Objectives:The propose of this research is to establish the basis for the clinical efficacy of scrapping therapy based on the theory of midnight-noon ebb-flow in the treatment of perimenopausal insomnia. Experiments are conducted using randomized controlled trials (RCTs) to compare the efficacy between scrapping therapy and diazepam tablets, assessing patient’s quality of sleep as well as overall improvements with regards to perimenopausal symptoms.Methods:Patients were selected and assessed using the questionnaire "The classification and determination of body type according to Traditional Chinese Medicine(TCM)" developed by the TCM association of China. From March 2014 till September 2014,86 patients were selected from the gynecological department of the TCM hospital ofSi Chuan Province and the acupuncture and tuina department of the 3rd affiliated hospital of Cheng Du TCM University to participate in the study.Using randomized control and utilizing a 1:1 comparison ratio, the therapeutic group and the control group each had 43 patients. The therapeutic group used scrapping therapy based on the midnight-noon ebb-flow theory,a single treatment session was conducted every Monday, Wednesday and Friday. The control group received a dosage of 10mg of diazepam tablets before sleep daily. After 4 weeks, patients were assessed using the Pittsburgh sleep quality index (PSQI), Improved Kupperman rating scale and body type scoring table, E2ã€FSHã€LH levels were also measured before and after treatments. Data were analyzed with SPSS18.0 software Package.Results:Of the 86 patients included in the study,83 patients completed the course of the treatments and 3 patients failed to complete the study.1. There is no statistically significant difference (P>0.05) between patients of the therapeutic and control group with regards to age and other primary physiological conditions.2. The overall efficacy between the two groups after treatments has statistical significance (P<0.05) with the therapeutic group achieving improvements in 92.86% patients and the control group achieving improvements in 80.49% patients.3. After treatment, comparing the PSQI score as well as results from other assessments within each group demonstrated statistical significance (P<0.05). Comparing the PSQI total score, quality of sleep between the two groups demonstrated statistical significance (P<0.05), but duration of sleep and daytime dysfunction between the two groups yielded no statistical significance (P>0.05).4. Comparing the Kupperman total score and twelve symptoms such including fever and sweating, heart palpitation and sexual dysfunction within the therapeutic group yielded statistical significance (P<0.05); Comparing insomnia, dizziness, tinnitus and fatigue within the control group yielded statistical significance (P<0.05). Comparing the Kupperman total score between the two groups demonstrated statistical significance (P<0.05).5. Comparing the E2, FSH and LH levels measured before and after treatments within the therapeutic and control group yielded no statistical significance (P>0.05). FSH and LH levels after treatments between the two groups failed to yield statistical significance (P>0.05), E2 levels after treatments between the two groups yielded statistical significance (P<0.05).6. Comparing the normal body type and dampness body type ratio within the therapeutic group after treatments yielded statistical significance (P<0.05); Comparing all items within the control group after treatments failed to yield statistical significance (P>0.05).Conclusions:1. Although both groups achieved good clinical efficacy, scrapping therapy based on the midnight-noon ebb-flow theory proved to be more effective than taking diazepam tablets.2. Both methods were able to improve the quality of sleep.The therapeutic group had better results with regards tototal PSQI score, quality of sleep, sleep latency, sleeping difficulties. Both groups achieved similar efficacy in improving duration of sleep, sleep efficiencyand daytime dysfunctionality.3. The therapeutic group had greater improvements with regards to perimenopausal symptoms such as fever, sweating, abnormal sensations and muscle soreness.4. The therapeutic group had decreased levels of FSH and LH, and increased E2 level after treatment. The E2 level increase was more significant in the therapeutic group.5. Scrapping therapy can dispel phlegm and dampness from the body. |