Evaluating the Efficacy of Fuzheng Shengjin Decoction in Lung Cancer Treatment: A Clinical Study

Evaluating the Efficacy of Fuzheng Shengjin Decoction in Lung Cancer Treatment: A Clinical Study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Evaluating the Efficacy of Fuzheng Shengjin Decoction in Lung Cancer Treatment: A Clinical Study Boning Liu, Jian Liu This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5354240/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background : Lung cancer is a leading cause of cancer-related death worldwide, with growing interest in complementary and alternative medicine (CAM) approaches to improve patient outcomes. This study aimed to evaluate the safety and efficacy of the traditional Chinese medicine (TCM) formulation, Fuzheng Shengjin Decoction, in lung cancer treatment. Methods : Fifty patients diagnosed with lung cancer received Fuzheng Shengjin Decoction. Primary outcomes included changes in lung function indices, symptom improvement, and quality of life, assessed via validated questionnaires (EORTC QLQ-C30 and QLQ-LC13). Symptom improvements in hemoptysis (42%), sputum production (68%), and cough (75%) were recorded. Lung function showed a mean increase of 0.25 liters in FEV1 and 0.18 liters in FVC. Quality of life improved, with a mean gain of 12.5 points in the EORTC QLQ-C30 Global Health Status and a mean decrease of 15.2 points in the EORTC QLQ-LC13 Lung Cancer Symptom Scale. Results : The decoction was well tolerated, with mild side effects such as diarrhea (16%) and nausea (20%) being the most common. Conclusion : This observational study suggests that Fuzheng Shengjin Decoction may be a promising complementary treatment for lung cancer, potentially improving symptoms, lung function, and quality of life. However, larger randomized controlled trials are necessary to confirm these findings Lung cancer traditional Chinese medicine Fuzheng Shengjin Decoction complementary treatment symptom improvement lung function quality of life 1 INTRODUCTION About 1.8 million people die each year from lung cancer, making it the top cancer killer globally. ( 1 ). The prognosis for lung cancer patients continues to be wrong, with a 5-year survival rate of only 19%, despite breakthroughs in early identification and treatment options. ( 2 ). The severe nature of the disease, the prevalence of co-morbidities, and the side effects of traditional treatments like radiation and chemotherapy make lung cancer management a formidable challenge ( 3 ). CAM therapies, or complementary and alternative medicine, to augment standard lung cancer treatments have grown in popularity in recent years ( 4 ). As a supplemental treatment for many cancers, including lung cancer, traditional Chinese medicine (TCM) has recently attracted a lot of interest due to its long history of use and holistic approach ( 5 ). Traditional Chinese Medicine (TCM) uses an original theoretical framework with several modalities to restore internal harmony and balance, including treatment, herbal medicine, Qigong, and more ( 6 ). In lung cancer, TCM practitioners aim to alleviate symptoms, enhance the body's resistance to disease, and improve overall quality of life ( 7 ). Herbal medicine, a cornerstone of TCM, has been widely studied for its potential benefits in lung cancer management ( 8 ). Herbal remedies made in China may include several components, all thought to have complementary therapeutic properties. As a reflection of TCM's emphasis on individualization, these formulations are frequently customized for each patient according to their particular combination of symptoms and disease patterns ( 9 ). Several studies have investigated the use of Chinese herbal medicines in lung cancer, either as stand-alone therapies or in combination with conventional treatments ( 10 ). A systematic review by ( 11 ) analyzed the benefits and risks of combining traditional Chinese medicine with standard cancer treatments for advanced non-small cell lung cancer (NSCLC). Results showed that compared to standard therapies alone, combining chemotherapy or radiation with Chinese herbal remedies increased tumor response rates, decreased cancer-related symptoms, and improved quality of life. The research included in the review was randomized controlled trials ( 12 ). The Fuzheng Shengjin Decoction is a Chinese herbal composition that has demonstrated potential for treating lung cancer. Traditional Chinese Medicine has long recognized this decoction benefits for various respiratory ailments, including improving lung health, increasing phlegm clearance, and fortifying the immune system. Astragalus, Platycodon, Bupleurum, Ophiopogon, Ginseng, and many more herbs make up the intricate composition known as the Fuzheng Shengjin Decoction. It is thought that the therapeutic effects of the decoction are due in part to the different mechanisms of action exhibited by each ingredient. Clinical trials are necessary to assess the safety and effectiveness of the Fuzheng Shengjin Decoction in human patients, as preclinical research has shown encouraging results about its potential effectiveness in lung cancer. Unfortunately, studies examining the efficacy of the Fuzheng Shengjin Decoction in the treatment of lung cancer have been few and far between. The Fuzheng Shengjin Decoction and other Chinese herbal formulations are gaining popularity as potential lung cancer treatments. Still, a more rigorous evaluation of their safety and effectiveness requires well-designed clinical trials. This research intends to fill that void by examining the Fuzheng Shengjin Decoction’s effectiveness in treating lung cancer in a single-arm, open-label, observational trial. Several end variables, such as changes in lung function indices, quality of life, and symptom improvement, will be evaluated in the trial to determine the effect of the Fuzheng Shengjin Decoction. Its safety profile will be meticulously recorded and monitored to guarantee further the decoctions' appropriateness for treatment in lung cancer patients. In conducting this research, we aim to add to the increasing data suggesting that Chinese herbal formulations like Fuzheng Shengjin Decoction may function in lung cancer treatment. 2 MATERIALS AND METHODS Study design: this was a single-arm, open-label, observational study conducted at our hospital. Inclusion and exclusion criteria : participation in the survey was open to patients with a lung cancer diagnosis. The following items were considered for inclusion: participants had to meet the following criteria: they had to be between the ages of 18 and 75, have a current diagnosis of lung cancer, be prepared to take part in the study, and not use any antibiotics or Chinese herbal remedies while it was under. These were the things that were not considered: symptoms of sudden breathing problems not caused by cancer of the lungs, every day, people with asthma must take medication, extensive lung disease, including bronchiectasis and severe interstitial lesions, acute immunodeficiency syndrome, severe primary immunodeficiency disease, congenital heart disease, congenital respiratory abnormalities, or abnormal lung development women who are expecting a child. Intervention: participants received the fuzheng shengjin decoction according to the following treatment procedure: fuzheng shengjin decoction: the following herbs and spices are included: astragalus (40g), codonopsis (12g), platycodon (12g), bupleurum (8g), ophiopogon (12g), almond (12g), honey (15g), scrophulariae (30g), salvitis miltiorrhiza (15g), yujin (15g), wolfberry (30g), raw rehmannia (15g), rhizoma atractylodis macrocephalae (12g), adenophora stricta (15g), aspartame (12g), hedyotis diffusa (30g). one dose was administered orally twice daily, and the treatment was 4 weeks. Modifications: 12-gram Spinelli, 12-gram poria, 12-gram orange peel, and 8-gram ginger will help a white cough with white sputum. Mix 15 grams of trichosanthes and 12 grams of baicalensis for a yellow phlegm cough. Mix 15g of white flower herb for loose stool with 15g of jade bamboo, 15g of sporculariae, 15g of radix ophiopogon, and 15g of pomegranate peel. Mix 12g of acid jujube kernel with 10g of fried radix polygonae for insomnia. Mix 12g of orange peel with 12g of chicken gold and 15g of magnolia officinalis for abdominal distension. • for constipation, mix 12g of sesame seed with 10g of rhubarb. Mix 15g of notoginseng powder with 15g of zephyr for hemoptysis. Outcome measures: the primary outcome measures were relief from symptoms (cough, sputum, hemoptysis), alterations to lung function measures (fev1, fvc), using a validated questionnaire, such as the eortc qlq-c30 or eortc qlq-lc13, one can measure quality of life. The secondary outcome measures were adverse events during the trial; investigators tracked and documented the incidence of adverse events, such as rash, nausea, vomiting, diarrhea, and others. Ethical considerations: all procedures in the study adhered to the highest standards of clinical research ethics. We got approval from the institutional review board, and the ethics committee's approval number is (czx2024-lw-024.1). Before engaging any participant, we made sure to get their informed consent. Statistical analysis: analysis of data: the study participants' demographic and clinical information, as well as their age and gender, were summarized using descriptive statistics. Categorical data were represented as frequencies and percentages, while continuous variables were shown as mean ± standard deviation (SD). 3 RESULTS Possible Outcomes: 50 patients were included in the research; their average age was 62, and 60% were men. Table 1 provides an overview of the study participants' baseline characteristics. Primary Outcome Measures: Improvement in symptoms : Table 2 shows the improvement in critical symptoms following four weeks of treatment with the Shengjin Decoction. Table 2 shows that of the patients, 76% (95% CI: 60–86%) reported improvement in cough symptoms, 68% (95% CI: 53–81%) showed improvement in sputum production, and 42% (95% CI: 28–57%) reported improvement in hemoptysis. Changes in lung function parameters: The changes in lung function parameters (FEV1 and FVC) are depicted in Table 3 . FEV1 increased by 0.25 liter on average (95% CI: 0.18–0.32), which is statistically significant (p < 0.001). Comparably, the average FVC change was 0.18 liter (95% CI: 0.12–0.24), which is likewise statistically significant (p < 0.001). Quality of life : The improvements in quality-of-life scores, as measured by the EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaires, are summarized in Table 4 . The EORTC QLQ-C30 Global Health Status score showed a statistically significant improvement (p < 0.001) with a mean change of 12.5 points (95% CI: 8.2–16.8). In addition, a statistically significant decrease in the burden of symptoms was seen, with the mean change in the EORTC QLQ-LC13 Lung Cancer Symptom Scale score being − 15.2 points (95% CI: -19.5 to -10.9) (p < 0.001). Secondary Outcome Measure: The frequencies and percentages of adverse events observed during the study are presented in Table 5 . The two most often reported side effects were infrequent diarrhea (16%, 95% CI: 7–29%) and mild nausea (20%, 95% CI: 10–34%). A small percentage of patients also had headaches (4%, 95% CI: 0–13%) and rashes (6%, 95% CI: 1–16%). Nonetheless, throughout the trial period, no significant adverse events were recorded. Table 1 Baseline Characteristics of Study Participants Characteristic Value Age, mean ± SD 62 ± 10 years Gender, n (%) Male 30 (60%) Female 20 (40%) Smoking status, n (%) Current smoker 18 (36%) Former smoker 12 (24%) Never smoker 20 (40%) Table 2 Improvement in Major Symptoms after 4 weeks of Shengjin Decoction Treatment Symptom Percentage of Patients with Improvement (95% CI) Cough 76% (60–86%) Sputum Production 68% (53–81%) Hemoptysis 42% (28–57%) Table 3 Changes in Lung Function Parameters after Shengjin Decoction Treatment Parameter Mean Change (95% CI) p-value FEV1 0.25 litre (0.18–0.32) < 0.001 FVC 0.18 litre (0.12–0.24) < 0.001 Table 4 Changes in Quality-of-Life Scores Quality of Life Measure Baseline Post-treatment Mean Change (95% CI) EORTC QLQ-C30 Global Health 52.3 64.8 12.5 (8.2, 16.8) * EORTC QLQ-LC13 Symptom Scale 48.7 33.5 -15.2 (-19.5, -10.9) * Table 5 Adverse Events Adverse Event n (%, 95% CI) Nausea 10 (20%, 10–34%) Diarrhea 8 (16%, 7–29%) Rash 3 (6%, 1–16%) Headache 2 (4%, 0–13%) 4 DISCUSSION The results presented in this open-label; single-arm observational trial raise the possibility of benefits for the traditional Chinese medicine formulation Fuzheng Shengjin Decoction in treating lung cancer. According to the study, patients who received the Fuzheng Shengjin Decoction as the recommended treatment improved some outcome measures, such as quality of life, lung function indices, and symptom relief. With recovery rates ranging from 42–76%, study participants saw notable improvements in symptoms like cough, sputum output, and hemoptysis. These results provide hope because managing symptoms is an essential part of treating lung cancer and has a direct effect on the quality of life of patients. The improvements in cough and sputum output that have been seen are in line with the results of earlier research by ( 13 ), which documented a substantial decrease in the scores for sputum and cough after non-small cell lung cancer patients received a Chinese herbal combination called Bu-Fei Decoction. The study also showed improvements in lung function measurements, including FEV1 (mean increase of 0.25 liter) and FVC (mean increase of 0.18 liter). Based on these objective measurements, the Fuzheng Shengjin Decoction might benefit respiratory function, which is frequently impaired in lung cancer patients. Complementary results were documented in a randomized controlled study by ( 14 ) When patients with advanced non-small cell lung cancer had improved lung function metrics and longer progression-free survival when a Chinese herbal compound was added to conventional treatment. Significant improvements were observed on the EORTC QLQ-C30 Global Health Status (mean gain of 12.5 points) and the EORTC QLQ-LC13 Lung Cancer Symptom Scale (mean decrease of 15.2 points) as a result of the quality-of-life assessments. These results demonstrate how the Fuzheng Shengjin Decoction may improve general health and lessen lung cancer patients' symptom burden. A study ( 15 ) found that the use of Chinese herbal medicines in conjunction with conventional treatments greatly enhanced the quality of life for patients with lung cancer when compared to the use of traditional therapies alone. Amazingly, the trial subjects tolerated the Fuzheng Shengjin Decoction well; only moderate side effects, including occasional diarrhea and nausea, were reported. This good safety profile is especially crucial for lung cancer patients whose general health may already be damaged and who may already be experiencing adverse effects from their treatment. The safety results align with other research assessing the application of Chinese herbal medicines in the treatment of lung cancer, including the study conducted by ( 16 , 17 ), a study found that patients with advanced non-small cell lung cancer who used a Chinese herbal recipe (Compound Kushen Injection) experienced reduced adverse event rates. Even while this study's results are positive, it's essential to recognize that its single-arm, open-label design and lack of a control group have disadvantages. These elements could impose bias and restrict how far the results can be applied. Furthermore, the research was carried out at our hospital, which can limit the results' generalizability to different contexts and demographics. The results of this study may offer insightful information to patients and medical professionals looking for integrative and complementary methods to enhance the quality of life and treatment outcomes for lung cancer. To assess the safety and effectiveness of Fuzheng Shengjin Decoction in lung cancer treatment, more extensive and carefully planned randomized controlled trials are necessary. To determine the robustness of the reported benefits and identify prospective subgroups who may benefit most from this complementary therapy, these studies should involve more diverse patient populations, extended follow-up periods, and adequate control groups. 5 CONCLUSION This observational study offers early evidence that individuals with lung cancer may benefit from the traditional Chinese medicine formulation, Fuzheng Shengjin Decoction, as a supplemental treatment. The results show that This observational study offers early evidence that individuals with lung cancer may benefit from the traditional Chinese medicine formulation known as Fuzheng Shengjin Decoction as a supplemental treatment. The results show that the Fuzheng Shengjin Decoction has a good safety profile and may help with symptoms, lung function, and quality of life. Nonetheless, it is important to take into account the study's shortcomings, which include the open-label, single-arm design and the absence of a control group. Larger, more carefully thought-out randomized controlled trials are needed to verify the Fuzheng Shengjin Decoction's safety and effectiveness in the treatment of lung cancer. Complementary therapies that are supported by research and incorporated into all-encompassing lung cancer treatment plans may provide more therapeutic options and enhance patient outcomes Declarations Ethical Approved number Ethical Considerations: All procedures in the study adhered to the highest standards of clinical research ethics. We got Approval from the institutional review board, and the ethics committee approval number is (CZX2024-LW-024.1) et. Conflict Of Interest There is no conflict of Interest in this paper Funding: There is no source of funding for this study. Author Contribution Author ContributionBoning Liu;Conceptualization, Methodology: Data Curation. InvestigationJian Liu; Resources, Conceptualization, Methodology: Data Curation. Investigation, Formal Analysis References Li C, Lei S, Ding L, Xu Y, Wu X, Wang H et al (2023) Global burden and trends of lung cancer incidence and mortality. Chin Med J 136(13):1583–1590 Siegel RL, Miller KD, Fuchs HE, Jemal A, Cancer statistics (2022) CA: a cancer journal for clinicians. 2022;72(1) Hani U, Wahab S, Siddiqua A, Osmani RAM, Rahmathulla M (2021) A comprehensive review of current perspectives on novel drug delivery systems and approaches for lung cancer management. J Pharm Innov. :1–24 Frenkel M, Slater R, Shapiro K, Sierpina V (2018) Complementary and integrative medicine in lung cancer: questions and challenges. J Altern Complement Med 24(9–10):862–871 Xu W, Yang G, Xu Y, Zhang Q, Fu Q, Yu J et al (2014) The possibility of traditional Chinese medicine as maintenance therapy for advanced nonsmall cell lung cancer. Evidence-Based Complement Altern Med. ;2014 Matos LC, Machado JP, Monteiro FJ, Greten HJ (eds) (2021) Understanding traditional Chinese medicine therapeutics: an overview of the basics and clinical applications. MDPI, Healthcare Guo H, Liu JX, Li H, Baak JP (2017) In metastatic non-small cell lung cancer platinum-based treated patients, herbal treatment improves the quality of life. A prospective randomized controlled clinical trial. Front Pharmacol 8:454 Zhang Y, Lou Y, Wang J, Yu C, Shen W (2021) Research status and molecular mechanism of the traditional Chinese medicine and antitumor therapy combined strategy based on tumor microenvironment. Front Immunol 11:609705 Pan H-D, Xiao Y, Wang W-Y, Ren R-T, Leung EL-H, Liu L (2019) Traditional Chinese medicine as a treatment for rheumatoid arthritis: From empirical practice to evidence-based therapy. Engineering 5(5):895–906 Nguyen THP, Kumar VB, Ponnusamy VK, Mai TTT, Nhat PT, Brindhadevi K et al (2021) Phytochemicals intended for anticancer effects at preclinical levels to clinical practice: Assessment of formulations at nanoscale for non-small cell lung cancer (NSCLC) therapy. Process Biochem 104:55–75 Yang J, Zhu X, Yuan P, Liu J, Wang B, Wang G (2020) Efficacy of traditional Chinese Medicine combined with chemotherapy in patients with non-small cell lung cancer (NSCLC): a meta-analysis of randomized clinical trials. Support Care Cancer 28:3571–3579 Qi F, Zhao L, Zhou A, Zhang B, Li A, Wang Z et al (2015) The advantages of using traditional Chinese medicine as an adjunctive therapy in the whole course of cancer treatment instead of only the terminal stage of cancer. Biosci Trends 9(1):16–34 He X-R, Han S-Y, Li X-H, Zheng W-X, Pang L-N, Jiang S-T et al (2017) Chinese medicine Bu-Fei decoction attenuates epithelial-mesenchymal transition of non-small cell lung cancer by inhibiting transforming growth factor β1 signaling pathway in vitro and in vivo. J Ethnopharmacol 204:45–57 Wang G, Liu B, Cao Y, Du Y, Zhang H, Luo Q et al (2014) Effects of two Chinese herbal formulae for treating moderate to severe stable chronic obstructive pulmonary disease: a multicenter, double-blind, randomized controlled trial. PLoS ONE 9(8):e103168 Wang C-Y, Huang H-S, Su Y-C, Tu C-Y, Hsia T-C, Huang S-T (2018) Conventional treatment integrated with Chinese herbal medicine improves the survival rate of patients with advanced non-small cell lung cancer. Complement Ther Med 40:29–36 Yin S-Y, Wei W-C, Jian F-Y, Yang N-S (2013) Therapeutic applications of herbal medicines for cancer patients. Evidence-Based Complementary and Alternative Medicine. ;2013 Zhongquan Z, Hehe L, Ying J (2016) Effect of compound Kushen injection on T-cell subgroups and natural killer cells in patients with locally advanced non-small-cell lung cancer treated with concomitant radiochemotherapy. J Tradit Chin Med 36(1):14–18 Additional Declarations No competing interests reported. Supplementary Files floatimage1.jpeg Graphical Abstract Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5354240","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":376973104,"identity":"dc635a96-a71d-4fc6-8b2d-ce10ec389ce5","order_by":0,"name":"Boning Liu","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAArElEQVRIiWNgGAWjYBACAwkg8bCBQY6Nvf0ACVoSGxiM+XjOJJCmJXGehIMBcVrMpZsff0jccSe9TYIhgeFHxTbCWiznHDMwSDzzLLdNuvEAY8+Z20Q47EYOQ0Ji2+HcNpkDCcyMbURqOQDUks4mkWBAtBbGBqCWBBK03DlmzJB45rBhGzCQDxLnl9vAEPu447C8fHv7wQc/KojQggIOkKh+FIyCUTAKRgEuAAC+xkFAYxoV8AAAAABJRU5ErkJggg==","orcid":"","institution":"Internal medicine of traditional Chinese medicine, Cangzhou Hospital of integrated TCM-WM·Hebei","correspondingAuthor":true,"prefix":"","firstName":"Boning","middleName":"","lastName":"Liu","suffix":""},{"id":376973105,"identity":"bd21b459-78eb-4054-97b2-dec897c3949d","order_by":1,"name":"Jian Liu","email":"","orcid":"","institution":"Hospital of integrated TCM-WM·Hebei","correspondingAuthor":false,"prefix":"","firstName":"Jian","middleName":"","lastName":"Liu","suffix":""}],"badges":[],"createdAt":"2024-10-29 12:23:11","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5354240/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5354240/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":70887535,"identity":"abffe6b3-4ef7-434e-b640-baa5bef0544b","added_by":"auto","created_at":"2024-12-09 02:31:34","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":348858,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5354240/v1/8bd7a845-585f-4747-9d67-6678494fb978.pdf"},{"id":70202875,"identity":"56255e51-7af1-46fb-9982-83f48087ccad","added_by":"auto","created_at":"2024-11-29 12:53:55","extension":"jpeg","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":284491,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eGraphical Abstract\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-5354240/v1/c66330fac827ccb30e721494.jpeg"}],"financialInterests":"No competing interests reported.","formattedTitle":"Evaluating the Efficacy of Fuzheng Shengjin Decoction in Lung Cancer Treatment: A Clinical Study","fulltext":[{"header":"1 INTRODUCTION","content":"\u003cp\u003eAbout 1.8\u0026nbsp;million people die each year from lung cancer, making it the top cancer killer globally. (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). The prognosis for lung cancer patients continues to be wrong, with a 5-year survival rate of only 19%, despite breakthroughs in early identification and treatment options. (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). The severe nature of the disease, the prevalence of co-morbidities, and the side effects of traditional treatments like radiation and chemotherapy make lung cancer management a formidable challenge (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). CAM therapies, or complementary and alternative medicine, to augment standard lung cancer treatments have grown in popularity in recent years (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). As a supplemental treatment for many cancers, including lung cancer, traditional Chinese medicine (TCM) has recently attracted a lot of interest due to its long history of use and holistic approach (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Traditional Chinese Medicine (TCM) uses an original theoretical framework with several modalities to restore internal harmony and balance, including treatment, herbal medicine, Qigong, and more (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). In lung cancer, TCM practitioners aim to alleviate symptoms, enhance the body's resistance to disease, and improve overall quality of life (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). Herbal medicine, a cornerstone of TCM, has been widely studied for its potential benefits in lung cancer management (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Herbal remedies made in China may include several components, all thought to have complementary therapeutic properties. As a reflection of TCM's emphasis on individualization, these formulations are frequently customized for each patient according to their particular combination of symptoms and disease patterns (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). Several studies have investigated the use of Chinese herbal medicines in lung cancer, either as stand-alone therapies or in combination with conventional treatments (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). A systematic review by (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) analyzed the benefits and risks of combining traditional Chinese medicine with standard cancer treatments for advanced non-small cell lung cancer (NSCLC). Results showed that compared to standard therapies alone, combining chemotherapy or radiation with Chinese herbal remedies increased tumor response rates, decreased cancer-related symptoms, and improved quality of life. The research included in the review was randomized controlled trials (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). The Fuzheng Shengjin Decoction is a Chinese herbal composition that has demonstrated potential for treating lung cancer. Traditional Chinese Medicine has long recognized this decoction benefits for various respiratory ailments, including improving lung health, increasing phlegm clearance, and fortifying the immune system. Astragalus, Platycodon, Bupleurum, Ophiopogon, Ginseng, and many more herbs make up the intricate composition known as the Fuzheng Shengjin Decoction. It is thought that the therapeutic effects of the decoction are due in part to the different mechanisms of action exhibited by each ingredient. Clinical trials are necessary to assess the safety and effectiveness of the Fuzheng Shengjin Decoction in human patients, as preclinical research has shown encouraging results about its potential effectiveness in lung cancer. Unfortunately, studies examining the efficacy of the Fuzheng Shengjin Decoction in the treatment of lung cancer have been few and far between. The Fuzheng Shengjin Decoction and other Chinese herbal formulations are gaining popularity as potential lung cancer treatments. Still, a more rigorous evaluation of their safety and effectiveness requires well-designed clinical trials. This research intends to fill that void by examining the Fuzheng Shengjin Decoction\u0026rsquo;s effectiveness in treating lung cancer in a single-arm, open-label, observational trial. Several end variables, such as changes in lung function indices, quality of life, and symptom improvement, will be evaluated in the trial to determine the effect of the Fuzheng Shengjin Decoction. Its safety profile will be meticulously recorded and monitored to guarantee further the decoctions' appropriateness for treatment in lung cancer patients. In conducting this research, we aim to add to the increasing data suggesting that Chinese herbal formulations like Fuzheng Shengjin Decoction may function in lung cancer treatment.\u003c/p\u003e"},{"header":"2 MATERIALS AND METHODS","content":"\u003cp\u003e\u003cb\u003eStudy design: this was a single-arm, open-label, observational study conducted at our hospital. Inclusion and exclusion criteria\u003c/b\u003e: participation in the survey was open to patients with a lung cancer diagnosis. The following items were considered for inclusion: participants had to meet the following criteria: they had to be between the ages of 18 and 75, have a current diagnosis of lung cancer, be prepared to take part in the study, and not use any antibiotics or Chinese herbal remedies while it was under. These were the things that were not considered: symptoms of sudden breathing problems not caused by cancer of the lungs, every day, people with asthma must take medication, extensive lung disease, including bronchiectasis and severe interstitial lesions, acute immunodeficiency syndrome, severe primary immunodeficiency disease, congenital heart disease, congenital respiratory abnormalities, or abnormal lung development women who are expecting a child. Intervention: participants received the fuzheng shengjin decoction according to the following treatment procedure: fuzheng shengjin decoction: the following herbs and spices are included: astragalus (40g), codonopsis (12g), platycodon (12g), bupleurum (8g), ophiopogon (12g), almond (12g), honey (15g), scrophulariae (30g), salvitis miltiorrhiza (15g), yujin (15g), wolfberry (30g), raw rehmannia (15g), rhizoma atractylodis macrocephalae (12g), adenophora stricta (15g), aspartame (12g), hedyotis diffusa (30g). one dose was administered orally twice daily, and the treatment was 4 weeks. Modifications: 12-gram Spinelli, 12-gram poria, 12-gram orange peel, and 8-gram ginger will help a white cough with white sputum. Mix 15 grams of trichosanthes and 12 grams of baicalensis for a yellow phlegm cough. Mix 15g of white flower herb for loose stool with 15g of jade bamboo, 15g of sporculariae, 15g of radix ophiopogon, and 15g of pomegranate peel. Mix 12g of acid jujube kernel with 10g of fried radix polygonae for insomnia. Mix 12g of orange peel with 12g of chicken gold and 15g of magnolia officinalis for abdominal distension. \u0026bull; for constipation, mix 12g of sesame seed with 10g of rhubarb. Mix 15g of notoginseng powder with 15g of zephyr for hemoptysis. Outcome measures: the primary outcome measures were relief from symptoms (cough, sputum, hemoptysis), alterations to lung function measures (fev1, fvc), using a validated questionnaire, such as the eortc qlq-c30 or eortc qlq-lc13, one can measure quality of life. The secondary outcome measures were adverse events during the trial; investigators tracked and documented the incidence of adverse events, such as rash, nausea, vomiting, diarrhea, and others. Ethical considerations: all procedures in the study adhered to the highest standards of clinical research ethics. We got approval from the institutional review board, and the ethics committee's approval number is (czx2024-lw-024.1). Before engaging any participant, we made sure to get their informed consent. Statistical analysis: analysis of data: the study participants' demographic and clinical information, as well as their age and gender, were summarized using descriptive statistics. Categorical data were represented as frequencies and percentages, while continuous variables were shown as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation (SD).\u003c/p\u003e"},{"header":"3 RESULTS","content":"\u003cp\u003ePossible Outcomes: 50 patients were included in the research; their average age was 62, and 60% were men. Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e provides an overview of the study participants' baseline characteristics. Primary Outcome Measures: \u003cb\u003eImprovement in symptoms\u003c/b\u003e: Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e shows the improvement in critical symptoms following four weeks of treatment with the Shengjin Decoction. Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e shows that of the patients, 76% (95% CI: 60\u0026ndash;86%) reported improvement in cough symptoms, 68% (95% CI: 53\u0026ndash;81%) showed improvement in sputum production, and 42% (95% CI: 28\u0026ndash;57%) reported improvement in hemoptysis. Changes in lung function parameters: The changes in lung function parameters (FEV1 and FVC) are depicted in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. FEV1 increased by 0.25 liter on average (95% CI: 0.18\u0026ndash;0.32), which is statistically significant (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Comparably, the average FVC change was 0.18 liter (95% CI: 0.12\u0026ndash;0.24), which is likewise statistically significant (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). \u003cb\u003eQuality of life\u003c/b\u003e: The improvements in quality-of-life scores, as measured by the EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaires, are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e. The EORTC QLQ-C30 Global Health Status score showed a statistically significant improvement (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) with a mean change of 12.5 points (95% CI: 8.2\u0026ndash;16.8). In addition, a statistically significant decrease in the burden of symptoms was seen, with the mean change in the EORTC QLQ-LC13 Lung Cancer Symptom Scale score being \u0026minus;\u0026thinsp;15.2 points (95% CI: -19.5 to -10.9) (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Secondary Outcome Measure: The frequencies and percentages of adverse events observed during the study are presented in Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e. The two most often reported side effects were infrequent diarrhea (16%, 95% CI: 7\u0026ndash;29%) and mild nausea (20%, 95% CI: 10\u0026ndash;34%). A small percentage of patients also had headaches (4%, 95% CI: 0\u0026ndash;13%) and rashes (6%, 95% CI: 1\u0026ndash;16%). Nonetheless, throughout the trial period, no significant adverse events were recorded.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline Characteristics of Study Participants\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eValue\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge, mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e62\u0026thinsp;\u0026plusmn;\u0026thinsp;10 years\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGender, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e30 (60%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20 (40%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSmoking status, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCurrent smoker\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18 (36%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFormer smoker\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12 (24%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNever smoker\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20 (40%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eImprovement in Major Symptoms after 4 weeks of Shengjin Decoction Treatment\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSymptom\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePercentage of Patients with Improvement (95% CI)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCough\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e76% (60\u0026ndash;86%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSputum Production\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e68% (53\u0026ndash;81%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHemoptysis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e42% (28\u0026ndash;57%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eChanges in Lung Function Parameters after Shengjin Decoction Treatment\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eParameter\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean Change (95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFEV1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.25 litre (0.18\u0026ndash;0.32)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFVC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.18 litre (0.12\u0026ndash;0.24)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eChanges in Quality-of-Life Scores\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eQuality of Life Measure\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eBaseline\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePost-treatment\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMean Change (95% CI)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEORTC QLQ-C30 Global Health\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e52.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e64.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e12.5 (8.2, 16.8) *\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEORTC QLQ-LC13 Symptom Scale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e48.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e33.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e-15.2 (-19.5, -10.9) *\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eAdverse Events\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAdverse Event\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003en (%, 95% CI)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNausea\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (20%, 10\u0026ndash;34%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiarrhea\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (16%, 7\u0026ndash;29%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRash\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (6%, 1\u0026ndash;16%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHeadache\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (4%, 0\u0026ndash;13%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e"},{"header":"4 DISCUSSION","content":"\u003cp\u003eThe results presented in this open-label; single-arm observational trial raise the possibility of benefits for the traditional Chinese medicine formulation Fuzheng Shengjin Decoction in treating lung cancer. According to the study, patients who received the Fuzheng Shengjin Decoction as the recommended treatment improved some outcome measures, such as quality of life, lung function indices, and symptom relief. With recovery rates ranging from 42\u0026ndash;76%, study participants saw notable improvements in symptoms like cough, sputum output, and hemoptysis. These results provide hope because managing symptoms is an essential part of treating lung cancer and has a direct effect on the quality of life of patients. The improvements in cough and sputum output that have been seen are in line with the results of earlier research by (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e), which documented a substantial decrease in the scores for sputum and cough after non-small cell lung cancer patients received a Chinese herbal combination called Bu-Fei Decoction. The study also showed improvements in lung function measurements, including FEV1 (mean increase of 0.25 liter) and FVC (mean increase of 0.18 liter). Based on these objective measurements, the Fuzheng Shengjin Decoction might benefit respiratory function, which is frequently impaired in lung cancer patients. Complementary results were documented in a randomized controlled study by (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e) When patients with advanced non-small cell lung cancer had improved lung function metrics and longer progression-free survival when a Chinese herbal compound was added to conventional treatment. Significant improvements were observed on the EORTC QLQ-C30 Global Health Status (mean gain of 12.5 points) and the EORTC QLQ-LC13 Lung Cancer Symptom Scale (mean decrease of 15.2 points) as a result of the quality-of-life assessments. These results demonstrate how the Fuzheng Shengjin Decoction may improve general health and lessen lung cancer patients' symptom burden. A study (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e) found that the use of Chinese herbal medicines in conjunction with conventional treatments greatly enhanced the quality of life for patients with lung cancer when compared to the use of traditional therapies alone. Amazingly, the trial subjects tolerated the Fuzheng Shengjin Decoction well; only moderate side effects, including occasional diarrhea and nausea, were reported. This good safety profile is especially crucial for lung cancer patients whose general health may already be damaged and who may already be experiencing adverse effects from their treatment. The safety results align with other research assessing the application of Chinese herbal medicines in the treatment of lung cancer, including the study conducted by (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e), a study found that patients with advanced non-small cell lung cancer who used a Chinese herbal recipe (Compound Kushen Injection) experienced reduced adverse event rates. Even while this study's results are positive, it's essential to recognize that its single-arm, open-label design and lack of a control group have disadvantages. These elements could impose bias and restrict how far the results can be applied. Furthermore, the research was carried out at our hospital, which can limit the results' generalizability to different contexts and demographics. The results of this study may offer insightful information to patients and medical professionals looking for integrative and complementary methods to enhance the quality of life and treatment outcomes for lung cancer. To assess the safety and effectiveness of Fuzheng Shengjin Decoction in lung cancer treatment, more extensive and carefully planned randomized controlled trials are necessary. To determine the robustness of the reported benefits and identify prospective subgroups who may benefit most from this complementary therapy, these studies should involve more diverse patient populations, extended follow-up periods, and adequate control groups.\u003c/p\u003e"},{"header":"5 CONCLUSION","content":"\u003cp\u003eThis observational study offers early evidence that individuals with lung cancer may benefit from the traditional Chinese medicine formulation, Fuzheng Shengjin Decoction, as a supplemental treatment. The results show that This observational study offers early evidence that individuals with lung cancer may benefit from the traditional Chinese medicine formulation known as Fuzheng Shengjin Decoction as a supplemental treatment. The results show that the Fuzheng Shengjin Decoction has a good safety profile and may help with symptoms, lung function, and quality of life. Nonetheless, it is important to take into account the study's shortcomings, which include the open-label, single-arm design and the absence of a control group. Larger, more carefully thought-out randomized controlled trials are needed to verify the Fuzheng Shengjin Decoction's safety and effectiveness in the treatment of lung cancer. Complementary therapies that are supported by research and incorporated into all-encompassing lung cancer treatment plans may provide more therapeutic options and enhance patient outcomes\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003ch2\u003eEthical Approved number\u003c/h2\u003e \u003cp\u003eEthical Considerations: All procedures in the study adhered to the highest standards of clinical research ethics. We got Approval from the institutional review board, and the ethics committee approval number is (CZX2024-LW-024.1) et.\u003c/p\u003e \u003c/p\u003e\u003cp\u003e \u003ch2\u003eConflict Of Interest\u003c/h2\u003e \u003cp\u003eThere is no conflict of Interest in this paper\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eFunding:\u003c/h2\u003e \u003cp\u003eThere is no source of funding for this study.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eAuthor ContributionBoning Liu;Conceptualization, Methodology: Data Curation. InvestigationJian Liu; Resources, Conceptualization, Methodology: Data Curation. Investigation, Formal Analysis\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eLi C, Lei S, Ding L, Xu Y, Wu X, Wang H et al (2023) Global burden and trends of lung cancer incidence and mortality. Chin Med J 136(13):1583\u0026ndash;1590\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSiegel RL, Miller KD, Fuchs HE, Jemal A, Cancer statistics (2022) CA: a cancer journal for clinicians. 2022;72(1)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHani U, Wahab S, Siddiqua A, Osmani RAM, Rahmathulla M (2021) A comprehensive review of current perspectives on novel drug delivery systems and approaches for lung cancer management. J Pharm Innov. :1\u0026ndash;24\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFrenkel M, Slater R, Shapiro K, Sierpina V (2018) Complementary and integrative medicine in lung cancer: questions and challenges. J Altern Complement Med 24(9\u0026ndash;10):862\u0026ndash;871\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eXu W, Yang G, Xu Y, Zhang Q, Fu Q, Yu J et al (2014) The possibility of traditional Chinese medicine as maintenance therapy for advanced nonsmall cell lung cancer. Evidence-Based Complement Altern Med. ;2014\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMatos LC, Machado JP, Monteiro FJ, Greten HJ (eds) (2021) Understanding traditional Chinese medicine therapeutics: an overview of the basics and clinical applications. MDPI, Healthcare\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGuo H, Liu JX, Li H, Baak JP (2017) In metastatic non-small cell lung cancer platinum-based treated patients, herbal treatment improves the quality of life. A prospective randomized controlled clinical trial. Front Pharmacol 8:454\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhang Y, Lou Y, Wang J, Yu C, Shen W (2021) Research status and molecular mechanism of the traditional Chinese medicine and antitumor therapy combined strategy based on tumor microenvironment. Front Immunol 11:609705\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePan H-D, Xiao Y, Wang W-Y, Ren R-T, Leung EL-H, Liu L (2019) Traditional Chinese medicine as a treatment for rheumatoid arthritis: From empirical practice to evidence-based therapy. Engineering 5(5):895\u0026ndash;906\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNguyen THP, Kumar VB, Ponnusamy VK, Mai TTT, Nhat PT, Brindhadevi K et al (2021) Phytochemicals intended for anticancer effects at preclinical levels to clinical practice: Assessment of formulations at nanoscale for non-small cell lung cancer (NSCLC) therapy. Process Biochem 104:55\u0026ndash;75\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYang J, Zhu X, Yuan P, Liu J, Wang B, Wang G (2020) Efficacy of traditional Chinese Medicine combined with chemotherapy in patients with non-small cell lung cancer (NSCLC): a meta-analysis of randomized clinical trials. 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J Ethnopharmacol 204:45\u0026ndash;57\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang G, Liu B, Cao Y, Du Y, Zhang H, Luo Q et al (2014) Effects of two Chinese herbal formulae for treating moderate to severe stable chronic obstructive pulmonary disease: a multicenter, double-blind, randomized controlled trial. PLoS ONE 9(8):e103168\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang C-Y, Huang H-S, Su Y-C, Tu C-Y, Hsia T-C, Huang S-T (2018) Conventional treatment integrated with Chinese herbal medicine improves the survival rate of patients with advanced non-small cell lung cancer. Complement Ther Med 40:29\u0026ndash;36\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYin S-Y, Wei W-C, Jian F-Y, Yang N-S (2013) Therapeutic applications of herbal medicines for cancer patients. Evidence-Based Complementary and Alternative Medicine. ;2013\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhongquan Z, Hehe L, Ying J (2016) Effect of compound Kushen injection on T-cell subgroups and natural killer cells in patients with locally advanced non-small-cell lung cancer treated with concomitant radiochemotherapy. J Tradit Chin Med 36(1):14\u0026ndash;18\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Lung cancer, traditional Chinese medicine, Fuzheng Shengjin Decoction, complementary treatment, symptom improvement, lung function, quality of life","lastPublishedDoi":"10.21203/rs.3.rs-5354240/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5354240/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Lung cancer is a leading cause of cancer-related death worldwide, with growing interest in complementary and alternative medicine (CAM) approaches to improve patient outcomes. This study aimed to evaluate the safety and efficacy of the traditional Chinese medicine (TCM) formulation, Fuzheng Shengjin Decoction, in lung cancer treatment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: Fifty patients diagnosed with lung cancer received Fuzheng Shengjin Decoction. Primary outcomes included changes in lung function indices, symptom improvement, and quality of life, assessed via validated questionnaires (EORTC QLQ-C30 and QLQ-LC13). Symptom improvements in hemoptysis (42%), sputum production (68%), and cough (75%) were recorded. Lung function showed a mean increase of 0.25 liters in FEV1 and 0.18 liters in FVC. Quality of life improved, with a mean gain of 12.5 points in the EORTC QLQ-C30 Global Health Status and a mean decrease of 15.2 points in the EORTC QLQ-LC13 Lung Cancer Symptom Scale.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: The decoction was well tolerated, with mild side effects such as diarrhea (16%) and nausea (20%) being the most common.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e: This observational study suggests that Fuzheng Shengjin Decoction may be a promising complementary treatment for lung cancer, potentially improving symptoms, lung function, and quality of life. However, larger randomized controlled trials are necessary to confirm these findings\u003c/p\u003e","manuscriptTitle":"Evaluating the Efficacy of Fuzheng Shengjin Decoction in Lung Cancer Treatment: A Clinical Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-11-29 12:53:34","doi":"10.21203/rs.3.rs-5354240/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"8daa2951-e7b2-4ff5-abaf-ea8cccf8589e","owner":[],"postedDate":"November 29th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-12-09T02:23:25+00:00","versionOfRecord":[],"versionCreatedAt":"2024-11-29 12:53:34","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5354240","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5354240","identity":"rs-5354240","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}