Study Protocol Systematic Review Medicine ®

OPEN

Efficacy and safety of Shenfuqiangxin pills in

complementary treatment of chronic heart failure
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A protocol for systematic review and meta-analysis

∗
Lili Ren, MDa, Hui Guan, MDa, Guohua Dai, PhDb, , Wulin Gao, MDb, Jing Su, BDb
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Abstract
Background: As the last link in the chain of cardiovascular events, chronic heart failure (CHF) has high morbidity, high mortality,
and poor prognosis. It is one of the main causes of death and disability worldwide. Shenfuqiangxin Pills (SFQX) is widely used as a
Chinese herbal medicine (CHM) prescription for CHF, but there is still a lack of strict evidence-based medical evidence. Therefore, we
make a protocol for evaluating the efficacy and safety of SFQX for CHF.
Methods: According to the search strategy, randomized controlled trials (RCTs) of SFQX for CHF will be retrieved from 8 databases
without limitation of publication date or language. First of all, the literature was screened according to the eligibility criteria, and use the
Cochrane Collaboration’s tool to assess the quality of the included literature. Then, using software for traditional meta-analysis.
Finally, using GRADE method to assess the strength of recommendations.
Results: This study will evaluate the efficacy and safety of SFQX for CHF, thereby providing more evidence support for clinical
decision-making in CHF.
Conclusion: Our research will provide more references for the clinical medication of patients with CHF.
Protocol registration number: INPLASY202110019
Abbreviations: CHF = chronic heart failure, CHM = Chinese herbal medicine, TCM = Traditional Chinese Medicine, SFQX =
Shenfuqiangxin Pills, RCTs = randomized controlled trials, LVEF = left ventricular ejection fraction, CI = confidence interval, OR =
odds ratio, SMD = standardized mean difference, RAAS = Renin-Angiotensin-Aldosterone System.
Keywords: chronic heart failure, meta-analysis, shenfuqiangxin pills, systematic review

1. Introduction HF has a high recurrence rate and a poor prognosis, which

Heart failure (HF) is a group of clinical syndromes in which the
left ventricular filling or the ability to eject blood is impaired due
to abnormal heart structure or (and) function.[1] The main
manifestations are dyspnea, fatigue, fluid retention, among
others. As the severe and terminal stage of various heart diseases,
LR and HG contributed equally to this work.
This work was supported by the National Key R&D Program of China (No.
2019YFC1710400; No. 2019YFC1710401).
The authors report no conflicts of interest.
Data sharing not applicable to this article as no datasets were generated or
analyzed during the current study.
a
First College of Clinical Medicine, Shandong University of Traditional Chinese
Medicine, b Department of Cardiology, Affiliated Hospital of Shandong University
of Traditional Chinese Medicine, Jinan, Shandong Province, China.
∗
Correspondence: Guohua Dai, Department of Cardiology, Affiliated Hospital of
Shandong University of Traditional Chinese Medicine, 16369, Jingshi Road, Jinan
250014, Shandong Province, China (e-mail: daigh2004@163.com).
Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.
This is an open access article distributed under the Creative Commons
Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
How to cite this article: Ren L, Guan H, Dai G, Gao W, Su J. Efficacy and safety
of Shenfuqiangxin pills in complementary treatment of chronic heart failure: A
protocol for systematic review and meta-analysis. Medicine 2021;100:15
(e24531).
Received: 6 January 2021 / Accepted: 8 January 2021
http://dx.doi.org/10.1097/MD.0000000000024531
seriously threatens people’s physical and mental health.[2] In
developed countries, the prevalence of HF in adults is about 1%
to 2%, and it gradually increases with age, and exceeds 10% in
people >80 years.[2,3] After being diagnosed with chronic heart
failure (CHF), the rehospitalization rate was as high as 83.1%,
and 42.6% were hospitalized >4 times.[4] The Framingham
Heart Study in the United States shows that within 5 years of the
initial diagnosis of CHF, the mortality rate of patients is about
50%.[5] In patients with acute myocardial infarction with CHF,
the 1-year mortality rate is >50%.[3] Therefore, extending the
survival period of patients with CHF, improving the quality of
life, improving the long-term prognosis, and reducing the
mortality rate are key issues that need to be resolved.
Traditional CHF focuses on the study of hemodynamics,
emphasizing the relief of symptoms in the acute phase, and the
conventional treatment is mainly to cardiotonic, diuresis, and
vasodilators. With the discovery of neuroendocrine mechanism,
early and comprehensive intervention of cardiovascular events
can improve the prognosis; conventional treatments are mostly
based on neuroendocrine antagonists, such as ACEI/ARB,
b-receptor blockers, and digoxin, among others. Nevertheless,
the mortality and rehospitalization rate of patients with CHF
remains high.
Chinese herbal medicine (CHM), as a complementary therapy,
originated in ancient China and has accumulated rich experience
for CHF.[6] Under the guidance of the holistic concept and the
thoughts of treatment based on syndrome differentiation, the

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 Ren et al. Medicine (2021) 100:15 Medicine

treatment of CHF has the characteristics of multi-level, multi-
link, and multi-target effects. A number of studies have shown
that combined treatment of Chinese and Western medicine can
reduce the rehospitalization rate of patients with CHF, improve
the quality of life, and improve the long-term prognosis.[7–9]
Evidence from clinical studies of traditional Chinese medicine
(TCM) is also used in the “Guidelines for the Diagnosis and
Treatment of Heart Failure in China” in 2014 and 2018.[10,11]
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We will retrieve the databases by combining subject words
with random words. Appropriate adjustments will be made
according to the grammatical rules of different databases to
ensure the completeness and comprehensiveness of the search.
We will first conduct a pre-search, and discuss the problems
encountered in the search process with the team. After confirming
that there are no problems, we will conduct a formal literature

search. Taking PubMed as an example, the retrieval strategy is

Shenfuqiangxin pills (SFQX) are approved by the state, and are shown in Table 1.
recommended as oral Chinese patent medicines for CHF in the 2014
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and 2016 TCM diagnosis and treatment expert consensus.[12,13] In

some clinical studies, it has also been shown that SFQX combined
with western medicine can further improve the heart function of
patients with CHF, reduce myocardial damage markers and
myocardial enzyme indexes, and improve the quality of life.[14,15]
In addition, it has also been found in some animal experiments that
SFQX can reduce water and sodium retention, correct electrolyte
disturbances, and inhibit autophagy and apoptosis of myocardial
cells, thereby protecting the heart.[16–18] It can be seen from this that
SFQX may bring hope to this research field and may also arouse the
interest of the international medical community. However, as there
is no systematic review, it is very necessary for us to strictly review
and evaluate the existing evidence so far. Therefore, the purpose of
this study is to evaluate the efficacy and safety of SFQX in
complementary treatment of CHF, so as to provide sufficient
evidence-based medical evidence for further guidance of clinical
medication and avoid unnecessary traps.
2. Methods
2.1. Research registration
Our protocol has been registered on the INPLASY. The number
was INPLASY202110019 (URL= https://inplasy.com/inplasy-
2021-1-0019/). We will be based on the Preferred Reporting
Items for Systematic Review and Meta-Analysis Protocols
(PRISMA-P), and strictly follow the requirements and conduct.[19]
2.2. Data sources and retrieval strategy
We will conduct literature search from the following databases:
PubMed, EMBASE, the Cochrane Library, Web of Science,
CNKI, Wan-fang Data, Chinese Biomedical Literature Database,
Chinese Scientific Journal Database. There are no restrictions on
publication date and language. In addition, the references listed in
each included article are also manually searched.
2.3. Eligibility criteria
We will formulate the eligibility criteria for this study based on
the PICOS principles.
2.3.1. Participants. Patients with CHF, whether diagnosed by a
clinician, or by any recognized criteria diagnosis of CHF, will be
included. There are no restrictions on nationality, age, sex, or
race. Patients who have received acute heart failure, or patients
with severe liver and kidney, or blood diseases, or malignant
tumors, or other uncontrolled systemic diseases are excluded.
2.3.2. Interventions and Comparators. The treatment group
was given SFQX on the basis of routine western medicine of
CHF. The control group was only given routine western
medicine, or the same dose of placebo was given on the basis
of routine western medicine. Routine western medicine mainly
includes diuretics, ACEI, ARB, b-receptor blockers, ivabradine,
digitalis and inotropic drugs, vasodilators, anticoagulants, etc.[1]
2.3.3. Outcomes. The primary outcomes include TCM syn-
drome scores, NYHA classification; the secondary outcomes
include N terminal pro B type natriuretic peptide (NT-proBNP),
left ventricular ejection fraction (LVEF), quality of life, among
others; the safety indicators include gastrointestinal reactions,
such as nausea and vomiting, liver function indicators, allergic
and other adverse reactions.
2.3.4. Type of studies. Randomized controlled trials (RCTs)
will be included in this study irrespective of language or
publication category. Animal trials, review article and the
incorrect RCT studies will be excluded.
2.4. Literature screening and data extraction
Endnote X9.0 software to manage literature was used. After
searching literature based on the above steps, it is imported into
endnote software for literature screening. First, 2 independent

Table 1
Retrieval strategy for PubMed.
Number Search item
#1 Heart Failure[Mesh]
#2 Heart Failure[Title/Abstract] OR Cardiac Failure[Title/Abstract] OR Heart Decompensation[Title/Abstract] OR Decompensation, Heart[Title/Abstract] OR Heart
Failure, Right-Sided[Title/Abstract] OR Heart Failure, Right Sided[Title/Abstract] OR Right-Sided Heart Failure[Title/Abstract] OR Right Sided Heart Failure
[Title/Abstract] OR Myocardial Failure[Title/Abstract] OR Congestive Heart Failure[Title/Abstract] OR Heart Failure, Congestive [Title/Abstract] OR Heart
Failure, Left-Sided[Title/Abstract] OR Heart Failure, Left Sided[Title/Abstract] OR Left-Sided Heart Failure[Title/Abstract] OR Left Sided Heart Failure[Title/
Abstract]
#3 #1 OR #2
#4 Shenfuqiangxin Pills[Title/Abstract] OR Shenfuqiangxin[Title/Abstract] OR SFQX [Title/Abstract]
#5 randomized controlled trial [Title/Abstract] OR controlled clinical trial[Title/Abstract] OR RCT [Title/Abstract] OR randomized[Title/Abstract] OR randomly[Title/
Abstract]
#6 #3 AND #4 AND #5

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 Ren et al. Medicine (2021) 100:15 www.md-journal.com

researchers will conduct a preliminary literature screening based
on the titles and abstracts of the included literature to eliminate
duplicate and non-RCTs. Then read the full text of the remaining
literature according to the previously designed principles of
eligibility criteria, and finally determine the appropriate
literature. When 2 researchers disagree, a third researcher will
resolve it. The specific screening process is shown in Figure 1.
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treatment status (eg, the initial dose and treatment period of
SFQX) and outcomes (eg, TCM syndrome scores, NYHA
classification). If any of the above information in the included
literature is incomplete, we will contact the corresponding author
via email to obtain the required data.
2.5. Quality assessment

According to the Cochrane Handbook for Systematic Reviews

of Interventions, 2 researchers independently extracted and Two reviewers will independently assess the quality of the
recorded the required information from all the included included literature. If there is a disagreement between 2 reviewers,
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literature. When 2 researchers disagree, they will discuss to
reach an agreement, otherwise they will work with the third
researcher to resolve. The required information mainly includes
the author, publication time, study design, participants’ number,
and demographic characteristics (age, sex, among others),
the third reviewer resolves the issue. According to Cochrane
Handbook V.5.2.0, Characteristics of each item will be evaluated
in three categories: low, unclear, and high.[20] The results of the
quality assessment will be completed using software Review
Manager 5.3.

Figure 1. PRISMA flow chart. The figure that explains the process required to follow the PRISMA guidelines to screen the literature suitable for this study after the
literature search is completed. Adapted from: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred Reporting Items for Systematic
Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med 6(7): e1000097. doi:10.1371/journal. pmed1000097.

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 Ren et al. Medicine (2021) 100:15
2.6. Statistical analysis
2.6.1. Traditional meta-analysis. We will execute Rev Man 5.3
and STATA 14.2 software for traditional meta-analysis. For
dichotomous data, we will calculate a summary estimate with
95% confidence interval (CI) odds ratio (OR) value; for
continuous data, we will calculate a summary estimate of
standardized mean difference (SMD) with 95% CI, and P < .05 is
considered statistically significant. The heterogeneity among the
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included literature will be assessed using the Q test method and I2
statistic method. When the Q statistic corresponds to P  .10 or
wCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8K2+Ya6H515kE= on 08/10/2023
I2 >50%, it indicates that there is heterogeneity among the
included literature, and assess the effect size by the random effect;
on the contrary, a fixed-effect model is used.
2.6.2. Subgroup analysis. Taking into account the issue of
heterogeneity, we will conduct a subgroup analysis based on the
specific circumstances of the included literature. If there is a
problem of heterogeneity, we will conduct a subgroup analysis of
age, sex, and interventions. In addition, to understand whether
the LVEF will affect the efficacy of SFQX, it will be used for CHF
patients with LVEF <40% and CHF with unknown LVEF the
TCM syndrome scores and NYHA classification are analyzed by
subgroups.
2.6.3. Sensitivity analysis. This systematic review will use
the method of eliminating each study one by one for sensitivity
analysis. If the effective indicators (eg, TCM syndrome
scores and NYHA classification) of SFQX in complementary
treatment of CHF have not changed significantly, it indicates that
the study is robustness. On the contrary, it is not robustness.
According to the specific situation, low-quality research is
excluded.
2.6.4. Publication biases. Publication biases will be assessed by
a funnel plot for meta-analysis and quantified by the Egger
method. It should be noted that if the number of included
literature is ≥10, it is appropriate to use a funnel plot. However, if
the included literature is <10, it may affect the overall test power
because the included number is too small, and it is difficult to
accurately evaluate the symmetry of the funnel plot.
2.7. Evidence quality assessment
The Grading of Recommendations, Assessment, Development
and Evaluation (GRADE) used to assess the quality of evidence.
The quality of evidence is divided into 4 levels from 5 aspects.[21]
2.8. Ethical considerations and Dissemination plans
This study does not involve medical ethics and patients’ informed
consent. And it will publish in journal papers.
3. Discussion
Some people say that CHF is “the last game of the heart.” From the
perspective of the causes of CHF, on the one hand, as the aging of
the population in various countries gradually accelerates, the
incidence of various cardiovascular-related diseases is gradually
increasing, such as coronary heart disease, hypertension, dyslipi-
demia, diabetes, obesity, and so on, and most of the end stages of
these diseases end in CHF; on the other hand, with the continuous
improvement of global medical technology and the change of
people’s medical thinking, the progress of cardiovascular disease is
slow, and the survival period of patients is prolonged, which will
4
Medicine
cause the incidence of CHF to continue to increase. At present,
studies have shown that the root cause of CHF is due to myocardial
remodeling. Excessive activation of the sympathetic adrenergic
system and the renin-angiotensin-aldosterone system leads to a
variety of endogenous neuroendocrine and cytokine activation,
which triggers myocardial remodeling, and long-term activation
promotes myocardium remodeling, aggravating myocardial
damage, and further activating neuroendocrine and cytokines,
forming a vicious circle.[22,23] Therefore, preventing the excessive
activation of neuroendocrine and blocking myocardial remodeling
is the key to treatment. However, in the current limited medical
technology, the cardiac function and structure cannot be
completely reversed temporarily. Some drugs and methods can
only be used to prevent myocardial remodeling to a certain extent,
improve or delay the deterioration of cardiac function, improve the
quality of life, and improve the long-term prognosis.
SFQX are made by adding and subtracting 2 TCM
preparations, the main ingredients include Ginseng (Renshen),
Radix Aconiti Carmichaeli (Fuzi), White Mulberry Root-bark
(Sangbaipi), Polyporus Umbellatus (Zhuling), Semen Lepidii
(Tinglizi), and Rhubarb (Dahuang). In a number of clinical
studies, it has been found that SFQX can inhibit the RASS system
by reducing the levels of Ang II and aldosterone, thereby
reversing myocardial remodeling and improving cardiac func-
tion.[24,25] In addition, pharmacological studies have also shown
that radix aconiti carmichaeli can warm yang and nourish fire,
ginseng can nourish qi, and the combination of the 2 drugs has
the effect of strengthening heart and expanding blood vessels to
enhance the contractility of the heart.[26,27] White mulberry root-
bark and polyporus umbellatus have promoting diuresis effects
and can improve heart function.[12]
It can be seen that it is very necessary for us to explore the
complementary therapeutic effect of SFQX by formulating a strict
plan, and we can make a more objective evaluation of the existing
evidence and make a more accurate evaluation of the effect
indicators. But at the same time, this research may also have some
problems. For example, this study is an evaluation of published
literature, and there may be problems such as unscientific and non-
strict RCT design, resulting in uneven quality of literature research,
which affects the credibility of this study, or the research results in
included literature have false negatives and false positives. In any
case, this study can provide reliable results for CHF, and provide
strong evidence for the significant advantages of SFQX in
complementary treatment of CHF.
Author contributions
Conceptualization: Lili Ren, Hui Guan, Wulin Gao.
Data curation: Lili Ren, Hui Guan, Jing Su.
Formal analysis: Lili Ren, Hui Guan, Jing Su.
Funding acquisition: Guo-hua Dai.
Methodology: Lili Ren, Wulin Gao.
Project administration: Guo-hua Dai.
Writing – original draft: Lili Ren.
Writing – review & editing: Lili Ren, Guohua Dai.
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