ArticleEvidence-based complementary and alternative medicine : eCAM2019
Randomized, Double-Blinded, Multicenter, Placebo-Controlled Trial of Shenfu Injection for Treatment of Patients with Chronic Heart Failure during the Acute Phase of Symptom Aggravation (Yang and Qi Deficiency Syndrome).
Article in Evidence-based complementary and alternative medicine : eCAM, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Efficacy of plant extracts in heart failure patients: a systematic review and network meta-analysis.BMC cardiovascular disorders · 2026Pooled it
- The efficacy of ginseng-containing traditional Chinese medicine in patients with acute decompensated heart failure: A systematic review and meta-analysis.Frontiers in pharmacology · 2022Pooled it
- Independent prognostic value of the triglyceride-glucose index and its incremental predictive contribution beyond traditional risk markers in acute heart failure: a retrospective cohort study.Frontiers in cardiovascular medicine · 2026Article
- Study on the role of Shenfu injection in mediating ferroptosis through the Akt/GSK-3β/Nrf2 pathway in yang-deficient chronic heart failure.Turkish journal of biology = Turk biyoloji dergisi · 2025Article
- Effects of plant extracts on patients with heart failure: a network meta-analysis of randomized controlled trials.Frontiers in pharmacology · 2025Article
- Shenfu injection as treatment for critical illness: a narrative review of clinical trials.Journal of thoracic disease · 2024Review
- Effectiveness and safety of Danshen injections in treatment of cardiac failure: a network meta-analysis.Frontiers in pharmacology · 2024Review
- Shenfu injection: a review of pharmacological effects on cardiovascular diseases.Frontiers in pharmacology · 2024Review
- The traditional Chinese medicines treat chronic heart failure and their main bioactive constituents and mechanisms.Acta pharmaceutica Sinica. B · 2023Review
- Potential traditional Chinese medicines with anti-inflammation in the prevention of heart failure following myocardial infarction.Chinese medicine · 2023Review
- Traditional Chinese medicine for treatment of sepsis and related multi-organ injury.Frontiers in pharmacology · 2023Review
- Efficacy and Mechanism of Buyang Huanwu Decoction in Patients With Ischemic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Trial Combined With Proteomic Analysis.Frontiers in pharmacology · 2022Article
- Efficacy of Dialectical Comprehensive Treatment of Traditional Chinese Medicine in Patients with Chronic Stable Heart Failure: A Randomized Controlled Trial.Cardiology research and practice · 2022Article
- Mechanism of tonifying-kidney Chinese herbal medicine in the treatment of chronic heart failure.Frontiers in cardiovascular medicine · 2022Review
- Effects of combination therapy with Shenfu Injection in critically ill patients with septic shock receiving mechanical ventilation: A multicentric, real-world study.Frontiers in pharmacology · 2022Article
- Mechanisms and Efficacy of Traditional Chinese Medicine in Heart Failure.Frontiers in pharmacology · 2022Review
- Effect of Shenfu Injection on Differentiation of Bone Marrow Mesenchymal Stem Cells into Pacemaker-Like Cells and Improvement of Pacing Function of Sinoatrial Node.Oxidative medicine and cellular longevity · 2022Article
- Article
- Efficacy and safety of traditional Chinese medicines for non-alcoholic fatty liver disease: a systematic literature review of randomized controlled trials.Chinese medicine · 2021Review
- Efficacy and Safety of TCMI in Patients With Combined Coronary Heart Disease and Heart Failure: A Systematic Review and Network Meta-Analysis.Frontiers in pharmacology · 2021Review
Corrections and comments
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Authors and funding
20 authors at 12 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundShenfu injection (SFI) has shown a remarkable therapeutic effect in patients with chronic heart failure (CHF) during the acute phase of symptom aggravation since it became commercially available in 1987. However, the therapeutic effect of SFI has not been validated in a standard clinical study. As a pilot clinical trial, this study aimed to evaluate the safety and efficacy of SFI for treatment of CHF patients during the acute phase.
methodsA total of 160 patients experiencing acute phase CHF were enrolled in this study and randomly assigned to receive the placebo (placebo group, 150 ml glucose (GS)) or SFI (SFI group, 50 ml SFI + 100 ml GS) in addition to their standard medications for CHF treatment. The treatment lasted for 7 ± 1 days, and the follow-up continued for 28 ± 3 days after treatment. The primary endpoints were New York Heart Association (NYHA) classification and Traditional Chinese Medicine (TCM) syndrome scores.
resultsAfter 7±1 days of treatment, the efficacy of SFI according to improvements in NYHA and TCM syndrome scores in the SFI group (78.38% and 89.19%, respectively) was significantly higher than that in the placebo group (61.43% and 60.00%, respectively; P<0.05). The SFI group had a longer increase in amplitude than the placebo group (113.00 m versus 82.99 m, P<0.05). The incidence of adverse events and other safety indices showed no significant differences between the two groups.
conclusionSFI combined with conventional therapy for treatment of CHF during acute symptom aggravation ameliorated the cardiac dysfunction and clinical symptoms and improved the patients' quality of life without any significant AEs compared with the conventional therapy alone.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.