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)

Abstract

Background. Shenfu 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. Methods. A 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. Results. After 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. Conclusion. SFI 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.

Efficacy and Safety of Fuzi Formulae on the Treatment of Heart Failure as Complementary Therapy: A Systematic Review and Meta-Analysis of High-Quality Randomized Controlled Trials

“…By reading the full text, 2700 studies were removed, including 194 studies with improper control interventions, 100 studies without control group, 32 studies without full text, 334 of them were unqualified, 1306 studies not using FZF, 154 studies containing other TCM therapies, such as acupuncture, massage, or scraping, and 571 studies with low methodological quality, and 9 studies as duplicates. Ultimately, 12 eligible studies with Cochrane RoB score ≥4 were included in this study [18][19][20][21][22][23][24][25][26][27][28][29]. A PRISMA flow diagram depicted the search process and study selection ( Figure 1).…”

“…All eligible studies were conducted in China. 2 articles were published in English [24,29], and the rest were in Chinese [18][19][20][21][22][23][25][26][27][28]. 3 were multicenter studies [19,24,29], and the others were single-center study [18,[20][21][22][23][25][26][27][28].…”

“…2 articles were published in English [24,29], and the rest were in Chinese [18][19][20][21][22][23][25][26][27][28]. 3 were multicenter studies [19,24,29], and the others were single-center study [18,[20][21][22][23][25][26][27][28]. Among the included studies, 9 were related to chronic heart failure (CHF) [18,19,[21][22][23][24][25][26]29], 2 were related to diastolic heart failure (DHF) [20,27], and 1 was related to systolic heart failure [27].…”

“…3 were multicenter studies [19,24,29], and the others were single-center study [18,[20][21][22][23][25][26][27][28]. Among the included studies, 9 were related to chronic heart failure (CHF) [18,19,[21][22][23][24][25][26]29], 2 were related to diastolic heart failure (DHF) [20,27], and 1 was related to systolic heart failure [27]. e sample size of the included studies ranged from 60 to 491, enrolling a total of 1490 participants, 735 patients in experimental groups, and 755 patients in control groups.…”

“…6 studies compared FZF plus CHFST with CHFST [18,21,[25][26][27][28], 4 studies compared FZF plus CHFST with placebo plus CHFST [20,[22][23][24]29], 1 study compared FZF plus digoxin tablets (DT) plus CHFST with placebo plus DT plus CHFST [22], and the last one compared FZF plus placebo plus CHFST with placebo plus DT plus CHFST [19]. e preparations used in the 12 RCTs were administered orally in decoction (4 comparisons) [22,[26][27][28], granules (2 comparisons) [19,21], capsules (4 comparisons) [18,20,23,24], pills (1 comparison) [25], and injections (1 comparison) [29]. e treatment duration ranged from 7 ± 1 days to 9 months.…”