Objective:Through observing the clinical efficacy of Blood-nourishing, liver-soothing and tranquilizing-mind Method on sleep disorders of liver-blood-deficiency type Parkinson’s Disease(PD), we evaluated the clinical effectiveness and safety of the method, and provide a new prescription drug in treating sleep disorders of PD patient.Methods:In compliance with selection criteria, 60 patients with sleep disorders in Parkinson’s Disease were divided into control group(28 cases) and observation group(32 cases) randomly. The observation group was treated with Traditional Chinese Medicine decoction based on Blood-nourishing, liver-soothing and tranquilizing-mind Method, and control group with zopiclone tablet(oral, 7.5mg), both daily. Both groups were assessed independently with The Traditional Chinese Medicine Symptom Scale(TCMSS), Hamilton Anxiety Scale(HAMA), Parkinson’s Disease Sleep Scale(PDSS), Unified Parkinson’s Disease Rating Scale(UPDRS-Ⅲ), Pittsburgh Sleep Quality Index(PSQI) on the 0, 14, 21 and 28 days of treatment. Data were compared for each patient individually before and after treatment, and analyzed by SPSS17.0 software.Results:(1) Clinical efficacy, total efficacy rate was 90.6% in observation group and 46.2% in control group after 28 days of treatment. There was statistical significance(P <0.05) in comparing the two groups.(2) TCMSS score, observation was made on the 14 th, 21 st and 28 th days of treatment. Along with the treatment, TCMSS score were dropped in both groups but only dramatic in treatment group, P <0.05.(3) PSQI score, based on the treatment record on the 14 th, 21 st and 28 th days, the TCMSS score were dropped in both groups but much more obvious in treatment group, P <0.05.(4) HAMA score, results on the treatment record on the 14 th, 21 st and 28 th days showed decrease in both groups, particularly evident in the treatment group(P <0.05). Not only the sleep, but also the mental state in PD patients has been improved after treating.(5) UPDRS-III score, results on the treatment record on the 14 th, 21 st and 28 th days showed decrease in both groups, predominantly manifest in the treatment group(P <0.05). Not only the sleep, but also the motor function in PD patients has been improved after treating.(6) PDSS score, results on the treatment record on the 14 th, 21 st and 28 th days showed increase in both groups, primarily obvious in the treatment group(P <0.05). Both the sleep quality and the spirit in PD patients has been improved greatly after treatment, parasomnias was reduced.(7) Safety index, there was no abnormal findings in routine test results on blood, urine, stool, liver and kidney function, and ECG after 14 th, 21 st and 28 th days of treatment. This demonstrated that the Traditional Chinese Medicine decoction based on Blood-nourishing, liver-soothing and tranquilizing-mind Method can improve the sleep quality, and it has safety.Conclusion:(1) Sleep disorders are common non-motor symptoms of Parkinson’s disease, it seriously affecting the quality of life of patients.(2) Blood-nourishing, liver-soothing and tranquilizing-mind Method is an effective treatment of sleep disorders in PD patients. It not only improves the quality of sleep, but also enhances motor function at the same time.(3) Blood-nourishing, liver-soothing and tranquilizing-mind Method can significantly improve the patient’s sleep disorder symptoms of PD patients, prolong sleep time, and improve sleep quality with fewer side effects. The effect is obvious with the prolonged treatment, is much more better than the control group using western medicine. |