Luo FG, Xing HY, Wang JJ, Wu WY, Fang KJ, Song HD, Yan J. Protective effect of Guanxinning on antipsychotic-induced cardiac impairment in long-term hospitalized psychiatric patients. World J Psychiatry 2026; 16(1): 111840 [DOI: 10.5498/wjp.v16.i1.111840]
Corresponding Author of This Article
Juan Yan, MD, Professor, Quality Control Office, Affiliated Mental Health Center and Hangzhou Seventh People’s Hospital, Zhejiang University School of Medicine, No. 305 Tianmushan Road, Xihu District, Hangzhou 310013, Zhejiang Province, China. 294162939@qq.com
Research Domain of This Article
Psychiatry
Article-Type of This Article
Clinical Trials Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Jan 19, 2026 (publication date) through Dec 31, 2025
Times Cited of This Article
Times Cited (0)
Journal Information of This Article
Publication Name
World Journal of Psychiatry
ISSN
2220-3206
Publisher of This Article
Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA
Share the Article
Luo FG, Xing HY, Wang JJ, Wu WY, Fang KJ, Song HD, Yan J. Protective effect of Guanxinning on antipsychotic-induced cardiac impairment in long-term hospitalized psychiatric patients. World J Psychiatry 2026; 16(1): 111840 [DOI: 10.5498/wjp.v16.i1.111840]
Fu-Gang Luo, Intensive Care Unit, Mental Health Center Affiliated to Zhejiang University School of Medicine/Hangzhou Seventh People’s Hospital, Hangzhou 310013, Zhejiang Province, China
Hao-Yu Xing, Department of Medical Engineering, The Affiliated Mental Health Center and Hangzhou Seventh People’s Hospital, Zhejiang University School of Medicine, Hangzhou 310013, Zhejiang Province, China
Jun-Jie Wang, Judicial Appraisal Institute, Affiliated Mental Health Center and Hangzhou Seventh People’s Hospital, Zhejiang University School of Medicine, Hangzhou 310013, Zhejiang Province, China
Wen-Ye Wu, Kai-Jie Fang, Juan Yan, Quality Control Office, Affiliated Mental Health Center and Hangzhou Seventh People’s Hospital, Zhejiang University School of Medicine, Hangzhou 310013, Zhejiang Province, China
Hai-Dong Song, Department of Medical Affairs, Affiliated Mental Health Center and Hangzhou Seventh People’s Hospital, Zhejiang University School of Medicine, Hangzhou 310013, Zhejiang Province, China
Hai-Dong Song, The Fourth School of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou 311402, Zhejiang Province, China
Juan Yan, Graduate School, Zhejiang Chinese Medical University, Hangzhou 311402, Zhejiang Province, China
Author contributions: Luo FG and Xing HY contributed equally to this article, they are the co-first authors of this manuscript; Luo FG and Yan J handled conceptualization; Luo FG and Fang KJ managed data curation; Xing HY took charge of formal analysis and validation; Wang JJ and Song HD participated in investigation; Wang JJ, Wu WY, Fang KJ, and Yan J shared the responsibility of funding acquisition; for writing-related tasks; Wang JJ and Song HD engaged in writing, reviewing and editing; Wu WY and Fang KJ managed methodology; Wu WY took charge of resources; Song HD handled supervision; Yan J was responsible for writing the original draft; and all authors thoroughly reviewed and endorsed the final manuscript.
Supported by the Special Project for Supporting the Development of Biomedicine and Health Industry in Hangzhou City, No. 2022WJC123; and Zhejiang Province Traditional Chinese Medicine Science and Technology Plan Project, No. 2022ZA143.
Institutional review board statement: This study was approved by the Medical Ethics Committee of Hangzhou Seventh People’s Hospital, No. 2022-037, No. Yan 2023-086, and No. Yan 2024-052.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Data sharing statement: The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Juan Yan, MD, Professor, Quality Control Office, Affiliated Mental Health Center and Hangzhou Seventh People’s Hospital, Zhejiang University School of Medicine, No. 305 Tianmushan Road, Xihu District, Hangzhou 310013, Zhejiang Province, China. 294162939@qq.com
Received: July 11, 2025 Revised: July 30, 2025 Accepted: October 15, 2025 Published online: January 19, 2026 Processing time: 173 Days and 22 Hours
Abstract
BACKGROUND
Long-term antipsychotic therapy in psychiatric patients carries significant cardiovascular risks, including QT interval prolongation, myocardial injury, and functional impairment. Guanxinning, a traditional Chinese medicine formulation, has demonstrated cardioprotective potential in preclinical studies, but clinical evidence in this population remains limited.
AIM
To evaluate the cardioprotective effects of Guanxinning against antipsychotic-induced cardiac injury in long-term hospitalized psychiatric patients.
METHODS
A randomized, double-blind, placebo-controlled trial was conducted with 120 psychiatric inpatients receiving chronic antipsychotic therapy. Participants were allocated to: Intervention group: Conventional antipsychotics + Guanxinning tablets (0.38 g × 4 tablets, ter in die); Control group: Conventional antipsychotics + identical placebo; Cardiac assessments at baseline and 12 months included: Electrocardiography (corrected QT interval), echocardiography (left ventricular ejection fraction, left ventricular end-diastolic diameter), serum biomarkers (cardiac troponin I, B-type natriuretic peptide, superoxide dismutase, malondialdehyde, high-sensitivity C-reactive protein).
RESULTS
Compared to controls, the Guanxinning group showed: Electrophysiological improvement: Corrected QT shortening (438 ± 25 milliseconds vs 465 ± 30 milliseconds, P < 0.01). Functional enhancement: Left ventricular ejection fraction increase (58.5% ± 5.2% vs 53.8% ± 4.8%, P < 0.05), left ventricular end-diastolic diameter reduction (49.8 ± 3.5 mm vs 52.6 ± 3.8 mm, P < 0.05), Biochemical modulation: Reduced myocardial injury markers (cardiac troponin I: 0.009 ng/mL vs 0.014 ng/mL; B-type natriuretic peptide: 52 pg/mL vs 78 pg/mL, P < 0.001), improved oxidative stress (superoxide dismutase: ↑13.3 U/mL; malondialdehyde: ↓0.9 nmol/mL, P < 0.001), attenuated inflammation (high-sensitivity C-reactive protein: 2.0 mg/L vs 3.2 mg/L, P < 0.001).
CONCLUSION
Guanxinning significantly mitigates antipsychotic-induced cardiac injury in psychiatric patients, demonstrating: Normalization of electrophysiological parameters, Preservation of systolic/diastolic function, suppression of oxidative stress and inflammation. These findings support its clinical application as an adjunctive cardioprotective therapy, potentially through inhibition of myocardial apoptosis and antioxidant upregulation.
Core Tip: This study highlights the cardioprotective effects of Guanxinning in patients with psychiatric disorders undergoing long-term antipsychotic therapy. The intervention significantly improved cardiac function, including shortened QT intervals, reduced myocardial enzyme fluctuations, and increased left ventricular ejection fraction. Notably, Guanxinning also enhanced antioxidant capacity and reduced oxidative stress and inflammation, suggesting its potential to mitigate antipsychotic-induced cardiac damage through anti-apoptotic mechanisms. These findings support its clinical use in protecting the heart of psychiatric patients on prolonged antipsychotic treatment.
Citation: Luo FG, Xing HY, Wang JJ, Wu WY, Fang KJ, Song HD, Yan J. Protective effect of Guanxinning on antipsychotic-induced cardiac impairment in long-term hospitalized psychiatric patients. World J Psychiatry 2026; 16(1): 111840
Psychiatric disorders, particularly schizophrenia, are chronic conditions associated with substantial functional impairment and reduced quality of life. Long-term hospitalization of patients with such disorders often requires prolonged antipsychotic treatment to manage symptoms and maintain clinical stability. However, chronic use of antipsychotics, such as chlorpromazine and clozapine, is associated with significant cardiovascular adverse effects, including a prolonged QT interval (the time from the start of the Q wave to the end of the T wave), arrhythmias, and cardiomyopathy[1-8]. Patients taking antipsychotics have a 2-3 times higher risk of cardiovascular mortality than the general population[9-12].
Long-term use of antipsychotic drugs, particularly first-generation such as chlorpromazine and second-generation antipsychotic drugs, has been widely associated with a variety of cardiovascular disorders, including but not limited to prolonged QT intervals, various types of arrhythmia, and cardiomyopathy[13-18]. Studies have demonstrated that these drugs affect cardiac structure and function through several mechanisms, including increased oxidative stress response, induction of inflammatory responses, and direct myocardial toxicity[19-22]. Consequently, their use can lead to cardiac arrhythmias, sudden cardiac death, and myocardial injury.
Given the heightened cardiovascular risks associated with antipsychotic therapy, identifying effective cardioprotective interventions is crucial to optimize clinical outcomes and improve patient survival. Guanxinning, a traditional Chinese medicine formulation composed of Salvia miltiorrhiza Bunge (Danshen) and Ligusticum chuanxiong Hort (Chuanxiong), has shown anti-ischemic and cardioprotective properties in preclinical studies. The botanical names were verified against the latest revisions on The World Flora Online (http://www.worldfloraonline.org, accessed February 25, 2025). Official product documentation and Zhang[23] support the pharmacological effects of Guanxinning. Rooted in the Xinmai Tongluo (unblocking heart vessels) principle documented in classical Chinese medicine texts[24-26], Guanxinning may offer protective benefits against antipsychotic-induced cardiac injury[27]. This study aimed to investigate its potential cardioprotective effect on patients with psychiatric disorders receiving long-term antipsychotic therapy.
MATERIALS AND METHODS
Study setting and period
This experimental study was conducted between January and June 2023. We collected data from 120 patients with schizophrenia hospitalized in Hangzhou, Zhejiang Province. This prospective, randomized, double-blind, placebo-controlled trial study received ethical approval from the Ethics Committee of the Medical Ethics Committee of Hangzhou Seventh People’s Hospital, No. 2022-037. This study was conducted in accordance with the Declaration of Helsinki, local legislation, and institutional requirements. Written informed consent was obtained from all participants or their legal guardians.
Study design and participants
A total of 120 patients with schizophrenia hospitalized between January and June 2023 were included in the study. The inclusion criteria were as follows: Age 18-65 years; International Statistical Classification of Diseases and Related Health Problems, 10th Revision diagnosis of schizophrenia; hospitalization duration ≥ 1 year; ≥ 6 months of continuous antipsychotic therapy; and positive and negative syndrome score < 60[1,8]. Exclusion criteria included: History of severe cardiovascular diseases (e.g., myocardial infarction, heart failure); hepatic/renal dysfunction (in order to ensure patient safety, individuals with preexisting hepatic or renal function abnormalities were excluded, as the medication may have an impact on liver and kidney function) alanine aminotransferase/aspartate transaminase > 3 × upper limit; estimated glomerular filtration rate < 60 mL/minute/1.73 m²); and pregnancy or lactation.
Sample size calculation: We conducted an initial six-month-long pilot study with 20 patients who met the inclusion criteria. Based on the results of the preliminary study, the expected difference in the primary endpoint - left ventricular ejection fraction (LVEF) - was assumed to be 5% with a standard deviation of 8%. With α = 0.05 and β = 0.2, and considering a 20% dropout rate, we determined that 60 participants were needed in each group.
Randomization and intervention
Patients who met the inclusion criteria were randomly assigned to the control group (n = 60) or the Guanxinning intervention group (n = 60) in a 1:1 ratio using the random number table method. A block randomization strategy was adopted, and patients were stratified according to age and baseline positive and negative syndrome score scores[28]. The control group received conventional antipsychotic drugs and a placebo, whereas the intervention group received conventional treatment with Guanxinning tablets (four tablets, thrice daily, 0.38 g per tablet; Zhejiang Zhengda Qingchunbao Pharmaceutical Co., LTD., Batch number 2303005). The intervention period was 12 months, and the types and doses of antipsychotic drugs in both groups remained unchanged throughout the study. The study drug and placebo, identical in appearance, were prepared and distributed by an independent pharmacist. The researchers, patients, and statistical analysts were unaware of the group assignments.
Outcome measures
Table 1 shows outcome measures assessed in this study, including the evaluation indicators, their measurement methods, and measurement frequency. We assessed the following: (1) Electrocardiography parameters: QT/corrected QT (QTc) intervals; (2) Echocardiographic indices: LVEF, left ventricular end diastolic dimension (LVEDD); (3) Serum biomarkers: Cardiac troponin I (cTnI) and B-natriuretic peptide (BNP); and (4) Oxidative stress, inflammatory markers, superoxide dismutase (SOD), malondialdehyde (MDA), and C-reactive protein (CRP).
Table 1 Evaluation indicators and measurement methods.
Data were analyzed using SPSS 25.0. The type of randomized controlled trial analysis carried out was intention-to-treat. Measurement data were expressed as mean ± SD, whereas t-tests were used for comparison between groups. Count data were expressed as percentages, and group comparisons were analyzed using the χ2 test. Continuous variables data were analyzed using the independent sample t-test for normally distributed data and the Mann-Whitney U test for non-normally distributed data. Categorical variables data were analyzed using the χ² or Fisher’s exact test. Repeated-measures analysis of variance was used to compare treatment effects between the intervention and control groups. P < 0.05 was considered statistically significant.
RESULTS
Baseline characteristics
No significant differences in age, sex, course of disease, type, and dose of antipsychotic drugs between the control group and the Guanxinning intervention group were determined (P > 0.05; Table 2).
Table 2 Baseline characteristics of the study participants, n (%).
The data showed no significant differences between the two groups in terms of cardiac function and biochemical measures at baseline (P > 0.05), indicating that the randomization process was successful and that the two groups were comparable (Table 3).
Table 3 Baseline cardiac function and biochemical measures, mean ± SD.
Measures
Guanxinning intervention group (n = 60)
Control group (n = 60)
P values
ECG parameters
QTc interval (millisecond)
462 ± 28
465 ± 30
0.572
Echocardiographic indicators
LVEF (%)
53.5 ± 4.9
53.2 ± 4.8
0.734
LVEDD (mm)
52.3 ± 3.7
52.6 ± 3.8
0.658
E/A ratio, median (interquartile spacing)
0.92 (0.81-1.05)
0.90 (0.79-1.03)
0.512
Serum biomarkers
cTnI (ng/mL), median (interquartile spacing)
0.012 (0.008-0.018)
0.013 (0.009-0.019)
0.628
BNP (pg/mL), median (interquartile spacing)
68 (45-95)
72 (48-98)
0.453
NT-proBNP (pg/mL), median (interquartile spacing)
125 (85-180)
132 (90-185)
0.389
Indicators of oxidative stress
SOD (U/mL)
85.3 ± 12.6
83.9 ± 13.1
0.545
MDA (nmol/mL)
4.8 ± 1.2
5.0 ± 1.3
0.371
GSH-Px (U/L)
168.5 ± 22.4
165.8 ± 23.1
0.512
Inflammatory markers
Hs-CRP (mg/L), median (interquartile spacing)
2.8 (1.5-4.6)
3.0 (1.7-4.8)
0.415
IL-6 (pg/mL), median (interquartile spacing)
3.2 (2.1-4.8)
3.4 (2.3-5.0)
0.378
TNF-α (pg/mL), median (interquartile spacing)
8.5 (6.2-11.3)
8.8 (6.5-11.6)
0.462
Metabolic indices
Fasting blood glucose (mmol/L)
5.6 ± 0.8
5.5 ± 0.7
0.457
Total cholesterol (mmol/L)
4.9 ± 0.9
5.0 ± 1.0
0.554
Triglycerides (mmol/L), median (interquartile spacing)
The comparison revealed that participants in the Guanxinning intervention group showed a markedly shortened QTc interphase (438 ± 25 milliseconds vs 465 ± 30 milliseconds, P < 0.01). Furthermore, the intervention group’s LVEF increased significantly (58.5% ± 5.2% vs 53.2% ± 4.8%, P < 0.05), whereas LVEDD reduced significantly (49.8 ± 3.5 mm vs 52.6 ± 3.8 mm, P < 0.05). Further, their cTnI and BNP levels decreased significantly (P < 0.05). The early maximal ventricular filling velocity/atrial maximal ventricular filling velocity in the experimental group was significantly higher than that in the control group (P = 0.002), suggesting that Guanxinning could improve left ventricular diastolic function. The cTnI, BNP, and high N-terminal pro-BNP levels in the experimental group were significantly lower than those in the control group (all P < 0.001). The activities of SOD and GSH-Px in the experimental group were significantly higher than those in the control group, whereas the MDA level in the experimental group was significantly lower than that in the control group (all P < 0.001), indicating that Guanxinning could enhance antioxidant capacity and reduce oxidative stress injury. In the experimental group, high-sensitivity CRP, IL-6, and TNF-α levels were significantly lower than those in the control group (all P < 0.001), suggesting that Guanxinning has anti-inflammatory effects. The experimental group’s fasting blood glucose, blood lipid level, and hemoglobin A1c showed different degrees of improvement (P < 0.05), indicating that Guanxinning can positively impact metabolic indices.
Longitudinal analysis
Repeated-measures analysis of variance confirmed significant time-group interactions for LVEF and QTc (P < 0.001). BNP levels diverged significantly between groups from month 3 onward (Table 6). As BNP data were not normally distributed, nonparametric methods were used for analysis (Tables 7 and 8).
Table 6 Comparison of left ventricular ejection fraction, corrected QT, and B-type natriuretic peptideindicators before and after treatment between the intervention group and the control group.
The LVEF index showed a significant time effect (P < 0.001), suggesting that LVEF changed over time. The group effect was statistically significant (P < 0.001), indicating an overall LVEF difference between the two groups. The interaction was statistically significant (P < 0.001), indicating that the tendencies of LVEF of the two groups were different. LVEF in the experimental group showed a continuous upward trend, whereas no significant change in the control group was observed. For the QTc interval, the time, group, and interaction effects were significant (all P < 0.001). In the experimental group, the QTc period showed a trend of continued decline, whereas that in the control group remained stable. The BNP levels of the two groups changed significantly over time (Friedman test, P < 0.001). After three months, the differences in BNP levels between the two groups gradually became significant (Mann-Whitney U test). The BNP levels in the experimental group continued to decline, whereas those in the control group increased slightly (Table 6).
DISCUSSION
This study aimed to investigate whether Guanxinning could mitigate or prevent cardiac impairment in long-term hospitalized psychiatric patients receiving antipsychotic treatment. By comparing the changes in cardiac function indices before and after treatment in the intervention and control groups, we found that Guanxinning had a significant protective effect on cardiac function. We discuss the key findings in this section.
A prolonged QT interval and a QTc interval in electrocardiogram parameters are important biomarkers of antipsychotic-induced arrhythmia. In this study, both intervals in the Guanxinning intervention group were significantly shorter than those in the control group (P < 0.01). This suggests that Guanxinning stabilizes myocardial cell membrane potential and reduces calcium ion flow, thereby mitigating antipsychotic-induced ECG abnormalities. Research has shown that the prolongation of the QT interval is associated with delayed cardiomyocyte repolarization, and Guanxinning may improve the electrophysiological characteristics of cardiomyocytes by regulating calcium and sodium channels, thereby reducing the prolongation of QT and QTc intervals[29]. This prospective, Randomized, double-blind, placebo-controlled trial confirmed the efficacy of Guanxinning in preventing and mitigating the cardiac side effects of antipsychotic drugs.
Echocardiographic parameters such as LVEF and LVEDD are important indicators of cardiac function. The results showed that LVEF was significantly higher (P < 0.05) and LVEDD was significantly lower (P < 0.05) in the Guanxinning intervention group than those in the control group. This suggests that Guanxinning enhances myocardial contractile function and reduces myocardial injury by improving energy metabolism and reducing oxidative stress in myocardial cells[30].
Serum biomarkers cTnI and BNP are key indicators of myocardial injury and cardiac insufficiency. The study showed that cTnI and BNP levels were significantly lower (P < 0.001) among patients treated with Guanxinning than those in the control group, further demonstrating the effectiveness of Guanxinning in cardiac function protection. The cardioprotective effects of Guanxinning may be attributed to its ability to inhibit myocardial apoptosis and optimize myocardial energy metabolic pathways, alleviating myocardial ischemia-reperfusion injury[31].
Anti-myocardial ischemic and cardiomyocyte protective properties of Guanxinning have been well documented. This study further elucidates its mechanistic role in mitigating antipsychotic-induced adverse cardiac effects. Specifically, Guanxinning alleviates antipsychotic-induced cardiac injury by modulating oxidative stress responses and inflammatory signaling pathways. Previous studies have indicated that its cardioprotective effects are mediated by suppressing reactive oxygen species generation and downregulating pro-inflammatory cytokine expression[32]. SOD, MDA, and GSH-Px are critical biomarkers for evaluating systemic oxidative stress. The results demonstrate that the Guanxinning group exhibited significantly higher SOD and GSH-Px levels (P < 0.001) and lower MDA levels (P < 0.001) than the control group. These findings suggest that Guanxinning enhances free radical scavenging by upregulating SOD expression and activity, thereby attenuating oxidative damage to vascular endothelial cells and inhibiting cardiomyocyte apoptosis. This aligns with the previously reported antioxidant mechanisms, reinforcing its pharmacological validity[33]. In terms of anti-inflammatory effects, high-sensitivity CRP, IL-6, and TNF-α are pivotal biomarkers for assessing inflammatory responses. The Guanxinning group showed significantly lower levels of these inflammatory markers (P < 0.001), indicating its potent anti-inflammatory properties[34]. This may protect cardiac function by suppressing the release of inflammatory mediators and reducing antipsychotic-induced cardiac inflammation. Studies have further corroborated the regulatory role of Guanxinning in inflammatory pathways, providing a theoretical foundation for its clinical application[35,36].
The study results suggest that Guanxinning exerts its cardioprotective effects through various mechanisms. Guanxinning contains active ingredients such as tanshinones and flavonoids, which have antioxidant, anti-inflammatory, and anti-myocardial fibrosis effects. These components protect cardiac function by reducing the oxidative stress response, inhibiting cardiomyocyte apoptosis, and alleviating myocardial fibrosis. Guanxinning can further enhance cardioprotective effects by regulating autonomic nerve function and improving energy metabolism in cardiomyocytes[37,38].
Moreover, the action mechanism of Guanxinning may involve diverse signal transduction pathways, such as nuclear factor kappa B signaling pathway and Janus kinase/signal transducer and activator of transcription pathway, which play a key role in inflammatory response and oxidative stress. By targeting these pathways, Guanxinning effectively inhibits inflammation and oxidative stress, exerting a cardioprotective effect[34,39,40].
This study has several noteworthy limitations. Firstly, the relatively small sample size and single-center design may constrain the statistical power and generalizability of our findings. Future multicenter studies with expanded cohorts are warranted to validate these observations. Secondly, it should be emphasized that participants were deliberately selected from long-term hospitalized psychiatric patients without documented cardiovascular pathology, specifically excluding individuals with conditions such as arrhythmias or baseline QTc abnormalities (Table 3).
Critically, while the QTc interval reduction in the intervention group reached statistical significance compared to controls after 12 months (P < 0.01), both groups’ post-intervention measurements remained within clinically normal parameters. This objectively confirms that the cohort maintained cardiological health throughout the study period. Consequently, our primary finding - that Guanfaxinning may exert cardioprotective effects - pertains exclusively to patients with preserved cardiac function receiving long-term antipsychotic therapy.
This inherent characteristic of our study population constitutes a fundamental limitation: Results cannot be extrapolated to individuals with pre-existing electrophysiological abnormalities or elevated cardiovascular risk profiles. We explicitly acknowledge that the generalizability of our conclusions is circumscribed by the baseline cardiac health of participants. Thus, we temper our conclusions to state that this randomized controlled trial provides preliminary evidence suggesting Guanfaxinning might offer cardioprotective benefits specifically in cardiac-healthy individuals undergoing sustained antipsychotic treatment. Further investigation is imperative to evaluate its efficacy and safety in patients with manifest cardiac comorbidities.
CONCLUSION
This prospective, randomized, double-blind, placebo-controlled trial confirmed the efficacy of Guanxinning in preventing and mitigating the cardiac side effects of antipsychotic drugs in long-term hospitalized patients with schizophrenia. Guanxinning can protect myocardial cells and improve cardiac function through its antioxidative and anti-inflammatory effects, demonstrating its potential for clinical applications. However, current research is limited to animal models and preclinical trials. More large-scale clinical trials are needed to verify these findings and further clarify the safety and efficacy of Guanxinning in broader patient populations. Future research should incorporate multicenter, long-term follow-up clinical trials to comprehensively evaluate Guanxinning’s therapeutic potential and provide a stronger scientific foundation for its clinical application in managing antipsychotic-induced cardiac dysfunction.
ACKNOWLEDGEMENTS
We thank the participants and their families. We are especially grateful to Yu-Quan Wang for his help with the formatting.
Footnotes
Provenance and peer review: Invited article; Externally peer reviewed.
Peer-review model: Single blind
Corresponding Author’s Membership in Professional Societies: Mental Health Professional Committee of Zhejiang Provincial Preventive Medicine Association; the Zhejiang Provincial Neuropsychiatric Drugs and Dependence Professional Committee; the Children and Adolescents Mental Health Branch of Hangzhou Medical Association.
Specialty type: Psychiatry
Country of origin: China
Peer-review report’s classification
Scientific Quality: Grade B, Grade B, Grade C
Novelty: Grade A, Grade B, Grade B
Creativity or Innovation: Grade A, Grade B, Grade B
Scientific Significance: Grade B, Grade B, Grade B
P-Reviewer: Noufi P, MD, Assistant Professor, United States; Zhang XB, PhD, Professor, China S-Editor: Bai Y L-Editor: A P-Editor: Yu HG
Chen D, Xue BY. [Investigation on the risk of cardiovascular diseases during the application of antipsychotics].Linchuang Xindianxue Zazhi. 2022;31:50-52, 56.
[PubMed] [DOI]
Kong LG, Lin CG, Huang QQ, Li YB, Xu DL, Xie HL, Zheng CQ, Cheng XY. [Influence of five antipsychotic drugs on liver function and heart function in the treatment of schizophrenia].Jianyan Yixue. 2018;33:196-200.
[PubMed] [DOI]
Alisauskiene R, Johnsen E, Gjestad R, Kroken RA, Kjelby E, Sinkeviciute I, Fathian F, Joa I, Reitan SK, Rettenbacher M, Løberg EM. Does drug use affect the efficacy of amisulpride, aripiprazole and olanzapine in patients with schizophrenia spectrum disorders? Results from a pragmatic, randomised study.Gen Hosp Psychiatry. 2023;83:185-193.
[RCA] [PubMed] [DOI] [Full Text][Reference Citation Analysis (0)]
Zhang M. [Effects of different doses of olanzapine on electrocardiogram and myocardial enzymes in patients with schizophrenia].Guoji Jingshenbingxue Zazhi. 2023;50:434-436.
[PubMed] [DOI] [Full Text]
Liu HY, Zhang CL, Chen CZ, Lin LY. [Research progress on the effects of antipsychotics on vascular endothelial cells].Guoji Jingshenbingxue Zazhi. 2021;48:13-16.
[PubMed] [DOI] [Full Text]
Wu YQ, Dang RL, Jiang P, Li HD, Tang MM, Cai HL. [Research progress of cardiovascular side effects and potential mechanisms of antipsychotic drugs].Zhongguo Yiyuan Yaoxue Zazhi. 2016;36:327-331.
[PubMed] [DOI] [Full Text]
Si TM, Yang JZ, Shu L, Wang XL, Kong QM, Zhou M, Li XN, Liu C. [A study on the reliability and validity of the Positive and Negative Syndrome Scale (PANSS, Chinese version)].Zhongguo Yixue Weisheng Zazhi. 2004;1:45-47.
[PubMed] [DOI]
Chen PC.
Effect of Guanxinning tablet on ventricular repolarization index in patients with unstable angina pectoris of coronary heart disease. M.Sc. Thesis, Zhejiang Chinese Medical University. 2022.
[PubMed] [DOI] [Full Text]
Liao J, Shen WY, Sun QY, Liu YH. [Effect and mechanism of Guanxinning on myocardial protection and regeneration in rats with acute myocardial infarction].Quanke Yixue Linchuang Yu Jiaoyu. 2023;21:699-703, 668.
[PubMed] [DOI]
Chen JL. [Effect of Guanxin tablet on stable angina pectoris of coronary heart disease and its effect on inflammatory factors and oxidative stress].Jiangxi Yiyao. 2023;58:222-224.
[PubMed] [DOI]
Zhang L, Zhang H, Chen TL. [Research progress of Guanxinning tablets in the prevention and treatment of atherosclerotic panvascular disease].Zhongguo Xiandai Yisheng. 2023;61:98-101.
[PubMed] [DOI]
Zhang T, Zhi XW, Zuo J. [Clinical efficacy of Guanxinning in the treatment of coronary heart disease with chronic heart failure and its effect on ventricular remodeling, hs-CRP, CysC, and NT-proBNP levels].Hainan Yixue. 2022;33:2862-2865.
[PubMed] [DOI]
