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WITHDRAWN: Shengmai (a traditional Chinese herbal medicine) for heart failure.
Chen, J, Yao, Y, Chen, H, Kwong, JS, Chen, J
The Cochrane database of systematic reviews. 2016;(4):CD005052
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Abstract
Cochrane Heart withdrew this review as the current author team is unable to progress. This review is considered low priority and therefore this review is not open for new authors. The editorial group responsible for this previously published document have withdrawn it from publication.
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Shengmai (a traditional Chinese herbal medicine) for heart failure.
Zhou, Q, Qin, WZ, Liu, SB, Kwong, JS, Zhou, J, Chen, J
The Cochrane database of systematic reviews. 2014;(4):CD005052
Abstract
BACKGROUND Heart failure is a major public health problem worldwide. Shengmai, a traditional Chinese herbal medicine, has long been used as a complementary treatment for heart failure in China. This is an update of a Cochrane Review published in 2012. OBJECTIVES To determine the effect (both benefits and harms) of Shengmai in treatment of people with heart failure. SEARCH METHODS We searched CENTRAL on The Cochrane Library (Issue 5 of 12, April 2013); DARE on The Cochrane Library (Issue 2 of 4, April 2013); MEDLINE (1948 to June Week 1 2013); EMBASE (1980 to 2013 Week 23); AMED (1985 to August 2008); BIOSIS (1969 to 7 June 2013); CBM (1978 to June 2013); VIP (1989 to June 2013); and CNKI (1979 to June 2013). We also handsearched Chinese journals and did not apply any language restrictions. SELECTION CRITERIA We included randomised controlled trials (RCTs) of Shengmai plus usual treatment for heart failure versus usual treatment alone, or Shengmai versus placebo, irrespective of blinding status. In this update we only included studies with a clear description of randomisation methods and classified as true RCTs. DATA COLLECTION AND ANALYSIS Two authors independently selected trials, assessed methodological quality and extracted data. We calculated dichotomous data as risk ratios (RRs) and continuous data as mean differences (MDs) or standardized mean differences (SMDs) with corresponding 95% confidence intervals (CIs). We used a fixed-effect model to perform meta-analysis for outcomes without heterogeneity; and a random-effects model to perform meta-analysis for outcomes with heterogeneity. MAIN RESULTS We included a total of 14 RCTs (858 patients) in this review update, four of which were new trials. Of these 14 RCTs, 11 trials compared Shengmai plus usual treatment with usual treatment alone, and three trials compared Shengmai with placebo. Improvement of NYHA functional classification was more common in patients taking Shengmai plus usual treatment than in those receiving usual treatment alone (RR 0.37; 95% CI 0.26 to 0.51; 10 trials, 672 participants; low quality evidence). Beneficial effects of Shengmai in treating heart failure were also observed in other outcomes, including exercise test, ejection fraction and cardiac output. The three RCTs (106 patients) comparing Shengmai with placebo reported improvement in NYHA functional classification and in stroke volume. Three of the 14 RCTs reported a total of six patients with mild adverse effects and two were withdrawn due to the adverse effects. The adverse events rate was 1.21%. AUTHORS' CONCLUSIONS Shengmai may exert a positive effect on heart failure, especially for improving NYHA functional classification when Shengmai plus usual treatment is used. The review results should be interpreted with caution due to the high risk of bias of the included studies (particularly regarding allocation concealment and blinding), the small sample size of these studies, and the significant heterogeneity in outcomes such as ejection function, cardiac output and stroke volume. There was no evidence available concerning the effect of Shengmai on mortality, and more high quality studies with long-term follow-up are warranted.
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Shengmai (a traditional Chinese herbal medicine) for heart failure.
Chen, J, Yao, Y, Chen, H, Kwong, JS, Chen, J
The Cochrane database of systematic reviews. 2012;:CD005052
Abstract
BACKGROUND This systemic review is an update of a review previously published in 2011. Heart failure is a major public health problem worldwide. Shengmai (a traditional Chinese herbal medicine) has long been used as a complementary treatment for heart failure in China. OBJECTIVES To assess the effects (both benefits and harms) of Shengmai for heart failure. SEARCH METHODS We searched CENTRAL and DARE on The Cochrane Library (2011, Issue 1), MEDLINE (1948 to March 2011), EMBASE (1980 to March 2011), AMED (1985 to August 2008) (AMED was not searched for the update as it is no longer available to the person conducting the searches), BIOSIS (1969 to March 2011), CBM (1978 to April 2011), VIP (1989 to April 2011) and CNKI (1979 to April 2011). We also handsearched Chinese journals. No language restrictions were applied. SELECTION CRITERIA Randomized controlled trials (RCTs) of Shengmai plus usual treatment versus usual treatment alone or Shengmai versus placebo in treating heart failure, irrespective of blinding status, were included. More stringent inclusion criteria were applied in this update and only studies with a clear description of randomization methods and classified as true RCTs were included. DATA COLLECTION AND ANALYSIS Two authors independently selected trials, assessed methodological quality and extracted data. Dichotomous and continuous data were calculated as relative risk (RR) and mean difference (MD) or standardized mean difference (SMD), respectively. A random-effects model and fixed-effect model were used to perform meta-analysis with and without heterogeneity, respectively. MAIN RESULTS Nine RCTs (600 patients) with seven comparing Shengmai plus usual treatment with usual treatment alone and three comparing Shengmai with placebo (one RCT contained three arms) were included in this updated review. Based upon the seven RCTs (494 patients), improvement of the New York Heart Association (NYHA) functional classification was more common in patients taking Shengmai plus usual treatment than in those receiving usual treatment alone (risk ratio 0.33, 95% confidence interval 0.23 to 0.47). Beneficial effects of Shengmai in treating heart failure were also observed on other outcomes, including an exercise test, ejection fraction, cardiac output, cardiac index and left ventricular end-systolic volume. The three RCTs (106 patients) which compared Shengmai with placebo reported an improvement in NYHA functional classification, ejection fraction, stroke volume, cardiac index and myocardial contractility. Three out of the nine RCTs reported mild adverse effects, and two patients were withdrawn due to the adverse effects. The results of this review should be interpreted with caution. This is due to the studies being of low quality, their small sample size, and the significant heterogeneity for certain outcomes including ejection fraction and cardiac output. AUTHORS' CONCLUSIONS Shengmai may be beneficial in treating heart failure, especially in terms of improving the NYHA functional classification with Shengmai plus usual treatment. However, the evidence for its effects on mortality and hospitalisation are not available yet. Therefore more studies, of higher quality and long-term follow-up, are needed to provide more evidence for the future use of Shengmai.
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Shengmai (a traditional Chinese herbal medicine) for heart failure.
Zheng, H, Chen, Y, Chen, J, Kwong, J, Xiong, W
The Cochrane database of systematic reviews. 2011;(2):CD005052
Abstract
BACKGROUND Heart failure is a major public health problem worldwide. Shengmai (a traditional Chinese herbal medicine) has long been used as a complementary treatment for heart failure in China. OBJECTIVES To determine the effects (both benefits and harms) of Shengmai plus usual treatment versus usual treatment alone for heart failure. SEARCH STRATEGY We searched CENTRAL and DARE on The Cochrane Library (Issue 3, 2008), MEDLINE (1966 to August 2008), EMBASE (1984 to August 2008), AMED (1985 to August 2008) and BIOSIS (1997 to August 2008) and CBM (1978 to August 2008). We added two new Chinese databases for the update; VIP (1989 to September 2008) and CNKI (1979 to September 2008). We also handsearched Chinese journals. No language restrictions were applied. SELECTION CRITERIA Randomized controlled trials (RCTs) of Shengmai plus usual treatment versus usual treatment alone or Shengmai versus placebo for heart failure, irrespective of blinding status, were included. More stringent inclusion criteria were applied in this update and only studies that have a clear description of randomisation methods are classed as true RCTs and hence included. DATA COLLECTION AND ANALYSIS Two authors independently selected trials, assessed methodological quality and extracted data. Dichotomous and continuous data were calculated as relative risk (RR), and mean differences (MD) or standardized mean difference (SMD). Random-effect model and fixed-effect model were used to perform meta-analysis for with and without heterogeneity respectively. MAIN RESULTS Only six RCTs with a total of 440 patients were included in this updated review. Compared to usual treatment alone, Shengmai plus usual treatment in five trials indicated an improvement in NYHA classification (RR 0.37; 95% CI 0.25 to 0.54). Other benefits were observed, but were limited to low patient numbers and significant heterogeneity: ejection fraction, cardiac output, stroke volume, exercise test and ratio of peak early to late diastolic filling velocity. Only one RCT with 40 patients compared Shengmai to placebo, and improvements were seen in stroke volume, Heath and Cardic index and myocardial contractility. Two studies reported mild adverse effects, but no patients were withdrawn or needed medication due to these adverse effects. AUTHORS' CONCLUSIONS Shengmai may be beneficial for heart failure compared to placebo or plus usual treatment compared to usual treatment alone. However, long-term and more high quality studies are needed to provide clear evidence for the future use of Shengmai.
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Shengmai (a traditional Chinese herbal medicine) for heart failure.
Chen, J, Wu, G, Li, S, Yu, T, Xie, Y, Zhou, L, Wang, L
The Cochrane database of systematic reviews. 2007;(4):CD005052
Abstract
BACKGROUND Heart failure is a major public health problem world-wide. Shengmai (a traditional Chinese herbal medicine) has long been used as a complementary treatment for heart failure in China. OBJECTIVES To determine the effect (both benefits and harms) of shengmai plus usual treatment versus usual treatment alone for heart failure. SEARCH STRATEGY We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (Issue 2, 2005), MEDLINE (1966 to May 2005), EMBASE (1984 to March 2004), AMED (1985 to July 2005), Chinese BioMedical Literature Database(1978 to April 2004), DARE (Issue 2, 2005) and BIOSIS (1997 to 2004). Seventeen Chinese journals were also handsearched. SELECTION CRITERIA Trials of shengmai plus usual treatment versus usual treatment alone for heart failure were included. Randomized or quasi-randomized controlled trials, regardless of whether they were blinded, were included. DATA COLLECTION AND ANALYSIS Two reviewers selected trials, assessed methodological quality and extracted data independently. Dichotomous and continuous data were calculated as relative risk (RR), and weighted mean differences (WMD), respectively. No heterogeneity was detected between included trials. A fixed-effect model was used to perform meta-analysis. MAIN RESULTS Nineteen trials were included studies. Methodological quality of the included studies was low. Compared to usual treatment alone, shengmai plus usual treatment showed significant improvement in New York Heart Association classification of clinical status (RR 0.32; 95% CI 0.25 to 0.40), mortality (RR 0.25; 95% CI 0.07 to 0.86), and tumour necrosis factor-alpha (WMD -0.52; 95% CI -0.99 to -0.05). Improvements were also seen in hemodynanic tests (one trial, 100 participants). No adverse affects were reported in any of the included trials. AUTHORS' CONCLUSIONS It is possible that shengmai plus usual treatment may be beneficial compared to usual treatment alone for heart failure. However the evidence is weak because of the poor quality of the included trials. Long-term and high quality studies are needed to provide clear evidence for the future use of shengmai.