Observation of the curative effect of Cistanche Total Glycoside on Alzheimer's disease

For more information: Ali.ma@wecistanche.com

Wang En Huang Qin Huang Miwu Bao Zuxiao Chen Baojun Wang Ying Zheng Haibin Zhou Yuanlin Jin Xiaoping

Linhai 317000, Taizhou Hospital, Zhejiang Province

Keywords: Alzheimer's disease, Cistanche Total Glycoside, Donepezil Clinical observation, Cistanche

Alzheimer's disease (AD) is a neurodegenerative disease characterized by progressive dementia. The prevalence of 65-69 years old is about 1%, and the prevalence of over 85 years old is nearly 20%E. The current prevalence of AD in China is 4.8%. As a cholinesterase inhibitor, donepezil hydrochloride (trade name: Aricept) is recognized as the "gold standard" drug for the treatment of mild to moderate AD. From January 2008 to February 2010, we used a controlled trial of donepezil hydrochloride to evaluate the effectiveness and safety of Cistanche Total Glycoside in the treatment of mild to moderate Alzheimer's disease. The report is as follows.

Click to Cistanche dosage for  Alzheimer's disease

1 clinical data

1.1 General information

The Alzheimer's disease patients are from the neurology clinic of our hospital, and the number table method is randomly divided into the treatment group 52 cases, 24 males and 28 females, with an average age of (69.5±5.0) years and an average duration of (3.0±0.5) years; X There were 50 cases in the Cunzhao group, including 24 males and 26 females, with an average age of (68.6 + 4.8) years and an average duration of (3.0 ± 0.3) years. There was no statistical difference in age and course of disease between the two groups, and they were comparable.

1.2 Inclusion criteria

Alzheimer's disease patients are aged 50-80-year-old men and postmenopausal women; in line with the American Psychiatric Association "Diagnostic and Statistical Manual of Mental Disorders" revised fourth edition (DSM-IV-R) dementia diagnostic criteria; in line with American neurology, language disorders, and The possible or likely AD diagnostic criteria set by the Stroke Institute AD and Related Diseases Association (NINCDS-ADRDA) are down; the cognitive function and the ability of daily living have been reduced for at least 6 months; the Hamilton Depression Rating Scale (HAM-D) score is W14 And modified Hachinski ischemia score W6 points, except moderate and severe depression and vascular dementia （Alzheimer's disease）. The severity of dementia was diagnosed as mild to moderate dementia according to DSM-1V-R, and the MMSE score ranged from 10 to 26 points.

1.3 Exclusion criteria

Patients with other diseases that may cause dementia except for Alzheimer's disease; severe or very mild dementia, ie MMSE <10 points or> 26 points; patients with obvious depressive symptoms on HAM-DN 15 points; patients with other severe and unstable diseases.

2 treatment methods

The control group was given Aricept 5mg, once a night, orally; the treatment group was given capsules of Cistanche glycoside, 2 capsules once, 3 times a day. The course of treatment for both groups was 16 weeks. Evaluate the curative effect after the course of treatment.

Observation index: Effectiveness evaluation: MMSE is used to determine the cognitive function of patients, ranging from 0 to 30 points. A high score indicates improvement of the condition. The Blessed-Roth scale assesses the patient’s ability of daily living (doing housework, managing a small amount of money, remembering shortlists, identifying familiar environments, recalling recent events, etc.), basic habits changes (eating, dressing, urinating, etc.) by asking caregivers in detail. ), changes in personality (changes in personality, emotion, internal drive, etc.) 22 items are scored, ranging from 0 to 28 points. A decrease in score indicates improvement in the condition. The Global Decline Scale (GDS) is used to assess the severity of dementia. Researchers make judgments after clinical examinations and interviews with caregivers. The score is 1-7. The higher the score, the more severe dementia.

Safety evaluation: Perform clinical and laboratory inspections after completing the 16-week trial. The outpatient follow-up is conducted every 4 weeks to distribute drugs and monitor adverse events. Adverse event reports record the duration, severity, relationship with the tested drugs, and measures are taken. The endpoint of the trial was the completion of 16 weeks of observation, or the occurrence of intolerable adverse events, or the volunteers' request to withdraw.

Statistical method: use SPSS13 statistical analysis software for statistical analysis. The comparison application/inspection of measurement data and the comparison of count data should use the X test. The statistical tests were all two-sided, and the significance level was set as cadaveric <0.05.

3 treatment results

3.1 Comparison of MMSE, Blessed-Roth, and GDS scores between the two groups.

After 16 weeks of treatment, the MMSE of the two groups was significantly increased (P<0.05), but the difference between the two groups was not statistically significant (P>0.05); Blessed-Roth decreased significantly (household<0.05), but the difference between the two groups was not statistically significant (P>0.05); there was no statistically significant difference in GDS scores between the two groups before and after treatment and between the two groups (P>0.05).

3.2 Adverse reactions

No death or serious adverse reactions were found during the treatment. In the control group, 10 cases (20%) of adverse reactions such as dizziness, nausea, loss of appetite, mild diarrhea, constipation, fatigue, and agitation occurred in 10 cases (20%), but the medication was continued. There were 3 cases (5.8%) of mild diarrhea in the treatment group, and the medication was still continued. Comparing the incidence of adverse reactions between the two groups, the treatment group was lower than the control group (P<0.05).

4 Discussion

AD is a degenerative disease of the nervous system, and its clinical manifestations are related to the dysfunction of acetylcholinergic neurons in the central nervous system. Allison can effectively and selectively inhibit the degradation of acetylcholine in the central nervous system, increase the concentration of acetylcholine in the synaptic space of nerve cells, and improve the cognitive dysfunction of AD patients. However, these drugs are expensive and difficult for many patients to accept.

Cistanche was first published in "Shen Nong's Materia Medica" and was listed as a top-grade Chinese medicine. It has the effects of nourishing kidney yang, nourishing essence and blood, moisturizing the intestines, and laxative. Studies have shown that"Qi Cistanche has multiple effects such as strengthening immunity, invigorating the kidney and strengthening yang, enhancing the body's anti-aging ability, protecting the liver, and anti-oxidation. Cistanche Total Glycoside is extracted from the Cistanche herb, and its main ingredient is the Total Phenylethanoid Glycoside of Cistanche. In animal experiments, Cistanche Total Glycoside has the effect of improving the learning ability of a variety of Alzheimer's disease (AD) mouse models. Xue Dejun et al. made Cistanche Total Glycoside into anti-aging preparations and conducted research on the human body to eliminate lipid peroxides in the blood. The results show that anti-aging preparations can reduce the LPO value in human blood, and at the same time can significantly improve the body's aging symptoms, restore energy and improve physical strength, and vitality of middle-aged and elderly people, and delay aging.

Both the MMSE and the Blessed-Roth scale are effective tools for evaluating the changes in cognition, the ability of daily living, and emotion in patients with dementia. GDS is a general scale for evaluating the severity of dementia. Compared with the total scores of MMSE before and after treatment in this group, both the treatment group and the control group showed increased scores, and the difference was statistically significant, indicating that both drugs can improve the cognitive function of patients with mild and moderate AD. Before and after the comparison of the total score of the Blessed-Roth scale, the difference between the treatment group and the control group was statistically significant, suggesting that both Cistanche Total Glycoside and donepezil hydrochloride can significantly improve the ability of daily living and mental behavior symptoms of patients with mild and moderate Alzheimer's disease. The selected cases in this study are all patients with mild and moderate dementia. The baseline GDS scores are mostly between 3 and 5 points. It is less likely that the severity of dementia will change significantly within 16 weeks. Therefore, the GDS score in this study is between two points. There was no statistical significance when comparing the groups before and after treatment. This study found that the MMSE score and the total score of the Blessed-Rothfi table were not statistically significant after 16 weeks, suggesting that Cistanche Total Glycoside and donepezil hydrochloride are equally effective in improving the cognitive function and living ability of patients with mild and moderate Alzheimer's disease (AD).

In summary, Cistanche Total Glycoside has a therapeutic effect on patients having Alzheimer's disease. The short-term efficacy is similar to that of Aricept, and the price is moderate, significantly lower than that of Aricept, with fewer adverse reactions, and has certain clinical application value.

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