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. 2023 Apr 14;102(15):e33545. doi: 10.1097/MD.0000000000033545

Efficacy and safety of Jinhua Qinggan granules in the treatment of coronavirus disease 2019 (COVID-19): A systematic review and meta-analysis

Xiuying Si a, Xiaoxue Ma b, Youpeng Wang c,*, Yongjun Li a, Lujia Liu c, Yang Yang c, Zheng Guo a, Yuan Liang a, Guangxia Pan a
PMCID: PMC10100637  PMID: 37058020

Objective:

To evaluate, using meta-analysis, the efficacy and safety profile of Jinhua Qinggan granules (JHQG) in the treatment of novel coronavirus pneumonia.

Methods:

We screened multiple publication databases (PubMed, Embase, The Cochrane Library, Web of Science, CNKI, WanFang, and VIP), using parameters designed to identify articles detailing randomized controlled trials relating to the treatment of novel coronavirus pneumonia with JHQG. The inclusion period for each search was the point of database inception to November 2022. Each piece of literature identified in our initial screening was independently reviewed by 2 researchers, who extracted the relevant data and evaluated the bias risk associated with the study. The data was split in 2: the control group (containing patients who had received routine treatment or placebo) and the experimental group (containing patients treated with JHQG). The meta-analysis was performed using Revman 5.4 software. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.

Results:

Four articles were selected for this study and combined included a total of 582 patients, which were subdivided into experimental (n = 347) and control (n = 235) groups. The results showed that treatment with JHQG could significantly: enhance the improvement rate of primary symptoms [relative ratio (RR) = 1.26,95% confidence interval (CI) (1.07, 1.49), P = .007] and fever [RR = 1.48, 95% CI (1.07, 2.04), P = .02]; decrease the viral nucleic acid in patients with coronavirus disease 2019 (COVID-19) [RR = 2.04, 95% CI (1.15, 3.62), P = .02] and reduce the progression of pneumonia [RR = 0.34, 95% CI (0.17, 0.67), P = .002]. However, there was no significant difference between the 2 groups with regards to: the improvement rate of cough, nausea and vomiting, fatigue, computed tomography, or frequency of adverse reactions.

Conclusions:

Current evidence indicates that JHQG is effective in treating COVID-19, increasing the rate of improvement for fever, increasing the negative rate of viral nucleic acid in patients with COVID-19 and reducing the aggravation rate of pneumonia. These conclusions need to be verified by further rigorous studies, as the existing results were limited by the number and quality of the included studies.

Keywords: COVID-19, Jinhua Qinggan granules, meta-analysis, systematic review, Western medicine

1. Introduction

By December 6, 2022, more than 539 million people worldwide had been or were currently infected with the novel coronavirus pneumonia virus, resulting in at least 6.64 million related deaths.[1] Fortunately, the rapid development of multiple vaccine programs has boosted global herd immunity, significantly reducing the coronavirus disease 2019 (COVID-19) mortality rate. However, like most viruses, SARS-CoV-2 continues to mutate, and evolve, giving rise to a number of mutant strains worldwide. Some variants, such as alpha, beta, and gamma have only become prevalent in a few countries, allowing the delta and omicron strains to compete for dominance on a global scale.[2–4] At present, western medicine is mainly focusing on symptomatic treatment for COVID-19, using α- interferon, antibiotics, antiviral drugs, and hormones. By contrast, China has adopted the strategy of using both Traditional Chinese Medicine (TCM) and western medicine in combination as an early intervention. This approach will hopefully be shown to have improved the survival rate of patients and have helped effectively control the spread of the disease. The combination of traditional Chinese medicine and Western medicine can effectively reduce the clinical symptoms of COVID-19 patients, improve pulmonary infection, and improve patient prognosis.[5–7]

In the spring of 2020, China began to standardize a popular Chinese herbal medicine (CHM) treatment protocol called “3 medicines and 3 traditional Chinese medicine prescriptions.”[8,9] The former refers to Jinhua Qinggan granules, Lianhua Qingwen capsules, and Xuebijing injections, while the latter refers to the TCM prescriptions: Qingfei Paidu decoction, Huashi Baidu decoction, and Xuanfei Baidu decoction.[10] The “China Plan” of traditional Chinese medicine is deeply involved in epidemic prevention and control, complementing the advantages of Western medicine, showing unique advantages and highlights in prevention, treatment and rehabilitation, and making important contributions to comprehensive epidemic control. Jinhua Qinggan granules are a pharmaceutical preparation developed from the optimization of 2 ancient classical TCM prescriptions: Firstly, Maxing Shigan; which has been in use for nearly 2000 years; and secondly, Yinqiao Powder, which has been in use for over 300 years. Both these prescriptions form part of the Treatise on Febrile Diseases and are well known for dispersing wind, decongesting lungs, clearing heat, and detoxification.[11] Jinhua Qinggan Granules are composed of 12 traditional Chinese medicines, including: honeysuckle, gypsum, Fritillaria thunbergii, Scutellaria baicalensis, Arctium lappa, Artemisia annua, Anemarrhena asphodeloides, Forsythia suspensa, Ephedra, bitter almond, mint and licorice. Among the “3 medicines,” Jinhua Qinggan granules are most often used for mild disease cases. These granules were first developed in 2009 and were immediately shown to be an effective CHM antiviral when they were used successfully during an outbreak of H1N1influenza in the same year. More recently, they have shown good efficacy in treating mild and moderate cases of COVID-19. The main active ingredients include: scutellarin, chlorogenic acid, ephedrine, kaempferol, luteolin, forsythiaside A, glycyrrhizin, salicylic acid, and caffeic acid.[12,13] Pharmacological studies have shown that CHMs, which naturally contain these compounds, can shorten illness duration, increase the recovery rate of lymphocytes and white blood cells and improve immune status.[10]

Ren and An showed that prescribing Jinhua Qinggan granules is advantageous for relieving symptoms such as fever, fatigue, and diarrhea and improving appetite. Their research also demonstrated that Jinhua Qinggan granules reduced serum C-reactive protein and γ interferon secretion level.[14,15] In addition, Duan and Liu research confirmed that Jinhua Qinggan granules not only significantly alleviate symptoms (such as cough and expectoration), but also improve the virus clearance rate (effectively shortening the time for the patient’s nucleic acid test to return to negative) and accelerates the absorption of inflammatory exudates in the lungs.[16,17] Network pharmacology analysis revealed that the main active ingredients of Jinhua Qinggan granules, with the highest comprehensive score in SARS-CoV-2 treatment, targeted the virus’s 3CL hydrolase enzyme with a binding capacity similar to that of ribavirin, but better than that of remdesivir, lopinavir, and ritonavir. In addition, it was found to be associated with pneumonia-related signaling pathways such as Tumor necrosis factor, PI3K/Akt, immune regulation, antivirus, bacterial inflammatory response, and other functions.[18,19] Using data from previous patient studies, we used a meta-analysis system to evaluate the clinical efficacy and safety of Jinhua Qinggan granules combined with conventional Western medicine for the treatment of COVID-19. Therefore, our study is more comprehensive than similar previous analyses, as it uses a larger sample size and more complete data, thus producing more reliable results.[20,21]

2. Methods

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed during this umbrella review.[22]

2.1. Ethics statement

This research has been registered on the PROSPERO platform with the registration number CRD42022380582. This study is a secondary analysis of previous experimental results. Therefore, no ethical approval is required.

2.2. Literature search

We screened the PubMed, Embase, The Cochrane Library, Web of Science, CNKI, WanFang, and VIP databases, searching for randomized controlled trials (RCTs) relating to the efficacy and safety of Jinhua Qinggan granules used in combination with conventional western medicine in the treatment of COVID-19. When setting the search parameters in terms of time, we used the date of inception for each database up until November 2022. The retrieval is carried out by searching for specific subject heading words and key words in the main body of the article (adjusted according to the characteristics of each database). In addition, the references included in the study were retrieved to supplement the relevant information. More specific methodology is provided in Supplemental Digital Content 1, http://links.lww.com/MD/I808.

2.3. Inclusion and exclusion criteria

Inclusion criteria: Study was an RCT; Trial involved treatment of COVID-19 and participants were not restricted by age, sex, nationality, and/or race; The main drug used for the treatment group was Jinhua Qinggan granules; The control group received routine treatment (including nutritional support; oxygen therapy; antiviral treatment such as interferon, lopinavir/ritonavir or Abidor; anti infection treatment; life support; symptomatic treatment, etc) or placebo.

Exclusion criteria: Repeated publication of research; Animal experiment; Full text could not be obtained or data were incomplete and the author could not be contacted; Treatment involved nondrug therapy (such as acupuncture, cupping, Qigong, massage, etc).

2.4. Data selection and data extraction

Firstly, all literature was screened using EndNote 9.0 software (https://endnote.com/) according to the preset inclusion/exclusion criteria, with duplicate results (i.e., articles included in multiple databases) removed. Then, any obviously irrelevant (based on title and abstract) literature was excluded. Finally, the full texts of all remaining literature were read manually and those papers conforming to the requirements were included.

Working independently, 2 investigators extracted data from the selected articles. The results were cross-referenced and any disagreement was settled through discussion or arbitration by a third investigator. The data extracted included: Basic information–first author, publication journal, sample size, intervention measures, control measures, outcome indicators etc; Baseline characteristics and interventions of subjects; Key elements of bias risk assessment.

2.5. Assessment of bias risk

The bias risk of each RCT study was evaluated according to the Cochrane Risk of Bias tool,[23] which assesses sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective outcome reporting, and other potential threats to validity. Studies were rated in terms of each variable as low risk, high risk, or unclear risk of bias. Two independent assessors conducted this qualitative assessment, and any disagreement was settled by reaching a consensus or by consulting a third researcher.

2.6. Statistical analysis

Revman 5.4 (https://training.cochrane.org/online-learning/core-software/revman) was used for the meta-analysis. The indicators analyzed in this study are all binary variables. The relative ratio (RR) was used as the effect size indicator for these variables and a 95% confidence interval (CI) was provided for each effect size. The heterogeneity of the statistical data was judged using the I2 value. If I2 < 50%, heterogeneity was considered to be very small and the fixed effect model was used for analysis. However, if I2 ≥ 50%, it indicates that there was statistical heterogeneity between data samples, the source of which should be analyzed. In addition, if the heterogeneity between studies was not clinical heterogeneity, the random effect model could be used for analysis. When the included literature > 10, a funnel plot was used to test for publication bias.

3. Results

3.1. Literature search and screening

Our initial keyword search identified 296 relevant studies, of which 114 were duplicate publications. Further application of the inclusion/exclusion criteria identified 155 noncompliant articles, based on the content of their titles/abstracts, leaving 27 papers requiring manual reading of the full text. Subsequently, 4 articles were included in our final meta-analysis. PRISMA Flow Diagram for searched, screened, and included studies is shown in Figure 1.

Figure 1.

Figure 1.

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PRISMA flow diagram.

3.2. Basic characteristics and quality evaluation of the included literature

The results from the included studies[15–17,24] yielded a combined sample size of 582 patients. Of the 4 studies, one was conducted in Pakistan and the remainder in China. The extracted patient data was split into 2 groups. The control group contained patients that had received conventional drugs such as antivirals, antibacterial agents, immune agents, and glucocorticoids. Patients who received Jinhua Qinggan granules were assigned to the experimental group. The patients in both groups received oxygen therapy and nutritional support when necessary. The bias risk assessment results were assessed using the Cochrane Risk of Bias tool. The detailed characteristics of the literature are shown in Table 1. The plot for risk of bias is shown in Figure 2. Datasets of all results and safety were uploaded as Supplemental Digital Content 2, http://links.lww.com/MD/I809.

Table 1.

Basic characteristics of the included literature.

Number Year Author Country Simple size (M/F) Ages (yr) Administration of Jinhua Qinggan Granules Conventional western therapy (Yes/No) Course Outcomes
1 2021 An Xuedong[15] China T: 42/50
C: 15/16		 T: 50.18 ± 12.25
C: 44.74 ± 11.65		 6 g, twice daily, take orally Yes: Antiviral therapy (oseltamivir and arbidol), and antimicrobial therapy (penicillin, cephalosporins, floxacins, and macrolides) 14 d ②③④⑤⑥⑦⑧
2 2020 Duan Can[16] China T: 39/43
C: 23/18		 T: 51.99 ± 13.88
C: 50.29 ± 13.17		 10 g, thrice daily, take orally Yes: Antivirus, anti-infection and other symptomatic treatment 5 d ②③④⑤⑥⑦⑩
3 2020 Liu Zengli[17] China T: 21/23
C: 16/20		 T: 50.73
C: 51.75		 6 g, twice daily, take orally Yes: Did not take Jinhua Qinggan
granules, or <2 d. Oxygen inhalation, and symptomatic and supportive treatment		 7 d ⑧⑨⑩
4 2022 Muhammad[24] Pakistani T: 129
C: 127		 - 5 g, thrice daily, take orally No. Placebo 10 d ①②⑧⑨⑩
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① Effective rate; ② Aggravation rate; ③ The recovery rate of fever; ④ The recovery rate of cough; ⑤ The recovery rate of fatigue; ⑥ The recovery rate of diarrhea; ⑦ The recovery rate of nausea and vomiting; ⑧ The negative conversion rate of nucleic acid test; ⑨ The improvement or recovery rate of chest CT manifestation; ⑩ Adverse events.

T =treatment group, C =control group, M = male, F = female.

Figure 2.

Figure 2.

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Risk of bias summary and graph.

3.3. Results of meta-analysis

3.3.1. Improvement rate of main symptoms

Two of the included studies[15,16] reported the effect of Jinhua Qinggan granules on the amelioration of the primary symptoms of COVID-19 in trial patients. Meta-analysis of the random effect model revealed that the combined experimental group exhibited a significantly better rate of improvement with regards to overall COVID-19 symptoms [RR = 1.26, 95% CI (1.07, 1.49), P = .007]. The data was further analyzed to assess the impact of Jinhua Qinggan granules (JHQG) on individual symptoms. The results showed that when comparing improvement rate of fever [RR = 1.48, 95% CI (1.07, 2.04), P = .02], the effects of the treatment received by the experimental group were better than those of the control group. However, when comparing the improvement rate of cough [RR = 1.20, 95% CI (0.69, 2.09), P = .51], fatigue [RR = 1.28, 95% CI (0.88, 1.85), P = .20] and nausea and vomiting [RR = 1.47, 95% CI (1.18, 1.81), P = .0004], there was no statistically significant difference between the 2 groups (Fig. 3).

Figure 3.

Figure 3.

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Forest plot of meta-analysis on recovery rate of main symptoms.

3.3.2. The negative conversion rate of nucleic acid test

Three studies[15,17,24] were included to report the effect of Jinhua Qinggan granules on the rate at which COVID-19 patients resumed testing negative for SARS-COV-2 nucleic acids. The meta-analysis results of the random effects model showed that there was no statistically significant difference between the 2 groups [RR = 1.31, 95% CI (0.63, 2.71), P = .47] (Fig. 4A). However, intergroup heterogeneity [P = .04, I2 = 70%] may have affected these results. Therefore, we repeated the analysis several times, each time excluding a specific study to provide a sensitivity analysis. The results showed that when Muhammad study was excluded, heterogeneity decreased significantly (P = .93, I2 = 0%), and the results of the meta-analysis changed [RR = 2.04, 95% CI (1.15,3.62), P = .02] (Fig. 4B). This suggests that Muhammad study was the source of heterogeneity, which our team believe may be related to their use of placebo only in their treatment of the control group.

Figure 4.

Figure 4.

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Forest plot of meta-analysis on negative conversion rate of nucleic acid test.

3.3.3. The improvement and recovery rate of chest computed tomography (CT) manifestation

Two studies[17,24] reported the CT improvement rate of patients. Meta-analysis, using the fixed effect model [P = .33, I2 = 0%], showed that there was no statistically significant difference between the 2 groups [RR = 1.30, 95% CI (0.83, 2.04), P = .26] (Fig. 5).

Figure 5.

Figure 5.

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Forest plot of meta-analysis on improvement or recovery rate of chest CT manifestation.

3.3.4. Aggravation rate

Three studies[15,16,24] reported deterioration rates. Meta-analysis using a fixed effect model [P = .27, I2 = 24%] showed that the difference between the 2 groups was statistically significant [RR = 0.34, 95% CI (0.17, 0.67), P = .002] (Fig. 6). The aggravation rate in patients receiving Jinhua Qinggan granules was lower than that of the control group.

Figure 6.

Figure 6.

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Forest plot of meta-analysis on aggravation rate.

3.3.5. Adverse events

Two studies[16,24] reported adverse events. The most common adverse reaction is diarrhea. Meta-analysis using the fixed effect model showed [P = .96, I2 = 0%] that there was no statistically significant difference between the 2 groups [RR = 0.71, 95% CI (0.46, 1.11), P = .13] (Fig. 7).

Figure 7.

Figure 7.

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Forest plot of meta-analysis on adverse events.

4. Discussion

COVID-19, first discovered in China in 2019, was declared a pandemic by the World Health Organization in 2020.[25] Currently, despite many studies into COVID-19, its pathogenesis is still poorly understood, although it is known that SARS-CoV-2 is a single strand positive-sense RNA virus. Its mode of replication in host cells is complex and has shown the propensity to rapidly mutate, making it difficult to develop specific drugs.[26] The symptoms of COVID-19 (and their intensity) vary dramatically from person to person, but the most common clinical symptoms include fever; fatigue; nausea and vomiting; diarrhea; cough; expectoration; loss of appetite and shortness of breath, which can occur at various stages of the disease.[27,28] Initial symptoms also vary from person to person, with fever and cough being the most common.[29,30] Western medicine adopts symptomatic treatment and basic conventional auxiliary treatment, such as antiviral drugs (lopinavir or ritonavir), anti-infective drugs (moxifloxacin) and hormonal drugs. These are all approved drugs for other conditions, but the treatment of Covid-19 may prove to be an addition indication. To date, a chemical agent specific to this virus has yet to be developed.

Traditional Chinese medicine is an ancient treatment strategy with a strong clinical history and success rate. TCM deems that COVID-19 is a type of the plague, which is highly infectious and epidemic. Clinical research shows that age is an important factor affecting the progression of COVID-19, with both infection and mortality rates being higher in older people than the rest of the population.[31–33] Jinhua Qinggan granules are one of the recommended drugs for the prevention and treatment of COVID-19 patients, particularly those exhibiting symptoms of fatigue and fever during medical observation.[14] Jinhua Qinggan granules can reduce serum levels of various cytokines and enhance immune function, particularly relating to IL-6, IL-1 β, CXCL8, CCL2, intercellular cell adhesion molecule-1, IL-10, IFNG, and IL-1A.[34] Some studies have analyzed the “3 parties” (Jinhua Qinggan granule, Lianhua Qingwen capsule, Shufeng Jiedu capsule) through network pharmacology. The results show that Jinhua Qinggan granules have more active ingredients than Lianhua Qingwen granules and Shufeng Jiedu granules, capable of interacting with the virus molecules. Its molecular mode of action appears to relate to PI3K/Akt and MAPK cell signaling pathways[35] (which are important for regulating cell growth, proliferation, differentiation, adhesion, invasion, and apoptosis) and JHQG also plays an important role in the treatment of respiratory diseases and viral infections.[36,37] Gong Puyang et al[19] used molecular docking technology to analyze the potential efficacy of Jinhua Qinggan granules, and the results showed that JHQG may regulate relevant signaling pathways by combining multiple components with SARS-CoV-2 3CL hydrolase and ACE2 on PTGS2, HSP90AB1, HSP90AA1, PTGS1, NCOA2, and other targets, thus preventing COVID-19.

Four studies were included in the present meta-analysis. Meta-analysis showed that, compared to conventional Western medicine treatment alone, Jinhua Qinggan granules combined with Western medicine treatment of COVID-19 can significantly improve overall patient prognosis, shorten the duration of fever, reduce the aggravation rate and have a better safety profile. There was no significant difference between the 2 groups with regards to the improvement rate for the following symptoms: cough, nausea and vomiting, fatigue or CT, nor in terms of frequency of adverse reaction. The analysis results of this study also have certain limitations: The number of research samples is small, which may reduce the credibility of the research results; Most studies come from China; There are differences in the severity of COVID-19 and drug dosage among groups, but due to the limited number of studies, in-depth analysis cannot be carried out.

5. Conclusions

In summary, Jinhua Qinggan granules combined with Western medicine is superior to Western medicine alone in improving fever, unhealthy levels of nucleic acid and the deterioration rate of pneumonia. However, there is no statistical significance between the 2 groups in terms of cough, fatigue, nausea, and vomiting, CT improvement rate and incidence of adverse reactions. Therefore, we have demonstrated the efficacy and development potential of Jinhua Qinggan granules in the treatment of mild and asymptomatic COVID-19 patients. Even so, we hope that there will be additional high quality RCTs in the future to verify the therapeutic effect of Jinhua Qinggan granules on the novel coronavirus.

Author contributions

Conceptualization: Youpeng Wang.

Data curation: Xiuying Si, Yongjun Li.

Methodology: Zheng Guo.

Software: Xiuying Si, Yongjun Li, Lujia Liu, Yang Yang.

Supervision: Yuan Liang.

Visualization: Lujia Liu.

Writing – original draft: Xiaoxue Ma, Youpeng Wang, Guangxia Pan.

Writing – review & editing: Xiuying Si.

Supplementary Material

medi-102-e33545-s001.pdf (131.1KB, pdf)

Abbreviations:

CHM
Chinese herb medicine
CI
confidence interval
CT
computed tomography
COVID-19
Coronavirus disease 2019
JHQG
Jinhua Qinggan granules
RCT
Randomized controlled trial
RR
Relative ratio
TCM
Traditional Chinese Medicine

The datasets generated during and/or analyzed during the current study are publicly available.

Supplemental Digital Content is available for this article.

The authors have no funding and conflicts of interest to disclose.

How to cite this article: Si X, Ma X, Wang Y, Li Y, Liu L, Yang Y, Guo Z, Liang Y, Pan G. Efficacy and safety of Jinhua Qinggan granules in the treatment of coronavirus disease 2019 (COVID-19): A systematic review and meta-analysis. Medicine 2023;102:15(e33545).

Contributor Information

Xiuying Si, Email: 1593851548@qq.com.

Xiaoxue Ma, Email: 83215452144@qq.com.

Yongjun Li, Email: 987752144@qq.com.

Lujia Liu, Email: 5216894@qq.com.

Yang Yang, Email: 56625488@qq.com.

Zheng Guo, Email: 102251478@qq.com.

Yuan Liang, Email: 921302154@qq.com.

Guangxia Pan, Email: 302516847@qq.com.

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