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      Shenmai injection as an adjuvant treatment for chronic cor pulmonale heart failure: a systematic review and meta-analysis of randomized controlled trials

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          Abstract

          Background

          Shenmai injection (SM), as a traditional Chinese medicine injection, is widely used for chronic cor pulmonale heart failure in mainland China. It is essential to systematically assess the efficacy and safety of SM as an adjuvant treatment for chronic cor pulmonale heart failure.

          Methods

          Eight English and Chinese electronic databases were searched, from inception to December 2014, to identify randomized controlled trials (RCTs) of SM for chronic cor pulmonale heart failure. The Cochrane Risk of Bias tool was used to evaluate the methodological quality of eligible studies. Meta-analysis was performed by Review Manager 5.2.

          Results

          Twenty-seven RCTs with 2045 participants were identified. The methodological quality of the included studies was generally low. Only one trial reported data on death. None of the included trials reported quality of life. The meta-analysis indicated that compared to conventional treatment, the combination of SM and conventional treatment was more effective in terms of the New York Heart Association classification (RR, 1.26; 95 % CI, 1.20–1.32; P < 0.00001), Left Ventricular Ejection Fraction (MD, 11.33; 95 % CI, 8.59–14.07; p < 0.00001), partial pressure of oxygen (MD, 1.00; 95 % CI, 0.64–1.36; P < 0.00001) and partial pressure of carbon dioxide (MD, 0.83; 95 % CI, 0.58–1.08; p < 0.00001). In addition, two trials reported that SM plus conventional treatment was superior to the conventional treatment alone to reduce B-type natriuretic peptide. No serious adverse drug events or reactions were reported.

          Conclusions

          SM plus conventional treatment appeared to be effective and relatively safe for chronic cor pulmonale heart failure. However, due to the generally low methodological quality and small sample size, this review didn’t find evidence to support routine use of SM as an adjuvant treatment for chronic cor pulmonale heart failure.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s12906-015-0939-2) contains supplementary material, which is available to authorized users.

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          Most cited references41

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          Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary.

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            Syndrome differentiation in modern research of traditional Chinese medicine.

            Syndrome differentiation (Bian Zheng) in traditional Chinese medicine (TCM) is the comprehensive analysis of clinical information gained by the four main diagnostic TCM procedures: observation, listening, questioning, and pulse analysis, and it is used to guide the choice of treatment either by acupuncture and/or TCM herbal formulae, that is, Fufang. TCM syndrome differentiation can be used for further stratification of the patients' conditions with certain disease, identified by orthodox medical diagnosis, which could help the improvement of efficacy of the selected intervention. In modern TCM research it is possible to integrate syndrome differentiation with orthodox medical diagnosis leading to new scientific findings in overall medical diagnosis and treatment. In this review, the focus is to screen published evidence on the role of syndrome differentiation in modern TCM research with particular emphasis on basic and clinical research as well as, pharmacological evaluation of TCM herbal formulary for drug discovery. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.
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              Do certain countries produce only positive results? A systematic review of controlled trials.

              To determine whether clinical trials originating in certain countries always have positive results. Abstracts of trials from Medline (January 1966-June 1995). Two separate studies were conducted. The first included trials in which the clinical outcome of a group of subjects receiving acupuncture was compared to that of a group receiving placebo, no treatment, or a nonacupuncture intervention. In the second study, randomized or controlled trials of interventions other than acupuncture that were published in China, Japan, Russia/USSR, or Taiwan were compared to those published in England. Blinded reviewers determined inclusion and outcome and separately classified each trial by country of origin. In the study of acupuncture trials, 252 of 1085 abstracts met the inclusion criteria. Research conducted in certain countries was uniformly favorable to acupuncture; all trials originating in China, Japan, Hong Kong, and Taiwan were positive, as were 10 out of 11 of those published in Russia/USSR. In studies that examined interventions other than acupuncture, 405 of 1100 abstracts met the inclusion criteria. Of trials published in England, 75% gave the test treatment as superior to control. The results for China, Japan, Russia/USSR, and Taiwan were 99%, 89%, 97%, and 95%, respectively. No trial published in China or Russia/USSR found a test treatment to be ineffective. Some countries publish unusually high proportions of positive results. Publication bias is a possible explanation. Researchers undertaking systematic reviews should consider carefully how to manage data from these countries.
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                Author and article information

                Contributors
                504176620@qq.com
                ktzu2014@163.com
                okfrom2008@hotmail.com
                chaiyanhi@hotmail.com
                1140714457@qq.com
                Journal
                BMC Complement Altern Med
                BMC Complement Altern Med
                BMC Complementary and Alternative Medicine
                BioMed Central (London )
                1472-6882
                24 November 2015
                24 November 2015
                2015
                : 15
                : 418
                Affiliations
                [ ]Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China
                [ ]Guang’an men Hospital, China Academy of Chinese Medical Sciences, Beijing, China
                [ ]Department of Epidemiology, University of California-Los Angeles, Los Angeles, CA USA
                Article
                939
                10.1186/s12906-015-0939-2
                4659214
                26603978
                971b0a17-edbe-4d48-ab58-06f2690de9e7
                © Shi et al. 2015

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 10 June 2015
                : 17 November 2015
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2015

                Complementary & Alternative medicine
                shenmai injection (sm),chronic cor pulmonale heart failure,systematic review,meta-analysis

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