Objectives: This study sought to evaluate the efficacy and safety of shenmai injection for chronic pulmonary heart disease (CPHD).
Methods: A systematic review was conducted of clinical trials that compared shenmai injection plus conventional medicine treatment versus conventional medicine treatment alone. Randomized controlled trials of clinical therapeutic studies on CPHD by shenmai injection were included. Searches were applied to the following electronic databases: the PubMed (1977-2008), the Cochrane Library, EMBASE, AMED, Chinese BioMedical Literature Database, and CBM. No blinding and language restriction was used. Data were extracted independently by 2 reviewers. All trials included were analyzed according to the criteria of the Cochrane Handbook. Review Manager 5.0 software was used for data analysis.
Results: Thirty-three (33) randomized clinical trials (2617 patients) with low methodological quality were included. Compared to conventional medicine treatment alone, shenmai plus conventional medicine treatment showed significant improvement in New York Heart Association classification of clinical status (odds ratio 0.24; 95% confidence interval 0.19-0.30), five studies had reported adverse events. No serious adverse effects were reported in any of the included trials.
Conclusions: While there is some evidence that suggests potential effectiveness of shenmai plus conventional medical treatment for CPHD, the results of this study were limited by the methodological flaws, unknowns in concealment of allocation, number of dropouts, and blinding methods in the studies. Long-term and high-quality studies are needed to provide clear evidence for the future use of shenmai injection.