{
    "abstract": "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.\nTo evaluate the beneficial effects and safety of Hongjin Xiaojie Capsule (HJXJC), a Chinese patent medicine, for the treatment of cyclical breast pain.\nThis 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.\nThe primary outcome was pain duration, and the patients recorded measurements at baseline and at the end of weeks 4, 8, 12 and 16 on a patient log card.\nThe full analysis set (FAS) population included 298 participants (intervention group, n\u00a0=\u00a0150; control group, n\u00a0=\u00a0148), while the per-protocol analysis set (PPS) included 274 participants. After 12\u00a0weeks, the duration of breast pain was significantly shorter in the intervention group (FAS: mean difference, -6.69; 95% CI, -7.58 to -5.80; P\u00a0<\u00a00.01, vs control. PPS: mean difference, -7.09; 95% CI, -8.01 to -6.16; P\u00a0<\u00a00.01, 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\u00a0<\u00a00.01, vs control. PPS: mean difference, -13.07; 95% CI, -14.48 to -11.66; P\u00a0<\u00a00.01, vs control). The above indicators continued to be significantly different through week 16. Moreover, in the intervention group, breast lumps shrank after 12\u00a0weeks and the size of breast lumps was statistically smaller than that in the control group (P\u00a0<\u00a00.05), whereas the sizes of breast nodules and uterine fibroid showed no statistically significant difference compared with the control group (P\u00a0>\u00a00.05). At weeks 8 and 12, the dysmenorrhea scores in the intervention group were lower than those in the control group (P\u00a0<\u00a00.05). No obvious adverse reactions were observed in any group.\nHJXJC 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.\nThis trial has been registered at the ISRCTN Registry. Number: ISRCTN44184398.\nZhang Q, Fan YY, Wu XQ, Huo YD, Wang CH, Liang SB, Wang T, Zhong R, Wang X, Lai BY, Pei XH, Liu JP. Hongjin Xiaojie Capsule, a Chinese patent medicine, for treating moderate to severe cyclical breast pain: A single-blind randomized controlled trial. J Integr Med. 2024; 22(5): 552-560.",
    "authors": [
        {
            "affiliation": "Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China; Department of Breast, Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing 100029, China.",
            "firstname": "Qiong",
            "initials": "Q",
            "lastname": "Zhang"
        },
        {
            "affiliation": "Department of Breast, Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing 100029, China.",
            "firstname": "Ying-Yi",
            "initials": "YY",
            "lastname": "Fan"
        },
        {
            "affiliation": "Department of Breast, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China.",
            "firstname": "Xue-Qing",
            "initials": "XQ",
            "lastname": "Wu"
        },
        {
            "affiliation": "Department of Breast, Sichuan Second Hospital of Traditional Chinese Medicine, Chengdu 610014, Sichuan Province, China.",
            "firstname": "Yan-Dan",
            "initials": "YD",
            "lastname": "Huo"
        },
        {
            "affiliation": "Department of Breast, Xiamen Hospital, Beijing University of Chinese Medicine, Xiamen 361015, Fujian Province, China.",
            "firstname": "Chun-Hui",
            "initials": "CH",
            "lastname": "Wang"
        },
        {
            "affiliation": "Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China.",
            "firstname": "Shi-Bing",
            "initials": "SB",
            "lastname": "Liang"
        },
        {
            "affiliation": "Department of Breast, Sichuan Second Hospital of Traditional Chinese Medicine, Chengdu 610014, Sichuan Province, China.",
            "firstname": "Ting",
            "initials": "T",
            "lastname": "Wang"
        },
        {
            "affiliation": "Department of Breast, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China.",
            "firstname": "Rong",
            "initials": "R",
            "lastname": "Zhong"
        },
        {
            "affiliation": "Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China; Department of Breast, Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing 100029, China.",
            "firstname": "Xuan",
            "initials": "X",
            "lastname": "Wang"
        },
        {
            "affiliation": "Department of Breast, Xiamen Hospital, Beijing University of Chinese Medicine, Xiamen 361015, Fujian Province, China.",
            "firstname": "Bao-Yong",
            "initials": "BY",
            "lastname": "Lai"
        },
        {
            "affiliation": "Department of Breast, Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing 100029, China; Department of Breast, Xiamen Hospital, Beijing University of Chinese Medicine, Xiamen 361015, Fujian Province, China. Electronic address: pxh_127@163.com.",
            "firstname": "Xiao-Hua",
            "initials": "XH",
            "lastname": "Pei"
        },
        {
            "affiliation": "Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China. Electronic address: Liujp@bucm.edu.cn.",
            "firstname": "Jian-Ping",
            "initials": "JP",
            "lastname": "Liu"
        }
    ],
    "conclusions": "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.",
    "copyrights": "Copyright \u00a9 2024 Shanghai Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine. Published by Elsevier B.V. All rights reserved.",
    "doi": "10.1016/j.joim.2024.08.005",
    "journal": "Journal of integrative medicine",
    "keywords": [
        "Cyclical breast pain",
        "Hongjin Xiaojie Capsule",
        "Randomized controlled trial",
        "Traditional Chinese medicine"
    ],
    "methods": null,
    "publication_date": "2024-09-05",
    "pubmed_id": "39232973",
    "results": "The full analysis set (FAS) population included 298 participants (intervention group, n\u00a0=\u00a0150; control group, n\u00a0=\u00a0148), while the per-protocol analysis set (PPS) included 274 participants. After 12\u00a0weeks, the duration of breast pain was significantly shorter in the intervention group (FAS: mean difference, -6.69; 95% CI, -7.58 to -5.80; P\u00a0<\u00a00.01, vs control. PPS: mean difference, -7.09; 95% CI, -8.01 to -6.16; P\u00a0<\u00a00.01, 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\u00a0<\u00a00.01, vs control. PPS: mean difference, -13.07; 95% CI, -14.48 to -11.66; P\u00a0<\u00a00.01, vs control). The above indicators continued to be significantly different through week 16. Moreover, in the intervention group, breast lumps shrank after 12\u00a0weeks and the size of breast lumps was statistically smaller than that in the control group (P\u00a0<\u00a00.05), whereas the sizes of breast nodules and uterine fibroid showed no statistically significant difference compared with the control group (P\u00a0>\u00a00.05). At weeks 8 and 12, the dysmenorrhea scores in the intervention group were lower than those in the control group (P\u00a0<\u00a00.05). No obvious adverse reactions were observed in any group.",
    "title": "Hongjin Xiaojie Capsule, a Chinese patent medicine, for treating moderate to severe cyclical breast pain: A single-blind randomized controlled trial.",
    "xml": "<Element 'PubmedArticle' at 0x7885044b62f0>"
}