10 Apr Zusammenfassung Literatur Tongxinluo (TXL)
Schon vor fast zwanzig Jahren (2006) wurde eine Studie zum Einsatz von Tongxinluo (TXL) veröffentlicht, da in China und einigen andere asiatischen Ländern kardiovaskuläre Erkrankungen mit diesem komplexen Mittel behandelt werden. Zahlreiche weitere Studien folgten und zeigen hervorragende Ergebnisse bei Erkrankungen wie Schlaganfall, Angina pectoris, Koronare Herzerkrankung (KHK), Herzinsuffizienz und vaskulärer Demenz.
Systematische Reviews und Metaanalysen
Schlaganfall
Yang P, Liu P, Yang R. Systematic Review of Tongxinluo Capsule on the Therapeutic Effect and Hemorheology of Patients with Transient Ischemic Attack. Evid Based Complement Alternat Med. 2021 Dec 6;2021:5541768. doi: 10.1155/2021/5541768. PMID: 34912462; PMCID: PMC8668333.
Objectives: This study aims to systematically evaluate the clinical efficacy of Tongxinluo capsule in the treatment of transient ischemic attack (TIA) and its effect on hemorheology, thereby providing scientific basis for clinical decision making.
Methods: A comprehensive and systematic literature retrieval was conducted in the CNKI, Wanfang database, SinoMed, EMbase, and PubMed to screen the randomized controlled trials (RCTs) of Tongxinluo capsule in the treatment of TIA. The retrieval time was from the inception of each database to September 10, 2020. Endnote X9 was used to screen the literature. Cochrane Collaboration tool for assessing risk of bias was used to evaluate the quality of the included studies. Stata16.0 statistical software was used for meta-analysis.
Results: A total of 12 RCTs were included, involving 946 subjects. (1) The clinical efficacy of the Tongxinluo group was better than that of the control group (RR = 1.19, 95% CI (1.09, 1.30), P ≤ 0.001). (2) The hemorheological characteristics of the Tongxinluo group were significantly improved compared with those of the control group (whole blood high shear viscosity: SMD = -1.61, 95% CI (-1.89, -1.34); P ≤ 0.001, whole blood low shear viscosity: SMD = -1.06, 95% CI (-1.31, -0.80), P ≤ 0.001, fibrinogen: SMD = -1.12, 95% CI (-1.94, -0.29), P = 0.008, plasma specific viscosity: SMD = -1.00, 95% CI (-1.69, -0.31), P = 0.004, and hematocrit: SMD = -1.47, 95% CI (-2.16, -0.77), P ≤ 0.001). (3) There was no significant difference in the incidence of adverse reactions between the Tongxinluo group and control group (RR = 7.76, 95% CI (0.98, 61.28), P = 0.052).
Conclusion: Tongxinluo capsule is superior to conventional treatment in improving clinical overall response rate and hemorheological indexes and is relatively safe. Due to the deficiencies of the existing studies, more high-quality studies with rigorous design are required for further verification.
Zhuo Q, Yang X, Wu T, Liu G, Zhou L. Tongxinluo capsule for acute stroke. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004584. doi: 10.1002/14651858.CD004584.pub2. PMID: 18843664.
Background: Tongxinluo capsules are a compound of Chinese traditional medicine which contain substances that are thought to have vasodilatory, antiplatelet, anticoagulant, thrombolytic and even lipid-lowering properties, and therefore may improve outcome after acute ischaemic stroke. To date the evidence of its effect has not been systematically reviewed, making it difficult to derive robust conclusions about its actual benefits, and indeed, possible harms.
Objectives: To assess the effectiveness and possible harms of tongxinluo capsule for acute cerebral infarction compared with control.
Search strategy: We searched the Cochrane Stroke Group trials register (last searched on 24 January 2008) the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 4, 2007), MEDLINE (1995 to 2006), EMBASE (1995 to 2006), China National Knowledge Infrastructure (CNKI, 1994 to 2006), CBM (Chinese Biomedical Database) (1995 to 2006), Current Controlled Trials (www.controlled-trials.com), National Research Register (http://www.update-software.com/national/). We handsearched 30 journals (1995 to 2006), and contacted drug companies and the principal of included trials.
Selection criteria: Randomised controlled trials comparing tongxinluo with placebo or open control (or tongxinluo plus standard therapy versus standard therapy alone) in people with definite acute stroke. We excluded trials if they sought to recruit patients with transient ischaemic attacks (TIA), intracerebral haemorrhage, heart failure, or renal failure.
Data collection and analysis: Two review authors extracted data and assessed trial quality.
Main results: Only two poor quality studies with a total of 232 participants were included in this review. Neither study reported any of our pre-specified outcomes, so no reliable estimate of the effect of treatment on major clinical outcomes could be obtained.
Authors‘ conclusions: It was not possible to reliably determine whether tongxinluo has a favourable or unfavourable effect in acute ischaemic stroke. High quality trials are required to assess the efficacy and safety of tongxinluo capsule for acute ischaemic stroke.
Koronare Herzerkrankung
Angina pectoris
Präventioin Myocardinfarkt
Liu Q, Dong T, Xi M, Gou L, Bai Y, Hou L, Li M, Ou L, Miao F, Wei P. Tongxinluo Capsule Combined with Atorvastatin for Coronary Heart Disease: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2021 Jul 17;2021:9413704. doi: 10.1155/2021/9413704. PMID: 34335841; PMCID: PMC8313336.
Introduction: Coronary heart disease (CHD) is a common clinical cardiovascular disease, and its morbidity and mortality rates are increasing, which brings a serious burden to the family and society. Dyslipidemia is one of the most important risk factors for CHD. However, it is difficult to reduce blood lipids to an ideal state with the administration of a statin alone. Tongxinluo capsule (TXLC), as a Chinese patent medicine, has received extensive attention in the treatment of CHD in recent years. This systematic review and meta-analysis aim to provide evidence-based medicine for TXLC combined with atorvastatin in the treatment of CHD.
Objective: To evaluate systematically the effectiveness and safety of TXLC combined with atorvastatin in the treatment of CHD.
Methods: Seven English and Chinese electronic databases (PubMed, Cochrane Library, Embase, CNKI, VIP, CBM, and Wanfang) were searched from inception to January 2020, to search for randomized controlled trials (RCTs) on TXLC combined with atorvastatin in the treatment of CHD. Two researchers independently screened the literature according to the literature inclusion and exclusion criteria and performed quality assessment and data extraction on the included RCTs. We performed a systematic review following Cochrane Collaboration Handbook and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and using a measurement tool to assess the methodological quality of systematic reviews (AMSTAR 2). The quality of outcomes was evaluated by the Grading of Recommendations Assessment, Development and Evaluation (GRADE). And meta-analysis was performed by Review Manager 5.2.
Results: A total of 15 RCTs with 1,578 participants were included in this review. Compared to atorvastatin treatment, TXLC combined with atorvastatin treatment showed potent efficacy when it came to the effectiveness of clinical treatment (RR = 1.24; 95% CI, 1.18, 1.29; P < 0.00001), total cholesterol (TC; MD = -1.21; 95% CI, -1.53, -0.89; P < 0.00001), triacylglycerol (TG; MD = -0.73; 95% CI, -0.81, -0.65; P < 0.00001), high-density lipoprotein cholesterol (HDL-C; MD = 0.27; 95% CI, 0.23, 0.31; P < 0.00001), low-density lipoprotein cholesterol (LDL-C; MD = -0.72; 95% CI, -0.80, -0.64; P < 0.00001), C-reactive protein (CRP; SMD = -2.06; 95% CI, -2.56, -1.57; P < 0.00001), frequency of angina pectoris (SMD = -1.41; 95% CI, -1.97, -0.85; P < 0.00001), duration of angina pectoris (MD = -2.30; 95% CI, -3.39, -1.21; P < 0.0001), and adverse reactions (RR = 0.84; 95% CI, 0.51, 1.39; P=0.50). No serious adverse events or reactions were mentioned in these RCTs. According to the PRISMA guidelines, although all studies were not fully reported in accordance with the checklist item, the reported items exceeded 80% of all items. With the AMSTAR 2 standard, the methodological quality assessment found that 9 studies were rated low quality and 6 studies were rated critically low quality. Based on the results of the systematic review, the GRADE system recommended ranking method was used to evaluate the quality of evidence and the recommendation level. The results showed that the level of evidence was low, and the recommendation intensity was a weak recommendation.
Conclusions: TXLC combined with atorvastatin in the treatment of CHD can effectively improve the effectiveness of clinical treatment, significantly reduce the frequency and duration of angina pectoris, decrease blood lipids, and improve inflammatory factors. However, due to the low quality of the literature included in these studies and the variability of the evaluation methods of each study, there is still a need for a more high-quality, large sample, multicenter clinical randomized control for further demonstration.
Wu T, Harrison RA, Chen X, Ni J, Zhou L, Qiao J, Wang Q, Wei J, Xin D, Zheng J. Tongxinluo (Tong xin luo or Tong-xin-luo) capsule for unstable angina pectoris. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD004474. doi: 10.1002/14651858.CD004474.pub2. PMID: 17054205; PMCID: PMC8406925.
Background: Tongxinluo capsule is a medicine consisting of traditional Chinese herbs and insects used for cardiovascular diseases in China and some other Asian countries. To date the evidence of its effect has not previously been subject to systematic review, making it difficult to derive robust conclusions about its actual benefits, and indeed, possible harms.
Objectives: To assess systematically the effects of tongxinluo capsule in people with unstable angina pectoris.
Search strategy: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library, Issue 4 2004, MEDLINE, EMBASE, Chinese Biomedical Database, China National Knowledge Infrastructure, Japana Centra Revuo Medicina (all 1995 to 2005). We also handsearched the relevant Chinese journals, checked with manufacturers and registers of ongoing studies.
Selection criteria: Randomised trials comparing either tongxinluo capsule only or standard treatment plus tongxinluo capsule with standard treatment or other anti-angina pectoris drugs, placebo or no intervention.
Data collection and analysis: Two authors identified relevant studies for the review independently and went on to abstract data, and assess trial quality. Authors of included studies were contacted to obtain further information as required.
Main results: 18 short term follow-up trials involving 1413 people were included. The studies did not provide strong support of a benefit of tongxinluo for reducing the combined outcome of acute myocardial infarction, angioplasty (PTCA) coronary artery bypass graft (CABG) and sudden death or all-cause mortality (RR 0.42, 95% CI 0.07 to 2.59, P=0.35; RR 0.33, 95% CI 0.01to 7.78, P=0.49, respectively). Tongxinluo reduced the frequency of acute angina attacks (WMD -1.20, 95%CI -1.38 to -1.02, P<0.00001 and RR -2.36, 95%CI -2.53 to -2.18, P<0.00001, respectively), improved ECG (RR 1.31, 95% CI 1.08 to 1.57, P=0.005) and angina symptoms (RR 1.21, 95% CI 1.06 to 1.40; P=0.007).
Authors‘ conclusions: Tongxinluo in combination with routine angina therapy appears to reduce the risk of subsequent AMI, PTCA or CABG, angina attacks and severity, as well as improving symptoms and ischaemic changes on the electrocardiogram (ECG). Due to the methodological limitations of the studies, the evidence is insufficient to make any conclusive recommendations about the use of this treatment for patients presenting with unstable angina. Large high quality randomised controlled trials are warranted.
Lv J, Liu S, Guo S, Gao J, Song Q, Cui X. Tongxinluo capsule as supplementation and cardiovascular endpoint events in patients with coronary heart disease: A systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials. J Ethnopharmacol. 2022 May 10;289:115033. doi: 10.1016/j.jep.2022.115033. Epub 2022 Jan 26. PMID: 35091010.
Ethnopharmacological relevance: Tongxinluo Capsule(TXLC) is a well-known traditional Chinese medicine prescription with effects of tonifying Qi and activating blood based on the Chinese herbal medicine theory that has been recommended as routine adjuvant treatment in patients with coronary heart disease (CHD) in China.
Aim of the study: This meta-analysis aimed to evaluate the efficacy and safety of TXLC as supplementation in the prevention of adverse cardiovascular events in patients with CHD.
Materials and methods: We performed a literature search in Pubmed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), Wan Fang Database, and Chinese Biomedical Database (CBM) from their inceptions to March 2020. Only randomized controlled trials (RCTs) that assessed supplementation with TXLC or placebo and with adverse cardiovascular outcomes, were included in this meta-analysis. Primary end points were myocardial infarction (MI), target vessel revascularization (TVR) or in-stent restenosis (ISR), and cardiovascular death. Secondary end points included cerebrovascular accidents, heart failure (HF), and unscheduled readmission for cardiovascular diseases (CVDs). Adverse drug events were also evaluated. Trial sequential analysis (TSA) was conducted to reduce random errors introduced by possible insufficient sample size.
Results: Eleven RCTs involving 1505 patients were analyzed. The mean(SD) age of included patients were 59.03(9.7) years. Treatment duration varied from 2 months to 12 months. Compared with placebo, TXLC supplementation showed significant effects on reducing the risk of MI (RR = 0.44, [95% CI, 0.24-0.80]), TVR or ISR (RR = 0.43, [95% CI, 0.31-0.58]), cerebrovascular accidents(RR = 0.17, [95% CI, 0.06-0.46]), HF (RR = 0.41, [95% CI, 0.21-0.79]), and unscheduled readmission for CVDs (RR = 0.72, [95% CI], P = 0.04), but did not have associations with incidence of cardiovascular death (RR = 0.53, [95% CI, 0.15-1.91]). Subgroups of trials with 2-month (MI: RR = 0.44, [95% CI, 0.13-1.53]; cardiovascular death: RR = 0.30, [95% CI, 0.01-7.67]; cerebrovascular accidents: RR = 0.04, [95% CI, 0.01-0.26]; unscheduled readmission for CVDs: RR = 0.43, [95% CI, 0.20-0.94]) and 12-month (MI: RR = 0.42, [95% CI, 0.20-0.89]; TVR or ISR: RR = 0.42, [95% CI, 0.31-0.58]; HF: RR = 0.34, [95% CI, 0.14-0.78]; unscheduled readmission for CVDs: RR = 0.85, [95% CI, 0.59-1.22]) intervention period were analyzed. The adverse drug reactions were mild with no significant difference between TXLC and placebo.
Conclusions: This meta-analysis indicated that TXLC supplementation had beneficial effects on the prevention of cardiovascular adverse events, especially in TVR or ISR after coronary revascularization and may possibly lower the incidence of first or recurrent MI and HF within 12 months in patients with CHD, while insufficient sample size implied that these results lacked certain stability. And the effects of TXLC on cardiovascular mortality, cerebrovascular events, and unscheduled readmission for CVDs could not be confirmed due to insufficient cases. Clinical trials with large-sample sizes and extended follow-up time are of interest in the future researches.
Hui J, Yuan R, Li P, Xin Q, Miao Y, Shen X, Xu F, Cong W. Efficacy and Safety of Different Courses of Tongxinluo Capsule as Adjuvant Therapy for Coronary Heart Disease after Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2022 May 25;11(11):2991. doi: 10.3390/jcm11112991. PMID: 35683377; PMCID: PMC9181557.
Tongxinluo capsule (TXLC) is a widely used traditional Chinese medicine for coronary heart disease (CHD). However, the efficacy and safety of different courses of TXLC for CHD after percutaneous coronary intervention (PCI) have not been systematically evaluated yet. The Cochrane Library, PubMed, Embase, China National Knowledge Infrastructure, Wanfang Database, and Chinese Scientific Journal Database were searched from the inception to 26 August 2021. A meta-analysis was performed using a fixed- or random-effects model. The risk of adverse cardiovascular events, mortality, or adverse effects was evaluated by risk ratio (RR) with 95% confidence interval (CI). Thirty-four studies involving 3652 patients were finally included. After the 6-month treatment, compared with conventional treatment alone, TXLC combined with conventional treatment achieved better efficacy in lowering the risk of angiographic restenosis (RR = 0.37, 95% CI = 0.28−0.48, p < 0.001), myocardial infarction (RR = 0.38, 95% CI = 0.25−0.60, p < 0.001), heart failure (RR = 0.32, 95% CI = 0.18−0.56, p < 0.001), angina (RR = 0.26, 95% CI = 0.17−0.38, p < 0.001), revascularization (RR = 0.20, 95% CI = 0.09−0.46, p < 0.001), all-cause mortality (RR = 0.24, 95% CI = 0.10−0.58, p = 0.001), and mortality due to any cardiovascular event (RR = 0.27, 95% CI = 0.09−0.80, p = 0.018). After the 12-month treatment, TXLC reduced the recurrence risk of angina (RR = 0.40, 95% CI = 0.20−0.80, p = 0.009). However, there was no difference in any outcomes after the 3-month treatment. Besides, no difference was found in the incidence of adverse effects after the 3-month and 6-month treatments (3 months: RR = 0.73, 95% CI = 0.35−1.56, p = 0.418; 6 months: RR = 1.71, 95% CI = 0.74−3.93, p = 0.209).
The certainty of evidence ranged from very low to moderate due to the risk of bias, inconsistency, and imprecision. TXLC showed beneficial effects on reducing the adverse cardiovascular events without compromising safety for CHD patients after PCI on the 6-month course. However, due to the unavoidable risk of bias, more high-quality and long-term studies are still needed to further evaluate the efficacy and safety of TXLC in many countries, not only in China.
Li P, Xin Q, Hui J, Yuan R, Wang Y, Miao Y, Lee SM, Leng SX, Cong W; BPNMI Consortium. Efficacy and Safety of Tongxinluo Capsule as Adjunctive Treatment for Unstable Angina Pectoris: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Front Pharmacol. 2021 Oct 11;12:742978. doi: 10.3389/fphar.2021.742978. PMID: 34707500; PMCID: PMC8544810.
Tongxinluo capsule (TXLC) is a commonly used Chinese medicine for unstable angina pectoris (UA). This article aimed to clarify the safety and efficacy of TXLC as an adjunctive treatment for UA. Two reviewers searched 7 databases from inception to August 2021, and performed literature screening and information extraction independently. The meta-analysis was implemented after evaluating the methodological quality of each randomized controlled trial (RCT) by the Cochrane Risk of Bias tool. Sensitivity analyses were conducted for testing the stability of the results, and the Begg and Egger tests were performed for any potential publication bias. After eligibility assessment, 42 RCTs with a total of 5,421 participants were included. Evidence showed that TXLC reduced the rate of cardiovascular events [RR = 0.29, 95% CI (0.19, 0.45), p < 0.00001, I 2 = 0%] {including cardiovascular mortality [RR = 0.16, 95% CI (0.03, 0.88), p = 0.03, I 2 = 20%], the incidence of acute myocardial infarction [RR = 0.27, 95% CI (0.13, 0.57), p = 0.0006, I 2 = 0%] and the occurrence of revascularization [RR = 0.28, 95% CI (0.15,0.54), p = 0.0001, I 2 = 0%]}, all-cause mortality [RR = 0.25, 95% CI (0.06, 0.99), p = 0.05, I 2 = 19%], recurrence of angina [RR = 0.25, 95% CI (0.11, 0.61), p = 0.002, I 2 = 0%], the number of ST-segment depression [MD = -0.45, 95% CI (-0.69, -0.20), p = 0.0005, I 2 = 0%], the summation of ST-segment depression [MD = -0.70, 95% CI (-1.08, -0.32), p = 0.0003, I 2 = 70%] and the hypersensitive C-reactive protein level [MD = -2.86, 95% CI (-3.73, -1.99), p < 0.00001, I 2 = 86%], increased the nitric oxide level [MD = 11.67, 95% CI (8.33, 15.02), p < 0.00001, I 2 = 33%], improved the electrocardiogram change [RR = 1.23, 95% CI (1.16, 1.30), p < 0.00001, I 2 = 0%] and the clinical efficacy in UA [RR = 1.26, 95% CI (1.21, 1.32), p < 0.00001, I 2 = 24%], and relieved the symptoms of angina pectoris {including chest pain or tightness [RR = 1.13, 95% CI (0.97, 1.32), p = 0.12, I 2 = 30%], palpitations [RR = 1.47, 95% CI (1.18, 1.84), p = 0.0007, I 2 = 0%], shortness of breath [RR = 1.53, 95% CI (1.24, 1.88), p < 0.0001, I 2 = 0%], and asthenia [RR = 1.69, 95% CI (0.83, 3.43), p = 0.15, I 2 = 90%]}. The most common adverse effect was gastrointestinal symptoms which could be relieved and eliminated through dose reduction, medication time adjustment and symptomatic remedy. Collectively, TXLC was effective and considerably safe for UA. However, due to the unavoidable risk of bias, these results must be interpreted with caution and further verified by large-scale and high-quality RCTs.
Zhang XY, Sun Y, Yang XY, Hu JY, Zheng R, Chen SQ, Li M, Li CY, Jiang Y, Liu S, Zhao C, Xing YW, Shang HC. Effect of Chinese Medicine on No or Slow Reflow after Percutaneous Coronary Intervention in Myocardial Infarction Patients: A Systematic Review and Meta-Analysis. Chin J Integr Med. 2020 Mar;26(3):227-234. doi: 10.1007/s11655-019-2703-9. Epub 2019 May 15. PMID: 31093877.
Objective: To systematic review the effect of Chinese medicine (CM) on no or slow reflow after percutaneous coronary intervention (PCI) in myocardial infarction (MI) patients.
Methods: The PubMed, EMBASE databases, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, China National Knowledge Infrastructure (CNKI), Chinese BioMedical Literature Database (CBM), Wanfang Knowledge Service Platform (Wanfang Database) and Chinese Scientific Journal Database (VIP) were searched up to December 2017. Randomized controlled trials (RCTs) which evaluated the effect of CM therapies on no or slow reflow after PCI in MI patients were included. The primary outcome was the effect of reperfusion. Secondary outcomes were left ventricular ejection fraction, incidence of major adverse cardiovascular events and adverse effect.
Results: Ten RCTs covering 814 patients were included. Two studies revealed that the incidence of no or slow reflow was less in Shenmai Injection () group than in the control group measured by thrombolysis in myocardial infarction (TIMI) ⩽ 2 (risk ratio=0.55, 95% confidence interval 0.38 to 0.81, P=0.003, I2=37%). Two studies indicated that Salvianolate Injection showed no additional benefit on no or slow reflow measured by corrected TIMI frame count compared with the conventional treatment (mean difference -4.24, 95% confidence interval -13.03 to 4.54, P=0.34, I2=86%). In addition, Tongxinluo Capsules (), Danhong Injection () and Xuesaitong Injection () may have the potential to reduce no or slow reflow measured during or after PCI in individual studies.
Conclusions: Current evidence from RCTs are not sufficient to evaluate the effect of CM adjuvant therapies on no or slow reflow after PCI for MI patients. The included studies are limited by small sample size and unclear baseline conditions. Further rigorously designed researches and verification studies with sufficient number of patients are warranted.
Herzinsuffizienz
Park YS, Wang W, Li YD, Liu K. [Network Meta-analysis of six Chinese patent medicines for replenishing Qi and activating blood in treatment of chronic heart failure]. Zhongguo Zhong Yao Za Zhi. 2022 Aug;47(15):4221-4237. Chinese. doi: 10.19540/j.cnki.cjcmm.20220510.502. PMID: 36046913.
The efficacy of six commonly used Chinese patent medicines for replenishing Qi and activating blood in the treatment of chronic heart failure was evaluated systematically by network Meta-analysis. Randomized controlled trials(RCTs) about the treatment of chronic heart failure were searched against CNKI, Wanfang, SinoMed, PubMed, and Cochrane library. Network Meta-analysis was performed in Stata 16. A total of 154 RCTs involving 15 620 patients were eventually included. The network Meta-analysis showed that Qili Qiangxin Capsules+conventional western medicine had the highest total effective rate, followed by Tongxinluo Capsules+conventional western medicine, Qishen Yiqi Drop Pills+conventional western medicine, Naoxintong Capsules+conventional western medicine, Shexiang Tongxin Drop Pills+conventional western medicine, Yangxinshi Tablets+conventional western medicine, and conventional western medicine. As for left ventricular ejection fraction(LVEF), Yangxinshi Tablets+conventional western medicine had the highest value, followed by Shexiang Tongxin Drop Pills+conventional western medicine, Qili Qiangxin Capsules+conventional western medicine, Tongxinluo Capsules+conventional western medicine, Qishen Yiqi Drop Pills+conventional western medicine, Naoxintong Capsules+conventional western medicine, and conventional western treatments. As for N-terminal pro-B type natriuretic peptide(NT-proBNP), Qishen Yiqi Drop Pills+conventional western medicine was the most effective treatment, followed by Yangxinshi Tablets+conventional western medicine, Shexiang Tongxin Drop Pills+conventional western medicine, Qili Qiangxin Capsules+conventional western medicine, Tongxinluo Capsules+conventional western medicine, and conventional the most effective treatment was. As for left ventricular end-diastolic diameter(LVEDD), Naoxintong Capsules+conventional western medicine was the best therapy, followed by Tongxinluo Capsules+conventional western medicine, Shexiang Tongxin Drop Pills+conventional western medicine, Yangxinshi Tablets+conventional western medicine, Qili Qiangxin Capsules+conventional western medicine, Qishen Yiqi Drop Pills+conventional western medicine, and conventional western medicine. In summary, the combination of Chinese patent medicines for replenishing Qi and activating blood with western medicines is superior to conventional western medicine alone in the treatment of chronic heart failure. It effectively improves cardiac function indicators such as LVEF, NT-proBNP, and LVEDD, and thus is worthy of popularization in clinical practice. The results of this study provide evidence-based options for the clinical treatment of chronic cardiac failure by combining the Chinese patent medicines for replenishing Qi and activating blood with western medicine.
Hypertension
Wang J, Xiong X, Liu W. Chinese patent medicine tongxinluo capsule for hypertension: a systematic review of randomised controlled trials. Evid Based Complement Alternat Med. 2014;2014:187979. doi: 10.1155/2014/187979. Epub 2014 Feb 17. PMID: 24693319; PMCID: PMC3947843.
This study was intended to evaluate the efficacy and safety of Tongxinluo capsule for hypertension. Search Strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, The PubMed, EMBASE, Chinese Bio-Medical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database, and Wan-fang Data started from the first of database to October 28, 2013. No language restriction was applied. We included randomized clinical trials testing Tongxinluo capsule against western medicine, Tongxinluo capsule versus placebo, and Tongxinluo capsule combined with western medicine versus western medicine. Study selection, data extraction, quality assessment, and data analyses were conducted according to the Cochrane standards. Results. 25 trials with 1958 participants were included. The methodological quality of the included trials was evaluated as generally low. The blood pressure (BP) lowering effect of Tongxinluo capsule plus western medicine was significantly higher than that of western medicine (systolic blood pressure (SBP): -3.87, -5.32 to -2.41, P < 0.00001; and diastolic blood pressure (DBP): -2.72, -4.19 to -1.24, P = 0.0003). The BP also decreased significantly from baseline with Tongxinluo capsule than placebo (SBP: -9.40, -10.90 to -7.90, P < 0.00001; and DBP: -11.80, -12.40 to -11.20, P < 0.00001) or western medicine (SBP: -3.90, -4.93 to -2.87, P < 0.00001; and DBP: -3.70, -3.83 to -3.57, P < 0.00001). 12 trials reported adverse events without details. Conclusions. There is some but weak evidence about the effectiveness of TXL in treating patients with hypertension.
Vaskuläre Demenz
Kim TH, Kang JW. Herbal Medicine for Vascular Dementia: An Overview of Systematic Reviews. Curr Vasc Pharmacol. 2020;18(4):394-409. doi: 10.2174/1570161117666190618164443. PMID: 31258089.
Introduction: Vascular dementia (VaD), a severe neurologic condition related to aging of the cerebrovascular structure, has been treated with herbal medications and products. In this overview of systematic reviews (SRs) on the effects of herbal medications, we aimed to summarize the current clinical evidence on the benefits of herbal drugs and to propose an evidence map outlining their effects on VaD.
Methods: SRs assessing their effects on cognitive function or performance and the associated safety, published until December 2018, were located from PubMed, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, China National Knowledge Infrastructure, and Oriental Medicine Advanced Searching Integrated System. A Measurement Tool to Assess systematic Reviews 2 was used to assess their overall confidence. A bubble plot was proposed to present the depth and width of the current status of the evidence supporting the use of individual herbal drugs.
Results: Ten SRs (4 on individual herbal medications and 6 on various herbal drugs) were included. The overall evidence on herbal medicines suggests that they are effective in improving cognitive function and performance. Individual herbal medications including FuFangHaiShe, NaoXinTong, YinDanXing- NaoTong, NaoMaiTai, ShenFuTang, and TongXinLuo showed favourable effects when assessed via a minimal mental state examination score but have limited evidence supporting their effectiveness due to the scarcity of randomized controlled trials. Concerning safety, most SRs did not outline the estimated risk ratio of adverse events.
Conclusion: Herbal medications might have benefits for VaD patients but they need to be evaluated further.
Chan ES, Bautista DT, Zhu Y, You Y, Long JT, Li W, Chen C. Traditional Chinese herbal medicine for vascular dementia. Cochrane Database Syst Rev. 2018 Dec 6;12(12):CD010284. doi: 10.1002/14651858.CD010284.pub2. PMID: 30520514; PMCID: PMC6516869.
Background: Traditional Chinese herbal medicine (TCHM) is widely used for treating vascular dementia (VaD) in China. Recent studies of a number of TCHMs have demonstrated in vitro biological activity and therapeutic effects in animals, but the published clinical evidence has not been systematically appraised.
Objectives: To evaluate the efficacy and safety of TCHMs listed in either the Chinese Pharmacopoeia (CP) or the Chinese National Essential Drug List (NEDL) that are used to treat VaD. A secondary aim was to identify promising TCHMs for further clinical research.
Search methods: We searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group’s Specialised Register (on 14 March 2018) and also several Chinese biomedical databases: the Chinese Biological Medicine Database (January 1979 to May 2015), Wanfang database (January 1998 to May 2015), Chongqing VIP Information Co. Ltd or Weipu (January 1998 to May 2015) and the Chinese National Knowledge Infrastructure (January 1979 to May 2015).
Selection criteria: We included randomised controlled trials (RCTs) of TCHMs compared to placebo, to Western medicine (WM) or to routine therapy for VaD risk factors. Eligible participants were men and women aged 18 years and above, diagnosed with VaD by any of the following four criteria: (1) Diagnostic and Statistical Manual of Mental Disorders (DSM) versions III, III-R, IV, IV-TR; (2) National Institute of Neurological Disorders and Stroke (NINDS-AIREN); (3) International Classification of Diseases 9 or 10; (4) the Hachinski or the Modified Hachinski Ischaemic Score. We required the use of an imaging technique to differentiate VaD from other dementias. We excluded (1) trials with participants diagnosed with mixed dementia or those that did not use an imaging technique to ascertain VaD; (2) trials of NEDL-listed Gingko biloba or Huperzine A as experimental interventions, to avoid duplication of existing Cochrane Reviews; (3) trials using acupuncture alone as the experimental intervention; (4) trials using another CP- or NEDL-listed TCHM (except for Huperzine A and Gingko which are popular in Western practice) as the control intervention; and (5) trials using purely non-pharmacological interventions as the control intervention unless explicitly described as ‚routine therapy for VaD risk factors‘.
Data collection and analysis: We assessed the risks of bias using the Cochrane ‚Risk of bias‘ tool and adapted the Outcome Reporting Bias in Trials (ORBIT) classification system for outcome reporting bias. We assessed TCHM effects on five clinically important outcomes: cognition, global performance, safety, activities of daily living and behaviour and summarised the effects using mean differences for continuous outcomes and risk ratios or risk differences for binary outcomes. We stratified the studies into those that estimated the TCHM versus ’no treatment‘ effect and those that estimated the TCHM versus the WM effect, with further stratification by the specific TCHM tested or by one of the four modes of action. We pooled using a random-effects model. Due to substantial clinical and design heterogeneity, we did not estimate an ‚overall TCHM effect‘.
Main results: We only found studies (47 studies, 3581 participants) for 18 of the 29 eligible TCHMs as defined by our inclusion criteria. All were superiority trials conducted in China between 1997 and 2013, with most employing a two-arm parallel design with sample sizes ranging from 26 to 240 and a median treatment duration of 12 weeks (range: 2 to 24 weeks).We found that reporting and trial methodology were generally poor; in particular, there was a lack of information on randomisation, an absence of blinding of participants and outcome assessors and incomplete reporting of adverse events (AEs). None of the 30 trials published from 2007 onwards adopted the CONSORT recommendations for reporting RCTs of herbal interventions.We found seven TCHMs which each had potentially large benefits in studies estimating the TCHM versus ’no treatment‘ effect and in studies estimating the TCHM versus the WM effect. Two TCHMs (NaoXinTong and TongXinLuo) were common to both groups. Three of these TCHMs – Nao XinTong, NaoMaiTai and TongXinLuo – had the strongest evidence to justify further research. Two TCHMs (NaoMaiTai and TongXinLuo) had a 5% or more increased risk of AEs compared to the ’no Treatment‘ control, but the quality of this evidence was poor.
Authors‘ conclusions: We found moderate- to very low-quality evidence of benefit and harm of TCHMs for VaD. Methodological inadequacies need to be addressed by better conducted and reported trials. We identified NaoMaiTai, NaoXinTong and TongXinLuo as warranting special research priority.