首页|Hongjin Xiaojie Capsule,a Chinese patent medicine,for treating moderate to severe cyclical breast pain:A single-blind randomized controlled trial

Hongjin Xiaojie Capsule,a Chinese patent medicine,for treating moderate to severe cyclical breast pain:A single-blind randomized controlled trial

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Background:Moderate to severe breast pain has major effects on the quality of life for patients.Patent Chinese medicines are widely used in the treatment of breast pain due to their stable dosage form and good efficacy.Objective:To evaluate the beneficial effects and safety of Hongjin Xiaojie Capsule(HJXJC),a Chinese patent medicine,for the treatment of cyclical breast pain.Design,setting,participants and intervention:This is a multicenter,single-blind randomized controlled trial conducted in 3 medical centers in China from 2019 to 2021.Patients with moderate to severe cyclic breast pain were randomly divided into the intervention group(who took HJXJC,four capsules per dose,three times a day for 12 weeks)and the control group(waiting for the treatment)in a 1∶1 ratio.Main outcome measures:The primary outcome was pain duration,and the patients recorded measure-ments at baseline and at the end of weeks 4,8,12 and 16 on a patient log card.Results:The full analysis set(FAS)population included 298 participants(intervention group,n=150;control group,n=148),while the per-protocol analysis set(PPS)included 274 participants.After 12 weeks,the duration of breast pain was significantly shorter in the intervention group(FAS:mean dif-ference,-6.69;95％CI,-7.58 to-5.80;P＜0.01,vs control.PPS:mean difference,-7.09;95％CI,-8.01 to-6.16;P＜0.01,vs control).The Short-form McGill Pain Questionnaire(SF-MPQ)scores were significantly lower in the intervention group(FAS:mean difference,-12.55;95％CI,-13.90 to-11.21;P＜0.01,vs con-trol.PPS:mean difference,-13.07;95％Cl,-14.48 to-11.66;P＜0.01,vs control).The above indicators continued to be significantly different through week 16.Moreover,in the intervention group,breast lumps shrank after 12 weeks and the size of breast lumps was statistically smaller than that in the control group(P＜0.05),whereas the sizes of breast nodules and uterine fibroid showed no statistically signifi-cant difference compared with the control group(P＞0.05).At weeks 8 and 12,the dysmenorrhea scores in the intervention group were lower than those in the control group(P＜0.05).No obvious adverse reac-tions were observed in any group.Conclusion:HJXJC can significantly shorten the duration of breast pain,reduce breast pain,reduce the size of breast lumps,and relieve dysmenorrhea.However,it has no significant effect on the size of breast nodules or uterine fibroid.

Hongjin Xiaojie CapsuleCyclical breast painRandomized controlled trialTraditional Chinese medicine

Qiong Zhang、Ying-yi Fan、Xue-qing Wu、Yan-dan Huo、Chun-hui Wang、Shi-bing Liang、Ting Wang、Rong Zhong、Xuan Wang、Bao-yong Lai、Xiao-hua Pei、Jian-ping Liu

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Graduate School,Beijing University of Chinese Medicine,Beijing 100029,China

Department of Breast,Beijing University of Chinese Medicine Third Affiliated Hospital,Beijing 100029,China

Department of Breast,Shuguang Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 200021,China

Department of Breast,Sichuan Second Hospital of Traditional Chinese Medicine,Chengdu 610014,Sichuan Province,China

Department of Breast,Xiamen Hospital,Beijing University of Chinese Medicine,Xiamen 361015,Fujian Province,China

Center for Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029,China

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2024

10.1016/j.joim.2024.08.005

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(5)