[Chinese herbal medicine for patients with mild to moderate Alzheimer disease based on syndrome differentiation: a randomized controlled trial].

BACKGROUND: Alzheimer disease (AD) is a chronic neurodegenerative disease that is characterized by its gradual progression. At present, the cause and mechanism of AD are yet unclear, and there is no effective therapy for treating it. With development of global aging, the prevalence rate of AD is increasing. The life quality of elderly people is affected severely by AD that is ultimately life-threatening. Recently, study on treating AD with traditional Chinese medicine (TCM) has deepened. OBJECTIVE: To explore the therapeutic effects of a syndrome differentiation-based TCM regime in treating patients with mild to moderate AD for improving cognition, and to evaluate the changes in brain function of AD patients observed by resting-state functional magnetic resonance imaging (fMRI) technique. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: Adopting the internationally recognized criteria developed by National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association, the clinical trial was conducted on 131 patients with mild to moderate AD from 5 communities and 7 social welfare institutions. Participants were accepted after informed consent was received, and laboratory tests and a head imaging study were conducted. The patients were randomly divided into Chinese medicine group (CMG) (66 cases) or Western medicine group (WMG) (65 cases). Patients in the CMG were treated monthly with Chinese medicine according to syndrome differentiation. Patients in the WMG were treated with donepezil at a dose of 5 mg once daily. The therapeutic course lasted 48 weeks. MAIN OUTCOME MEASURES: The scores of Mini-Mental State Examination (MMSE), Fuld Object-Memory Evaluation (FOM), Block Design (BD) and Digit Span (DS) were used to evaluate the cognitive function; resting-state fMRI was used for observing brain function. The questionnaires and fMRI were performed before and after treatments. RESULTS: The cognitive functions of the patients in the CMG and WMG were improved after treatment. MMSE score was improved significantly in both groups (P<0.05 or P<0.001). After 48 weeks of treatment, 70.91% patients in the CMG had an improved MMSE score and 20% got worse, however, 55.77% patients in the WMG were improved in MMSE score and 34.62% got worse. Scores of FOM denominator and BD increased significantly in both groups; scores of FOM numerator and DS were also increased in the CMG (P<0.05 or P<0.01). The results of fMRI suggested that both Chinese medicine and donepezil treatment improved the connectivity between posterior cingulated gyrus and specific areas in the brain. The influence range of Chinese medicine primarily impacted on the left parietal lobe, being less than the influence range of donepezil, which primarily affected both sides of frontal lobes. CONCLUSION: TCM treatment based on syndrome differentiation is effective in improving cognitive function of patients with mild to moderate AD and increasing the brain function by increasing connectivity between posterior cingulated gyrus and specific areas in the brain.

[Clinical study on effect of Shenyin Oral Liquid in treating mild cognitive impairment].

OBJECTIVE: To observe the therapeutic effect of Shenyin Oral Liquid (SOL) in relieving mild cognitive impairment (MCI) and decreasing the Alzheimer's disease (AD) transformation rate. METHODS: One hundred and seventeen MCI patients were randomly assigned to the Chinese medicine group (42 cases), the vitamin E group (38 cases) and the placebo group (37 cases). The treatment course was 12 months and a 6-month follow-up was conducted after ending the treatment course. RESULTS: After treatment, the scores of clock drawing test (CDT), nonsensical figure recognition and mini-mental state examination (MMSE) raised significantly in the Chinese medicine group (P < 0.05 or P < 0.01), the activity of acetylcholine esterase in erythrocytic membrane was lower in the Chinese medicine group than that in the placebo group and the Vitamin E group (P < 0.05 or P < 0.01). Six months after the treatment, there were 2 and 5 cases in the placebo group and the vitamin E group which were diagnosed as AD, respectively, and none in the Chinese medicine group. CONCLUSION: SOL has an effect similar to cholinesterase inhibitor, it could improve cognitive function in MCI patients and reduce the AD transformation rate in them.

[Clinical study on treatment of Alzheimer's disease from the viewpoint of Xin and Shen].

OBJECTIVE: To explore the therapeutic mechanism of Tiaoxin Recipe (TXR) and Bushen Recipe (BSR) in treating Alzheimer's disease (AD). METHODS: Sixty patients with AD were divided into 3 groups according to their MMSE and ADL scores before treatment, using randomized block design. They were treated separately with TXR, BSR and Donepezil (Dp) for 12 weeks. The changes of MMSE score, ADL score, neuro-psychology amount table score, including FOM, RVR, DS and BD, as well as the overall operational evaluation before and after treatment were analyzed. RESULTS: The recognition and daily life capacity of patients in the 3 groups were improved after treatment. MMSE score in the TXR group increased from 16.10 +/- 1.94 scores before treatment to 17.90 +/- 2.59 scores after treatment, in the BSR group, from 16.15 +/- 2.16 to 17.50 +/- 2.59, and in the Dp group, from 17.35 +/- 1.90 to 19.60 +/- 3.39, all showed significant difference (all P < 0.01). Change of ADL score showed that in TXR from 43.10 +/- 3.86 to 41.50 +/- 4.40, in the BSR group from 43.30 +/- 4.53 to 41.60 +/- 4.12 and in the Dp group, from 42.95 +/- 3.58 to 40.60 +/- 5.23, which also showed significant difference (P < 0.05 or P < 0.01). Moreover, increase of FOM, RVR and DS score was shown in the TXR and the Dp group, and increase of RVR and BD score was shown in the BSR group with significant difference in comparison of corresponding score before and after treatment, inter-groups comparison showed significant difference of FOM score between the BSR and the Dp group (P < 0.01). Overall operational evaluation (total effective rate) in the TXR group was 70%, in the BSR group 65% and in Dp group 75%, with no significant difference among them. CONCLUSION: TXR and BSR are effective TCM drugs in treating AD.