion

We hypothesize that patients with hyperuricemia will benefit from JNSF. This study will provide evidence-based recommendations for clinicians.

Dissemination

The results will be published in a peer-reviewed journal and disseminated by academic conferences. The datasets analyzed during the current study are available from the corresponding author on reasonable request.

Trial registration

Chinese Clinical Trials Register ChiCTR2000041083. Registered on 3 May 2021. The protocol version number is V3.0, 20210301.

Trifiro G, Morabito P, Cavagna L, et al. Epidemiology of gout and hyperuricaemia in Italy during the years 2005-2009: a nationwide population-based study. Ann Rheum Dis. 2013;72(5):694–700. https://doi.org/10.1136/annrheumdis-2011-201254.CrossRefPubMed

Liu R, Han C, Wu D, Xia X, Gu J, Guan H, et al. Prevalence of hyperuricemia and gout in mainland China from 2000 to 2014: a systematic review and meta-analysis. Biomed Res Int. 2015;2015:762820–12. https://doi.org/10.1155/2015/762820.CrossRefPubMedPubMedCentral

Dong X, Liu X, Zhang L. Residential greenness associated with lower serum uric acid levels and hyperuricemia prevalence in a large Chinese rural population. Sci Total Environ. 2021;20:770. https://doi.org/10.1016/j.scitotenv.2021.145300.CrossRef

Bardin T, Richette P. Impact of comorbidities on gout and hyperuricaemia: an update on prevalence and treatment options. BMC Med. 2017;15(1):123. https://doi.org/10.1186/s12916-017-0890-9.CrossRefPubMedPubMedCentral

Feig DI, Kang DH, Johnson RJ. Uric acid and cardiovascular risk. N Engl J Med. 2008;359(17):1811–21. https://doi.org/10.1056/NEJMra0800885.CrossRefPubMedPubMedCentral

Li M, Hou W, Zhang X, Hu L, Tang Z. Hyperuricemia and risk of stroke: a systematic review and meta-analysis of prospective studies. Atherosclerosis. 2014;232(2):265–70. https://doi.org/10.1016/j.atherosclerosis.2013.11.051.CrossRefPubMed

Feig DI, Mazzali M, Kang DH, Nakagawa T, Price K, Kannelis J, et al. Serum uric acid: a risk factor and a target for treatment? J Am Soc Nephrol. 2006;17(4 suppl 2):S69–73. https://doi.org/10.1681/ASN.2005121331.CrossRefPubMed

Wang MX, Liu YL, Yang Y, Zhang DM, Kong LD. Nuciferine restores potassium oxonate-induced hyperuricemia and kidney inflammation in mice. Eur J Pharmacol. 2015;747:59–70. https://doi.org/10.1016/j.ejphar.2014.11.035.CrossRefPubMed

Eun SR, Mi JK. Hyun- Soo Shin, et al, Uric acid-induced phenotypic transition of renal tubular cells as a novel mechanism of chronic kidney disease. Am J Physiol Renal Physiol. 2013;304(5):F471–80. https://doi.org/10.1152/ajprenal.00560.2012.CrossRef

10.

Takae K, Nagata M, Hata J, Mukai N, Hirakawa Y, Yoshida D, et al. Serum uric acid as a risk factor for chronic kidney disease in a Japanese community-the Hisayama study[J]. Circ J. 2016;80(8):1857–62. https://doi.org/10.1253/circj.CJ-16-0030.CrossRefPubMed

11.

Hosoya T, Ohno I, Nomura S, Hisatome I, Uchida S, Fujimori S, et al. Effects of topiroxostat on the serum urate levels and urinary albumin excretion in hyperuricemic stage 3 chronic kidney disease patients with or without gout. Clin Exp Nephrol. 2014;18(6):876–84. https://doi.org/10.1007/s10157-014-0935-8.CrossRefPubMedPubMedCentral

12.

Kamatani N, Fujimori S, Hada T, Hosoya T, Kohri K, Nakamura T, et al. An allopurinol-controlled, randomized, double-dummy, double-blind, parallel between-group, comparative study of febuxostat (TMX-67), a non-purine-selective inhibitor of xanthine oxidase, in patients with hyperuricemia including those with gout in Japan: phase 3 clinical study. J Clin Rheumatol. 2011;17(4):S13–8.26. https://doi.org/10.1097/RHU.0b013e31821d36cc.CrossRefPubMed

13.

Luo H, Fang WG, Zuo XX, et al. Analysis of clinical characteristics and diagnosis and treatment status of gout patients in China. Chin J Intern Med. 2018;57(1):27–31.

14.

Sheng F, Fang W, Zhang B. Adherence to gout management recommendations of Chinese patients. Medicine. 2017;96(45):e8532.CrossRefPubMedPubMedCentral

15.

Singh JA, N. Lawrence Edwards., Gout management and outcomes during the COVID-19 pandemic: a cross-sectional internet survey[J]. Ther Adv Musculoskel Dis. 2020;11(12):1–8. https://doi.org/10.1177/1759720X20966124.CrossRef

16.

Zheng PD. Discussion on the treatment of gout by activating blood circulation and removing phlegm and turbidity[J]. Shanghai J Tradis Chin Med. 2004;38(12):3–4.

17.

Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7. https://doi.org/10.7326/0003-4819-158-3-201302050-00583.CrossRefPubMedPubMedCentral

18.

Zheng PD, Zou SL, Huang L. Clinical study on chronic hyperuricemia nephropathy treated by integrated traditional Chinese and Western medicine[J]. Chi J Integr Tradis West Nephrol. 2003;4(11):644–6.

19.

Zhang Y, Yang YY, Qu Y, et al. Evaluation of protective effect of polydatin and emodin combination on hyperuricemia model rats by mean effect principle. China Pharmacy. 2020;31(21):2603–8.

20.

Guo YF, Chen WS, Liu QY. Clinical observation of rhubarb external intervention in elderly patients with acute gouty arthritis. J Emerg Tradis Chin Med. 2015;24(8):1418–21.

21.

Wang J, Xu BB, Zeng JX. Comparative study of ethanol extract and verbascoside from Semen Plantaginis on experimental hyperuricemia mice. Chin J New Drugs Clin Rem. 2016;35(9):653–9.

22.

Lin FP, Ren KM, Song KM, et al. Protective effect of Clematis on tubulointerstitial lesions in rats with uric acid nephropathy[J]. J Pract Med. 2006;35(1):18–20.

23.

Zhang ZG, Yang H. Effects of hawthorn leaf flavonoids on serum uric acid and vascular endothelial cell function in hyperuricemia rats. Chin J Exp Tradit Med Formulae. 2012;18(12):259–61.

24.

Zhu L, Dong Y, Na S, Han R, Wei C, Chen G. Saponins extracted from Dioscorea collettii rhizomes regulate the expression of urate transporters in chronic hyperuricemia rats[J]. Biomed Pharmacother. 2017;93:88–94. https://doi.org/10.1016/j.biopha.2017.06.022.CrossRefPubMed

25.

Li GY, Zhang WZ, Jiang L, et al. Effect of total saponins of Dioscorea bulbifera on Toll-like receptor/nuclear transcription factor-κB (TLR/NF-κB) signaling pathway induced by sodium urinate in THP-1 cells. Chin J Exp Tradis Med Formulae. 2020;26(5):34–41.

26.

Liu W, Liu W, Wang S, Tong H, Yuan J, Zou Z, et al. Prevalence and risk factors associated with hyperuricemia in the Pearl River Delta, Guangdong Province, China. Risk Manag Healthc Policy. 2021;14:655–63. https://doi.org/10.2147/RMHP.S293913.CrossRefPubMedPubMedCentral

27.

Hou Y-l, Yang X-l, Wang C-x, et al. Hypertriglyceridemia and hyperuricemia: a retrospective study of urban residents. Lipids Health Dis. 2019;18(81):1–5.

28.

Nephrology branch of Chinese society of traditional Chinese Medicine. Diagnosis, syndrome differentiation and curative effect evaluation of hyperuricemia nephropathy. Shanghai J Tradis Chin Med. 2008;42(1):23–5.

29.

McWherter C, Choi YJ, Serrano RL, Mahata SK, Terkeltaub R, Liu-Bryan R. Arhalofenate acid inhibits monosodium urate crystal-induced inflammatory responses through activation of AMP-activated protein kinase ( AMPK) signaling. Arthritis Res Ther. 2018;20(1):204. https://doi.org/10.1186/s13075-018-1699-4.CrossRefPubMedPubMedCentral

Title: Efficacy of Chinese herbal medicine Jiangniaosuan formula for treatment of hyperuricemia: study protocol for a double-blinded non-inferiority randomized controlled clinical trial
Authors: Yafang Guo
Hong Lu
Jing Gan
Dongdong Li
Jiandong Gao
Changming Zhang
Publication date: 01-12-2022
Publisher: BioMed Central
Keyword: Febuxostat
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-021-05959-2

At a glance: The STEP trials

Springer Medicine

Efficacy of Chinese herbal medicine Jiangniaosuan formula for treatment of hyperuricemia: study protocol for a double-blinded non-inferiority randomized controlled clinical trial

Abstract

Background

Methods

Discussion

Dissemination

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Discussion

Dissemination

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2022

Statistical analysis plan for an international, double-blind, randomized controlled clinical trial on the use of phantom motor execution as a treatment for phantom limb pain

The effectiveness and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma patients with uncontrolled torso haemorrhage: study protocol for a randomised clinical trial (the UK-REBOA trial)

Efficacy of repetitive transcranial magnetic stimulation (rTMS) for reducing consumption in patients with alcohol use disorders (ALCOSTIM): study protocol for a randomized controlled trial

Efficacy and safety of 5% lidocaine patches for postoperative pain management in patients undergoing unilateral inguinal hernia repair: study protocol for a prospective, double-blind, randomized, controlled clinical trial

Sharing individual participant data: through a systematic reviewer lens