| Research background and purpose:Alzheimer’s disease(AD)accounts for 60 to 80 percent of dementia,and it affects about 45 million people worldwide.China has more than 10 million AD patients,the largest number of patients in the world,accounting for 1/5 of the global patient population,and the number of patients is expected to double within 30 years.A few drugs have been approved for clinical use in China,including the cholinesterase inhibitors donepezil and rivastigmine,but they just provide symptom relief and do not stop the progression of the disease.In recent years,Chinese medicine has been developing,and Chinese medicine treatment has the advantage of multi-faceted and multi-targeted comprehensive analysis to provide multi-targeted treatment for dementia.Compared to the treatment with conventional clinical drugs,the clinical treatment with the addition of Chinese medicine formula and acupuncture can more effectively improve the survival and quality of life of patients,and provide new ideas for clinical prevention and treatment.Meta-analysis of modern studies shows that the combination of acupuncture and medicine is more effective than acupuncture or Chinese medicine alone in the treatment of dementia,and no adverse effects were observed,which can improve the total clinical efficiency.Fei Teng Eight Method of acupuncture therapy with acupuncture points taken on time can be used to adjust the whole meridian system and get better therapeutic effect by acupuncturing its open points at that time during the best therapeutic time,but there are few reports on the treatment of AD.The consensus of Chinese medicine treatment for AD points out that AD is located in the brain and kidney deficiency is the pathological basis of AD pathogenesis,and kidney tonification is used throughout the course of the disease.Studies have shown that rejuvenating Huanshaodan can alleviate memory function in early and mid-stage AD,but its therapeutic mechanism is unclear.We therefore designed a randomized controlled study and the purpose of this study was to:1.To observe the clinical effects of the Fei Teng Eight Method group on patients with mild to moderate AD;2.The efficacy of acupuncture and Fei Teng Eight Method combined with the Chinese herbal medicine revert to Huanshaodan to intervene in mild to moderate AD;3.To elucidate the mechanism of action of the eight methods of acupuncture Fei Teng Eight Method and the Fei Teng Eight Method combined with Huanshaodan on mild to moderate AD;4.If the expected clinical effect can be achieved,it can provide a theoretical basis and practical foundation for the establishment and promotion of a comprehensive treatment system for mild to moderate AD.Materials and Methods:Ninety patients with mild to moderate Alzheimer’s disease collected in this trial were randomly divided into three groups,30 in the control group,30 in the Fei Teng Eight Method group,and 30 in the needle-drug combination group,with a total of 85 cases completing the trial,of whom(42)were male and(43)were female.In the control group,30 cases were treated conventionally(oral donepezil hydrochloride),the Fei Teng Eight Method group was given Fei Teng Eight Method acupuncture treatment 3times/week on the basis of the control group,and the combination of acupuncture and medicine group was given the combination of Huanshaodan(1 bag/day)and Fei Teng Eight Method acupuncture treatment(3 times/week)on the basis of the control group.Patients in the test group were continuously intervened for 12 weeks for clinical efficacy observation,and mini-mental state examination(MMSE),Chinese Medicine Clinical Symptom Score(CMSS),Pittsburgh sleep quality index(PSQI),and Self-care Rating Scale(Barthel)were statistically analyzed using SPSS 21.0 statistical software at the beginning of the test,and the end of the test to observe and compare the pretest and post-test.The changes of serum brain-derived neurotrophic factor(BDNF)and plasma homocysteine(Hcy)levels were observed and compared before and after the test.Results:1.The Fei Teng Eight Method group and the combination of needle-drug group can improve the cognitive function of mild to moderate AD patientsAfter 12 weeks of continuous intervention,there was no change in cognitive function in the control group(P > 0.05),and the MMSE scores increased in the Fei Teng Eight Method group and the needle-drug combination group compared with the control group,respectively(both P < 0.05),indicating that both Fei Teng Eight Method acupuncture and needle-drug combination could improve the cognitive status of mild to moderate AD,and the comparison between the two intervention groups(P > 0.05)showed that the improvement of cognitive function status in the needle-drug combination group.There was no statistical difference between the acupuncture Fei Teng Eight Method group and the acupuncture group.2.The Fei Teng Eight Methods group and the needle-drug combination group can improve the clinical symptoms of Chinese medicine in patients with mild to moderate AD.After 12 weeks of continuous intervention,there was no significant change in the TCM clinical symptoms in the control group(P>0.05),while the TCM clinical symptoms improved in the Fei Teng Eight Method group and the needle-drugneedle-drug combination group compared with the control group respectively(both P<0.001),and the CMSS scores in the Fei Teng Eight Method group compared with the needle-drug combination group(P<0.05),which showed that the CMSS scores in the needle-drug combination group improved better than those in the Fei Teng Eight Method group,especially in The results showed that the CMSS scores of the needle-drug combination group improved better than those of the Fei Teng Eight Method group,especially in the areas of emotional anxiety,lumbar and knee weakness,and lack of facial color,which were lower in the needle-drug combination group(all P<0.05).3.The Fei Teng Eight Method group and needle-drug combination group can improve the sleep status of mild to moderate AD patientsAfter 12 weeks of continuous intervention,there was no change in the sleep status of the control group,and the PSQI scores were reduced in both test groups(P<0.001),and the PSQI scores were reduced in both test groups compared with the control grouprespectively(both P<0.001),and the results showed that there was no statistical difference between the improvement of sleep status in the needle-drug combination group and the acupuncture Fei Teng Eight Method group.4.The effect of the Fei Teng Eight Method group and the needle-drug combination group on the self-care ability of patients with mild to moderate AD was not significant.After 12 consecutive weeks of intervention,there was no significant change in Barthel scores in the three groups(all P > 0.05).5.The Fei Teng Eight Method group and the needle-drug combination group can improve the serum BDNF level of mild to moderate AD patients.After 12 consecutive weeks of intervention,serum BDNF levels were higher in the control group than before treatment(P<0.05)and the serum BDNF level in both test groups increased compared with that before treatment(both P < 0.001),and the difference was statistically significant when compared with the control group after treatment between groups(both P< 0.001),and the results showed that the improvement of serum BDNF level in the needle-drug combination group was different from that in the acupuncture the Fei Teng Eight Method group was statistically different(P<0.05).6.The Fei Teng Eight Method group and the needle-drug combination group can reduce plasma Hcy levels in patients with mild to moderate AD.After 12 consecutive weeks of intervention,reduced plasma Hcy levels in the control group(P<0.05),and plasma Hcy level decreased in both test groups(P<0.001),and the difference was statistically significant when compared with the control group after treatment between groups(both P<0.001),and the plasma Hcy level in the needle-drug combination group was lower than that in the Fei Teng Eight Method group when compared with the two intervention groups(P<0.001).Conclusions:1.Acupuncture Fei Teng Eight Method can improve cognitive function,sleep quality and some TCM clinical symptoms in patients with mild to moderate AD,increase serum BDNF concentration and reduce plasma Hcy concentration in patients with mild to moderate AD.However,the improvement effect was not obvious in terms of facial dullness,waist and knee weakness,and emotional isolation,and there was no significant effect on self-care ability.2.The combination of acupuncture Fei Teng Eight Method and Huanshaodan improved cognitive function,sleep quality and TCM clinical syndromes in patients with mild to moderate AD,and was better than the Fei Teng Eight Method group in terms of improvement of facial dullness,lumbar and knee weakness,and emotional isolation.The combination of acupuncture and medicine was better than the Fei Teng Eight Method in improving serum BDNF levels and lowering plasma Hcy levels,with no significant effect on self-care ability. |
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