Zhou Guirong, Chen Danfei, Qian Lin, Song Dianrong, Zhang Qin, Yan Ying, Lin Jie, Li Li, Wan Guiping, Li Shuping, Hou Lili, He Yi, Qi Cong, Yuan Weian
National Key Laboratory of Chinese Medicine Modernization, Tasly Pharmaceutical Group Co., Ltd., Tianjin, China.
Zhejiang Institute of Traditional Chinese Medicine Co., Ltd., Hangzhou, China.
Front Pharmacol. 2025 Jul 10;16:1512110. doi: 10.3389/fphar.2025.1512110. eCollection 2025.
Menopausal syndrome is a general term for a series of physical and psychological symptoms that women experience during menopause and perimenopause, which can lead to the occurrence of a variety of diseases. Many ingredients in Kunxinning granules have been used clinically to treat menopausal syndrome. However, evidence for its effectiveness is lacking.
To investigate the efficacy and safety of Kunxinning Granules in patients with menopausal syndrome and to fully verify its clinical application value. Study design: A multicenter, randomized, double-blinded, placebo-controlled trial.
Eligible participants from 9 hospitals were randomly assigned in a ratio of 3:1 to the experimental group (Kunxinning granules) and the placebo group (Kunxinning granules simulated agent) for 12 weeks. The primary efficacy outcome was the score reduction of the modified Kupperman index compared with the baseline. The secondary efficacy index is the disappearance rate of 13 single symptoms of the modified Kupperman index. The evaluation time points are baseline, 4 weeks, 8 weeks, 12 weeks and 4 weeks of drug withdrawal.
A total of 475 patients (356 in experimental group and 119 in placebo groups) were included in the analysis. The modified Kupperman index of patients in the experimental group and placebo group were 28.81 ± 6.81 and 27.61 ± 7.38. The modified Kupperman index of the experimental group improved after 4 weeks of treatment (experimental group: 21.45 ± 6.29, placebo group: 23.79 ± 6.90, 97.5%CI: -3.68 to -0.99, = 0.007) and 8 weeks (experimental group: 15.18 ± 5.82, placebo group: 20.93 ± 7.29, 97.5%CI: -7.05 to -4.45, < 0.0001), 12 weeks (experimental group: 10.27 ± 5.44, placebo group: 19.70 ± 7.25, 97.5%CI: -10.68 to -8.19, < 0.0001) and 4 weeks of drug withdrawal (experimental group: 10.27 ± 5.44, placebo group: 19.70 ± 7.25, 97.5%CI: -10.86 to -8.35, < 0.0001) were significantly lower than placebo group. Moreover, the experimental group's modified Kupperman index reduction from baseline was better than that of the placebo group at 4 weeks, 8 weeks, 12 weeks of treatment and 4 weeks of drug withdrawal ( < 0.0001). Moreover, the experimental group had a good improvement effect on all 13 symptoms of the modified Kupperman index after 12 weeks of treatment. There were no significant differences in adverse events between the two groups.
Kunxinning granules are a promising treatment for menopausal syndrome which can effectively reduce patients' hot flashes and sweating, insomnia, irritability and urinary symptoms and improve their quality of life.
http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml, identifier CTR20140289.
更年期综合征是女性在绝经及围绝经期经历的一系列身体和心理症状的统称，可导致多种疾病的发生。坤宁心颗粒中的多种成分已在临床上用于治疗更年期综合征。然而，其有效性缺乏证据。
探讨坤宁心颗粒治疗更年期综合征患者的疗效和安全性，并充分验证其临床应用价值。研究设计：一项多中心、随机、双盲、安慰剂对照试验。
来自9家医院的符合条件的参与者按3:1的比例随机分配至试验组（坤宁心颗粒）和安慰剂组（坤宁心颗粒模拟剂），治疗12周。主要疗效指标是改良Kupperman指数较基线的评分降低情况。次要疗效指标是改良Kupperman指数13项单一症状的消失率。评估时间点为基线、4周、8周、12周及停药4周。
共纳入475例患者进行分析（试验组356例，安慰剂组119例）。试验组和安慰剂组患者的改良Kupperman指数分别为28.81±6.81和27.61±7.38。试验组治疗4周后（试验组：21.45±6.29，安慰剂组：23.79±6.90，97.5%CI：-3.68至-0.99，P = 0.007）、8周（试验组：15.18±5.82，安慰剂组：20.93±7.29，97.5%CI：-7.05至-4.45，P<0.0001）、12周（试验组：10.27±5.44，安慰剂组：19.70±7.25，97.5%CI：-10.68至-8.19，P<0.0001）及停药4周（试验组：10.27±5.44，安慰剂组：19.70±7.25，97.5%CI：-10.86至-8.35，P<0.0001）时改良Kupperman指数均显著低于安慰剂组。此外，试验组在治疗4周、8周、12周及停药4周时改良Kupperman指数较基线的降低情况优于安慰剂组（P<0.0001）。而且，试验组治疗12周后对改良Kupperman指数的所有13项症状均有良好的改善作用。两组不良事件无显著差异。
坤宁心颗粒是一种有前景的治疗更年期综合征的药物，可有效减轻患者潮热盗汗、失眠、烦躁及泌尿症状，提高生活质量。
http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml，标识符CTR20140289。
