| BackgroundPerimenopausal syndrome refers to a series of symptoms that are caused by decreasing sex hormone level in the women between the age of45-55. The symptoms are related to autonomic nerve disorders and neuropsychological symptoms, for example:insomnia, hot flushes, night sweats, irritability, mild cognitive impairment, palpitation, vaginal dryness, and urinary symptoms. It is a common gynecological disease which among its many comapints, insomnia is the most prevalent complaint within the region of Asia, including China. Prolonged period of insomnia would further aggravate the conditions of other diseases and lower one’s immune system. This could greatly affect the quality of life of women in the later part of their postmenopausal period.Hormone Replacement Therapy (HRT) and sedatives were commonly used in the western medicine treatment of perimenopausal insomnia. Both the side effects and benefits are currently debatable. In comparison, Chinese Medicine(CM) has lesser side effects and deals in a holistic approach in treatments. The mainstream CM treatment methods for perimenopausal insomnia are:disperse stagnant Liver qi, invigorate Kidney, tranquilizing Liver Yang, nourish Yin for lowering fire. However, a group of patients does not benefits from the conventional treatment. Through researching into the body constitution of the perimenopausal women described in ancient Chinese text, this group of patients fits into the ’Jue Yin syndrome’diagnosis. By prescribing’wu mei pill’concoction to the patients has achieved satisfactory response. The aim of this clinical trial is to validate the efficacy and Chinese medicine diagnostic, treatment method and formulation through the changes in PSQI, KI score and hormone levelAimThe aim of this clinical trial is to validate the efficacy and Chinese medicine diagnostic, treatment method and formulation through the changes in PSQI, KI score and hormonal level. The results will further provide evidences Chinese medicine technique of using ’jue yin syndrome’ as diagnostic method and’wu mei pill’concoction as the treatment for perimenopausal insomnia.Methodology The clinical trial was randomized controlled trial,58patients were randomly assigned to treatment group (n=30) and positive control group (n=28). Particulars, medical history, symptoms, blcodtest and questionnaires were filled by patients. Follow-up on the day7,15,22,30th days of treatment and symptoms changes.sleep diaries were recorded. The data was analysed using SPSS16.0.Results1Primary objective:PSQI score difference for treatment group and control group were7.43±3.00, and6.12±2.93respectively, both data showed the difference was dignificant(P<0.05); Comparing PSQI score after treatment between treatment group and control group, P=0.036(<0.05),the difference was significant; Within different sleep factors, sleep latency (P=0.010)and sleep efficiency(P=0.022) had better improvenment in treatment group compared to control group.2Secondary objective:the KI score before and after treatment group was lowered by10.20±4.20, P=3.69x10-6(<0.05), control group6.32±4.72, P=1.46±10-6(<0.05), the differences for both group were significant; comparing after treatment KI score difference between the treatment group and control group was significant(P=4.05×10-5<0.05);the individual symptom score of KI was compared between before and after treatment, treatment group’s hot flush and sweating, muscle joint ache and vertigo were significant different while (P<0.05)control group’s was not(P>0.05). the Chinese medicine symptoms score before and after treatment group was lowered by11.54±4.29, control group5.72±3.26, the differences for both group were significant; comparing after treatment Chinese medicine symptoms score difference between the treatment group and control group was significant (1.98×10-6,<0.05).3Hormonal level:Compare the hormonal level before and after in treatment group, FSH level was Z=-2.030, P=0.042(<0.05); E2level was Z=-2.030, P=0.042(<0.05), the difference was significant; control group FSH and E2level was Z=-0.872、P=0.383(>0.05), there were no significant differences in the change.Conclusion1’Wu Mei Pill’concoction improved sleep quality, among the PSQI factors, sleep latency and sleep efficiency had significant improvement using’Wu Mei Pill’concoction by reducing numer of times awake during sleep and sleep quality.2’Wu Mei Pill’concoction not only better improved sleep quality, also showed good efficacy in treating menopausal symptoms which includes, hot flush, sweating, joint and muscle ache and vertigo.’Wu Mei Pill’can be used in treating permenopausal symptoms when a patient is diagnosed to have ’Jue Yin Syndrome’based on CM diagnostics.3’Wu Mei Pill’concoction had an effect in regulating or imporving the FSH and E2 level in peri menopausal women which could be the main contributing factor to the improving sleep quality and perimenopausal symptoms.4’Wu Mei Pill’concoction had better efficacy in allivate insomnia, perimenopausal symptorns and Chinese medicine symptoms than’zao ren an shen ye’... |
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