Efficacy and safety of Kunxinning granules in patients with menopausal syndrome: a multicenter, randomized, double-blinded, and placebo-controlled trial
BackgroundMenopausal 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 menopaus...
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Frontiers Media S.A.
2025-07-01
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| author | Guirong Zhou Danfei Chen Lin Qian Dianrong Song Qin Zhang Ying Yan Jie Lin Li Li Guiping Wan Shuping Li Lili Hou Yi He Cong Qi Weian Yuan |
| author_facet | Guirong Zhou Danfei Chen Lin Qian Dianrong Song Qin Zhang Ying Yan Jie Lin Li Li Guiping Wan Shuping Li Lili Hou Yi He Cong Qi Weian Yuan |
| author_sort | Guirong Zhou |
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| description | BackgroundMenopausal 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.PurposeTo 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.MethodsEligible 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.ResultsA 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, p = 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, p < 0.0001), 12 weeks (experimental group: 10.27 ± 5.44, placebo group: 19.70 ± 7.25, 97.5%CI: −10.68 to −8.19, p < 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, p < 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 (p < 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.ConclusionKunxinning 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.Clinical Trial Registrationhttp://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml, identifier CTR20140289. |
| format | Article |
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| language | English |
| publishDate | 2025-07-01 |
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| spelling | doaj-art-4fad2e3ecfa142a0a262cffda970779c2025-08-20T02:36:18ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-07-011610.3389/fphar.2025.15121101512110Efficacy and safety of Kunxinning granules in patients with menopausal syndrome: a multicenter, randomized, double-blinded, and placebo-controlled trialGuirong Zhou0Danfei Chen1Lin Qian2Dianrong Song3Qin Zhang4Ying Yan5Jie Lin6Li Li7Guiping Wan8Shuping Li9Lili Hou10Yi He11Cong Qi12Weian Yuan13National Key Laboratory of Chinese Medicine Modernization, Tasly Pharmaceutical Group Co., Ltd., Tianjin, ChinaZhejiang Institute of Traditional Chinese Medicine Co., Ltd., Hangzhou, ChinaDepartment of Acupuncture and Moxibustion, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaDepartment of Internal Medicine (TCM), The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaDepartment of Orthopedics and Traumatology (TCM), Guangxing Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Hangzhou, ChinaDepartment of Spleen and Stomach Diseases (TCM), The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaDepartment of Gynecology (TCM), The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha, ChinaDepartment of Geriatrics (TCM), Nanjing Hospital of Traditional Chinese Medicine, Nanjing, ChinaDepartment of Integrated Traditional Chinese and Western Medicine, Jiangsu Provincial Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing, China0Department of Pediatrics (TCM), Changzhou Traditional Chinese Medicine Hospital, Changzhou, China1Department of Obstetrics and Gynecology, Nanjing Maternal and Child Health Hospital, Nanjing, ChinaNational Key Laboratory of Chinese Medicine Modernization, Tasly Pharmaceutical Group Co., Ltd., Tianjin, ChinaZhejiang Institute of Traditional Chinese Medicine Co., Ltd., Hangzhou, ChinaDepartment of Acupuncture and Moxibustion, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaBackgroundMenopausal 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.PurposeTo 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.MethodsEligible 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.ResultsA 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, p = 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, p < 0.0001), 12 weeks (experimental group: 10.27 ± 5.44, placebo group: 19.70 ± 7.25, 97.5%CI: −10.68 to −8.19, p < 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, p < 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 (p < 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.ConclusionKunxinning 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.Clinical Trial Registrationhttp://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml, identifier CTR20140289.https://www.frontiersin.org/articles/10.3389/fphar.2025.1512110/fullfull analysis setKunxinning granulesmenopausal syndromemodified ADR, adverse drug reactionsadverse events (AE)confidence interval (CI) |
| spellingShingle | Guirong Zhou Danfei Chen Lin Qian Dianrong Song Qin Zhang Ying Yan Jie Lin Li Li Guiping Wan Shuping Li Lili Hou Yi He Cong Qi Weian Yuan Efficacy and safety of Kunxinning granules in patients with menopausal syndrome: a multicenter, randomized, double-blinded, and placebo-controlled trial Frontiers in Pharmacology full analysis set Kunxinning granules menopausal syndrome modified ADR, adverse drug reactions adverse events (AE) confidence interval (CI) |
| title | Efficacy and safety of Kunxinning granules in patients with menopausal syndrome: a multicenter, randomized, double-blinded, and placebo-controlled trial |
| title_full | Efficacy and safety of Kunxinning granules in patients with menopausal syndrome: a multicenter, randomized, double-blinded, and placebo-controlled trial |
| title_fullStr | Efficacy and safety of Kunxinning granules in patients with menopausal syndrome: a multicenter, randomized, double-blinded, and placebo-controlled trial |
| title_full_unstemmed | Efficacy and safety of Kunxinning granules in patients with menopausal syndrome: a multicenter, randomized, double-blinded, and placebo-controlled trial |
| title_short | Efficacy and safety of Kunxinning granules in patients with menopausal syndrome: a multicenter, randomized, double-blinded, and placebo-controlled trial |
| title_sort | efficacy and safety of kunxinning granules in patients with menopausal syndrome a multicenter randomized double blinded and placebo controlled trial |
| topic | full analysis set Kunxinning granules menopausal syndrome modified ADR, adverse drug reactions adverse events (AE) confidence interval (CI) |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2025.1512110/full |
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