• 国家药监局综合司 国家卫生健康委办公厅
  • 国家药监局综合司 国家卫生健康委办公厅

Clinical Observation on the Treatment of Perimenopausal Insomnia of the Heart-kidney Disharmony Type by Regulating the Spirit and Nourishing the Heart Tang

Corresponding author: Li Yaping, liyapin0186@vip.sina.com
DOI: 10.12201/bmr.202408.00031
Statement: This article is a preprint and has not been peer-reviewed. It reports new research that has yet to be evaluated and so should not be used to guide clinical practice.
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    Abstract: Objective To observe the improvement of insomnia and perimenopausal symptoms in perimenopausal patients with cardiorenal and renal dysfunction by using Zhi Shen Nang Xin Tang, with a view to exploring new ideas for clinical treatment of perimenopausal insomnia. Methods A total of 60 patients who met the diagnostic criteria for perimenopausal sleep disorders of the cardiorenal and renal dysfunction type were selected from the outpatient clinic of Professor Li Yaping and the psychiatric clinic of Zhejiang Tongde Hospital, and the 60 patients included in the trial were divided into the experimental group and the control group by the method of randomisation, with a total of 30 patients in each group. The test group was treated with increasing and decreasing the number of tonifying the spirit and nourishing the heart soup, and the control group was treated with the proprietary Chinese medicine wuling capsule. All patients filled in and recorded the PSQI score, Kuperman score, HAMA scale and TCM symptom score before treatment and at the 4th and 8th week after treatment, respectively.Methods A total of 60 patients who met the diagnostic criteria of perimenopausal sleep disorders of cardiorenal dysfunction type were selected from the outpatient clinic of Professor Li Yaping and the psychiatric clinic of Zhejiang Provincial Tongde Hospital, and the 60 patients included in the trial were classified into the test group and the control group by the method of randomisation table, with a total of 30 cases in each group. The test group was treated with increasing and decreasing the number of tonifying the spirit and nourishing the heart soup, and the control group was treated with the proprietary Chinese medicine wuling capsule. All patients filled in and recorded the PSQI score, Kuperman score, HAMA scale and TCM symptom score before treatment and at the 4th and 8th week after treatment, respectively.Results The PSQI scores of both groups before and after treatment showed significant improvement (P<0.01), in which the efficacy of the experimental group was better than that of the control group (P<0.05).In the comparison of the specific scores of the PSQI, the experimental group had a better efficacy than the control group in terms of the quality of sleep, time of falling asleep, and time of sleep after treatment (P<0.05), and there was no significant difference in the scores of the daytime dysfunction between the two groups (P>0.05). Improvement of perimenopausal symptoms: Kupperman scores before and after treatment were significantly improved in both groups (P < 0.01), with the efficacy of the test group being significantly better than that of the control group (P < 0.01). After treatment, the experimental group was better than the control group in terms of hot flashes and sweating, insomnia and palpitations (P < 0.05), and there was no significant difference between the two groups in terms of vertigo, fatigue, ants in the skin, and urinary tract infection (P > 0.05). The HAMA scores of both groups before and after treatment were significantly improved (P < 0.01), and the efficacy of the experimental group was better than that of the control group (P < 0.05). Both groups showed improvement in Chinese medicine symptoms before and after treatment (P < 0.05), and the therapeutic effect of the experimental group was better than that of the control group (P < 0.05), and the therapeutic efficiency and apparent efficiency of the experimental group were better than that of the control group (P < 0.05). In terms of the points of Chinese medicine, both groups improved compared with the pre-treatment period, and the experimental group differed from the control group in terms of the points of insomnia, tinnitus, chest tightness, palpitation, hot flashes and night sweating (P<0.05), and the points of heartburn, lumbar and knee soreness, dizziness (P<0.05), and did not differ significantly from the control group (P<0.05). There was no significant difference with the control group (P>0.05) in the points of heartburn, lumbar and knee pain and dizziness.Conclusion For patients with perimenopausal insomnia of the heart-kidney disharmony type, Tonify the Spirit and Nourish the Heart Soup can improve sleep disorders by improving sleep quality, shortening the time to sleep, and lengthening the duration of sleep, and it can also alleviate perimenopausal symptoms, especially hot flushes and sweating, palpitations, and so on. Tonify the Spirit and Nourish the Heart Soup can alleviate perimenopausal anxiety symptoms.

    Key words: Insomnia, Perimenopausal, Heart-kidney Disharmony Type, Regulating the Spirit and Nourishing the Heart Tang.

    Submit time: 15 August 2024

    Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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    1 2024-07-02

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Li Yaping. Clinical Observation on the Treatment of Perimenopausal Insomnia of the Heart-kidney Disharmony Type by Regulating the Spirit and Nourishing the Heart Tang. 2024. biomedRxiv.202408.00031

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