Clinical randomized controlled study of Jieyu Anshen Decoction combined with otopoint therapy on insomnia of postmenopausal femalewith kidney deficiency and liver depression type / 中国医师进修杂志

ABSTRACT

Objective:To observe the differences in clinical efficacy of Jieyu Anshen Decoction combined with auricular points and oral tibolone in the treatment of patients with perimenopausal sleep disorders, and provide effective treatment for patients with contraindications to hormone supplement therapy in clinicalMethods:Using a randomized trial design, from July 2018 to August 2020,102 perimenopausal insomnia patients in International Peace Maternity and Child Health Hospital of China Welfare Institutewith kidney deficiency and liver depression who met the inclusion criteria were randomly divided into a treatment group and a control group with 51 cases each. The treatment group took Jieyu Anshen Recipe. At the same time, unilateral auricular point pressing treatment was given, and the opposite ear was changed in 5 d. The control group was treated with tiburon for a period of 3 months. The changes in the scores of each scale were observed in the two groups after 1 month and 3 months treatment. The scale included Pittsburgh sleep quality index (PSQI), modified Kupperman score (KMI), Generalized Anxiety Disorder Scale (GAD-7) and Patient Health Questionnaire Depression Screening Scale (PHQ-9). Its effectiveness and differences were evaluated and analyzed comprehensively through the above scale.Results:PSQI, KMI, GAD-7, PHQ-9 scores decreased significantly in the control and treatment groups after 1 month and 3 months of treatment, and the difference were statistically significant PSQI (8.58 ± 1.94) and (5.81 ± 1.93) scores vs. (13.10 ± 2.53), (9.15 ± 2.59) and (6.33 ± 1.98) scores vs.(13.52 ± 2.27) scores; KMI (19.92 ± 2.16) and (14.67 ± 4.11) scores vs. (28.54 ± 7.65) scores, (19.02 ± 5.92) and(14.10 ± 4.37) scores vs. (27.42 ± 7.34) scores; GAD-7 (4.54 ± 2.03) and (3.81 ± 1.63) scores vs. (5.69 ± 2.95) scores, (3.71 ± 2.48) and (3.32 ± 1.73) scores vs. (4.90 ± 3.17) scores; PHQ-9(6.90 ± 2.52) and (4.98 ± 1.96) scores vs. (9.83 ± 3.71) scores, (6.15 ± 2.62) and (4.44 ± 1.81) scores vs. (9.02 ± 3.73) scores ( P<0.01). PSQI, KMI, PHQ-9, and GAD-7 scores declined between the two groups, but there were no significant differences between the two groups ( P>0.05). After 1 month and 3 months of treatment, using PSQI scale and KMI score, the total efficiency of patients in the control group was slightly higher than that of the treatment group, but the difference was not statistically significant ( P>0.05); after 1 month and 3 months of treatment, using PHQ-9 score and GAD-7 score, the total efficiency of patients in the treatment group was slightly higher than that of the control group, but the difference was not statistically significant ( P>0.05). Conclusions:Traditional Chinese medicine combined with ear acupoint pressing has similar effects to tibolone in treating perimenopausal insomnia with kidney deficiency and liver depression. It can significantly improve the quality of sleep and quality of life of patients, and has good safety. For patients who are not suitable for hormone, Chinese medicine can be used as an alternative. The therapies are worthy of clinical application.