Efficacy and Safety of Guilingji Capsules () for Treating Mild-to-Moderate Cognitive Impairment: Study Protocol for A Randomized, Double-Blind, Positive-Controlled, Multicenter and Noninferiority Trial / 中国结合医学杂志

BACKGROUND@#The incidence of cognitive impairment (CI) is gradually increasing, which has attracted more attention from medical researchers worldwide. Definitive mechanisms of pathogenesis remain elusive, and there are few medications that have been proven effective for CI. The utilization of Chinese herbal medicine has shown positive therapeutic effects for a broad spectrum of diseases, including CI.@*OBJECTIVE@#The purpose of this study is to evaluate the safety and efficacy of Guilingji Capsules (GLJC, ) in treating mild-to-moderate CI with Shen (Kidney) and marrow deficiency syndrome.@*METHODS@#This is a randomized, double-blind, positive-controlled, multicenter clinical trial with a noninferiority design that included 348 participants randomly divided into an experimental arm and an active comparator arm. Individuals in the experimental arm (174 cases) took 0.6 g of GLJC once a day and 19.2 mg of Gingko biloba extract mimetic 3 times a day. Individuals in the active comparator arm (174 cases) took 0.6 g of GLJC mimetic once a day and 19.2 mg of Gingko biloba extract in tablet form 3 times a day. The intervention period included two sessions over 24 weeks. The primary outcome be the effectiveness of GLJC on cognitive improvement after 24 weeks of treatment, which was defined as an increase in the Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) Scale. The secondary outcomes were improvement in independence, daily living ability, and Chinese medicine (CM) syndrome, which were measured with the Alzheimer's disease Rating Scale-Cognitive Project (ADAS-Cog), Clinical Dementia Rating (CDR) Total Score, Activities of Daily Living (ADL) Total Score and the Chinese Medicine Symptom Scale (CM-SS), respectively. Serum acetylcholine, acetylcholinesterase, bax and bcl-2 were monitored to explore the mechanism of GLJC on CI. In addition, safety measures, including vital signs, electrocardiography, laboratory indicators (full blood count, kidney and liver function tests, routine urine test and routine stool test) and adverse events, were also recorded.@*DISCUSSION@#The purpose of this trial is to evaluate the efficacy and safety of GLJC in patients with mild-to-moderate CI with kidney and marrow deficiency syndrome. If successful, the results would provide a viable treatment for patients with mild-to-moderate CI. (Clinical Trials.gov. ID: NCT03647384. Registered on 23 August 2018).

Comparison between Ye Tianshi and Wu Jutong in treatment of summer-heat disease / 中国中药杂志

Through the traditional Chinese medicine inheritance platform system, with the help of medical records, Ye Tianshi and Wu Jutong's medication characteristics for summer heat sickness were analyzed, the laws of the two people's medication were summarized, and the similarities and differences between the two were explored to explore the relationship. As a result, it was found that both of them recognized the relationship between summer heat and wetness, and Wu Jutong believed that "wind" was also an important pathogenic factor. Both of the patients were treated with cold medicine and warm medicine. They used mostly bitter, sweet, pungent taste and lungs, spleen, stomach, and heart meridian are the main components; two are commonly used Armeniacae Semen Amarum, Talcum, Rehmanniae Radix, Ophiopogonis Radix, Pinelliae Rhizoma and other drugs, Ye Tianshi use Scrophulariae Radix, Tetrapanacis Medulla, Coicis Semen and other drugs more, Wu Jutong use Gypsum Fibrosum, Sojae Semen Praeparatum, Menthae Haplocalycis Herba and other drugs more; at the same time, a combination of two high-frequency medicines used by two people has been excavated, and a new prescription has been deduced to provide a reference for further understanding and treatment of summer diseases.

Long-term follow-up of Chinese herbal medicines combined with conventional treatment in patients with acute coronary syndrome after percutaneous coronary intervention: A multicenter randomized controlled trial / 中国结合医学杂志

<p><b>OBJECTIVE</b>To evaluate the prognosis effect of Chinese herbal medicines (CHMs) for benefiting qi and activating blood circulation adjunctive to conventional treatment in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI).</p><p><b>METHODS</b>A total of 702 patients with ACS who underwent PCI were enrolled and randomly assigned to receive conventional treatment plus CHMs for benefiting qi and activating blood circulation (treatment group, 351 cases) or conventional treatment alone (control group, 351 cases) for 6 months. Six months later, all patients received conventional treatment alone. Follow-ups were scheduled at 6th, 12th, 18th, 24th month after enrollment in April 2008, and the final follow-up visit was during September 2011 and November 2011. The primary endpoint was the composite of cardiac death, nonfatal myocardial infarction or revascularization (PCI or coronary artery bypass grafting); and the secondary endpoint was the composite of re-admission for ACS, congestive heart failure, nonfatal stroke or other thrombus events.</p><p><b>RESULTS</b>A total of 621 (88.59%) patients completed 35.4±3.8 months follow-up, while 80 (11.41%) patients withdrew from the trial (41 in the treatment group and 39 in the control group). The incidence of primary endpoint was 5.7% (20 patients) in the treatment group versus 10.86% (38 patients) in the control group [relative risk (RR): 0.53; 95% confidence interval (CI): 0.30, 0.88; P=0.013; absolute risk reduction (ARR):-0.052, 95% CI: -0.06, 0.01]. The incidence of secondary endpoint was 5.98% (21 patients) in the treatment group versus 10.28% (36 patients) in control group (RR: 0.58, 95% CI: 0.33, 0.97, P=0.037; ARR: -0.043, 95% CI: 0.06, 0.01). Most of the primary and secondary endpoints were occurred in 18 months (84.50% in the treatment group versus 78.10% in the control group).</p><p><b>CONCLUSION</b>CHMs for benefiting qi and activating blood circulation adjunctive to conventional treatment improved clinical outcomes for patients with ACS after PCI in long-term follow-up.</p>

Application of qualitative interviews in inheritance research of famous old traditional Chinese medicine doctors: ideas and experience / 中国中西医结合杂志

The inheritance of famous old traditional Chinese medicine (TCM) doctors plays an essential role in the fields of TCM research. Qualitative interviews allow for subjectivity and individuality within clinical experience as well as academic ideas of doctors, making it a potential appropriate research method for inheritance of famous old TCM doctors. We summarized current situations of inheritance research on famous old TCM doctors, and then discussed the feasibility of applying qualitative interviews in inheritance of famous old TCM doctors. By combining our experience in research on inheritance of famous old TCM doctors, we gave some advice on study design, interview implementation, data transcription and analyses , and report writing, providing a reference for further relevant research.

Ginkgo preparations of Chinese medicine and treatment of diabetes: mechanisms and clinical applications / 中国中药杂志

Ginkgo is one of the most successful cases of botanical drugs developed by modern science and technology during the past fifty years all over the world. At present ginkgo has been applied to the prevention and treatment of cardiovascular disease widely, and has good clinical efficacy. Type 2 diabetes has been proved to be the risk equivalents of cardiovascular disease, therefore it has an important scientific significance for looking for more effective drugs of prevention and control of diabetes. To seek more efficient and safe drug from the plant medicine which has the function of regulate blood sugar and improve insulin resistance becomes a hotspot at home and abroad. Basic and clinical studies have shown the ginkgo preparations of Chinese medicine have certain regulation effect on blood sugar and insulin resistance. In this paper, we review the mechanisms and clinical applications of ginkgo preparations on diabetes and its applications during the past 10 years.

Multifactor dimensionality reduction analysis of the correlation of Chinese medicine syndrome evolvement and cardiovascular events in patients with stable coronary heart disease / 中国结合医学杂志

<p><b>OBJECTIVE</b>To analyze the correlation of Chinese medicine syndrome evolvement and cardiovascular: events in patients with stable coronary heart disease (CHD).</p><p><b>METHODS</b>This prospective cohort study investigated and: collected the clinical information of patients with stable CHD and observed the syndrome type at the baseline and 6-month at follow-up, as well as the cardiovascular events during the 6-month and 12-month follow-up. The patients were divided into the event group and the non-event group. The interaction and the impact of syndrome evolvement on cardiovascular events were examined through multifactor dimensionality reduction (MDR) analysis and the results were verified by Chi-square test.</p><p><b>RESULTS</b>Totally 1,333 of 1,503 stable CHD patients enrolled met the inclusion criteria: of MDR analysis. Among them, 959 (71.9%) cases were males and 374 (28.1%) cases were females. Thirty seven cases had cardiovascular events during 6 to 12 months after the study began. The results of the MDR analysis and verification using Chi-square test showed that the development of cardiovascular events was positively correlated with interaction between blood stasis and toxic syndrome at the baseline, blood stasis at the baseline and qi deficiency at the 6-month follow-up, toxic syndrome at the baseline and qi deficiency at the 6-month follow-up, toxic syndrome at the base line and blood stasis at the 6-month follow-up, qi deficiency and blood stasis at the 6-month follow-up (P<0.05 for all).</p><p><b>CONCLUSIONS</b>Blood stasis, toxic syndrome and qi deficiency are important factors of stable CHD. There: are positive correlation between cardiovascular events and syndrome evolution from blood stasis to qi deficiency, from toxic syndrome to qi deficiency and from toxic syndrome to blood stasis, indicating the pathogenesis of toxin consuming qi, toxin leading to blood-stasis in stable CHD patients prone to recurrent cardiovascular events.</p>

Study on the diagnostic criteria for coronary heart disease patients of blood stasis syndrome / 中国中西医结合杂志

The diagnostic criteria of blood stasis syndrome (BBS) established by the Specialty Committee of Activating Blood Circulation and Removing Stasis, Chinese Association of Integrative Medicine 1986 has been widely used in clinical practice of Chinese medicine. But coronary heart disease (CHD) of BBS has its own features. By using clinical epidemiological methods, establishing the diagnostic criteria for CHD patients of BBS is of great significance in furthering its studies, exerting the advantages of Chinese medicine in preventing and treating CHD, and elevating the clinical efficacy.

Preliminary comparative study on the effect of different chinese drugs for strengthening Pi in antagonizing diet induced obesity / 中国结合医学杂志

<p><b>OBJECTIVE</b>To observe the difference in fatty degree, glucose-lipid disorder and adipose-hormones between diet induced obesity (DIO) rats and diet induced obesity resistance (DIO-R) rats, and to explore the effect and acting mechanism of Chinese drugs for strengthening Pi (CD-SP) and those for both strengthening Pi and dissolving phlegm (CD-SPDP) in inhibiting obesity.</p><p><b>METHODS</b>Excepting eight rats allocated in the blank control group, the other 54 rats were fed with high-lipid forage for 12 weeks to establish models of obesity. Finally, 30 DIO rats and 8 DIO-R rats (shown by their body weight) were obtained. The DIO rats were divided into three groups, which were given gastric perfusion, respectively, with normal saline (Group A), CD-SP (Group B), and CD-SPDP (Group C). Fourteen weeks later, the animals' body weight (BW), length (BL), blood levels of fasting insulin (FIn), fasting glucose (FBG), triglyceride (TG), cholesterol (TC), leptin (LP), neuropeptide Y (NPY), C-reactive protein (CRP), tumor necrosis factor-alpha(TNF-alpha), adiponectin (AN), and resistin (RS) were measured; insulin resistance index (IRI) was calculated, and the degree of obesity and lipid content in abdominal cavity of rats were estimated. Moreover, the levels of LP, CRP, TNF-alpha, AN and RS in homogenate of rats' adipose tissues (ATH) were determined.</p><p><b>RESULTS</b>After 12 weeks of high-lipid diet, the BW of DIO rats was higher than that of normal or DIO-R rats. After a 14-week continuous high-lipid diet feeding, in DIO rats, BW, lipid coefficient (LC), and IRI were significantly increased (P<0.01); serum levels of TNF-alpha, LP and AN were lower, NPY was higher, while the ATH levels of LP and AN were lower and TNF-alpha was higher in DIO rats than in DIO-R rats (P<0.05 or P<0.01); blood levels of FBG and lipids in DIO rats showed an increasing trend but was statistically insignificant (P>0.05); no significant difference was found in serum levels of CRP and RS due to the overly high data dispersion. Comparisons of the 3 DIO groups showed that BW, body weight index (BWI), LC and IRI were significantly lowered after treatment (P<0.01) in Group C, while these indexes were not significantly different between Group A and B; the serum levels of TNF-alpha, LP, and AN increased, NPY decreased in Group B and C, ATH levels of LP and AN increased, and TNF-alpha decreased in the two groups; but NPY, LP, and AN in blood and ATH were higher in Group C than those in Group B (P<0.05 or P<0.01).</p><p><b>CONCLUSION</b>CD-SPDP could inhibit DIO and IR, showing that the effect is better than that of CD-SP, and its mechanism is related to promotion of LP and AN secretion and elevation of serum NPY.</p>