Efficacy and safety of Huzhang Granule,a compound Chinese herbal medicine,for acute gouty arthritis:A double-blind,randomized controlled trial

Hao Wang ¹Si-ting Chen ²Xiao-jie Ding ¹Le Kuai ¹Liang Hua ¹Xin Li ¹Yi-fei Wang ¹Ming Zhang ¹Bin Li ³Rui-ping Wang ⁴Mi Zhou¹

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作者信息

1. Department of Dermatology,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China;Institute of Dermatology,Shanghai Academy of Traditional Chinese Medicine,Shanghai 201203,China
2. Department of Dermatology,the Affiliated Hospital of Jiangxi University of Chinese Medicine,Nanchang 330000,Jiangxi Province,China
3. Institute of Dermatology,Shanghai Academy of Traditional Chinese Medicine,Shanghai 201203,China;Institute of Dermatology,Shanghai Skin Disease Hospital,School of Medicine,Tongji University,Shanghai 200443,China
4. Institute of Dermatology,Shanghai Skin Disease Hospital,School of Medicine,Tongji University,Shanghai 200443,China
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Abstract

Background:Acute gouty arthritis(AGA)is an inflammatory joint disease with a high prevalence.Typical medical interventions,including nonsteroidal anti-inflammatory drugs,colchicine and glucocorticoids,can have serious adverse reactions.Huzhang Granule(HZG),a compound Chinese herbal medicine,has been used to treat AGA for more than 30 years with satisfactory effects and no significant adverse reac-tions.However,the efficacy and safety of HZG in AGA patients remains unknown.Objective:The present investigation was designed to examine the efficacy and safety profile of HZG in managing AGA patients.Design,setting,participants and interventions:The current study was conducted as a noninferiority,ran-domized controlled clinical trial on 180 eligible enrolled participants.Participants were randomly assigned into the HZG and etoricoxib groups.Treatments were administered for 5 d,during which the HZG group received HZG and placebo etoricoxib,while the etoricoxib group received etoricoxib and pla-cebo HZG in the same ratio(1∶1).Main outcome measures:The primary outcome was pain experienced by the patient in the gout-afflicted joint from days 2 to 5 of the treatment window.The pain level was measured via a visual analogue scale,ranging from 0 mm to 100 mm.The secondary outcomes comprised joint tenderness and swelling,reduc-tion of inflammatory biomarkers,and the patient's and investigator's global evaluations of therapeutic response.Results:The mean reduction in pain was-51.22 mm(95% confidence interval[CI],[-53.42,-49.03]mm)for the HZG and-52.00 mm(95% CI,[-54.06,-49.94]mm)for the etoricoxib groups.The mean differ-ence between the two groups was 0.78 mm(95% CI,[-2.25,3.81]mm).All additional efficacy endpoints,covering decreased inflammation and pain relief,yielded compelling proof of noninferiority.Patients in the HZG group exhibited a comparatively lower rate of adverse events compared to those in the etori-coxib group(4.44% vs 13.33% ;P ≤ 0.05).Conclusion:HZG and etoricoxib groups demonstrated similar levels of analgesic effectiveness.The safety and efficacy of HZG indicates that it can be used as a potential therapeutic option for treating AGA.Trial registration:Chinese Clinical Trial Registry(ChiCTR2000036970).

Key words

Acute gouty arthritis/Huzhang Granule/Randomized controlled trial/Blind

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基金项目

Clinical Research Plan of SHDC(SHDC2020CR4053)

Clinical Research Plan of SHDC(SHDC2022CRS053)

Research Project of Shanghai Municipal Health Care Commission(20204Y0312)

Shanghai Clinical Key Specialty Construction Project(shslczdzk05001)

Threeyear Action Plan of Shanghai to Further Accelerate the Inheritance and Innovation of Traditional Chinese Medicine(ZY[2021-2023]-0302)

Jiangxi Provincial Natural Science Foundation(20224BAB216096)

Shanghai Municipal Health Commission Health Industry Clinical Research Special Project(20234Y0075)

Shanghai Dermatology Research Center(2023ZZ02017)

Shanghai Dermatology Hospital Demonstration Research Ward Project(SHDC2023CRW009)

Xinglin Youth Scholar of Shanghai University of Traditional Chinese Medicine(RY411.33.10)

Youth Talent Promotion Project of China Association of Traditional Chinese Medicine(2021-2023)Category A(CACM-2021-QNRC2-A10)

Health Young Talents of Shanghai Municipal Health Commission(2022YQ026)

Shanghai Municipal Education Commission and Shanghai Education Development Foundation(22CGA50)

Highlevel Chinese Medicine Key Discipline Construction Project(Integrative Chinese and Western Medicine Clinic)of National Admin(zyyzdxk-2023065)

Clinical Research Program of Shanghai Municipal Health Commission(202240371)

Shanghai Talent Development Fund(2021073)

Shanghai Sailing Program(20YF1450500)

出版年

2024

结合医学学报(英文版)

上海市中西医结合学会,上海长海医院

结合医学学报(英文版)

CSTPCDCSCD

影响因子：0.711

ISSN：2095-4964

参考文献量1

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