"Guixue" Acupuncture Treatment For Patients With Behavioral And Psychological Symptoms Of Dementia: Phase I Study

Objective:To evaluate the safety, acceptability and efficacy of "Guixue" acupuncture treatment for behavior and psychological symptoms of dementia (BPSD).Methods:we conducted an open label, phase I clinical trial in which 30 participants (15 BPSD patients and 15 healthy volunteers, respectively) received "Guixue" acupuncture treatment. The treatment was administered once daily and lasted for 7 days. Treatment Emergent Symptom Scale (TESS), Questionnaire of Acupuncture—related Events (AQE), the Vital sign and laboratory examination, electrocardiogram examination; electroencephalogram examination were used to asses the safety of "Guixue" acupuncture treatment. We adopted the number of times for acupuncture treatment in fact/the number of times for acupuncture treatment expected to evaluate the acceptability of this therapy. Mini Mental Status Evaluation(MMSE), Behavioral pathology in Alzheimer's disease rating scale (BEHAVE—AD), and Activity of Daily Living Scale (ADL) were employed to each enrolled participant to investigate the efficacy of the plan for BPSD patients. And the data of the trial was analyzed by the SPSS 13.0 statistical package.Results:24 participants (11 BPSD patients and 13 healthy old volunteers) held on to the end of the trial. The baselines of the two armies have no difference except for assessment scores of MMSE, TESS, and ADL. (1)Safety:The decrease of the TESS scores were significant in the healthy old volunteers group (P=0.004<0.05), but the BPSD patients'TESS scores changed not significantly enough. Excessive pain in needle points, Dizziness/vertigo, Acupuncture fainting, Headache, Blooding after acupuncture, and the details were noted in QAE. For the kinds of medical examinations, only the electroencephalogram examination results changed significantly. (2) Compliance:According to the methods of calculation for compliance, the compliance was 90%.(3):Efficacy:After the 7-day acupuncture treatment, the patient's army showed clinical improvement in BPSD, the reduction from baseline to endpoint in BEHAVE-AD total score was significant (P=0.004<0.05), and compared to the baseline of MMSE, ADL scores, there were no significant changes in MMSE, ADL scores of all the participants (P>0.05)Conclusions:The results showed that the protocol for BPSD treatment could be high safety, well compliance, and good responded.