[Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

[Correlation analysis on changes between cognitive ability and brain fMRI after acupoint thread embedding in Alzheimer's disease patients].

OBJECTIVE: To explore the mechanism of acupoint thread embedding (ATE) in treating Alzheimer's disease (AD) by means of brain functional magnetic resonance imaging (fMRI). METHODS: Twenty-six patients with mild to moderate AD were assigned to the tested group and the control group in pairing, 13 in each group. ATE was performed in patients of the tested group at Shenmen (HT7), Fenglong (ST40), Taixi (KI3) and Zusanli (ST36) acupoints, once every month for 6 times in total; but for patients of the control group only sham operation was done at the same acupoints. The correlation between cognitive ability and fMRI were assessed by comparing the scores of Mini-Mental State Examination (MMSE) and Alzhemer's Disease Assessment Scale-Cognitive section (ADAS-Cog), monitored at two time points, namely, in one week before starting treatment and 1 week after terminating 6-month treatment. Furthermore, fMRI was detected to obtain the data of the cerebral blood oxygen content before treatment and 6 months after completing the 6-month therapeutic course. Correlation analysis was conducted on the obtained data using software SPM. RESULTS: After treatment, changes of MMSE score significently increased in the test group (P < 0.01) and decreased in the control group (P < 0.01), and ADAS-Cog decreased in the test group (P < 0.01) and increased in the control group (P < 0.05), showing statistical significance between the two groups (P < 0.01, P < 0.05). The activated regions related with the change of MMSE were mainly inferior frontal gyrus, middle frontal gyrus, superior frontal gyrus, transverse temporal gyrus, on the left cerebrum and superior frontal gyrus, middle frontal gyrus, precentral gyrus, hippocampal gyrus, cingulate gyrus, postcentral gyrus, paracentral lobule on the right cerebrum; those related with change of ADAS-Cog were superior frontal gyrus, middle frontal gyrus, fusiform gyrus, inferior temporal gyrus, hippocampal gyrus on the left cerebrum, and superior frontal gyrus, middle frontal gyrus, precentral gyrus, fusiform gyrus, transverse temporal gyrus, postcentral gyrus, middle occipital gyrus on the right cerebrum. CONCLUSION: ATE could improve the cognitive ability of AD patients, its possible mechanism may be through the activation on the cognition related regions of frontal, temporal lobe and marginal system, as well as those of cerebellum.

[Clinical observation on catgut implantation at acupoint for treatment of Alzheimer's disease].

OBJECTIVE: To observe clinical therapeutic effect of catgut implantation at acupoint on Alzheimer's disease (AD). METHODS: Twenty-six cases with mild-moderate AD were divided into an acupoint catgut implantation group and a control group by sample-paired method. The acupoint catgut implantation group were treated with cat-gut implantation at Shenmen (HT 7), Zusanli (ST 36), Fenglong (ST 40) and Taixi (KI 3), and the control group with the same manipulation at the same acupoints with no catgut implanted, once each month, for 6 months. Mini-Mental State Examination (MMSE), Activity of Daily Living (ADL) and Alzheimer's Disease Assessment Scale-Cognitive Section (ADAS-Cog) scores were recorded before and after treatment and analyzed statistically. RESULTS: After treatment, the score of MMSE significantly increased (P < 0.01), the score of ADAS-Cog significantly decreased (P < 0.01) and the score of ADL did not significantly change in the acupoint catgut implantation group; compared with the control group, the score of MMSE in the acupoint catgut implantation significantly increased (P < 0.01), the score of ADAS-Cog significantly decreased (P < 0.05) and the score of ADL did not significantly change in the acupoint catgut implantation. CONCLUSION: Acupoint catgut implantation therapy increases cognitive function of the patient of AD, which provides a new therapeutic method for aged AD.

[Effects of acupuncture at Neiguan (PC 6) on human brain functional imaging in different functional states].

OBJECTIVE: To study on effects of acupuncture at a same point at physiological or pathological state on brain functional imaging. METHODS: Electroacupuncture was given at Neiguan (PC 6) of the healthy senile persons (normal group) and the patients of Alzheimer's disease (AD group), and they were scanned on a 1.5 T MRI scanner and the data of functional magnetic resonance imaging (fMRI) were analyzed by Statistical Parametric Mapping (SPM99). The functional imaging of different brain regions were obtained from both the healthy group and the AD group. RESULTS: Both the frontal lobe and the temporal lobe were activated in varying degrees by electroacupuncture at Neiguan (PC 6) in the healthy group. However, the frontal lobe, the temporal lobe and the cingulate gyrus as well as the cerebellum were activated in varying degrees and other brain regions were not activated by electroacupuncture at Neiguan (PC 6) in the AD group. CONCLUSION: Acupuncture at Neiguan (PC 6) can activate functions of different brain regions in the healthy group and the AD group, indicating that acupuncture at Neiguan (PC 6) has different effects on functional magnetic resonance imaging in different functional states.

[Effects of electroacupuncture at neiguan (PC 6) and Shenmen (HT 7) on brain functional imaging].

OBJECTIVE: To observe effect of electroacupuncture at Shenmen (HT 7) and Neiguan (PC 6) on brain functional imaging. METHODS: The technique of functional magnetic resonance imaging was used to observe the activated state in different brain regions caused by electroacupuncture. RESULTS: The frontal lobe was activated by electroacupuncture at Neiguan (PC 6) and the temporal lobe by Shenmen (HT 7). CONCLUSION: Electroacupuncture at different acupoints can activate different brain regions, which provides objective basis for treatment of intellectual impairment by electroacupuncture at Neiguan (PC 6) and Shenmen (HT 7).