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, Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing 100029, China.
J Integr Med. 2024 Sep;22(5):552-560. doi: 10.1016/j.joim.2024.08.005. Epub 2024 Aug 20.
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.
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.
The 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.
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 difference, -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 control. PPS: mean difference, -13.07; 95% CI, -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 significant 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 reactions were observed in any group.
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.
This trial has been registered at the ISRCTN Registry. Number: ISRCTN44184398.
Zhang 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.
中重度乳房疼痛会对患者的生活质量产生重大影响。专利中药由于其稳定的剂型和良好的疗效，在治疗乳房疼痛方面得到了广泛的应用。
评估中药红金消结胶囊（HJXJC）治疗周期性乳房疼痛的疗效和安全性。
设计、地点、参与者和干预措施：这是一项多中心、单盲、随机对照临床试验，于 2019 年至 2021 年在中国的 3 家医疗中心进行。将中重度周期性乳房疼痛患者随机分为干预组（服用 HJXJC，每次 4 粒，每日 3 次，共 12 周）和对照组（等待治疗），比例为 1:1。
主要结局指标为疼痛持续时间，患者在基线和第 4、8、12 和 16 周时在患者日志卡上记录测量结果。
全分析集（FAS）人群包括 298 名参与者（干预组，n=150；对照组，n=148），而符合方案集（PPS）包括 274 名参与者。12 周后，干预组乳房疼痛持续时间明显缩短（FAS：平均差值，-6.69；95%CI，-7.58 至-5.80；P<0.01，与对照组相比。PPS：平均差值，-7.09；95%CI，-8.01 至-6.16；P<0.01，与对照组相比）。干预组简明疼痛问卷（SF-MPQ）评分明显降低（FAS：平均差值，-12.55；95%CI，-13.90 至-11.21；P<0.01，与对照组相比。PPS：平均差值，-13.07；95%CI，-14.48 至-11.66；P<0.01，与对照组相比）。上述指标在第 16 周时仍持续显著差异。此外，干预组乳房肿块在 12 周后缩小，与对照组相比肿块大小有统计学意义（P<0.05），而乳房结节和子宫肌瘤大小与对照组相比无统计学意义（P>0.05）。在第 8 和 12 周时，干预组痛经评分低于对照组（P<0.05）。任何组均未观察到明显的不良反应。
HJXJC 能明显缩短乳房疼痛持续时间，减轻乳房疼痛，缩小乳房肿块，缓解痛经。然而，它对乳房结节或子宫肌瘤的大小没有显著影响。
本试验已在 ISRCTN 注册。编号：ISRCTN44184398。
张 Q，范 YY，吴 XQ，霍 YD，王 CH，梁 SB，王 T，钟 R，王 X，赖 BY，裴 XH，刘 JP。红金消结胶囊治疗中重度周期性乳房疼痛的单盲随机对照试验。综合医学杂志。2024；22（5）：552-560。
