Jingyuan Mao

Study on the evaluation of the clinical effects of traditional chinese medicine in heart failure by complex intervention: protocol of SECETCM-HF

BackgroundExperts in Traditional Chinese Medicine (TCM) have studied the TCM subject of the pathogenesis of heart failure (HF) for several decades. As a result, the general idea is ben deficiency and biao excess. However, the clinical evaluation system which combined the TCM and western medicine in HF has not been developed yet. The objective is to establish the evaluation index system for the integration of TCM and western medicine. The evaluation indexes which include TCM items will specify the research design and methods.MethodsNine medical centers in different cities in China will participate in the trial. A population of 340 patients with HF will be enrolled through a central randomized system for different test groups. Group A will be treated with only western medicine, while group B with western and Chinese medicine together. The study will last for 12 months from the date of enrollment. The cardiovascular death will be the primary outcome.DiscussionBy putting the protocol into practice, the clinical effects of TCM for HF will be identified scientifically, objectively as well as rationally. The proper index system which built in the study will be helpful for the clinical effect expression of HF by integrated medicine in future.Trial RegistrationChiCTR-TRC-00000059

Clinical assessment of Shenfu injection loading in the treatment of patients with exacerbation of chronic heart failure due to coronary heart disease: study protocol for a randomized controlled trial

BackgroundAcute exacerbation is a common cause of hospitalization in patients with chronic heart failure, and coronary heart disease is the most common cause. Shenfu injection, a Traditional Chinese Medicine injection, widely used in the adjuvant treatment of patients with acute exacerbation of chronic heart failure, shows some treatment effect in improving the symptoms and the quality of life, but it lacks the rigorous clinical evaluation of research reports. This paper describes the protocol for the clinical assessment of Shenfu injection loading in the treatment of patients with acute exacerbation of chronic heart failure.MethodsThis protocol adopts the design of a prospective, randomized, multicenter, blind imitation, placebo-controlled trial to assess the efficacy and safety of Shenfu injection loading in the treatment of patients with acute exacerbation of chronic heart failure due to coronary heart disease. The research will be carried out in 12 hospitals in China and is expected to enroll 160 inpatients with acute exacerbation of chronic heart failure due to coronary heart disease (yang and qi deficiency syndrome). On the basis of the conventional therapy of western medicine, patients will be randomized to either the treatment group (100 ml 5% glucose injection + 50 ml Shenfu injection) or the control group (150 ml 5% glucose injection) for 7 ± 1 days and follow-up for 28 ± 3 days. The primary outcomes are New York Heart Association cardiac function classification and Traditional Chinese Medicine syndromes. The secondary outcomes are left ventricular ejection fraction, brain natriuretic peptide level, Lee’s heart failure score, 6-minute walking distance, and the incidence and readmission rate of cardiovascular events (including the emergency rate due to acute exacerbation of chronic heart failure).DiscussionThis trial will assess the effect of loading Shenfu injection in the treatment of patients with acute exacerbation of chronic heart failure caused by coronary heart disease (yang-qi deficiency syndrome) on the symptoms and signs of heart failure, exercise tolerance, and other aspects, and observe its influence on the short-term prognosis with follow-up. The results of the study will provide clinical research evidence for application of Shenfu injection in the treatment.Trial registrationThis trial was registered on 26 December 2012 at the Chinese Clinical Trials Register (Identifier: ChiCTR-TRC-12002857).

Cavum septum pellucidum and first-episode psychosis: A meta-analysis

Objectives To investigate the prevalence and changes of cavum septum pellucidum (CSP) in first-episode psychosis (FEP) patients. Methods Medline, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched to identify eligible studies comparing FEP patients and healthy controls from inception to Feb 29, 2016. Results Ten cross-sectional studies and three longitudinal studies reported in ten articles met our criteria. Our meta-analysis found no significant differences in the prevalence of either “any CSP” (OR = 1.41; 95% CI 0.90–2.20; p = 0.13; I2 = 52.7%) or “large CSP” (OR = 1.10; 95% CI 0.77–1.58; p = 0.59; I2 = 24.1%) between FEP patients and healthy controls. However, the heterogeneity analysis of the prevalence of “any CSP” suggested bias in outcome reporting. Conclusions The results based on current evidence suggest it is unclear whether “any CSP” is a risk factor for FEP due to the heterogeneity of the studies. There is insufficient evidence to support that “large CSP” is a possible risk factor for FEP.

Contemporary treatment of Western and Chinese medicine for cardiac syndrome X

Clinical reports on cardiac syndrome X (CSX) have been increasing in recent years. In general, CSX does not increase the cardiovascular mortality, but it can affect the patient’s quality of life (QOL) and increase the incidence rates of cardiovascular and cerebrovascular events. Although a variety of drugs and therapies have been utilized in the clinical treatment, the management of CSX still represents a major challenge due to its unclear pathogenesis. It is necessary to explore more effective treatment programs. Many attempts have been made on trials of the Chinese medicine (CM) treatment for CSX and proved that CM has a certain advantage in efficacy to improve clinical symptoms and QOL. CM may provide a new approach for the effective treatment of CSX.