Objective To assess the effects and safety of Tongxinluo (TXL) Capsule for patients with acute ischemic stroke. Methods PubMed (1966 to 2011.12.23), EMbase (1966 to 2011.12.23), Ovid CENTRAL (2011.10), CBM (1978 to 2011.12.23), VIP (1989 to 2011.12.23), CNKI (1980 to 2011.12.23), CDFD (1999 to 2011.12.23), and CDFD (1999 to 2011.12.23) were electronically searched for randomized controlled trials (RCTs) on TXL Capsule for patients with acute ischemic stroke. Meanwhile, relevant data were retrieved by hand search and data from pharmaceutical factories were collected. Two reviewers independently screened literature, extracted data, and assessed the methodological quality. Then, meta-analysis was performed using RevMan 5.1 software. Results Thirty nine RCTs (non-placebo-controlled trials) involving 3 906 patients were included. The quality of the included studies was generally low. The follow-up time started from the end of treatment (minimum: 7 days) to 6 months. The result of meta-analysis (16 trials, 1 445 patients) showed that the TXL group was better than the control group in improving neurological function (SMD= −1.09, 95%CI −1.68 to −0.49). The result of meta-analysis (21 trials, 2 500 patients) showed that, the effectiveness rate (91.3%) of the TXL group was significantly higher than that of the control group (RR=1.22, 95%CI 1.14 to 1.30). Eight trials reported adverse reactions such as nausea and gastric discomfort. Four trials reported that 5 patients in the control group died during the treatment. No studies reported the data of mortality, dependency rate during 3-month follow up, or quality of life. Conclusion Current studies show that, TXL Capsule improves neurological impairment of patients with acute ischemic stroke which has less adverse reactions. Further studies are still needed to verify the effects of TXL on long-term mortality and disability. It is necessary to conduct more high quality RCTs especially with placebo-controlled trials to confirm the efficacy of Tongxinluo for acute ischemic stroke.
Objective To assess the efficacy of Tongxinluo for diabetic kidney disease. Methods we conducted a systematic review of randomized controlled trials (RCTs) in which Tongxinluo was used to treat diabetic kidney disease. And we screened relevant studies according to predefined inclusion and exclusion criteria, evaluated the quality of the included studies, and performed meta-analyses by using The Cochrane Collaboration’s Revman 5.0 software. Results A total of 11 RCTs were enrolled in the review. The results of meta-analysis showed that Tongxinluo was better on attenuating 24 hour urinary protein,BUN and UAER; Tongxinluo was not superior to no treatment on the improvement of Scr and Ccr; Tongxinluo was better than no treatment on the Regulation of blood lipids, such as TC, TG, LDL-C. However, Tongxinluo might have similar effects on the improvement of HDL-C; Tongxinluo was better than no treatment on the improvement of FBG, but xuezhikang was not superior to no treatment on the improvement of P2BG and HbA1c. Tongxinluo was better than no treatment in decreasing plasma endothelin (ET). No significant adverse effects or Allergic reactions were reported. Conclusion The evidence currently available shows that Tongxinluo has some effect and is relatively safe in treating patients with diabetic kidney disease.Due to a high risk of selection bias and detection bias in the included studies, the evidence is insufficient to determine the effect of Tongxinluo. Further large-scale trials are required to define the role of xuezhikang in the treatment of DKD.
Background Tongxinluo capsule is a new drug for cardio- cerebral vascular diseases on the national essential drug list of China, and the second-class award of National Science and Technology Development of China, 2001. Objective This review aims to assess the effect (harms and benefits) of Tongxinluo capsule for unstable angina. Search strategy electronic searchs The Cochrane Heart Review Group specialised trials register,The Cochrane Controlled Trials Register, published in the latest issue of the Cochrane Library, MEDLINE, EMBASE, CBM, Chinese Cochrane Centre Controlled Trials Register, Current Controlled Trials (www. controlled-trials. com), The National Research Register Handsearchs We will search 83 journals of Chinese traditional medicine. Inclusion riteria We will include randomised controlled trials of Tonxinluo capsule versus placebo or other current phamarcotherapy or other Chinese medicinal herbs in the participants with unstable angina pectoris. Studies will report mortality (sudden death from acute myocardial infarction), severity of angina pectoris, frequency of acute attack angina, ECG improvement, rate of dosage reducing or taking frequency of nitroglycerine and symptom improvement, etc. Data analysis Data will be included in a meta-analysis if they are available, of sufficient quality and sufficiently similar.
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 assess the effectiveness and safety of Tongxinluo Capsule in the treatment of vertebrobasilar artery insufficiency. Methods The Cochrane Library, MEDLINE, VIP and CNKI were searched. Two authors independently collected data, including randomized controlled trials that met the inclusion criteria. They evaluated the quality of these trials and performed meta-analysis using The Cochrane Collaboration’s RevMan 5.0. Results Eleven studies involving 1157 participants were included. All the included studies were inadequate at reporting randomization, concealment of allocation and blinding. Meta-analysis based on the included studies showed that Tongxinluo Capsule with Danshen was better than Danshen alone in vertebrobasilar artery insufficiency (RR= 1.35, 95%CI 1.24 to 1.48) and blood flow velocity of vertebrobasilar artery (WMD=3.60, 95%CI 2.44 to 4.77 and WMD=3.46, 95%CI 1.89 to 5.04). Tongxinluo Capsule with simple basic therapy was better than simple basic therapy alone in vertebrobasilar artery insufficiency (RR=1.21, 95%CI 1.11 to 1.31) and blood flow velocity of vertebrobasilar artery (WMD=3.85, 95%CI 2.19 to 5.51). Conclusion Tongxinluo Capsule is an effective and safe drug for vertebrobasilar artery insufficiency. However, due to the limited quantity and quality of the included studies, we can not draw a firm conclusion about the effectiveness of Tongxinluo Capsule compared to the simple basic therapy or Danshen. The results suggest that further and larger-scale trials using Tongxinluo Capsule for vertebrobasilar artery insufficiency are needed.