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

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

扫码查看
原文链接
  • 万方数据
  • 维普
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).

Acute gouty arthritisHuzhang GranuleRandomized controlled trialBlind

Hao Wang、Si-ting Chen、Xiao-jie Ding、Le Kuai、Liang Hua、Xin Li、Yi-fei Wang、Ming Zhang、Bin Li、Rui-ping Wang、Mi Zhou

展开 >

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

Department of Dermatology,the Affiliated Hospital of Jiangxi University of Chinese Medicine,Nanchang 330000,Jiangxi Province,China

Institute of Dermatology,Shanghai Skin Disease Hospital,School of Medicine,Tongji University,Shanghai 200443,China

展开 >

Clinical Research Plan of SHDCClinical Research Plan of SHDCResearch Project of Shanghai Municipal Health Care CommissionShanghai Clinical Key Specialty Construction ProjectThreeyear Action Plan of Shanghai to Further Accelerate the Inheritance and Innovation of Traditional Chinese MedicineJiangxi Provincial Natural Science FoundationShanghai Municipal Health Commission Health Industry Clinical Research Special ProjectShanghai Dermatology Research CenterShanghai Dermatology Hospital Demonstration Research Ward ProjectXinglin Youth Scholar of Shanghai University of Traditional Chinese MedicineYouth Talent Promotion Project of China Association of Traditional Chinese Medicine(2021-2023)Category AHealth Young Talents of Shanghai Municipal Health CommissionShanghai Municipal Education Commission and Shanghai Education Development FoundationHighlevel Chinese Medicine Key Discipline Construction Project(Integrative Chinese and Western Medicine Clinic)of National AdminClinical Research Program of Shanghai Municipal Health CommissionShanghai Talent Development FundShanghai Sailing Program

SHDC2020CR4053SHDC2022CRS05320204Y0312shslczdzk05001ZY[2021-2023]-030220224BAB21609620234Y00752023ZZ02017SHDC2023CRW009RY411.33.10CACM-2021-QNRC2-A102022YQ02622CGA50zyyzdxk-2023065202240371202107320YF1450500

2024

10.1016/j.joim.2024.03.008

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)

CSTPCD
影响因子：0.711
ISSN：2095-4964
年,卷(期)：2024.22(3)
  • 1