Objective To assess the efficacy and safety of Dan Hong injection for patients with angina pectoris compared with compound salvia injection as the control group. Methods Databases were electronically searched from MEDLINE, EMbase, CBM, CNKI, VIP, and Wanfang Data (January, 2007 to July, 2010), and reference lists of all papers identified were also checked. Randomized controlled trials (RCTs) of the effect of Dan Hong injection on angina pectoris were identified and assessed according to the Cochrane Handbook for Systematic Reviews of Interventions and then RevMan 4.3 was used to undertake Meta analysis. Results Twenty-seven trials involving 3 030 patients were included. Meta-analysis showed that: a) Compared with compound salvia injection, Dan Hong injection was capable of significantly decreasing the angina incidence (OR=3.84, 95% CI 3.03 to 4.88, Plt;0.000 01); b) Dan Hong injection was capable of significantly improving ECG review effectiveness compared with compound salvia injection (OR=1.98, 95% CI 1.44 to 2.66, Plt;0.000 01); c) Dan Hong injection was obviously superior to compound salvia injection in improving the NST (WMD= 0.78, 95%CI 0.42 to 1.14, Plt;0.000 1) and ∑ST (WMD= 0.45, 95%CI 0.32 to 0.57, Plt;0.000 01); and d) Dan Hong injection was able to obviously improve the hemorheology index after angina pectoris; Meta-analyses of eight trials in which adverse events were reported showed that no significant difference was found between Dan Hong injection and salvia injection (OR=0.64, 95%CI 0.33 to 1.25, P=0.19). Conclusion Dan Hong injection can effectively improve the ST segment ischemia and hemorheology index after angina pectoris, significantly increase the effectiveness of electrocardiogram reviews and eventually significantly reduce the recurrence rate of angina, and appears to be much safer. Further high quality RCTs are required to provide reliable evidence on the treatment of patients with angina pectoris.
Objective To investigate the quality of randomized controlled trials (RCTs) involving Danhong Injection for angina of coronary heart disease, and to provide references for improving the quality of clinical research on Chinese medicine (CM) injection. Methods The RCTs published from 2002 to July 2010 about Danhong Injection for angina of coronary heart disease were searched. The methodological quality of the literatures was evaluated according to the methods recommended by the Cochrane Collaboration, and the reporting quality was assessed by means of the Jadad scale and the CONSORT checklist. Results A total of 104 RCTs were included. The assessment result of Jadad scale showed: nine RCTs (8.7%) scored two, 87 (83.6%) scored one, and the other 8 (7.7%) scored zero. According to the standard of CONSORT, only 1 RCT (0.96%) described the random method; no literatures explained how to execute randomization and use placebo control; 3 RCTs (2.9%) reported endpoint outcome; 1 (0.96%) RCT performed single blind; 2 (1.9%) RCTs performed double blind; 54 (51%) RCTs calculated statistic values; 5 (4.8%) RCTs reported follow-up; no RCT reported equivalent results or negative results; 74 (71.2%) RCTs reported adverse events; no RCTs conducted sample size estimation, intention-to-treat analyses and stratified analyses; no RCTs were multicenter trials; and no RCTs recorded the accreditation and the informed consent. Conclusion The quality of RCTs about Danhong Injection for angina of coronary heart disease is still low in methodological aspects such as randomization, estimation of sample size, statistic methods, reporting of follow-up and non-follow-up, and adverse reactions, which has influences on the real evaluation of the effect of Danhong Inection. It is suggested that the future RCTs on CM injection should be conducted with references of CONSORT statement, that a clinical mode of integration of disease and syndrome should be applied according to the treatment theory based on syndrome differentiation, and that more attention should be paid to the clinical observation on adverse reactions of CM injection, so as to be helpful for safe medication and patients’ right protection.
Objective To evaluate the cardiac protection function of high thoracic epidural anesthesia (HTEA) for patients with acute coronary syndrome or heart failure. Methods A literature search was conducted with computerized database on PubMed, EBSCO, Springer, Ovid, and CNKI from 1990 to May 2010. Further searches for articles were conducted by checking all references describing cardiac protection studies with HTEA. All included articles were assessed and data were extracted according to the standard of Cochrane review. The homogeneous studies were pooled using RevMan 4.2.10 software. Results A total of 28 articles involving 1 041 patients were included. The results of meta-analyses showed that, a) cardiac function: HTEA could significantly improve ejection fraction of left ventricle (WMD= – 10.28, 95%CI – 14.14 to – 6.43) and cardiac output (WMD= – 1.26, 95%CI – 1.63 to – 0.89), contract left ventricular diastolic dimension (WMD= 5.02, 95%CI 3.72 to 6.32), increase E peak (WMD= – 17.50, 95%CI – 29.40 to – 5.59) and decrease A peak (WMD= 27.36, 95%CI 24.46 to 30.26); b) ischemic degree for patients with heart failure: the change of NST-T (WMD= 1.45, 95%CI 1.12 to 1.78) and ∑ST-T (WMD= 1.02, 95%CI 0.78 to 1.26) got significantly decreased after HTEA; c) ischemic degree for patients with acute coronary syndrome: HTEA could obviously lessen the times (WMD= 4.24, 95%CI 0.48 to 8.00) and duration (WMD= 23.29, 95%CI 4.66 to 42.11) of myocardial ischemia, decrease the times of heart attack (WMD= 3.44, 95%CI 0.92 to 5.97), and decrease the change of NST-T (WMD= 1.10, 95%CI 0.84 to 1.36) and ∑ST-T (WMD= 1.33, 95%CI 1.01 to 1.65); d) hemodynamic change for patients with acute coronary syndrome: HTEA could obviously decrease heart beat (WMD= 8.44, 95%CI 3.81 to 13.07) and systolic arterial pressure (WMD= 2.07, 95%CI 0.81 to 3.34), but not decrease the diastolic blood pressure (WMD= 2.06, 95%CI – 0.52 to 4.64) so as to avoid influencing the infusion of coronary artery; and e) influence on Q-T interval dispersion: HTEA could significantly decrease Q-Td (WMD= 9.51, 95%CI 4.74 to 14.27), Q-Tcd (WMD= 11.82, 95%CI 5.55 to 18.09), and J-Td (WMD= 9.04, 95%CI 2.30 to 15.79). Conclusions High thoracic epidural anesthesia can obviously improve the systolic and diastolic function of left ventricle, decrease the heart beat and stabilize hemodynamic change, lessen the times and duration for myocardial ischemia, reserve the ST segment change, contract Q-T interval dispersion, which has to be further proved with more high quality studies.
Objective To assess the effectiveness and safety of tongxinluo capsule for coronary heart disease. Methods Both the randomized controlled trials (RCTs) and quasi-RCTs of tongxinluo capsule for coronary heart disease were collected through searching on computer from the following databases, The Cochrane Library (Issue 4, 2010), PubMed (2000 to April 2010), WanFang Data (1996 to April 2010), CNKI (1994 to April 2010) and VIP (1989 to April 2010). The trials selection based on inclusion and exclusion criteria, data extraction, cross check and quality assessment were conducted by two reviewers independently, and meta-analysis was performed with RevMan 5.0 software. Results A total of 13 studies involving 1 496 participants were included. The results of meta-analyses showed that: compared with the nitrate esters group, the tongxinluo capsule group had a better curative effect on the coronary heart disease than isosorbide dinitrate (RR=0.50, 95%CI 0.36 to 0.70) and isosorbide mononitrate (RR=0.19, 95%CI 0.12 to 0.30); there was significant difference in the total curative effect between the two groups (RR=0.34, 95%CI 0.26 to 0.44, Plt;0.000 01); the tongxinluo capsule was also better in improving the ECG than isosorbide dinitrate (RR=0.55, 95%CI 0.46 to 0.66) and isosorbide mononitrate (RR=0.58, 95%CI 0.48 to 0.70); there was significant difference in the total ECG improvement between the two groups (RR=0.56, 95%CI 0.49 to 0.64, Plt;0.000 01); the tongxinluo capsule group had a lower incidence rate of adverse reaction than the nitrate esters group with a significant difference (RR=0.33, 95%CI 0.20 to 0.53, Plt;0.000 01). Conclusion The present evidence indicates that tongxinluo capsule is not inferior to isosorbide dinitrate or isosorbide mononitrate in improving the curative effect and ECG, and it has fewer adverse reactions. More well-designed and large scale multi-centered RCTs are required with longer follow-up time to confirm this conclusion.
Objective Danshen dripping pill (DSP) and tongxinluo capsule (TXL) are popular Chinese medicinal products and often compared with isosorbide dinitrate (ISDN) in treating angina pectoris. Hundreds of randomized controlled trials (RCTs) about DSP and TXL have been published; however, there has been no systematic review on comparing DSP with TXL. This study aims to provide a comprehensive PRISMA-compliant systematic review with sensitivity analysis and subgroup analysis to valuate indirectly the efficacies of DSP and TXL in treating angina pectoris. Methods RCTs published between 1994 and 2009 on DSP and TXL in treating angina pectoris for four or more weeks were retrieved from databases. The qualities of RCTs included were evaluated with Jadad scale. Meta-analysis was performed on overall effects of symptomatic and electrocardiographic (ECG) improvements. Odds ratios (OR) and 95% confidence intervals (95%CI) were used to measure the effect size. Subgroup analysis, sensitivity analysis and meta-regression were conducted on basic characteristics of RCTs. Results 65 RCTs with 6 969 participants were included. Average Jadad score was 2.11. Overall ORs were 3.66 (95%CI 2.67 to 5.02) for TXL versus ISDN and 2.38 (95%CI 1.90 to 2.99) for DSP versus ISDN. There was a significant difference (W=521.5, P=0.049 45) in ORs between DSP and TXL. Statistical analyses found no significant factors affecting overall efficacies of TXL and DSP. The rates of adverse events under DSP and TXL treatments were 2.37% and 2.11%, respectively. Conclusion DSP and TXL are more effective than ISDN in treating angina pectoris. TXL might be more effective than DSP. However, further RCTs of larger scale, multi-centre/country, longer follow-up periods and higher quality are still required to verify.
Objective To investigate the current situation of randomized controlled trials (RCTs) on compound salvia pellet (CSP) for angina pectoris and assess whether there is adequate evidence for clinical practice. Methods We collected all the published clinical studies on CSP for angina pectoris from 1994 to December 2005, and assessed each included report using the Jadad scale, the revised CONSORT statement and other self-edited items. Results We finally identified 115 RCTs. Among which, 1 scored 3 points, 6 scored 2 points, 106 scored 1 points and 2 socred 0 points. No RCT performed allocation concealment according to the CONSORT criteria, only 4 RCTs (3.5%) described the generation of the randomization sequence, among which 2 were quasi-randomized. No RCT provided randomization implementation,1 RCT (0.9%) carried out placebo control, 1 RCT (0.9%) reported endpoint, 9 RCTs (7.8%) adopted single blinding, 4 RCTs (3.5%) reported double blinding, 11 RCTs (9.6%) calculated statistical values, 2 RCTs (1.7%) provided the record of follow-up, 1 RCT (0.9%) reported negative outcome, 25 RCTs (21.8%) described adverse events, no RCT described how the sample size was estimated, and how an intent-to-treat (ITT) analysis and correlation analysis were reported, 1 RCT (0.9%) was multi-center, no RCT completed ethical approval and informed consent, 27 RCTs (23.5%) described syndrome type of TCM. Conclusion Currently, the methodology and reporting of studies on CSP for angina pectoris are not good enough to provide reliable evidence for clinical practice.
Objective To assess the effect of Dengzhanhua Injection for angina pectoris. Methods We performed an electronic search for MEDLINE (1966 to 2004), EMBASE (1974 to 2004), The Cochrane Library (Issue 4, 2004), CBM and CNKI (1980 to 2004). We included randomized controlled trials that met the inclusion and exclusion criteria and evaluated the quality of those trials and performed the meta-analysis by RevMan 4.2.7. Results Eight trials were included involving 634 patients. However, they were of poor quality. The results of meta-analysis indicated that there were statistical difference on symptoms and electrocardiogram (ECG) improvements between Dengzhanhua and control group (Breviscarpine≥30 mg) with RR 1.26, 95%CI 1.11 to 1.44 and RR 1.30, 95%CI 1.14 to 1.49, respectively. However, Dengzhanhua Injection (Breviscarpinelt;30 mg) vs. basic therapy showed no statistical difference in either symptom improvement (RR 1.03, 95%CI was 0.90 to 1.18) or ECG improvement (RR 1.01, 95%CI 0.86 to 1.20). In addition, Dengzhanhua decreased the myocardial infarction attacks in one year following up (OR 0.06, 95%CI 0.01 to 0.29). Conclusions Little evidence shows that Dengzhanhua is superior to simple basic therapy in the symptoms and ECG improvements as an auxiliary drug. However, this systematic review can not draw a conclusion about the effectiveness of Dengzhanhua Injection compared to simple basic therapy in the treatment of angina pectoris due to the poor quantity of included trials.
Objective To evaluate the efficacy and safety of safflower yellow pigment lyophilized power amp; dripping solution in the treatment of patients with angina, by using parenteral solution of Dan-shen root extraction as control, we designed the nonferiority clinical trial phase Ⅲ. Method 784 patients with stable angina pectoris Ⅰ, Ⅱ, Ⅲ degree and occurred more than twice per week were selected. They were randomly, stratified and blindly assigned into 5 parallel groups including one control. They were treated by using safflower yellow pigment lyophilized power (SYPLP) 80 mg + 0.9% NS 250ml, intravenously guttae, daily (trial group 1); SYPLP 160 mg + 0.9% NS 250 ml, intravenously guttae, daily (trial group 2); safflower yellow pigment lyophilized dripping solution (SYPLDS) 200 ml (160 mg), intravenously guttae, daily (trial group 3); SYPLDS 100 ml (80 mg), intravenously guttae, daily (trial group 4) and parenteral solution of Dan-shen root extraction 20 ml + 0.9% NS 250 ml, intravenously guttae, daily (control group) respectively. Efficacy and safety were evaluated after 14 days of continuous treatment. Results The angina efficacy (per-protocol population, PP): The notable effective rates of trial groups 1 to 4 and control group were 53.27%，69.44%，70.09%，55.09% and 26.00% respectively, and the effective rates were 88.79%，92.59%，93.46%，89.81% and 73.00% respectively。There was significant differences between trial group 1 and 2, trial group 3 and 4. All trial groups showed significant different effect when compared with control (P＜0.05). The effect of trial group 2 was better than those of trial group 1, and trial group 3 better than trial group 4, the four trial groups better than control group. The intention-to-treat (ITT) analysis result was almost the same to PP analysis, but trial group 3 showed no significant difference to trial group 4. In trial group 2, 3 and 4, each occurred one adverse effect, while the number was 10 in control group.Conclusion SYPLP amp; SYPLDS have certain effect on angina. They are more effective than parenteral solution of Dan-shen root extraction. No toxic side effect has been found in clinic tests.
Objective To investigate the current situation of clinical studies on puerarin for angina pectoris and assess whether it is adequate to provide evidence for clinical practiice. Methods We collected all the published clinical studies on puerarin for angina pectoris from 1966 to October 2003, and assessed all the included reports according to international clinical epidemiological standard. Results 106 RCTs, 8 non-randomized controlled studies and 24 case series were included and analyzed. 126 studies reported diagnosis criteria, 10 desccribed inclusion criteria; 3 studies were quasi-random, 1 double blind, 4 single blind; no study reported follow-up; 117 studies reported adverse effects. Conclusions Currently the quality of studies on puerarin for angina pectoris is not good enough to provide reliable evidence for clinical practice.
ObjectiveTo systematically review the effectiveness and safety of salvianolate injection and Danshen injection for patients with angina pectoris, and evaluate the cost of drug. MethodsWe electronically searched databases including PubMed, CENTRAL (Issue 4, 2013), CNKI, VIP and WanFang Data (2004.1 to 2013.5) for the randomized controlled trials (RCTs) on the comparison between salvianolate injection and Danshen injection for angina pectoris from January 2004 to May 2013. Relevant journals and conference proceedings were also manually retrieved. Two reviewers independently screened literature in accordance with the inclusion and exclusion criteria, extracted the data and assess the methodological quality of included studies. Then, meta-analysis was performed using RevMan 5.2 software. ResultsA total of 10 RCTs involving 1 196 patients were included. The results of meta-analysis showed that, salvianolate injection was obviously superior to Danshen injection in the effectiveness (OR=3.79, 95%CI 2.78 to 5.17, P < 0.000 01) and safety (OR=0.24, 95%CI 0.09 to 0.64, P=0.004), but lack of economic advantages in the treatment of the angina pectoris diseases. ConclusionCurrent evidence indicates that, salvianolate injection is a safe and effective scheme for angina pectoris, and Danshen injection is considered as a economic method. Because of the limited quantity and quality of currently-available research, the aforementioned conclusion should be verified by strictly-designed and large-scale sample RCTs.